The FDA approved a new "extended release" version of Bristol-Myers Squibb's Zerit (d4T, stavudine). The new formulation, which will be marketed as Zerit XR, has been shown to maintain measurable plasma concentrations in patients for 24 hours following the once-a-day dose. Zerit XR is indicated for treatment of HIV infection in combination with other antiretrovirals. The full label will be available in the future at www.fda.gov/cder/approval/index.htm. As of January 10, 2003, Zerit XR was not yet available in pharmacies. (Kaiser Daily HIV/AIDS Report, 1/02/03)
A recent issue of Nature reports findings from Bruce Walker, M.D., a researcher at Massachusetts General Hospital and Harvard Medical School, of an individual infected with two closely related strains of HIV. The two strains differed in overall amino acid sequence by about 12 percent (variation between subtypes of HIV is about 30 percent) and is the first published report of infection by two strains of the same subtype. This data provides further strength to the recommendation that HIV-infected individuals protect themselves from super-infection with other HIV strains. (NIH News Release, 11/27/02)
California-based Gilead Sciences has agreed to buy North Carolina-based Triangle Pharmaceuticals for $464 million. With the deal, Gilead's development portfolio is strengthened with three of Triangle's HIV and HBV drugs, including Coviracil (FTC, emtricitabine), which could be approved by the FDA in 2003. According to Gilead's chief operating officer, Coviracil (an NRTI) could be combined with Gilead's Viread to make a once-a-day tablet. (Kaiser Daily HIV/AIDS Report, 12/06/02)
The Bill & Melinda Gates foundation awarded a $6.5 million, three-year grant for a multinational clinical trial to evaluate Gilead Science's tenofovir (Viread) as an approach to HIV prevention. The trial is designed to evaluate the safety and efficacy of tenofovir as a method of reducing the risk of HIV infection in sexually active adults who are regularly exposed to the virus. (Gilead Press Release, 10/28/02)
A suit filed on behalf of five HIV-positive inmates at Alabama's Limestone Correctional Facility charges the state Department of Corrections and NaphCare with "inadequate living conditions" and medical care. According to the plaintiffs' lawyer, more than 40 inmates with HIV have died at the Limestone facility over the past three years. Limestone is a special unit of the state prison system and houses more than 200 HIV-positive inmates. (Kaiser Daily HIV/AIDS Report, 11/25/02)
The FDA approved combination therapy with Roche Pharmaceutical's Pegasys and Copegus (ribavirin) for the treatment of adults with chronic HCV infection who have compensated liver disease, and have not been treated with interferon alpha. Pegasys, a premixed solution, is injected once a week; Copegus is available as a 200 mg tablet (administered at 800 to 1200 mg) taken twice daily as a split dose. (Kaiser Daily HIV/AIDS Report, 12/05/02)
A study presented at AASLD examined whether the degree of depression caused by HCV therapy was related to the type of therapy (either INF/ribavirin or PEG-INF/ribavirin compared to INF monotherapy). Results showed that combination therapy significantly increased the depression induced by therapy, and as adherence is affected by severe depression, it often results in early dropout, resulting in poor viral response. The study suggests that better control of depression at the initiation of therapy might improve compliance, and ultimately, viral response. (www.hivandhepatitis.com, 11/18/02)
This article was provided by Brown Medical School. It is a part of the publication HEPP Report.