Tacrolimus and Sirolimus Once Daily Monotherapy Regimen as a Safe and Effective Long-Term Maintenance Immunosuppressive Therapy in Pediatric Liver Transplantation

Background: Long-term efficiency of attenuated immunosuppressive therapies is not well characterized in pediatric liver transplantation (LT). Objective: To assess the efficiency of tacrolimus once daily (TAC-OD) and sirolimus once daily (SLR-OD) immunosuppression in pediatric LT. Methods: We retrospectively evaluated 59 children who underwent LT in our center during 2002 to 2016. Those including children who underwent planned decrease in immunosuppressant dose (stable clinical conditions after 2 years of LT), and those who underwent unplanned decrease in immunosuppressant dose (because of complications such as post-transplant lymphoproliferative disorder [PTLD] and renal failure). Results: 25 of 59 children underwent planned decrease in immunosuppressant dosage (mean +/- SD duration of 4.5 +/- 1.8, range: 3-11 years); 34 had unplanned decrease (mean +/- SD of 1.3 +/- 0.6, range: 0.5-2.6 years). 19 of 25 children with planned conversion received TAC-OD; 6 received SLR-OD (22 with 1 mg/day dose, and 3 with 1 mg every two days). Of 34 children with unplanned conversion, 27 received TACOD, 7 SLR-OD (25 children with 1 mg/day, 7 with 1 mg every two days, 1 with 0.5 mg/day TAC, and 1 with 0.5 mg TAC every two days). We found no adverse events including acute or chronic graft rejection, renal insufficiency, infections, PTLDs, or cardiovascular thrombotic events after initiation of the modified immunosuppression in none of the groups. Conclusion: TAC-OD or SLR-OD monotherapies are safe and effective for long-term management of LT children with either stable clinical conditions or those with LT complications.