No HBV or HIV co-infection

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Presentation transcript:

No HBV or HIV co-infection STREAGER Study: EBR/GZR for 8 weeks in genotype 1b without severe fibrosis W8 Open-label Design ≥ 18 years HCV genotype 1b Treatment-naïve No severe fibrosis * No HBV or HIV co-infection N = 120 EBR/GZR SVR12 * Fibroscan® < 9.5 kPa + FibroTest® < 0.59 or Fibrometer ® < 0.63 EBR/GZR: 50/100 mg 1 tablet QD Objective SVR12 (HCV RNA < LLOQ) STREAGER Abergel A. EASL 2018, Abs. LBP-010

Baseline characteristics and outcome STREAGER Study: EBR/GZR for 8 weeks in genotype 1b without severe fibrosis Baseline characteristics and outcome EBR/GZR 8W N = 90 * Mean age, years 53 Female, % 66 ALT > ULN, % 41 Mean BMI, kg/m2 24.5 Baseline viral load, % ≤ 800,000 IU/mL > 800,000 IU/mL 40 60 Fibrosis Fibroscan® F0-F1, % Fibrotest® F0-F1, % 89 61 SVR12 (exclusion of a patient with genotype 1a) 98% ** * Interim analysis on 90 patients ** 3 relapses: 1 patient, F0-F1, with genotype 1b, at relapse: emergence of Y93H RAS ; 1 patient, F2, with genotype 1e, at relapse: emergence of L28M + R30Q + A92T + Y93H RASs, 1 patient, F0-F1, with genotype 1b, at relapse: emergence of L31 M + Y93H RASs Another patient relapsed post SVR12 STREAGER Abergel A. EASL 2018, Abs. LBP-010

STREAGER Study: EBR/GZR for 8 weeks in genotype 1b without severe fibrosis Safety No adverse event of grade 3 or 4 Adverse events > 10% related to treatment: Asthenia: 28% Headache: 23% Digestive disorders: 13% STREAGER Abergel A. EASL 2018, Abs. LBP-010

STREAGER Study: EBR/GZR for 8 weeks in genotype 1b without severe fibrosis Summary High cure rate (SVR12 97%) was achieved in a treatment-naïve non severe fibrosis GT1b-infected population treated for 8 weeks with the combination of EBR/GZR Good safety profile These results are in agreement with the results obtained in the C-WORTHY study with 8 weeks of EBR/GZR + RBV (SVR12 of 97%) very similar to those obtained in patients treated 12 weeks with EBR/GZR (SVR12 of 98%) These results are preliminary STREAGER Abergel A. EASL 2018, Abs. LBP-010