Skip Navigation LinksHome > September 2012 - Volume 46 - Issue 8 > Peginterferon-α-2b and Ribavirin for Hepatitis C Recurrence...
Journal of Clinical Gastroenterology:
doi: 10.1097/MCG.0b013e31825833be

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

Gordon, Fredric D. MD*; Kwo, Paul MD; Ghalib, Reem MD; Crippin, Jeffrey MD§; Vargas, Hugo E. MD; Brown, Kimberly A. MD; Schiano, Thomas MD#; Chaudhri, Eirum MD**; Pedicone, Lisa D. PhD**; Brown, Robert S. Jr MD, MPH††

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Goals: To evaluate the safety and efficacy of peginterferon-α-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-α-2b (1.5 µg/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.

© 2012 Lippincott Williams & Wilkins, Inc.


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