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Reuters Health Information 2002. 2002 Reuters Ltd
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Introduction
WASHINGTON (Reuters Health) Apr 23 - Lawmakers on Tuesday threw their support behind new federal safeguards--including the formation of a new national research oversight agency--to protect people who volunteer to participate in medical studies.

Democratic and Republican senators both declared that they will move to increase the government's role in monitoring institutions' oversight of clinical trials and in making sure that patients are adequately informed about risks of research. Some lawmakers also want a law guaranteeing subjects the right to know about researchers' financial ties to industry.

"I believe its going to take legislation...to accomplish that goal," said Sen. William Frist (R-TN), the senior Republican on the Health, Education, Labor, and Pensions (HELP) public health subcommittee.

Congress began targeting human subjects research in early 2000 after the death of 17-year-old Jesse Gelsinger in a gene therapy trial at the University of Pennsylvania. Several other incidents since, including the death of a woman participating in a Johns Hopkins University allergy medication experiment, have helped galvanize public demands for greater oversight of research and the boards that oversee experimental protocols at universities.

Witnesses testifying on Capitol Hill Monday told lawmakers that rules currently governing human trials are confusing and often crisscross different agencies at both the state and local level. The system has left many researchers confused about their ethical responsibilities to subjects, they said.

Cherlynn Mathias, a clinical trials manager at Harris Methodist Fort Worth Hospital in Texas, told the committee that the National Institute of Health, the country's largest supporter of human-based research, does a poor job of monitoring the ethical quality of studies it funds.

"I've been doing an NIH study for four-and-a-half years and they've never sent around a monitor," she said.

The National Bioethics Advisory Council issued a report last year calling for the formation of a single federal agency responsible for writing and enforcing a single set of research regulations.

The council also recommended that the agency oversee a national accreditation system for academic institutions, companies, and university-based institutional review boards (IRB's). Lawmakers said they support passing a law implementing both recommendations.

But despite bipartisan enthusiasm, several hurdles remain before lawmakers agree on the form of any new laws. Lawmakers and experts are still at odds over whether new federally-monitored accreditation should be voluntary or mandatory.

"Accreditation works best when organizations will make the commitment to change their culture and behavior in the direction we wish," said Marjorie Speers, executive director of the Association for the Accreditation of Human Research Protection Programs.

Mathias disagreed, saying that medium- and small-sized hospital and institutions will ignore federal ethical standards unless they are forced to comply. "Most places just simply won't do them," she said.

Frist, a former researcher at Vanderbilt University, said in an interview that new federal standards would be easier to implement if they are voluntary. "I don't think you could make it mandatory and fully enforce it for years," he said.

A GOP aide told Reuters Health that the issue is a key sticking point standing in the way of a human subjects protection bill in the Senate.

Lawmakers will also have to decide how broad to make their bill. A law covering research performed through the Department of Health and Human Services (HHS) would cover important agencies including the NIH, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). But it would leave out other human-based research funded by the US Departments of Defense, Education and Veterans' Affairs.

Researchers told lawmakers that while unified and simpler oversight was needed, any new regulations would only serve to slow important research on human diseases.

"Are the current protections adequate? Yes," said Dr. P. David Charles, a Vanderbilt University Parkinson's disease researcher.

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South Africa's Mbeki Says He Will Lead AIDS Campaign -- Anonymous, 11:39:19 05/16/02 Thu

http://www.medscape.com/viewarticle/432589_print

South Africa's Mbeki Says He Will Lead AIDS Campaign

Reuters Health Information 2002. 2002 Reuters Ltd
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Introduction
CAPE TOWN, South Africa (Reuters) Apr 24 - South African President Thabo Mbeki, who last week announced a dramatic change in the government's HIV/AIDS policy, has promised to take the lead in fighting the disease.

Mbeki, who defied medical opinion by questioning the link between HIV and AIDS and blocked wide access to crucial drugs, told South African Independent Newspapers his government had failed to communicate its policies on the disease.

