C-SCAPE

C-SCAPE Study: grazoprevir ± elbasvir ± RBV in genotypes 2, 4, 5 or 6
C-SCAPE Study: grazoprevir ± elbasvir ± RBV in genotypes 2, 4, 5 or 6
Brown A. J Hepatol 2015;62 ( Suppl 2):S619

Anti-HCV
Grazoprevir
Elbasvir
Ribavirin
Genotype
2
4
5
6
Treatment history
Naive
Cirrhosis
No

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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 < 15 IU/ml), with 2-sided 95% CI, comparison between groups (modified intention to treat analysis)

Baseline characteristics and patient disposition


* Excluded from mITT analysis for efficacy

SVR12 (HCV RNA < 15 IU/ml), %, mITT

SVR12 (HCV RNA < 15 IU/ml) by subgroup in genotype 2, %, mITT

Adverse events and laboratory abnormalities, N (%)


* Flushing ; ** Increased AST/ATLT confounded by concurrent use of hepatotoxic drug

Summary

  • In genotype 2
    • 12 weeks of GZR + EBR + RBV is more efficacious than GZR + RBV, due to the added benefit of EBR in treating patients with 31 L variant (SVR12 of 100%)
    • 12 weeks of GZR + RBV is inadequate for non-cirrhotic, treatment-naive patients with genotype 2. The triple combination is not optimal
  • In genotype 4
    • 12 weeks of GZR + EBR, with or without RBV, is highly efficacious for non-cirrhotic, treatment-naive patients
  • In genotype 5
    • 12 weeks of GZR + EBR + RBV appears to be more effective than GZR + EBR
  • In genotype 6
    • 12 weeks regimen of GZR + EBR ± RBV is moderately effective (SVR12 of 75%) for non-cirrhotic, treatment-naive patients
  • Safety
    • 1 case of discontinuation for adverse event (1%)