Real‐World Utilization Pattern and Outcomes of Letermovir in Adult Cytomegalovirus‐Seropositive Allogeneic Hematopoietic Cell Transplant Recipients: An International Retrospective Study From the Infectious Diseases Working Party of EBMT
Year: 2026
Type: article
Study design: Observational Study
Abstract: INTRODUCTION: The objective of this study was to analyze outcomes associated with letermovir for CMV primary prophylaxis in adult CMV-seropositive allo-HCT recipients in a multicenter real-world scenario. METHODS: This retrospective real-world international study involved 481 adults undergoing allo-HCT between 2018 and 2020 who received letermovir for primary prophylaxis. Outcomes included clinically significant CMV infection (csCMVi), graft-versus-host disease, opportunistic infections, all-cause mortality, hospitalizations, and ICU admissions. The median follow-up was 33.8 months. RESULTS: The median start time of letermovir was 3 days after transplant, with a median duration of prophylaxis of 100 days. The cumulative incidence of csCMVi was 2.7% (95% CI = 1.5-4.5) at 3 months, 13.1% (95% CI = 10.3-16.3) at 6 months, and 17.1% (95% CI = 13.9-20.6) at 12 months. The median time from HCT to csCMVi was 142 days. In multivariate analysis, four factors contributed to development of csCMVi: reduced-intensity conditioning (HR = 1.90; 95% CI = 1.17-3.08; p = 0.009), peripheral blood as cell source (HR = 2.92; 95% CI = 1.00-8.50; p = 0.0495), pretransplant CMV serostatus D-/R+ (HR = 2.24; 95% CI = 1.42-3.53; p = 0.0005), use of alemtuzumab (HR = 3.91; 95% CI = 1.60-9.59; p = 0.003). There was no difference in the cumulative incidence of csCMVi in the first 100 days between patients who started letermovir ≤ 5 versus > 5 days after transplant. Factors adversely contributing to overall survival: age as a continuous variable, 10-year effect (HR = 1.23; 95% CI = 1.08-1.41; p = 0.002), patient male sex (HR = 1.48; 95% CI = 1.02-2.13; p = 0.038), status > CR1 of disease at transplant (HR = 1.97; 95% CI = 1.36-2.85; p = 0.0004), PB as stem cell source (HR = 1.81; 95% CI = 1.04-3.15; p = 0.04), acute leukemia diagnosis (HR = 1.61; 95% CI = 1.10-2.34; p = 0.01), CMV high-risk patients (HR = 1.52; 95% CI = 1.02-2.27; p = 0.04). CONCLUSIONS: An analysis of real-world use of letermovir in CMV prophylaxis after allo-HCT showed a low incidence of csCMVi compared to previously published information.
Source: Transplant Infectious Disease
Authors: Jan Styczynski, Gloria Tridello, Nina Knelange, Lotus Wendel, Per Ljungman, Dina Averbuch, Domenico Russo, Alienor Xhaard, Alida Dominietto, Francesco Onida, David Beauvais, Emma Kempshall, Ilaria Cutini, Patrizia Chiusolo, Uwe Platzbecker, Angelo Michele Carella, Annie Ferreri, Maria Catarina Mico, Sabrina Kraus, Varun Mehra, Leotta Salvatore, Vincenzo Federico, Yuexin Tang, Irina Kolobova, Andrew P. Beyer, Deepa Patel, Rafael de la Camara
Institutions: Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, European Society for Blood and Marrow Transplantation, Karolinska University Hospital, Karolinska Institutet, Hebrew University of Jerusalem, Hadassah Medical Center, Hôpital Saint-Louis, Ospedale Policlinico San Martino, University of Milan, ASST Fatebenefratelli Sacco, Inserm, Centre Hospitalier Universitaire de Lille, Protéomique, Réponse Inflammatoire et Spectrométrie de Masse, University Hospital of Wales, Azienda Ospedaliero-Universitaria Careggi, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico, Casa Sollievo della Sofferenza, Azienda ospedaliera "Bianchi-Melacrino-Morelli", Ospedale Papa Giovanni XXIII, Universitätsklinikum Würzburg, King's College Hospital, Policlinico Universitario di Catania, Merck & Co., Inc., Rahway, NJ, USA (United States), Hospital Universitario de La Princesa
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7133233915
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