Poor Countries Hit Hardest by Viracept Recall, Immediate Treatment of Infants Improves Survival, Maraviroc Approved

Recall of AIDS Drug Hits World's Poorest Patients
Tens of thousands of persons with HIV/AIDS have seen their treatment interrupted by the worldwide recall of Roche Pharmaceuticals' protease inhibitor Viracept (nelfinavir). Roche pulled the medicine off shelves in June after finding that some batches made in its Swiss plant contained a dangerous chemical. The contaminant, ethyl mesylate, has been linked to cancer at high doses and to genetic mutations at lower levels, company spokesperson Martina Rupp said (Rosenthal E. New York Times. July 23, 2007).

Some health advocates charge that Roche did a poor job of informing patients and care providers of the potential risk and of helping them access alternative treatments. Roche maintains it notified authorities promptly and offered to cover "reasonable costs" associated with the recall.

According to the World Health Organization (WHO), Roche's discounted median price for Viracept in poor countries is $0.28 per dose. Patients in some countries-including Panama-have had to switch to much more expensive treatments. For patients in other countries, including Venezuela, no alterative is available.

"Roche has provided information, but there has been much less support in terms of who is going to pay the additional cost," said Dr Cesar Nunez, United Nations AIDS coordinator for Latin America.

For patients in very poor countries, the result has been "sort of a disaster," said Dr Lembit Rago of the WHO. In Venezuela, where 3000 people were receiving Viracept, Roche has promised to donate an alternative medicine, but "most people are still waiting," said Alberto Nieve, a local AIDS advocate.

The recall does not affect the United States, Canada, or Japan, where a version of Viracept is manufactured by Pfizer. Switching patients in developing nations to the Pfizer version is in discussion but could take “some time” because of licensing and regulatory issues, Rupp said. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Tuesday, July 24, 2007]

Early Treatment Sees More HIV Babies Survive
A study of HIV-infected infants found that 96% who were given immediate antiretroviral (ARV) therapy were still alive 2 years later, compared with 84% of children given later treatment, researchers told the 4th International AIDS Society Conference in Sydney, Australia (Perry M. Reuters. July 24, 2007).

The US National Institute of Allergy and Infectious Disease (NIAID)-led study of infants in Cape Town and Soweto in South Africa began in 2005. Researchers had initially studied 337 infants, aged 6 to 12 weeks, to determine whether early ARV treatment over a limited period would delay progression of the virus. Doctors had hoped that early treatment would allow the infants’ immune systems to develop and possibly allow for planned treatment interruptions. A 2007 review, however, found such profound differences in survival rates that the study was cut short so that all children could receive treatment, and the results were forwarded to the World Health Organization.

"Children with HIV infection frequently show rapid disease progression within the first year of life due to their developing immune systems and susceptibility to other serious infections," said Dr Elias Zerhouni, director of the NIH. "This is the first randomized clinical trial that shows that infants treated before 3 months of age will do better than infants who have their treatment delayed."

"The results of this trial could have significant public health implications worldwide because these findings will cause experts to consider changes in standards of care in many parts of the world," said NIAID director Dr Anthony Fauci. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Friday, July 20, 2007]

Self-Assessment May Reduce HIV Patients' Risk-Taking
A key component of HIV/AIDS care is encouraging patients to curb high-risk behaviors, such as unprotected sex and drug use. Often, this means time-intensive and costly counseling. A new study, however, suggests that self-assessments could provide the push that some HIV-infected patients need to make better lifestyle choices (Norton A. Reuters. July 17, 2007).

The study involved 365 HIV-infected patients recruited from various community health clinics and HMOs. Before each medical appointment (scheduled 3 to 4 months apart), the patients were taken to a private room to answer questions about their behavior on a laptop computer. Patients who completed 4 or more self-assessments over time posted the largest increases in abstinence, from 47% to 61%. They also had the greatest improvement in condom use. At the study's start, 73% said they used a condom when their partner was HIV-negative or when they did not know their partner’s HIV status; that increased to 85%.

