Gilead preparing to submit pan-genotypic HCV combo

Gilead Sciences Inc. (NASDAQ:GILD) said 98% of mixed-genotype HCV patients treated with sofosbuvir/velpatasvir had an SVR12 in three Phase III studies to treat HCV infection. Gilead said the fixed-dose, single-tablet combination of Sovaldi sofosbuvir and pan-genotypic NS5A inhibitor velpatasvir ( GS-5816) could eliminate the need for genotype testing in treating HCV. The company plans to submit an NDA to FDA and MAA to EMA next quarter.

The Phase III ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies enrolled a total of 1,035 patients with genotype 1-6 HCV infection. A combined 21% of total patients had compensated cirrhosis. ...