Immunoguided Discontinuation of Prophylaxis for Cytomegalovirus Disease in Kidney Transplant Recipients Treated With Antithymocyte Globulin: A Randomized Clinical Trial
Por:
Paez-Vega, A, Gutierrez-Gutierrez, B, Aguera, ML, Facundo, C, Redondo-Pachon, D, Suner, M, Lopez-Oliva, MO, Yuste, JR, Montejo, M, Galeano-Alvarez, C, Ruiz-San Millan, JC, Los-Arcos, I, Hernandez, D, Fernandez-Ruiz, M, Munoz, P, Valle-Arroyo, J, Cano, A, Rodriguez-Benot, A, Crespo, M, Rodelo-Haad, C, Lobo-Acosta, MA, Garrido-Gracia, JC, Vidal, E, Guirado, L, Cantisan, S, Torre-Cisneros, J
Publicada:
9 mar 2022
Ahead of Print:
1 ago 2021
Resumen:
Background Antiviral prophylaxis is recommended in cytomegalovirus (CMV)-seropositive kidney transplant (KT) recipients receiving antithymocyte globulin (ATG) as induction. An alternative strategy of premature discontinuation of prophylaxis after CMV-specific cell-mediated immunity (CMV-CMI) recovery (immunoguided prevention) has not been studied. Our aim was to determine whether it is effective and safe to discontinue prophylaxis when CMV-CMI is detected and to continue with preemptive therapy. Methods In this open-label, noninferiority clinical trial, patients were randomized 1:1 to follow an immunoguided strategy, receiving prophylaxis until CMV-CMI recovery or to receive fixed-duration prophylaxis until day 90. After prophylaxis, preemptive therapy (valganciclovir 900 mg twice daily) was indicated in both arms until month 6. The primary and secondary outcomes were incidence of CMV disease and replication, respectively, within the first 12 months. Desirability of outcome ranking (DOOR) assessed 2 deleterious events (CMV disease/replication and neutropenia). Results A total of 150 CMV-seropositive KT recipients were randomly assigned. There was no difference in the incidence of CMV disease (0% vs 2.7%; P = .149) and replication (17.1% vs 13.5%; log-rank test, P = .422) between both arms. Incidence of neutropenia was lower in the immunoguided arm (9.2% vs 37.8%; odds ratio, 6.0; P < .001). A total of 66.1% of patients in the immunoguided arm showed a better DOOR, indicating a greater likelihood of a better outcome. Conclusions Prophylaxis can be prematurely discontinued in CMV-seropositive KT patients receiving ATG when CMV-CMI is recovered since no significant increase in the incidence of CMV replication or disease is observed.
In cytomegalovirus (CMV)-seropositive kidney transplant recipients receiving ATG induction, immunoguided prevention is not inferior to prophylaxis to prevent CMV complications. Prophylaxis can be prematurely discontinued after CMV-cell-mediated immunity recovery with no significant increase in the incidence of CMV replication or disease.
Filiaciones:
Paez-Vega, A:
Univ Cordoba UCO, Reina Sofia Univ Hosp, Maimonides Inst Biomed Res Cordoba IMIBIC, Cordoba, Spain
Inst Salud Carlos III, Spanish Network Res Infect Dis, Madrid, Spain
Gutierrez-Gutierrez, B:
Inst Salud Carlos III, Spanish Network Res Infect Dis, Madrid, Spain
Univ Seville, Virgen Macarena Univ Hosp, Biomed Inst Seville IBiS, Clin Unit Infect Dis Microbiol & Prevent Med, Seville, Spain
Aguera, ML:
Univ Cordoba UCO, Reina Sofia Univ Hosp, Maimonides Inst Biomed Res Cordoba IMIBIC, Cordoba, Spain
Reina Sofia Univ Hosp, Nephrol Serv, Cordoba, Spain
