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

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Presentation on theme: "C-CORAL Study: elbasvir/grazoprevir for genotype 1, 4, 6"— Presentation transcript:

1 C-CORAL Study: elbasvir/grazoprevir for genotype 1, 4, 6
Design Randomisation * 3 : 1 Double-blind W12 W16 W24 W28 N = 365 EBR/GZR AVEUGLE LEVEE SVR12 ≥ 18 years, HCV genotype 1, 4, 6 Treatment-naïve No cirrhosis or compensated cirrhosis** No HBV or HIV co-infection Placebo EBR/GZR SVR12 N = 123 * 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 C-CORAL Zhdanov K. EASL 2017, Abs. FRI-265 1

2 C-CORAL Study: elbasvir/grazoprevir for genotype 1, 4, 6
Baseline characteristics and SVR12 Immediate treatment N = 365 Deferred treatment N = 123* Mean age, years 48.1 48.6 Female, % 56 54 Race: Asian, White, % 72 / 28 Genotype 1a / 1b / 4 / 6, % 7 / 80 / < 1 / 11 9 / 80 / < 1 / 10 Baseline HCV RNA > IU/mL, % 69 70 Cirrhosis, % 18 19 Baseline ALT, IU/L, mean 64 SVR12, n/N (%) ITT Breakthrough/rebound Relapse Discontinued for administrative reasons 344/365 (94.2 %) 6 14 1 115/121 ( 95.0 %) 4 * 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% C-CORAL Zhdanov K. EASL 2017, Abs. FRI-265 2

3 C-CORAL Study: elbasvir/grazoprevir for genotype 1, 4, 6
SVR12 by genotype (%) 98.2 100 100 91.9 66.7 n 37 389 6 3 51 Impact of baseline NS5A RASs on SVR12 Genotype 1a Genotype 1b Genotype 4 Genotype 6 RASs 4/6 (67%) 62/65 (95%) 1/1 6/15 (40%) No RASs 19/20 (95%) 226/226 (100%) 15/19 (79%) C-CORAL Zhdanov K. EASL 2017, Abs. FRI-265 3

4 C-CORAL Study: elbasvir/grazoprevir for genotype 1, 4, 6
Adverse events and laboratory abnormalities, N (%) Immediate treatment N = 365 Deferred treatment N = 121* At least one adverse event 186 (51%) 44 (36%) Serious adverse event ** 5 (1%) 3 (3%) Adverse event leading to discontinuation 1 (< 1%) 2 (2%) Drug-related adverse event 78 (21%) 13 (11%) Biological adverse events ALT/AST > 2-5 x ULN ALT/AST > 5 x ULN Total bilirubin > 5 x baseline 5 (1.4%) 4 (1.1%) 1 (0.3%) 2 (1.7%) 3 (2.5%) 1 (0.8%) * 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 C-CORAL Zhdanov K. EASL 2017, Abs. FRI-265 4

5 C-CORAL Study: elbasvir/grazoprevir for genotype 1, 4, 6
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 SVR12 rate in genotypes 1a and 6 Treatment was safe and well tolerated C-CORAL Zhdanov K. EASL 2017, Abs. FRI-265 5

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