*Purpose: The HEPHAISTOS study was set up to compare early use of everolimus [EVR] combined with reduced tacrolimus [rTAC] versus standard-dose tacrolimus [TAC-C) in de novo liver transplant [LTx] recipients

*Methods: In this 12 months [M] prospective, open-label, multi-center study 333 patients [pts] were randomized 1:1 between day 7 to 21 after Tx to either EVR(3-8ng/ml) + rTAC(&lt5ng/ml), or TAC-C(6-10ng/ml), all with steroids until M6. Here we report M12 efficacy and safety results (169 EVR+rTAC, 164 TAC-C).

*Results: Randomization occurred on average 15 days after LTx. Efficacy between both groups was comparable. Incidence rates for Biopsy Proved Acute Rejection [BPAR] were 8.9% in EVR+rTAC and 6.9% in TAC-C group at M12 (Kaplan-Meier estimates). Most events were graded as mild (9 vs.7) and only few events as moderate or severe (in total 8 vs 7). Under treatment, no graft loss and 2 deaths occurred in the EVR arm, and 3 graft losses and 3 deaths in the TAC-C arm. Safety profiles were similar, incidences of AEs leading to study drug discontinuation were 23.7% in EVR+rTAC, vs 23.2% in TAC-C arm. Main reasons for discontinuation were renal and urinary disorders (1.2% EVR+rTAC, 7.3%TAC-C) and leucopenia (2.4%, 0.0%). No new safety signals were identified during the study

*Conclusions: HEPHAISTOS confirmed early use of EVR plus rTAC in LTx recipients is feasible and safe with good efficacy Outcomes.

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