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TN KY CARES/ HIV/AIDS NEWS
WELCOME TO TN KY CARES / HIV/AIDS NEWS. WE WILL BE POSTING NEWS AND ISSUES CONCERNING HIV/AIDS: THIS SITE IS OWNED AND COPYRIGHTED BY TN KY CARES 2000 / PRESENT
TN KY CARES / HIV/AIDS

DRUGS;ETC. -- TN_KY_CARES, 13:11:10 01/26/02 Sat

1. NUCLEOSIDE ANALOG REVERSE TRANSCRIPTASE INHIBITORS (NUKES)


DRUG
DAILY PILLS (Adults)
HOW TO TAKE & STORE
SIDE EFFECTS
NOTES
Abacavir (Ziagenョ) 2 (300 mg: 1, 2x/day) No food restrictions. Hypersensitivity reaction in 5% of patients
AZT (Retrovirョ) 6 (100 mg: 2, 3x/day) or

2 (300 mg: 1, 2x/day)
No food restrictions Anemia, nausea, vomiting, headache, fatigue, muscle aches, bone marrow toxicity Don't combine with d4T.
ddI (Videxョ) 4 (100 mg: 2, 2x/day or 4, 1x/day) Chew or dissolve in water; take on empty stomach; not within 1 hour of indinavir or 2 hours of ritonavir. Diarrhea, pancreatitis, adbominal pain, neuropathy, nausea & vomiting. Don't combine with ddC.
ddC (Hividョ) 3 (0.75 mg: 1, 3x/day) Take on an empty stomach. Don't take with antacids. Peripheral neuropathy, rash, mouth ulcers, sore throat, coughing. Don't combine with ddI.
d4T (Zeritョ) 2 (40 mg: 1, 2x/day) No food restrictions. Peripheral neuropathy, headache, chills & fever, diarrhea, nausea. Don't combine with AZT.
3TC (Epivirョ) 2 (150 mg: 1, 2x/day) No food restrictions. Nausea, vomiting, fatigue, headaches. Can reverse resistance to AZT.
Combivirョ 2 (150 mg 3TC + 300 mg AZT: 1, 2x/day) No food restrictions. See AZT and 3TC above. Combines AZT and 3TC in a single twice-daily pill.
Tenofovirョ 1 (300 mg: 1, 1x/day) Take with a meal. Take 2 hours before, or one hour after ddI. Mild side effects; some nausea, vomiting, loss of appetite.
Trizivirョ 2 (150 mg 3TC + 300 mg AZT + 300 mg abacavir: 1, 2x/day) No food restrictions. See AZT, 3TC and abacavir above. Combines AZT, 3TC and abacavir in a single twice-daily pill.






2. NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NNRTIs or NON-NUKES)


DRUG
DAILY PILLS (Adults)*
HOW TO TAKE & STORE
SIDE EFFECTS
NOTES
Nevirapine (Viramuneョ) 2 (200 mg: 1, 2x/day) No food restrictions. Skin rash, fever, headache, nausea. Serious interactions with many other drugs**
Delavirdine (Rescriptorョ) 12 (100 mg: 4, 3x/day) No food restrictions. Can be dissolved in water. Take one hour apart from ddI or antacids. Skin rash, nausea, diarrhea, vomiting, headache, fatigue.
Efavirenz (Sustivaョ) 3 (200 mg: 3, 1x/day) No food restrictions, but avoid a high-fat meal. Take before going to sleep. Rash, nausea, dizziness, diarrhea, headache and insomnia


**NNRTI's are metabolized by the liver, as are many other commonly used drugs. Drug interactions can cause large increases or decreases in the blood levels of drugs you are taking, leading to under-doses that are ineffective, or overdoses that can be fatal. Make sure your physician knows about all medications you are taking.

3. PROTEASE INHIBITORS


DRUG
DAILY PILLS (Adults)*
HOW TO TAKE & STORE
SIDE EFFECTS
NOTES
Amprenavir (Ageneraseョ) 16 (150 mg: 8, 2x/day) Take with or without food. Avoid high-fat foods. Don't take within 1 hour of antacids. Nausea, diarrhea, vomiting, rash, numbness around mouth, abdominal pain Serious interactions with many other drugs.**
Indinavir (Crixivanョ) 8 (400 mg: 2, every 8 hours, not just 3x/day) Take with lots of water, on empty stomach or with low-fat snack. Keep cool and dry. Headache, nausea, abdominal pain, kidney stones.
Lopinavir/ritonavir (Kaletraョ) 6 (133 mg lopinavir + 33 mg ritonavir: 3, 2x/day) Take with food. Keep at room temperature. Diarrhea, fatigue, nausea, headache
Nelfinavir (Viraceptョ) 9 (250 mg: 3, 3x/day) or 10 (5, 2x/day Take with meals or a snack. Diarrhea, nausea, gas, abdominal pain, weakness.
Ritonavir (Norvirョ) 12 (100 mg: 6, 2x/day) Take with a full meal. Keep refrigerated. Take 2 hours apart from ddI. Nausea, vomiting, diarrhea, tingling & numbness around the mouth.
Saquinavir soft gel (Fortovaseョ) 18 (200 mg: 6, 3x/day) Take with high-fat food. Refrigerate in hot climates. Minimal nausea, diarrhea, vomiting, headache, fatigue.


*These pill counts reflect the "normal" use of each drug. However, doctors are now combining antiviral medications in new ways. Doses of each drug may be higher or lower in these new combinations.

**Protease inhibitors are metabolized by the liver, as are many other commonly used drugs. Drug interactions can cause large increases or decreases in the blood levels of drugs you are taking, leading to under-doses that are ineffective, or overdoses that can be fatal. Make sure your physician knows about all medications you are taking.



--------------------------------------------------------------------------------

None of these drugs can kill the HIV virus, but each class slows down the multiplication of the virus (replication) in a particular way.


--------------------------------------------------------------------------------


1. REVERSE TRANSCRIPTASE INHIBITORS (NUKES)

The first anti-HIV drugs. They block reverse transcription (the creation of viral DNA from RNA) by providing "decoy" building blocks that interrupt the process. Most are nucleoside analogs; tenofovir is a nucleotide analog.


Year*
Generic Name
Trade Name
Also known as:
Manufacturer
1987 Zidovudine Retrovirョ AZT, ZDV GlaxoSmithKline
1991 Didanosine Videxョ ddI Bristol-Myers Squibb
1992 Zalcitabine Hividョ ddC, dideoxycytidine Roche
1994 Stavudine Zeritョ d4T Bristol-Myers Squibb
1995 Lamivudine Epivirョ 3TC GlaxoSmithKline
1997 Zidovudine/ Lamivudine Combivirョ Combines AZT and 3TC GlaxoSmithKline
1998 Abacavir Ziagenョ 1592U89 GlaxoSmithKline
2000 Zidovudine/Lamivudine/Abacavir Trizivirョ Combines AZT, 3TC, Abacavir GlaxoSmithKline
2001 Tenofovir Vireadョ bis-poc PMPA Gilead Sciences
Other nukes in human trials: Coviracilョ (FTC, emtricitabine) and DAPD by Triangle Pharmaceuticals, MIV-310 by Medivir.



--------------------------------------------------------------------------------


2. NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NNRTIs or NON-NUKES)

These also interrupt reverse transcription, by binding to the reverse transcriptase enzyme and restricting its activity.


Year*
Generic Name
Trade Name
Also known as:
Manufacturer
1996 Nevirapine Viramuneョ NVP, BI-RG-587 Boehringer Ingelheim
1997 Delavirdine Rescriptorョ DLV Agouron Pharmaceuticals
1998 Efavirenz Sustivaョ EFV, DMP-266 Bristol-Myers Squibb
Other NNRTI's in human trials: +/-Calanolide A by Sarawak MediChem Pharmaceuticals, Capravirine (AG1549) by Agouron Pharmaceuticals, DPC083 by Bristol-Myers Squibb, MIV-150 by Medivir and TMC120 and TMC125 by Tibotec Virco.



--------------------------------------------------------------------------------


3. PROTEASE INHIBITORS

Block the action of protease, an enzyme that cuts HIV protein chains into specific proteins needed to assemble a new copy of the virus.


Year*
Generic Name
Trade Name
Also Known As:
Manufacturer
1995 Saquinavir Inviraseョ SQV Roche
1996 Ritonavir Norvirョ RTV Abbott
1996 Indinavir Crixivanョ IDV Merck
1997 Nelfinavir Viraceptョ NFV Agouron
1997 Saquinavir Fortovaseョ SQV Roche
1999 Amprenavir Ageneraseョ APV, 141W94 GlaxoSmithKline
2000 Lopinavir Kaletraョ ABT-378/r Abbott
Other PIs in human trials: Atazanavirョ (BMS 232632) by Bristol-Myers Squibb, GW433908 by GlaxoSmithKline, L-756,423 by Merck, Mozenavir (DMP-450) by Triangle Pharmaceuticals, Tipranavirョ by Boehringer Ingelheim and TMC114 by Tibotec Virco.



--------------------------------------------------------------------------------


4. INTEGRASE INHIBITORS
Block the action of integrase, an enzyme that inserts the viral DNA into the infected cell's DNA strands. S-1360 by Shionogi Pharmaceuticals and GlaxoSmithKline is currently in Phase II human trials.


--------------------------------------------------------------------------------


5. ATTACHMENT AND FUSION INHIBITORS
Prevent the HIV virus from attaching to a cell. No fusion inhibitors have been approved yet. Several are in human trials: FP21399 by Fuji Pharmaceuticals, PRO 452 by Progenics Pharmaceuticals, Inc. (Phase I/II trials); SCH-C by Schering, Trimeris and Roche's T-20 (Pentafuside) (Phase III trials) and T-1249 (Phase I trials), and TNX-355 by Tanox.


--------------------------------------------------------------------------------


6. ANTISENSE DRUGS
These are a "mirror image" of part of the HIV genetic code that locks onto the virus to prevent it from functioning. One antisense drug, HGTV43 by Enzo Therapeutics, is in Phase I trials.


--------------------------------------------------------------------------------


7. IMMUNE STIMULATORS
Use the body's chemical messengers to stimulate the immune response. Interleukin 2 (Il-2, Aldesleukinョ, Proleukinョ) by Chiron Corporation is in Phase III trials, Multikine by Cel-Sci Corporation is in Phase I trials, and Reticulose by Advance Viral Research Corporation is in Phase III trials. Trials of Remuneョ, an inactivated virus preparation by Immune Response Corporation, were halted in 2001. HRG214 by Virionyx is in a Phase I trial, and resveratrol, a plant chemical, is also in a Phase I trial.


--------------------------------------------------------------------------------


*Year of approval in the USA.



REVERSE TRANSCRIPTASE INHIBITORS
These drugs stop HIV from multiplying by blocking the reverse transcriptase enzyme. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This step has to occur before HIV's genetic code gets combined with an infected cell's own genetic codes. There are two types of reverse transcriptase inhibitors:

Nucleoside analogs (often called "nukes"). These drugs mimic the building blocks used by reverse transcriptase to make copies of the HIV genetic material. These fake building blocks disrupt the copying.
Non-nucleoside reverse transcriptase inhibitors, called NNRTIs, physically prevent the reverse transcriptase enzyme from working.


--------------------------------------------------------------------------------


A. NUCLEOSIDE ANALOGS (NUKES)
Nucleoside analogs (nukes) in development include DAPD, FTC and MIV-310. Tenofovir is a closely-related nucleotide analog.

DAPD (amdoxovir) by Triangle Pharmaceuticals is being studied in twice-daily doses. It appears to be effective against HIV that is resistant to other nukes and against hepatitis B. DAPD is in Phase I/II trials.

Emtricitabine (Coviracilョ, formerly FTC) by Triangle Pharmaceuticals is closely related to the drug 3TC. FTC was much stronger than 3TC in the laboratory but is not stronger in humans. It is taken once a day and is in Phase III trials. Trials were halted in late 1999 due to a high rate of liver problems. It now appears these were not caused by emtricitabine. Development resumed in early 2002.



NUCLEOTIDE ANALOGS

Tenofovir (bis-poc PMPA, Vireadョ) by Gilead was approved by the FDA in October 2001. See fact sheet 428 for more information.



--------------------------------------------------------------------------------


B. NON-NUKES (NNRTIs)

Non-nucleoside reverse transcriptase inhibitors (NNRTIs) in development include Calanolide A, Capravirine, DPC083, Emivirine, MIV-150, TMC120 and TMC125.

(+)-Calanolide A by Sarawak MediChem Pharmaceuticals was derived from a rain forest plant. It can easily cross the blood-brain barrier, and seems to stay in the bloodstream for a long time. It is in Phase I human trials. There are no recent reports on its status.

Capravirine (AG1549, formerly S-1153) by Agouron Pharmaceuticals appears to be about 10 times stronger than nevirapine or delavirdine against wild type virus. HIV needs 2 or 3 mutations to develop resistance to capravirine, compared to just one mutation for current NNRTIs. The dose will probably be two 700 mg tablets twice a day. Development was put on hold due to toxicity in dogs. The hold has reportedly been lifted but no further development plans have yet been announced.

DPC083 by Bristol-Myers Squibb is closely related to Efavirenz (Sustivaョ). It has a very long half-life, so it will probably be dosed once a day. It can suppress HIV with some resistance to NNRTIs. It is in Phase I/II trials.

MIV-150 by Medivir and Chiron shows good results in the laboratory against HIV that is resistant to other NNRTIs. It takes a long time for HIV to develop resistance to MIV-150. Phase II trials are scheduled.

TMC120 and TMC125 by Tibotec Virco are active against some strains of HIV that are resistant to other NNRTIs. It takes longer for HIV to develop resistance to TMC120 or 125 than to the first NNRTI drugs. They are being studied in Phase II trials.



--------------------------------------------------------------------------------


DRUGS NO LONGER IN DEVELOPMENT
The following drugs are no longer being developed for use against HIV:

Nukes:

Adefovir dipivoxil (bis POM PMEA) by Gilead Sciences
dOTC (BCH-10652) by BioChem Pharma
FddA (Beta-fluoro-ddA, Lodenosineョ) by US Bioscience
GW420867X by GlaxoSmithKline
Lobucavir by Bristol-Myers Squibb
NNRTIs:

Atevirdine by Upjohn
Emivirine (Coactinon) by Triangle Pharmaceuticals
Loviride by Janssen Pharmaceuticals
HBY-097 by Hoechst-Bayer
PNU142721 by Pharmacia & Upjohn


--------------------------------------------------------------------------------

PROTEASE INHIBITORS
These drugs block the protease enzyme. When new viral particles break off from an infected cell, protease cuts long protein strands into the parts needed to assemble a mature virus. When protease is blocked, the new viral particles cannot mature. Protease inhibitors being tested in humans include Atazanavir, GW433908, L-756,423, Mozenavir (DMP-450), Tipranavir, and TMC114. Several firms are trying to develop a new type of protease inhibitor that will not be cross-resistant with existing drugs.

Atazanavir (BMS232632) by Bristol-Myers Squibb is as strong as nelfinavir. It has few side effects and doesn't raise cholesterol like many PIs, but can cause high levels of bilirubin. It is being tested as a once daily drug in Phase III trials.

GW433908 by GlaxoSmithKline is a "prodrug" form of amprenavir. A prodrug becomes active after it is broken down in the body. GW433908 will be just 2 tablets instead of the current 8 capsules, twice daily, and will not contain Vitamin E. See Fact Sheet 445 for more information on amprenavir. GW433908 is in Phase III trials.

L-756,423 by Merck is chemically similar to indinavir. However, it stays in the blood longer and should cause fewer kidney problems. L-756,423 is being studied in combination with indinavir. The dose being studied is 5 capsules once a day with food. There have been no recent reports on its status.

Mozenavir (DMP450) by Triangle Pharmaceuticals is a very potent protease inhibitor that appears to improve the activity of several other antiviral drugs. Unfortunately, it is cross-resistant with indinavir and ritonavir. It is not broken down by the same liver enzyme as other protease inhibitors, so it is expected to have fewer interactions with other drugs. Development is on hold due to heart irregularities.

Tipranavir (PNU-140690) by Boehringer Ingelheim is a new HIV protease inhibitor. It appears to work against HIV that is already resistant to other protease inhibitors. It is being studied in twice-daily dosing combined with ritonavir and is in Phase II trials. It seems to have a high rate of side effects including diarrhea, nausea and vomiting.

TMC114 by Tibotec Virco produces very rapid drops in viral load. It is in Phase I studies.




--------------------------------------------------------------------------------


Revised December 22, 2001



ATTACHMENT AND FUSION INHIBITORS
This is a new class of anti-HIV drugs. They are intended to protect cells from infection by HIV by preventing the virus from attaching to a new cell and breaking through the cell membrane. Researchers hope that these drugs can prevent infection of a cell by either free virus (in the blood) or by contact with an infected cell.

Because digestive acids break them down, most of these drugs are given by injections or intravenous infusion. Fusion inhibitors in human trials include FP21399, PRO 542, Schering C, T-20 (Pentafuside), T-1249 and TNX-355.

FP21399 by Fuji Pharmaceuticals was tested for safety in a Phase I trial as a single infusion or a series of 4 weekly 1-hour intravenous infusions. The drug produced viral load decreases and CD4+ cell increases. Side effects were minor, including blue-tinted urine and temporary blue marks on the skin. There have been no recent reports on its status.

PRO 542 by Progenics Pharmaceuticals is in Phase II trials. It blocks fusion by binding to a protein on the outside of the virus.

Schering C (SCH-C) by Schering Plough blocks the CCR5 receptor on CD4 cells. It is in Phase I studies. There is some concern about heart irregularities. Schering has other, related compounds in development.

T-20 (Pentafuside) by Trimeris and Roche is currently in Phase III trials. It can lower viral load even for patients who have already used many of the approved drugs. T-20 is injected twice daily.

T-1249 by Trimeris and Roche is a new fusion inhibitor drug. It is in Phase I/II trials. T-1249 is effective against HIV that is resistant to T-20. It stays in the body longer, so it might require just one injection a day or every other day.

TNX-355 by Tanox blocks the CD4 receptor. It is a genetically engineered drug, a "monoclonal antibody." It is in Phase I trials.




--------------------------------------------------------------------------------


INTEGRASE INHIBITORS
After HIV's genetic code is changed from a single strand to a double strand by the reverse transcriptase enzyme, it gets inserted (integrated) into the genetic code of the infected cell. Then the HIV genetic code gets "read", producing new viruses. Scientists hope that integration will be another point in the HIV life cycle that can be targeted by drugs.

S-1360 by Shionogi and GlaxoSmithKline is currently in Phase II trials.


--------------------------------------------------------------------------------


ZINC FINGER INHIBITORS
The inner core of HIV is called the nucleocapsid. It is held together by structures called "zinc fingers". Zinc finger inhibitors (or zinc ejectors) are drugs that can break apart these structures and prevent the virus from functioning.

