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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.

Model‐Based Once‐Daily Darunavir/Ritonavir Dosing Recommendations in Pediatric HIV‐1‐Infected Patients Aged ≥ 3 to <12 Years