"It is critically important that I, sitting in the position that I sit in, communicate correct messages," he said in an interview published on Tuesday in the group's newspapers.

In 2000, Mbeki withdrew briefly from the debate on AIDS and he has regularly deflected questions about the pandemic to officials and ministers. Now he has promised to take the lead, adding: "I think if people are told the truth they can get through this. And it is necessary to tell the truth repeatedly."

Physicians and activists fighting the pandemic have slammed Mbeki in the past for undermining the prevention campaign by expressing doubt that HIV causes AIDS and refusing wide access to antiretroviral drugs, saying they are too costly and toxic.

Last week, Mbeki chaired a cabinet meeting that resulted in a radical shift of policy on AIDS. While the cabinet stopped short of acknowledging the link between HIV and AIDS as a fact, it said in a statement it would act on the "premise" that HIV caused AIDS.

The cabinet reversed a ban on the treatment of rape victims in state hospitals with antiretroviral drugs, saying it would be allowed if patients accepted the risk posed by the drugs. The government also announced plans to offer universal access next year to antiretroviral drugs that can help prevent vertical HIV transmission.

AIDS activists hailed the turnaround as the most significant policy shift, but urged the government to make up for lost time. Mbeki clashed last year with the state-funded Medical Research Council over the impact of the pandemic and said crime and poverty were the biggest killers.

The council said in a report last year that AIDS would kill up to 7 million people by 2010 if the state continued its policies on treatment and prevention.

Mbeki made no comment in the interview on the causes of AIDS or its impact, but it said he accepted and emphasised the link between sex and infection. "You can't be going around having promiscuous sex...and hope that you won't be affected by something or other," he said.

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Ethics Body Says Drug Trials in Poor Countries May Have to Be Second Best -- Anonymous, 11:37:47 05/16/02 Thu

http://www.medscape.com/viewarticle/432617_print

Ethics Body Says Drug Trials in Poor Countries May Have to Be Second Best

Reuters Health Information 2002. 2002 Reuters Ltd
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Introduction
LONDON (Reuters Health) Apr 24 - A leading British medical ethics body said this week that it is not always appropriate to offer participants in clinical trials conducted in poor countries the same standard of care offered to clinical trial participants in rich countries.

The Nuffield Council on Bioethics said that the issue was particularly controversial. Ideally, participants in developing countries should be offered the best standard of care available in the world.

"But this is not always appropriate or possible," said Professor Sir Kenneth Calman, Britain's former chief medical officer and chairman of a new Nuffield Council working party report on the ethics of research in poor countries.

"For example, sometimes the medical facilities to provide such treatment just don't exist in developing countries. In these situations, we recommend that, as a minimum, participants should be offered the best treatment available from the national public health system," Calman said in a statement.

The working party included specialists in medicine, healthcare, philosophy and public policy. Its report follows growing public concern about the huge gap in healthcare between rich and poor countries. Each year £35-40 billion is spent on healthcare research but, according to the authors, only 10% is directed to 90% of the world's population.

The report says more research in developing countries is crucial but it must be subject to rigorous ethical safeguards. "We want to ensure that there is no exploitation of those who take part," said Calman, now Vice-Chancellor of Durham University.

One worry highlighted by the report is that research into new treatments is being done in countries that may never be able to afford them.

"There are concerns that people in poorer countries will sometimes bear the risks of research, while those in wealthier countries will receive the benefits," said Dr. Fred Binka, a member of the working party and associate professor of epidemiology, at the University of Ghana,

"However this is not a straightforward issue. For example, sometimes the price of treatments can drop dramatically after research, or an agreement may be reached with a pharmaceutical company that the treatment will be provided for free for a certain period"

The report says it is not ethically acceptable for research to begin without first thinking about what will be provided once the research is completed. It also urges developing countries to produce their own national guidance to promote ethically sound research.

