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BROWSE SLIDES

Design

* GS-9451 ( vedroprevir ) : 1st generation PI ; GS-9256 : 1st generation PI

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

Objective

• Primary endpoint : SVR₁₂ (HCV RNA < 25 IU /ml) by intention to treat, with 2-sided 95% CI, no statistical hypothesis

Baseline characteristics

Outcome

Emergence of NS5B RAV at relapse : 1 patient with emergence of L159F and 1 with emergence of S282G ; no emergence of S282T

Adverse events

• Serious adverse event : 1 (dysphagia , unrelated)
• Discontinuation due to adverse event : 3 (PEG-IFN in 2, RBV in 1)
• Most common adverse events :
  • Fatigue (43%)
  • Headache (35%)
  • Nausea (24%)
  • Neutropenia (23%)
  • Influenza-like illness (19%)
  • Myalgia (15%)
  • Pruritus (15%)
  • Rash (15%)
• Grade 3 / grade 4 laboratory abnormalities : 41% / 10%
• Mean decrease in hemoglobin : -2.8 g/dl

Summary

• In this open-label study, 12 weeks of treatment with SOF + PEG- IFN + RBV resulted in a high rate of SVR₁₂ in patients without cirrhosis who had not achieved SVR in previous trials involving PEG- IFN/RBV plus a protease inhibitor with and without other DAAs
  • Similar SVR₁₂ by baseline patient characteristics
  • High efficacy regardless of baseline RAVs : benefit of using a different class (SOF)
• Limitations
  • Small sample size
  • Uncontrolled design
  • Lack of patients with cirrhosis