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. 2025 Jun 23:S1071-9164(25)00284-2.
doi: 10.1016/j.cardfail.2025.05.017. Online ahead of print.

Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Heart Transplant Recipients with Moderate to High-Risk CMV Serostatus

Afsana Rahman  1 , Changhee Lee  1 , Salwa Rahman  1 , Julia Baranowska  1 , Cathrine M Moeller  1 , Andrea Fernandez Valledor  1 , Gal Rubenstein  1 , Daniel Oren  1 , Adel T Alnatour  1 , Brian Labarre  2 , Kyung Taek  1 , David Bae  1 , Jayant Raikhelkar  1 , Dor Lotan  1 , Ersilia M Defilippis  1 , Adil A Yunis  1 , Justin Fried  1 , Farhana Latif  1 , Melana Yuzefpolskaya  1 , Paolo C Colombo  1 , Edward Lin  1 , David T Majure  3 , Kevin J Clerkin  1 , Jason Choe  2 , Gabriel Sayer  1 , Nir Uriel  4
Affiliations

Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Heart Transplant Recipients with Moderate to High-Risk CMV Serostatus

Afsana Rahman et al. J Card Fail. .

Abstract

Background: Cytomegalovirus (CMV) infection post-heart transplantation (HT) is associated with worse outcomes. Antiviral prophylaxis for at-risk patients is the standard of care. Valganciclovir, the most commonly used antiviral drug, is associated with significant adverse events, particularly leukopenia. Letermovir is a CMV-specific antiviral drug with a favorable side effect profile but its efficacy in HT recipients is unclear. This study aims to assess the safety and efficacy of letermovir for CMV prophylaxis in HT recipients.

Methods: This single-center retrospective analysis included HT recipients at our center from January 2020 to September 2023. Patients who were switched to letermovir for CMV prophylaxis for leukopenia/neutropenia on valganciclovir, and remained on letermovir for at least 60 days or developed CMV viremia on letermovir within 60 days of initiation were included. The primary endpoint was the incidence of CMV viremia/disease during letermovir therapy. Secondary endpoints included changes in white blood cell (WBC) count, tacrolimus dosing, and clinically significant acute rejection.

Results: A total of 52 patients received letermovir for an average of 8.2 months (range, 1-35 months). The average time from transplantation to letermovir initiation was 9.2 months (range, 0.9-77 months). Eight (15.4%) patients developed breakthrough CMV viremia on letermovir with a median viral load of 205 [IQR, 142.0-367.5] copies/mL; 4 of these patients were converted back to valganciclovir. Overall, 92.3% of patients completed therapy with letermovir. There were no episodes of suspected or biopsy-proven CMV disease. The majority of patients (78%) required dose reductions of tacrolimus following letermovir initiation, with no episodes of tacrolimus toxicity requiring hospitalization. WBC counts increased, on average, from 2.6 to 5.3 × 103 cells/μL (P < .001).

Conclusion: Letermovir holds promise as an effective and safe alternative to valganciclovir for CMV prophylaxis in HT recipients.

Keywords: CMV; Heart transplant; letermovir; prophylaxis.

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Conflict of interest statement

Disclosures Dr Lotan receives consulting fees from Kiniksa. Dr DeFilippis serves on a clinical trial committee for Abiomed and is a speaker for AstraZeneca. Dr Sayer received consulting fees from Abbott. Dr Clerkin has grant support from NIH grant number K23 HL148528. Dr Uriel receives consulting fees from Medtronic and has research grants from Abbott, FIRE1, and AbioMed.

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