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].
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.
Participants were randomly assigned to either immunoguided prevention or fixed-duration prophylaxis.
150 CMV-seropositive kidney transplant patients.
Incidence of CMV disease and replication.
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.
ClinicalTrials.gov - NCT03123627