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Long term outcomes and safety profile of sirolimus in post liver transplant children

Title: Long term outcomes and safety profile of sirolimus in post liver transplant children

Source: Pediatric Transplantation 2025, 29 (8): e70235

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Date of publication: December 2025

Publication type: Single centre retrospective study 

Abstract: Background: Tacrolimus is the maintenance immunosuppression of choice in pediatric liver transplant (LT) recipients. However, in selective cases, sirolimus is used as an alternative immunosuppressive treatment. We aimed to review a single centre’s experience of using sirolimus as an alternative to tacrolimus in pediatric LT recipients.

Methods: Single centre retrospective study of pediatric LT recipients who were started on sirolimus as an alternative immunosuppressant to tacrolimus. Children (< 16 years) who were started on sirolimus between May 2000 and May 2024 were included in the study.

Results: A total of 19 children were started on sirolimus following LT and followed up for a median of 4 years (range 0.4-12.8). Post-transplant lymphoproliferative disorder (PTLD) was the most common reason for tacrolimus discontinuation and conversion to sirolimus (n = 14), followed by tacrolimus-related adverse effects (n = 4) and disease recurrence (n = 1). There were no cases of PTLD recurrence or biopsy-confirmed rejection whilst on sirolimus. Proteinuria and hyperlipidaemia were the most common sirolimus side effects observed. Eighteen children remain on sirolimus to date, and none required discontinuation from side effects. In those with PTLD, 4 episodes of rejection occurred between the period of tacrolimus discontinuation and starting sirolimus (median immunosuppression-free time of 5 months), with one child requiring regrafting due to chronic rejection.

Conclusion: The experience from our centre demonstrates sirolimus to be a safe and effective alternative to tacrolimus in a selected population of pediatric LT recipients. Further research with a larger sample size is required to confirm these findings and evaluate the long-term safety of sirolimus in this population.

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