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WHO Provides HIV Drug Advice to Developing World -- Anonymous, 11:35:49 05/16/02 Thu

http://www.medscape.com/viewarticle/432311_print

WHO Provides HIV Drug Advice to Developing World

Reuters Health Information 2002. 2002 Reuters Ltd
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Introduction
LONDON (Reuters Health) Apr 22 - The World Health Organization for the first time on Monday issued guidelines designed to encourage developing countries to provide effective drug treatments for HIV infection.

Until recently, the high cost of antiretroviral drugs has put them beyond the reach of African countries.

But the life-extending medicines are coming within reach of more nations thanks to treatment access campaigns, cut-price generic competition and international funding, such as the UN's Global Fund, which announced its first round of spending on Monday, WHO officials told Reuters Health.

"This is the first time we have issued treatment guidelines on the use of antiretroviral drugs for the treatment of HIV infection in developing countries," Dr. Bernard Schwartzlande, director of WHO's HIV/AIDS programme, told Reuters Health.

"This is actually quite timely. The fact that we now have prices that are increasingly reachable by many health systems has made it a burning issue for us to set out guidelines."

Although just 5% of about 6 million people living with HIV/AIDS who need access to antiretroviral treatment are currently receiving these medicines, WHO says that by 2005 at least 3 million should be able to get medicines.

The agency guidelines propose a standardized and simplified combination of antiretrovirals.

"I think it is very important to identify what is rational [in terms of treatment]," Dr. Joseph Perriens, Director for Care in WHO's HIV/AIDS department, told Reuters Health.

"In developing countries it is not always possible to sift through all the combinations available. If you're in a country and looking at all these drugs and wondering 'What am I going to recommend as a first-line treatment,' it helps to have this list available."

The recommendations offer several choices of regimens that governments and others running HIV treatment campaigns can choose, depending on the cost and availability of drugs in their particular country.

They include several medicines with multiple drugs in a single pill.

"There is a strong case for more use of single-pill combinations," said Dr. Jonathan Quick from WHO's essential medicine programme. These pills make HIV medications less complicated to take, and reduce the risk of drug interactions, he said.

WHO has also for the first time added antiretroviral drugs to its Essential Medicines List, which provides countries with an example of the drugs that they ought to make available.

The Essential Medicines List now includes abacavir, didanosine, efavirenz, indinavir, lamivudine, lopinavir, nelfinavir, ritonavir (low-dose), saquinavir, and stavudine.

It also recommends nevirapine and zidovudine, previously listed for prevention of mother-to-child transmission, for treatment of HIV in adults and children.

"The goal is to provide clear and scientific advice to government policy advisors that these drugs work," Dr. Quick said.

"The experience since the first list was drawn up in 1977 is [also] that they tend to force prices down and improve quality assurance. When you have a set of promoted medicines, it tends to focus demand."

"The antiretroviral treatment guidelines developed by WHO will greatly assist governments and national AIDS programmes in providing people living with HIV/AIDS with greater access to these life-saving medicines," Dr. Peter Piot, UNAIDS Executive Director, said.

"The long-sought inclusion of antiretrovirals in WHO's Essential Medicines List will encourage governments in hard-hit countries to further expand the distribution of these vital drugs to those who need them."

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Many HIV-Infected Individuals in US Remain Undiagnosed -- Anonymous, 11:33:10 05/16/02 Thu

http://www.medscape.com/viewarticle/432344_print

Many HIV-Infected Individuals in US Remain Undiagnosed

Reuters Health Information 2002. 2002 Reuters Ltd
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Introduction
NEW YORK (Reuters Health) Apr 22 - Data from a voluntary HIV testing program instituted in the general medical service of a teaching hospital indicate a high prevalence of previously undiagnosed HIV infection. The findings appear in the April 22nd issue of the Archives of Internal Medicine.

"The Centers for Disease Control and Prevention estimates that about one third of the people in the US who have HIV are undiagnosed," lead author, Dr. Rochelle P. Walensky, from Massachusetts General Hospital, Boston, told Reuters Health

Dr. Walensky and colleagues note that although hospitals with a prevalence of HIV exceeding 1% are encouraged to offer HIV testing and counseling, there are still about 300,000 HIV-infected individuals in the US who are undiagnosed.

