Population pharmacokinetic modeling and simulation of maribavir to support dose selection and regulatory approval in adolescents with posttransplant refractory cytomegalovirus
Kefeng Sun, Siobhan Hayes, Colm Farrell, Ivy Song
Abstract
Maribavir was approved by the US Food and Drug Administration for the treatment of patients aged ≥12 years and weighing ≥35 kg with posttransplant cytomegalovirus infection/disease refractory (with/without resistance) to valganciclovir, ganciclovir, cidofovir, or foscarnet, with an oral dose of 400 mg twice daily. With no pediatric clinical data available and difficulty in trial recruitment, population pharmacokinetic modeling and simulations were conducted to predict the pharmacokinetics and inform maribavir dosing in adolescents.
Topics & Concepts
GanciclovirValganciclovirFoscarnetPharmacokineticsDosingMedicineCidofovirCytomegalovirusRefractory (planetary science)PopulationPharmacologyHuman cytomegalovirusVirologyHuman immunodeficiency virus (HIV)VirusViral diseaseHerpesviridaeBiologyAstrobiologyEnvironmental healthCytomegalovirus and herpesvirus researchNeonatal Health and BiochemistryPolyomavirus and related diseases