C-CORAL

C-CORAL Study: elbasvir/grazoprevir for genotype 1, 4, 6

Zhdanov K. EASL 2017, Abs. FRI-265

Anti-HCV
Grazoprevir
Elbasvir
Genotype
1
1b
6
Treatment history
Naive
Cirrhosis
Yes
No

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Design


* Randomisation was stratified by cirrhosis status (yes vs no) and study site (country)
** Fibroscan® > 12.5 kPa, or liver biopsy (F4), or Fibrotest® > 0.75 or APRI > 2

  • EBR/GZR: 50/100 mg 1 tablet QD

Objective

  • SVR12 (HCV RNA < 15 IU/mL), by ITT

Baseline characteristics and SVR12


* Two patients did not receive the active treatment (EBV/GZR) after the placebo treatment

  • SVR12 in all participants: 94.4%
  • Race, gender and age had no impact on SVR12
  • Cirrhotic patients had the same SVR12 rate than non-cirrhotic patients: 93.3% vs 94.7%

SVR12 by genotype (%)

Impact of baseline NS5A RASs on SVR12

Adverse events and laboratory abnormalities, N (%)


* Data given for the EBR/GZR period
** Suicide, Evan's syndrome, contusion, enteritis, gastric lymphoma, atrial fibrillation, ankle fracture, uterine hemorrhage. Only atrial fibrillation was considered related to EBR/GZR

Summary

  • Treatment with a 12-week regimen of EBR/GZR achieved a global rate of SVR12 of 94% in a heterogeneous population with GT1, 4 and 6
  • Low rates of SVR12 were observed in GT6 patients (66.7%)
  • Cirrhosis, gender and race had no impact on SVR12
  • RASs decreased SSVR12 rate in genotypes 1a and 6
  • Treatment was safe and well tolerated