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BROWSE SLIDES

Design

• SOF/VEL: 400/100 mg FDC qd ; GS-9857: 100 mg qd
• RBV: 1000 or 1200 mg/day in 2 doses according to weight (< or = 75 kg)

Objective

• SVR₁₂ (HCV RNA < 15 IU/ml), by ITT, with 2-sided 95% CI (no inferential statistics)

Baseline characteristics

SRV₁₂, ITT, % (95% CI)

Resistance analysis (1% deep sequencing)

• At baseline, presence of class RASs (NS3, NS5A or NS5B)
  • 81/134 (60%) treatment-naïve patients
  • 51/63 (81%) DDA-experienced patients
    • 93% if NS5A-experienced vs 18% if not NS5A-experienced
• In treatment-naïve patients, 8 weeks of SOF/VEL + GS-9857 led to SVR 12 in 96% (25/26) and 97% (42/43) of patients without and with baseline RASs, respectively
• All DAA-experienced patients, regardless of the presence of single or multi-class RASs, achieved SVR₁₂ following 12 weeks of SOF/VEL + GS-9857
• At relapse (sequencing data in 17/18):
  • 10/17 (59%) had the same number or fewer RASs at the time of virologic relapse than at baseline
  • 4/17(24%) had no RASs both at baseline and at virologic relapse
  • Only 3 patients had treatment-emergent RASs, all in the NS3 gene and all at frequencies less than 2% of the viral population: V170T, Q41R + A156T, V36M

Adverse events, %

Laboratory abnormalities, N (%)

Summary

• In this phase 2 open-label trial, 8 weeks treatment with SOF/VEL + GS-9857 was safe and effective in treatment-naïve patients ; 12 weeks was safe and effective in patients previously treated with DAAs
• The combination was safe and effective in patients with or without compensated cirrhosis