Purpose: To compare three formulations of tacrolimus (TAC) and assess differences in time within therapeutic range (TTR) and variability in levels.

Methods: Renal transplant recipients from 01/01/2013 to 10/01/2017 were retrospectively identified for analysis. Deviation from standard TAC protocol or formulation changes excluded patients. The primary outcome is percentage in TTR (%TTR) over the first 12 weeks post-transplant. Secondary outcomes include: TAC CV%, TAC levels, TAC dose, eGFR, rejection, and patient/graft survival.

Results: The following results are preliminary, as research is ongoing. Ninety-four patients were included in analysis. Demographics were similar among groups (Table 1). %TTR was similar between groups (60.4% vs. 56% vs. 59.4%, p=0.582) (Table 2). There were no differences with respect to CV%, weight-normalized dose, average TAC level, eGFR at all time points. Median dose-normalized TAC levels were significantly higher in the TAC-XL arm at month 1 (p=0.023), but at no other time points. BPAR rates were numerically higher in the TAC-XL arm (p=0.08).

Conclusions: In the early transplant period, all formulations of TAC have similar variability with regard to time within therapeutic range and levels. Patient specific factors such as race, obesity, genetic polymorphisms may impact this variability and inevitably clinical outcomes. Further analysis is necessary to understand the effect of each patient specific factor on TAC exposure.

CITATION INFORMATION: Khalil K., West-Thielke P., Lichvar A., Benedetti E., Patel S. Time within Therapeutic Range: A Comparison of Three Tacrolimus Formulations in Renal Transplant Recipients Am J Transplant. 2017;17 (suppl 3).

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