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Randomized Controlled Trial
. 2022 Mar 9;74(5):757-765.
doi: 10.1093/cid/ciab574.

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

Aurora Páez-Vega  1   2 , Belén Gutiérrez-Gutiérrez  2   3 , Maria L Agüera  1   4 , Carme Facundo  5 , Dolores Redondo-Pachón  6 , Marta Suñer  7 , Maria O López-Oliva  8 , Jose R Yuste  2   9 , Miguel Montejo  2   10 , Cristina Galeano-Álvarez  11 , Juan C Ruiz-San Millan  12 , Ibai Los-Arcos  2   13 , Domingo Hernández  14 , Mario Fernández-Ruiz  2   15 , Patricia Muñoz  16 , Jorge Valle-Arroyo  1   2 , Angela Cano  1   2 , Alberto Rodríguez-Benot  1   4 , Marta Crespo  6 , Cristian Rodelo-Haad  1   4 , María A Lobo-Acosta  17 , Jose C Garrido-Gracia  18 , Elisa Vidal  1   2   19 , Luis Guirado  5 , Sara Cantisán  1   2 , Julian Torre-Cisneros  1   2   19 ; TIMOVAL Study Group
Collaborators, Affiliations
Free article
Randomized Controlled Trial

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

Aurora Páez-Vega et al. Clin Infect Dis. .
Free article

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. 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.

Clinical trials registration: NCT03123627.

Keywords: CMV-specific cell-mediated immunity; QuantiFERON-CMV assay; antithymocyte globulin; cytomegalovirus infection; kidney transplant.

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