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BROWSE SLIDES

Design

* Randomisation was stratified on genotype (2 or 3), prior therapy (yes or no) and cirrhosis (presence or absence)

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

Objective

• SVR₁₂ (HCV RNA < 15 IU/ml)

Baseline characteristics

SVR₁₂ (HCV RNA < 15 IU/ml), % (95% CI)

• In genotype 3, higher SVR₁₂ with SOF + PEG-IFN + RBV 12W compared to SOF + RBV for 16W or 24W, particularly in patients with cirrhosis and/or prior treatment

SVR₁₂ in GT3

Reasons for not achieving SVR₁₂

Resistance analysis

• Deep sequencing successful on 78/88 patients with virologic failure
  • No S282T variants
  • SOF treatment-emergent variants L159F and V321A in 9/78 (21 %)
    • L159F at baseline and failure, N = 1, only at failure, N = 5
    • V321A emerged at failure in 2 patients

Adverse events, N (%)

Summary

• Genotype 2 : treatment-experienced patients with cirrhosis achieved high SVR₁₂ rates with all regimens
• Genotype 3 : higher SVR₁₂ rates with SOF + PEG/RBV than with SOF + RBV for 16 or 24 weeks
  • Genotype 3 treatment-experienced patients with cirrhosis achieved an SVR₁₂ of 86% with SOF + PEG + RBV for 12 weeks
• SOF + RBV for 24 weeks achieved SVR₁₂ rates > 80% in all other subgroups; results consistent with earlier phase III studies
• SOF + RBV for 16 or 24 weeks and SOF + PEG + RBV for 12 weeks were well tolerated with a low rate of treatment discontinuations due to adverse events