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


Correspondence to: Professor Andrew K. Burroughs
Liver Transplantation and Hepatobiliary Unit,
Academic Department of Surgery (9th Floor),
Royal Free Hospital, Pond Street, Hampstead,
London, UK
Tel: 0044-207-4726229
Fax: 0044-207-4726226


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.