title: Peginterferon alfa-2a for hepatitis C after liver transplantation: two randomized, controlled trials.
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 microg 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 In the prophylaxis trial, 8 patients (31%) in the peginterferon alfa-2a group and 9 (32%) in the untreated group were withdrawn prematurely; whereas in the treatment trial, 10 patients (30%) in the peginterferon alfa-2a group and 6 (19%) in the untreated group were withdrawn prematurely.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.
authors.affiliation: Indiana University Medical Center, Indianapolis, USA. nchalasa@iupui.edu <nchalasa@iupui.edu>
authors.forename: Naga
authors.initials: N
authors.lastname: Chalasani
authors.forename: Cosme
authors.initials: C
authors.lastname: Manzarbeitia
authors.forename: Peter
authors.initials: P
authors.lastname: Ferenci
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Vogel
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Fontana
authors.forename: Michael
authors.initials: M
authors.lastname: Voigt
authors.forename: Caroline
authors.initials: C
authors.lastname: Riely
authors.forename: Paul
authors.initials: P
authors.lastname: Martin
authors.forename: Lewis
authors.initials: L
authors.lastname: Teperman
authors.forename: James
authors.initials: J
authors.lastname: Jiao
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Lopez-Talavera
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy* / Q000473:pathology / Q000517:prevention & control*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D016031:Liver Transplantation; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011184:Postoperative Period; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a