Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial

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• dc.contributor.author Páez-Vega, Aurora
• dc.contributor.author Redondo Pachón, María Dolores
• dc.contributor.author Crespo Barrio, Marta
• dc.contributor.author Torre-Cisneros, Julian
• dc.date.accessioned 2022-01-11T06:48:29Z
• dc.date.issued 2022
• dc.description.abstract 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. The aim of this study was to evaluate 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, non-inferiority clinical trial, patients were randomized 1:1 to follow immunoguided strategy, receiving prophylaxis (valganciclovir 900 mg daily) 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 two 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 = 0.149) and replication (17.1% vs. 13.5%; log-rank test, P = 0.422) between both arms. Incidence of neutropenia was lower in the immunoguided arm (9.2% vs. 37.8%; OR, 6.0; P < 0.001). 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.
• dc.format.mimetype application/pdf
• dc.identifier.citation Páez-Vega A, Gutiérrez-Gutiérrez B, Agüera ML, Facundo C, Redondo-Pachón D, Suñer M et al. Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial. Clin Infect Dis. 2022;74(5):757-65. DOI: 10.1093/cid/ciab574
• dc.identifier.doi http://dx.doi.org/10.1093/cid/ciab574
• dc.identifier.issn 1058-4838
• dc.identifier.uri http://hdl.handle.net/10230/52179
• dc.language.iso eng
• dc.publisher Oxford University Press
• dc.relation.ispartof Clin Infect Dis. 2022;74(5):757-65
• dc.rights © Oxford University Press. This is a pre-copyedited, author-produced version of an article accepted for publication in Clinical infectious diseases following peer review. The version of record Páez-Vega A, Gutiérrez-Gutiérrez B, Agüera ML, Facundo C, Redondo-Pachón D, Suñer M et al. Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial. Clin Infect Dis. 2022;74(5):757-65. DOI: 10.1093/cid/ciab574 is available online at: https://doi.org/10.1093/cid/ciab574
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.subject.keyword CMV-specific cell-mediated immunity
• dc.subject.keyword Cytomegalovirus infection
• dc.subject.keyword QuantiFERON-CMV assay
• dc.subject.keyword Antithymocyte globulin
• dc.subject.keyword Kidney transplant
• dc.title Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/acceptedVersion