Rejection rates in a randomised trial of tacrolimus monotherapy versus triple therapy in liver transplant recipients with hepatitis C virus cirrhosis.
BACKGROUND
Reducing immunosuppression not only reduces complications but also may lessen recurrent hepatitis C virus (HCV) infection after liver transplantation.


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.


CONCLUSIONS
Tacrolimus monotherapy is a viable immunosuppressive strategy in HCV-infected liver transplant recipients.
Samonakis
D N
DN
Liver Transplantation and Hepatobiliary Unit, Royal Free Hospital, Hampstead, London, UK.
Mela
M
M
Quaglia
A
A
Triantos
C K
CK
Thalheimer
U
U
Leandro
G
G
Pesci
A
A
Raimondo
M L
ML
Dhillon
A P
AP
Rolles
K
K
Davidson
B R
BR
Patch
D W
DW
Burroughs
A K
AK
D000328:Adult; D000368:Aged; D001379:Azathioprine / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control*; D006526:Hepatitis C / Q000150:complications / Q000628:therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000628:therapy* / Q000821:virology; D016031:Liver Transplantation / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control; D011239:Prednisolone / Q000627:therapeutic use; D055502:Secondary Prevention; D016019:Survival Analysis; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors; D014184:Transplantation, Homologous; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D011239:Prednisolone; D001379:Azathioprine; D016559:Tacrolimus