Safety and Efficacy of Once-Daily Prolonged-Release Tacrolimus in Living Donor Liver Transplantation: An Open-Label, Prospective, Single-Arm, Phase 4 Study.

BACKGROUND After liver transplantation (LT), nonadherence to immunosuppressants due to the complex regimen can lead to graft rejection and loss. This study assessed the efficacy and safety of conversion from twice-daily tacrolimus (Bid-Tac) to once-daily prolonged-release tacrolimus (OD-Tac) in living donor LT (LDLT) recipients. MATERIAL AND METHODS Among patients who underwent LDLT between November 2015 and October 2016, those who agreed to participate in this study were screened, and those with good general condition and stable liver functions were enrolled. Participants underwent a conversion from Bid-Tac to OD-Tac with a dose ratio of 1: 1 at about 10-14 weeks after LDLT and were followed-up for 24 weeks. RESULTS Thirty-one patients were enrolled. The median number of conversion days after LDLT was 12.3 weeks (range, 10.3-13.8). Adherence was evaluated during the outpatient visits at weeks 2, 4, 8, 16, and 24 after Tac conversion, and 100% adherence was observed at all time points. There were no cases of acute rejection, graft loss, or patient death after Tac conversion. Nineteen cases of adverse events occurred in 11 patients (35.5%), none of which were severe. Alopecia was the most common, affecting 3 (9.7%) patients, followed by pruritus (n=2, 6.45%). There were no changes in renal function or in liver function test, serum glucose level, and lipid profile. CONCLUSIONS Early Tac conversion from Bid-Tac to OD-Tac is safe and feasible. However, further studies are needed to elucidate its long-term effects.