Gilead Sciences reports positive clinical data for new hepatitis C therapy

Gilead Sciences has announced topline results from four international phase III clinical studies showing the benefits of its new combination hepatitis C therapy.

Data from the ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4 studies showed that its once-daily fixed-dose combination of sofosbuvir and velpatasvir was effective in the treatment of genotype 1-6 chronic hepatitis C virus infections.

A sustained virological response after 12 weeks was achieved in 98 percent of the 1,035 patients treated in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, as well as the vast majority of those in the ASTRAL-4 decompensated cirrhosis study.

This fixed-dose combination remains an investigational product, though it has been granted breakthrough treatment designation in the US.

Dr Norbert Bischofberger, executive vice-president of research and development and chief scientific officer at Gilead Sciences, said: "The ASTRAL study results demonstrate that a 12-week course of therapy with the first fixed-dose combination of two pan-genotypic compounds can provide high cure rates for patients with all HCV genotypes."

This comes after the firm's investigational fixed-dose combination of emtricitabine/tenofovir alafenamide for the treatment of HIV met its primary objective in a new trial reported earlier this month.