Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

Summary

The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.

Timeline

Start

2018-05-03

Primary completion

2022-04-05

Completion

2022-04-05

Outcome

Met primary endpoint

paper stratum-adjusted difference -1.4% [95% CI, -6.5% to 3.8%] PMID 37279999 ↗

release “( NCT03443869 ) that demonstrated non-inferior efficacy” merck.com ↗

release “At 52 weeks following kidney transplant, trial results met the primary endpoint demonstrating that PREVYMIS was effective and non-inferior to valganciclovir” merck.com ↗

Publications

• Results Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106.
• Limaye AP, Crespo M, Kamar N, Humar A, Carroll RP, Pereira MR, Broyde N, Wang W, Haber B. Cytomegalovirus (CMV)-Specific Cell-Mediated Immunity for Prediction of Postprophylaxis CMV Disease in a Phase 3 Trial of Letermovir Versus Valganciclovir Prophylaxis in Donor CMV-Seropositive/Recipient CMV-Seronegative Kidney Transplant Recipients. Clin Infect Dis. 2026 Feb 25;82(2):e316-e324. doi: 10.1093/cid/ciaf632.
• Strizki JM, Diamond TL, Teal VL, Gilbert CL, Wang W, Stauffer N, Haber BA. Cytomegalovirus Antiviral Resistance Among Kidney Transplant Recipients in a Phase 3 Trial of Letermovir vs Valganciclovir Prophylaxis. J Infect Dis. 2024 Dec 16;230(6):e1287-e1298. doi: 10.1093/infdis/jiae287.
• Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Letermovir	Small molecule	240 mg	Oral
Subject	Letermovir	Small molecule	480 mg	Oral
Comparator	Valganciclovir	Small molecule	900 mg	Oral
Background	Acyclovir	Small molecule	400 mg	Oral

Indications