Multicenter, Double-Blind, Randomized Trial of Emricasan in Hepatitis C Treated Liver Transplant Recipients with Residual Fibrosis or Cirrhosis.
Weinberg, E. W., et alLiver Transplantation 2020 [record in progress].
Aims
This study aimed to investigate the effect of emricasan in patients with recurrent hepatitis C (HCV) following liver transplant that had subsequently achieved sustained virologic response (SVR) with antiviral treatment but still had residual fibrosis.
Interventions
Patients were randomly assigned to either the emricasan group or the placebo group.
Participants
64 hepatitis C treated liver transplant patients.
Outcomes
The outcomes of interest were changes in fibrosis at two years, changes in the Knodell Histologic Activity Index at 2 years, pharmacodynamic activity and assessment of safety.
Follow-up
2 years
CET Conclusions
This is a good quality double-blind, randomised, controlled trial in liver transplantation for HCV-associated liver failure. 60 patients were randomised in a 2:1 fashion to receive the study drug (emricasan) or placebo. There was no significant difference seen in the primary endpoint, with very similar rates of fibrosis in the 2 arms. Both arms achieved much higher response rates than previously anticipated. The rate of adverse events was similar between the arms. In critique, the study was small and no power calculation is presented. The included patients were also generally starting with low rates of fibrosis, and hence little room for improvement.
Data analysis
Strict intention-to-treat analysis
Trial registration
N/A