Real‐world effectiveness of preemptive therapy (PET) for cytomegalovirus (CMV) disease prevention in CMV high‐risk donor seropositive/recipient seronegative (D+R‐) liver transplant recipients (LTxR)

Abstract

AbstractBackgroundDespite superiority of preemptive therapy (PET) compared to universal prophylaxis for prevention of cytomegalovirus (CMV) disease in the CAPSIL randomized trial among CMV D+R‐ liver transplant recipients (LTxRs), real‐world effectiveness may be lower because of logistical concerns about feasibility of PET.MethodsWe retrospectively assessed PET as standard clinical care at a single transplant center among 50 consecutive adult CMV D+R‐ LTxRs undergoing a first liver transplant between 4/4/2019 and 5/18/2021 and compared outcomes and adherence to those randomized to PET in the CAPSIL study (N = 100). The primary outcome was CMV disease and secondary outcomes were biopsy‐confirmed acute allograft rejection, retransplant, invasive fungal infections, and death, all assessed by 1‐year post‐transplant. Exploratory outcomes included virologic parameters and measures of adherence to protocol‐specified CMV qPCR monitoring.ResultsBaseline characteristics were similar between groups. The cumulative incidence of CMV disease at 1‐year post‐transplant was 4/50 (8%) versus 9/100 (9%) in the real‐world and CAPSIL cohorts, respectively, p = 1.0. The rate of breakthrough CMV disease during the 100‐day PET period was low (2/50 [4%]) and similar to the PET cohort from the CAPSIL study (3/100 [3%]).  All secondary and exploratory outcomes were not significantly different between the real‐world and CAPSIL PET cohorts.ConclusionsIn this first reported study of real‐world PET, the feasibility and effectiveness for CMV disease prevention and for other clinical outcomes in CMV D+R‐ LTxRs were similar to those reported with PET in a clinical trial. Additional studies to confirm feasibility and generalizability in other settings are warranted. image