Efficacy of an escalating dose regimen of pegylated interferon alpha-2a plus ribavirin in the early phase of HCV reinfection after liver transplantation.
We evaluated the safety and efficacy of an escalating dose regimen of pegylated interferon alpha-2a (PEG-IFN(alpha-2a)) and ribavirin in the early phase of recurrent hepatitis C after orthotopic liver transplantation (OLT). In this prospective study, 26 patients transplanted for hepatitis C virus cirrhosis with recurrent hepatitis C were treated 3.4 +/- 3.6 months after OLT and compared with an untreated historical control. PEG-IFN(alpha-2a) was initiated as monotherapy, following stepwise dose escalation up to 180 mug/week and the addition of ribavirin up to 1200 mg/day or maximally tolerated doses for 48 weeks. In the intent-to-treat analysis, 38% showed an early virological response (EVR), 35% an end of treatment response (ETR) and 19% a sustained virological response (SVR). SVR was associated with EVR (P = 0.0001) and cumulative PEG-IFN(alpha-2a) dose (P = 0.04). There was no significant histological improvement compared with untreated patients. There were no treatment-related serious adverse events. Adverse events included leucopenia (77%) and thrombocytopenia (46%). Three patients discontinued therapy due to side effects, fourteen were nonresponders and four relapsers. Treatment with PEG-IFN(alpha-2a) and ribavirin in the acute phase of post-transplant recurrent hepatitis C yielded an EVR of 38% and an SVR of 19%. The combination was safe and well tolerated.
Zimmermann
Tim
T
1st Department of Medicine, University of Mainz, Langenbeck Strasse 1, 55101 Mainz, Germany.
Böcher
Wulf O
WO
Biesterfeld
Stefan
S
Zimmermann
Anca
A
Kanzler
Stefan
S
Greif-Higer
Gertrud
G
Barreiros
Ana Paula
AP
Sprinzl
Martin F
MF
Wörns
Marcus A
MA
Lohse
Ansgar W
AW
Mönch
Christian
C
Otto
Gerd
G
Galle
Peter R
PR
Schuchmann
Marcus
M
D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015331:Cohort Studies; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000601:surgery* / Q000821:virology*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011183:Postoperative Complications / Q000188:drug therapy*; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012008:Recurrence; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D000410:Alanine Transaminase; C100416:peginterferon alfa-2a