Immune Monitoring-Guided Versus Fixed Duration of Antiviral Prophylaxis Against Cytomegalovirus in Solid-Organ Transplant Recipients: A Multicenter, Randomized Clinical Trial.
Details
State: Public
Version: Final published version
License: CC BY-NC-ND 4.0
Serval ID
serval:BIB_AA450EA2BB8A
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Immune Monitoring-Guided Versus Fixed Duration of Antiviral Prophylaxis Against Cytomegalovirus in Solid-Organ Transplant Recipients: A Multicenter, Randomized Clinical Trial.
Journal
Clinical infectious diseases
Working group(s)
Swiss Transplant Cohort Study (STCS)
Contributor(s)
Amico P., Aubert J.D., Banz V., Beckmann S., Beldi G., Berger C., Berishvili E., Berzigotti A., Binet I., Bochud P.Y., Branca S., Bucher H., Catana E., Cairoli A., Chalandon Y., De Geest S., De Rougemont O., De Seigneux S., Dickenmann M., Lynn Dreifuss J., Duchosal M., Fehr T., Ferrari-Lacraz S., Garzoni C., Golshayan D., Goossens N., Haidar F., Halter J., Heim D., Hess C., Hillinger S., Hirsch H.H., Hirt P., Hoessly L., Hofbauer G., Huynh-Do U., Immer F., Koller M., Laesser B., Lamoth F., Lehmann R., Leichtle A., Manuel O., Marti H.P., Martinelli M., McLin V., Mellac K., Merçay A., Mettler K., Mueller N.J., Müller-Arndt U., Müllhaupt B., Nägeli M., Oldani G., Pascual M., Passweg J., Pazeller R., Posfay-Barbe K., Rick J., Rosselet A., Rossi S., Rothlin S., Ruschitzka F., Schachtner T., Schaub S., Scherrer A., Schnyder A., Schuurmans M., Schwab S., Sengstag T., Simonetta F., Stampf S., Steiger J., Stirnimann G., Stürzinger U., Van Delden C., Venetz J.P., Villard J., Vionnet J., Wick M., Wilhelm M., Yerly P.
ISSN
1537-6591 (Electronic)
ISSN-L
1058-4838
Publication state
Published
Issued date
17/02/2024
Peer-reviewed
Oui
Volume
78
Number
2
Pages
312-323
Language
english
Notes
Publication types: Randomized Controlled Trial ; Multicenter Study ; Journal Article
Publication Status: ppublish
Publication Status: ppublish
Abstract
The use of assays detecting cytomegalovirus (CMV)-specific T cell-mediated immunity may individualize the duration of antiviral prophylaxis after transplantation.
In this randomized trial, kidney and liver transplant recipients from 6 centers in Switzerland were enrolled if they were CMV-seronegative with seropositive donors or CMV-seropositive receiving antithymocyte 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 ELISpot assay (T-Track CMV); prophylaxis in the intervention group was stopped if the assay was positive. The co-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.
Overall, 193 patients were randomized (92 in the immune-monitoring group and 101 in the control group), of whom 185 had evaluation of the primary outcome (87 and 98 patients). CMV infection occurred in 26 of 87 (adjusted percentage, 30.9%) in the immune-monitoring group and in 32 of 98 (adjusted percentage, 31.1%) in the control group (adjusted risk difference, -0.1; 95% confidence interval [CI], -13.0% to 12.7%; P = .064). The duration of prophylaxis was shorter in the immune-monitoring group (adjusted difference, -26.0 days; 95%, CI, -41.1 to -10.8 days; P < .001).
Immune monitoring resulted in a significant reduction of antiviral prophylaxis, but we were unable to establish noninferiority of this approach on the co-primary outcome of CMV infection.
NCT02538172.
In this randomized trial, kidney and liver transplant recipients from 6 centers in Switzerland were enrolled if they were CMV-seronegative with seropositive donors or CMV-seropositive receiving antithymocyte 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 ELISpot assay (T-Track CMV); prophylaxis in the intervention group was stopped if the assay was positive. The co-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.
Overall, 193 patients were randomized (92 in the immune-monitoring group and 101 in the control group), of whom 185 had evaluation of the primary outcome (87 and 98 patients). CMV infection occurred in 26 of 87 (adjusted percentage, 30.9%) in the immune-monitoring group and in 32 of 98 (adjusted percentage, 31.1%) in the control group (adjusted risk difference, -0.1; 95% confidence interval [CI], -13.0% to 12.7%; P = .064). The duration of prophylaxis was shorter in the immune-monitoring group (adjusted difference, -26.0 days; 95%, CI, -41.1 to -10.8 days; P < .001).
Immune monitoring resulted in a significant reduction of antiviral prophylaxis, but we were unable to establish noninferiority of this approach on the co-primary outcome of CMV infection.
NCT02538172.
Keywords
Humans, Cytomegalovirus, Antiviral Agents/therapeutic use, Monitoring, Immunologic, Cytomegalovirus Infections/diagnosis, Transplant Recipients, Organ Transplantation/adverse effects, Ganciclovir/therapeutic use, cell-mediated immunity, personalized medicine, prevention, transplant, viral infection
Pubmed
Web of science
Open Access
Yes
Create date
29/09/2023 14:09
Last modification date
01/03/2024 8:06
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