A general overview of the clinical pharmacology of Paxlovid, authorized for emergency use by FDA under an EUA for the treatment of mild-to-moderate COVID-19 in a adults and pediatric patients (greater than 12 years of age and weighing greater than 40 kg) who are at high risk for progression to severe COVID-19 disease, including hospitalization or death will be described. An overview of the study design and results of the Paxlovid clinical pharmacology studies performed in special populations such as renal and hepatic impairment, as well as the pediatric population and Japanese population will be provided. Paxlovid dosing recommendations arising from both the study results as well as modeling and simulation analyses performed that helped drive these dosing recommendations in the EUA FACT sheet will be highlighted.
Learning Objectives:
Upon completion, participants will be able to describe the clinical pharmacology of Paxlovid
Upon completion, participants will be able to illustrate how study results from special population studies translated into dosing recommendations for the Paxlovid EUA Fact Sheet
Upon completion, participants will recognize how modeling and simulation analyses impacted dosing recommendation in the Paxlovid EUA FACT sheet in those with moderate renal impairment and in adolescents greater than 12 years of age weighing greater than 40 kg.
