Pharmaceutical Update

The Food and Drug Administration has approved label changes for Viread to include new dose recommendations for patients with kidney impairment, a new warning about HIV'hepatitis B coinfection, dose recommendations for using Viread with Videx, and updated information on the drug's effects on the body's bones. The new label also says Viread can be taken with or without food. GlaxoSmithKline has warned health care providers that the combination of its anti-HIV drugs Epivir and Ziagen with Viread appears to be significantly less potent than other combinations of anti-HIV medications. Bristol-Myers Squibb has warned doctors that combining Reyataz, its new protease inhibitor, with Viread may result in a reduction in blood-based Reyataz levels by up to 40%, posing a risk for treatment failure. If the two drugs are used together, Reyataz should be boosted with Norvir. An experimental drug developed by Bristol-Myers Squibb, BMS-378806, has been shown in animal studies to be effective in preventing a key HIV protein from binding to a CD4-cell surface receptor. The drug is being developed as an HIV fusion inhibitor. Researchers at the University of Kentucky are developing a prescription patch that would deliver synthetic cannabinoids, the active ingredient in marijuana, through the skin to help ease nausea and stimulate appetite in AIDS and cancer patients. Australian company Starpharma has received FDA approval to begin U.S. human trials of VivaGel, a microbicide designed to prevent vaginal HIV transmission. A study in the July 25 issue of AIDS shows that intravaginal application of a gel containing the experimental nonnucleoside reverse transcriptase inhibitor TMC120, developed by Tibotec, was effective in preventing vaginal HIV infection in animals. A research letter in the July 25 issue of AIDS suggests that combining the protease inhibitors Kaletra and Fortovase could be effective as a cornerstone of a salvage therapy regimen for heavily treated HIV-positive adults. Once-daily dosing of Emtriva was as effective as twice-daily administration of Ziagen, according to a study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment. A study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment shows that a regimen containing Crixivan boosted by Norvir and two nucleoside reverse transcriptase inhibitors was an effective and welltolerated first-line therapy. A study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment shows that an antiretroviral regimen containing Sustiva outperforms a triple nucleoside regimen. Researchers at the Aaron Diamond AIDS Research Center have reported that viral loads of treatment-naive patients can be rapidly reduced to undetectable levels with a first-line regimen of Trizivir plus Sustiva. Most neurological side effects of Sustiva, including vivid dreams and sleep disturbances, are generally resolved after four weeks of treatment, according to a study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment. Two studies presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment show that elevated cholesterol and triglyceride levels in treatment-experienced patients improve when anti-HIV drug regimens were changed to include Reyataz. A study in the August 15 edition of AIDS shows that switching from a nonnucleoside reverse transcriptase inhibitor'based regimen to Trizivir can result in significant lipid improvements without losing viral control. Researchers in Canada report that patients with advanced HIV disease are at a higher risk than others for eventually developing kidney problems linked with the use of Viread. Gilead Sciences has announced the recruitment of treatment-naive study subjects for a Phase III comparative study of a once-daily anti-HIV drug regimen containing its drugs Viread and Emtriva plus Sustiva to a twice-daily regimen. The trial will include 300 patients in the United States and Europe.