| Title: |
Immune monitoring-guided vs fixed duration of antiviral prophylaxis against cytomegalovirus in solid-organ transplant recipients. A Multicenter, Randomized Clinical Trial |
| Authors: |
Manuel, Oriol; Laager, Mirjam; Hirzel, Cédric; Neofytos, Dionysios; Walti, Laura N; Hoenger, Gideon; Binet, Isabelle; Schnyder, Aurelia; Stampf, Susanne; Koller, Michael; Mombelli, Matteo; Kim, Min Jeong; Hoffmann, Matthias; Koenig, Katrin; Hess, Christoph; Burgener, Anne-Valérie; Cippà, Pietro E; Hübel, Kerstin; Mueller, Thomas F; Sidler, Daniel; Dahdal, Suzan; Suter-Riniker, Franziska; Villard, Jean; Zbinden, Andrea; Pantaleo, Giuseppe; Semmo, Nasser; Hadaya, Karine; Enriquez, Natalia Beatriz; Meylan, Pascal R; Froissart, Marc; Golshayan, Dela; Fehr, Thomas; Huynh-Do, Uyen; Pascual, Manuel; Van Delden, Christian; Hirsch, Hans H; Jüni, Peter; Mueller, Nicolas J; Swiss Transplant Cohort Study (STCS) |
| Contributors: |
Berishvili Berney, Ekaterine; Chalandon, Yves; De Seigneux Matthey, Sophie; Mclin, Valérie Anne; Posfay Barbe, Klara |
| Source: |
ISSN: 1058-4838 ; Clinical infectious diseases, (2023) ciad575. |
| Publication Year: |
2023 |
| Collection: |
Université de Genève: Archive ouverte UNIGE |
| Subject Terms: |
info:eu-repo/classification/ddc/616; info:eu-repo/classification/ddc/617; info:eu-repo/classification/ddc/618; Cell-mediated immunity; Personalized medicine; Prevention; Transplant; Viral infection |
| Description: |
Background: The use of assays detecting cytomegalovirus (CMV)-specific T-cell-mediated immunity may individualize the duration of antiviral prophylaxis in transplant recipients. Methods: In this open-label randomized trial, adult kidney and liver transplant recipients from six centers in Switzerland were enrolled if they were CMV-seronegative with seropositive donors or CMV-seropositive receiving anti-thymocyte globulins. Patients were randomized to a duration of antiviral prophylaxis based on immune-monitoring (intervention) or a fixed duration (control). Patients in the control group were planned to receive 180 days (CMV-seronegative) or 90 days (CMV-seropositive) of valganciclovir. Patients were assessed monthly with a CMV-specific interferon gamma release assay (T-Track® CMV); prophylaxis in the intervention group was stopped if the assay was positive. The primary outcomes were the proportion of patients with clinically significant CMV infection and reduction in days of prophylaxis. Between-group differences were adjusted for CMV serostatus. Results: Overall, 193 patients were randomized (92 in the immune-monitoring and 101 in the control group) of which 185 had evaluation of the primary endpoint (87 and 98 patients, respectively). Clinically significant CMV infection occurred in 26/87 (adjusted percentage, 30.9%) in the immune-monitoring group and in 32/98 (adjusted percentage, 31.1%) in the control group (adjusted risk difference -0.1, 95%CI -13.0%, 12.7%; p = 0.064). The duration of antiviral prophylaxis was shorter in the immune-monitoring group (adjusted difference -26.0 days, 95%-CI -41.1 to -10.8 days, p < 0.001). Conclusions: Immune monitoring resulted in a significant reduction of antiviral prophylaxis, but we were unable to establish noninferiority of this approach on the co-primary endpoint of CMV infection. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/37738676; unige:174123 |
| Availability: |
https://archive-ouverte.unige.ch/unige:174123 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.5D9F37D1 |
| Database: |
BASE |