Letermovir Approved to Prevent CMV Infection and Disease in Transplant Patients

The FDA approval provides a long-awaited alternative for preventing cytomegalovirus infection in allogenic hematopoietic stem cell transplant recipients.

On November 9, 2017, the FDA approved letermovir for prevention of cytomegalovirus (CMV) infection and disease in adult allogeneic hematopoietic stem cell transplant (HSCT) recipients. The drug has a novel mechanism of action, inhibition of the CMV DNA terminase complex.

The registration trial compared letermovir to placebo in CMV-positive adult HSCT recipients. Treatment/placebo began within 28 days after transplant and continued until 100 days posttransplant. The primary endpoint was CMV disease or viremia leading to preemptive antiviral administration. Of 495 participants analyzed, among those who remained on drug, clinically significant CMV infection occurred in 18% on letermovir and 42% on placebo by week 24 — a significant difference. …

Author

Daniel Kaul, MD

Disclosures

Grant/Research SupportNobelpharma; Pfizer

Leadership Positions in Professional SocietiesAmerican Society of Transplantation (Program Committee)

Daniel Kaul, MD

Disclosures

Grant/Research SupportNobelpharma; Pfizer

Leadership Positions in Professional SocietiesAmerican Society of Transplantation (Program Committee)

Letermovir Approved to Prevent CMV Infection and Disease in Transplant Patients

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