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Design

* Biopsy or Fibroscan > 12.5 kPa or Fibrotest > 0.75 and APRI > 2

• LDV/SOF: 90/400 mg 1 pill qd ; RBV 1000 or 1200 mg/d in 2 doses, according to body weight

Objective

• SVR₁₂ (HCV RNA < 15 IU /ml), with 2-sided 95% CI, by ITT. No inferential statistics or statistical comparisons were planned.

Baseline characteristics

Treatment response

• Virologic failure in genotype 3, N = 17
  • Genotype 3a, N = 16/17
  • Cirrhosis, N = 9/17
• Deep sequencing of NS5A at failure, N = 17
  • No Y93H, No RAVs associated with NS5A resistance
• Deep sequencing of NS5B at failure, N = 18
  • S282T at relapse, N = 2, L159F, N = 1

Treatment-emergent adverse events, N (%)

* 2 related to treatment (upper abdominal pain, abdominal pain)
** diverticular perforation (not related to treatment)

Laboratory abnormalities, N (%)

Summary

• In this open-label, phase 2 study, all 26 (100%) treatment-naive patients with genotype 3 HCV who were randomized to receive 12 weeks of LDV/SOF + RBV achieved SVR₁₂ as compared with only 16 of 25 (64%) patients who received
  12 weeks of LDV/SOF alone
• The SVR₁₂ rate was 82% in genotype 3 treatment-experienced patients receiving 12 weeks of LDV/SOF + RBV
• The SVR₁₂ rate was 96% in genotype 6 patients receiving 12 weeks of LDV/SOF
• At virologic failure
  • No emergence of NS5A RAVs
  • Emergence of S282T in 2 patients and L159F in 1
• Most common adverse events were headache, upper respiratory infection, and fatigue
• Limitation
  • Small size of treatment arms
  • Lack of control group