ArticleClinical and translational science2026
Differences in Early Tacrolimus Exposure in Kidney Transplant Recipients With and Without CYP3A5 Genotype-Guided Tacrolimus Dosing.
Article in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
CYP3A5 genotype is a known predictor of tacrolimus dose requirements. This single-center retrospective study evaluated the impact of CYP3A5 genotype-guided dosing, implemented at our institution in 10/2023, on early tacrolimus exposure. Patients were included if they were adult kidney transplant recipients between 7/2014 and 10/2024; patients in the weight-based cohort had research CYP3A5 genotypes in the institutional research biorepository and the genotype-guided cohort had a clinical CYP3A5 genotype available at transplant. The primary outcome was time to therapeutic steady-state (TSS) and secondary outcomes included classification of trough concentration on postoperative-day (POD) 2, tacrolimus dose at TSS, and tacrolimus intrapatient variability (IPV) at 14- and 30-day post-transplant. Outcomes were also evaluated within each CYP3A5 phenotype and a per-protocol evaluation. Outcomes were compared via Mann-Whitney U, Chi-squared, or Fischer's exact tests. The median TSS was decreased in CYP3A5 normal metabolizers (6.0 days (3.0-6.0) vs. 16.0 days (8.0-16.0); p = 0.01) and CYP3A5 intermediate metabolizers had significantly fewer subtherapeutic troughs on POD2 (25.8% vs. 61.1%; p = 0.01) in the genotype-guided cohort. CYP3A5 poor metabolizers were more likely to have a subtherapeutic trough on POD2 in the genotype-guided cohort. The time below therapeutic range in the first 14 days was significantly reduced for CYP3A5 intermediate metabolizers who received per-protocol, genotype-guided dosing. The TSS dose did not differ between the cohorts but was lower than the genotype-guided protocol dosing. CYP3A5 genotype-guided dosing reduced the likelihood of early subtherapeutic exposure in CYP3A5 normal and intermediate metabolizers. Refinement of the genotype-guided dosing strategy may help further improve early tacrolimus exposure.
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