Scientists believe that the nucleocapsid core cannot mutate very easily, so a drug that works against zinc fingers might be effective for a long time. Unfortunately, zinc fingers are not only used by the HIV virus. Drugs that attack them could have serious side effects.

One zinc finger inhibitor - azodicarbonamide (ADA) - has been tested in a Phase I/II trial.



--------------------------------------------------------------------------------


ANTISENSE DRUGS
These are a "mirror image" of part of the HIV genetic code. The drug locks onto the virus to prevent it from functioning. One antisense drug, HGTV43 by Enzo Therapeutics, is starting Phase II trials.


--------------------------------------------------------------------------------


DRUGS NO LONGER IN DEVELOPMENT

AMD3100 by AnorMed


--------------------------------------------------------------------------------


Revised December 22, 2001

IMMUNE STIMULATORS
We can think of most antiviral drugs as "offense", attacking the virus to slow down its multiplication. Another approach to treating HIV infection is "defense", strengthening the immune response of people who are infected. This Fact Sheet describes new immune stimulators being developed.


--------------------------------------------------------------------------------


CYTOKINES
Some of these treatments use the body's own chemical messengers (cytokines) to increase the immune system's response to HIV. Different cytokines carry different messages to cells of the immune system. Some cytokines tell a cell to start multiplying; others can tell a cell to self-destruct.

The best-known cytokine is interleukin-2 (IL-2, Aldesleukin, Proleukin) by Chiron Corporation. It is currently in Phase III trials.

Multikine by Cel-Sci Corporation, is a mixture of several different cytokines. It is in Phase I human trials.


--------------------------------------------------------------------------------


VACCINE-LIKE TREATMENT
Another approach to stimulating the immune system is similar to vaccination, except that it is used in people who are already infected with HIV. HRG214 by Virionyx is a genetically engineered group of antibodies to HIV. It is called a "passive immuno-therapeutic pharmaceutical." HRG 214 is in a Phase I trial.

HIV-1 Immunogen (Remune) by Immune Response Corporation includes all of the core proteins of HIV, in an inactive form. This stimluates the immune system to respond. The development of Remune has been long and difficult. Some Phase III trials were halted in 2001 when Pfizer withdrew from a joint development agreement. Remune's future is uncertain.


--------------------------------------------------------------------------------


OTHER IMMUNE STIMULATORS

Ampligen by Hemispherx Biopharma is supposed to activate some of the cell's own defenses against viruses. It is in Phase II and Phase III trials.

HE2000 by Hollis-Eden Pharmaceuticals is a new drug that works on an infected person's immune system. It is designed to stregthen the "humoral" immune response which is responsible for producing antibodies. HE2000 is being tested in Phase I/II trials.

Murabutide is under study by Dr. Georges Bahr in France. It uses fragments of bacteria to stimulate the overall immune response. Murabutide is given by injection. Phase I results, reported late in 2001, were promising.

Reticulose by Advanced Viral Research Corporation is a nucleic acid that stimulates the cell-killing arm of the immune system. It is administered as a subcutaneous (beneath the skin) injection. Early clinical trials showed that patients receiving Reticulose had increases in their CD4 and CD8 cells, weight increases, and fewer opportunistic infections than patients receiving placebo. No toxic side effects have been reported yet. Reticulose is in Phase III trials.

Cell Genesys has developed an AIDS gene therapy. CD4 and CD8 cells are collected from an HIV-infected patient. The cells are genetically modified to recognize and kill HIV-infected cells. They are multiplied, and then given back to the same patient. This AIDS therapy is given along with antiviral drugs, and is in Phase II trials.

Resveratrol is a chemical found in several plants and the skin of red grapes. It protects plants against pathogens and may have other immune-boosting properties. It is being studied in a Phase I trial in people with HIV.



--------------------------------------------------------------------------------


Revised December 22, 2001


[ Edit | View ]



DRUGS;ETC. -- No name, 13:12:51 01/26/02 Sat

WHAT IS ANTIVIRAL THERAPY?

Antiviral therapy means treating viral infections like HIV with drugs. The drugs slow down the growth of the virus. When the virus is slowed down, so is HIV disease. Because HIV is a retrovirus, these drugs are sometimes called antiretroviral therapy.



--------------------------------------------------------------------------------
WHAT IS THE HIV LIFE CYCLE?

There are several steps in the HIV life cycle. See Fact Sheet 415 for a diagram.

1. Free virus circulates in the bloodstream.
2. HIV attaches to a cell.
3. HIV empties its contents into the cell (infects the cell).
4. The HIV genetic code (RNA) is changed into DNA by the reverse transcriptase enzyme.
5. The HIV DNA is built into the infected cell's DNA by the integrase enzyme.
6. When the infected cell reproduces, it activates the HIV DNA, which makes the raw material for new HIV viruses.
7. Packets of material for a new virus come together.
8. The immature virus pushes out of the infected cell in a process called "budding."
9. The immature virus breaks free of the infected cell.
10. The new virus matures: raw materials are cut by the protease enzyme and assembled into a functioning virus.



--------------------------------------------------------------------------------


WHAT ARE THE ANTIVIRAL DRUGS?

Each type, or "class", of antiviral drugs attacks HIV in a different way. The first class of anti-HIV drugs was the nucleoside reverse transcriptase inhibitors, also called "nukes". These drugs work by blocking Step 4, where the HIV genetic material is converted from RNA into DNA. Approved drugs in this class include:

AZT (ZDV, zidovudine, Retrovirョ)
ddI (didanosine, Videxョ)
ddC (zalcitabine, Hividョ)
d4T (stavudine, Zeritョ)
3TC (lamivudine, Epivirョ)
Abacavir (Ziagenョ)
Tenofovir (Vireadョ)
Combivirョ (AZT/3TC combination)
Trizivirョ (AZT/3TC/Abacavir combination)
Another class of drugs blocks the same step of the life cycle, but in a different way. This class is the non-nucleoside reverse transcriptase inhibitors, or NNRTIs. Three NNRTIs have been approved:

Nevirapine (NVP, Viramuneョ)
Delavirdine (DLV, Rescriptorョ)
Efavirenz (EFV, Sustivaョ)
There has been a lot of excitement about the third class of antiviral drugs, the protease inhibitors. These drugs block Step 7, where the raw material for new HIV virus is cut into specific pieces. Five protease inhibitors have been approved:

Saquinavir (SQV, Inviraseョ and Fortovaseョ)
Indinavir (IDV, Crixivanョ)
Ritonavir (RTV, Norvirョ)
Nelfinavir (NFV, Viraceptョ)
Amprenavir (APV, Ageneraseョ)
Lopinavir (LPV, Kaletraョ)


--------------------------------------------------------------------------------


HOW ARE THE DRUGS USED?

When HIV multiplies, most of the new copies are mutations: they are slightly different from the original virus. Some mutations keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

If only one antiviral drug is used, it is easy for the virus to develop resistance. But if two drugs are used, a successful mutant would have to "get around" both drugs at the same time. And if three drugs are used, especially if they attack HIV at different points in its life cycle, it's very hard for a mutation to show up that can resist all three drugs at the same time.

Using a triple-drug combination means that it takes much longer for resistance to develop. For this reason, using just one antiviral drug (monotherapy) is not recommended.



--------------------------------------------------------------------------------


CAN THESE DRUGS CURE AIDS?

A blood test called the "viral load" measures the amount of HIV virus in your bloodstream. People with lower viral loads stay healthier longer. See Fact Sheet 413 for more information on the viral load test.

Some people's viral load is so low that it is "undetectable" by the viral load test. This does not mean that all the virus is gone. Researchers used to believe that antiviral therapy could eventually kill off all of the HIV virus in the body. Now this seems unlikely.



--------------------------------------------------------------------------------


WHEN DO I START?

There is not a clear answer to this question. Most doctors will consider three things: 1) your viral load; 2) your T-cell count; and 3) any symptoms you've had. Antiviral therapy is usually started if your viral load is over 30,000, if your T-cell count is below 350, or if you've had any symptoms of HIV disease. This is an important decision you should discuss with your doctor.



--------------------------------------------------------------------------------


WHICH DRUGS DO I USE?

Each antiviral drug has side effects. Some are serious. Refer to the fact sheet for each individual drug. Some combinations of drugs are easier to tolerate than others, and some seem to work better than others. Each person is different, and you and your doctor will have to decide which drugs to use.

The viral load test is now being used to see if antiviral drugs are working. If the viral load does not go down, or if it goes down but comes back up, it might be time to change antiviral drugs.



--------------------------------------------------------------------------------


WHAT'S NEXT?

New drugs are being developed in all three of the existing classes. Researchers are also trying to develop new types of drugs, such as drugs that will block HIV from attaching to cells (Step 2), and drugs that will strengthen the body's immune defenses.



--------------------------------------------------------------------------------


Revised January 9, 2002

WHY DO THE GUIDELINES KEEP CHANGING?

The best way to fight HIV changes as we learn more about how to use new drugs. In 1998, the US Department of Health and Human Services created a panel of physicians, researchers, and consumers to develop and revise treatment guidelines. The panel released the latest version of these guidelines in February 2001.

NOTE: These are guidelines, not rules. Patients should receive individualized care from a doctor with experience treating HIV infection. The full text of these guidelines is available on the Internet at http://www.hivatis.org/trtgdlns.html



--------------------------------------------------------------------------------


VIRAL LOAD TESTING

Viral load testing provides critical information for decisions on antiviral therapy. Viral load should be tested:

Before starting or changing medications, to get a reference value;
About 2 to 8 weeks after starting or changing medications, to see if the new drugs are working;
Every 3 or 4 months to make sure the medications are still working; or, for patients not yet taking medications, to help decide when to start.


--------------------------------------------------------------------------------


RESISTANCE TESTING

Viral resistance testing helps doctors choose the most effective drugs. It is recommended when viral load is not controlled by new medications, or when it "breaks through" a regimen that used to work. The tests also indicate if someone got infected with drug-resistant virus.


--------------------------------------------------------------------------------


WHEN TO START TREATMENT

Patients with symptoms of HIV disease should all be treated.
Patients with no symptoms who have less than 350 T-cells OR viral load over 30,000* should be offered treatment. Consider the risk of disease progression and the patient's willingness to start therapy. Some experts would delay treatment for patients with 200 to 350 T-cells and viral loads under 30,000.
Patients with no symptoms who have more than 350 T-cells AND viral load below 30,000* do not need to start treatment. They should get regular blood tests. However, some experts would begin treatment for these patients.


--------------------------------------------------------------------------------


GOALS OF THERAPY

The guidelines list the following goals for HIV therapy:

Reduce viral load as much as possible for as long as possible
Restore or preserve the immune system
Improve the patient's quality of life
Reduce sickness and death due to HIV
The following tools are suggested to help achieve these goals:

Maximize adherence. Help the patient take medications correctly.
Think about future regimens when choosing drugs. Keep future options open
Use resistance testing when it will help.


--------------------------------------------------------------------------------


WHAT DRUGS SHOULD BE USED AT FIRST?


The guidelines recommend using 2 nucleoside analogs (nukes) plus one of the following:

the protease inhibitors indinavir or nelfinavir;
double-protease combinations of ritonavir plus saquinavir, indinavir or lopinavir; or
the NNRTI efavirenz.
Other drugs and combinations are recommended as alternatives. The guidelines do not comment on the use of hydroxyurea. They discourage the use of a single drug (monotherapy), or of two nukes.




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INTERRUPTING TREATMENT

A patient may need to interrupt treatment if they can't tolerate the side effects, if there's a drug interaction, if they run out of any of the drugs, or for women who choose to stop treatment during the first 3 months of pregnancy.

If antiviral therapy is stopped, all drugs should be stopped at the same time, and re-started together. This will reduce the risk of the virus developing resistance to the medications.



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WHEN TO CHANGE


Treatment should be changed due to treatment failure, or intolerance of current drugs.

Treatment failure: Treatment failure: Compare the viral load to the reference level (before the current medications). Within 8 weeks, there should be about a 90% drop in viral load. Within 6 months, the viral load should be less than 50 copies. If the viral load does not drop this much, change the treatment.

Other signs of treatment failure include:


An increase in viral load from undetectable to detectable levels, or to more than 3 times its lowest level on the current drugs;
A continuing drop in T-cells; or
A new AIDS-related illness.
Intolerance: If a patient cannot take the prescribed drugs because of their side effects or interactions with other needed medications, the drugs should be changed.



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WHAT TO CHANGE TO?

Decisions to change antiviral therapy should be based on the reason for changing, how sick the patient is, medications previously used, other drugs currently available, the side effects the patient has had, and what other medications are being used.

Changes due to drug intolerance: Reduce the dose of the drug causing the problems, or replace it with one or more drugs from the same class and of the same strength.

Changes due to treatment failure:

Use at least two new drugs, and preferably an entirely new combination.
If possible, it is best to avoid using any drug a patient has used before.
Do not switch to any drug that has shown cross-resistance with a drug now being used: don't switch between ritonavir and indinavir, or between nevirapine and delavirdine.
If there are few options to change to, and viral load was reduced, it may make sense not to change medications. Another choice may be to combine two protease inhibitors, or a protease inhibitor and an NNRTI.
Doctors who are less experienced in treating people with HIV should consult with a more experienced physician on decisions about changing antiviral therapies.


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*NOTE: These viral load levels are for tests done using the branched DNA (bDNA) technique. Tests using the polymerase chain reaction (PCR) give higher results. A 30,000 result by bDNA is equivalent to a 55,000 result by PCR. See Fact Sheet 413 for more information on viral load testing.



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WHAT ARE T-CELLS?

T-cells are a type of lymphocyte (white blood cell). They are an important part of the immune system. There are two main types of T-cells. T-4 cells, also called CD4+, are "helper" cells. They lead the attack against infections. T-8 cells, (CD8+), are "suppressor" cells that end the immune response. CD8+ cells can also be "killer" cells that kill cancer cells and cells infected with a virus.

Researchers can tell the T-cells apart by specific proteins on the cell surface. These proteins are also called "receptor sites" because they can lock onto certain molecules. So a T-4 cell is a T-cell with a CD4 receptor on its surface. This type of T-cell is also called "CD4 positive", or CD4+.



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WHY ARE T-CELLS IMPORTANT IN HIV?

When HIV infects humans, the cells it infects most often are CD4+ cells. The virus becomes part of the cells, and when they multiply to fight an infection, they also make more copies of HIV.

When someone is infected with HIV for a long time, the number of CD4+ cells they have (their T-cell count) goes down. This is a sign that the immune system is being weakened. The lower the T-cell count, the more likely the person will get sick.

There are millions of different families of T-cells. Each family is designed to fight a specific type of germ. When HIV reduces the number of T-cells, some of these families can be totally wiped out. You can lose the ability to fight off the particular germs those families were designed for. If this happens, you might develop opportunistic infections.



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HOW ARE THE TEST RESULTS REPORTED?

T-cell tests are normally reported as the number of cells in a milliliter of blood. There is some disagreement about the normal range for T-cell counts, but CD4+ counts are between 500 and 1600, and CD8+ counts are between 375 and 1100. CD4+ counts drop dramatically in people with HIV, in some cases down to zero.

The ratio of CD4+ cells to CD8+ cells is often reported. This is calculated by dividing the CD4+ value by the CD8+ value. In healthy people, this ratio is between 0.9 and 1.9, meaning that there are about 1 to 2 CD4+ cells for every CD8+ cell. In people with HIV infection, this ratio drops dramatically, meaning that there are many times more CD8+ cells than CD4+ cells.

The T-cell value bounces around a lot. Time of day, fatigue, and stress can affect the test results. It's best to have blood drawn at the same time of day for each T-cell test, and to use the same laboratory.

Infections can have a large impact on T-cell counts. When your body fights an infection, the number of white blood cells (lymphocytes) goes up. CD4+ and CD8+ counts go up, too. Vaccinations can cause the same effects. Don't check your T-cells until a couple of weeks after you recover from an infection, or after you get a vaccination.

Because the T-cell counts are so variable, some doctors prefer to look at the T-cell percentages. These percentages refer to total lymphocytes. If your test reports CD4+% = 34%, that means that 34% of your lymphocytes were CD4+ cells. This percentage is more stable than the number of T cells. The normal range is between 20% and 40%.



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WHAT DO THE NUMBERS MEAN?

The meaning of CD8+ cell counts is not clear, but it is being studied.

Most researchers believe that the CD4+ cell count is a good measure of the health of the immune system. The lower the count, the greater damage HIV has done. But some people with almost no CD4+ cells have stayed healthy for a long time.

CD4+ counts are used together with the viral load to estimate how long someone will stay healthy. See Fact Sheet 413 for more information on the viral load test.

CD4+ counts are now used to indicate when to start certain types of drug therapy:

When to start antiviral therapy:
When the CD4+ count goes below 350, most doctors begin antiviral drugs such as AZT, ddI, or 3TC. Also, some doctors use the CD4+% going below 15% as a sign to start aggressive antiviral therapy, even if the CD4+ count is high.

However, the viral load test has become at least as important as the CD4+ count in deciding when to start antiviral drugs.

When to start drugs to prevent opportunistic infections:
Most doctors prescribe drugs to prevent opportunistic infections at the following CD4+ levels:

Less than 200: pneumocystis carinii pneumonia (PCP)
Less than 100: toxoplasmosis and cryptococcosis
Less than 75: mycobacterium avium complex (MAC).


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WHAT IS VIRAL LOAD?

The viral load test measures the amount of HIV virus in your blood. There are different techniques for doing this:

The PCR (polymerase chain reaction) test uses an enzyme to multiply the HIV in the blood sample. Then a chemical reaction marks the virus. The markers are measured and used to calculate the amount of virus. Roche produces this test.
The bDNA (branched DNA) test combines a material that gives off light with the sample. This material connects with the HIV particles. The amount of light is measured and converted to a viral count. Chiron produces this test.
The PCR test results are usually about double the bDNA results for the same sample. Because the tests are different, you should stick with the same kind of test (PCR or bDNA) to measure your viral load over time.

Viral loads are usually reported as copies of HIV in one milliliter of blood. The tests count up to about 1.5 million copies, and are always being improved to be more sensitive. The first bDNA test measured down to 10,000 copies. The second generation could detect as few as 500 copies. Now there are ultra sensitive tests that can detect less than 5 copies.

The best viral load test result is "undetectable". This does not mean that there is no virus in your blood; it just means that there is not enough for the test to find and count. With the first generation test, "undetectable" could mean 9,999 copies. "Undetectable" depends on the sensitivity of the test used on your blood sample.



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HOW IS THE TEST USED?

