Impact of tacrolimus versus cyclosporine in hepatitis C virus-infected liver transplant recipients on recurrent hepatitis: a prospective, randomized trial

Liver Transpl. 2004 Oct;10(10):1258-62. doi: 10.1002/lt.20222.

Abstract

Hepatitis C virus (HCV)-induced cirrhosis is the commonest indication for orthotopic liver transplantation, but HCV recurrence is nearly universal and may worsen patient / graft outcomes. The frequency and severity of HCV recurrence has apparently increased in recent years, raising concern about a possible role for newer immunosuppression regimens in this increase, including potentially tacrolimus. We randomized 79 patients to receive tacrolimus or cyclosporine as primary immunosuppressant posttransplantation. A pathologist blinded to treatment reviewed serial liver biopsies. Month 12 cumulative probabilities of histological hepatitis C recurrence for tacrolimus- and cyclosporine-treated patients were .38 and .54 (P = .19) and failure / death were .25 and .28, respectively (P = .789). Although cyclosporine-treated patients had significantly larger increases in median serum HCV RNA levels (months 1, 6, and 12), no significant differences were observed between the two treatment arms in histologically-diagnosed HCV recurrence / survival rates. In conclusion, choice of calcineurin inhibitors does not impact severity of recurrent HCV.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Biopsy, Needle
  • Cyclosporine / therapeutic use*
  • Female
  • Hepacivirus / genetics
  • Hepacivirus / isolation & purification*
  • Hepatitis C / complications
  • Hepatitis C / drug therapy*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Liver / pathology
  • Liver Cirrhosis / virology
  • Liver Transplantation*
  • Male
  • Middle Aged
  • Prospective Studies
  • RNA, Viral / blood
  • Recurrence
  • Tacrolimus / therapeutic use*
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • RNA, Viral
  • Cyclosporine
  • Tacrolimus