The use of cyclosporine for recurrent hepatitis C after liver transplant: a randomized pilot study.
BACKGROUND
Cyclosporine has antiviral activity in vitro against hepatitis C (HCV). We performed a pilot study to prospectively determine the antiviral effect of cyclosporine during therapy with PEGalfa-2a and ribavirin in liver transplant recipients with recurrent HCV infection.


METHODS
Patients with HCV recurrence (Ishak Fibrosis Stage > or = 2) were enrolled for 2 years at the University of Florida. Thirty-eight patients were randomized to continued tacrolimus or switched to cyclosporine. Both groups received PEGalfa-2a and ribavirin.


RESULTS
Twenty patients received tacrolimus and 18 cyclosporine, with a mean age of 53. Eighty-two percent were men, 84% Caucasian, and 90% genotype 1. In patients switched from tacrolimus to cyclosporine, HCVRNA levels decreased by a mean of 0.39 million IU/ml during the 1 month prior to initiating PEG/RBV. Sustained viral response for cyclosporine was higher than in patients on tacrolimus receiving PEG/RBV therapy.


CONCLUSIONS
This randomized controlled pilot study is the first in vivo study evaluating cyclosporine versus tacrolimus in liver transplant recipients undergoing antiviral therapy. Change from tacrolimus to cyclosporine led to a modest HCV RNA drop and appeared to enhance the antiviral response of PEG/RBV. A larger randomized study is necessary to see if cyclosporine offers any advantage over tacrolimus.
Firpi
Roberto J
RJ
Division of Gastroenterology, Hepatology and Nutrition, Section of Hepatobiliary Diseases and Liver Transplantation, Department of Medicine, University of Florida, Gainesville, FL 32610-0214, USA. firpirj@medicine.ufl.edu
Soldevila-Pico
Consuelo
C
Morelli
Giuseppe G
GG
Cabrera
Roniel
R
Levy
Cynthia
C
Clark
Virginia C
VC
Suman
Amitabh
A
Michaels
Anthony
A
Chen
Chaoru
C
Nelson
David R
DR
D000998:Antiviral Agents / Q000008:administration & dosage*; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy / Q000473:pathology / Q000601:surgery / Q000821:virology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D008099:Liver / Q000473:pathology; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012008:Recurrence; D012254:Ribavirin / Q000008:administration & dosage; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use
D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D016572:Cyclosporine; C100416:peginterferon alfa-2a; D016559:Tacrolimus