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Abstract Details
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, Asonuma K, Sakurai H, Kubo S, Kiuchi T, Inomata Y, Isaji S, Tsumura H, Teramukai S, Matsubara Y, Sakabayashi S, Uemoto S. Liver Transpl. 2013 May 21. doi: 10.1002/lt.23679. [Epub ahead of print]
Source
Department of HBP and Transplant Surgery, Ehime University, Toon, Japan.
Abstract
The purpose of this prospective randomized multicenter trial was to evaluate the effects of a steroid-avoiding immunosuppression protocol in hepatitis C virus (HCV)-positive recipients of living donor liver transplantation (LDLT). Seventy-five HCV-positive LDLT recipients were included in this study and randomized to receive tacrolimus + steroid (ST group, n=35) or tacrolimus + mycophenolate mofetil (MMF) (MMF group, n=40). Biopsy-proven acute rejection (BPAR) was treated using steroid pulse therapy in both groups. Protocol biopsy was performed at 3, 6, and 12 months after LDLT, and annually thereafter. Histological recurrence of hepatitis C (fibrosis stage ≥F1 according to METAVIR score), BPAR resistant to 2 sets of steroid pulse therapy, hepatocellular carcinoma (HCC) recurrence, re-transplantation and patient death were defined as events, and the primary endpoint was event-free survival. Median follow-up was 55 months. Event-free survival rates at 1, 3, and 5 years were 38.2%, 11.8%, and 5.9% for the ST group and 25.0%, 17.5%, and 14.6% for the MMF group, respectively (p=0.452). Overall 5-year patient survival rates were similar between the ST group (82.7%) and MMF group (81.0%, p=0.281). Steroid-resistant BPAR occurred in only 1 MMF group patient. HCC recurrence occurred in 1 ST group patient and 2 MMF group patients. Recurrence rates of hepatitis C with ≥F1 at 1 and 3 years after LDLT were 59.4% and 85.9% for the ST group and 74.2% and 81.9% for the MMF group, respectively (p=0.571). In conclusion, our steroid-avoidance regimen had no apparent impact on LDLT outcomes for HCV-positive recipients.