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Design

* Randomisation was stratified on cirrhosis (presence vs absence) and genotype (2 vs 3)

• SOF : 400 mg qd
• RBV (bid dosing) : 1000 mg/day if < 75 kg or 1200 mg/day if = 75 kg

Objective

• SVR = 20% compared with historical control of 25%, 97% power
• Difference of SVR > 20% between the 2 groups, 82% power

Baseline characteristics and patient disposition

* Excluded from efficacy analysis

HCV RNA < 25 IU/ml

Virologic breakthrough during treatment

• none

Relapse in patients with HCV RNA < 25 IU/ml at end of completed treatment

• 46/99 (46%) in 12W group vs 26/95 (27%) in 16W group

Multivariate analysis of factors associated with SVR₁₂

Resistance testing (sequencing)

• 73 relapses :
  • No SOF-associated mutation (S282T)
  • 11 NS5B substitutions in > 2 subjects (no change in susceptibility to SOF)

Adverse events , n (%)

Summary

• In this phase III study, 12 or 16 weeks of treatment with SOF and RBV resulted in a SVR₁₂ in 50 to 73% of patients with prior treatment failure
  • In genotype 2, h igh response rates (SVR₁₂ > 96% ) were observed in patients with no cirrhosis ; those with cirrhosis had lower SVR₁₂ (60 to 78%)
  • In genotype 3 infection, response rates were sub-optimal, whether patients had or not cirrhosis
• No virologic resistance was detected in patients who did not have a sustained virologic response
• The rate of premature discontinuation of treatment with SOF and RBV due to adverse events was low (1%)
• In conclusion, 12 weeks of treatment with SOF and RBV can be an effective option for patients with HCV genotype 2 infection who failed prior IFN-based therapy, in the absence of cirrhosis