The researchers implemented the "Think HIV" program, which offers voluntary HIV testing to all in patients as a routine procedure. "We tried to do a global screening of patients admitted to the hospital's general medical service, and we excluded people who knew that they were HIV-positive," Dr. Walensky said.

During the 9-month program, patients were 3.4 times more likely to have HIV testing compared with patients admitted during a 15-month control period when the Think HIV program was not in effect, the investigators found.

When the Think HIV program was employed, approximately two new cases of HIV infection were diagnosed each month compared with one new case of HIV infection each month during the control period, Dr. Walensky's team reports.

The estimated prevalence of HIV infection among individuals who would not have undergone HIV testing if it had not been for the Think HIV program was 3.8%.

"We are grossly under screening for HIV infection in the US," Dr. Walensky said. "Not only are we not good at targeted screening, we are not even good at targeting. We don't ask the appropriate questions to decide who should be tested, and we don't go the step further to test them," she added.

"My recommendation," Dr Walensky said, "is that HIV screening should be universal, especially in hospitals with a high prevalence of HIV."

Arch Intern Med 2002;162:887-892.

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Study Supports Voluntary Inpatient HIV Screening -- Anonymous, 11:30:48 05/16/02 Thu

http://www.medscape.com/viewarticle/432626_print

Study Supports Voluntary Inpatient HIV Screening

Laurie Barclay, MD

MedscapeWire 2002. 2002 Medscape Portals, Inc
Introduction
NEW YORK (MedscapeWire) Apr 26 ? The Centers for Disease Control and Prevention (CDC) recommends voluntarily screening all inpatients for HIV, according to an article in the April 22 issue of the Archives of Internal Medicine . At Boston Medical Center, this testing program detected 2 new cases per month, compared with 1 case per month before testing was routinely offered.

"The stigma associated with HIV infection continues to plague aggressive testing endeavors," write Rochelle P. Walensky, MD, MPH, from Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues. "It is our hope that with widespread screening for HIV and treatment of infected persons, the stigma associated with testing will decrease."

Because HIV testing efforts that target only symptomatic patients fail to identify the one-third of HIV-seropositive people in the United States who are asymptomatic, the Think HIV program offered voluntary HIV counseling and testing to all patients admitted to the medical service of Boston Medical Center.

Patients admitted during the 15-month program period were 3.4 times more likely to undergo testing for HIV than were those admitted during a comparable control period (6.4% vs 2%). This testing program detected approximately 2 new cases of HIV infection monthly compared with 1 case per month during the control period. Estimated prevalence of HIV infection was 3.8% in patients tested during the program, who likely would have declined testing without this initiative.

"This study explores the impact of implementing the recommended CDC policy of routine inpatient HIV testing," the authors write, noting that their outcomes analysis supports the vast expense of expanding this testing initiative nationally. "Physicians must make the commitment to enroll patients in such a testing program if it is to have an impact. This study can serve as an example for other facilities to establish similar screening efforts so that most of the estimated 300,000 people with undiagnosed HIV infection in the United States can be identified and provided with appropriate care."

Arch Intern Med.2002;162(8):887-892

Reviewed by Gary D. Vogin, MD



Laurie Barclay, MD, is a staff writer with WebMD.

MedscapeWire is edited by Deborah Flapan, an associate editor at Medscape. Please send press releases and comments to MedscapeWire@exchange.webmd.net.

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'Safer Sex Fatigue,' Confidence in HIV Treatment Lead to Risky Sex Behavior -- Anonymous, 11:24:44 05/16/02 Thu

http://www.medscape.com/viewarticle/432461_print

'Safer Sex Fatigue,' Confidence in HIV Treatment Lead to Risky Sex Behavior

Reuters Health Information 2002. 2002 Reuters Ltd
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Introduction
NEW YORK (Reuters Health) Apr 23 - Impatience with safer sex practices and a decreased concern about HIV transmission in the era of highly active antiretroviral therapy are associated with unprotected anal sex among homosexual men in the US.

