Hephaistos Study Outcome on Renal Function after 12 Month Everolimus Plus Reduced Tacrolimus in De Novo Liver Transplant Recipients versus Standard Tacrolimus

F. Braun¹, P. Schemmer¹, H. Schlitt¹, A. Pascher¹, C. Klein¹, U. Neumann¹, I. Kroeger², P. Wimmer², B. Nashan¹

¹Study Group, Hephaistos, Germany, ²Novartis Pharma GmbH, Nuernberg, Germany

Meeting: 2019 American Transplant Congress

Abstract number: 553

Keywords: Immunosuppression, Liver transplantation, Renal function

Session Information

Session Name: Concurrent Session: Liver - Kidney Issues in Liver Transplantation

Session Type: Concurrent Session

Date: Tuesday, June 4, 2019

Session Time: 4:30pm-6:00pm

Presentation Time: 5:06pm-5:18pm

Location: Room 302

*Purpose: The HEPHAISTOS study was designed to compare efficacy and safety of earlyuse of everolimus [EVR] combined with reduced tacrolimus [rTAC] versus Standard tacrolimus [TAC-C) in de novo liver transplant [LTx] recipients and to demonstrateimpact of CNI minimization on renal function.

*Methods: In this 12 months [M] prospective, open-label, randomized study with 15 German sites, 333 patients [pts] were randomized 1:1 between day 7 to 21 after LTx to either EVR(3-8ng/ml) + rTAC (&it5ng/ml), or TAC-C(6-10ng/ml), all with steroids until M6. Here we report M12 outcomes on renal function from full analysis [FAS] and per protocol [PP] set.

*Results: FAS consisted of 169 pts in the EVR+rTAC and 164 TAC-C group. Mean TAC trough concentration in the EVR+rTAC group exceeded target range until month 3 and remained close to the upper limit of the target range thereafter. Efficacy at M12 was similar with EVR+rTAC or TAC-C. Mean eGFR (MDRD4) was numerically higher with EVR+rTAC to M12 (adjusted mean difference of 4.09 mL/min/1.73m²;p=0.0970; FAS). Among patients in the PP (110 EVR+rTAC, 101 TAC-C), eGFR was significantly higher in favor of EVR+rTAC (+7.79 mL/min/1.73m²;p=0.0085) vs. TAC-C without compromising efficacy.

*Conclusions: Use of EVR with rTAC as early as 15 days post-LTx allowed for better renal function sustained for 12M compared to TAC-C. Hephaistos confirms that an early reduction of TAC post LTx offers renal benefits.

To cite this abstract in AMA style:

Braun F, Schemmer P, Schlitt H, Pascher A, Klein C, Neumann U, Kroeger I, Wimmer P, Nashan B. Hephaistos Study Outcome on Renal Function after 12 Month Everolimus Plus Reduced Tacrolimus in De Novo Liver Transplant Recipients versus Standard Tacrolimus [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/hephaistos-study-outcome-on-renal-function-after-12-month-everolimus-plus-reduced-tacrolimus-in-de-novo-liver-transplant-recipients-versus-standard-tacrolimus/. Accessed May 12, 2025.

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