Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands

The Pediatric Infectious Disease Journal
Diane E T BastiaansPENTA 18KONCERT Study Group

Abstract

Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval and only body surface area by the EMA. This can lead to a different recommended dose. In addition, weight band-based dosing has not been formally studied in the target population. We evaluated the pharmacokinetics (PK) of LPV/r in children, administered twice daily according to the FDA weight bands, using pediatric tablets. Fifty-three HIV-infected children were included in the PK substudy of the Paediatric European Network for the Treatment of AIDS 18 trial (KONCERT). In this study, children were randomized to receive LPV/r twice or once daily, according to FDA weight bands. A PK assessment was performed in 17, 16 and 20 children in the 15-25 kg, ≥ 25-35 kg and >35 kg weight band, respectively, while children took the tablets twice daily. Rich sampling was performed, and PK parameters were calculated by noncompartmental analysis. Given the high percentage of Asian children, it was also tested whether there was a difference in PK parameters betwe...Continue Reading

References

Nov 19, 2002·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Margaret K MaHoward L McLeod
Mar 14, 2003·The Pediatric Infectious Disease Journal·Xavier Sáez-LlorensEugene Sun
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Nov 3, 2009·HIV Medicine·UNKNOWN PENTA Steering CommitteeDiane Bastiaans
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Aug 31, 2011·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Brookie M BestNatella Rakhmanina

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Citations

Dec 12, 2017·The Pediatric Infectious Disease Journal·Moherndran ArcharyStefanie Hennig
Nov 13, 2015·AIDS·UNKNOWN Paediatric European Network for Treatment of AIDS (PENTA)
Apr 23, 2019·Therapeutic Drug Monitoring·Hylke WaalewijnUNKNOWN Pediatric Antiretroviral Working Group (PAWG)
May 26, 2018·The Journal of Antimicrobial Chemotherapy·Marieke Roskam-KwintDavid Burger

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