DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

Design

* Randomisation stratified on genotype (2 or 3)

• DCV : 60 mg qd or matching placebo (2 pills) ; PEG-IFNα-2a : 180 mg SC once weekly
• RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or ≥ 75 kg)

Objective

• SVR₂₄ (HCV RNA undetectable) : non-inferiority of DCV regimens (lower limit of the 80% CI : - 20%), 85% power

Baseline characteristics and patient disposition

SVR₂₄ (HCV RNA undetectable), % (95% CI)

• DCV 12W or 16W was non inferior to placebo (lower bound of the 80% CIs for the difference (DCV - placebo) : 4.9% and 3.9% for genotype 2, respectively ; - 6.8% and - 9.4% for genotype 3, respectively

Virologic failure in genotype 3

• Resistance analysis
  • All 12 relapses in DCV groups had DCV resistant NS5A variants Y93H or A30K
  • 4/8 patients with baseline Y93H or A30K at baseline relapsed
  • 8/43 patients without these variants at baseline relapsed
• Baseline characteristics associated with post-treatment relapse
  • Cirrhosis : 36% relapse if present vs 21%
  • BMI > 30 kg/m2 : 56% vs 16%
  • Baseline HCV RNA > 800,000 IU/ml : 30% vs 0%

Adverse events and laboratory abnormalities, n (%)

Summary

• 12 or 16 weeks of treatment with DCV, in combination with PEG-IFN + RBV, is a well tolerated and effective therapy for patients with HCV genotype 2 or 3 infections
  • For the primary end point of SVR₂₄ , the differences between both DCV arms and placebo met statistical criteria for noninferiority in patients with genotype 2 and genotype 3 infection
  • DCV containing regimens could reduce the duration of therapy for these patients, when given with PEG-IFN + RBV
• These results suggest that combinations of DCV with other potent oral antiviral agents may offer alternatives to the current standard of care for genotypes 2 and 3 infection