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Clinical Trial
. 2024 Aug;28(8):822-831.
doi: 10.1007/s10157-024-02471-0. Epub 2024 Apr 13.

Letermovir safety and efficacy for cytomegalovirus prophylaxis in adult Japanese kidney transplant recipients: a multicenter, open-label, noncomparative Phase 3 study

Hideki Ishida  1 , Norihiko Goto  2 , Ryoichi Imamura  3 , Hajime Sasaki  4 , Kohei Unagami  1 , Kenta Futamura  2 , Yoshihiko Murata  5 , Nobuyuki Oshima  6 , Toshiko Eto  7 , Barbara Haber  5
Affiliations
Clinical Trial

Letermovir safety and efficacy for cytomegalovirus prophylaxis in adult Japanese kidney transplant recipients: a multicenter, open-label, noncomparative Phase 3 study

Hideki Ishida et al. Clin Exp Nephrol. 2024 Aug.

Abstract

Background: Letermovir is approved for cytomegalovirus (CMV) prophylaxis in adult allogeneic hematopoietic cell transplantation recipients worldwide and is also approved in the United States for CMV prophylaxis in adult high-risk (D+/R-) kidney transplant recipients (KTRs). The safety and efficacy of letermovir for CMV prophylaxis in adult Japanese KTRs are reported here.

Methods: In this Phase 3, single-arm, open-label study, adult Japanese KTRs with CMV serostatuses D+/R-, D+/R+, and D-/R+ received letermovir 480 mg daily orally within 7 days post-transplant through Week 28. Participants were followed through Week 52. The primary objective was to evaluate letermovir safety and tolerability. Efficacy was a secondary objective, measured by CMV disease, CMV disease or infection requiring intervention, and quantifiable CMV DNAemia. All CMV disease cases were confirmed by an independent adjudication committee.

Results: Among 22 participants (12 were D+/R-) who received letermovir prophylaxis, 20 (90.9%) experienced ≥ 1 AE through Week 28. Most AEs were mild to moderate in severity; no deaths were reported. During the prophylaxis period through Week 28, one transient case of quantifiable CMV DNAemia was detected, but no CMV disease or infection requiring intervention was reported. Through Week 52, four D+/R- participants met the endpoint of CMV disease or infection requiring intervention, of whom two had committee-confirmed CMV syndrome; all recovered with CMV therapy. A total of 5 participants had quantifiable CMV DNAemia through Week 52.

Conclusion: Letermovir was generally well tolerated, and the data support its use for the prevention of CMV disease/infection in adult Japanese KTRs.

Trial registration: ClinicalTrials.gov NCT04129398.

Keywords: Cytomegalovirus; Japanese; Kidney transplant; Letermovir.

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Conflict of interest statement

Employment, stock ownership or options: Barbara Haber is a current employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and may own stock/stock options in Merck & Co., Inc., Rahway, NJ, USA. Yoshihiko Murata was an employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, at the time of study and may own stock/stock options in Merck & Co., Inc., Rahway, NJ, USA. Nobuyuki Oshima and Toshiko Eto are current employees of MSD K.K., Tokyo, Japan, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and may own stock/stock options in Merck & Co., Inc., Rahway, NJ, USA. Hideki Ishida, Norihiko Goto, Ryoichi Imamura, Hajime Sasaki, Kohei Unagami, and Kenta Futamura have declared no competing interests.

Figures

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Participant disposition
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