Peginterferon Alfa-2a for hepatitis C after liver transplantation: Two randomized, controlled trials

Naga Chalasani, Cosme Manzarbeitia, Peter Ferenci, Wolfgang Vogel, Robert J. Fontana, Michael Voigt, Caroline Riely, Paul Martin, Lewis Teperman, James Jiao, Juan Carlos Lopez-Talavera

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247 Scopus citations

Abstract

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In the prophylaxis trial, 8 patients (31 %) in the peginterferon alfa-2a group and 9 (32%) in the untreated group were withdrawn prematurely; whereas in the treatment trial, 10 patients (30%) in the peginterferon alfa-2a group and 6 (19%) in the untreated group were withdrawn prematurely.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.

Original languageEnglish (US)
Pages (from-to)289-298
Number of pages10
JournalHepatology
Volume41
Issue number2
DOIs
StatePublished - Feb 1 2005

ASJC Scopus subject areas

  • Hepatology

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    Chalasani, N., Manzarbeitia, C., Ferenci, P., Vogel, W., Fontana, R. J., Voigt, M., Riely, C., Martin, P., Teperman, L., Jiao, J., & Lopez-Talavera, J. C. (2005). Peginterferon Alfa-2a for hepatitis C after liver transplantation: Two randomized, controlled trials. Hepatology, 41(2), 289-298. https://doi.org/10.1002/hep.20560