1. 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

2. 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

3. 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

4. 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