REVENGE

REVENGE: retreatment with SOF + EBR + GZR + RBV after failure with SOF + (LDV or DCV or SMV)

De Ledinghen V. AASLD 2016, Abs. LB-18

Anti-HCV
Grazoprevir
Elbasvir
Sofosbuvir
Ribavirin
Genotype
1a
1b
4
Treatment history
NS5A experienced
SOF-experienced
Cirrhosis
Yes
No

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Design

  • SOF: 400 mg ; EBR: 50 mg ; GZR: 100 mg

Objective

  • SVR4 (HCV RNA < 15 IU/ml)

Baseline characteristics and outcome (SVR4)

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

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