Premium
Peginterferon alfa‐2a for hepatitis C after liver transplantation: Two randomized, controlled trials
Author(s) -
Chalasani Naga,
Manzarbeitia Cosme,
Ferenci Peter,
Vogel Wolfgang,
Fontana Robert J.,
Voigt Michael,
Riely Caroline,
Martin Paul,
Teperman Lewis,
Jiao James,
LopezTalavera Juan Carlos
Publication year - 2005
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.20560
Subject(s) - medicine , randomized controlled trial , peginterferon alfa 2a , gastroenterology , clinical trial , liver transplantation , transplantation , incidence (geometry) , hepatitis c , surgery , chronic hepatitis , ribavirin , immunology , virus , physics , optics
There is currently no effective treatment for recurrent hepatitis C after orthotopic liver transplantation (OLT). We therefore performed two randomized, controlled trials—a prophylaxis trial and a treatment trial—to evaluate the safety and efficacy of peginterferon alfa‐2a in patients who had undergone OLT. The prophylaxis trial enrolled 54 patients within 3 weeks after OLT, and the treatment trial enrolled 67 patients 6 to 60 months after OLT. In each trial, patients were randomized to treatment with once weekly injections of 180 μg peginterferon alfa‐2a or no antiviral treatment for 48 weeks and were followed up for 24 weeks thereafter. Peginterferon alfa‐2a treated patients had significantly lower hepatitis C virus RNA levels and more favorable changes in hepatic histological features compared with untreated controls. However, only 2 treated patients in the prophylaxis trial (8%) and 3 in the treatment trial (12%) achieved a sustained virological response. In the prophylaxis trial, 8 patients (31%) in the peginterferon alfa‐2a group and 9 (32%) in the untreated group were withdrawn prematurely; whereas in the treatment trial, 10 patients (30%) in the peginterferon alfa‐2a group and 6 (19%) in the untreated group were withdrawn prematurely. The incidence of acute rejection was similar in the treated and untreated groups in both the prophylaxis (12% vs. 21%; P = .5) and treatment (12% vs. 0%; P = .1) trials. In conclusion , peginterferon alfa‐2a treatment for 48 weeks is safe and tolerable and offers some efficacy in the post‐OLT setting. Randomized controlled studies are needed to establish the efficacy of pegylated interferon and ribavirin in patients who have undergone OLT. (H EPATOLOGY 2005;41:289–298.)