Design Randomisation 1 : 1 Open-label W16 W24 > 18 years

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Presentation transcript:

REVENGE: retreatment with SOF + EBR + GZR + RBV after failure with SOF + (LDV or DCV or SMV) Design Randomisation 1 : 1 Open-label W16 W24 > 18 years HCV infection Genotype 1 or 4 Failure to a prior therapy with SOF ± RBV + (SMV or DCV or LDV) with documented presence of NS5A or NS3 RASs at failure Fibrosis at any stage No HBV or HIV co-infection N = 12 SOF + EBR + GZR + RBV SOF + EBR + GZR + RBV N = 13 SOF: 400 mg ; EBR: 50 mg ; GZR: 100 mg Objective SVR4 (HCV RNA < 15 IU/mL) REVENGE De Ledinghen V. AASLD 2016, Abs. LB-18

Baseline characteristics and outcome (SVR4) REVENGE: retreatment with SOF + EBR + GZR + RBV after failure with SOF + (LDV or DCV or SMV) Baseline characteristics and outcome (SVR4) SOF + EBR + GZR + RBV 16 weeks, N = 12 24 weeks, N = 13 Age, years, mean 61 59 Female,% 31 15 BMI, kg/m2, mean 29.9 26.6 Genotype, % 1a 1b/1d 4 23.1 61.5 15.4 38.5 30.8 HCV RNA log10 IU/mL, median 6.1 6.2 Fibroscan (kPa), % ≤ 9.5 0.5-20 > 20 23 31 46 54 Previous HCV treatment, % SOF + LDV SOF + DCV SOF + SMV 69 RAS, n NS5A NS3 13 11 2 SVR4 100% REVENGE De Ledinghen V. AASLD 2016, Abs. LB-18

REVENGE: retreatment with SOF + EBR + GZR + RBV after failure with SOF + (LDV or DCV or SMV) Safety Serious adverse events, N = 9, in 7 patients (28%) : right hypochondrium pain, dermo-hypodermitis, decompensated cirrhosis, hepatocellular carcinoma (HCC) (N = 3), liver transplantation for HCC, liver biopsy of nodule and septic shock with acute kidney failure None were related to study drugs Of the 3 HCC, 2 were recurrences during the treatment phase, 1 was de novo 3 days after the end of treatment Hemoglobin < 10 g/dL, N = 4 (16%) ; < 8.5 g/dL in 1 patient REVENGE De Ledinghen V. AASLD 2016, Abs. LB-18

REVENGE: retreatment with SOF + EBR + GZR + RBV after failure with SOF + (LDV or DCV or SMV) Summary Retreating patients who failed a DAA-based regimen with NS5A/NS3 RASs with the combination of SOF + GZR + EBR + RBV for 16 weeks is efficacious and represent an interesting option Safety needs to be monitored cautiously in these patients with a severe disease REVENGE De Ledinghen V. AASLD 2016, Abs. LB-18