Phase 3 Results Announced for Sofosbuvir in HCV

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Gilead Sciences announced topline results from the Phase 3 FUSION study which evaluated 12- and 16-week courses of once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment.

In FUSION, HCV genotype 2 or 3 patients who failed prior interferon-based therapy were randomized (1:1) to receive either a 12-week (n=103) or 16-week (n=98) course of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200mg/day). Sixty-three percent of patients were infected with genotype 3. In the 12-week arm, sustained virologic response (SVR12) rates were 86% among genotype 2 and 30% among genotype 3 patients. In the 16-week arm, SVR12 rates were 94% among genotype 2 and 62% among genotype 3 patients. Among the 34% of FUSION participants who had compensated cirrhosis at baseline, 31% achieved SVR12 in the 12-week arm, and 66% achieved SVR12 in the 16-week arm. All patients in the study became HCV negative on treatment, and relapse accounted for all virologic failures.

The study met its primary efficacy endpoint of superiority compared to a predefined historic control sustained virologic response rate of 25%. In FUSION, 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 (P<0.001 for both arms).

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