Gilead Sciences reports positive hepatitis B drug data

Gilead Sciences has announced clinical trial data showing the safety and efficacy of tenofovir alafenamide, its new treatment for hepatitis B virus (HBV) infections.

Results from two phase III clinical trials – Study 108 and Study 110 – have shown that the once-daily tenofovir alafenamide 25 mg regimen, when used in treatment-naive and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV infections, was able to meet its primary study objectives.

It was shown that the new therapy was non-inferior to Gilead's established product Viread, based on the suppression of HBV DNA levels at 48 weeks of therapy. In addition, tenofovir alafenamide demonstrated improved renal and bone laboratory safety parameters compared to Viread.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said: "HBV is a chronic condition that requires prolonged therapy, and we look forward to the opportunity to offer patients an improved option that has the potential to advance the long-term treatment of HBV."

Based on these results, Gilead plans to submit regulatory applications for the new drug for chronic HBV in the US and the EU in the first quarter of 2016.