Pharmacokinetics of Pediatric Lopinavir/Ritonavir Tablets in Children When Administered Twice Daily According to FDA Weight Bands

• DOI: 10.1097/inf.0000000000000014
• Publication Date: 2013-12-19T12:05:29Z
• Authors: Diane E. T. Basti...; Silvia Forcat; Hermione Lyall; Tim R. Cressey; Rawiwan Hansudewe...; Suparat Kanjanavanit; Antoni Noguera-Ju...; Christoph Königs; Jamie R. J. Inshaw; Suwalai Chalermpa...; Yacine Saïdi; Alexandra Compagn...; Lynda M. Harper; Carlo Giaquinto; Angela P. H. Colbers; David M. Burger
• Keywords: Ritonavir; Body surface area; Lopinavir; Lopinavir/ritonavir

Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or surface area under FDA approval only EMA. This can lead to a different recommended dose. In addition, band-based dosing has not been formally studied in target population. We evaluated pharmacokinetics (PK) LPV/r children, administered twice daily according bands, using tablets.Fifty-three HIV-infected children were included PK substudy Paediatric Network for Treatment AIDS 18 trial (KONCERT). this study, randomized receive once daily, bands. A assessment was performed 17, 16 20 15-25 kg, ≥ 25-35 kg >35 band, respectively, while took daily. Rich sampling performed, parameters calculated noncompartmental analysis. Given high percentage Asian it also tested whether there difference between non-Asian children.For total group, LPV geometric mean AUC0-12, Cmax C12 106.9 h × mg/L, 12.0 mg/L 4.9 respectively. There no significant differences found be associated with variability Cmax, AUC0-12 parameters.FDA recommendations provide adequate exposure when tablets.