FDA Advisory Panel to Decide on Approval Recommendation for AIDS Drug Viread
An FDA advisory panel will vote today on whether to recommend agency approval of Gilead Sciences' experimental AIDS drug tenofovir, the San Francisco Chronicle reports. At issue is whether the drug should be approved only as a "last resort" treatment for HIV-positive patients who have developed resistance to other medications or as an "early stage medicine" (Abate, San Francisco Chronicle, 10/3). Tenofovir, the only HIV antiretroviral currently under consideration by the FDA for marketing approval, works by blocking an enzyme needed in the HIV replication process (Kaiser Daily HIV/AIDS Report, 9/26). Gilead, which will market the drug under the name Viread, is seeking to make the drug available to patients in November as a "first-line treatment for new AIDS patients." The company tested tenofovir on HIV-positive patients who had been taking other antiretrovirals for at least five years, most of whom had developed drug resistance and had experienced an increase in viral load. Trial results showed that when paired with other antiretroviral drugs, tenofovir reduced viral load by 75%. Gilead has also begun tenofovir trials with 601 patients newly diagnosed with HIV who are receiving antiretroviral drugs for the first time, with results expected in the first six months of 2002. Gilead's Vice President Carol Brosgart said that the firm is "confident" this study will show Viread as "safe and effective in fighting new HIV infections." The FDA is expected to make a final decision on drug approval by Nov. 1 (San Francisco Chronicle, 10/3).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.