DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

Design

• SOF/VEL: 400/100 mg FDC QD ; GS-9857: 100 mg QD

Objective

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

Baseline characteristics

SRV₁₂, ITT, % (95% CI)

SRV₁₂ and relapse by genotype

Resistance analysis (1% deep sequencing)

• At baseline, presence of class RASs (NS3, NS5A or NS5B)
  • 32/63 (51%) treatment-naïve patients
  • 6/27 (22%) IFN-experienced, DDA-naïve
  • 20/38 (53%) DDA-experienced patients

SRV₁₂ according to presence or absence of baseline RASs

• At relapse, N = 7
  • Emergence of RAS in 1 patient with genotype 3a: Y93H at baseline and relapse, emergence of Q80R

Adverse events, %

Laboratory abnormalities, N (%)

Summary

• In this phase 2 open-label trial, SOF/VEL + GS-9857 (8 weeks in treatment-naïve patients or 12 weeks in treatment-experienced patients) was safe and effective for patients with HCV genotype 2, 3, 4, or 6 infections, with or without compensated cirrhosis