Letermovir Noninferior for CMV Prophylaxis in Kidney Recipients

TUESDAY, June 13, 2023 (HealthDay News) -- Letermovir is noninferior to valganciclovir for prevention of cytomegalovirus (CMV) among CMV-seronegative kidney transplant recipients who receive an organ from a CMV-seropositive donor, according to a study published online June 6 in the Journal of the American Medical Association. The research was published to coincide with the annual American Transplant Congress, a joint meeting of the American Society of Transplant Surgeons and American Society of Transplantation, held from June 3 to 7 in San Diego.

Ajit Limaye, M.D., from the University of Washington in Seattle, and colleagues compared the efficacy and safety of letermovir with valganciclovir for prevention of CMV disease in a randomized phase 3 trial involving adult CMV-seronegative kidney transplant recipients who received an organ from a CMV-seropositive donor. Participants were randomly assigned to letermovir or valganciclovir (289 and 297, respectively) for up to 200 days after transplant.

The researchers found that letermovir was noninferior to valganciclovir for prevention of CMV through week 52 (10.4 versus 11.8 percent with committee-confirmed CMV disease). No participants who received letermovir and 1.7 percent who received valganciclovir developed CMV through week 28. Between the groups, the time to onset of CMV was comparable. Quantifiable CMV DNAnemia was detected in 2.1 and 8.8 percent of participants in the letermovir and valganciclovir groups, respectively, by week 28. Those receiving letermovir had a lower rate of leukopenia or neutropenia through week 28 compared with valganciclovir (26 versus 64 percent). Discontinuation of prophylaxis due to adverse events or drug-related adverse events occurred in fewer participants in the letermovir versus the valganciclovir group.

"Letermovir was noninferior to valganciclovir for prevention of CMV disease when taken for up to 200 days after transplant by adult high-risk CMV-seronegative kidney transplant recipients who received an organ from a CMV-seropositive donor, with less leukopenia or neutropenia," the authors write.

Several authors disclosed ties to pharmaceutical companies, including Merck, which manufactures letermovir and funded the study.

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