Gilead Sciences Viread
Executive Summary
FDA's Antiviral Drugs Advisory Committee will review Gilead Sciences nucleotide reverse transcriptase inhibitor Viread (tenofovir) Oct. 3 for treatment of HIV. Phase III results with heavily treatment-experienced patients showed significant HIV RNA decreases compared to placebo; drug would be first nucleotide RTI approved for HIV, Gilead said. The Viread NDA was submitted May 1 and has priority review status. Data from Viread trial in treatment-naive patients is slated to be available in first half of 2002. The meeting will begin at 8:30 am at the Town Center Hotel in Silver Spring, Md