Rejection rates in a randomised trial of tacrolimus monotherapy versus triple therapy in liver transplant recipients with hepatitis C virus cirrhosis

Transpl Infect Dis. 2006 Mar;8(1):3-12. doi: 10.1111/j.1399-3062.2006.00124.x.

Abstract

Background: Reducing immunosuppression not only reduces complications but also may lessen recurrent hepatitis C virus (HCV) infection after liver transplantation.

Patients/methods: HCV-infected cirrhotic patients randomised to tacrolimus monotherapy (MT) or triple therapy (TT) using tacrolimus 0.1 mg/kg/day, azathioprine 1 mg/kg/day, and prednisolone 20 mg/day, tapering over 3 months.

Results: Twenty-seven patients (MT) and 29 (TT)--median follow up 661 days (range, 1-1603). Rejection episodes (protocol/further biopsies) within first 3 months and use of empirical treatment were evaluated. New rejection was diagnosed if repeat biopsy (5-day interval) did not show improvement. Treated rejection episodes: 20 MT (15 biopsy-proven) vs. 24 TT (21 biopsy-proven), with 19 (MT) vs. 24 (TT) methylprednisolone boluses. Overall: 35 episodes (MT) and 46 (TT). Fewer MT patients had histological rejection (70%) than TT patients (86%), with fewer episodes of rejection (18.5% vs. 10%), and more moderate rejection (22% vs. 41%). The MT group had higher early tacrolimus levels. Rates of renal dysfunction, retransplantation, and death were not significantly different.

Conclusion: Tacrolimus monotherapy is a viable immunosuppressive strategy in HCV-infected liver transplant recipients.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Azathioprine / therapeutic use
  • Drug Therapy, Combination
  • Female
  • Graft Rejection / prevention & control*
  • Hepatitis C / complications
  • Hepatitis C / therapy*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Liver Cirrhosis / therapy*
  • Liver Cirrhosis / virology
  • Liver Transplantation* / immunology
  • Male
  • Middle Aged
  • Postoperative Complications / epidemiology
  • Postoperative Complications / prevention & control
  • Prednisolone / therapeutic use
  • Secondary Prevention
  • Survival Analysis
  • Tacrolimus / therapeutic use*
  • Time Factors
  • Transplantation, Homologous
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • Prednisolone
  • Azathioprine
  • Tacrolimus