Open AccessModel‐Based Once‐Daily Darunavir/Ritonavir Dosing Recommendations in Pediatric HIV‐1‐Infected Patients Aged ≥ 3 to <12 Years
Author(s) -
Brochot A,
Kakuda TN,
Van De Casteele T,
Opsomer M,
Tomaka FL,
Vermeulen A,
Vis P
Publication year - 2015
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.44
Subject(s) - darunavir , dosing , ritonavir , medicine , pharmacokinetics , cmin , pharmacology , population , human immunodeficiency virus (hiv) , cmax , virology , viral load , antiretroviral therapy , environmental health
An existing population pharmacokinetic model of darunavir in adults was updated using pediatric data from two studies evaluating weight‐based, once‐daily dosing of darunavir/ritonavir (ARIEL, NCT00919854 and DIONE, NCT00915655). The model was then used to provide once‐daily dosing recommendations for darunavir/ritonavir in pediatric patients aged ≥ 3 to <12 years. The final model comprised two compartments with first‐order absorption and apparent clearance dependent on the concentration of α 1 ‐acid glycoprotein. The recommended darunavir/ritonavir once‐daily dosing regimens in children aged ≥ 3 to <12 years are: 35/7 mg/kg from 10 to <15 kg, 600/100 mg from 15 to <30 kg, 675/100 mg from 30 to <40 kg, and 800/100 mg for ≥ 40 kg. These doses should result in exposures similar to the adult exposure after treatment with darunavir/ritonavir 800/100 mg once daily, while minimizing pill burden and allowing a switch from suspension to tablet(s) as early as possible.