*Current address: Histopathology Department, Ospedale Sacro Cuore Don Calabria, Negrar (Verona), Italy.
Rejection rates in a randomised trial of tacrolimus monotherapy versus triple therapy in liver transplant recipients with hepatitis C virus cirrhosis
Article first published online: 7 APR 2006
Transplant Infectious Disease
Volume 8, Issue 1, pages 3–12, March 2006
How to Cite
Samonakis, D.N., Mela, M., Quaglia, A., Triantos, C.K., Thalheimer, U., Leandro, G., Pesci, A., Raimondo, M.L., Dhillon, A.P., Rolles, K., Davidson, B.R., Patch, D.W. and Burroughs, A.K. (2006), Rejection rates in a randomised trial of tacrolimus monotherapy versus triple therapy in liver transplant recipients with hepatitis C virus cirrhosis. Transplant Infectious Disease, 8: 3–12. doi: 10.1111/j.1399-3062.2006.00124.x
- Issue published online: 7 APR 2006
- Article first published online: 7 APR 2006
- Received 21 June 2005, revised 15 October 2005, accepted for publication 26 October 2005
- randomised trial;
- tacrolimus monotherapy;
- hepatitis C;
- liver transplantation
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.