A Randomized Controlled Trial of Pretransplant Antiviral Therapy to Prevent Recurrence of Hepatitis C After Liver Transplantation.
Everson GT, Terrault NA, et al.Hepatology [record in progress].
Aims
To evaluate the efficacy and safety of pre-transplant antiviral therapy with peginterferon alfa-2b plus ribavirin (PEGIFN/RBV) for prevention of post-transplant hepatitis C virus (HCV) recurrence.
Interventions
Peginterferon alfa-2b plus ribavirin versus no pre-transplant antiviral therapy.
Participants
47 patients with HCV genotypes 1/4/6 and 32 patients with HCV genotypes 2/3 who were listed for liver transplantation.
Outcomes
The primary endpoint was post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation. Pre-transplant sustained virologic response (SVR12) was defined as undetectable HCV RNA at week 12 after the end of treatment. Combined virologic response included both pTVR and SVR12. Safety assessment included physical examination, adverse events, laboratory monitoring, serious adverse events and deaths. Variables predictive of pTVR were tested by logistic regression analysis. Covariates included baseline HCV RNA, HCV genotype, graft type, treatment durat
Follow-up
1 year post transplant
CET Conclusions
Administration of peginterferon alpha-2b plus ribavirin in patients with hepatitis C virus awaiting a liver transplant did result in remission of the HC viremia compared to non treated patients, in those patients analysed on a per protocol basis but not on an ITT basis. Serious adverse events occurred in both arms but were higher in the group receiving treatment. Thus pre-transplant treatment with PEGIFN/RBV did prevent post-transplant recurrence of HCV in selected patients but at least 12 weeks of treatment was required and there was an increase in potentially serious complications in the treated patients.
Data analysis
Per protocol analysis
Trial registration
NCT00135798 (ClinicalTrials.gov)