Randomized multicenter trial comparing tacrolimus plus mycophenolate mofetil with tacrolimus plus steroids among HCV-positive recipients of living donor liver transplantation.
Takada Y, Kaido T, et al.Liver Transplantation 2013; 19(8):896-906
Aims
To investigate the efficacy and safety between tacrolimus (TAC) plus mycophenolate mofetil (MMF) and conventional TAC plus corticosteroids in hepatitis C virus (HCV) positive liver transplant recipients.
Interventions
The participants were randomized to receive either TAC plus MMF or conventional TAC plus corticosteroids. In both groups TAC was administered within 12 hours after transplantation. In the steroid group methylprednisolone was initiated before graft reperfusion and continued until the end of the third month. In the steroid avoidance group MMF was administered on day one and was gradually increased for 6 months.
Participants
75 HCV-positive recipients of living donor liver transplantation.
Outcomes
The primary outcome of the study included event-free survival. The secondary outcomes included patient survival, HCV viral load, histological hepatitis C recurrence, BPAR requiring steroid pulse therapy and chronic rejection.
Follow-up
55 months.
CET Conclusions
This paper reports a randomised trial comparing tacrolimus and MMF with tacrolimus and steroids in HCV-positive living-donor liver transplant recipients. The authors demonstrate no difference between the regimens in a composite outcome of “treatment failure†that includes steroid resistant acute rejection, death, graft loss, HCC and histological HCV recurrence. However, there is a strong trend (p=0.051) towards an increased risk of acute rejection in the MMF arm. The main problem with this study is the lack of power. The authors calculated a required recruitment of 120 patients for 80% power at 5% significance, but only 75 patients were recruited. Given this, and the higher event-free rates at 1 year than expected, the study is likely to be underpowered to show differences between the arms.
Data analysis
Modified intention-to-treat analysis
Trial registration
NCT00469131