Letermovir for prevention of recurrent cytomegalovirus in high-risk allogeneic hematopoietic cell transplantation recipients Journal Article

   


Authors: Han, G.; Stern, A.; Lee, Y. J.; Li, Y.; Dahi, P. B.; Tamari, R.; Gyurkocza, B.; Jakubowski, A. A.; Papadopoulos, E. B.; Shaffer, B.; Perales, M. A.; Obeid, K. M.; Young, J. A. H.; Papanicolaou, G. A.
Article Title: Letermovir for prevention of recurrent cytomegalovirus in high-risk allogeneic hematopoietic cell transplantation recipients
Abstract: We evaluated letermovir (LTV) for secondary prophylaxis for cytomegalovirus (CMV) in allogeneic hematopoietic cell transplant recipients (HCT) at high-risk for CMV recurrence. This open-label study was conducted at Memorial Sloan Kettering Cancer Center and the University of Minnesota. Patients with clinically significant CMV infection (cs-CMVi) and ≥1 high-risk criteria for CMV who achieved viral suppression with standard CMV antivirals received LTV secondary prophylaxis for up to 14 weeks. The primary endpoint was cs-CMVi at week 14; secondary endpoints included LTV resistance, CMV end-organ disease (EOD), CMV-related death, and LTV-related adverse events at week 14. Thirty-six patients were analyzed (CMV seropositive, n = 33; T cell-depleted HCT, n = 25; cord blood allograft, n = 5). By week 14 post-transplantation, 5 patients met the primary endpoint of cs-CMVi, for a cumulative incidence of 14.9% (95% confidence interval, 2.6% to 27.1%). Four patients developed LTV breakthrough cs-CMVi (including 2 patients with confirmed LTV resistance). The remaining patient developed rebound cs-CMVi after premature discontinuation of LTV due to enrollment in a clinical trial. There were no cases of CMV EOD, CMV-related death, or LTV-related adverse events by week 14 or by week 24. Our data support that LTV secondary prophylaxis is safe and effective in high-risk HCT recipients. © 2024 The American Society for Transplantation and Cellular Therapy
Keywords: adult; clinical article; controlled study; aged; middle aged; transplantation, homologous; young adult; clinical trial; side effect; risk factors; recurrence; hematopoietic stem cell transplantation; drug effect; risk factor; drug combination; prophylaxis; hematopoietic cell; recurrent disease; allogeneic hematopoietic stem cell transplantation; umbilical cord blood; open study; antivirus agent; drug dose; prematurity; quinazolines; acetic acid; cytomegalovirus infection; therapy; quinazoline derivative; cytomegalovirus; graft recipient; alemtuzumab; allotransplantation; cell transplantation; antiviral activity; prevention and control; oral drug administration; antiviral agents; prevention; hematopoietic cell transplantation; adverse event; cytomegalovirus infections; acetates; very elderly; humans; human; male; female; article; secondary prophylaxis; letermovir; cmv recurrence
Journal Title: Transplantation and Cellular Therapy
Volume: 31
Issue: 2
ISSN: 2666-6375
Publisher: Elsevier Inc.  
Date Published: 2025-02-01
Start Page: 105.e1
End Page: 105.e9
Language: English
DOI: 10.1016/j.jtct.2024.12.010
PUBMED: 39701288
PROVIDER: scopus
PMCID: PMC11936460
DOI/URL:

https://www.scopus.com/inward/record.uri?eid=2-s2.0-85213986299&doi=10.1016%2fj.jtct.2024.12.010&partnerID=40&md5=2f9dbe07a952ecf008982b8e8cb6f0cf
Notes: The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF. Corresponding MSK author is Genovefa Papanicolaou -- Source: Scopus
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MSK Authors
  1. Yeon Joo Lee
    50 Lee
  2. Guangming Han
    25 Han
  3. Genovefa A Papanicolaou
    238 Papanicolaou
  4. Esperanza B Papadopoulos
    417 Papadopoulos
  5. Ann Jakubowski
    457 Jakubowski
  6. Miguel-Angel Perales
    915 Perales
  7. Parastoo Bahrami Dahi
    295 Dahi
  8. Roni Tamari
    210 Tamari
  9. Boglarka Gyurkocza
    136 Gyurkocza
  10. Brian Carl Shaffer
    166 Shaffer
  11. Anat Stern
    13 Stern
  12. Yuxuan Li
    1 Li
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