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

✍ Scribed by 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

• Publisher: John Wiley and Sons
• Year: 2005
• Tongue: English
• Weight: 201 KB
• Volume: 41
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.20560

✦ Synopsis

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 g 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 In the prophylaxis trial, 8 patients (31%) in the peginterferon alfa-2a group and 9 (32%) in the untreated group were withdrawn prematurely; whereas in the treatment trial, 10 patients (30%) in the peginterferon alfa-2a group and 6 (19%) in the untreated group were withdrawn prematurely.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. (HEPATOLOGY 2005