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BROWSE SLIDES

Design

• SMV 150 mg qd + DCV 90 mg qd + SOF 400 mg qd

Objective

• SVR₁₂ (HCV RNA < 15 IU/ml), with 2-sided 95% CI, by ITT

Baseline characteristics

Outcome

SMV, DCV and SOF pharmacokinetics following administration of SMV + DCV + SOF

• Intensive PK analysis performed at Week 2 and Week 8
  • Mean SMV exposure: 2.2-fold higher in CP B than CP A
  • Mean DCV exposure: similar in CP B and CP A
  • Mean SOF exposure: 1.4-fold higher in CP B than CP A
  • Mean GS-331007 exposure (SOF metabolite): similar in CP B and CP A

Adverse events and laboratory abnormalities, N (%)

Summary

• Treatment for 12 weeks with SMV, SOF, and DCV resulted in 100% response rate; all 19 Child-Pugh A patients and all 21 Child-Pugh B patients achieved SVR₁₂
• High virologic response was observed regardless
  • of Child-Pugh class (<7 or 7–9)
  • or the presence of resistance-associated variants at baseline
• This 3-DAA combination was generally safe and well tolerated
  • No discontinuations due to adverse events
  • No deaths
• 5-year follow-up will be important in providing long-term outcomes in association with SVR