Significant Anti-CMV/BKV Effect of a Modern Everolimus-Based Regimen Comparted to a Standard Tacrolimus-MPA Regimen in De Novo Kidney Transplant Recipients: ATHENA 12 Months Data on Infections

A. Hauser,¹ C. Sommerer,¹ B. Suwelack,¹ D. Dragun,¹ O. Witzke,¹ C. Hugo,¹ N. Kamar,² P. Merville,² P. Schenker,¹ M. Junge,³ F. Thaiss,¹ B. Nashan.¹

¹Athena Study Group, Germany
²Athena Study Group, France
³Novartis, Pharma, Germany.

Meeting: 2018 American Transplant Congress

Abstract number: 183

Keywords: Cytomeglovirus, Infection, Kidney transplantation

Session Information

Session Name: Concurrent Session: CMV: Bench to Bedside

Session Type: Concurrent Session

Date: Monday, June 4, 2018

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

Presentation Time: 2:30pm-2:42pm

Location: Room 608/609

The ATHENA trial was designed to compare everolimus [EVR] in combination with tacrolimus [TAC] or cyclosporine A [CyA] vs. a standard regimen of mycophenolic acid [MPA] and TAC in de novo kidney transplant [Tx] recipients. Of specific interest was monitoring of infections, mainly CMV and BKV.

Methods: In this randomized 12 months [M] prospective, open-label study with 15 German and 12 French study sites, in total 612 patients [pts] were randomized 1:1:1 at time of Tx to either EVR (3-8ng/ml M1-M12) +TAC (4-8ng/ml M1-M3; 3-5ng/ml M3-M12), or EVR (3-8ng/ml M1-M12) +CyA (75-125 ng/ml M1-M3; 50-100 ng/ml M3-M12) or to control MPA+TAC (4-8ng/ml M1-M3; 3-5ng/ml M3-M12) regimen; all +steroids. Here we present M12 data on infections from 208 EVR+TAC pts, 199 EVR+CyA pts and 205 TAC+MPA pts.

Results: From randomization to M12 total incidence of infections was significantly higher in TAC+MPA group with 82% compared to 73% in EVR+TAC and 72% in EVR+CyA treated pts (p<0.05). In general, most frequent event was urinary tract infection with similar incidence across groups: 41% vs 41% vs 40%, respectively. Major differences were seen for viral infections with an incidence of 41% in TAC+MPA vs 26% in EVR+TAC and 12% in EVR+CyA treated pts (p<0.01). Of specific interest: BKV with 23% in TAC+MPA vs 17% in EVR+TAC vs 9% in EVR+CyA treated pts and CMV infections with 21% in TAC+MPA vs 6% in EVR+TAC and 3% in EVR+CyA treated pts, occurred significantly less under EVR treatment compared to TAC+MPA (p<0.01). CMV disease and / or recurrent CMV events occurred only in TAC+MPA group, but not under EVR-treatment. Matching of CMV-donor / recipient status at baseline was balanced across groups for all risk-constellations and 3 months CMV-prophylaxis with valganciclovir for D+/R- and D+/R+ pts was requested per protocol.

Conclusion: ATHENA as largest European KTx study confirmed comparable efficacy and safety of all 3 regimens together with beneficial outcomes on viral infections: significantly less viral infections under EVR-treatment compared to TAC+MPA and a significant, protective effect of EVR-based regimens vs CMV/BKV events was robustly demonstrated.

CITATION INFORMATION: Hauser A., Sommerer C., Suwelack B., Dragun D., Witzke O., Hugo C., Kamar N., Merville P., Schenker P., Junge M., Thaiss F., Nashan B. Significant Anti-CMV/BKV Effect of a Modern Everolimus-Based Regimen Comparted to a Standard Tacrolimus-MPA Regimen in De Novo Kidney Transplant Recipients: ATHENA 12 Months Data on Infections Am J Transplant. 2017;17 (suppl 3).

To cite this abstract in AMA style:

Hauser A, Sommerer C, Suwelack B, Dragun D, Witzke O, Hugo C, Kamar N, Merville P, Schenker P, Junge M, Thaiss F, Nashan B. Significant Anti-CMV/BKV Effect of a Modern Everolimus-Based Regimen Comparted to a Standard Tacrolimus-MPA Regimen in De Novo Kidney Transplant Recipients: ATHENA 12 Months Data on Infections [abstract]. https://atcmeetingabstracts.com/abstract/significant-anti-cmv-bkv-effect-of-a-modern-everolimus-based-regimen-comparted-to-a-standard-tacrolimus-mpa-regimen-in-de-novo-kidney-transplant-recipients-athena-12-months-data-on-infections/. Accessed November 21, 2024.

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