Safety and efficacy of immunoguided prophylaxis for cytomegalovirus disease in low-risk lung transplant recipients in Spain: a multicentre, open-label, randomised, phase 3, noninferiority trial.
Paez-Vega, A., et al.The Lancet Regional Health. Europe 2025; 52: 101268.
Aims
The aim of this study was to examine the safety and effectiveness of immunoguided prophylaxis in cytomegalovirus (CMV)-seropositive lung transplant patients.
Interventions
Participants were randomised to either the immunoguided prophylaxis group or the standard prophylaxis group.
Participants
150 adult CMV- seropositive lung transplant recipients.
Outcomes
The primary efficacy outcome was CMV disease. The secondary efficacy outcome was asymptomatic CMV replication. The safety outcomes was neutropenia (primary outcome), and rejection and the number of valganciclovir prophylaxis days (secondary outcomes).
Follow-up
18 months
CET Conclusions
This is a well-written report of an interesting and well-conducted study in liver transplantation. Conducted at seven centres in Spain, liver transplant recipients were randomised to standard CMV prophylaxis, or to ummuen guided prophylaxis, in a non-inferiority study design. The study was adequately randomised but there was no blinding to treatment. The study was sufficiently powered for the primary outcome for non-inferiority and at a reasonable expected level. There was no significant difference in the rate of CMV disease between the two study arms, however CMV disease did appear earlier after randomisation in the immunoguided arm. Asymptomatic CMV replication was significantly lower in the immunoguided arm. There was no significant difference in neutropenia. As the study was conducted during the COVID pandemic there were difficulties with follow up and with follow up testing for CMV cell-mediated immunity. In this study, the withdrawal of CMV prophylaxis in CMV immune lung recipients was non-inferior to standard care. Loss to follow up could have caused problems with analysing secondary outcomes, such as neutropenia.
Data analysis
Strict intention-to-treat analysis
Trial registration
EudraCT - 2018-003300-39; ClinicalTrials.gov - NCT03699254