In 1999, Dr. Steffanie A. Strathdee, of The Johns Hopkins University in Baltimore, and colleagues surveyed homosexual men enrolled in the Multicenter AIDS Cohort Study who reported having engaged in anal sex within the previous 6 months. Of this group, 218 were HIV-seronegative and 329 were seropositive.

According to the authors' report in the March 29th issue of AIDS, HIV-positive men who scored in the upper quartile for less concern about infecting another person because of HAART were six times more likely than those in the lowest quartile to have engaged in unprotected insertive anal sex. The risk was nearly five times higher for those reporting "safer sex fatigue," i.e. they agreed with the statement 'I am tired of always having safer sex.'

Similar associations were found for HIV-uninfected men and their risk of engaging in unprotected receptive anal sex.

"A message of complacency has arisen in the gay community and the general population," Dr. Strathdee told Reuters Health. "We've been telling gay men for the last 2 decades that they need to use a condom each time they have sex, so any kind of suggestion that this is not so important anymore, provides justification for people who want to relax and experience the sexual liberation of the 1970s."

She added that pharmaceutical companies need to be "responsible" and not run ads in which models appear to be "the picture of health." Instead, she said, the companies should continue to reinforce the message that HIV is ultimately fatal.

"What is concerning is that these are men in major urban areas who have so far survived the AIDS epidemic, but despite all that they've seen, they are having unprotected sex," Dr. Strathdee pointed out. "So what is going on in suburban and rural America and among young men and men of color who are at very high risk? We need to revamp the prevention paradigm."

AIDS 2002;16:775-780.

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CCR5 Density on CD4 Cells Governs Course of HIV Infection in Children -- Anonymous, 11:21:51 05/16/02 Thu

http://www.medscape.com/viewarticle/432289_print

CCR5 Density on CD4 Cells Governs Course of HIV Infection in Children

Reuters Health Information 2002. 2002 Reuters Ltd
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Introduction
NEW YORK (Reuters Health) Apr 19 - The density of CC chemokine receptor 5 (CCR5) molecules on the surface of inactivated CD4 cells correlates with disease progression and with treatment response in children vertically infected with HIV. Development of therapy to reduce CCR5 density could therefore be expected to slow disease progression and increase response to treatment, a team of French and Swiss investigators suggests.

Dr. Pierre Corbeau, of the Hopital Saint Eloi in Montpellier, France, and associates monitored the density of CCR5 molecules on CD4 cells in 22 HIV-infected children for 12 months. As reported in The Journal of Infectious Diseases for April 15, the density remained stable over time.

Among 35 therapy-na ve children, ages 10 to 201 months, the CCR5 density was correlated with severity of disease according to clinical and biologic stage (p < 0.001) and annual percentage of CD4 cell loss (p = 0.034). CD4 cell loss was dramatically increased when CCR5 density exceeded 10,000 molecules per cell.

The CCR5 density was also associated with the drop in viral load among 21 children who initiated treatment with two nucleoside inhibitors and one protease inhibitor (p = 0.026).

Dr. Corbeau's team theorizes that viral replication is more difficult to block when cells express high densities of CCR5 molecules. Specifically, "In high CCR5 expressers, low residual viremia will result in the productive infection of cells with a high density of membrane CCR5, and replication will be sustained."

The authors conclude that determination of CCR5 density could aid in determining prognosis and in decision-making regarding treatment.

J Infect Dis 2002;185:1055-1061.

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Extending PCP Prophylaxis in HIV-Infected Patients Proves Cost-Effective -- Anonymous, 11:19:55 05/16/02 Thu

http://www.medscape.com/viewarticle/432484_print

Extending PCP Prophylaxis in HIV-Infected Patients Proves Cost-Effective

Reuters Health Information 2002. 2002 Reuters Ltd
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Introduction
NEW YORK (Reuters Health) Apr 23 - Continuing prophylaxis for Pneumocystis carinii pneumonia (PCP) in HIV-infected patients until CD4+ counts have rebounded to more than 300 cells/L is a cost-effective measure for averting disease, investigators report in the Archives of Internal Medicine for April 22.