In answering the questions, people have to reflect on their behavior and may see it in a more objective way, explained Dr Marguerita Lightfoot, the study's lead author and a research psychologist at the University of California, Los Angeles. "I think that's a big reason that this intervention is powerful," she said.

In addition, the use of computers frees people from the fear of being judged. "People are much more truthful and let down their guard when talking to a computer," said Lightfoot. Although she cautioned that more research is needed, "practically speaking," she said, "self-assessments require only some laptop computers and would be relatively inexpensive and simple for clinics to implement."

The results of the study-"Self-Monitoring of Behaviour as a Risk Reduction Strategy for Persons Living with HIV"-were published in July (Lightfoot M, Rotheram-Borus MJ, Comulada S, et al. AIDS Care. 2007;19:757-763.)

FDA Approves Drug for Resistant HIV
On Monday, August 6, the FDA approved Pfizer's Selzentry (maraviroc), the first of a new HIV drug class. Selzentry, which the FDA approved for patients experiencing failure of multiple HIV drugs, does not attack HIV but rather prevents it from accessing the CCR5 receptor, a key pathway HIV uses to infect human immune cells (Chong JR. Los Angeles Times. August 7, 2007).

According to data from more than 600 patients, Selzentry in combination with other HIV drugs reduced HIV to undetectable levels in about 45% of the patients. Among patients who received placebo combined with other HIV drugs, about 23% achieved undetectable HIV levels.

However, the FDA has mulled its decision on Selzentry since June, when it received a report of one woman in whom Selzentry was associated with high levels of a liver enzyme. In addition to a warning about possible liver complications, Selzentry will carry a black box notice, the strongest possible advisory, about increased risk of heart attack.

"I think the benefits of the drug clearly outweigh the risks," said Dr Debra B. Birnkrant, director of the FDA's antiviral products division. The FDA will also collect data on patients taking Selzentry for 5 years to check on the drug's long-term effects, she said.

Since the end of last year, patients with limited treatment options have been able to obtain Selzentry through an expanded access program. Pfizer plans to make Selzentry available to the broader market by September at a wholesale cost of $29 per day. About 50% to 60% of patients with drug-resistant HIV have strains that use the CCR5 receptor to infect human immune cells. The lone test available to determine whether an HIV strain targets CCR5 was introduced on August 6 and will be priced at about $1700 per patient, according to Monogram Biosciences, its manufacturer. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Tuesday, August 7, 2007]

Abstinence-Only Programs Do Not Reduce HIV Risk
Data from 13 trials involving almost 16,000 US youth suggest that abstinence-only programs are not an effective way of preventing HIV infection in high-income countries, according to a study by researchers from the University of Oxford, United Kingdom (Reuters. August 3, 2007).

Dr Kristen Underhill and colleagues found that compared with no program, safer sex programs, and various other prevention programs, abstinence-only programs did not appear to reduce HIV infection risk. Specifically, abstinence programs did not influence the rate of unprotected vaginal sex, condom use, the number of sexual partners, or the timing of sexual debut.

Data from one trial suggested that abstinence-only programs may have had an adverse effect: Compared with no HIV prevention program, abstinence programs were associated with a rise in sexually transmitted diseases and pregnancy. Other studies did not show a significant link between these outcomes and abstinence-only programs, the authors noted.

"In contrast to abstinence-only programs, programs that promote the use of condoms greatly reduce the risk of acquiring HIV, especially when such programs are culturally tailored behavioral interventions targeting people at highest risk of HIV infection," said a related editorial by Dr Stephen E. Hawes of the University of Washington, Seattle, and colleagues.

The study, "Sexual Abstinence-Only Programs to Prevent HIV Infection in High-Income Countries: Systematic Review," and the editorial, "Is There a Role for Abstinence-Only Programs for HIV Prevention in High-Income Countries?" were published in the British Medical Journal (2007;335:248 and 217-218, respectively). [CDC HIV/Hepatitis/STD/TB Prevention News Update, Monday, August 6, 2007].