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Immunoguided Discontinuation of Prophylaxis for Cytomegalovirus Disease in Kidney Transplant Recipients Treated With Antithymocyte Globulin: A Randomized Clinical Trial

2021; Oxford University Press; Volume: 74; Issue: 5 Linguagem: Inglês

10.1093/cid/ciab574

1537-6591

Aurora Páez-Vega, Belén Gutiérrez‐Gutiérrez, M.L. Agüera, Carme Facundo, Dolores Redondo‐Pachón, Marta Suñer, María O. López‐Oliva, José Ramón Yuste, Miguel Montejo, C. Galéano, Juan C. Millán, Ibai Los‐Arcos, Domingo Hernández, Mario Fernández‐Ruiz, Patricia Muñóz, Jorge Valle-Arroyo, Ángela Cano, Alberto Rodríguez‐Benot, Marta Crespo, Cristian Rodelo-Haad, María Ángeles Lobo-Acosta, José C. Garrido-Gracia, Elisa Vidal, Luís Guirado, Sara Cantisán, Julián Torre‐Cisneros, A Salinas, Tamara Ruiz, Patricia Parra, Francisco Valverde‐López, María José Caño, José María Aguado, M. Carmen Fariñas, F.J. Arnáiz, Carlos Armiñanzas, Emilio Rodrigo, Vicente C Piñera, P.De La Barreda, Jesús Agüero, Carlos Ruı́z de Alegrı́a, Claudia González, Miriam Fernandez, Trinidad Serrano, Paloma Leticia Martín-Moreno, Virginia Martínez, Teresa Bellón, Carlos Jiménez, Elena González, Cristina Gutiérrez, Verónica López, Marı́a José Blanco, Itxasne Cabezón, Francisco Javier Gainza Ríos, Óscar Len, Manel Perelló, Oreto Prat, Ana Jaureguízar, Fiona Robert, Julio Pascual, Ma José Pérez, Carlos Arias, Anna Faura, Sara Álvarez, Miguel Ángel Pérez Nieto, A. Suarez, Carmen González, Alejandro Molina, Javier Sánchez, Marisa Fernández, Amelia Dueñas, Elisa Cordero, Caroline Agnelli, Maricela Valerio, Marisa Fernández, María Olmedo, Luis Alberto Pomed Sánchez, Sara Rodríguez Diego, Ana Fernández, Sandra Elías, Sara Jiménez, Andrea Collado‐Alsina, Rosa Escudero, Jesús Fortün, Núria Serra, Cristina Canal, A Vilà, Rosana Gelpi, Irene Silva, Beatriz Bardají,

Parvovirus B19 Infection Studies

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.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).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.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.NCT03123627.