Please use this identifier to cite or link to this item: http://cmuir.cmu.ac.th/jspui/handle/6653943832/57642
Title: Assessment of Nevirapine Prophylactic and Therapeutic Dosing Regimens for Neonates
Authors: Tim R. Cressey
Baralee Punyawudho
Sophie Le Coeur
Gonzague Jourdain
Chalermpong Saenjum
Edmund V. Capparelli
Kanokwan Jittayanun
Siriluk Phanomcheong
Anita Luvira
Thitiporn Borkird
Achara Puangsombat
Leon Aarons
Pra Ornsuda Sukrakanchana
Saik Urien
Marc Lallemant
Suraphan Sangsawang
Jullapong Achalapong
Kanchana Preedisripipat
Chaiwat Putiyanun
Vanichaya Wanchaitanawong
Prapap Yuthavisuthi
Chaiwat Ngampiyaskul
Prateep Kanjanavikai
Nantasak Chotivanich
Suchat Hongsiriwon
Weerapong Suwankornsakul
Phantip Sreshthatat
Annop Kanjanasing
Ratchanee Kwanchaipanich
Boonsong Rawangban
Sadhit Santadusit
Tapnarong Jarupanich
Boonyarat Warachit
Thitiporn Siriwachirachai
Pornpimon Rojanakarin
Kraisorn Vivatpatanakul
Sansanee Hanpinitsak
Phaiboon Wanasiri
Sakulrat Srirojana
Rucha Kongpanichkul
Suthunya Bunjongpak
Prapan Sabsanong
Prateung Liampongsabuddhi
Kultida Pongdetudom
Prayoon Khamja
Noppadon Akarathum
Supha Arth Phonin
Wannee Limpitikul
Jantana Jungpipun
Ratikorn Petprakorp
Sukit Mahattanan
Somsri Kotchawet
Toranong Pilalai
Keywords: Medicine
Issue Date: 15-Aug-2017
Abstract: © Copyright 2017 Wolters Kluwer Health, Inc. All rights reserved. Background: Nevirapine (NVP) is a key component of antiretroviral prophylaxis and treatment for neonates. We evaluated current World Health Organization (WHO) weight-band NVP prophylactic dosing recommendations and investigated optimal therapeutic NVP dosing for neonates. Methods: The PHPT-5 study in Thailand assessed the efficacy of "Perinatal Antiretroviral Intensification" to prevent mother-to-child transmission of HIV in women with <8 weeks of antiretroviral treatment before delivery (NCT01511237). Infants received a 2-week course of zidovudine/lamivudine/NVP (NVP syrup/once daily: 2 mg/kg for 7 days; then 4 mg/kg for 7 days). Infant samples were assessed during the first 2 weeks of life. NVP population pharmacokinetics (PK) parameters were estimated using nonlinear mixed-effects models. Simulations were performed to estimate the probability of achieving target NVP trough concentrations for prophylaxis (>0.10 mg/L) and for therapeutic efficacy (>3.0 mg/L) using different infant dosing strategies. Results: Sixty infants (55% male) were included. At birth, median (range) weight was 2.9 (2.3-3.6) kg. NVP concentrations were best described by a 1-compartment PK model. Infant weight and postnatal age influenced NVP PK parameters. Based on simulations for a 3-kg infant, ≥92% would have an NVP trough >0.1 mg/L after 48 hours through 2 weeks using the PHPT-5 and WHO-dosing regimens. For NVP-based therapy, a 6-mg/kg twice daily dose produced a trough >3.0 mg/L in 87% of infants at 48 hours and 80% at 2 weeks. Conclusion: WHO weight-band prophylactic guidelines achieved target concentrations. Starting NVP 6 mg/kg twice daily from birth is expected to achieve therapeutic concentrations during the first 2 weeks of life.
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85025687300&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/57642
ISSN: 10779450
15254135
Appears in Collections:CMUL: Journal Articles

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