Optimizing Dolutegravir Initiation in Neonates Using Population Pharmacokinetic Modeling and Simulation.

ABSTRACT:

Background

A knowledge gap exists for dolutegravir (DTG) pharmacokinetics and safety during the first 4 weeks of life, preventing safe and effective DTG use in neonates.

Setting

Population pharmacokinetic modeling and simulation were used to assess newborn DTG dosing requirements during the first few days of life as a function of maternal DTG dosing history before delivery.

Methods

DTG PK data were obtained from pregnant women and infants enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1026S study. Maternal and neonate population pharmacokinetic models were separately developed. Monte Carlo simulations were performed to simulate neonatal concentrations after 2 doses of DTG after birth for infants born to mothers either receivi

SUBMITTER: Piscitelli J 

PROVIDER: S-EPMC8665018 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature