Approval Sought for Only-Daily Hepatitis B Treatment

Gilead Sciences Inc has submitted a new drug application to the FDA for tenofovir alafenamide, a once-daily treatment for adults with chronic hepatitis B virus infection.

The application includes data from 2 phase 3 studies that met their primary objective of non-inferiority in efficacy compared with tenofovir disoproxil fumarate (Viread). The rates of discontinuation of the drug due to adverse effects were similar to the rates seen in patients who received Viread.

Tenofovir alafenamide is a targeted prodrug of tenofovir that has shown high antiviral efficacy similar to Viread and at a dose less than one-tenth that of Viread.

“Chronic hepatitis B is a potentially life-threatening disease that impacts millions of people worldwide and often requires prolonged therapy,” said Norbert Bischofberger, executive vice president of research and development and chief scientific officer of Gilead Sciences, in a press release. “Given its lower dose, efficacy, and safety profile, TAF [tenofovir alafenamide] has the potential to offer patients an improved treatment option that may advance their long-term care of chronic HBV [hepatitis B virus].”