Dr. Sue J. Goldie, of the Harvard School of Public Health in Boston, and associates developed a computer-based simulation model to estimate the lifetime costs and quality-adjusted life expectancy associated with extending PCP prophylaxis in HIV-infected patients on highly active antiretroviral therapy.

Based on data from several clinical trials, nine cases of opportunistic infection per 1000 patients would be prevented by extending prophylaxis until patients reached >300 cells/L, at a cost of $9400 per quality-adjusted life year. Even though this additional clinical benefit can be considered small, "the additional costs are so low that continued prophylaxis has an attractive cost-effectiveness ratio nonetheless," the authors write.

For patients intolerant of trimethoprim-sulfamethoxazole (TMP/SMX), switching to dapsone involved little additional cost. However, initiating treatment with atovaquone led to cost-effectiveness ratios of greater than $300,000 per quality-adjusted life year. Therefore, Dr. Goldie's group suggests, "using atovaquone before a trial of dapsone does not make policy sense."

Arch Intern Med 2002;162:921-928.

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Fomivirsen Reasonably Safe, Effective for CMV Retinitis -- Anonymous, 11:18:23 05/16/02 Thu

http://www.medscape.com/viewarticle/432629_print

Fomivirsen Reasonably Safe, Effective for CMV Retinitis

Laurie Barclay, MD

MedscapeWire 2002. 2002 Medscape Portals, Inc
Introduction
NEW YORK (MedscapeWire) Apr 26 ? The antisense oligonucleotide fomivirsen is reasonably safe and effective in treating CMV retinitis in AIDS patients, according to the results of 3 trials by the Vitravene Study Group and an accompanying editorial in the April issue of the American Journal of Ophthalmology.

"Cytomegalovirus (CMV) retinitis is among the most common opportunistic infections in patients with the acquired immunodeficiency syndrome (AIDS)," write D. A. Jabs and P. D. Griffiths, from Johns Hopkins University School of Medicine, Baltimore, Maryland, in an editorial. "There is an ongoing need for treatment options...for patients who develop CMV resistance to initial therapy."

As of September 2001, 4 drugs have been approved by the US Food and Drug Administration (FDA) for the treatment of CMV retinitis: ganciclovir, foscarnet, cidofovir, and fomivirsen. Ganciclovir is available as an intravenous (IV) or oral formulation, as a sustained release implant surgically placed in the eye, and as a prodrug (valganciclovir) with improved gastrointestinal absorption. Foscarnet and cidofovir are available only as IV formulations and fomivirsen only as a formulation for intravitreous injections.

"Although the number of patients treated in any one of these studies is small and although there are problems with both the design and analysis of these studies, these reports give us a better understanding of the drug, its efficacy, and its safety profile," write Jabs and Griffiths.

The first report describes a randomized, controlled clinical trial of fomivirsen 165 g given weekly for 3 weeks as induction therapy and then every 2 weeks as maintenance therapy to patients with small peripheral CMV retinitis lesions. Compared with patients in the observation group, time to retinitis progression among patients on fomivirsen was longer, and it was similar to that reported with systemically administered agents in other studies of this type.

The second report described 2 clinical trials comparing 2 treatment regimens differing in intensity, but both using a 330 g dose for patients with relapsed retinitis. Because progression rates were similar, the authors concluded that the 2 regimens were equally effective. "Intravitreous fomivirsen appears to be an effective antiviral agent for arresting CMV replication and halting progression of CMV retinitis among patients whose lesions have reactivated or have been persistently active despite other anti-CMV therapies," they write.

However, the editorialists note that an analysis combining both data sets to evaluate risk factors for progression might have answered questions about the effects of oral ganciclovir and of HAART on the time to retinitis progression and time to treatment failure.

