ArticleCureus2026
Letermovir Prophylaxis for Cytomegalovirus Infection in Adult Allogeneic Stem Cell Transplantation: A Retrospective Analysis From a Lower-Middle-Income Country.
Article in Cureus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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13 authors.
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Abstract
backgroundCytomegalovirus (CMV) reactivation remains a leading cause of morbidity and non-relapse mortality following allogeneic hematopoietic stem cell transplantation (HSCT), especially in high-seroprevalence, resource-limited settings. Letermovir has significantly improved CMV prophylaxis by providing effective antiviral protection without hematologic or renal toxicity. The present study provides the first real-world comparative data of innovator and bioequivalent letermovir formulations for CMV prophylaxis in adult allogenic HSCT recipients from India.
methodsThis retrospective study was conducted at the Adult Hematology and Bone Marrow Transplant Unit, Fortis Memorial Research Institute, Gurugram, India. It included 29 CMV-seropositive patients' data of allogeneic HSCT recipients who received letermovir prophylaxis from day +7 to day +100 (innovator n = 7; bioequivalent n = 22). Treatment allocation was based on institutional availability and consultant discretion, with baseline characteristics comparable in both groups. Weekly quantitative CMV PCR monitoring was performed during prophylaxis, with continued surveillance thereafter as per institutional practice. The primary endpoint was CMV-free survival through day +100. Secondary endpoints included CMV reactivation incidence, time to CMV breakthrough, and overall survival. Statistical analyses were performed using IBM SPSS Statistics for Windows version 25.0, with
resultsThe mean recipient age in the analysed data was 34.1 ± 13.2 years, with 82.8% males; 62% patients that underwent haploidentical transplants. CMV reactivation data showed occurrence in six patients (20.7%) overall, four (13.8%) in the bioequivalent group, and two (28.6%) in the innovator group (
conclusionNo statistically significant differences were observed between innovator and bioequivalent letermovir formulations with respect to safety or CMV outcomes. Availability of a cost-effective bioequivalent formulation may substantially expand access to CMV prophylaxis, supporting improved transplant outcomes in high-burden LMICs.
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