BioCentury
ARTICLE | Clinical News

Sofosbuvir: Phase III data

December 23, 2013 8:00 AM UTC

Gilead reported top-line data from 647 non-cirrhotic, treatment-naive patients with chronic HCV genotype 1 infection in the open-label, U.S. Phase III ION-3 trial evaluating a once-daily, oral fixed-dose combination of 400 mg sofosbuvir plus 90 mg ledipasvir with or without ribavirin for 8 weeks or without ribavirin for 12 weeks. SVR12 rates were 93.1% for sofosbuvir plus ledipasvir with ribavirin for 8 weeks (n=216), 94% for sofosbuvir plus ledipasvir without ribavirin for 8 weeks (n=215) and 95.4% for sofosbuvir plus ledipasvir without ribavirin for 12 weeks (n=216). 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. ...