Peginterferon-α-2b and Ribavirin for Hepatitis C Recurrence Postorthotopic Liver Transplantation

Goals: To evaluate the safety and efficacy of peginterferon-alpha-2b plus ribavirin in patients with recurrent hepatitis C after orthotopic liver transplant. Background: Reinfection of liver allografts in hepatitis C virus infected transplant recipients begins immediately after transplantation. Treatment of these patients is challenging because of poor tolerability. Study: A multicenter, open-label study enrolling patients with persistent viremia after primary orthotopic liver transplant for cirrhosis related to hepatitis C virus infection. Patients received peginterferon-alpha-2b (1.5 mg/kg/wk) plus ribavirin (400 to 1200 mg/d administered using a dose-escalating regimen and according to body weight) for 48 weeks. The primary endpoint was sustained virologic response (SVR). Results: In total, 125 patients started treatment and 58.4% completed 48 weeks. SVR rate was 28.8% (G1, 23.8%; G2/3, 55.0%), end-of-treatment response rate was 40.8%, and relapse rate was 18.2%. SVR was 55% among patients who completed treatment. Genotype 2/3 infection, male sex, baseline hemoglobin >14 g/dL, 80: 80: 80 compliance, rapid virologic response (RVR), and complete early virologic response (cEVR) were predictors of SVR. SVR was higher among patients with RVR compared with those without RVR (83.3% vs. 25.7%; P = 0.0098), and among patients with cEVR compared with those without EVR (66.7% vs. 1.8%; P < 0.0001). Thirty-eight patients discontinued because of an adverse event and 69 required dose reduction or interruption. Anemia (74%) and neutropenia (30%) were common, and rejection was low (3.2%). Conclusions: SVR was low in this study. Anemia was a particular challenge in achieving maximal ribavirin therapeutic exposure and may account in part for the lower SVR.