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

⁰Department of Organ Transplant Medicine, Tokyo Women's Medical University, Tokyo, Japan.

Clinical and Experimental Nephrology +

|

April 13, 2024

View abstract on PubMed

Summary

Letermovir prophylaxis demonstrated good tolerability and efficacy in preventing cytomegalovirus (CMV) disease or infection in adult Japanese kidney transplant recipients. These findings support its use in this patient population.

Area Of Science

Nephrology
Infectious Diseases
Transplantation Immunology

Background

Letermovir is approved for cytomegalovirus (CMV) prophylaxis in adult hematopoietic cell transplant recipients and high-risk kidney transplant recipients (KTRs) in the US.
This study reports the safety and efficacy of letermovir for CMV prophylaxis in adult Japanese KTRs.

Purpose Of The Study

To evaluate the safety and tolerability of letermovir for CMV prophylaxis in adult Japanese KTRs.
To assess the efficacy of letermovir in preventing CMV disease, CMV disease or infection requiring intervention, and CMV DNAemia.

Main Methods

Phase 3, single-arm, open-label study of adult Japanese KTRs (CMV serostatuses D+/R-, D+/R+, D-/R+).
Letermovir 480 mg orally daily from within 7 days post-transplant through Week 28, with follow-up through Week 52.
Primary objective: safety and tolerability. Secondary objective: efficacy endpoints including CMV disease, CMV disease or infection requiring intervention, and CMV DNAemia.

Main Results

22 participants received letermovir; 90.9% experienced treatment-emergent adverse events (AEs), mostly mild to moderate. No deaths were reported.
Through Week 28, one transient case of quantifiable CMV DNAemia occurred; no CMV disease or infection requiring intervention was reported.
Through Week 52, four D+/R- participants experienced CMV disease or infection requiring intervention (two with confirmed CMV syndrome), all recovered with treatment. Five participants had quantifiable CMV DNAemia.

Conclusions

Letermovir was generally well tolerated in adult Japanese KTRs.
The study data support the use of letermovir for the prevention of CMV disease and/or infection in this population.

Keywords:

Cytomegalovirus Japanese Kidney transplant Letermovir