The viral load test is helpful in several areas:

In basic science, the test has been used to prove that HIV is never "latent" but is always multiplying. Many people with no symptoms of AIDS and high T-cell counts also had high viral loads. If the virus was latent, the test wouldn't have found any HIV in the blood.
The test can be used for diagnosis, because it can detect a viral load at any time after HIV infection. This is better than the standard HIV (antibody) test, which can be "negative" after HIV infection and before the development of antibodies (See Fact Sheet 102 for more information on HIV antibody testing).
For prognosis, viral load can help predict how long someone will stay healthy. The higher the viral load, the faster HIV disease progresses.
Finally, the viral load test is valuable for managing therapy, to see if antiviral drugs are controlling the virus. Current guidelines suggest measuring baseline (pre-treatment) viral load. A drug is "working" if it lowers viral load by at least 90% within 8 weeks. With good antiviral therapy, the viral load should continue to drop to less than 50 copies within 6 months.


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HOW ARE CHANGES IN VIRAL LOAD MEASURED?

Repeat tests of a blood sample can give results that vary by a factor of 3. This means that a meaningful change would be a drop to less than 1/3 or an increase to more than 3 times the previous test result. For example, a change from 200,000 to 600,000 is within the normal variability of the test. A drop from 50,000 to 10,000 would be significant. The most important change is to reach an undetectable viral load.

Viral load changes are often described as "log" changes. This refers to scientific notation, which uses powers of 10. For example, a 2-log drop is a drop of 102 or 100 times. A drop from 60,000 to 600 would be a 2-log drop.



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WHAT DO THE NUMBERS MEAN?

There are no "magic" numbers for viral loads. We don't know how long you'll stay healthy with any particular viral load. We don't know if 150,000 is twice as bad as 75,000. All we know so far is that lower is better and seems to mean a longer, healthier life.

US treatment guidelines (See Fact Sheet 411) suggest that anyone with a viral load over 30,000 by bDNA should be treated with antiviral drugs.

Some people may think that if their viral load is undetectable, they can't pass the HIV virus to another person. THIS IS NOT TRUE. There is no "safe" level of viral load. Even if your viral load is undetectable, you can pass HIV to another person.



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ARE THERE PROBLEMS WITH THE VIRAL LOAD TEST?

There are some concerns with the viral load test:

Some scientists think that only 2% of the HIV in your body is in the blood. The viral load test does not measure how much HIV is in body tissues like the lymph nodes, spleen, or brain. HIV levels in lymph tissue go down when blood levels go down, but not at the same time or the same rate. Viral levels in semen seem to be unrelated to blood levels.
The viral load test results can be thrown off if your body is fighting an infection, or if you have just received an immunization (like a flu shot). You should not have blood taken for a viral load test within four weeks of any infection or immunization.


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WHAT IS RESISTANCE?

HIV is "resistant" to a drug if it keeps multiplying rapidly while you are taking the drug. Changes (mutations) in the virus cause resistance. HIV mutates almost every time a new copy is made. Not every mutation causes resistance. The "wild type" virus is the most common form of HIV. Anything different from the wild type is considered a mutation.

Antiviral drugs control most types of the virus. However, they won't control resistant virus. It can "escape" from the drug. As long as you take the drug, the resistant virus will multiply the fastest. This is called "selective pressure."

If you stop taking medications, there is no selective pressure. The wild type virus will multiply the fastest. We don't know if drug resistance goes away, or if it comes back when you re-start the same drugs.

Resistance testing helps doctors make better treatment decisions for their patients.



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HOW DOES RESISTANCE DEVELOP?
HIV usually becomes resistant when someone is taking drugs that don't totally control it. However, more people are getting infected with HIV that is already resistant to one or more anti-HIV drugs.

The more that HIV multiplies, the more mutations show up. These mutations happen by accident. The virus doesn't "figure out" which mutations will resist medications.

Just one mutation can make HIV resistant to some drugs. This is true for 3TC (Epivir) and the non-nucleoside reverse transcriptase inhibitors (NNRTIs). However, HIV has to go through a series of mutations to develop resistance to other drugs, including most protease inhibitors.

The best way to prevent resistance is to control HIV by taking strong antiviral medications. If you miss doses of your medications, HIV will multiply more easily. More mutations will occur. Some of them could cause resistance.

If you have to stop taking any antiviral medication, talk to your doctor. You may have to stop some drugs sooner than others. If you stop taking drugs while the virus us under control, you should be able to use them again.



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TYPES OF RESISTANCE
There are three types of resistance:


Clinical resistance: HIV multiplies rapidly in your body even though you're taking antiviral drugs.
Phenotypic resistance: HIV multiplies in a test tube when antiviral drugs are added.
Genotypic resistance: The genetic code of HIV has mutations that are linked to drug resistance.
Laboratory tests can measure phenotypic and genotypic resistance.


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PHENOTYPIC TESTING
A sample of HIV is grown in the laboratory. A dose of one antiviral drug is added. The growth rate of the HIV is compared to the rate of wild type virus. If the sample grows more than normal, it is resistant to the medication.

Phenotypic resistance is reported as "fold" resistance. If the test sample grows twenty times as much as normal, it has "20-fold resistance".

Phenotypic tests cost about $800. It used to take over a month to get the results. New phenotypic tests are quicker.



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GENOTYPIC TESTING
The genetic code of the sample virus is compared to the wild type. The code is a long chain of molecules called nucleotides. Each group of three nucleotides, called a "codon", defines a particular amino acid used to build a new virus.

Mutations are described by a combination of letters and numbers, for example K103N. The first letter (K) is the code for the amino acid in the wild type virus. The number (103) identifies the mutant codon. The second letter (N) is the code for the "changed" amino acid in the mutant sample.

Genotypic testing costs about $250. Results come back in about two weeks.



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VIRTUAL PHENOTYPE

This test combines some elements of genotypic and phenotypic testing. First, genotypic testing is done on the sample. Phenotypic test results for other virus samples with a similar genotypic pattern are taken from a database. These matched samples tell you how the virus is likely to behave. The virtual phenotype is faster and less expensive than a phenotypic test.


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CROSS-RESISTANCE
Sometimes a mutant version of HIV is resistant to more than one drug. When this happens, the drugs are called "cross-resistant". For example, most HIV that is resistant to indinavir (Crixivan) is also resistant to ritonavir (Norvir). This means that indinavir and ritonavir are cross-resistant.

Cross-resistance is important when you change medications. You need to choose new drugs that are not cross-resistant to drugs you've already taken.

We do not totally understand cross-resistance. However, many drugs are at least partly cross-resistant. As HIV develops more mutations, it gets harder to control. Take every dose of your antiviral medications according to instructions. This reduces the risk of resistance and cross-resistance. It saves the most options for changing medications in the future.



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PROBLEMS WITH RESISTANCE TESTING
Resistance tests are not available everywhere. They are expensive. However, they are becoming more common, faster and cheaper.

The tests aren't good at detecting "minority" mutations (less than 20% of the virus population.) Also, they work better when the viral load is higher. If your viral load is very low, the tests might not work.

Test results can be difficult to understand. Sometimes they don't explain what actually happens with a patient. Drugs that should work according to the tests sometimes don't work, and vice versa.

Despite these problems, many researchers believe that resistance testing will become a normal part of HIV treatment in the next several years. More physicians will probably use resistance testing before choosing someone's first antiviral medications to see if they were infected by drug-resistant virus.



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Revised December 2, 2001

HOW DO AIDS DRUGS WORK?
The HIV virus can make millions of copies of itself every day. Antiviral drugs can't kill the virus, but they can almost stop it from multiplying.

A "viral load" test measures the amount of virus in your blood. If you take anti-HIV drugs, the amount of virus in your blood should go down. If your viral load is very low, you probably won't develop any AIDS-related illnesses. See Fact Sheet 413 for more information on viral load.



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WHAT IS RESISTANCE?
The HIV virus is sloppy when it makes copies of itself. Many new copies of HIV are slightly different from the original (mutations). Some mutations can multiply easily even though you are taking drugs that stop "normal" HIV. This is called "developing resistance" to the drugs. If your virus develops resistance, it will multiply faster and your HIV disease will probably get worse.

Resistance develops quickly if you take just one drug. If you take three drugs, HIV multiplies much more slowly and it is much harder for resistance to develop.

Sometimes, when HIV becomes resistant to a drug you are taking, it will also be resistant to other antiviral drugs - even if you haven't used them yet. This is called "cross-resistance". Many HIV drugs are at least partly cross-resistant. If your virus develops resistance to an HIV drug, you might not be able to use any other drugs of the same type. To avoid using up your treatment options, take all of your medications according to instructions.



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KEEPING PRESSURE ON THE VIRUS
When you take medications, they get into your blood and are carried around your body. Then your liver and kidneys start to clean the drug out of your system, and the amount of medication in your blood goes down.

Some drugs get into your bloodstream better if there is no food in your stomach. You take these medications on an empty stomach. Other drugs get into your bloodstream better if your stomach is full. You should take these drugs with food. With some drugs, food doesn't matter.

The instructions for taking each drug tell you how many pills to take, when to take them, and how to take them, in order to keep enough medicine in your blood. If you skip a dose, don't take a full dose, or don't follow the eating instructions, the drug levels in your blood will drop.

If there is not enough medicine in your blood, HIV can continue to multiply. The more HIV multiplies, the greater the chance that resistance will develop.

The best way to keep pressure on HIV is to take all the pills you're supposed to, every time you're supposed to, and follow the directions about food.



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HOW MUCH ADHERENCE IS ENOUGH?
Adherence means taking your medications correctly. If you don't, HIV might multiply out of control. Several research studies have measured how much adherence is "enough." They found that, for the best viral load results, people had to take 90% to 95% of their pills correctly. If you take pills three times a day, this means that you don't miss more than one dose a week.



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MAKE IT EASY ON YOURSELF
It can be difficult to take your medications the way you're supposed to. Make it as easy as you can!

Tell your doctor about your daily schedule so that you can choose the medications that will be easiest for you to take.
Make sure you understand your medications:
Which medications to take
How many pills to take, and how many times a day
Whether to take your pills with food, or on an empty stomach
How to store your pills
Side effects you might have, and what to do about them
Plan ahead so you don't run out of any of your medications.
Use a pillbox and count your pills out ahead of time. Some boxes hold enough for a whole week.
Set a timer or alarm to go off when you have to take pills.
Choose a regular daily activity to help you remember to take pills:
Making your morning coffee
Getting out of bed
A favorite TV show
Coming home from work
Make sure your family members know how important it is for you to take your pills. Ask them to help you remember.
You might have problems with side effects, or it might be difficult to take your pills as prescribed. Don't cut back or stop taking your medications until you have talked to your doctor. You might be able to change your medications and get some that are easier for you to take.


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THE BOTTOM LINE
In order for your medications to work, you need to take them according to the instructions. If you don't, your virus might develop resistance to drugs you are taking. If your virus becomes resistant to one drug, it might also be resistant to other HIV drugs. For the best results you have to take over 90% of your pills correctly.

Be sure that you understand which medications your doctor has prescribed. Make sure you know how many to take, when to take them, and whether you need to take them with food or when your stomach is empty.

Work with your health care provider to make it as easy as possible to take your medications. Use whatever you need to keep on your medication program: pillboxes, timers, friends, or support groups. Be sure to talk with your doctor before you make any changes in your medications or how you take them.



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Revised August 23, 2001

WHAT ARE TREATMENT INTERRUPTIONS?
Many people with HIV infection stop taking antiviral medications for various reasons. Their viral load climbs very quickly and their T-cell count drops. In late 1997, however, an HIV patient in Berlin stopped taking medications. His viral load climbed briefly, then dropped and stayed undetectable.

This patient started medications soon after he was infected. Maybe HIV didn't have a chance to damage his immune system. Maybe his viral load increase was like a vaccination that stimulated his immune system to control the virus.

Researchers immediately tried to copy the Berlin patient's success in other patients. They stopped treatment for a certain period of time, or until the viral load climbed to a certain point. This kind of treatment interruption is called "STI" which means either "structured" or "strategic" treatment interruption.


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WHICH PATIENTS ARE BEING STUDIED, AND WHY?
STI studies are divided according to three groups of HIV patients:

HIV is under control; antiviral treatment started within six months of infection. These "primary infection" patients, like the Berlin patient, may have the best chance to control HIV without medications.
HIV is under control; treatment started more than six months after infection. These "chronic infection" patients may just want a break from taking medications, or may want to reduce side effects.
HIV is not controlled by antiviral medications. These "drug-resistant" patients may want a break from side effects, may be waiting for new treatment options, or may want to experiment with shifting their virus back to the "wild type" that is more drug-sensitive.
Doctors and patients should plan treatment interruptions. Viral load and T-cell levels should be carefully monitored. Just skipping doses has more risks and does not contribute to knowledge about HIV treatments.


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WHAT ARE THE RISKS?
The most obvious risks of an STI are that the viral load will climb and the T-cell count will drop. These risks are greatest for people whose virus is not under control. If you have only 50 T-cells, losing another 10 might have serious consequences.

Stopping and re-starting medications could make it easier for the virus to develop resistance to medications. Surprisingly, there is almost no evidence of resistance developing in people who took part in studies of STIs.

This risk may be greatest for people taking drugs like Efavirenz (Sustivaョ) that stay in the body much longer than other antiviral drugs. They could be discontinued before other drugs in a regimen, but this has not been carefully studied.

Also, if the viral load increases while people are off medications, people might be more likely to transmit HIV infection to others. On the other hand, if they are off medications, they might be more likely to transmit the wild type virus, not drug-resistant virus.

People ending a treatment interruption might have a hard time re-starting medications.


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WHAT ARE THE POSSIBLE BENEFITS?
Ideally, an STI would have several benefits:

Stimulate the immune system. The best case is immune control of HIV without antiviral medications.
Allow patients to take less medication. This should reduce side effects and lower drug costs for individuals and public programs.


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WHAT DOES THE RESEARCH SHOW?
Many people who stop antiviral drugs feel better, at least for a short time. However, long-term benefits are unclear.

Primary infection: During an STI, viral loads go up and T-cell counts go down except for very rare exceptions. Researchers cannot predict who will control HIV without drugs.

Chronic infection: Again, viral loads go up and T-cell counts go down. Patients in this group who control HIV without antiviral medications are very rare. Researchers are adding immune-boosting therapies to treatment interruptions.

For a few drug-resistant patients, it seems that medications were not doing anything, because when they stopped, viral loads and t-cell counts didn't change very much. In some cases, HIV shifts back to a more "wild type" virus that is not resistant to antiviral medications. Scientists are not sure that this is a good thing, because the wild type virus is stronger than virus that is resistant to several drugs.


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THE BOTTOM LINE
HIV patients stop antiviral treatments for various reasons. In very rare cases, treatment interruption has led to immune system control of HIV without medications. However, there is no way to predict when this will happen.

If we can learn how to use treatment interruptions, patients might be able to take periods of time off of antiviral drugs. This could mean fewer side effects and lower drug costs. However, we will have to learn how to minimize drug resistance and transmission of HIV, and learn the best scheduling of treatment interruptions to avoid long term increases in viral load and decreases in T-cells.



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Revised August 30, 2001


[ Edit | View ]



DRUGS;ETC. -- No name, 13:14:37 01/26/02 Sat

WHAT IS ddC?


ddC (Hividョ), is a drug used for antiviral therapy. It is manufactured by Roche. ddC is also known as zalcitabine or dideoxycytidine.

ddC is a nucleoside analog reverse transcriptase inhibitor, or nuke. These drugs block the reverse transcriptase enzyme. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This has to occur before HIV's genetic code gets inserted into an infected cell's own genetic codes.



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WHO SHOULD TAKE ddC?

ddC was approved as an antiviral drug for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) is over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.



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WHAT ABOUT DRUG RESISTANCE?

The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

With combination therapy (taking more than one antiviral drug at the same time), HIV mutates much more slowly and it takes much longer for resistance to develop.



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HOW IS ddC TAKEN?

ddC is available in tablets of 0.75mg or 0.375mg. The normal adult dose is one 0.75mg tablet three times a day.

ddC should be taken on an empty stomach: 2 hours after eating, or 1 hour before a meal.

Be sure your doctor knows if you have had liver or kidney problems. Your liver and kidney will have to be watched carefully if you take ddC, and your doctor might decide that you should not use ddC at all.



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WHAT ARE THE SIDE EFFECTS?


When you start any anti?viral treatment you may have temporary side effects such as headaches, hypertension, or a general sense of feeling ill. These side effects usually get better or disappear over time.

The most common side effects of ddC are rashes, chest pain, fever, nausea, changes in liver function, and mouth sores.

The most serious side effects of ddC are peripheral neuropathy and, in rare cases, pancreatitis.

Peripheral neuropathy is a form of nerve damage. It usually shows up as tingling, numbness, or a sharp burning sensation in the feet, legs, or hands. The nerve damage is usually temporary and will go away if you stop taking ddC, or reduce the dose. If you continue to take ddC after nerve damage shows up, it may become permanent.

Pancreatitis is an inflammation of the pancreas, a large gland located behind the stomach. Pancreatitis can be fatal. If you are taking ddC and have sharp pain near your stomach, back, or sides, with nausea and vomiting, you should stop taking ddC immediately and call your doctor.



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HOW DOES ddC REACT WITH OTHER DRUGS?

ddC is more effective if taken with other antiviral drugs.

ddC should not be combined with 3TC (lamivudine, Epivirョ), d4T (stavudine, Zeritョ), or ddI (didanosine, Videxョ).

Blood levels of ddC may be decreased by antacids or cimetidine.

Blood levels of ddC may be increased by aminoglycosides, amphotericin B, foscarnet, or probenecid.

Several other medications can make the side effects of ddC worse. Be sure your doctor knows about all the medications you are taking.



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Revised February 14, 2001



WHAT IS ddI?

ddI (Videxョ), is a drug used for antiviral therapy. It is manufactured by Bristol-Myers Squibb. ddI is also known as didanosine or dideoxyinosine.

ddI is a nucleoside analog reverse transcriptase inhibitor, or nuke. These drugs block the reverse transcriptase enzyme. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This has to occur before HIV's genetic code gets inserted into an infected cell's own genetic codes.



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WHO SHOULD TAKE ddI?

ddI was approved as an antiviral drug for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000. Pregnant women should not take ddI and d4T at the same time.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.



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WHAT ABOUT DRUG RESISTANCE?

The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

If you take a "nuke" by itself, resistance can develop in about 6 to 12 months. When you take more than one antiviral drug at the same time, HIV mutates much more slowly and it takes much longer for resistance to develop.

Sometimes, if you develop resistance to one drug, you will also have resistance to other antiviral drugs. This is called "cross-resistance".



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HOW IS ddI TAKEN?


ddI is available as a chewable tablet (which can also be dissolved in water) and as a powder that is dissolved in water. The recommended dose of ddI for adults is based on weight. For people weighing more than 132 pounds, the dose is 200mg (milligrams) in tablet form, or 250mg of powder, twice a day. For those weighing less than 132 pounds, the dose is 125mg in tablet form, or 167mg of powder, twice a day.

