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) recover...
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| Tipo de documento: | Artigo |
| Estado: | Published version |
| Data de publicação: | 2022 |
| País: | España |
| Recursos: | Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau) |
| Repositório: | r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau |
| OAI Identifier: | oai:iibsantpau.fundanetsuite.com:p7765 |
| Acesso em linha: | https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=7765 http://hdl.handle.net/10230/52179 |
| Nível de acesso: | Acesso aberto |
| Palavra-chave: | cytomegalovirus infection kidney transplant CMV-specific cell-mediated immunity QuantiFERON-CMV assay antithymocyte globulin |
| _version_ | 1878731139619749888 |
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| author | Paez-Vega, A |
| author2 | 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 |
| author2_role | author author author author author author author author author author author author author author author author author author author author author author author author author |
| author_browse | Aguera, ML Cano, A Cantisan, S Crespo, M Facundo, C Fernandez-Ruiz, M Galeano-Alvarez, C Garrido-Gracia, JC Guirado, L Gutierrez-Gutierrez, B Hernandez, D Lobo-Acosta, MA Lopez-Oliva, MO Los-Arcos, I Montejo, M Munoz, P Paez-Vega, A Redondo-Pachon, D Rodelo-Haad, C Rodriguez-Benot, A Ruiz-San Millan, JC Suner, M Torre-Cisneros, J Valle-Arroyo, J Vidal, E Yuste, JR |
| author_facet | 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 |
| author_role | author |
| collection | r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau |
| 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. 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. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_29a73ffd5250a7f3551ddbd17e4c709e |
| institution | Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau) |
| instname_str | Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau) |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:iibsantpau.fundanetsuite.com:p7765 |
| publishDate | 2022 |
| publishDateSort | 2022 |
| publisher | OXFORD UNIV PRESS INC |
| publisherStr | OXFORD UNIV PRESS INC |
| reponame_str | r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau |
| spelling | Immunoguided Discontinuation of Prophylaxis for Cytomegalovirus Disease in Kidney Transplant Recipients Treated With Antithymocyte Globulin: A Randomized Clinical Trial 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 cytomegalovirus infection kidney transplant CMV-specific cell-mediated immunity QuantiFERON-CMV assay antithymocyte globulin 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. OXFORD UNIV PRESS INC https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=7765 http://hdl.handle.net/10230/52179 |
| spellingShingle | Immunoguided Discontinuation of Prophylaxis for Cytomegalovirus Disease in Kidney Transplant Recipients Treated With Antithymocyte Globulin: A Randomized Clinical Trial Paez-Vega, A cytomegalovirus infection kidney transplant CMV-specific cell-mediated immunity QuantiFERON-CMV assay antithymocyte globulin |
| status_str | publishedVersion |
| title | 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_short | 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 |
| topic | cytomegalovirus infection kidney transplant CMV-specific cell-mediated immunity QuantiFERON-CMV assay antithymocyte globulin |
| topic_facet | cytomegalovirus infection kidney transplant CMV-specific cell-mediated immunity QuantiFERON-CMV assay antithymocyte globulin |
| url | https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=7765 http://hdl.handle.net/10230/52179 |