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Date Posted: 13:16:30 01/26/02 Sat
Author: No name
Subject: DRUGS;ETC.

WHAT IS ABACAVIR?
Abacavir (Ziagen®), 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.



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


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.


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


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.


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


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.


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


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®) or with d4T (stavudine, Zerit®).

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.



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


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.


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


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.


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


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.


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


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.


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


HOW DOES TRIZIVIR REACT WITH OTHER DRUGS?

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

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.



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


Revised February 14, 2001



WHAT IS TENOFOVIR?
Tenofovir (Viread®), 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).


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


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.


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


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


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


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.


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


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.



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


Revised October 30, 2001



WHAT IS DELAVIRDINE?

Delavirdine (Rescriptor®) 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.



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


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.



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

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.



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


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.



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

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.



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

Revised February 14, 2001

WHAT IS NEVIRAPINE?

Nevirapine, also called Viramune®, 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.



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


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.



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


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 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.


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


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®, 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®, 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).


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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.



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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.



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Revised December 31, 2001

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