Evaluation of an Immune-guided Prevention Strategy Against CMV Among Intermediate-risk Kidney Transplant Recipients: A Quasi-experimental Study

BACKGROUND: Observational studies have shown that kidney transplant (KT) recipients who are cytomegalovirus (CMV)-seropositive (R+) but lack effective CMV-specific cell-mediated immunity (CMV-CMI) are at increased risk of CMV infection. METHODS: In this quasi-experimental study, an immune-guided prevention strategy based on early CMV-CMI assessment (1-2 posttransplant weeks) was evaluated in intermediate-risk KT recipients (R+ without lymphocyte-depleting induction). CMV-CMI was measured using the QuantiFERON assay (QTF-CMV). Recipients with nonreactive QTF-CMV received antiviral prophylaxis until either CMV-CMI reconstitution or month 6, while those with reactive QTF-CMV were managed with preemptive therapy. The primary outcome was the proportion of patients who developed CMV infection during the first posttransplant year. Secondary outcomes included CMV disease, CMV DNAemia requiring preemptive therapy, rejection, vascular events, and all-cause mortality. Outcomes were compared with a prospective preintervention cohort managed by standard-of-care preemptive therapy. RESULTS: We included 91 and 100 patients in the preintervention and intervention groups, with similar baseline characteristics. One-year incidence of CMV infection was similar between both groups (48.4% versus 50.0%; odds ratio [OR], 1.07; 95% confidence interval [CI], 0.61-1.89; P = 0.820). One-year incidence of CMV disease (secondary outcome) was lower in the intervention group (9.9% versus 3.0%; OR, 0.28; 95% CI, 0.07-1.08; P = 0.064), as confirmed in the per-protocol analysis (9.9% versus 2.2%; OR, 0.20; 95% CI, 0.04-0.97; P = 0.028). CONCLUSIONS: Although the tested QTF-CMV-based immune-guided strategy did not result in a reduction in the overall occurrence of CMV infection in intermediate-risk KT recipients, the lower incidence of CMV disease observed merits further research.