Pharmaceutical Update

A study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment shows that a once-daily regimen containing Sustiva, Bristol-Myers Squibb's nonnucleoside reverse transcriptase inhibitor, is as effective in continuing to suppress HIV in people with undetectable viral loads as ongoing protease inhibitor therapy. The Food and Drug Administration granted marketing approval for Emtriva (emtricitabine), Gilead Sciences' nucleoside reverse transcriptase inhibitor, formerly known as FTC, on July 2. Emtriva is taken once daily, with or without food. The FDA has approved Advate, Baxter Healthcare's genetically engineered blood clotting factor, for the prevention and control of bleeding episodes in people with hemophilia A. Advate is the first hemophilia treatment made without any added human or animal plasma proteins. OraSure Technologies has announced Mexico's Ministry of Health's approval to market its OraQuick Rapid HIV-1 Antibody Test in the country. OraQuick can detect HIV antibodies in about 20 minutes. GlaxoSmithKline announced in July that it is ending a 200-person study of a combination anti-HIV drug regimen including Ziagen, Viread, and Epivir because of a high rate of failure seen after 16 weeks of treatment. VaxGen officials have said the company might stop funding its clinical trial of the experimental HIV vaccine AIDSVAX in Thailand before final data is collected because of financial constraints. A separate Phase III trial showed the vaccine is largely ineffective at preventing HIV infections in the general population, though it may be more useful for African-Americans and Asians. New data from a Phase III clinical trial of Fuzeon, the world's first HIV fusion inhibitor, developed by Roche and Trimeris, shows that two thirds of treatment-experienced patients who began a Fuzeon-based regimen were able to achieve undetectable viral loads. The companies also announced that supplies of the drug for 2003 will be higher than initially projected, with enough medication available to treat about 18,000 patients by the end of the year. A study in the June issue of the journal AIDS shows that Reyataz, the newly approved protease inhibitor developed by Bristol-Myers Squibb, is easier on the heart than Norvir when used in a salvage regimen. Reyataz lowered both bad cholesterol and triglyceride levels. A new study has shown that symptoms of depression can be eased by switching from a protease inhibitor or nonnucleoside reverse transcriptase inhibitor to Kaletra, a second-generation protease inhibitor made by Abbott Laboratories. Researchers in Thailand report that reducing the dosing level of d4T, the nucleoside reverse transcriptase inhibitor sold as Zerit in the United States by Bristol-Myers Squibb, can improve lipoatrophy while still maintaining viral suppression in HIV-positive adults. Researchers at Montreal's Theratechnologies report that studies of the peptide TH9507 in elderly and diabetes patients have shown that the compound stimulates the production of human growth hormone, which in turn helps speed up fat loss. The company plans a clinical trial to determine if the peptide is effective in combating antiretroviral-related lipodystrophy in HIV-positive adults. A study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment shows that treatment with Avandia, GlaxoSmithKline's antidiabetes medication, can help improve insulin sensitivity and lipoatrophy in HIV-positive patients. A study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment shows that psyllium, calcium carbonate, and loperamide supplements'along with dietary changes'can reduce diarrhea caused by Viracept, marketed by Agouron Pharmaceuticals. A study in the July 25 issue of the journal AIDS shows that treatment with Arava, an immunomodulatory treatment for rheumatoid arthritis developed by Aventis Pharmaceuticals, may boost the anti-HIV activity of AZT, sold in the United States as Retrovir, by GlaxoSmithKline. A study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment shows that switching from a protease inhibitor'based regimen to one containing Viramune, Boehringer Ingelheim's nonnucleoside reverse transcriptase inhibitor, maintains long-term viral suppression and immunological improvements. A study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment shows a treatment regimen including low-dose Norvir and Reyataz, the newly approved protease inhibitor developed by Bristol-Myers Squibb, is as effective as a regimen containing the protease inhibitor Kaletra. Data from a Phase III trial of the recently approved HIV nucleoside reverse transcriptase inhibitor Emtriva, developed by Gilead Sciences, shows that the once-daily drug is more potent than Bristol-Myers Squibb's Zerit in suppressing HIV viral loads and boosting CD4-cell counts. Researchers have announced the development of a flexible intravaginal ring that time-releases anti-HIV drugs and may protect users against HIV infection. The ring, similar to a diaphragm, can be used continuously for six to 12 months.