GS-US-367-1168

GS-US-367-1168 Study: SOF/VEL + GS-9857 in genotype 1 - Phase II

Lawitz E, Gastroenterology 2016; 151:893-901

Anti-HCV
Voxilaprevir (GS-9857)
Velpatasvir (GS-5816)
Sofosbuvir
Ribavirin
Genotype
1
1a
1b
Treatment history
Naive
NS5A experienced
PI-experienced
SOF-experienced
Cirrhosis
Yes
No

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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