Immuno-guided prevention of Cytomegalovirus (CMV) in CMV-seropositive lung transplant recipients

The development of CMV-specific immunity monitoring techniques enables the exploration of personalized, immuno-guided prevention strategies. The aim of the study was to investigate the efficacy and safety of immuno-guided prevention in CMV-seropositive lung transplant recipients. The CYTOCOR clinical trial, phase III randomised, multicentre, non-inferiority, was designed to assess the efficacy and safety of directing valganciclovir prophylaxis using the QF-CMV. During the initial 3 months, patients in both groups received prophylaxis. From month 4 to 12, patients randomized to the experimental arm were monitored monthly with QF-CMV. If the result was reactive(interferon-gamma production≥0.2 IU/ml),prophylaxis was discontinued;if non-reactive or indeterminate, prophylaxis was restarted. Control group patients were given prophylaxis for 6 months, followed by preventive therapy with ganciclovir adjusted based on CMV-PCR results through month 12. The primary efficacy endpoint was the presence of CMV disease, and the secondary endpoint was clinically significant asymptomatic CMV replication. Safety was assessed by the presence of neutropenia(<1500 cells/μl). Group differences were calculated using the Mantel-Haenszel method. Cumulative incidence curves for CMV disease were compared using the Log-rank test.CMV disease and neutropenia were jointly analyzed using a DOOR analysis.A total of 150 patients were randomized,75 in each arm.52.5% with a 95%CI(44.47-60.45%)of patients had a better DOOR in the experimental group. The combination of reduced duration prophylaxis followed by immuno-guided prophylaxis using QF-CMV is as effective and safe as standard prevention in CMV seropositive lung transplant recipients