title: Model-Based Once-Daily Darunavir/Ritonavir Dosing Recommendations in Pediatric HIV-1-Infected Patients Aged ≥3 to <12 Years.
abstract: 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 α1-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.
authors: Janssen Research & Development Beerse, Belgium.
authors: A
authors: A
authors: Brochot
authors: Janssen Research & Development Titusville, New Jersey, USA.
authors: T N
authors: TN
authors: Kakuda
authors: Janssen Infectious Diseases BVBA Beerse, Belgium.
authors: T
authors: T
authors: Van De Casteele
authors: Janssen Infectious Diseases BVBA Beerse, Belgium.
authors: M
authors: M
authors: Opsomer
authors: Janssen Research & Development Titusville, New Jersey, USA.
authors: F L
authors: FL
authors: Tomaka
authors: Janssen Research & Development Beerse, Belgium.
authors: A
authors: A
authors: Vermeulen
authors: Janssen Infectious Diseases BVBA Beerse, Belgium ; LAP&P Consultants BV Leiden, The Netherlands.
authors: P
authors: P
authors: Vis