Gilead Sciences reports positive data for phase III hepatitis C trial

Gilead Sciences has reported positive clinical trial data for sofosbuvir, a new therapy for treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus.

The phase III Fusion study evaluated the once-daily nucleotide sofosbuvir plus ribavirin among patients who had failed prior treatment and found that the new therapy provided a superior sustained virologic response compared to a predefined historic control.

All four of the pivotal phase III trials of this new compound – Fusion, Positron, Fission and Neutrino – have yielded positive outcomes and met their primary efficacy endpoints, with full results from the studies set to be presented at a future scientific conference.

Dr Norbert Bischofberger, executive vice-president of research and development and chief scientific officer at Gilead Sciences, said: "With positive results from all four phase III trials now in hand, Gilead is on track to meet its goal of filing regulatory applications in the United States and Europe in the second quarter."

Last month, the company commenced the first of two planned phase III studies of a new single-tablet regimen for HIV-1 infections containing tenofovir alafenamide.