FDA APPROVES GILEAD'S HIV MEDICATIONS

Gilead Sciences has announced that the FDA has approved its once-daily antiretroviral Viread (tenofovir disoproxil fumarate) and its fixed-dose product Truvada (emtricitabine and tenofovir disoproxil fumarate), which combines the company's two antiretrovirals Emtriva (emtricitabine) and Viread in a single daily tablet.

The approval is based on data from Study 934, a Phase III open-label trial comparing a once-daily regimen of Viread, Emtriva and efavirenz to twice-daily Combivir (lamivudine/zidovudine) and once-daily efavirenz in treatment-naive patients. Eighty-four percent of patients in the Viread/Emtriva group, compared to 73 percent of patients in the Combivir group achieved and maintained HIV RNA less than 400 copies/ml through week 48.