Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands
© 2013 by Lippincott Williams & Wilkins. Background: 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...
Saved in:
Main Authors: | , , , , , , , , , , , , , , , |
---|---|
Format: | Journal |
Published: |
2018
|
Online Access: | https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84890378736&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/45156 |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Institution: | Chiang Mai University |
id |
th-cmuir.6653943832-45156 |
---|---|
record_format |
dspace |
spelling |
th-cmuir.6653943832-451562018-01-24T06:06:05Z Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands Diane E.T. Bastiaans Silvia Forcat Hermione Lyall Tim R. Cressey Rawiwan Hansudewechakul Suparat Kanjanavanit Antoni Noguera-Julian Christoph Konigs Jamie R.J. Inshaw Suwalai Chalermpantmetagul Yacine Saidi Alexandra Compagnucci Lynda M. Harper Carlo Giaquinto Angela P.H. Colbers David M. Burger © 2013 by Lippincott Williams & Wilkins. Background: 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. Methods: 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 p arameters were calculated by noncompartmental analysis. Given the high percentage of Asian children, it was also tested whether there was a difference in PK parameters between Asian and non-Asian children. Results: For the total group, LPV geometric mean AUC 0.12 , C max and C 12 were 106.9 h × mg/L, 12.0 mg/L and 4.9 mg/L, respectively. There were no significant differences in LPV PK parameters between the weight bands. In addition, weight was not found to be associated with variability in C max , C 12 or AUC 0.12 for the LPV PK parameters. Conclusions: FDA weight band.based dosing recommendations provide adequate exposure to LPV when using LPV/r pediatric tablets. 2018-01-24T06:06:05Z 2018-01-24T06:06:05Z 2014-03-01 Journal 15320987 08913668 2-s2.0-84890378736 10.1097/INF.0000000000000014 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84890378736&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/45156 |
institution |
Chiang Mai University |
building |
Chiang Mai University Library |
country |
Thailand |
collection |
CMU Intellectual Repository |
description |
© 2013 by Lippincott Williams & Wilkins. Background: 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. Methods: 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 p arameters were calculated by noncompartmental analysis. Given the high percentage of Asian children, it was also tested whether there was a difference in PK parameters between Asian and non-Asian children. Results: For the total group, LPV geometric mean AUC 0.12 , C max and C 12 were 106.9 h × mg/L, 12.0 mg/L and 4.9 mg/L, respectively. There were no significant differences in LPV PK parameters between the weight bands. In addition, weight was not found to be associated with variability in C max , C 12 or AUC 0.12 for the LPV PK parameters. Conclusions: FDA weight band.based dosing recommendations provide adequate exposure to LPV when using LPV/r pediatric tablets. |
format |
Journal |
author |
Diane E.T. Bastiaans Silvia Forcat Hermione Lyall Tim R. Cressey Rawiwan Hansudewechakul Suparat Kanjanavanit Antoni Noguera-Julian Christoph Konigs Jamie R.J. Inshaw Suwalai Chalermpantmetagul Yacine Saidi Alexandra Compagnucci Lynda M. Harper Carlo Giaquinto Angela P.H. Colbers David M. Burger |
spellingShingle |
Diane E.T. Bastiaans Silvia Forcat Hermione Lyall Tim R. Cressey Rawiwan Hansudewechakul Suparat Kanjanavanit Antoni Noguera-Julian Christoph Konigs Jamie R.J. Inshaw Suwalai Chalermpantmetagul Yacine Saidi Alexandra Compagnucci Lynda M. Harper Carlo Giaquinto Angela P.H. Colbers David M. Burger Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands |
author_facet |
Diane E.T. Bastiaans Silvia Forcat Hermione Lyall Tim R. Cressey Rawiwan Hansudewechakul Suparat Kanjanavanit Antoni Noguera-Julian Christoph Konigs Jamie R.J. Inshaw Suwalai Chalermpantmetagul Yacine Saidi Alexandra Compagnucci Lynda M. Harper Carlo Giaquinto Angela P.H. Colbers David M. Burger |
author_sort |
Diane E.T. Bastiaans |
title |
Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands |
title_short |
Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands |
title_full |
Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands |
title_fullStr |
Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands |
title_full_unstemmed |
Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands |
title_sort |
pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to fda weight bands |
publishDate |
2018 |
url |
https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84890378736&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/45156 |
_version_ |
1681422692888084480 |