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BROWSE SLIDES

Design

* Metavir F4, or Fibroscan > 14.6 kPa , or Fibrotest ® = 0.75 + APRI > 2

Objective

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

Baseline characteristics and patient disposition

* 7 patients with previous failure to SOF, and 2 to alisporivir

SVR₁₂ (HCV RNA < 25 IU/ml)

• SVR₁₂ in 5/7 prior failure to SOF and in 2/2 prior failure to alisporivir

Virologic failure

• Virologic breaktrough : none
• Failure at end of treatment : 1 naïve patient with cirrhosis
• Post-treatment relapse
  • 9 in the naïve group (cirrhosis : 7/9)
  • 7 in the pre-treated group (cirrhosis : 4/7)
  • 15/16 occurred by W4 post-treatment
  • Emergence of resistance-associated variant : 10/16
    • Y93H, n = 9
    • L31I, n = 1
  • In the 6 other : presence of baseline Y93H variant
• No NS5B-resistant variants (159, 282, 321) detected at baseline or relapse

Adverse events and Grade 3-4 laboratory abnormalities, N (%)

Summary

• A 12-week regimen of DCV plus SOF achieved SVR₁₂ in 96% of treatment-naïve and treatment-experienced patients with genotype 3 infection without cirrhosis and was well tolerated
• SVR in patients with cirrhosis was sub-optimal
• SVR₁₂ rates were comparable across subgroups based on gender, age, baseline HCV-RNA levels, and IL28B genotype
• Among the 16 patients with relapse, 11 had cirrhosis
• 6/13 patients with baseline Y93H variant had relapse post-treatment, including 3 of 4 patients with cirrhosis
• Safety was good with no discontinuation for adverse event