Gilead reports data for latest HCV combo

Gilead Sciences Inc. (NASDAQ:GILD) reported top-line data from four Phase III trials of pan-genotypic HCV combination therapy sofosbuvir/velpatasvir/voxilaprevir, including sustained viral response data in patients previously treated with direct-acting antivirals (DAAs) and patients with cirrhosis. The company plans to submit an NDA for the combination next quarter, and said it could be the first approved once-daily salvage therapy following DAAs.

In the 333-patient POLARIS-4 study, Gilead said a 12-week course of the triple combo led to an SVR12 in 97% of patients vs. 90% for Gilead's Epclusa sofosbuvir/velpatasvir. The study evaluated patients with HCV genotype 1-4 infection, 46% of whom had cirrhosis, who had previously received a DAA such as Sovaldi sofosbuvir, but not an NS5A inhibitor. ...