Newly Approved Prophylaxis Assessed in CMS-Seropositive Transplant Recipients
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.
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."
The study was funded by Merck, the manufacturer of letermovir.