Merck announced that the Phase 3 clinical study of letermovir for the prevention of clinically significant cytomegalovirus (CMV) infection in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT) patients met its primary endpoint. The full results will be submitted for presentation at a future scientific conference.
The Phase 3 study was a global, multicenter, randomized, placebo-controlled trial that studied once-daily letermovir as an oral tablet or intravenous (IV) formulation. Letermovir was administered as early as the day of HSCT transplant and no later than 28 days post-transplant, and continued through approximately 100 days post-transplant.
The study’s primary outcome measure was the percentage of patients with clinically significant CMV infection through 24 weeks post-transplant. Secondary outcome measures included time to onset of clinically significant CMV infection, percentage of patients with clinically significant CMV infection, percentage of patients with CMV disease up to 14 weeks and 24 weeks post-transplant, percentage of patients with pre-emptive therapy for CMV viremia up to 14 weeks and 24 weeks post-transplant, and time to initiation of pre-emptive therapy for CMV viremia (up to 24 weeks after transplant.
Letermovir is an investigational once-daily antiviral agent in development for CMV infection and disease. It belongs to a new drug class called non-nucleoside CMV inhibitors (3,4 dihydro-quinazolines) and inhibits viral replication by targeting the viral terminase complex. The study is estimated to reach completion in January 2017.
For more information visit Merck.com.