In November 1999, the FDA approved a new formulation of ddI that can be taken just once a day. The dosage is two 200 mg tablets taken at the same time. The new tablets cannot be used for twice a day dosing. However, in July 2000, the FDA said that twice-daily dosing of ddI is preferred. Once-daily dosing should only be used by adults with a special need to take their medications just once a day. If you want to change how often you take ddI, talk to your doctor.

If you have had liver or kidney problems, the dose of ddI may need to be reduced.

ddI cannot be absorbed in an acid environment. ddI contains a buffer to reduce the effects of stomach acid. ddI is taken on an empty stomach, one hour before eating or two hours after a meal. Taking ddI with food may reduce blood levels by as much as 50%.

Bristol-Myers Squibb developed a new "enteric coated" version of ddI called Videx EC. It can be taken as a single capsule once a day. Videx EC does not contain a buffer, so side effects and drug interactions could be reduced. The FDA approved Videx EC in October 2000.



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WHAT ARE THE SIDE EFFECTS?


When you start any antiviral treatment you may have temporary side effects such as headaches, hypertension, or a general sense of feeling ill. These side effects usually get better or disappear over time.

The most common side effects of ddI are diarrhea, headaches, vomiting and rash. Diarrhea, caused by the buffer in the tablets, is sometimes severe.

The most serious side effects of ddI are peripheral neuropathy, pancreatitis, and lactic acidosis:

Peripheral neuropathy is a form of nerve damage. It usually shows up as tingling, numbness, or a sharp burning sensation in the feet, legs, or hands. The nerve damage is usually temporary and will go away if you stop taking ddI, or reduce the dose. If you continue to take ddI after nerve damage shows up, it may become permanent. See Fact Sheet 553 for more information.

Pancreatitis is an inflammation of the pancreas, a large gland located behind the stomach. Pancreatitis can be fatal. If you are taking ddI and have sharp pain near your stomach, back, or sides, with nausea and vomiting, stop taking ddI immediately and call your doctor.

Lactic acidosis is a buildup of lactic acid in the blood. This is a by-product of abnormal energy production by the cells. It may be caused by damage to the mitochondria. See Fact Sheet 554 for more information on mitochondrial toxicity. Lactic acidosis can cause severe damage to the pancreas and liver. Symptoms of lactic acidoss can include weight loss, abdominal pain, and severe fatigue.



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HOW DOES ddI REACT WITH OTHER DRUGS?

ddI may be more effective if taken with hydroxyurea. However, this increases the risk of developing pancreatitis.

Methadone decreases blood levels of ddI

ddI should not be combined with ddC (zalcitabine, Hividョ).

Pregnant women should not take ddI and d4T at the same time due to an increased risk of lactic acidosis.

Do not take ddI at the same time as a protease inhibitor. Separation times are different for different protease inhibitors. Check the instructions for your medications.



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Revised February 14, 2001



WHAT IS d4T?

d4T (Zeritョ), is a drug used for antiviral therapy. It is manufactured by Bristol-Myers Squibb. d4T is also known as stavudine or didehydro-deoxythymidine.

d4T is a nucleoside analog reverse transcriptase inhibitor, or nuke. These drugs block the reverse transcriptase enzyme. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This has to occur before HIV's genetic code gets inserted into an infected cell's own genetic codes.



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WHO SHOULD TAKE d4T?

d4T was approved as an antiviral drug for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) is over 30,000. Pregnant women should not take d4T and ddI at the same time.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.



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WHAT ABOUT DRUG RESISTANCE?

The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

With combination therapy (taking more than one antiviral drug at the same time), HIV mutates much more slowly and it takes much longer for resistance to develop.



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HOW IS d4T TAKEN?

d4T is available in capsules of 15mg, 20mg, 30mg, and 40mg. The normal adult dose depends on body weight. If you weigh more than 60 kilograms (132 pounds), the dose is 40 mg twice daily. If you weigh less, the dose is 30 mg twice daily.

Be sure your doctor knows if you have had liver problems. Your liver will have to be watched carefully if you take d4T, and your doctor might decide that you should not use d4T at all.



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WHAT ARE THE SIDE EFFECTS?

When you start any anti?viral treatment, you may have temporary side effects such as headaches, hypertension, or a general sense of feeling ill. These side effects usually get better or disappear over time.

The most serious side effects of d4T are peripheral neuropathy and lactic acidosis.

Peripheral neuropathy is a form of nerve damage. It usually shows up as tingling, numbness, or a sharp burning sensation in the feet, legs, or hands. The nerve damage is usually temporary and will go away if you stop taking d4T, or reduce the dose. If you continue to take d4T after nerve damage shows up, it may become permanent.

Lactic acidosis is a buildup of lactic acid in the blood. This is a by-product of abnormal energy production by the cells. It may be caused by damage to the mitochondria. See Fact Sheet 554 for more information on mitochondrial toxicity. Lactic acidosis can cause severe damage to the pancreas and liver. Symptoms of lactic acidosis can include weight loss, abdominal pain, and severe fatigue.



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HOW DOES d4T REACT WITH OTHER DRUGS?


d4T is more effective if taken with other antiviral drugs.

d4T should not be taken with AZT (zidovudine, Retrovirョ) or ddC (zalcitabine, Hividョ).

d4T's side effects may be worse if taken with ganciclovir or pentamidine.

Pregnant women should not take d4T and ddI at the same time due to an increased risk of lactic acidosis.



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Revised February 14, 2001



WHAT IS 3TC?

3TC (Epivirョ), is a drug used for antiviral therapy. It is manufactured by GlaxoSmithKline. 3TC is also known as lamivudine.

3TC is a nucleoside analog reverse transcriptase inhibitor, or nuke. These drugs block the reverse transcriptase enzyme. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This has to occur before HIV's genetic code gets inserted into an infected cell's own genetic codes.



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WHO SHOULD TAKE 3TC?

3TC was approved as an antiviral drug for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.



--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?

The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

Resistance to 3TC can appear in a few months if it is taken by itself. With combination therapy (taking more than one antiviral drug at the same time), HIV mutates much more slowly and it takes much longer for resistance to develop.

3TC seems to be able to reverse resistance to AZT. That is, after people develop resistance to AZT and then take 3TC, AZT seems to work for them again.



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HOW IS 3TC TAKEN?

3TC is available in tablets of 150 milligrams (mg). It is also available in liquid form. The normal dose of 3TC is 150 mg (one tablet) twice a day. The dosage should be reduced for people who weigh less than 50 kilograms (110 pounds).

3TC can be taken with food or between meals.

Be sure your doctor knows if you have had kidney problems: your dose of 3TC may need to be lowered.

3TC is also available in Combivir and Trizivir. Combivir contains AZT and 3TC. Trizivir contains AZT, 3TC, and abacavir. For more information, see Fact Sheet 426 on Combivir or Fact Sheet 427 on Trizivir.



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WHAT ARE THE SIDE EFFECTS?

When you start any anti?viral treatment, you may have temporary side effects such as headaches, hypertension, or a general sense of feeling ill. These side effects usually get better or disappear over time.

The most common side effects of 3TC are nausea, vomiting, fatigue, and headaches. Some people have trouble sleeping. There have been rare cases of hair loss.



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HOW DOES 3TC REACT WITH OTHER DRUGS?


3TC is more effective if taken with other antiviral drugs.

3TC should not be combined with ddC (zalcitabine, Hividョ).

Blood levels of 3TC may be increased by bactrim or septra. See Fact Sheet 535 for more information on these drugs.



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Revised February 14, 2001


[ Edit | View ]



DRUGS;ETC. -- No name, 13:16:30 01/26/02 Sat

WHAT IS ABACAVIR?
Abacavir (Ziagenョ), is a drug used for antiviral therapy. It is manufactured by GlaxoSmithKline. Abacavir used to be called 1592U89. The FDA approved abacavir late in 1998.

Abacavir is a type of drug called a nucleoside analog reverse transcriptase inhibitor, or nuke. These drugs block the reverse transcriptase enzyme. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This has to occur before HIV's genetic code gets inserted into an infected cell's own genetic codes.



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WHO SHOULD TAKE ABACAVIR?
Abacavir was approved as an antiviral drug for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.

Abacavir seems to get into the central nervous system (spinal fluid). Therefore, it may help prevent mental problems such as dementia.


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WHAT ABOUT DRUG RESISTANCE?
The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

With combination therapy (taking more than one antiviral drug at the same time), HIV mutates much more slowly and it takes much longer for resistance to develop.

Abacavir appears to work even when HIV has some resistance to other reverse transcriptase inhibitors.



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HOW IS ABACAVIR TAKEN?
Abacavir is taken by mouth as a capsule. The normal adult dose is 300 milligrams (mg) two times a day. The capsules are 300mg, so you will take 1 capsule at a time. Children take a liquid form. The amount of liquid depends on the child's body weight.

Abacavir can be taken with food, or between meals.

Abacavir is also available in Trizivir. Trizivir contains AZT, 3TC, and abacavir. For more information, see Fact Sheet 427 on Trizivir.



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WHAT ARE THE SIDE EFFECTS?
When you start any anti?viral treatment, you may have temporary side effects such as headaches, high blood pressure, or a general sense of feeling ill. These side effects usually get better or disappear over time. The most common side effects of abacavir are headache, nausea and vomiting.



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HYPERSENSITIVITY REACTION
About 3-5% of people who take abacavir have an allergic reaction. This usually develops within two weeks of starting abacavir. However, it can appear up to six weeks or more after starting. Patients had the following symptoms:

Fever (80% of patients)
Rash (60-70%)
Headache/feeling bad/no energy (60%)
Nausea, vomiting, diarrhea, or stomach pain (50%)
Cough, shortness of breath, or sore throat (20%)
If you have a hypersensitivity reaction, the symptoms will get worse each time you take a dose and will not go away until you stop taking the drug. If you develop any of these symptoms while taking abacavir, call your doctor immediately. If you have an allergic reaction to abacavir, stop taking it and do not start again. A few allergic patients who re-started abacavir had life-threatening reactions.

If you ever stopped abacavir for any reason (for example, because you ran out), talk to your doctor before you start again. In rare cases, people who thought they weren't allergic had serious reactions when re-starting abacavir.



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HOW DOES ABACAVIR REACT WITH OTHER DRUGS?
Abacavir is intended to be used along with other antiviral drugs. No specific interactions with other antiviral drugs have been identified yet.

Although most reverse transcriptase inhibitors are used along with a protease inhibitor, Abacavir has been tested in combination with two other reverse transcriptase inhibitors. The results were almost as good as combinations that include a protease inhibitor.

Abacavir works better if it is taken with the protease inhibitor amprenavir.



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Revised February 14, 2001

WHAT IS COMBIVIR?
Combivir is a pill that contains two drugs used to fight HIV: Retrovir (AZT) and Epivir (3TC). Combivir is manufactured by GlaxoSmithKline.

The drugs in combivir are called nucleoside analog reverse transcriptase inhibitors, or nukes. These drugs block the reverse transcriptase enzyme. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This has to occur before HIV's genetic code gets inserted into an infected cell's own genetic codes.


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WHO SHOULD TAKE COMBIVIR?
Combivir was approved for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.

Children under 12 years old and people with kidney problems should not take Combivir.

Combivir provides two drugs in one pill. It can be more convenient to use combivir that some other combinations of drugs. This could mean fewer missed doses and better control of HIV.


--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?
The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

With combination therapy (taking more than one antiviral drug at the same time), HIV mutates much more slowly and it takes much longer for resistance to develop.


--------------------------------------------------------------------------------


HOW IS COMBIVIR TAKEN?
Combivir is taken by mouth as a tablet. The normal adult dose is one tablet, two times a day. Each tablet includes 300 milligrams (mg) of Retrovir (AZT) and 150 mg of Epivir (3TC).

Combivir can be taken with food, or between meals.

The dosage of 3TC should be reduced for people who weigh less than 50 kilograms (110 pounds). People who weigh less than 110 pounds should normally not take Combivir.


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WHAT ARE THE SIDE EFFECTS?
When you start any anti?viral treatment, you may have temporary side effects such as headaches, high blood pressure, or a general sense of feeling ill. These side effects usually get better or disappear over time.

The most common side effects of combivir are the same as with Retrovir (AZT) and Epivir (3TC). They include headache, upset stomach, and fatigue.

The most serious side effects of AZT are anemia, granulocytopenia, and myopathy. Very few people have these side effects. If they occur, your doctor will probably have you stop using Combivir. See Fact Sheet 420 on AZT for more information on these side effects.

Anemia is a shortage of red blood cells caused by damage to bone marrow.

Granulocytopenia is a shortage of white blood cells caused by damage to bone marrow.

Myopathy is muscle pain and weakness. There is no specific treatment for myopathy.


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HOW DOES COMBIVIR REACT WITH OTHER DRUGS?

Combivir should not be taken with with ddC (zalcitabine, Hividョ) or with d4T (stavudine, Zeritョ).

Blood levels of 3TC may be increased by bactrim or septra. See Fact Sheet 535 for more information on these drugs.

AZT's side effects may be worse if you are taking several other drugs. Be sure your doctor knows about all the medications you are taking.



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Revised February 14, 2001



WHAT IS TRIZIVIR?
Trizivir is a pill that contains three drugs used to fight HIV: Retrovir (AZT), Epivir (3TC) and Abacavir (Ziagen). Trizivir is manufactured by GlaxoSmithKline.

The drugs in Trizivir are called nucleoside analog reverse transcriptase inhibitors, or nukes. These drugs block the reverse transcriptase enzyme. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This has to occur before HIV's genetic code gets inserted into an infected cell's own genetic codes.


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WHO SHOULD TAKE TRIZIVIR?
Trizivir was approved for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.

Children under 12 years old and people with kidney problems should not take Trizivir.

Trizivir provides three drugs in one pill. It can be more convenient to use Trizivir that some other combinations of drugs. This could mean fewer missed doses and better control of HIV.

Trizivir can be an effective combination of antiviral medications in one pill, but it is less effective for people with viral loads above 100,000.


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WHAT ABOUT DRUG RESISTANCE?
The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

With combination therapy (taking more than one antiviral drug at the same time), HIV mutates much more slowly and it takes much longer for resistance to develop.


--------------------------------------------------------------------------------


HOW IS TRIZIVIR TAKEN?
Trizivir is taken by mouth as a tablet. The normal adult dose is one tablet, two times a day. Each tablet includes 300 milligrams (mg) of Retrovir (AZT), 150 mg of Epivir (3TC), and 300 mg of abacavir.

Trizivir can be taken with food, or between meals.

The dosage of 3TC should be reduced for people who weigh less than 50 kilograms (110 pounds). People who weigh less than 110 pounds should normally not take Trizivir.


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WHAT ARE THE SIDE EFFECTS?
When you start any anti?viral treatment, you may have temporary side effects such as headaches, high blood pressure, or a general sense of feeling ill. These side effects usually get better or disappear over time.

The most common side effects of Trizivir are the same as with Retrovir (AZT), Epivir (3TC), and abacavir (Ziagen). They include headache, upset stomach, nausea, and fatigue.

The most serious side effects of AZT are anemia, granulocytopenia, and myopathy. Very few people have these side effects. If they occur, your doctor will probably have you stop using Trizivir. See Fact Sheet 420 on AZT for more information on these side effects.

The most serious side effect of abacavir is a hypersensitivity reaction. Less than 5% of people who take abacavir have this reaction, but they have to stop taking abacavir and cannot take it again. If they do, they will have a serious and possibly fatal reaction.

The reaction usually starts within two weeks of starting abacavir. Patients had at least two of the following symptoms: fever, rash, headache, feeling bad, no energy, nausea, vomiting, diarrhea, or stomach pain, cough, shortness of breath, or sore throat. If you develop any of these symptoms while taking Trizivir, call your doctor immediately.

See Fact Sheet 425 for more information on the abacavir hypersensitivity reaction.


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HOW DOES TRIZIVIR REACT WITH OTHER DRUGS?

Trizivir should not be taken with ddC (zalcitabine, Hividョ) or with d4T (stavudine, Zeritョ).

Blood levels of 3TC may be increased by bactrim or septra. See Fact Sheet 535 for more information on these drugs.

AZT's side effects may be worse if you are taking several other drugs. Be sure your doctor knows about all the medications you are taking.



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Revised February 14, 2001



WHAT IS TENOFOVIR?
Tenofovir (Vireadョ), also called bis-POC PMPA, is a drug used for antiviral therapy. It is manufactured by Gilead Sciences. The FDA approved tenofovir for use against HIV in October 2001.

Tenofovir is a nucleotide analog reverse transcriptase inhibitor, or nuke. These drugs stop HIV from multiplying by preventing the reverse transcriptase enzyme from working. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This has to occur before HIV's genetic code gets inserted into an infected cell's genetic codes.

In addition to fighting HIV, tenofovir helps control Hepatitis B and cytomegalovirus (CMV).


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WHO SHOULD TAKE TENOFOVIR?
Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.


--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?
The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original virus. Some mutations can continue to multiply even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

Resistance to tenofovir takes a long time to develop. With combination therapy (taking more than one antiviral drug at the same time), HIV mutates much more slowly and it takes much longer for resistance to develop.

A benefit of tenofovir is that it works against several strains of HIV that are already resistant to AZT, ddC, or ddI.

Sometimes, if you develop resistance to one drug, you will also have resistance to other antiviral drugs. This is called "cross-resistance". However, tenofovir seems to have very little cross resistance with other antiviral drugs. In fact, the mutation that makes HIV resistant to the drug 3TC might actually make tenofovir work better.


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HOW IS TENOFOVIR TAKEN?
The normal adult dose of tenofovir is 300 milligrams (mg) taken as one pill, once a day, with a meal.


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WHAT ARE THE SIDE EFFECTS?
With the start of any antiviral treatment there may be temporary side effects such as headaches, high blood pressure, or a general sense of feeling ill. These side effects are likely to get better or even disappear over time.

The most common side effects of tenofovir are nausea, vomiting and loss of appetite. In some people, tenofovir can increase creatine and transaminases. These are enzymes related to the kidneys and liver. High levels can indicate damage to these organs.


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HOW DOES TENOFOVIR REACT WITH OTHER DRUGS?

Tenofovir increases blood levels of didanosine (Videx.) People who are taking both drugs should take tenofovir 2 hours before, or one hour after didanosine. Tenofovir is eliminated by the kidneys. It is not metabolized in the liver, so it is not expected to interact with many other drugs. However, antiviral drugs with names that end in "-ovir," such as acyclovir and ganciclovir, may interact with tenofovir. Be sure your doctor knows about all medications you are taking.

Tenofovir should be used as part of combination antiviral therapy against HIV. It is normally used along with a nucleoside analog reverse transcriptase inhibitor (nuke) plus a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor.



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Revised October 30, 2001



WHAT IS DELAVIRDINE?

Delavirdine (Rescriptorョ) is a drug used for antiviral therapy. Pharmacia & Upjohn developed delavirdine, and Agouron Pharmaceuticals is marketing it.

