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Letermovir prevents clinically significant cytomegalovirus infection in high-risk HSCT recipients
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A pivotal phase 3 study designed to evaluate letermovir for the prevention of clinically significant cytomegalovirus infection in high-risk patients who underwent bone marrow transplant met its primary endpoint, according to the agent’s manufacturer.
Letermovir (Merck) is an investigational antiviral medicine that inhibits viral replication by targeting the viral terminase complex.
The global, multicenter, randomized, placebo-controlled study evaluated the safety and efficacy of letermovir in cytomegalovirus–seropositive adults who underwent allogeneic hematopoietic stem cell transplant.
Study participants received letermovir once daily in oral tablet or IV formulation. Treatment started as early as the day of transplant and no later than 28 days after transplant, and it continued through approximately 100 days after transplant.
The percentage of study participants with clinically significant cytomegalovirus infection through 24 weeks after transplant served as the primary outcome measure.
Complete results of the study will be submitted for presentation at a scientific conference, according to a Merck-issued press release.
“There is an unmet need for therapeutic options in the prevention of cytomegalovirus infection in high-risk allogeneic HSCT recipients,” Roy Baynes, MD, PhD, senior vice president of clinical development at Merck Research Laboratories, said in the press release. “Merck is pleased this pivotal phase 3 study with letermovir met its primary endpoint.”