Abstract
Despite effective treatments, cytomegalovirus (CMV) continues to have a significant impact on morbidity and mortality in allogeneic stem cell transplant (allo-SCT) recipients. This multicenter, retrospective, cohort study aimed to evaluate the reproducibility of the safety and efficacy of commercially available letermovir for CMV prophylaxis in a real-world setting. Endpoints were rates of clinically significant CMV infection (CSCI), defined as CMV disease or CMV viremia reactivation within day +100-+168. 204 adult CMV-seropositive allo-SCT recipients from 17 Italian centres (median age 52 years) were treated with LET 240 mg/day between day 0 and day +28. Overall, 28.9% of patients underwent a haploidentical, 32.4% a matched related, and 27.5% a matched unrelated donor (MUD) transplant. 65.7% were considered at high risk of CSCI and 65.2% had a CMV seropositive donor. Low to mild severe adverse events were observed in 40.7% of patients during treatment [gastrointestinal toxicity (36.3%) and skin rash (10.3%)]. Cumulative incidence of CSCI at day +100 and day +168 was 5.4% and 18.1%, respectively, whereas the Kaplan-Meier event rate was 5.8% (95% CI: 2.4-9.1) and 23.3% (95% CI: 16.3-29.7), respectively. Overall mortality was 6.4% at day +100 and 7.3% at day +168. This real-world experience confirms the efficacy and safety of CMV.
Highlights
Significant cytomegalovirus (CMV) infection (CSCI), defined as CMV disease or CMV viremia reactivation after allogeneic stem-cell transplantation, is often a serious complication given the delayed immune recovery of the host [1,2,3]
CSCI has been associated with increased non-relapse mortality (NRM) in transplant patients [2,3,4,5,6]
Up until the introduction of LET, no antiviral prophylaxis had proven capable of preventing CSCI in seropositive patients
Summary
Significant cytomegalovirus (CMV) infection (CSCI), defined as CMV disease or CMV viremia reactivation after allogeneic stem-cell transplantation (allo-SCT), is often a serious complication given the delayed immune recovery of the host [1,2,3]. During the past few decades, both clinical trials and real-world experiences have evaluated the role of CMV prophylaxis, reporting conflicting results [11, 12]. In a pivotal registration Phase 3 clinical trial, prophylaxis with LET significantly reduced the incidence of CSCI after allo-SCT [15]. In the US and Europe, LET was approved for prophylaxis of CSCI in adult CMV-seropositive recipients of allo-SCT [16]. FDA considers it a first-in-class medication [17]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
