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Design

LDV/SOF: 90/400 mg 1 tablet qd ; VDV ( vedroprevir ): 80 mg 1 tablet qd ; GS-9669: 250 mg 1 tablet qd

Objective

• SVR₁₂ (HSV RNA < 12 IU /ml) , with 95% CI, by intention-to-treat analysis
• Sample size with 93% probability of observing = 1 participant with an AE occurring in = 10% of patients

Baseline characteristics and outcome

Treatment outcomes by subgroups

• SVR₁₂ higher if lower age, genotype 1b, HCV RNA < 6 M IU/ml

Analysis of Resistance associated variants

• Genotype 1a, N = 33
  • NS3 Q80K at baseline (3-fold reduced susceptibility to VDV), N = 10
    • Viral relapse: 60% if Q80K+ vs 97% if Q80K-
  • NS3 R155K and D168E and/or NS5A L31M, Y93H and Y93N (> 20-fold reduced susceptibility to VDV and LDV, respectively), N = 10
    • Viral relapse: 100% if these RAVS present vs 63% if absent (p = 0.022)
  • NS5B M423I (4.6 fold resistance to GS-9669), N = 1
    • Viral relapse in this patient

Adverse events, N

Summary

• Treatment for 4 weeks with the all oral combination DAA regimens used in this study seems to have high tolerability but limited response in achieving SVR₁₂ in non cirrhotic treatment-naive patients with HCV genotype 1 infection