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BROWSE SLIDES

Design

• SOF : 400 mg qd
• PEG-IFNα-2a : 180 mg SC once weekly
• RBV (bid dosing) : 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg

Objective

• SVR₁₂ > 60%, 90% power

Baseline characteristics and patient disposition

HCV RNA < 25 IU/ml

SVR₁₂ = 90% (95% CI: 87-93) : superiority to adjusted historal SVR₁₂ of 60% (two-sided exact test, p < 0.001)

• Virologic breakthrough during treatment : none
• Relapse in patients with HCV RNA < 25 IU/ml at end of completed treatment : 28
  • 25/320 (8%) in patients who completed treatment
  • 3/6 (50%) in patients who did not complete treatment

Multivariate analysis of factors associated with SVR₁₂

• Resistance testing (sequencing) : 28 relapse
  • No SOF-associated mutation (S282T)
  • 2 NS5B substitutions in > 2 subjects (no change in susceptibility to SOF)

Adverse events , n (%)

Summary

• In this open-label, single-group study of SOF + PEG-IFNαnd RBV in previously untreated patients with HCV genotype 1 or 4 infection, a SVR of 90% at 12 weeks was obtained
  • In patients with genotype 1 infection who had cirrhosis SVR₁₂ was lower than for patients without cirrhosis (81% vs 92%)
• Patients with genotype 1, 4, 5, or 6 infection who received 12 weeks of SOF + PEG-IFN + RBV had a very low rate of treatment discontinuation (2%)
• No virologic resistance was detected in patients who did not have a sustained virologic response