A Comprehensive Monograph on Maribavir (Livtencity): Pharmacology, Clinical Efficacy, and Therapeutic Use in Post-Transplant Cytomegalovirus Infection

Executive Summary

Maribavir, marketed under the brand name Livtencity, represents a first-in-class therapeutic agent for the management of cytomegalovirus (CMV) infection in the post-transplant setting.[1] It is an orally bioavailable antiviral belonging to the benzimidazole riboside class, distinguished by a novel mechanism of action that sets it apart from conventional anti-CMV therapies.[2] Maribavir functions as a competitive inhibitor of the human CMV pUL97 protein kinase, an enzyme essential for viral DNA replication, encapsidation, and nuclear egress.[1] This mode of action differs fundamentally from that of established agents like ganciclovir, valganciclovir, foscarnet, and cidofovir, which target the viral DNA polymerase.[2]

The primary approved indication for maribavir is the treatment of post-transplant CMV infection or disease that is refractory, with or without genotypic resistance, to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir, or foscarnet.[1] This indication is for adult and adolescent patients (12 years of age and older, weighing at least 35 kg) in the United States, and for adults in Europe and Canada.[1]

Clinical efficacy was definitively established in the pivotal Phase 3 SOLSTICE trial, which demonstrated the statistical superiority of maribavir over investigator-assigned therapy (IAT) in a difficult-to-treat population of transplant recipients with refractory or resistant CMV.[8] At the end of the 8-week treatment period, 55.7% of patients receiving maribavir achieved confirmed CMV viremia clearance, compared to 23.9% of patients receiving IAT.[8]