Gilead Gains Approval To Market Combination Antiretroviral Drugs Truvada and Viread

Foster City, Calif.-based biotech company Gilead on Wednesday received "traditional approval" status from FDA to market its once-a-day antiretroviral drugs Viread and Truvada, which is a combination pill that contains Viread and Emtriva, Reuters reports (Reuters, 3/8). Viread and Truvada had been granted "accelerated approval" status in October 2001 and August 2004 respectively (AP/BusinessWeek, 3/8). The approvals were based on FDA's review of data from a 48-week study showing that a combination of Viread and Emtriva was more effective when compared with GlaxoSmithKline's Combivir, United Press International reports (United Press International, 3/8). Gilead and Bristol-Myers Squibb in January announced they jointly developed a regimen for treating HIV that is effective in suppressing HIV viral loads with few side effects. Joel Gallant of Johns Hopkins University and colleagues looked at 517 HIV-positive patients who had never received antiretroviral therapy and had HIV viral loads greater than 10,000 copies per milliliter. The patients were randomly divided into two groups: one group received a combination of BMS' Sustiva and Gilead's Viread and Emtriva as separate components and the other group received a combination of Sustiva and Combivir. After 48 weeks, researchers found "significantly greater responses" in the group receiving the Sustiva, Viread and Emtriva treatment, with 84% of patients in that group showing a reduced viral load compared with 73% in the other group. According to the study, published in the Jan. 19 edition of the New England Journal of Medicine, patients taking the Sustiva, Viread and Emtriva treatment also experienced fewer side effects than those associated with the standard three-drug regimen (Kaiser Daily HIV/AIDS Report, 1/19). The change in FDA approval status will allow the company to include data from the study on Truvada's and Viread's labels (AP/BusinessWeek, 3/8).