Immunoguided Discontinuation of Prophylaxis for Cytomegalovirus Disease in Kidney Transplant Recipients Treated with Antithymocyte Globulin: A Randomized Clinical Trial.
Paez-Vega, A., et al.Clinical Infectious Diseases 2021 [record in progress].
Aims
This study aimed to assess if it is safe and effective to terminate antiviral prophylaxis when cytomegalovirus (CMV)- specific cell-mediated immunity (CMI) is detected following induction treatment and to continue with preemptive therapy (immunoguided prevention), in renal transplant patients.
Interventions
Participants were randomly assigned to either immunoguided prevention or fixed-duration prophylaxis.
Participants
150 CMV-seropositive kidney transplant patients.
Outcomes
Incidence of CMV disease and replication.
Follow-up
12 months
CET Conclusions
This non-inferiority design trial randomized kidney transplant recipients to either fixed-duration CMV prophylaxis, or CMV cell-immunity guided prophylaxis. The authors report both strategies to be equivalent, supporting the idea that prophylaxis can be terminated early in patients with restored cellular immunity to CMV. Immunoguided prophylaxis resulted in less neutropenia. The study design is robust and provides good evidence that CMI-guided prophylaxis is safe and effective in this low-risk population of CMI positive and seropositive patients. Future studies will be needed to evaluate generalizability to other populations, and to establish cost-effectiveness.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT03123627