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BROWSE SLIDES

Design

• SOF 400 mg : 1 pill qd ; PEG-IFNα-2a : 180 m g SC once weekly
• RBV : 1000 or 1200 mg/ day ( bid dosing ) according to body weight (< or = 75 kg)

Objective

• Primary endpoint : SVR₁₂ (HCV RNA < 15 IU/ml) by intention to treat, with 2-sided 95% CI, no statistical hypothesis

Baseline characteristics, patient disposition and outcome

Adverse events

• Serious adverse events : 5 in 4 patients
• Discontinuation of RBV in 3 patients, because of anemia
• Discontinuation of all therapy in 1 patient, because of pain
• Most common adverse events (> 20%) :
  • Influenza-like illness
  • Fatigue
  • Anemia
  • Neutropenia
• Grade 3 elevations in bilirubin in 4 patients, of whom 3 had cirrhosis

Summary

• This phase II study was the first to evaluate the efficacy, safety, and tolerability of 12-week administration of SOF + PEG-IFN + RBV in treatment-experienced patients with genotype 2 and 3 HCV infection, with and without cirrhosis
• This study showed high SVR rates in patients who have historically exhibited suboptimal response rates to HCV treatment
  • SVR₁₂ and SVR₂₄ rates were similar
• 2 relapses occurred in patients with genotype 3
• There was no clinically significant treatment-emergent safety issues related to SOF
• Limitations
  • Small size
  • Study not powered