Sofosbuvir: Phase III data

Gilead reported top-line data from 440 treatment-experienced patients with chronic HCV genotype 1 infection in the open-label, U.S. Phase III ION-2 trial evaluating a once-daily, oral fixed-dose combination of 400 mg sofosbuvir plus 90 mg ledipasvir with or without ribavirin for 12 or 24 weeks. SVR12 rates were 96.4% for sofosbuvir plus ledipasvir with ribavirin for 12 weeks (n=111), 93.6% for sofosbuvir plus ledipasvir without ribavirin for 12 weeks (n=109), 99.1% for sofosbuvir plus ledipasvir with ribavirin for 24 weeks (n=111) and 99.1% for sofosbuvir plus ledipasvir without ribavirin for 24 weeks (n=109). The trial enrolled patients who had failed prior therapy with regimens containing pegylated interferon, including 136 patients with cirrhosis. Next quarter, Gilead plans to submit an NDA to FDA and an MAA to EMA for the fixed-dose combination of sofosbuvir and ledipasvir to treat chronic HCV genotype 1 infection. The combination product has breakthrough therapy designation in the U.S. ...