The third article reports the safety profile and adverse effects of fomivirsen used to treat CMV retinitis and demonstrates that "the rates of ocular complications among patients treated with fomivirsen are nontrivial and are dose-dependent," according to Jabs and Griffiths. Approximately 10% of eyes will experience a ''key ocular adverse event'' with each fomivirsen injection. This figure probably underestimates the potential impact of toxicity, in part due to lack of guidelines for evaluation of complications and failure to perform routine visual fields or electroretinography in any of these trials.

The rate of ocular inflammation may be as high as 0.87/person-year for the FDA-approved 330- g regimen and 1.88/person-year for the more intensive 330-g regimen. Transient elevation of intraocular pressure occurred at rates of 0.36/person-year for the 330-g dose given by the less intensive regimen and 1.39/person-year for the 330-g dose with the more intensive regimen. Rates of retinal detachment were 0.16/person-year for the 165-g dose, 0.36/person-year for the less-intensive 330-g regimen, and 0.60/person-year for the more intensive 330-g regimen.

Although fomivirsen has a more favorable dosing schedule than alternative therapies, the editorialists note that "the ocular toxicity associated with fomivirsen may make this drug a less attractive initial choice," and "it would seem prudent to combine fomivirsen with an oral agent whenever possible.... Nevertheless, clinicians should now be more confident than previously in using fomivirsen in an appropriate setting."

Isis Pharmaceuticals Inc and Novartis Ophthalmics supported these studies.

Am J Ophthalmol. 2002;133(4):467-474, 475-483, 484-498, 552-556

Reviewed by Gary D. Vogin, MD



Laurie Barclay, MD, is a staff writer with WebMD.

MedscapeWire is edited by Deborah Flapan, an associate editor at Medscape. Please send press releases and comments to MedscapeWire@exchange.webmd.net.

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Filgrastim Seems to Increase Survival in AIDS Patients but Mechanism Unclear -- Anonymous, 11:16:57 05/16/02 Thu

http://www.medscape.com/viewarticle/432340_print

Filgrastim Seems to Increase Survival in AIDS Patients but Mechanism Unclear

Reuters Health Information 2002. 2002 Reuters Ltd
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Introduction
NEW YORK (Reuters Health) Apr 22 - Granulocyte colony-stimulating factor therapy in patients with AIDS-related cytomegalovirus (CMV) retinitis is associated with a 56% reduction in mortality, according to a recent report. However, the reason for this survival benefit does not appear to involve a reduction in bacterial infections.

Prior to the advent of highly active antiretroviral therapy (HAART), neutropenia was a relatively common finding in patients with AIDS, study author Dr. Douglas A. Jabs, from The Johns Hopkins University in Baltimore, and colleagues note in the March 29th issue of AIDS.

Because neutropenia is an established risk factor for bacterial infection, the authors hypothesized that treatment with filgrastim--granulocyte colony-stimulating factor, which reverses neutropenia--might prevent such infections and thereby improve survival.

To investigate, the researchers retrospectively studied 709 patients with AIDS-related CMV retinitis who were treated between 1990 and 1997. Of these patients, 398 had used filgrastim at some point.

Filgrastim use was associated with a significant reduction in the risks of catheter-related bacteremia and repeat bacterial infection (p = 0.02 and < 0.01, respectively), Dr. Jabs and colleagues found.

However, after adjustment for CD4+ T-cell count and antibiotic/antiretroviral therapy, filgrastim therapy was no longer linked to a significant reduction in these risks. The authors believe this may have been due to the confounding effect of trimethoprim-sulfamethoxazole use.

Despite no clear effect on bacterial infections, filgrastim use was tied to a 56% reduction in mortality (p < 0.001), the researchers state.

"Our observation of a large survival benefit with the use of filgrastim, while unexplained by a reversal of neutropenia or reduction of infection, deserves further exploration in a randomized controlled trial of this cytokine in non-neutropenic AIDS patients receiving HAART," Dr. Jab's team concludes.

AIDS 2002;16:757-765.

