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

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) recove...

ver descrição completa

Detalhes bibliográficos
Autores: Páez-Vega, Aurora, Redondo Pachón, María Dolores, Crespo Barrio, Marta, Torre-Cisneros, Julian
Tipo de documento: artigo
Estado:Versión aceptada para publicación
Data de publicação:2022
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositório:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10230/52179
Acesso em linha:http://hdl.handle.net/10230/52179
http://dx.doi.org/10.1093/cid/ciab574
Access Level:Acceso aberto
Palavra-chave:CMV-specific cell-mediated immunity
Cytomegalovirus infection
QuantiFERON-CMV assay
Antithymocyte globulin
Kidney transplant
id ES_c4daae3756be5c239e327f88401cbdcd
oai_identifier_str oai:recercat.cat:10230/52179
network_acronym_str ES
network_name_str España
repository_id_str
spelling Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trialPáez-Vega, AuroraRedondo Pachón, María DoloresCrespo Barrio, MartaTorre-Cisneros, JulianCMV-specific cell-mediated immunityCytomegalovirus infectionQuantiFERON-CMV assayAntithymocyte globulinKidney transplantBackground: 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.Oxford University Press20222022info:eu-repo/semantics/articleinfo:eu-repo/semantics/acceptedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/52179http://dx.doi.org/10.1093/cid/ciab574reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésClin Infect Dis. 2022;74(5):757-65© 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/ciab574info:eu-repo/semantics/openAccessoai:recercat.cat:10230/521792026-05-29T05:05:01Z
dc.title.none.fl_str_mv Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial
title Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial
spellingShingle Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial
Páez-Vega, Aurora
CMV-specific cell-mediated immunity
Cytomegalovirus infection
QuantiFERON-CMV assay
Antithymocyte globulin
Kidney transplant
title_short Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial
title_full Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial
title_fullStr Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial
title_full_unstemmed Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial
title_sort Immunoguided discontinuation of prophylaxis for cytomegalovirus disease in kidney transplant recipients treated with antithymocyte globulin: A randomized clinical trial
dc.creator.none.fl_str_mv Páez-Vega, Aurora
Redondo Pachón, María Dolores
Crespo Barrio, Marta
Torre-Cisneros, Julian
author Páez-Vega, Aurora
author_facet Páez-Vega, Aurora
Redondo Pachón, María Dolores
Crespo Barrio, Marta
Torre-Cisneros, Julian
author_role author
author2 Redondo Pachón, María Dolores
Crespo Barrio, Marta
Torre-Cisneros, Julian
author2_role author
author
author
dc.subject.none.fl_str_mv CMV-specific cell-mediated immunity
Cytomegalovirus infection
QuantiFERON-CMV assay
Antithymocyte globulin
Kidney transplant
topic CMV-specific cell-mediated immunity
Cytomegalovirus infection
QuantiFERON-CMV assay
Antithymocyte globulin
Kidney transplant
description 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.
publishDate 2022
dc.date.none.fl_str_mv 2022
2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/acceptedVersion
format article
status_str acceptedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/52179
http://dx.doi.org/10.1093/cid/ciab574
url http://hdl.handle.net/10230/52179
http://dx.doi.org/10.1093/cid/ciab574
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Clin Infect Dis. 2022;74(5):757-65
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
dc.source.none.fl_str_mv reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869418938037698560
score 15,812429

Registros relacionados