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BROWSE SLIDES

Design

* Randomisation only in genotype 1, stratified on cirrhosis (yes or no) ; No randomisation (open-label SOF/VEL/VOX) for all other genotypes
**** Metavir F4 or Ishak 5-6 or Fibroscan® > 12.5 kPa or Fibrotest® > 0.75 + APRI > 2

Objective

• SVR₁₂ (HCV RNA < 15 IU/ml), with 95% CI, by ITT: superiority > 10% to a prespecified rate of 85% (2-sided significance level of 5%), for each regimen, 90% power

Baseline characteristics and patient disposition

SOF/VEL/VOX 12 weeks: SVR₁₂ overall and by subgroups, % (95% CI)

* Superiority to 85% (p < 0.001)

SVR₁₂ by baseline RASs (15% cutoff), %

• Two patients had S282T at baseline, both achieved SVR₁₂
• None of the patients who relapsed had treatment-emergent RASs

Characteristics of patients with virologic failure (n = 7)

* Only patient with virologic breakthrough : low plasma concentrations of GS-331007 ( the chief SOF metabolite ), VEL, and VOX at weeks 8 and 12, suggestive of nonadherence

Adverse events

Summary

• In NS5A-inhibitor experienced patients, treatment with SOF/VEL/VOX for 12 weeks resulted in a 96.2% SVR₁₂ rate in difficult-to-cure patients with multiple unfavorable characteristics
• Treatment-emergent NS5A RAS was observed in 1/6 patients with relapse
• SOF/VEL/VOX was well tolerated with an adverse event profile similar to that observed in placebo recipients
• SOF/VEL/VOX for 12 weeks provides a single tablet, once daily, highly effective, RBV-free treatment for NS5A inhibitor-experienced patients