title: Antiviral re-treatment of IFN-ribavirin non-responders for recurrent post-transplantation hepatitis C.
abstract: BACKGROUND
  The aim of the study was to compare the efficacy and tolerability of pegylated interferon (PEG-IFN) plus ribavirin (RIB) and PEG-IFN monotherapy after unsuccessful initial therapy with interferon-α2b (IFN) plus RIB after recurrent post-transplantation hepatitis C.
  
  
  METHODS
  Twenty-four patients with either no response (n = 10) or relapse (n = 14) after treatment with IFN plus RIB were prospectively randomized in the two treatment arms: 1) PEG-IFN monotherapy at a dosage of 0.8 μg/kg per week (n = 12) and 2) PEG-IFN (0.8 μg/kg per week) plus RIB (800-1200 mg/d) (n = 12).
  
  
  RESULTS
  Twenty-one patients (86%) were treated for at least six months. Three patients are still being treated. At the end of therapy, 18 patients (75%) were HCV RNA negative. Five (45%) patients in PEG-IFN and five (50%) in PEG-IFN plus RIB arms had sustained virological response. Two patients (10%) died from recurrent hepatocellular carcinoma. The histologic activity indices significantly improved in both treatment arms. In the PEG-IFN arm, one patient experienced an acute rejection and discontinued therapy.
  
  
  CONCLUSIONS
  Both treatment arms showed to be effective, well tolerated and lead to an improvement in histologic outcome. Because of lower rates in side effects and equal outcome, PEG-IFN monotherapy is an adequate option for antiviral re-treatment.
authors.affiliation: Department of General Surgery, University of Erlangen-Nuremberg, Krankenhausstr, Erlangen, Germany. Sueleyman.Yedibela@uk-erlangen.de
authors.forename: Süleyman
authors.initials: S
authors.lastname: Yedibela
authors.forename: Resit
authors.initials: R
authors.lastname: Demir
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Melling
authors.forename: Ünal
authors.initials: Ü
authors.lastname: Aydin
authors.forename: Detlef
authors.initials: D
authors.lastname: Schuppan
authors.forename: Volker
authors.initials: V
authors.lastname: Müller
authors.forename: Werner
authors.initials: W
authors.lastname: Hohenberger
authors.forename: Frank
authors.initials: F
authors.lastname: Schönleben
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000235:genetics / Q000472:pathogenicity; D006526:Hepatitis C / Q000628:therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D012367:RNA, Viral / Q000235:genetics; D011994:Recombinant Proteins; D019233:Retreatment; D012254:Ribavirin / Q000627:therapeutic use*; D055502:Secondary Prevention; D015996:Survival Rate; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin