The safety and efficacy of substitution with a novel once-daily extended-release tacrolimus (LCPT;Envarsus®)to immediate-release tacrolimus (IR-Tac, Prograf®) twice daily in liver transplant patients have not been evaluated.

Methods: Tacrolimus trough concentrations and indices of liver function were recorded before and after LCPT substitution in 30 liver transplant (LT) recipients and compared with case matched 30 LT recipients with the IR-Tac. Inclusion criteria included age > 18 years, LT recipient at least 6 months posttransplant, switched from the IR-tacrolimus product to the LCPT formulation from June 2016 to November 2017. All subjects received care in the outpatient transplant clinic where tacrolimus trough concentrations, weight, total bilirubin, albumin, serum creatinine, alkaline phosphatase, ALT, AST, GGTP and graft rejection status was routinely monitored. Patients were followed for a minimum of 14 days and a maximum of 1 year before and after the conversion. At the time of the switch from the IR-Tac to LCPT product, a 1:0.7 dose conversion was employed and the dose of LCPT tacrolimus was then adjusted to maintain trough concentrations within the therapeutic range.

Results: The tacrolimus concentration to dose (C/D)ratio, expressed as the concentration divided by daily weight-adjusted dose ([ng/mL]/[mg/kg/day]), was calculated for each trough concentration. In LT patients, the mean tacrolimus concentration/dose (C/D) ratio (±SD) was 178.1 (±123.2) ([ng/mL]/[mg/kg/day]) for the IR-Tac product and 150.7 (±87.8) ([ng/mL]/[mg/kg/day]) for LCPT product (p < 0.05). Mean total day dose (TDD) for LCPT was 30% lower than for the IR-Tac group (P , 0.001), but troughs were similar (LCPT, 5.47 6 0.17 ng/mL; IR-Tac, 5.8 6 0.30 ng/mL; P<0.4).No change was observed in biochemical indices of liver or kidney function and no cases of acute rejection occurred following the substitution.

Conclusions: LT patients currently taking the IR-tacrolimus formulation may be safely switched to the LCPT product (Envarsus®). Lower TDD reflects LCPT's improved bioavailability and absorption.

CITATION INFORMATION: Del Gaudio M., Cescon M., Ravaioli M., Bertuzzo V., Zanfi C., Serenari M., Maroni L., Morelli C., Pinna A. The Impact of Conversion from Immediate Release Twice-Daily Tacrolimus (Prograf®) to Once-Daily Extended Release Tacrolimus (Envarsus®) in Liver Transplant Recipients Am J Transplant. 2017;17 (suppl 3).

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