Delavirdine is a non-nucleoside reverse transcriptase inhibitor (a "non-nuke" or NNRTI). These drugs stop HIV from multiplying by preventing the reverse transcriptase enzyme from working. This enzyme changes HIV's genetic material (RNA) into DNA. This has to occur before HIV's genetic code gets combined with an infected cell's genetic codes.



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WHO SHOULD TAKE DELAVIRDINE?

Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.


--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?

The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are different from the original virus. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

If you take an NNRTI by itself, resistance develops in a few weeks. For this reason, research on NNRTIs was stopped several years ago. However, when you take more than one antiviral drug at the same time, HIV mutates much more slowly and it takes much longer for resistance to develop. This means that NNRTIs can be useful as part of combination therapy.

Sometimes, if you develop resistance to one drug, you will also have resistance to other antiviral drugs. This is called "cross-resistance". Cross-resistance among NNRTIs develops very easily. If you develop resistance to one NNRTI, you probably won't be able to use any of them in your antiviral therapy.

Resistance can develop quickly. It is very important to take NNRTIs according to instructions, on schedule, and not to skip or reduce doses.



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HOW IS DELAVIRDINE TAKEN?


Delavirdine is available in pills of 100 milligrams (mg) or 200 mg. The recommended dose of delavirdine for adults is 400 mg three times a day. This would be a daily total of 6 of the 200 mg pills, or 12 of the 100 mg pills. You can dissolve the 100 mg pills (but not the 200 mg pills) in water to make them easier to swallow.

Delavirdine can be taken with or without food.



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WHAT ARE THE SIDE EFFECTS?

When you start any anti?viral treatment, you may have temporary side effects such as headaches, hypertension, or just feeling ill. These side effects usually get better or disappear over time.

The most common side effect of delavirdine is a skin rash, which develops in about 25 percent of people taking the drug. The risk of the rash can be reduced if you start taking the drug at a lower dose and then increase to the full dose.



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HOW DOES DELAVIRDINE REACT WITH OTHER DRUGS?


Delavirdine is broken down by the liver and can interact with other drugs that also use the liver. Combining these drugs can change the amount of each drug in your bloodstream and cause an under- or overdose. Drugs to watch out for include several antihistamines, sedatives, and anti-fungal drugs. Make sure that your doctor knows about ALL drugs you are taking.

Blood levels of delavirdine may be decreased by ddI, antacids, rifabutin, and rifampin. Be sure to take delavirdine at least one hour apart from ddI or antacids.

Delavirdine makes the liver work slower. This increases the blood levels of most protease inhibitors. There is very little specific information about combining delavirdine with protease inhibitors.



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Revised February 14, 2001

WHAT IS NEVIRAPINE?

Nevirapine, also called Viramuneョ, is a drug used for antiviral therapy. It is manufactured by Boehringer Ingelheim.

Nevirapine is a non-nucleoside reverse transcriptase inhibitor, (a "non-nuke" or NNRTI). These drugs stop HIV from multiplying by preventing the reverse transcriptase enzyme from working. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This step has to occur before HIV's genetic code gets inserted into an infected cell's genetic codes.



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WHO SHOULD TAKE NEVIRAPINE?

Nevirapine was approved as an antiviral drug for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.

Nevirapine can also be used to prevent transmission of HIV from a pregnant woman to her new child. Although AZT (another anti-HIV drug) prevents more infections, nevirapine costs less and works better where women breast-feed their babies. The mother gets one dose when she arrives at the hospital in labor, and the newborn gets one dose during the first three days of life. This approach could be very beneficial in developing countries.



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WHAT ABOUT DRUG RESISTANCE?

The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original virus. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

If you take an NNRTI by itself, resistance develops in a few weeks. For this reason, research on NNRTIs was stopped several years ago. However when you take more than one antiviral drug at the same time, HIV mutates much more slowly and it takes much longer for resistance to develop. This means that NNRTIs can be useful as part of combination therapy.

Sometimes, if you develop resistance to one drug, you will also have resistance to other antiviral drugs. This is called "cross-resistance". Cross-resistance among NNRTIs develops very easily. If you develop resistance to one NNRTI, you probably won't be able to use any of them in your antiviral therapy.

Resistance can develop quickly. It is very important to take NNRTIs according to instructions, on schedule, and not to skip or reduce doses.



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HOW IS NEVIRAPINE TAKEN?


Nevirapine is available in 200-milligram (mg) pills. The recommended dose for adults is 200 mg per day for two weeks (the lead-in period), then 400mg per day (200mg twice per day). It is important to follow this schedule to reduce the risk of serious side effects.


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WHAT ARE THE SIDE EFFECTS?

When you start any anti?viral treatment you may have temporary side effects such as headaches, hypertension, or a general sense of feeling ill. These side effects usually get better or disappear over time.

The most common side effect of nevirapine is a skin rash, which develops in about 25 percent of people taking the drug. This side effect is much more common for women than for men. The manufacturer recommends that if you develop a rash during the lead-in (lower dose) period, you should not increase to the full dose. If the rash is uncomfortable, you should stop taking the drug. Some doctors used the drug prednisone to treat the rash caused by nevirapine. However, research showed that it can actually make the rash worse. A rare side effect of nevirapine is Stevens-Johnson syndrome. This is a serious skin rash that can be fatal.

Nevirapine can also cause liver damage. Patients should be carefully monitored during the first two months of taking nevirapine to watch for signs of skin or liver problems. Nevirapine can also cause liver damage. Patients should be carefully monitored during the first two months of taking nevirapine to watch for signs of skin or liver problems. Because of the risk of liver damage, nevirapine should not be used for post-exposure prophylaxis (PEP).



--------------------------------------------------------------------------------


HOW DOES NEVIRAPINE REACT WITH OTHER DRUGS?

Nevirapine is broken down by the liver and can interact with other drugs that also use the liver. Combining these drugs can change the amount of each drug in your bloodstream and cause an under- or overdose. Drugs to watch out for include several antihistamines, sedatives, and anti-fungal drugs. Make sure that your doctor knows about ALL drugs you are taking.

Nevirapine makes the liver work faster. This reduces the blood levels of most protease inhibitors. There is very little information about combining nevirapine with protease inhibitors.

Nevirapine lowers blood levels of some birth control medications, which could make them ineffective.

Nevirapine also lowers blood levels of methadone. This can cause symptoms of drug withdrawal. Methadone doses may need to be increased for people taking nevirapine.



--------------------------------------------------------------------------------

Revised February 14, 2001



WHAT IS EFAVIRENZ?
Efavirenz, also called Sustivaョ, is a drug used for antiviral therapy. It is manufactured by Bristol-Myers Squibb.

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (a "non-nuke" or NNRTI). These drugs stop HIV from multiplying by preventing the reverse transcriptase enzyme from working. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This step has to occur before HIV's genetic code gets inserted into an infected cell's genetic codes.



--------------------------------------------------------------------------------


WHO SHOULD TAKE EFAVIRENZ?
Efavirenz was approved as an antiviral drug for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or if their viral load is over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.

Efavirenz seems to get into the central nervous system (spinal fluid). It may help prevent mental problems such as dementia.



--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?
The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original virus. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

If you take an NNRTI by itself, resistance develops in a few weeks. For this reason, research on NNRTIs was stopped several years ago. However, when you take more than one antiviral drug at the same time, HIV mutates much more slowly and it takes much longer for resistance to develop. This means that NNRTIs can be useful as part of combination therapy.

Sometimes, if you develop resistance to one drug, you will also have resistance to other antiviral drugs. This is called "cross-resistance". Cross-resistance among NNRTIs develops very easily. If you develop resistance to one NNRTI, you probably won't be able to use any of them in your antiviral therapy.

Resistance can develop quickly. It is very important to take NNRTIs according to instructions, on schedule, and not to skip or reduce doses.



--------------------------------------------------------------------------------


HOW IS EFAVIRENZ TAKEN?
Efavirenz is taken by mouth as a capsule. The normal adult dose is 600 milligrams (mg) once a day at bedtime. Efavirenz will be available in capsules of 50 mg, 100 mg, and 200 mg. It will also be available in a liquid formulation for children. Most adults will take 3 of the 200 mg capsules at a time. A 600 mg pill of efavirenz is being developed.

Efavirenz can be taken with or without food, but high-fat meals should be avoided.



--------------------------------------------------------------------------------


WHAT ARE THE SIDE EFFECTS?
When you start any anti?viral treatment, you may have temporary side effects such as headaches, high blood pressure, or just feeling ill. These side effects usually get better or disappear over time.

The most common side effects of Efavirenz are rash, nausea, dizziness, diarrhea, headache and insomnia. To avoid dizziness after taking Efavirenz, take it before you go to sleep. Some people have vivid dreams when taking Efavirenz. For most people, these side effects disappear within the first two weeks.

Studies in monkeys showed that Efavirenz is likely to cause birth defects. Pregnant women should not take Efavirenz.

People who take Efavirenz may falsely test positive for marijuana use. To prove that the results are false, you would have to say that you are taking Efavirenz. This would mean disclosing that you have HIV infection.



--------------------------------------------------------------------------------


HOW DOES EFAVIRENZ REACT WITH OTHER DRUGS?
Efavirenz is broken down by the liver and can interact with other drugs that also use the liver. Combining these drugs can change the amount of each drug in your bloodstream and cause an under- or overdose. Drugs to watch out for include several antihistamines, sedatives, and anti-fungal drugs. Make sure that your doctor knows about ALL drugs you are taking.

Efavirenz lowers blood levels of most protease inhibitors. Your doctor will need to increase the dosage of indinavir or amprenavir if you take them with efavirenz. Efavirenz and saquinavir should not be used together.
Efavirenz decreases blood levels of methadone. People using both efavirenz and methadone will need to increase their dosage of methadone.


--------------------------------------------------------------------------------


Revised December 29, 2001



WHAT IS INDINAVIR?

Indinavir, also called Crixivanョ, is a drug used for antiviral therapy. It is manufactured by Merck Pharmaceuticals. Indinavir is a protease inhibitor. These drugs prevent the protease enzyme from working. HIV protease acts like a chemical scissors. It cuts the raw material for HIV into specific pieces needed to build a new virus. Protease inhibitors "gum up" these scissors.


--------------------------------------------------------------------------------


WHO SHOULD TAKE INDINAVIR?

Indinavir was approved as an antiviral drug for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.

If you take indinavir with other antiviral drugs, you can reduce your viral load to extremely low levels, and increase your T-cell counts. This should mean staying healthier longer.



--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?

The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are different from the original virus. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

If you take a protease inhibitor by itself, resistance develops within one month. When you take more than one antiviral drug at the same time, HIV mutates much more slowly and it takes much longer for resistance to develop.

Sometimes, if you develop resistance to one drug, you will also have resistance to other antiviral drugs. This is called "cross-resistance".

Resistance can develop quickly. It is very important to take protease inhibitors according to instructions, on schedule, and not to skip or reduce doses.



--------------------------------------------------------------------------------


HOW IS INDINAVIR TAKEN?

The normal dose of Indinavir is 800 milligrams (mg) every 8 hours. The capsules are either 200mg or 400mg. A 333mg capsule is also available for people who need to take 1000mg of indinavir because of drug interactions in some combinations.

If indinavir is combined with ritonavir (another protease inhibitor), you can take it twice a day without food restrictions. If you take indinavir by itself, you should take it when your stomach is empty. This means taking indinavir two hours after eating, or one hour before eating. If you need to, you can eat dry toast with jelly and drink skim milk, juice, coffee, tea, or water with Indinavir. Fat, protein, and high-calorie foods will reduce the absorption of Indinavir.

The American Dietetic Association has a list of foods that you can safely eat when you take a dose of indinavir. You can get this list on the internet at http://www.apla.org/apla/nutrition/factsheets/indlist.html.

Indinavir is sensitive to moisture. Store it in its original container, which contains a desiccant (a material that helps keep it dry).


--------------------------------------------------------------------------------


WHAT ARE THE SIDE EFFECTS?

The most serious side effect of Indinavir is kidney stones, including pain in the sides. You can reduce the risk of kidney stones by drinking at least 8 glasses of water each day. In rare cases, Indinavir can cause serious anemia, a loss of red blood cells. This may show up as extreme fatigue, jaundice (yellowing of the skin), or rust-colored urine.

Indinavir can also cause upset stomach, bloating, and skin rash. Indinavir capsules contain lactose (milk sugar). If you have trouble digesting dairy products, you may have more stomach problems with Indinavir.

Indinavir may also cause "frozen shoulder." Also called adhesive capsulitis, this causes a reduced range of motion and pain in the shoulder.



--------------------------------------------------------------------------------

HOW DOES INDINAVIR REACT WITH OTHER DRUGS?


Indinavir is broken down by the liver. It can interact with other drugs that also use the liver. Combining these drugs can change the amount of each drug in your bloodstream and cause an under- or overdose. Drugs to watch out for include Viagra, several antihistamines, sedatives, drugs to lower cholesterol and anti-fungal drugs. Make sure that your doctor knows about ALL drugs you are taking.

If you are taking Indinavir and ddI, take them an hour apart with your stomach empty.

Some birth control pills may not work if you are taking indinavir. Talk to your doctor about how to prevent an unwanted pregnancy.

The herb St. John's Wort (See Fact Sheet 729) lowers the blood levels of some protease inhibitors. Tell your doctor about any herbs or other supplements that you use.



--------------------------------------------------------------------------------

Revised December 31, 2001


[ Edit | View ]



DRUGS;ETC. -- No name, 13:18:26 01/26/02 Sat

WHAT IS RITONAVIR?

Ritonavir, also called Norvirョ, is a drug used for antiviral therapy. It is manufactured by Abbott Laboratories. Ritonavir is a protease inhibitor. These drugs prevent the protease enzyme from working. HIV protease acts like a chemical scissors. It cuts the raw material for HIV into specific pieces needed to build a new virus. Protease inhibitors "gum up" these scissors.


--------------------------------------------------------------------------------


WHO SHOULD TAKE RITONAVIR?

Ritonavir was approved as an antiviral drug for adults and children with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the most powerful drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.

If you take ritonavir with other antiviral drugs, you can reduce your viral load to extremely low levels, and increase your T-cell counts. This should mean staying healthier longer.

Ritonavir makes the liver work more slowly. This can increase the blood levels of some drugs, including other protease inhibitors. Some doctors combine ritonavir with other protease inhibitors to produce better blood levels.



--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?

The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original virus. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.
If you take a protease inhibitor by itself, resistance develops within one month. When you take more than one antiviral drug at the same time, HIV mutates much more slowly and it takes much longer for resistance to develop.

Sometimes, if you develop resistance to one drug, you will also have resistance to other antiviral drugs. This is called "cross-resistance".

Resistance can develop quickly. It is very important to take protease inhibitors according to instructions, on schedule, and not to skip or reduce doses.



--------------------------------------------------------------------------------

HOW IS RITONAVIR TAKEN?

Ritonavir is taken by mouth as a liquid or capsule. The normal dose is 600 milligrams (mg) twice a day. The capsules are 100mg, so you will take 6 capsules every 12 hours. Ritonavir should be taken with meals, if possible.

Ritonavir is sometimes combined with other protease inhibitors. These combinations might use a different amount of ritonavir. Be sure you know how much ritonavir you are supposed to take.

During 1998, Abbott Laboratories noticed problems with the original ritonavir capsules. Production was stopped. Everyone taking ritonavir had to take the liquid form. Many people think the liquid version tastes bad. However, some people find the liquid more convenient. It will still be available.

Liquid ritonavir comes with a measuring cup. It takes 7.5mL (milliliters) of liquid (1-1/2 teaspoons) to equal the normal dose of 600 mg. The liquid version should not be refrigerated. Shake the bottle before taking each dose.

Your pharmacist must keep the new ritonavir soft-gel capsules refrigerated. You should keep ritonavir in your refrigerator, but it can also stay out at room temperature (below 77 degrees F, or 25 degrees C) for up to 30 days.



--------------------------------------------------------------------------------


WHAT ARE THE SIDE EFFECTS?

The most serious side effects of ritonavir are nausea, vomiting, gas, and diarrhea. Some people also experience tingling or numbness around the mouth, or find that foods taste strange. Side effects made almost one-third of people stop taking ritonavir.

For many people, the side effects of ritonavir lasted only 2 to 4 weeks. If they lasted beyond 4 weeks, in most cases they were permanent.

To reduce stomach upset with ritonavir, the manufacturer recommends starting with half the usual dose and increasing the drug on the following schedule:
Day 1: 300mg every 12 hours
Days 2-3: 400mg every 12 hours
Day 4: 500mg every 12 hours
Day 5 and after: 600mg every 12 hours



--------------------------------------------------------------------------------

HOW DOES RITONAVIR REACT WITH OTHER DRUGS?

Ritonavir is broken down by the liver. It can interact with other drugs that use the liver. Combining these drugs can change the amount of each drug in your bloodstream and cause an under- or overdose. Drugs to watch out for include Viagra, several antihistamines, sedatives, drugs to lower cholesterol and anti-fungal drugs. Make sure that your doctor knows about ALL drugs you are taking.

If you are taking ritonavir and ddI, you should take them 2-1/2 half hours apart.

Some birth control pills may not work if you are taking ritonavir. Talk to your doctor about how to prevent an unwanted pregnancy.

The herb St. John's Wort (See Fact Sheet 729) lowers the blood levels of some protease inhibitors. Tell your doctor about any herbs or other supplements that you use.



--------------------------------------------------------------------------------

Revised February 14, 2001

WHAT IS SAQUINAVIR?

Saquinavir, also called Fortovaseョ or Inviraseョ, is a drug used for antiviral therapy. It is manufactured by Roche Laboratories. Saquinavir is a protease inhibitor. These drugs prevent the protease enzyme from working. HIV protease acts like a chemical scissors. It cuts the raw material for HIV into specific pieces needed to build a new virus. Protease inhibitors "gum up" these scissors.


--------------------------------------------------------------------------------


WHO SHOULD TAKE SAQUINAVIR?

Saquinavir was approved as an antiviral drug for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the most powerful drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.

If you take saquinavir with other antiviral drugs, you can reduce your viral load to extremely low levels, and increase your T-cell counts. This should mean staying healthier longer.



--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?

The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original virus. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

If you take a protease inhibitor by itself, resistance develops within one month. When you take more than one antiviral drug at the same time, HIV mutates much more slowly and it takes much longer for resistance to develop.

Sometimes, if you develop resistance to one drug, you will also have resistance to other antiviral drugs. This is called "cross-resistance".

Resistance can develop quickly. It is very important to take protease inhibitors according to instructions, on schedule, and not to skip or reduce doses.



--------------------------------------------------------------------------------


HOW IS SAQUINAVIR TAKEN?

The normal dose of the Saquinavir soft-gel capsule (Fortovaseョ) is 1,200 milligrams (mg) three times a day. The capsules are 200mg, so you will take 6 capsules every 8 hours. Researchers are studying twice a day dosing of saquinavir.

Some physicians prescribe saquinavir in combination with another protease inhibitor, ritonavir. Studies are underway using a single daily dose of saquinavir taken with a small amount of ritonavir.

