C-WORTHY part D

C-WORTHY Study part D: grazoprevir + elbasvir + RBV in genotype 3
Efficacy of 12 or 18 Weeks of Grazoprevir plus Elbasvir with Ribavirin in Treatment-Naive, Noncirrhotic HCV Genotype 3–Infected Patients
Gane E. J Viral Hepatitis 2017 (Epubahead of print)

Anti-HCV
Grazoprevir
Elbasvir
Ribavirin
Genotype
3
Treatment history
Naive
Cirrhosis
No

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Design

  • Grazoprevir (GZR): 100 mg qd
  • Elbasvir (EBR): 50 mg qd
  • RBV (bid dosing): 800 mg/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)

Baseline characteristics and patient disposition

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

Resistance associated substitutions in subjects with virologic failure

SVR12 according to baseline RAVs

Adverse events, N (%)


* dyspnea , fatigue and asthenia 2-3 days after starting treatment

Summary

  • Efficacy of 12 or 18 weeks of GZR + EBR + RBV in HCV genotype 3 infected patients
    • Was suboptimal due to on-treatment virologic failure in 17 of 41 patients
    • No subject relapsed after the end of therapy
    • NS5A RASs found in 16 of 17 failures, Y93H the most common NS5A RAS identified
  • GZR + EBR + RBV was generally safe and well tolerated
  • Adverse events were slightly more common in the 18-week arm compared with the 12-week arm
    • No differences in serious adverse events or laboratory abnormalities
    • Adverse event considered to be severe in intensity reported in only 1 patient (non-drug related depression during follow-up)