Pharmaceutical Update

Data from an early-stage clinical trial of Viramune, a Boehringer Ingelheim nonnucleoside reverse transcriptase inhibitor, show that the drug may be useful in preventing HIV transmission. The study found that a single dose of Viramune taken weekly, twice weekly, or every other day maintained high levels of the drug in the bloodstream, which could thus prevent HIV infection. The Food and Drug Administration approved a new dosing formulation for Agouron's protease inhibitor Viracept on April 30. The new dosage is a 625-milligram tablet that can be taken as two tablets twice a day. The FDA on April 17 approved MedMira's Reveal Rapid HIV-1 Antibody Test, which can detect HIV antibodies in blood serum or plasma within three minutes. The test will be distributed exclusively to U.S. health care providers by Cardinal Health. The FDA on April 11 approved Roche's Cobas Amplicor HIV-1 Monitor Test, version 1.5, used to detect and measure HIV in blood. The FDA approved a supplemental drug application by GlaxoSmithKline on April 2 for the use of Valtrex to treat recurrent genital herpes in HIV-positive adults. The FDA issued a warning in March about fake batches of Procrit, Ortho Biotech Products' antianemia drug, that are medically useless and possibly contaminated with bacteria. The three fake batches bear the following lot numbers and expiration dates: P007645, expiration October 2004; P004677, expiration February 2004; and P004839, expiration February 2004. For more information visit www.procrit.com. A U.S. district court judge in March dismissed a lawsuit filed by the AIDS Healthcare Foundation against drugmaker GlaxoSmithKline that claimed the company's patent on Retrovir (AZT) is invalid. However, in late April, AHF lawyers filed an amended version of the dismissed suit. Data from a Phase III clinical trial of the nucleoside reverse transcriptase inhibitor Coviracil (emtricitabine) developed by Triangle Pharmaceuticals (which was acquired by Gilead Sciences in January) show that the drug is effective in suppressing HIV replication when taken as part of a once-daily protease inhibitor'sparing regimen. Data from a clinical trial of Reyataz (atazanavir), a Bristol-Myers Squibb protease inhibitor, show that the drug is as effective as Viracept in suppressing HIV replication and does not appear to cause clinically relevant increases in cholesterol and triglycerides. Studies under way at the National Institutes of Health and at Family Health International are trying to determine if Viread, Gilead's nucleotide reverse transcriptase inhibitor, is effective in preventing HIV transmission. The NIH Phase I clinical trial is evaluating a Viread-based gel in preventing vaginal HIV transmission; the Family Health International study is examining the use of Viread pills as an HIV preventive. Meanwhile, Gilead Sciences introduced a program in April to sell Viread at cost in 68 developing countries, including all African nations. Second-generation fusion inhibitor T-1249, developed by Hoffman-LaRoche and Trimeris, was shown in a study of 54 patients to reduce blood-based viral levels in patients experiencing resistance to a regimen containing Fuzeon. Tipranavir, Boehringer Ingelheim's experimental protease inhibitor, has been shown to be effective in a Phase II clinical trial for patients resistant to all currently approved protease inhibitors. Researchers in Switzerland report that the antidiabetic drug pioglitozone, sold as Actos by Eli Lilly and Takeda Pharmaceuticals, increased total fat mass in 10 of 11 HIV-positive adults experiencing lipoatrophy. German scientists report that six months of treatment with Peg-Intron (pegylated interferon Alfa-2b), Schering-Plough's antihepatitis drug, reduced blood-based HIV viral loads and boosted CD4-cell counts in HIV-positive study participants. A study of Niaspan, KOS Pharmaceuticals' cholesterol-lowering medication, shows that the drug lowers triglyceride and cholesterol levels in HIV-positive patients but also reveals that the medication may worsen insulin resistance. German researchers report that a study of the anabolic steroid oxymetholone shows that the drug is effective in countering wasting and promoting significant weight gain among HIV-positive adults taking anti-HIV medications. A study of 24 HIV-positive patients on anti-HIV drug therapy showed that the addition of the corticosteroid prednisone produced an increase in circulating CD4 cells and total lymphocytes. New compounds discovered by researchers at the Howard Hughes Medical Institute at the University of Maryland, Baltimore County, have been shown to interfere with the assembly of HIV copies by binding to HIV's capsid proteins. Researchers say the discovery could lead to a new class of anti-HIV drugs.