Saquinavir should be taken within two hours after a full meal or a large snack. Saquinavir is absorbed better (more of the drug gets into your bloodstream) if you take it after eating foods that are high in calories, fat, and protein.

NOTE: Saquinavir was initially marketed as Inviraseョ. This formulation of the drug was not absorbed very well, and is being replaced by Fortovaseョ.

Your pharmacist should keep saquinavir refrigerated. When you take it home, you can refrigerate it, or else keep it below 77コ F or 25コ C and use it within three months.



--------------------------------------------------------------------------------

WHAT ARE THE SIDE EFFECTS?

The side effects of saquinavir are usually mild. Most people can take it with no problems. However, some people get nausea, diarrhea, upset stomach, and heartburn.


--------------------------------------------------------------------------------

HOW DOES SAQUINAVIR REACT WITH OTHER DRUGS?

Saquinavir is broken down by the liver and can interact with other drugs that also use the liver. Combining these drugs can change the amount of each drug in your bloodstream and cause an under- or overdose. Drugs to watch out for include several antihistamines, sedatives, and anti-fungal drugs. Make sure that your doctor knows about ALL drugs you are taking.

Some birth control pills may not work if you are taking saquinavir. Talk to your doctor about how to prevent an unwanted pregnancy.

The herb St. John's Wort (See Fact Sheet 729) lowers the blood levels of some protease inhibitors. Tell your doctor about any herbs or other supplements that you use.



--------------------------------------------------------------------------------

Revised February 14, 2001

WHAT IS NELFINAVIR?

Nelfinavir, also called Viraceptョ, is a drug used for antiviral therapy. It is manufactured by Agouron Pharmaceuticals. Nelfinavir is a protease inhibitor. These drugs prevent the protease enzyme from working. HIV protease acts like a chemical scissors. It cuts the raw material for HIV into specific pieces needed to build a new virus. Protease inhibitors "gum up" these scissors.


--------------------------------------------------------------------------------


WHO SHOULD TAKE NELFINAVIR?

Nelfinavir is an antiviral drug for adults and children with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) is over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the most powerful drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.

If you take nelfinavir with other antiviral drugs, you can reduce your viral load to extremely low levels, and increase your T-cell counts. This should mean staying healthier longer.



--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?

The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original virus. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

If you take a protease inhibitor by itself, resistance develops within one month. When you take more than one antiviral drug at the same time, HIV mutates much more slowly and it takes much longer for resistance to develop.

Sometimes, if you develop resistance to one drug, you will also have resistance to other antiviral drugs. This is called "cross-resistance". Researchers are excited about nelfinavir because it appears that it will not be cross-resistant with other protease inhibitors.

Resistance can develop quickly. It is very important to take protease inhibitors according to instructions, on schedule, and not to skip or reduce doses.



--------------------------------------------------------------------------------
HOW IS NELFINAVIR TAKEN?

Nelfinavir is taken by mouth as a capsule. The normal dose is 750 milligrams (mg) three times a day. The capsules are 250mg, so you will take 3 capsules at a time.

Late in 1999, the FDA approved twice-daily dosing of nelfinavir at 1250 mg per dose. This means taking 5 capsules at a time. If you want to change how often you take nelfinavir, talk to your doctor.

The former capsules dissolved quickly and were difficult to swallow. A film-coated tablet was approved in March 2000 and replaced the old capsules.

Nelfinavir should be taken with meals. It should be stored at room temperature and protected from moisture, freezing, or excessive heat.



--------------------------------------------------------------------------------
WHAT ARE THE SIDE EFFECTS?

The most common side effects of nelfinavir are diarrhea, weakness, headache, nausea, and abdominal pain. None of these side effects seem to be very serious. The diarrhea in most cases can be controlled with over-the-counter medications.


--------------------------------------------------------------------------------
HOW DOES NELFINAVIR REACT WITH OTHER DRUGS?

Nelfinavir is broken down by the liver and can interact with other drugs that also use the liver. Combining these drugs can change the amount of each drug in your bloodstream and cause an under- or overdose. Drugs to watch out for include Viagra, several antihistamines, sedatives, drugs to lower cholesterol and anti-fungal drugs. Make sure that your doctor knows about ALL drugs you are taking.

If you are taking nelfinavir and ddI, you should take ddI one hour before or two hours after nelfinavir.

Some birth control pills may not work if you are taking nelfinavir. Talk to your doctor about how to prevent an unwanted pregnancy.

The herb St. John's Wort (See Fact Sheet 729) lowers the blood levels of some protease inhibitors. Tell your doctor about any herbs or other supplements that you use.



--------------------------------------------------------------------------------


Revised February 14, 2001



WHAT IS AMPRENAVIR?
Amprenavir, also called Ageneraseョ, is a drug used for antiviral therapy. It is manufactured by GlaxoSmithKline. Amprenavir used to be called 141W94.

Amprenavir is a protease inhibitor. These drugs prevent the protease enzyme from working. HIV protease acts like a chemical scissors. It cuts the raw material for HIV into specific pieces needed to build a new virus. Protease inhibitors "gum up" these scissors.



--------------------------------------------------------------------------------

WHO SHOULD TAKE AMPRENAVIR?
Amprenavir was approved as an antiviral drug for people with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.


There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the most powerful drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.

If you take amprenavir with other antiviral drugs, you can reduce your viral load to extremely low levels, and increase your T-cell counts. This should mean staying healthier longer.

Amprenavir is a sulfa drug. If you know that you are allergic to sulfa drugs, be sure to tell your doctor before taking amprenavir.

The liquid form of amprenavir contains an inactive ingredient called propylene glycol. This ingredient can cause problems for infants or children under 4 years old, pregnant women, people with liver or kidney failure, or people taking certain medications. They should not use liquid amprenavir.



--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?
The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original virus. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

If you take a protease inhibitor by itself, resistance develops within one month. When you take more than one antiviral drug at the same time, HIV mutates much more slowly and it takes much longer for resistance to develop.

Sometimes, if you develop resistance to one drug, you will also have resistance to other antiviral drugs. This is called "cross-resistance". Researchers are excited about Amprenavir because it might not be cross-resistant with other protease inhibitors.

Resistance can develop quickly. It is very important to take protease inhibitors according to instructions, on schedule, and not to skip or reduce doses.



--------------------------------------------------------------------------------


HOW IS AMPRENAVIR TAKEN?
Amprenavir is taken by mouth as a capsule. The normal adult dose is 1200 milligrams (mg) two times a day. The capsules are 150mg, so you will take 8 capsules at a time. The dose is lower, based on body weight, for children and people who weigh less than 50 kilograms (110 pounds).

Amprenavir is available as gelatin capsules and as a liquid. The gelatin capsules should be kept at room temperature. If they get too warm, they can melt. The liquid form contains an inactive ingredient (propylene glycol) that should not be taken by infants or children under 4 years old, pregnant women, or people with liver or kidney failure, or people taking certain drugs.

Amprenavir can be taken with or without food, but high-fat meals should be avoided. Do not take antacids within one hour of taking amprenavir.

GlaxoSmithKline is developing GW433908, a new form of amprenavir. It is a "prodrug" of amprenavir. A prodrug becomes active after it is broken down in the body. GW433908 should provide the same benefits as amprenavir with fewer pills to take.

If you have liver problems, you may need to take a lower dose of amprenavir.



--------------------------------------------------------------------------------


VITAMIN E
Amprenavir capsules contain vitamin E. The Vitamin E makes amprenavir easier for the body to absorb and makes it work better. Each 150mg capsule contains 109 International Units (IU) of Vitamin E. The normal adult dose of amprenavir contains 1,744 IU of vitamin E. This information can help you decide what vitamin supplements to take.



--------------------------------------------------------------------------------


WHAT ARE THE SIDE EFFECTS?
The most common side effects of amprenavir are nausea, diarrhea, vomiting, rash, numbness around the mouth, and abdominal pain. About 1% of people taking amprenavir get serious skin reactions, including Stevens-Johnson syndrome. No other side effects seem to be very serious. The diarrhea in most cases can be controlled with over-the-counter medications.

Amprenavir might not cause problems with fat redistribution (lipodystrophy) the way that other protease inhibitors do.



--------------------------------------------------------------------------------


HOW DOES AMPRENAVIR REACT WITH OTHER DRUGS?
Amprenavir is broken down by the liver and can interact with other drugs that also use the liver. Combining these drugs can change the amount of each drug in your bloodstream and cause an under- or overdose. Drugs to watch out for include Viagra, several antihistamines, sedatives, drugs to lower cholesterol and anti-fungal drugs. Make sure that your doctor knows about ALL drugs you are taking.

Amprenavir works better if it is taken with the reverse transcriptase inhibitor abacavir.

If you are taking amprenavir and ddI, you should take them one hour apart. You should also take amprenavir one hour apart from antacids.

Some birth control pills may not work if you are taking amprenavir. Talk to your doctor about how to prevent an unwanted pregnancy.

The herb St. John's Wort (See Fact Sheet 729) lowers the blood levels of some protease inhibitors. Tell your doctor about any herbs or other supplements that you use.



--------------------------------------------------------------------------------


Revised February 14, 2001



WHAT IS LOPINAVIR?
Lopinavir is a drug used for antiviral therapy. Lopinavir used to be called ABT-378. It is manufactured by Abbott Laboratories. Lopinavir is a protease inhibitor. The amount of Lopinavir in the blood stream stays much higher if it is taken with a small amount of ritonavir, another protease inhibitor. See Fact Sheet 442 for more information on ritonavir. Kaletraョ is a combination of lopinavir and ritonavir in the same capsule.

Protease inhibitors prevent the protease enzyme from working. HIV protease acts like a chemical scissors. It cuts the raw material for HIV into specific pieces needed to build a new virus. Protease inhibitors "gum up" these scissors.



--------------------------------------------------------------------------------


WHO SHOULD TAKE KALETRA?
Kaletra is an antiviral drug for adults with HIV infection. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, has a T-cell count (CD4+ cells) below 350, or has a viral load (a measure of the amount of virus in the blood) over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the most powerful drugs to preserve the immune system. Others want to save the strongest drugs until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, your viral load, any symptoms you are having, and your attitude about taking HIV medications.

If you take Kaletra with other antiviral drugs, you can reduce your viral load to extremely low levels, and increase your T-cell counts. This should mean staying healthier longer.


--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?
The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original virus. Some mutations can keep multiplying even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

If you take a protease inhibitor by itself, resistance develops within one month. When you take more than one antiviral drug at the same time, HIV mutates much more slowly and it takes much longer for resistance to develop.

Sometimes, if you develop resistance to one drug, you will also have resistance to other antiviral drugs. This is called "cross-resistance".

Doctors are excited about Kaletra because it provides blood levels that are high enough to control HIV that has already developed some resistance to other protease inhibitors.

Resistance can develop quickly. It is very important to take protease inhibitors according to instructions, on schedule, and not to skip or reduce doses.


--------------------------------------------------------------------------------


HOW IS KALETRA TAKEN?
Kaletra is taken by mouth as a capsule. Each capsule contains 133 milligrams (mg) of lopinavir and 33 mg of ritonavir. The normal dose is three capsules twice a day. Kaletra should be taken with food.

Kaletra is also available in liquid form. The adult dose is 5 milliliters (ml) twice a day.

Kaletra is approved for use by children. Their dosage is based on their body weight.

Your pharmacist should keep Kaletra refrigerated. When you take it home, you can refrigerate it, or else keep it below 77コ F or 25コ C and use it within two months.


--------------------------------------------------------------------------------

WHAT ARE THE SIDE EFFECTS?
The most common side effects of Kaletra are diarrhea, fatigue, headache, and nausea. None of these side effects seem to be very serious. Kaletra can increase the amount of fat (cholesterol and triglycerides) in your blood. High levels of blood fats can increase your risk of problems with your heart or pancreas.


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HOW DOES KALETRA REACT WITH OTHER DRUGS?
Kaletra is broken down by the liver and can interact with other drugs that also use the liver. Combining these drugs can change the amount of each drug in your bloodstream and cause an under- or overdose. Drugs to watch out for include Viagra, several antihistamines, sedatives, drugs to lower cholesterol and anti-fungal drugs. Make sure that your doctor knows about ALL drugs you are taking.

If you are taking Kaletra and ddI, you should take ddI one hour before or two hours after Kaletra. You should also take Kaletra one hour apart from antacids.

Some birth control pills may not work if you are taking Kaletra. Talk to your doctor about how to prevent an unwanted pregnancy.

The herb St. John's Wort (See Fact Sheet 729) lowers the blood levels of some protease inhibitors. Tell your doctor about any herbs or other supplements that you use.



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Revised February 14, 2001


[ Edit | View ]



DRUGS;ETC. -- No name, 13:21:07 01/26/02 Sat

WHAT IS AZITHROMYCIN?
Azithromycin is an antibiotic drug. In the US, its brand name is Zithromax. It is sold under many other brand names in other countries.

Antibiotics fight infections caused by bacteria. Azithromycin is used to fight opportunistic infections in people with HIV. Pfizer manufactures it.


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WHY DO PEOPLE WITH HIV TAKE AZITHROMYCIN?
Azithromycin is used for mild or moderate bacterial infections. It works against several different bacteria, especially chlamydia, hemophilus and streptococcus. These bacteria can infect the skin, nose, throat, and lungs. They can also be transmitted through sexual activity and cause infections in the genital area.

Many germs live in our bodies or are common in our surroundings. A healthy immune system can fight them off or keep them under control. However, HIV infection can weaken the immune system. Infections that take advantage of weakened immune defenses are called "opportunistic infections." People with advanced HIV disease can get opportunistic infections. See Fact Sheet 500 for more information on Opportunistic Infections.

One opportunistic infection in people with HIV is MAC. This stands for mycobacterium avium complex. See Fact Sheet 510 for more information on MAC. People who have a T-cell count of less than 75 may develop MAC.

Azithromycin is often used with another antibiotic to treat MAC. It can also be used to prevent MAC infection. If your T-cell count is below 75, talk to your doctor about using azithromycin.

Some people are allergic to azithromycin and similar antibiotics. Be sure to tell your doctor if you are allergic to erythromycin or other antibiotics.


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WHAT ABOUT DRUG RESISTANCE?
Whenever you take medication, be sure to take all of the prescribed doses. Many people stop if they feel better. This is not a good idea. If the drug doesn't kill all of the germs, they might change (mutate) so that they can survive even when you are taking medications. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

For example, if you are taking azithromycin to fight MAC and you miss too many doses, the MAC in your body could develop resistance to azithromycin. Then you would have to take a different drug or combination of drugs to fight MAC.


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HOW IS AZITHROMYCIN TAKEN?
Azithromycin is available in capsules or tablets of 250 milligram (mg.) There is also a 600 mg tablet. It is also available in powder and liquid forms. To fight most infections, the dose for adults is 500 mg on the first day, and then 250 mg each day for 4 more days.

The dose used to prevent MAC infection is 1200 mg or 1250 mg once a week.

Azithromycin tablets can be taken with or without food. Take it with plenty of water. The capsules or liquid should be taken on an empty stomach, either 1 hour before eating or 2 hours after eating. Be sure to check the instructions carefully.

Do not take azithromycin at the same time as antacids that contain aluminum or magnesium. They will reduce the amount of azithromycin in your blood.


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WHAT ARE THE SIDE EFFECTS?
The side effects of azithromycin mostly affect the digestive system. They include diarrhea, nausea, and pain in the abdomen. Some people get very sensitive to sunlight. Others may get headaches, be dizzy or sleepy, or have some problems hearing. Very few people who take azithromycin get these side effects. However, most anti-HIV medications also cause problems in the digestive system. Azithromycin could make those problems worse.

Antibiotics kill some helpful bacteria that normally live in the digestive system. You can eat yogurt or take supplements of acidophilus to replace them.


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HOW DOES AZITHROMYCIN REACT WITH OTHER DRUGS?
Azithromycin is broken down by the liver. It can interact with other drugs that also use the liver. Scientists have not yet studied all the possible interactions. Azithromycin probably interacts with some blood thinners, heart medications, seizure medications, and other antibiotics. Be sure your doctor knows about all the medications you are taking.

Your doctor may need to monitor you carefully if you are taking azithromycin and the protease inhibitor ritonavir.

Antacids with aluminum or magnesium can lower blood levels of azithromycin. Do not take antacids at the same time as azithromycin.



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Revised May 4, 2001



WHAT IS CIPROFLOXACIN?
Ciprofloxacin, also called Ciproョ, is an antibiotic drug. Antibiotics fight infections caused by bacteria. Cipro fights many different bacteria. It is also used to fight some opportunistic infections in people with HIV. Bayer Corporation manufactures it.


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WHY DO PEOPLE WITH HIV TAKE CIPRO?
Cipro is used for a wide range of bacterial infections. It works against many different bacteria. Cipro works against some bacteria that are resistant to other antibiotics, including penicillin.

Many germs live in our bodies or are common in our surroundings. A healthy immune system can fight them off or keep them under control. However, HIV infection can weaken the immune system. Infections that take advantage of weakened immune defenses are called "opportunistic infections." People with advanced HIV disease can get opportunistic infections. See Fact Sheet 500 for more information on Opportunistic Infections.

One opportunistic infection in people with HIV is MAC. This stands for mycobacterium avium complex. See Fact Sheet 510 for more information on MAC. People who have a T-cell count of less than 75 may develop MAC.

Cipro is often used along with other antibiotics to treat MAC. If your T-cell count is below 75, talk to your doctor about using Cipro.

Some people are allergic to Cipro and similar antibiotics. Be sure to tell your doctor if you are allergic to any antibiotics.



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WHAT ABOUT DRUG RESISTANCE?
Whenever you take medication, be sure to take all of the prescribed doses. Many people stop if they feel better. This is not a good idea. If the drug doesn't kill all of the germs, they might change (mutate) so that they can survive even when you are taking medications. When this happens, the drug will stop working. This is called "developing resistance" to the drug.


For example, if you are taking Cipro to fight MAC and you miss too many doses, the MAC in your body could develop resistance to Cipro. Then you would have to take a different drug or combination of drugs to fight MAC.



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HOW IS CIPRO TAKEN?
Cipro is available in several different strength tablets. They contain between 100 milligrams (mg) and 750 mg of Cipro. It is also available in a liquid form. Cipro is taken every 12 hours. The dose of Cipro and the length of time you will take it depend on the type of infection you have.

Cipro tablets can be taken with or without food. Take them with plenty of water. Drink lots of water while you are taking Cipro to make sure the drug doesn't accumulate in your kidneys.

Do not take Cipro at the same time as antacids that contain aluminum or magnesium. They will reduce the amount of Cipro in your blood.



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WHAT ARE THE SIDE EFFECTS?
The most common side effects of Cipro are nausea, diarrhea, vomiting, abdominal pain or discomfort, headache, rash and restlessness. It can also cause dizziness and drowsiness. Very few people who take Cipro get these side effects. However, most anti-HIV medications also cause problems in the digestive system. Cipro could make these problems worse.

