Gilead Says Two Phase 3 Trials On Tenofovir Alafenamide Met Primary Objectives

(RTTNews) - Gilead Sciences, Inc. (GILD) announced that two Phase 3 clinical trials, Studies 108 and 110, regarding investigational use of once-daily tenofovir alafenamide (TAF) 25 mg in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus infection met their primary objectives.

Gilead noted that studies showed TAF was non-inferior to Viread (tenofovir disoproxil fumarate, TDF) based on the percentage of patients with HBV DNA levels below 29 IU/mL at 48 weeks of therapy. In addition, TAF demonstrated improved renal and bone laboratory safety parameters compared to Viread.

Gilead plans to submit regulatory applications for TAF for chronic HBV in the U.S. and the European Union in the first quarter of 2016. Gilead also plans to submit data from both studies for presentation to a scientific conference in 2016.