Abstract: SA-PO484
Significantly Less CMV- and BKV-Events with Everolimus-Based versus Tacrolimus-MPA Regimen in De Novo Renal Transplant Recipients: 12 Months Data on Infections from the Athena Study
Session Information
- Transplantation: Balancing Rejection and Infection
November 04, 2017 | Location: Hall H, Morial Convention Center
Abstract Time: 10:00 AM - 10:00 AM
Category: Transplantation
- 1702 Transplantation: Clinical and Translational
Authors
- Hauser, Ingeborg Anni, University Clinic Frankfurt (UKF), Frankfurt Main, Germany
- Sommerer, Claudia, University Hospital of Heidelberg, HEIDELBERG, Germany
- Suwelack, Barbara M., None, Muenster, Germany
- Dragun, Duska, University Hospital Charite, Campus Virchow, Berlin, Germany
- Schenker, Peter, Ruhr-University Bochum, Bochum, Germany
- Witzke, Oliver, University Duisburg-Essen, Essen, Germany
- Hugo, Christian, University of Dresden, Dresden, Germany, Dresden, SN, Germany
- Kamar, Nassim, Toulouse University Hospital, Toulouse, France
- Merville, Pierre, PELLEGRIN HOSPITAL, Bordeaux, France
- Junge, Martina, Novartis Pharma GmbH Germany, Nuremberg, Germany
- Thaiss, Friedrich, University Hospital, Hamburg, Germany
- Nashan, Björn, Bundesärztekammer , Hamburg, Germany
Group or Team Name
- Athena Study Group
Background
The ATHENA trial was designed to compare everolimus [EVR] in combination with tacrolimus [TAC] or cyclosporine A [CyA] vs. a standard of mycophenolic acid [MPA] and TAC in de novo kidney transplant [KTx] recipients.
Methods
In this 12 months [M], prospective, open-label, randomized study with 15 German and 12 French sites, 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 (75-125ng/ml M1-M3; 50-100ng/ml M3-M12) or to control TAC regimen (4-8ng/ml M1-M3; 3-5ng/ml M3-M12) with MPA. All pts continued on steroids. Herein we report M12 outcomes on infections and CMV events from ITT with 208 EVR+TAC pts, 199 EVR+CyA pts and 205 TAC+MPA pts.
Results
From randomization to M12 total incidences of infections were 73% in EVR+TAC and 72% in EVR+CyA treated pts vs 82% in TAC+MPA pts. Whilst incidences of bacterial infections were similar between the three treatment groups (44% EVR+TAC, 43% EVR+CyA, 42% TAC+MPA) major differences were seen for viral infections with incidences of 41% in TAC+MPA vs only 26% in EVR+TAC and 12% in EVR+CyA groups. Incidence of BKV events was 23% in TAC+MPA vs 17% in EVR+TAC vs 9% in EVR+CyA pts (p<0.01). CMV events occurred two thirds less in EVR treated pts compared to TAC+MPA control group with an incidence of 21% in TAC+MPA vs 6% for EVR+TAC and 3% for EVR+CyA treatment pts (p<0.001).
Conclusion
ATHENA as largest European KTx study confirmed comparable efficacy and safety together with less viral infections for EVR-based treatment groups compared to TAC+MPA group. A significant, protective effect of EVR-based regimens vs CMV/BKV events was robustly confirmed.
Funding
- Commercial Support – Novartis Pharma GmbH, Germany