Gilead Sciences reports positive data from new hepatitis B drug trial

Gilead Sciences has announced clinical data from two phase III trials showing the safety and efficacy of its new hepatitis B drug tenofovir alafenamide.

Detailed 48-week results from Studies 108 and 110 have highlighted the strong performance of once-daily tenofovir alafenamide (TAF) in treatment-naive and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus (HBV) infections.

Both studies met their primary endpoints of non-inferiority to Gilead's established therapy Viread, while offering a better performance in terms of improvements in renal and bone laboratory safety parameters.

The randomised double-blind trials lasted for 96 weeks and involved a total of 1,298 patients.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said: "The TAF phase III results presented this week demonstrate its potential to advance the treatment of HBV – offering a similar efficacy profile to Viread with improved bone and renal safety parameters."

The drug was approved in the US for the treatment of HIV earlier this month.