Manuel, OriolOriolManuelLaager, MirjamMirjamLaagerHirzel, CédricCédricHirzel0000-0002-7870-912XNeofytos, DionysiosDionysiosNeofytosWalti, Laura NaëmiLaura NaëmiWalti0000-0002-7048-6590Hoenger, GideonGideonHoengerBinet, IsabelleIsabelleBinetSchnyder, AureliaAureliaSchnyderStampf, SusanneSusanneStampfKoller, MichaelMichaelKollerMombelli, MatteoMatteoMombelliKim, Min JeongMin JeongKimHoffmann, MatthiasMatthiasHoffmannKoenig, KatrinKatrinKoenigHess, ChristophChristophHessBurgener, Anne-ValérieAnne-ValérieBurgenerCippà, Pietro EPietro ECippàHübel, KerstinKerstinHübelMueller, Thomas FThomas FMuellerSidler, DanielDanielSidlerDahdal, SuzanSuzanDahdalSuter, Franziska MartaFranziska MartaSuterVillard, JeanJeanVillardZbinden, AndreaAndreaZbindenPantaleo, GiuseppeGiuseppePantaleoSemmo, NasserNasserSemmoHadaya, KarineKarineHadayaEnríquez, NataliaNataliaEnríquezMeylan, Pascal RPascal RMeylanFroissart, MarcMarcFroissartGolshayan, DelaDelaGolshayanFehr, ThomasThomasFehrHuynh-Do, UyenUyenHuynh-Do0000-0002-7276-032XPascual, ManuelManuelPascualVan Delden, ChristianChristianVan DeldenHirsch, Hans HHans HHirschJüni, PeterPeterJüniMueller, Nicolas JNicolas JMueller2024-10-252024-10-252024-02-17https://boris-portal.unibe.ch/handle/20.500.12422/170153BACKGROUND 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.encell-mediated immunity personalized medicine prevention transplant viral infection600 - Technology::610 - Medicine & health500 - Science::570 - Life sciences; biologyarticle10.48350/1865243773867610.1093/cid/ciad575