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BROWSE SLIDES

Design

Treatment regimens

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

Objective

• Difference in SVR = 40% between the 2 groups, 99% power

Baseline characteristics and patient disposition

HCV RNA < 25 IU/ml

• Virologic breakthrough during treatment : none
• Relapse in patients with HCV RNA < 25 IU/ml at end of completed treatment
  • 40/201 (20%) in patients who completed treatment
  • 2/4 (50%) in patients who did not complete treatment

Multivariate analysis of factors associated with SVR₁₂ in genotype 1

• Resistance testing (sequencing)
  • Done in 39/42 relapses
    • No SOF-associated mutation (S282T)
    • 5 NS5B substitutions in > 2 subjects (no change in susceptibility to SOF)

Adverse events, n (%)

Summary

• In this phase III study, 12 weeks of treatment with SOF and RBV resulted in a SVR₁₂ in 78% of patients for whom interferon treatment was not an option
  • In genotype 2 infection, high response rates (SVR₁₂ > 92%) were observed in all patient subgroups
  • In genotype 3 infection, response rates were lower than in genotype 2 infection, especially in the subgroup of patients with 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 (2%)
• In conclusion, 12 weeks of treatment with SOF and RBV can be an effective option for patients with HCV genotype 2 infection