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BROWSE SLIDES

Design

* Treatment-naïve and relapsers stopped therapy at W24 if HCV RNA < 25 IU/ml at W4 and HCV RNA undetectable at W12 ; All other patients continued therapy until W48

Treatment regimens

• SMV : 150 mg qd ; PEG-IFNα-2a : 180 mg SC once weekly
• RBV weight based (bid dosing) : 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg

Objective

• SVR₁₂ (HCV RNA < 25 IU/ml) with 95% two-sided CI, by ITT, descriptive analysis

Baseline characteristics and patient disposition

SVR₁₂ (HCV RNA < 25 IU/ml), % (95% CI)

Resistance testing (NS3) in treatment failure

• Available in 32/37
• 28/32 with emergence of NS3 mutations at positions 80, 122, 155, 156 and/or 168
  • Most frequent profile :D168V alone or D168E ± mutations at position 80

Adverse events during the SMV + PEG-IFN + RBV phase, N (%)

Summary

• In this open-label study of genotype 4 infection, 12 weeks of SMV + 24-48 weeks of PEG-IFN + RBV achieved an overall SVR₁₂ of 65%
  • In treatment-naïve and prior relapsers SVR₁₂ was 83% and 86%, respectively, which is in line with SVR₁₂ rates observed in phase III studies of SMV + PEG-IFN + RBV in patients with genotype 1
  • Most of naïve and prior relapsers could stop PEG-IFN + RBV at W24
  • SVR₁₂ rates were similar across the different HCV genotype 4 subtypes, with slightly lower rates observed among patients with genotype 4d
• Adverse events were mainly grade 1 or 2, with few serious adverse events and no deaths
• Limitations
  • No control arm