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HAART Reduces Mortality in HIV-Related Malignancy -- Anonymous, 11:15:34 05/16/02 Thu

http://www.medscape.com/viewarticle/432622_print

HAART Reduces Mortality in HIV-Related Malignancy

Reuters Health Information 2002. 2002 Reuters Ltd
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Introduction
NEW YORK (Reuters Health) Apr 24 - Highly active antiretroviral therapy (HAART) is associated with prolonged survival of HIV-infected men diagnosed with Kaposi sarcoma (KS) or non-Hodgkin lymphoma (NHL), even when it is initiated after diagnosis of the cancer.

Dr. Roger Detels, of the University of California, Los Angeles, and associates reviewed data from the Multicenter AIDS Cohort Study to identify 287 men with KS and 100 with NHL diagnosed between 1990 and 1999.

As reported in the International Journal of Cancer for April 20, the median survival time was 13 months for KS patients never exposed to HAART. Survival was significantly different (P =0.0001) for the two patients in whom HAART was initiated before diagnosis of KS and the 41 in whom HAART was initiated afterward, for whom the median survival time had not been reached by December of 1999.

After adjusting for year of KS diagnosis and baseline CD4 cell count, HAART exposure resulted in an 81% drop in mortality risk.

Eight-seven individuals with NHL were never treated with HAART, and for them, the median overall survival was 3 months. Among those who received HAART, four men died at 3, 4, 6 and 83 months after diagnosis of the malignancy. The nine other patients had survived for a median of 28 months by the end of 1999.

In this group, the reduction in the risk of death was 84%.

The investigators attribute the effect of HAART on survival to the enhanced ability of patients to tolerate higher doses of chemotherapy.

"Given the short expected median non-HAART survival...and the advanced stage at which most NHL cases are diagnosed, it was particularly encouraging to find that treatment with HAART resulted in prolonged survival," Dr. Detels and his colleagues write.

For both types of cancer, they recommend serious consideration of HAART treatment even after diagnosis.

Int J Cancer 2002;98:916-922.

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Goals of Directly Observed Therapy for HIV Differ From Those for TB -- Anonymous, 11:12:32 05/16/02 Thu

Goals of Directly Observed Therapy for HIV Differ From Those for TB

Reuters Health Information 2002. 2002 Reuters Ltd
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Introduction
NEW YORK (Reuters Health) Apr 19 - Directly observed therapy (DOT) improves treatment of HIV and AIDS, results of pilot programs suggest. However, experience with DOT for tuberculosis (TB), for which DOT was designed, cannot answer such questions as ideal candidacy, cost-effectiveness, appropriate duration, and ultimate goals of such a program for HIV-infected patients.

In an invited article that appears in the April 1st issue of Clinical Infectious Diseases, Dr. Jennifer Adelson Mitty and associates note that DOT makes some sense for HIV-infected patients, since poor adherence to treatment for both TB and HIV can lead to the development of drug resistance.

However, treatment for HIV must be administered more frequently than TB treatment and, unlike TB, HIV treatment can be expected to last a lifetime.

DOT for HIV has been successful in prison settings, reducing patients' plasma viral levels over that of control subjects. In programs that enrolled patients with a history of poor adherence to therapy, patients who were compliant with the programs exhibited decreased blood levels of HIV mRNA, and in one program, increased CD4 cell counts.

Dr. Mitty, from Miriam Hospital in Providence, Rhode Island, and colleagues recommend that when DOT programs are being considered, they should be flexible in terms of the frequency and location of visits, and that they maintain patient confidentiality. They urge that consideration be given to the goal of providing individuals with the skills they need to maintain independent adherence to therapy.

The authors conclude that while short-term DOT programs directed at "marginalized" populations can be successful, "a multitude of questions remain." Nonetheless, they believe that the DOT approach "could allow clinicians to consider prescribing highly active antiretroviral therapy to individuals who may otherwise be considered untreatable."

Clin Infect Dis 2002;34:984-990.

http://www.medscape.com/viewarticle/432265_print

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Saquinavir Suboptimal in HIV-Positive Children Unless Combined With Other PIs -- Anonymous, 11:09:16 05/16/02 Thu

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