HealthDay News — For cytomegalovirus (CMV)-seronegative patients undergoing hematopoietic-cell transplantation, letermovir prophylaxis is associated with a lower risk of CMV infection than placebo, according to a study published online December 6 in the New England Journal of Medicine.

Francisco M. Marty, MD, from the Dana-Farber Cancer Institute in Boston, and colleagues randomized CMV-seropositive transplant recipients in a 2:1 ratio to receive letermovir or placebo through week 14 after transplantation. The trial regimen was discontinued in patients in whom clinically significant CMV infection developed, and they received anti-CMV treatment. 

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The researchers found that among 495 patients with undetectable CMV DNA at randomization, fewer patients in the letermovir group had clinically significant CMV infection or were classified as having a primary end point event by week 24 after transplantation, compared with the placebo group (37.5 vs. 60.6%; P<0.001). The 2 groups had similar frequency and severity of adverse events. Vomiting occurred in 18.5 and 13.5% of those who received letermovir and placebo, respectively; edema in 14.5 and 9.4%, respectively; and atrial fibrillation or flutter in 4.6 and 1.0%, respectively. Similar rates of myelotoxic and nephrotoxic events were seen in both groups.

“Letermovir prophylaxis resulted in a significantly lower risk of clinically significant CMV infection than placebo,” the authors write. “Adverse events with letermovir were mainly of low grade.”

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The study was funded by Merck, the manufacturer of letermovir.

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