Cipro makes some people very sensitive to sunlight. It increases the effects of caffeine and can make you very jittery and nervous. In rare cases, Cipro causes an allergic reaction that can be serious.

Antibiotics kill some helpful bacteria that normally live in the digestive system. You can eat yogurt or take supplements of acidophilus to replace them.



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HOW DOES CIPRO REACT WITH OTHER DRUGS?
Cipro is not broken down by the liver. This means that it does not have many interactions with HIV antiviral medications. However, it is still a good idea to tell your doctor about all the medications you are taking.

Antacids that contain aluminum or magnesium can lower blood levels of Cipro. Do not take antacids at the same time as Cipro.

Supplements that contain calcium, iron, or zinc can also reduce levels of Cipro. Do not take them while you are taking Cipro. Ask your doctor whether you should keep taking multivitamins that contain iron, calcium or zinc while you are taking Cipro.

Probenecid is a drug used to lower uric acid levels. This is a treatment for gout. Probenecid causes large increases in the blood levels of Cipro.

Cipro can increase methadone levels, possibly causing a serious overdose.



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Revised May 4, 2001



WHAT IS CLARITHROMYCIN?
Clarithromycin is an antibiotic drug. In the US, its brand name is Biaxinョ.

Antibiotics fight infections caused by bacteria. Clarithromycin is also used to fight opportunistic infections in people with HIV. Abbott manufactures it.



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WHY DO PEOPLE WITH HIV TAKE CLARITHROMYCIN?
Clarithromycin is used for mild or moderate bacterial infections. It works against several different bacteria, especially chlamydia, hemophilus and streptococcus. These bacteria can infect the skin, nose, throat, lungs and ears.

Many germs live in our bodies or are common in our surroundings. A healthy immune system can fight them off or keep them under control. However, HIV infection can weaken the immune system. Infections that take advantage of weakened immune defenses are called "opportunistic infections." People with advanced HIV disease can get opportunistic infections. See Fact Sheet 500 for more information on Opportunistic Infections.

One opportunistic infection in people with HIV is MAC. This stands for mycobacterium avium complex. See Fact Sheet 510 for more information on MAC. People who have a T-cell count of less than 75 may develop MAC.

Clarithromycin is often used with other antibiotics to treat MAC. It can also be used to prevent MAC infection. If your T-cell count is below 75, talk to your doctor about using clarithromycin.

Some people are allergic to clarithromycin and similar antibiotics. Be sure to tell your doctor if you are allergic to erythromycin or other antibiotics.



--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?
Whenever you take medication, be sure to take all of the prescribed doses. Many people stop if they feel better. This is not a good idea. If the drug doesn't kill all of the germs, they might change (mutate) so that they can survive even when you are taking medications. When this happens, the drug will stop working. This is called "developing resistance" to the drug.


For example, if you are taking clarithromycin to fight MAC and you miss too many doses, the MAC in your body could develop resistance to clarithromycin. Then you would have to take a different drug or combination of drugs to fight MAC.



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HOW IS CLARITHROMYCIN TAKEN?
Clarithromycin is available in tablets of 250 or 500 milligrams (mg.) It is also available in granules to prepare a liquid form. The dose and the length of time you will take it depend on the type of infection you have.

The dose used to prevent MAC infection is 500 mg every 12 hours. The treatment continues as long as your T-cell count is low enough for you to develop MAC.

Regular clarithromycin tablets can be taken with or without food. There is also "Biaxin XL" which is an extended release version. Biaxin XL should be taken with food. Taking Biaxin with food can reduce stomach upset.

Take clarithromycin with a full glass of water.



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WHAT ARE THE SIDE EFFECTS?
The side effects of clarithromycin mostly affect the digestive system. They include diarrhea, nausea, heartburn and pain in the abdomen. Some people get headaches or rash. Very few people who take clarithromycin get these side effects. However, most anti-HIV medications also cause problems in the digestive system. Clarithromycin could make those problems worse.

Clarithromycin can be hard on the liver. Your doctor will probably watch your lab results carefully for any sign of liver damage. Let your doctor know if your urine gets dark or your bowel movements get light-colored.

Antibiotics kill some helpful bacteria that normally live in the digestive system. You can eat yogurt or take supplements of acidophilus to replace them.



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HOW DOES CLARITHROMYCIN REACT WITH OTHER DRUGS?
Clarithromycin is broken down by the liver. It can interact with other drugs that also use the liver. Scientists have not yet studied all the possible interactions. Clarithromycin probably interacts with all of the non-nucleoside reverse transcriptase inhibitors (NNRTIs), some blood thinners, heart medications, seizure medications, and other antibiotics. Be sure your doctor knows about all the medications you are taking.

The protease inhibitors ritonavir (Norvir) or lopinavir (Kaletra) can increase blood levels of clarithromycin.

Clarithromycin may change blood levels of zidovudine (AZT, Retrovir.)



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Revised November 22, 2000



WHAT IS DAPSONE?
Dapsone is an antibiotic drug. It is sold as Dapsone or Avlosulfonョ.

Antibiotics fight infections caused by bacteria. Dapsone is also used to fight opportunistic infections in people with HIV. Jacobus manufactures it.


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WHY DO PEOPLE WITH HIV TAKE DAPSONE?
Dapsone is usually used to fight leprosy or a skin problem called dermatitis herpetiformis.

Many germs live in our bodies or are common in our surroundings. A healthy immune system can fight them off or keep them under control. However, HIV infection can weaken the immune system. Infections that take advantage of weakened immune defenses are called "opportunistic infections." People with advanced HIV disease can get opportunistic infections. See Fact Sheet 500 for more information on Opportunistic Infections.

One opportunistic infection in people with HIV is PCP. This stands for pneumocystis carinii pneumonia, which affects the lungs. See Fact Sheet 512 for more information on PCP. People who have a T-cell count of less than 200 may develop PCP.

Doctors sometimes use a combination of trimethoprim and dapsone to treat PCP. Dapsone can also be used to prevent PCP. If your T-cell count is below 200, ask your doctor if you should be taking dapsone or another drug to prevent PCP.

Another opportunistic infection is toxoplasmosis (toxo), which affects the brain. See Fact Sheet 517 for more information on toxo. People who have a T-cell count of less than 100 may develop toxo. Dapsone can be used with the drug pyrimethamine to treat cases of toxo. This combination can also be used to prevent toxo.

Some people are allergic to dapsone. Be sure to tell your doctor if you are allergic to any antibiotics.

Dapsone can cause anemia, so people who are anemic should talk to their doctor about whether dapsone is the best drug for them. Also, some people have low levels of an enzyme known as glucose-6-phosphate dehydrogenase or G6PD. Up to 15% of African-American men, and many men of Mediterranean ancestry have this shortage and should not take dapsone. They could develop sudden, severe anemia.


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WHAT ABOUT DRUG RESISTANCE?
Whenever you take medication, be sure to take all of the prescribed doses. Many people stop if they feel better. This is not a good idea. If the drug doesn't kill all of the germs, they might change (mutate) so that they can survive even when you are taking medications. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

For example, if you are taking dapsone to fight PCP and you miss too many doses, the PCP in your body could develop resistance to dapsone. Then you would have to take a different drug or combination of drugs to fight it.


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HOW IS DAPSONE TAKEN?
Dapsone is available in tablets of 25 or 100 milligrams (mg.) It is normally taken once a day. The dose you take depends on the type of infection you are trying to treat or prevent.

The treatment continues as long as your T-cell count is low enough for you to develop toxo or PCP.

Dapsone can be taken with or without food. If your stomach gets upset when you take dapsone, take it with food.


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WHAT ARE THE SIDE EFFECTS?
The main side effect of dapsone is anemia, a loss of red blood cells. Stomach upset is also common. A few people get nausea, vomiting, headache, dizziness, or peripheral neuropathy (See Fact Sheet 553 on Peripheral Neuropathy.)

Dapsone can also make you sensitive to sunlight. If this occurs, use sun block on your skin and/or wear sunglasses.

Tell your doctor if your skin gets pale or yellowish, or you get a sore throat, fever, or rash, even after a few weeks of taking dapsone. These might indicate a serious drug reaction.


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HOW DOES DAPSONE REACT WITH OTHER DRUGS?
Dapsone is broken down by the liver. It can interact with other drugs that also use the liver. Scientists have not yet studied all the possible interactions. Dapsone probably interacts with some blood thinners, heart medications, seizure medications, and other antibiotics. Be sure your doctor knows about all the medications you are taking.

Your doctor should watch carefully for drug interactions if you are taking dapsone along with the protease inhibitors amprenavir (Ziagenョ) or saquinavir (Fortovaseョ), or the non-nucleoside reverse transcriptase inhibitor delavirdine (Rescriptorョ).

Blood levels of dapsone can be reduced if you take rifampin, a drug used to treat tuberculosis or MAC. Also, ddI can reduce absorption of dapsone. Take dapsone at least 2 hours before or after you take ddI.

The risk of developing anemia is higher if you take dapsone at the same time as other drugs that can cause anemia, such as AZT.

The risk of developing peripheral neuropathy is higher if you take dapsone at the same time as other drugs that can cause neuropathy, such as ddI, ddC, and d4T.



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Revised May 4, 2001



WHAT IS FLUCONAZOLE?
Fluconazole is an antifungal drug. In the US, its brand name is Diflucanョ. It is sold under many different names in other parts of the world.

Antifungals fight infections caused by fungus. Fluconazole fights opportunistic infections in people with HIV. Pfizer manufactures it.



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WHY DO PEOPLE WITH HIV TAKE IT?
Fluconazole is used when fungal infections can't be treated with skin lotions or creams. It works against several different types of fungus, including the yeast infection called candidiasis or thrush.

Many germs live in our bodies or are common in our surroundings. A healthy immune system can fight them off or keep them under control. However, HIV infection can weaken the immune system. Infections that take advantage of weakened immune defenses are called "opportunistic infections." People with advanced HIV disease can get opportunistic infections. See Fact Sheet 500 for more information on Opportunistic Infections.

The yeast infection candidiasis, or thrush, is fairly common. It can be more serious in people with HIV. See Fact Sheet 516 for more information on thrush. Another opportunistic infection, cryptococcal meningitis, is discussed in Fact Sheet 503. Fluconazole has been approved to treat both of these infections.

Some doctors also use fluconazole to treat other opportunistic infections caused by fungus.



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WHAT ABOUT DRUG RESISTANCE?
Whenever you take medication, be sure to take all of the prescribed doses. Many people stop if they feel better. This is not a good idea. If the drug doesn't kill all of the germs, they might change (mutate) so that they can survive even when you are taking medications. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

For example, if you are taking fluconazole to fight thrush and you miss too many doses, the thrush in your body could develop resistance to fluconazole. Then you would have to take a different drug or combination of drugs to fight thrush.

Many doctors prefer to treat thrush with creams, or lozenges that dissolve in the mouth. Thrush is much less likely to develop resistance when the treatment is applied directly to the infection instead of through the whole body.



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HOW IS IT TAKEN?
Fluconazole is available in several forms. It comes in tablets of 50, 100, 150, or 200 milligrams (mg.) It is also available in granules to prepare a liquid form, and as a liquid for intravenous use. The dose and the length of time you will take it depend on the type of infection you have.

If you have had kidney problems, your doctor might need to reduce your dose of fluconazole.

You can take fluconazole with or without food.



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WHAT ARE THE SIDE EFFECTS?
The most common side effects of fluconazole are headache, nausea and pain in the abdomen. A few people get diarrhea. Most anti-HIV medications cause problems in the digestive system. Fluconazole could make those problems worse.

Fluconazole can be hard on the liver. Your doctor will probably watch your lab results carefully for any sign of liver damage. Let your doctor know if your urine gets dark or your bowel movements get light-colored.

Fluconazole can also cause kidney damage. Let your doctor know if you notice a rapid increase in your weight, or if any part of your body gets swollen.

In rare cases, fluconazole can cause a serious reaction (Stevens-Johnson syndrome) that shows up as a skin rash.



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HOW DOES FLUCONAZOLE REACT WITH OTHER DRUGS?
Fluconazole is mostly processed by the kidneys. It does not interact very much with drugs that use the liver, including most antiviral drugs used to fight HIV. However, fluconazole interacts with several other types of drugs. These include some blood thinners, seizure medications, water pills (diuretics), pills to lower blood sugar, and other antibiotics. Be sure your doctor knows about all the medications you are taking.



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Revised December 19, 2001



WHAT IS TMP/SMX?
TMP/SMX is combination of two antibiotic drugs: trimethoprim and sulfamethoxazole. It is also known as cotrimoxazole. It is sold as Bactrimョ (manufactured by Roche) or Septraョ (by Monarch Pharmaceuticals). TMP/SMX is sold under many other names in different parts of the world.

Antibiotics fight infections caused by bacteria. TMP/SMX is also used to fight some infections caused by protozoa, and some opportunistic infections in people with HIV.


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WHY DO PEOPLE WITH HIV TAKE TMP/SMX?
TMP/SMX is used for many bacterial infections. It is effective and inexpensive. Unfortunately, up to one third of the people who take it get an allergic reaction

Many germs live in our bodies or are common in our surroundings. A healthy immune system can fight them off or keep them under control. However, HIV infection can weaken the immune system. Infections that take advantage of weakened immune defenses are called "opportunistic infections." People with advanced HIV disease can get opportunistic infections. See Fact Sheet 500 for more information on Opportunistic Infections.

One opportunistic infection in people with HIV is PCP. This stands for pneumocystis carinii pneumonia, which affects the lungs. See Fact Sheet 512 for more information on PCP. People who have a T-cell count of less than 200 may develop PCP.

TMP/SMX is the first choice to treat or prevent PCP. If your T-cell count is below 200, ask your doctor if you should be taking TMP/SMX or another drug to prevent PCP.

Another opportunistic infection is toxoplasmosis (toxo), which affects the brain. See Fact Sheet 517 for more information on toxo. People who have a T-cell count of less than 100 may develop toxo. TMP/SMX is sometimes used to treat or prevent cases of toxo.

Some people are allergic to TMP/SMX. Be sure to tell your doctor if you are allergic to sulfa drugs or antibiotics. People who are anemic should not use TMP/SMX.


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WHAT ABOUT DRUG RESISTANCE?
Whenever you take medication, be sure to take all of the prescribed doses. Many people stop if they feel better. This is not a good idea. If the drug doesn't kill all of the germs, they might change (mutate) so that they can survive even when you are taking medications. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

For example, if you are taking TMP/SMX to fight PCP and you miss too many doses, the PCP in your body could develop resistance to TMP/SMX. Then you would have to take a different drug or combination of drugs to fight it.


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HOW IS TMP/SMX TAKEN?
TMP/SMX is available in tablets that contain 80 milligrams (mg) of trimethoprim and 400 mg of sulfamethoxazole. There is also a "double strength" tablet with 160 mg of trimethoprim and 800 mg of sulfamethoxazole. The dose you take depends on the type of infection you are trying to treat or prevent.

The treatment continues as long as your T-cell count is low enough for you to develop toxo or PCP.

TMP/SMX can be taken with or without food. You should drink plenty of water when taking TMP/SMX.


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WHAT ARE THE SIDE EFFECTS?
HIV infection causes higher rates of TMP/SMX side effects. The main side effects of TMP/SMX are nausea, vomiting, loss of appetite, and allergic skin reactions (rashes.) The skin rashes can be fairly common. TMP/SMX can cause Stevens-Johnson syndrome, a very serious skin rash.

TMP/SMX can also cause neutropenia, a low level of neutrophils. These are white blood cells that fight bacterial infections. HIV infection can also cause neutropenia.

Some doctors use a "desensitization" procedure with patients who get an allergic reaction. Starting with a very low dose of TMP/SMX that does not cause an allergic reaction, they gradually increase the dose to the full amount. Another option is to use the drug Dapsone (See Fact Sheet 533.)

TMP/SMX can also make you sensitive to sunlight. If this occurs, use sun block on your skin and/or wear sunglasses.

Tell your doctor if your skin gets pale or yellowish, or you get a sore throat, fever, or rash, even after a few weeks of taking TMP/SMX. These might indicate a serious drug reaction.


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HOW DOES TMP/SMX REACT WITH OTHER DRUGS?
TMP/SMX is mostly processed by the kidneys. It does not interact very much with drugs that use the liver, including most antiviral drugs used to fight HIV. However, TMP/SMX interacts with several other types of drugs, including some blood thinners, pills to lower blood sugar, seizure medications, and water pills. Be sure your doctor knows about all the medications you are taking.

The risk of developing anemia is higher if you take TMP/SMX at the same time as other drugs that can cause it, such as AZT.

The risk of developing neutropenia is higher if you take TMP/SMX at the same time as other drugs that can cause it, such as AZT or ganciclovir.



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Revised May 4, 2001


[ Edit | View ]



DRUGS;ETC. -- No name, 13:24:17 01/26/02 Sat

WHY ARE VITAMINS AND MINERALS IMPORTANT?
Vitamins and minerals are sometimes called micronutrients. Our bodies need them, in small amounts, to support the chemical reactions our cells need to live. Different nutrients affect digestion, the nervous system, thinking, and other body processes.

Micronutrients can be found in many foods. Healthy people might be able to get enough vitamins and minerals from their food. People with HIV or another illness need more micronutrients to help repair and heal cells. Also, many medications can create shortages of different nutrients.



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WHAT ARE ANTIOXIDANTS?
Some molecules in the body are in a form called oxidized. These molecules are also called free radicals. They react very easily with other molecules, and can damage cells. High levels of free radicals seem to cause a lot of the damage associated with aging.

Free radicals are produced as part of normal body chemistry. Antioxidants are molecules that can stop free radicals from reacting with other molecules. This limits the damage they do. Several nutrients are antioxidants.

Antioxidants are important for people with HIV, because HIV infection leads to higher levels of free radicals. Also, free radicals can increase the activity of HIV. Higher levels of antioxidants can slow down the virus and help repair some of the damage it does.



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HOW MUCH DO I NEED?
You might think that all you have to do to get enough vitamins and minerals is to take a "one-a-day" multivitamin pill. Unfortunately, it's not that easy. The amounts of micronutrients in many of these pills are based on the Recommended Dietary Allowances (RDAs) set by the US government. The problem with the RDAs is that they are not the amounts of micronutrients that are needed by people with HIV. Instead, they are the minimum amounts needed to prevent shortages in healthy people. HIV disease and many AIDS medications can use up some nutrients. One study of people with HIV showed that they needed between 6 and 25 times the RDA of some nutrients! Still, a high potency multivitamin is a good way to get basic micronutrients.


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WHICH NUTRIENTS ARE IMPORTANT?
There has not been a lot of research on specific nutrients and HIV disease. Also, many nutrients interact with each other. Most nutritionists believe in designing an overall program of supplements.

