biostudies-literatureUnknown88(10)Han K<h4>Aim</h4>To characterize cabotegravir population pharmacokinetics using data from phase 1, 2 and 3 studies and evaluate the association of intrinsic and extrinsic factors with pharmacokinetic variability.<h4>Methods</h4>Analyses were implemented in NONMEM and R. Concentrations below the quantitation limit were modelled with likelihood-based approaches. Covariate relationships were evaluated using forward addition (P < .01) and backward elimination (P < .001) approaches. The impact of each covariate on trough and peak concentrations was evaluated through simulations. External validation was performed using prediction-corrected visual predictive checks.<h4>Results</h4>The model-building dataset included 23 926 plasma concentrations from 1647 adult HIV-1-infected (72%) and uninfected (28%)British journal of clinical pharmacology4607-4622https://www.ebi.ac.uk/biostudies/studies/S-EPMC9543358biostudies-literaturePopulation pharmacokinetics of cabotegravir following administration of oral tablet and long-acting intramuscular injection in adult HIV-1-infected and uninfected subjects.PMC9543358Landovitz RJHan KBenn PDMarzinke MAPaul PMoore KPFord SLXiong YPatel PBaker MSeal CSLovern MSpreen WRD'Amico RDCutrell AGfalsePopulation pharmacokinetics of cabotegravir following administration of oral tablet and long-acting intramuscular injection in adult HIV-1-infected and uninfected subjects.<h4>Aim</h4>To characterize cabotegravir population pharmacokinetics using data from phase 1, 2 and 3 studies and evaluate the association of intrinsic and extrinsic factors with pharmacokinetic variability.<h4>Methods</h4>Analyses were implemented in NONMEM and R. Concentrations below the quantitation limit were modelled with likelihood-based approaches. Covariate relationships were evaluated using forward addition (P < .01) and backward elimination (P < .001) approaches. The impact of each covariate on trough and peak concentrations was evaluated through simulations. External validation was performed using prediction-corrected visual predictive checks.<h4>Results</h4>The model-building dataset included 23 926 plasma concentrations from 1647 adult HIV-1-infected (72%) and uninfected (28%)2022-01-01T00:00:00Z2022 Oct2025-04-04T20:03:48.534Z2025-04-04T20:03:48.534ZS-EPMC95433583569547610.1111/bcp.15439