Gilead's TAF non-inferior to Viread in HBV

Gilead Sciences Inc. (NASDAQ:GILD) said it plans to submit U.S. and EU regulatory filings this quarter for single-agent tenofovir alafenamide ( GS-7340) to treat chronic HBV after reporting on Tuesday that the compound met the primary endpoint in two double-blind Phase III trials.

TAF was non-inferior to Gilead's Viread tenofovir disoproxil fumarate (TDF) as evaluated by the proportion of patients with HBV DNA levels below 29 IU/mL at 48 weeks. The trials enrolled treatment-naive and treatment-experienced HBV patients to receive 25 mg TAF once daily, or Viread. One trial enrolled 425 patients who were negative for hepatitis B envelope antigen (HBeAg); the other enrolled 873 HBeAg-positive patients. ...