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BROWSE SLIDES

Design

* Randomisation on prior treatment-experience (naïve or IFN-experienced)
** 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 of SOF/VEL/VOX > 5% to a prespecified rate of 83% (two-sided significance level of 5%, 80% power)

Baseline characteristics and patient disposition

SVR₁₂ overall and by prior treatment, % (95% CI)

* p < 0.001 for superiority compared with prespecified 83% performance goal

SVR₁₂ according to baseline RASs (present in 22% and 23% of patients)

• If absent, SVR₁₂ = 98% vs 97% ; If present, SVR₁₂ = 100% (in both treatment groups)

Adverse events

Summary

• In patients with HCV genotype 3 infection and cirrhosis, SOF /VEL/VOX for 8 weeks resulted in a 96% SVR₁₂ rate as did SOF/VEL for 12 weeks
• Baseline NS5A RASs, including Y93H, did not impact treatment outcome for either SOF/VEL/VOX or SOF/VEL
  • No treatment emergent RASs in the SOF/VEL/VOX group
  • In the SOF/VEL group, both virologic failures had Y93H emergence
• SOF/VEL/VOX and SOF/VEL were safe and well tolerated
  • Mild gastrointestinal adverse events (nausea and diarrhea) were associated with treatment regimens that included VOX
  • There was no evidence of VOX-related hepatotoxicity
• SOF/VEL/VOX for 8 weeks and SOF/VEL for 12 weeks both provide simple, safe, and effective treatment regimens for patients with HCV genotype 3 and cirrhosis