Horizon scanning: Phase III results for sofosbuvir in chronic hepatitis C

Source: BioSpace Area: News BioSpace has reported on the results of two Phase III studies of the investigative antiviral sofosbuvir in combination with ribavirin (FISSION) and in combination with ribavirin and pegylated interferon (NEUTRINO) in the first-line treatment of patients with chronic hepatitis C virus (HCV) infection.   In the FISSION study, treatment-naïve patients with HCV genotype 2 or 3 were randomised to receive either 12 weeks of sofosbuvir (400mg once daily) plus ribavirin (1,000 or 1,200 mg/day) (n=256) or standard of care with 24 weeks of pegylated interferon alfa-2a (peg-IFN; 180 mcg/week) plus ribavirin (800mg/day) (n=243). The primary endpoint was sustained virological response (SVR) - this was achieved in 67% of patients in both arms (95% CI for the difference: -7.5% to +8.0% for sofosbuvir plus RBV versus peg-IFN plus RBV; predefined criterion for non-inferiority was met). Three patients (1%) receiving sofosbuvir discontinued treatment due to adverse events compared to 26 ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news