FDA Approves Fuzeon

The Food and Drug Administration (FDA) granted accelerated approval of enfuviritide (Fuzeon) for use in combination with other anti-HIV medications to treat advanced HIV infection. Fuzeon, also known as T-20, is the first product in a new class of medications called fusion inhibitors to receive marketing approval. Unlike existing drugs that work inside the cell, Fuzeon blocks HIV from entering healthy immune cells. The drug was designed for patients in advanced stages of the disease who have shown resistance to other AIDS drugs, and is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. Fuzeon is administered twice-daily as a subcutaneous injection. Local injection site reactions were the most common side effects reported, and approved labeling warns physicians to carefully monitor patients for signs and symptoms of pneumonia.

Developed with Trimeris Inc. and Roche Pharmaceuticals, Fuzeon will be distributed by Roche. Initial demand for Fuzeon is expected to outstrip supply, and the companies are still working on a distribution plan. The U.S. price has not yet been finalized, but is expected to reach new records for drug pricing based on the price set in Europe at 52 euros a day, or more than $20,000/year. Roche says the high cost (more than double the cost of other HIV/AIDS drugs on the market) is due to the complexity of the manufacturing process, which involves more than 100 production steps.
FDA News and Reuters, 3/14/03

Trizivir Trial Halted: Less Effective When Taken Alone

The National Institutes of Health (NIH) halted a trial of GlaxoSmithKline's Trizivir (abacavir sulfate/lamivudine/zidovudine) after it proved less effective than when used in combination with other AIDS drugs. The study involved 1,147 treatment-naïve patients and compared Trizivir alone with a combination of Trizivir and Sustiva (efavirenz), and a combination of Sustiva and Combivir (lamivudine/zidovudine). The NIH decided to stop the Trizivir-only arm of the trial after participants in that arm experienced virologic failure sooner and more often than patients in the other two arms of the study. After an average of 32 weeks in the study, 167 participants out of 1,147 experienced virologic failure; 21% of the patients taking Trizivir alone experienced failure, compared with 10% in the other two arms of the study. The trial comparing the other combinations will continue.
Wall Street Journal and Reuters, 3/13/03

FDA Issues Alert About Counterfeit Procrit

The US Food and Drug Administration warned about counterfeit versions of Procrit (erythropoietin) that are ineffective and contaminated with bacteria that could harm patients. Laboratory testing discovered the three lots of the counterfeit Procrit with the following lot numbers and expiration dates: P007645, expiration 10-2004; P004677, expiration 02-2004; and P004839, expiration 02-2004. If a counterfeit version is found, it should be quarantined and the FDA should be notified (1-800-835-4709).
FDA News, 3/11/03

NEJM: Antiretroviral Drugs Have Lower Heart Attack, Stroke Risk Than Previously Stated

Contrary to data presented at the 10th CROI (see the results from the D: A: D study discussed in the main article), antiretroviral drugs do not cause "premature" heart attack or stroke in HIV-positive patients, according to a study published in the Feb. 20 issue of the New England Journal of Medicine. Samuel Bozzette et al. conducted a retrospective study of almost 37,000 patients who received care for HIV infection at Veterans Affairs facilities nationwide between 1993 and 2001. "Use of newer therapies for HIV was associated with a large benefit in terms of mortality that was not diminished by any increase in the rate of cardiovascular or cerebrovascular events or related mortality," the authors state.
New England Journal of Medicine, 2/20/03

Boehringer Ingelheim Launches Phase III Clinical Trials for Tipranavir

Boehringer Ingelheim (BI) launched Phase III RESIST clinical trials to study the efficacy and safety of tipranavir for use in combination therapy for HIV infection. Tipranavir is the first non-peptidic protease inhibitor (NPPI) in development for the treatment of HIV infection. The RESIST trials will evaluate triple-class-experienced patients in more than 280 clinical trial sites worldwide.
PRNewswire, 2/6/03

Officials Urge Increased Use of HIV Rapid Test

CDC officials at the 10th Conference on Retroviruses and Opportunistic Infections (CROI) called for more widespread use of a rapid HIV test approved by the FDA in November 2002. More widespread use could help curb the spread of the disease by identifying newly-infected people as soon as possible in order to reduce their chance of transmitting the virus to others. The rapid test also can be very useful in the setting of post-exposure management of health care workers when the source's HIV status is not known. Officials recommended that the new test, which can provide results in 20 minutes, be part of routine health care for those at risk of infection.
Boston Globe, 2/11/03

Nearly 41% of South Africa's Prison Population is HIV-Positive

A study released by the nongovernmental Institute for Security Studies estimates that nearly 41% of inmates in South Africa's "overburdened" prisons are infected with HIV/AIDS. Since 1995, reported cases of HIV/AIDS in South African prisons rose by 750%, and the number of natural deaths in prison have surged by about 600 percent. Most of the deaths are believed to be AIDS-related. According to Reuters, the disease's progress is being hastened by severe overcrowding in the prisons.
Reuters, 2/18/03

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©1997,1998,1999,2000,2001,2002, 2003. The recently formed HIV Education Prison Project (HEPP) is a medical education program that targets a growing population, inmates in correctional facilities, that has been underserved in HIV care. It is part of the Brown University AIDS Program. Permission to use and reproduce portions of this newsletter is hereby granted provided that author and publication are fully credited and both copyright and permission notice appear with reprinted material. Inquiries may be directed to heppnews@brown.edu. Website: HIV Education Prison Project.

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