Outcome of recurrent hepatitis C virus after liver transplantation in a randomized trial of tacrolimus monotherapy versus triple therapy.
Τίτλος | Outcome of recurrent hepatitis C virus after liver transplantation in a randomized trial of tacrolimus monotherapy versus triple therapy. |
Publication Type | Journal Article |
Year of Publication | 2009 |
Authors | Manousou, P., Samonakis D., Cholongitas E., Patch D., O'Beirne J., Dhillon A. P., Rolles K., McCormick A., Hayes P., & Burroughs A. K. |
Journal | Liver Transpl |
Volume | 15 |
Issue | 12 |
Pagination | 1783-91 |
Date Published | 2009 Dec |
ISSN | 1527-6473 |
Λέξεις κλειδιά | Adolescent, Adult, Aged, Azathioprine, Biopsy, Child, Drug Therapy, Combination, Female, Graft Rejection, Graft Survival, Hepatitis C, Humans, Hypertension, Portal, Immunosuppressive Agents, Kaplan-Meier Estimate, Liver Cirrhosis, Liver Transplantation, Male, Middle Aged, Prednisolone, Proportional Hazards Models, Recurrence, Risk Assessment, Risk Factors, Severity of Illness Index, Tacrolimus, Time Factors, Treatment Outcome, Young Adult |
Abstract | Less potent immunosuppression is considered to reduce the severity of hepatitis C virus (HCV) recurrence after liver transplantation. An optimal regimen is unknown. We evaluated tacrolimus monotherapy versus triple therapy in a randomized trial of 103 first transplants for HCV cirrhosis. One hundred three patients who underwent transplantation for HCV were randomized to tacrolimus monotherapy (n = 54) or triple therapy with tacrolimus, azathioprine, and steroids (n = 49), which were tapered to zero by 3 to 6 months. Both groups had serial transjugular biopsies with hepatic venous pressure gradient (HVPG) measurement. The time to reach Ishak stage 4 was the predetermined endpoint. All factors documented in the literature as being associated with HCV recurrence and the allocated treatment were evaluated for reaching stage 4 and HVPG >or= 10 mm Hg. No significant preoperative, perioperative, or postoperative differences, including the frequency of biopsies between groups, were found. During a mean follow-up of 53.5 months, 9 monotherapy patients and 6 triple therapy patients died, and 5 monotherapy patients and 4 triple therapy patients underwent retransplantation. Stage 4 fibrosis was reached in 17 monotherapy patients and 10 triple therapy patients (P = 0.04), with slower fibrosis progression in the triple therapy patients (P = 0.048). Allocated therapy and histological acute hepatitis were independently associated with stage 4 fibrosis. HVPG increased to >or=10 mm Hg more rapidly in monotherapy patients versus triple therapy patients (P = 0.038). In conclusion, long-term maintenance immunosuppression with azathioprine and shorter term prednisolone with tacrolimus in HCV cirrhosis recipients resulted in a slower onset of histologically proven severe fibrosis and portal hypertension in comparison with tacrolimus alone, and this was independent of known factors affecting fibrosis. |
DOI | 10.1002/lt.21907 |
Alternate Journal | Liver Transpl. |
PubMed ID | 19938143 |