People with HIV may benefit from taking supplements of the following vitamins and minerals:

B Vitamins: Vitamin B-1 (Thiamine), Vitamin B2 (Riboflavin), Vitamin B6 (Pyridoxine), Vitamin B12 (Cobalamin), and Folate (Folic Acid).
Antioxidants, including beta-carotene (the body breaks down beta-carotene to make Vitamin A), selenium, Vitamin E (Tocopherol), and Vitamin C.
Magnesium and Zinc


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WHAT ABOUT OTHER SUPPLEMENTS?

In addition to vitamins and minerals, some nutritionists suggest that people with HIV take supplements of other nutrients:

Acidophilus, a bacterium that grows naturally in the intestines, helps with digestion.
Alpha-lipoic acid is a powerful antioxidant that may help with neuropathy and mental problems.
Coenzyme Q10 may help with immune function.
Essential fatty acids found in evening primrose oil or flaxseed oil can help with dry skin and scalp.
N-Acetyl-Cysteine, an antioxidant, can help maintain body levels of glutathione. Glutathione is one of the body's main antioxidants.


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CAN NUTRIENTS BE HARMFUL?
Most vitamins and nutrients appear to be safe as supplements, even at levels higher than the Recommended Dietary Allowances (RDAs). However, some can cause problems at higher doses, including Vitamin A, Vitamin D, copper, iron, niacin, selenium, and zinc.

A basic program of vitamin and mineral supplementation should be safe. This would include the following, all taken according to directions on the bottle:

A multiple vitamin/mineral (without extra iron),
An antioxidant supplement with several different ingredients, and
A trace element supplement. There are seven essential trace elements: chromium, copper, cobalt, iodine, iron, selenium, and zinc. Some multivitamins also include trace elements.
Any other program of supplements should be based on discussion with a doctor or nutritionist. Remember that higher price may not mean better quality.


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FOR MORE INFORMATION
You can get more information on nutrition and HIV from the following books:

Nutrition and HIV: A New Model for Treatment by Mary Romeyn, MD, $18.95, published by Jossey-Bass, Inc, telephone 415-433-1740.

Positively Well: Living with HIV as a Chronic, Manageable, Survivable Disease by Lark Lands, Ph.D., $24.95, available soon by calling 1-800-542-8102.



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Revised January 27, 2001



HOW SERIOUS IS HIV FOR WOMEN?
More women are being infected with HIV. Only 7% of AIDS cases reported in 1985 were women. That percentage grew to 14% in 1992 and 23% in 1999. About 40% of women are infected through sex with an HIV-infected man (often an injection drug user), and about 27% through drug use (see Fact Sheet 153 on Drug Use and HIV). Almost 80% of infected women in the US are Black or Hispanic.

Many women do not have good information on how they can be infected with HIV, and scientists know very little about HIV infection in women.


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WHAT DO WOMEN NEED TO KNOW?

More women are being infected through heterosexual sex. Many women think AIDS is a disease of gay men. But women get HIV from sharing needles and from heterosexual sex. Heterosexual sex is a growing source of HIV infection in women in the US.
During sex, HIV is transmitted from men to women much more easily than from women to men. A woman's risk of infection is higher with anal intercourse, or if she has a vaginal disease.
Women should know the HIV risk factors for their sex partners. The risk of infection is higher if your sex partner is or was an injection drug user, has other sex partners, has had sex with infected people, or has sex with men. Talk about these risk factors and take steps to protect yourself.
If you are not absolutely certain about your sex partner's HIV status, take precautions. Using a condom (see Fact Sheet 152) correctly can prevent most cases of HIV infection.
Many women feel they can not ask their boyfriends or husbands to use condoms. But condoms are the safest way to avoid HIV infection. There is a female condom that provides some protection, but not as much as a male condom. Other forms of birth control, such as birth control pills, diaphragms, or implants do NOT provide protection against HIV.
Get tested for HIV if you think a sex partner might be at risk. Many women don't find out they have HIV until they become ill or get tested during pregnancy. If women don't get tested for HIV, they seem to get sick and die faster than men. But if they get tested and treated, they live as long as men.
Viral loads may be lower in women. Several studies have shown that women may have lower viral loads during the first few years of HIV infection. At this point, treatment guidelines are the same for women and men.
Vaginal problems can be early signs of HIV infection. Ulcers in the vagina, or yeast infections that come back within 2 months and don't clear up easily, can be signs of HIV. Hormone changes, birth control pills, or antibiotics can also cause them. See your doctor to make sure you know the cause.
Mothers can pass HIV infection to their babies. When a woman with HIV gets pregnant, she can pass HIV to her unborn child. Also, a mother's breast milk can infect her new baby. See Fact Sheet 611 for more information on HIV and pregnancy.


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WHAT DO RESEARCHERS NEED TO KNOW?


More women need to be studied. In 1997 the FDA said that women could no longer be kept out of clinical trials just because they might become pregnant. The proportion of women in AIDS research studies is increasing but is rarely over 20% of total patients studied.
Some HIV-related diseases are different in women.
Women get vaginal infections, genital ulcers, pelvic inflammatory disease, and genital warts more often - and more severely - than uninfected women. Cervical cancer was added to the list of HIV-related infections in 1993. HIV-infected women should get pap and pelvic exams at least once a year. See Fact Sheet 507 for more information.
Only 1 woman gets Kaposi's Sarcoma, a skin cancer (See Fact Sheet 508), for every 8 men who get it.
Women get thrush (a fungal infection, Fact Sheet 516) in their throats, and herpes (a virus that causes cold sores and genital herpes) about 30% more often than men.
Women are much more likely than men to get a severe rash when using nevirapine (See Fact Sheet 431.)
Women with fat redistribution (see Fact Sheet 551 on Lipodystrophy) are more likely than men to accumulate fat in the abdomen or breast areas and are less likely to lose fat in the arms or legs.
More research is needed on how HIV medications affect women. Most HIV medications have not been studied to see if they affect women differently or if they affect menstrual cycles. Many of them reduce the effectiveness of birth control pills.


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THE BOTTOM LINE
More women are becoming infected with HIV. With early testing and treatment, women can live with HIV as long as men. Women need to know more about how they can be infected, and should get tested for HIV if they think there is any chance they have been exposed. This is especially true for pregnant women. If they test positive for HIV, they can take steps to reduce the risk of infecting their babies.

The best way to prevent infection in heterosexual sex is with the male condom. Other birth control methods do not protect against HIV. Women who shoot drugs should not share needles, or should learn how to clean them.

Women should discuss vaginal problems with their doctor, especially yeast infections that don't go away or ulcers. These could be signs of HIV infection.



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Revised March 28, 2001



HOW DO BABIES GET AIDS?
The virus that causes AIDS, HIV, can be transmitted from an infected mother to her newborn child. Without treatment, about 20% of babies of infected mothers get infected.

Mothers with higher viral loads are more likely to infect their babies. However, no viral load is low enough to be "safe". Infection can occur any time during pregnancy, but usually happens just before or during delivery.

The baby is more likely to be infected if the delivery takes a long time. During delivery, the newborn is exposed to the mother's blood.

Drinking breast milk from an infected woman can also infect babies. Mothers who are HIV-infected should not breast-feed their babies.



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HOW CAN WE PREVENT INFECTION OF NEWBORNS?
Mothers can reduce the risk of infecting their babies if they:

Use antiviral medications,
Keep the delivery time short, and
Don't breast-feed the baby
Use antiviral medications: The risk of transmitting HIV drops from 20% to 8% or less if antiviral medications are used. Transmission rates are lowest if the mother takes AZT during the last six months of her pregnancy, and the newborn takes AZT for six weeks after birth.

Even if the mother does not take antiviral medications until she is in labor, the transmission rate can be cut by almost half. Two methods have been studied:

AZT and 3TC during labor, and for both mother and child for one week after the birth.
One dose of nevirapine during labor, and one dose for the newborn, 2 to 3 days after birth.
Although these shorter treatments do not work as well, they are less expensive and might be helpful in developing countries.
Keep delivery time short: The risk of transmission increases with longer delivery times. If the mother uses AZT and delivers her baby by cesarean section (C-section), she can reduce the risk of transmission to about 2%.

Do not breast-feed the baby: There is about a 14% chance that a baby will get HIV infection from infected breast milk. This risk can be eliminated if HIV-infected women do not breast-feed babies. Baby formulas should be used.

In developing countries, however, there might not be clean water to prepare baby formulas. The World Health Organization believes that the risk of transmitting HIV is less than the health risk of using contaminated water.



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HOW DO WE KNOW IF A NEWBORN IS INFECTED?
Most babies born to infected mothers test positive for HIV. Testing positive means you have HIV antibodies in your blood. See Fact Sheet 102 for more information on HIV tests. Babies get HIV antibodies from their mother even if they aren't infected with the virus.

If babies are infected with HIV, their own immune systems will start to make antibodies. They will continue to test positive. If they are not infected, the mother's antibodies will gradually disappear and the babies will test negative after about 6 to 12 months.

Another test, similar to the HIV viral load test, can be used to find out if the baby is infected with HIV. Instead of antibodies, these tests detect the HIV virus in the blood.



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WHAT ABOUT THE MOTHER'S HEALTH?
Recent studies show that HIV-positive women who get pregnant do not get any sicker than those who are not pregnant. That is, becoming pregnant does not appear to be dangerous to the health of an HIV-infected woman.

However, although AZT by itself can help protect newborns from HIV, it is not the best choice for the mother's health. Combination therapies using at least three drugs are the standard treatment. If a pregnant woman takes AZT by itself, she may get less benefit from combination therapy in the future.

On the other hand, combination therapy might cause birth defects, especially during the first three months. For example, pregnant women should not use the drug efavirenz (Sustiva). Preliminary studies of pregnant women who used protease inhibitors show good results, with virtually no HIV-infected newborns and no unusual birth defects.

A pregnant woman should consider all of the possible side effects of antiviral medications. Some of them could be worse for pregnant women. For example, in January 2001, the FDA warned pregnant women not to use both ddI and d4T in their antiviral treatment due to a high rate of a dangerous side effect called lactic acidosis.

If you have HIV and you are pregnant, or if you want to become pregnant, talk with your doctor about your options for taking care of yourself and reducing the risk of HIV infection or birth defects for your new child.



--------------------------------------------------------------------------------


THE BOTTOM LINE
An HIV-infected woman who becomes pregnant needs to think about her own health and the health of her new child.

The risk of transmitting HIV to a newborn can be cut to just 2% if the mother takes AZT during the last 6 months of her pregnancy, delivers her child by Cesarean section, and the newborn takes AZT for six weeks.

Pregnancy does not seem to make the mother's HIV disease any worse. However, some medications used to fight HIV or to treat opportunistic infections might cause birth defects. This is especially true during the first 3 months of pregnancy. If a mother chooses to stop taking some medications during pregnancy, her HIV disease could get worse.

Any woman with HIV who is thinking about getting pregnant should carefully discuss treatment options with her doctor.



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Revised January 8, 2001



WHAT IS IMMUNE RESTORATION?
Immune restoration refers to repairing the damage done to the immune system by HIV.


In a healthy immune system, there is a full range of T-cells (CD4+ cells) that can fight different diseases. As HIV disease progresses, the number of T-cells drops. The first T-cells that HIV attacks are the ones that specifically fight HIV. Some types of T-cells can disappear, leaving gaps in the immune defenses. Immune restoration looks for ways to fill these gaps.

A healthy immune system can fight off opportunistic infections (OIs). Because these infections develop when T-cell levels are low, many researchers think that we can use T-cell counts as a measure of immune function. They believe that increases in T-cell counts are a sign of immune restoration. There is disagreement on this point (see "Are New T-Cells As Good As Old?" below.)


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HOW CAN THE IMMUNE SYSTEM BE RESTORED?
We can preserve the immune system's ability to fight HIV if we start antiviral medications immediately after infection with HIV. Unfortunately, very few cases of HIV are identified that early. As HIV infection continues, it can damage the immune system. Scientists are exploring several ways to repair this damage.

Improving the function of the thymus: The thymus, a small organ located at the base of the throat, takes white blood cells that come from the bone marrow and turns them into T-cells. It works the hardest when you're just 6 months old, and then starts to shrink. Scientists used to think that the thymus stopped working by the age of 20, but newer research shows that it keeps producing new T-cells much longer, maybe until age 50. Strong antiviral medications can allow the thymus to replace lost types of T-cells.

When scientists thought that the thymus stopped working at a young age, they looked into the possibility of transplanting a young thymus into someone with HIV, or even transplanting an animal's thymus. They also tried to stimulate the thymus using thymic hormones. These methods might still be important for older people with HIV.

Restoring the number of immune cells: As HIV disease progresses, the numbers of both CD4+ (T4) and CD8+ (T8) cells drop. Some researchers are trying to prevent these decreases, or to increase the numbers of cells.

One approach, cell expansion, takes an individual's cells, multiplies them outside the body, and then infuses them back into the body. A second, cell transfer, involves giving a patient immune cells from the patient's twin, HIV-negative relative, or from a different species that is HIV-immune.

A third method uses cytokines. These are chemical messengers that support the immune response. The most work has been done on interleukin-2 (IL-2), which can lead to large increases in CD4+ cells. Fact Sheet 622 has more information on IL-2.

Another approach is gene therapy. This involves changing the bone marrow cells that will travel to the thymus and become T-cells. Gene therapy tries to make the bone marrow cells immune to HIV infection.

Letting the immune system repair itself: CD4+ counts have increased for many people who have taken combination antiviral therapy. Some scientists believe that the immune system might be able to heal and repair itself if it's not fighting off large numbers of HIV viruses. This approach seems more likely now that we know that the thymus keeps working until a person is almost 50 years old.

Most people take medication to prevent opportunistic infections when their T-cell counts go below 200. Several studies have shown that if these people take antiviral medications and their T-cell counts climb back over 200, it is safe in most cases to stop taking medications to prevent these infections. Be sure to talk to your doctor before you stop taking any medication.

Stimulating HIV-specific immune response: Researchers are using a special preparation of modified, killed HIV virus (Remuneョ) to stimulate the body's response to HIV. Remune is essentially the same as a vaccine, but it is given to people who are already HIV-infected. An initial study of Remuneョ added to antiviral therapy showed that it decreased viral load, increased CD4+ cell counts, and increased immune system response to HIV.



--------------------------------------------------------------------------------


ARE NEW T-CELLS AS GOOD AS OLD?
Most approaches to immune restoration are based on increasing the numbers of CD4+ cells. This is based on the assumption that when T-cells increase, the immune system is stronger.


When people with HIV start taking antiviral medications, their T-cell counts usually go up. At first, the new T-cells are probably copies of existing types of T-cells. If some "types" of T-cells were lost, they won't come back right away. This could leave some gaps in the body's immune defenses.

However, if HIV stays under control for a few years, the thymus might make new T-cells that could fill in these gaps and restore the immune system. Some of these T-cells will specifically fight HIV, and can help control HIV infection.



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Revised March 30, 2001



WHAT IS HYDROXYUREA?
Hydroxyurea (Hydreaョ) is a drug used for antiviral therapy. It is manufactured by Bristol-Myers Squibb. Hydroxyurea is sometimes referred to as HU.

Hydroxyurea was approved for use against cancer. It also works against sickle cell anemia. Hydroxyurea has not yet been approved by the FDA for use against HIV.

Hydroxyurea blocks an enzyme produced by human cells. This enzyme makes building blocks used by cells that are multiplying. Cancer cells multiply very quickly, so when hydroxyurea blocks this enzyme, the cancer grows more slowly.

These building blocks are also used by HIV when it multiplies. Some of the drugs used against HIV (the nucleoside analog reverse transcriptase inhibitors) are "fake" versions of these same building blocks. When HIV uses the fake materials, it can't multiply.

When hydroxyurea reduces the amount of "real" building blocks, then HIV is forced to use more of the "fake" versions: the anti-HIV drugs. Even though hydroxyurea does not attack HIV directly, it can make some anti-HIV drugs work better. Hydroxyurea works very well with the drugs ddI and d4T. Researchers are studying how Hydroxyurea works with other anti-HIV drugs.


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WHO SHOULD TAKE HYDROXYUREA?
Hydroxyurea has been studied in combination with the antiviral drugs ddI and d4T. Most doctors start antiviral therapy when a person has some symptoms of HIV disease, when their T-cell count (CD4+ cells) falls below 350, or if their viral load is over 30,000.

There are no absolute rules about when to start antiviral drugs. Some people want to "hit HIV hard and early", starting with the strongest drugs to preserve the immune system. Others think that the strongest drugs should be saved until they are needed, later in the course of HIV disease. You and your doctor should consider your T-cell count, viral load, any symptoms you are having, and your attitude about taking HIV medications.


--------------------------------------------------------------------------------


WHAT ABOUT DRUG RESISTANCE?
The HIV virus is sloppy when it makes copies of its genetic code (RNA). This means that many new copies of HIV are slightly different from the original (mutations). Some mutations can resist an antiviral drug and continue to multiply. When this happens, the drug will stop working. This is called "developing resistance" to the drug.

Hydroxyurea blocks an enzyme produced by our own cells, not by HIV. This means that HIV can not develop resistance to Hydroxyurea. Taking hydroxyurea can slow down HIV mutations so that it takes much longer for resistance to develop to the other anti-HIV drugs you are taking.


--------------------------------------------------------------------------------


HOW IS HYDROXYUREA TAKEN?
Hydroxyurea is available in 500 mg tablets. The most common doses studied have been 1 gram taken once a day, or 500 mg taken twice a day.

Scientists are working to find out the best dose of hydroxyurea for people with HIV.


--------------------------------------------------------------------------------


WHAT ARE THE SIDE EFFECTS?
With the start of any anti-viral treatment there may be temporary side effects such as headaches, hypertension, or a general sense of feeling ill. These side effects are likely to get better or even disappear over time.

Hydroxyurea may cause nausea, vomiting, and diarrhea. It can also lead to weight gain, hair loss, and changes in skin coloring. It may cause birth defects, so pregnant women should not take hydroxyurea. It can also damage the bone marrow. This can result in anemia (a drop in the number of red blood cells) or neutropenia (a drop in the number of white blood cells).

Scientists reported in early 2000 that hydroxyurea appears to increase the risk of peripheral neuropathy.


--------------------------------------------------------------------------------


HOW DOES HYDROXYUREA REACT WITH OTHER DRUGS?

Hydroxyurea is most effective if taken with reverse transcriptase inhibitors such as ddI or d4T. Hydroxyurea is still being studied in combination with other antiviral drugs.

Hydroxyurea's side effects may be worse if taken with AZT, because both drugs can damage the bone marrow.



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Revised July 27, 2001


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Copyright テδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつεδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつεδεつεδづつづδεつづδづつづδεつεδづつεδεつづδづつづδεつεδづつづδεつづδづつゥ1995-2003 NAA/YWH/TNKYCARES/POLIO HEROES/CASA INVESTIGATIONS
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