C-WORTHY part C

C-WORTHY Study part C: grazoprevir + elbasvir ± RBV in genotype 1b
Efficacy of an Eight-Week Regimen of Grazoprevir plus Elbasvir with and without Ribavirin in Treatment-Naive, Noncirrhotic HCV Genotype 1B Infection
Vierling JM. EASL 2015, Abs . P0769

Anti-HCV
Grazoprevir
Elbasvir
Ribavirin
Genotype
1b
Treatment history
Naive
Cirrhosis
No

DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

Design


Grazoprevir (GZR) 100 mg qd
Elbasvir (EBR) : 50 mg qd
RBV (bid dosing) : 800mg/day if 51-65 kg, 1000 mg/day if 66-80 kg, 1200 mg/day if 81-105 kg, 1400 mg/day if > 105 kg

Primary efficacy endpoint

  • SVR12 (HCV RNA < 25 IU/ml), with 2-sided 95% CI, comparison between groups (intention to treat analysis) Treatment groups

Baseline characteristics and patient disposition

SVR12 (HCV RNA < 25 IU/ml), % (95% CI), mITT


* No NS5A RAVs at failure ; ** NS5A RAV Y93H at baseline and failure in 1 patient

Adverse events and laboratory abnormalities, N (%)

Summary

  • GZR + EBR ± RBV for 8 weeks in treatment-naïve , non-cirrhotic patients with HCV genotype 1b infection was
    • highly efficacious
    • safe and well-tolerated
    • rarely associated with resistance-associated variants at the time of failure