Safety and Efficacy of Conversion to Once-Daily Tacrolimus from Twice-Daily Tacrolimus in Pediatric Liver Transplant Recipients

J Pediatr Surg. 2023 Oct;58(10):2054-2058. doi: 10.1016/j.jpedsurg.2023.05.005. Epub 2023 May 11.

Abstract

Background: Nonadherence to immunosuppression is the most common cause of late acute rejection in pediatric liver transplant (LT) recipients. A prolonged-release once-daily tacrolimus formulation was developed to improve adherence and long-term allograft survival.

Methods: We screened 179 pediatric LT recipients who converted from twice-daily tacrolimus (TD-TAC) to once-daily tacrolimus (OD-TAC) between February 2011 and September 2019.

Results: One hundred seventy-nine recipients converted to OD-TAC and were followed for 18 months. 152 OD-TAC-converted recipients (84.9%) experienced uneventful follow-up, while 21 recipients showed LFT elevation. Four recipients had biopsy-proven acute rejection within six months of conversion, all of which were successfully treated with steroid pulse. 166 recipients (92.7%) remain on OD-TAC and 13 (7.3%) were switched back to TD-TAC. The mean tacrolimus trough level significantly decreased three months following conversion (3.14 ± 1.9 ng/mL) compared with pre-conversion levels (3.69 ± 1.98 ng/mL). Mean tacrolimus trough levels remained unchanged from 3 months to 12 months following conversion. Percent coefficient of variation of tacrolimus trough levels decreased significantly from 32.5 ± 16.4 ng/mL to 27.5 ± 15.6 ng/mL after conversion to OD-TAC, reflecting a decrease in variation of tacrolimus trough levels following conversion.

Conclusions: Conversion to OD-TAC in pediatric LT recipients with stable graft function is safe and effective.

Level of evidence: Level IV.

Keywords: Adherence; Liver transplantation; Once-daily; Pediatric; Tacrolimus.

MeSH terms

  • Child
  • Delayed-Action Preparations
  • Drug Administration Schedule
  • Graft Rejection / prevention & control
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Liver Transplantation*
  • Tacrolimus* / adverse effects
  • Transplantation, Homologous

Substances

  • Tacrolimus
  • Immunosuppressive Agents
  • Delayed-Action Preparations