Treatment of Recurrent HCV Infection Following Liver Transplantation: Results of a Multicenter, Randomized, versus Placebo, Trial of Ribavirin alone as Maintenance Therapy after One Year of Peginterferon Alfa-2A plus Ribavirin.
Calmus Y, Duvoux C, et al.Journal of Hepatology, 57(3): 564-571, 2012.
Aims
To determine the effect of maintenance therapy with ribavirin alone on viral response and liver histology in liver transplant recipients who had had a year of combination therapy consisting of peginterferon-alfa 2a (PEG-IFNa-2a) and ribavirin.
Interventions
All patients were given PEG-IFNa-2a and ribavirin combination therapy for 12 months. At 12months the combination therapy was discontinued and patients were randomized to ribavirin or placebo for a further 12 months.
Participants
78 patients who had recurrent hepatitis C virus (HCV) with a minimum of stage 1 fibrosis, 1 to 5 years liver transplantation.
Outcomes
Primary endpoint was virologic response, defined as undetectable serum HCV RNA. The secondary endpoints were the change in serum HCV RNA levels and liver histology from baseline; other outcomes included alanine aminotransferase and gamma-glutamyl transpeptidase values, the number and severity of rejection episodes and adverse events.
Follow-up
30 months post-transplant
CET Conclusions
Patients who had recurrent HCV and at least stage 1 fibrosis 1 to 5 years after liver transplantation and who had been treated with PEG-IFNa-2a and ribaverin for a year did not show any benefit if maintained on ribaverin for a further year compared to a placebo.
Data analysis
Per protocol analysis
Trial registration
Not reported