Reduced fibrosis in recurrent HCV with tacrolimus, azathioprine and steroids versus tacrolimus: randomised trial long term outcomes
Manousou P, Cholongitas E, et al.Gut 2014; 63(6): 1005-1013.
Aims
To evaluate outcomes of a trial which compared tacrolimus monotherapy versus tacrolimus, azathioprine and methylprednisolone triple therapy in fibrosis and clinical decompensation of liver transplant recipients.
Interventions
Patients were administered with tacrolimus or tacrolimus with azathioprine and methylprednisolone.
Participants
103 consecutive liver transplant recipients.
Outcomes
The primary endpoints included progression to Ishak stage 4 and graft failure resulting in patient death or retransplantation. Secondary endpoints included patient survival, acute cellular rejection episodes, chronic rejection, recurrence of HCV, HVPG progression to 10mmHg, calcineurin phosphatase activity(CPA) fibrosis progression assessed by CPA and Ishak stage, and time to first episode of clinical decompensation defined as whichever occurred first, of ascites/hydrothorax, variceal bleeding or encephalopathy.
Follow-up
8 years.
CET Conclusions
This is long-term follow up of a previously published study in liver transplant recipients with HCV cirrhosis. Lower tacrolimus trough levels were achieved in the triple therapy group for the first 6 months. Monotherapy was associated with quicker progression to Ishak stage 4, increased fibrosis (as measured by hepato-venous pressure gradient) clinical decompensation and worse graft survival.
Data analysis
Modified intention-to-treat analysis
Quality notes
Previously assessed - Manousou P, Samonakis D, Cholongitas E, et al. Outcome of recurrent hepatitis C virus after liver transplantation in a randomized trial of tacrolimus monotherapy versus triple therapy. Liver Transpl 2009;15:1783–91.
Trial registration
ISRCTN94834276