12 Dec Letermovir (Prevymis) Prevents CMV Infection in Stem Cell Transplant
MedicalResearch.com Interview with:
Francisco M. Marty, M.D
Associate Professor, Harvard Medical School
Dana–Farber Cancer Institute and
Brigham and Women’s Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Cytomegalovirus (CMV) is the most common infection in patients who undergo allogeneic hematopoietic-cell transplantation (bone marrow transplantation with cells from donors different than the patient). Up until now, we had no antiviral agent that could be used for prophylaxis (prevention) of CMV post-transplant because of the side effects of drugs available to date (ganciclovir, valganciclovir, foscarnet, cidofovir).
This trial confirmed that letermovir was highly effective in preventing CMV infection when used in the first 100 days after allogeneic HCT, was associated with minimal side effects of concern and was also associated with lower all-cause mortality by Week 24 post-HCT.
MedicalResearch.com: What should readers take away from your report?
Response: With the FDA’s approval of letermovir in the US in November and other approvals in other countries pending, we will now have a new antiviral against CMV that can be used for prophylaxis of after allogeneic HCT that does not cause myelosuppression and is not nephrotoxic.
It is important to note that letermovir is active only against CMV, so patients will continue to need antiviral prophylaxis for herpes simplex and herpes zoster with acyclovir or valacyclovir. Letermovir has some mild-to-moderate drug interactions, so other drugs may be need to be adjusted and monitored during treatment with letermovir.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: There will be a formal head-to-head comparison trial of letermovir vs. valganciclovir for prophylaxis against CMV in high-risk kidney transplant recipients. This trial will inform the role of letermovir for prophylaxis in solid-organ transplant recipients. We look forward to research in other potential uses, including the use of letermovir for treatment of active infection or the role of combination treatments, but doctors should be cautioned that the drug has not yet been used for these indications in a systematic way.
MedicalResearch.com: Is there anything else you would like to add?
Response: We are grateful to all the patients that took part in this and previous trials that have led to this important development in the care of allogeneic HCT patients.
Disclosures available in publication.
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Francisco M. Marty, M.D., Per Ljungman, M.D., Ph.D., Roy F. Chemaly, M.D., M.P.H., Johan Maertens, M.D., Ph.D., Sanjeet S. Dadwal, M.D., Rafael F. Duarte, M.D., Ph.D., Shariq Haider, M.D., D.T.M.&H., Andrew J. Ullmann, M.D., Yuta Katayama, M.D., Ph.D., Janice Brown, M.D., Kathleen M. Mullane, D.O., Pharm.D., Michael Boeckh, M.D., Ph.D., Emily A. Blumberg, M.D., Hermann Einsele, M.D., David R. Snydman, M.D., Yoshinobu Kanda, M.D., Ph.D., Mark J. DiNubile, M.D., Valerie L. Teal, M.S., Hong Wan, Ph.D., Yoshihiko Murata, M.D., Ph.D., Nicholas A. Kartsonis, M.D., Randi Y. Leavitt, M.D., Ph.D., and Cyrus Badshah, M.D., Ph.D.
December 6, 2017DOI: 10.1056/NEJMoa1706640
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