Clinical and Economic Burden Associated With Anti-Cytomegalovirus (CMV) Prophylaxis Therapies in Adult Kidney Transplant Recipients (LECOCYT): An Observational Study.

Abstract

The incidence of leukopenia and neutropenia associated with cytomegalovirus (CMV) prophylaxis in kidney transplant (KT) recipients is not well established. LECOCYT, a prospective observational multicenter study, aimed to investigate the clinical and economic burdens of CMV prophylaxis during the first 6 months post-transplantation. Grade 3 or 4 leukopenia or neutropenia was assessed in CMV-seropositive donors/CMV-seronegative recipients (D+/R-) who received current anti-CMV prophylaxis, and in CMV-seronegative donors/CMV-seronegative recipients (D-/R-) who did not. The economic burden in D+/R- was also evaluated. The adjusted odds ratio for grade 3 or 4 leukopenia or neutropenia was 5.16 [95% confidence interval: 1.97-13.53] for D+/R- group. The median costs, excluding the KT procedure, for D+/R- subgroup patients who experienced at least one episode of severe leukopenia or neutropenia were approximately €4,500 (Q1 = €561; Q3 = €10,000). D+/R- patients with no episode incurred significantly lower costs, with a median of nearly €2,100 (Q1 = €182; Q3 = €6,500) (p = 0.02). D+/R- patients with severe leukopenia or neutropenia had a higher rate of outpatient consultations than those without episode (73.9% vs. 57.6%, p = 0.002), and a higher average number of consultations per patient (5.5 ± 4.1 vs. 4.5 ± 3.3, p = 0.042) than D+/R- patients without. Anti-CMV prophylaxis in D+/R- transplant recipients was significantly associated with a higher rate of severe leukopenia or neutropenia compared to no prophylaxis in D-/R- recipients.