AIM: The aim of our study was to define the possible influence of early tacrolimus exposure on long-term outcomes in patients treated with de novo once-daily tacrolimus (T-QD) after liver transplantation (LT).

METHODS: Adult patients who received a LT between April 2008 and August 2011 whose initial immunosuppression was based on de novo T-QD comprised the study cohort. All recipients were Caucasians and received whole grafts from donors after brain-dead. Exclusion criteria were: Pre-LT renal dysfunction (n=23), retransplantation (n = 12), combined transplantation (n = 4). T-QD was started within the first 24 hours after OLT, either by oral route or through a naso-gastric tube. Initial dose of T-QD was 0.15 mg/kg/day or 0.1 mg/kg/day if combined with MMF. Tacrolimus target trough levels were 5-10 ng/ml during the first 3 post-transplant months and were progressively reduced to <7 ng/ml after the first post-transplant year. Long-term renal function was assessed through the MDRD-4 formula.

RESULTS: The final sample consisted of 137 patients with a median follow-up of 57.6 months (range 1-80) who were divided into three groups according to the mean tacrolimus level within 15 days after LT: 53 (38.7%) had <7 ng/ml (5.3 ± 1.2), 39 (28.5%) had 7-10 ng/ml (8.5 ± 0.9) and 45 (32.8%) had >10 ng/ml (13.0 ± 2.7). Overall, biopsy proven acute rejection (BPAR) was reported in 16 patients (11.6%). BPAR rate in the study groups was: 13.2%, 12.8% and 11.1%, respectively (p = 0.94). There was no significant difference between the three groups in mean glomerular filtration at 5 years: 81.0 ± 11.5, 82.6 ± 24.3 and 80.9 ± 14.9 ml/min/1.73 m2, respectively (p = 0.13). Overall, 16 recipients died during follow-up: 5, 3 and 8 recipients, respectively in the study groups. Patient survival was 96.2%, 97.4% and 95.6% at 1 year and 89.5%, 97.4% and 81.4% at 5 years, respectively (p = 0.30).

CONCLUSION: Early tacrolimus exposure after de novo use of T-QD in LT did not influence the rate of BPAR and the long-term renal function. A trend to lower patient survival was observed in recipients with mean tacrolimus trough level >10 ng/ml within 15 days after LT.

CITATION INFORMATION: Gastaca M, Valdivieso A, Bustamante J, Ruiz P, Fernandez J, Ventoso A, Testillano M, Palomares I, Prieto M, Salvador P, Matarranz A, Suarez M, Ortiz de Urbina J. Early Tacrolimus Exposure in Patients Treated De Novo with Once-Daily Tacrolimus After Liver Transplantation: Relationship with Acute Rejection and Long-Term Outcome. Am J Transplant. 2016;16 (suppl 3).

« Back to 2016 American Transplant Congress