Therapeutics and Clinical Risk Management (Mar 2022)
Evaluating the Safety of Maribavir for the Treatment of Cytomegalovirus
Abstract
Ronak G Gandhi,1 Camille N Kotton2 1Department of Pharmacy, Massachusetts General Hospital, Boston, MA, USA; 2Infectious Diseases Division, Massachusetts General Hospital, Boston, MA, USACorrespondence: Ronak G Gandhi, Senior Attending Pharmacist – Infectious Diseases, Department of Pharmacy, Massachusetts General Hospital, 55 Fruit Street, GRB 005, Boston, MA 02114, USA, Tel +1 617-643-6570, Fax +1 617-726-9232, Email [email protected] of Review: Cytomegalovirus (CMV) infections are a common complication in solid organ (SOT) and hematopoietic stem cell transplant (HSCT) recipients, leading to increased morbidity and mortality. Currently available treatment options have reduced the burden of infection, but utilization of these agents can be limited by toxicities such as nephrotoxicity and/or myelosuppression as well as emergence of resistance. The expansion of our current armamentarium towards CMV infection is crucial. Here, we review an emerging therapy, maribavir, and the safety and efficacy of this potential new agent for the prophylaxis and treatment of CMV infections including resistant/refractory disease.Recent Findings: Maribavir is a novel agent with CMV activity approved by Federal Food and Drug Administration (FDA) in December 2021 for resistant/refractory disease. Compared to currently available treatment for CMV infection, maribavir has a unique mechanism of action, retains activity against most (val)ganciclovir resistant strains, provides a more predictable pharmacokinetic profile, and fewer severe toxicities. Maribavir has been studied in phase 2 and 3 studies with ongoing phase 3 studies. While maribavir failed to meet the primary endpoints in the initial phase 3 study for prophylaxis therapy in allogeneic-HSCT and liver transplant recipients, results from the phase 2 study when used for pre-emptive therapy after HSCT show similar efficacy to valganciclovir, and results from the phase 3 study examining resistant/refractory disease demonstrate superiority to investigator-initiated therapy of (val)ganciclovir, foscarnet, or cidofovir.Summary: Maribavir provides a new agent for the management of resistant/refractory CMV infection. Results of the recently published phase 3 study provide further insight into the role of this novel therapy.Keywords: cytomegalovirus, maribavir, safety, efficacy
