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

Source: BioSpace Area: News Gilead Sciences has announced topline results from the phase III FUSION study evaluating sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior interferon-based treatment.   In the FUSION study, patients were randomised to either a 12-week (n=103) or 16-week (n=98) course of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200 mg/day). The primary efficacy endpoint was superiority compared to a predefined historic control sustained virological response (SVR) rate of 25%.   The following results were reported:   . A total of 50% of patients (n=50/100) in the 12-week arm and 73% of patients (n=69/95) in the 16-week arm achieved SVR12 (ie the percentage of patients who have no detectable HCV in their blood 12 weeks after the cessation of treatment) (p<0.001 for both arms).   . In the 12-week arm, SVR12 rates were 86% among genotype 2 and ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news