Premyvis for CMV prophylaxis after stem cell transplantation – pro
Letermovir is a highly specific antiviral agent against human CMV that possessed a unique mechanism of action by inhibiting the CMV terminase complex. It is supported for prophylaxis of CMV after stemcell transplantation by the results from a randomized, placebo-controlled, phase III clinical trial conducted in CMV-seropositive AHCT recipients in which letermovir was administered through week 14 after HCT. A total of 495 patients had undetectable CMV DNA at randomization. Only 37.5 percent of patients (122 of 325) given letermovir prophylaxis had clinically significant CMV infection or a primary endpoint event by week 24 after AHCT, compared with 60.6 percent of the placebo group (103 of 170; p<0.001). Overall, the frequency and severity of adverse events in the two groups were similar. At 48 weeks after AHCT, all-cause mortality was 20.9 percent among letermovir recipients and 25.5 percent among placebo recipients. The drug was well tolerated and did not demonstrate toxic effects on the bone marrow, kidney, or liver. Both the U.S. Food and Drug Administration and the European Medicines Agency recently approved the drug based on these study results. The approval is for 100 days.
P. Ljungman et al, Optimal Management Approach to Prevent Cytomegalovirus Infection in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation, The Heamotlogist,March-April 2018, Volume 15, Issue 2,
Prevymis, Prescribing Information 2018