Facundo, C:
Autonomous Univ Barcelona UAB, Nephrol Serv, Inst Invest Biosanitaria St Pau, Fundacio Puigvert,Renal Transplant Unit, Barcelona, Spain
Redondo-Pachon, D:
Hosp del Mar, Hosp del Mar Med Res Inst IMIM, Nephrol Serv, Barcelona, Spain
Suner, M:
Virgen del Rocio Univ Hosp, Nephrol Serv, Seville, Spain
Lopez-Oliva, MO:
La Paz Univ Hosp, Nephrol Serv, Madrid, Spain
Yuste, JR:
Inst Salud Carlos III, Spanish Network Res Infect Dis, Madrid, Spain
Clin Univ Navarra, Infect Dis Unit, Pamplona, Spain
Montejo, M:
Inst Salud Carlos III, Spanish Network Res Infect Dis, Madrid, Spain
Cruces Univ Hosp, Infect Dis Serv, Bilbao, Spain
Galeano-Alvarez, C:
Ramon y Cajal Univ Hosp, IRYCIS, Nephrol Serv, Madrid, Spain
Ruiz-San Millan, JC:
Univ Cantabria, Marques de Valdecilla Hosp, Nephrol Serv, IDIVAL, Santander, Spain
Los-Arcos, I:
Inst Salud Carlos III, Spanish Network Res Infect Dis, Madrid, Spain
Vall dHebron Univ Hosp, Infect Dis Serv, Barcelona, Spain
Hernandez, D:
Univ Malaga, Carlos Haya Reg Univ Hosp, Inst Biomed Res Malaga IBIMA, Nephrol Serv, Malaga, Spain
Fernandez-Ruiz, M:
Inst Salud Carlos III, Spanish Network Res Infect Dis, Madrid, Spain
12 Octubre Univ Hosp, Hlth Res Inst Imas12, Infect Dis Unit, Madrid, Spain
Munoz, P:
Gregorio Maranon Univ Hosp, Dept Clin Microbiol & Infect Dis, Madrid, Spain
Gregorio Maranon Biomed Res Inst, Madrid, Spain
Univ Complutense Madrid, Dept Med, Madrid, Spain
CIBERES, Madrid, Spain
Valle-Arroyo, J:
Univ Cordoba UCO, Reina Sofia Univ Hosp, Maimonides Inst Biomed Res Cordoba IMIBIC, Cordoba, Spain
Inst Salud Carlos III, Spanish Network Res Infect Dis, Madrid, Spain
Cano, A:
Univ Cordoba UCO, Reina Sofia Univ Hosp, Maimonides Inst Biomed Res Cordoba IMIBIC, Cordoba, Spain
Inst Salud Carlos III, Spanish Network Res Infect Dis, Madrid, Spain
Rodriguez-Benot, A:
Univ Cordoba UCO, Reina Sofia Univ Hosp, Maimonides Inst Biomed Res Cordoba IMIBIC, Cordoba, Spain
Reina Sofia Univ Hosp, Nephrol Serv, Cordoba, Spain
Crespo, M:
Hosp del Mar, Hosp del Mar Med Res Inst IMIM, Nephrol Serv, Barcelona, Spain
Rodelo-Haad, C:
Univ Cordoba UCO, Reina Sofia Univ Hosp, Maimonides Inst Biomed Res Cordoba IMIBIC, Cordoba, Spain
Reina Sofia Univ Hosp, Nephrol Serv, Cordoba, Spain
Lobo-Acosta, MA:
Virgen del Rocio Univ Hosp CTU HUVR, Clin Trials Unit, Seville, Spain
Garrido-Gracia, JC:
Univ Cordoba, Reina Sofia Univ Hosp, Maimonides Inst Biomed Res Cordoba IMIBIC, Clin Trials Unit, Cordoba, Spain
Vidal, E:
Univ Cordoba UCO, Reina Sofia Univ Hosp, Maimonides Inst Biomed Res Cordoba IMIBIC, Cordoba, Spain
Inst Salud Carlos III, Spanish Network Res Infect Dis, Madrid, Spain
Reina Sofia Univ Hosp, Infect Dis Serv, Cordoba, Spain
Guirado, L:
Autonomous Univ Barcelona UAB, Nephrol Serv, Inst Invest Biosanitaria St Pau, Fundacio Puigvert,Renal Transplant Unit, Barcelona, Spain
Cantisan, S:
Univ Cordoba UCO, Reina Sofia Univ Hosp, Maimonides Inst Biomed Res Cordoba IMIBIC, Cordoba, Spain
Inst Salud Carlos III, Spanish Network Res Infect Dis, Madrid, Spain
Torre-Cisneros, J:
Univ Cordoba UCO, Reina Sofia Univ Hosp, Maimonides Inst Biomed Res Cordoba IMIBIC, Cordoba, Spain
Inst Salud Carlos III, Spanish Network Res Infect Dis, Madrid, Spain
Reina Sofia Univ Hosp, Infect Dis Serv, Cordoba, Spain
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