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Early Use of Everolimus Plus Reduced Tacrolimus vs Standard Tacrolimus in De Novo Livertransplant Recipients: 12 Months Efficacy and Safety Data from HEPHAISTOS Study

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

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

Meeting: 2019 American Transplant Congress

Abstract number: 40

Keywords: Efficacy, Immunosuppression, Liver transplantation

Session Information

Date: Sunday, June 2, 2019

Session Name: Concurrent Session: Liver: Immunosuppression and Rejection

Session Time: 2:30pm-4:00pm

 Presentation Time: 2:30pm-2:42pm

Location: Room 312

Related Abstracts
  • Hephaistos Study Outcome on Renal Function after 12 Month Everolimus Plus Reduced Tacrolimus in De Novo Liver Transplant Recipients versus Standard Tacrolimus
  • The ATHENA Study: 12 Months Safety and Efficacy Data from Everolimus Combined with Tacrolimus or Cyclosporine Compared to a Standard Tacrolimus-Mycophenolate Regimen in De Novo Kidney Transplant Patients

*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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To cite this abstract in AMA style:

Nashan B, Schemmer P, Schlitt H, Pascher A, Klein C, Neumann U, Kroeger I, Wimmer P, Braun F. Early Use of Everolimus Plus Reduced Tacrolimus vs Standard Tacrolimus in De Novo Livertransplant Recipients: 12 Months Efficacy and Safety Data from HEPHAISTOS Study [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/early-use-of-everolimus-plus-reduced-tacrolimus-vs-standard-tacrolimus-in-de-novo-livertransplant-recipients-12-months-efficacy-and-safety-data-from-hephaistos-study/. Accessed April 15, 2021.

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