Comparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients.

<h4>Objectives</h4>To investigate the potential of nevirapine 200 mg once-daily regimen and evaluate the influence of patient characteristics on nevirapine concentrations.<h4>Methods</h4>This was a prospective, multicentre cohort study with 532 HIV-infected patients receiving...

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Autores principales:	Huijuan Kou, Xiaoli Du, Yanling Li, Jing Xie, Zhifeng Qiu, Min Ye, Qiang Fu, Yang Han, Zhu Zhu, Taisheng Li
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2013
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/1f0bc92babc14af696cd9a24174aab6f
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spelling	oai:doaj.org-article:1f0bc92babc14af696cd9a24174aab6f2021-11-18T08:00:12ZComparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients.1932-620310.1371/journal.pone.0052950https://doaj.org/article/1f0bc92babc14af696cd9a24174aab6f2013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23359265/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Objectives</h4>To investigate the potential of nevirapine 200 mg once-daily regimen and evaluate the influence of patient characteristics on nevirapine concentrations.<h4>Methods</h4>This was a prospective, multicentre cohort study with 532 HIV-infected patients receiving nevirapine as a part of their initial antiretroviral therapy. Plasma samples were collected at trough or peak time at the end of week 2 (lead-in period) and week 4, 12, 24, 36, and 48 (steady-state period), and nevirapine concentrations were determined using a validated HPLC method. Potential influencing factors associated with nevirapine concentrations were evaluated using univariate and multivariate logistic regression.<h4>Results</h4>A total of 2348 nevirapine plasma concentrations were collected, including 1510 trough and 838 peak values. The median nevirapine trough and peak concentration during the lead-in period were 4.26 µg/mL (IQR 3.05-5.61) and 5.07 µg/mL (IQR 3.92-6.44) respectively, which both exceeded the recommended thresholds of nevirapine plasma concentrations. Baseline hepatic function had a moderate effect on median nevirapine trough concentrations at week 2 (4.25 µg/mL v.s. 4.86 µg/mL, for ALT <1.5 × ULN and ≥ 1.5 × ULN, respectively, P = 0.045). No significant difference was observed in median nevirapine trough concentration between lead-in and steady-state periods in patients with baseline ALT and AST level ≥ 1.5 × ULN (P = 0.171, P = 0.769), which was different from the patients with ALT/AST level <1.5ULN. The median trough concentrations were significantly higher in HIV/HCV co-infected patients than those without HCV at week 48 (8.16 µg/mL v.s. 6.15 µg/mL, P = 0.004).<h4>Conclusions</h4>The 200 mg once-daily regimen of nevirapine might be comparable to twice-daily in plasma pharmacokinetics in Chinese population. Hepatic function prior to nevirapine treatment and HIV/HCV coinfection were significantly associated with nevirapine concentrations.Huijuan KouXiaoli DuYanling LiJing XieZhifeng QiuMin YeQiang FuYang HanZhu ZhuTaisheng LiPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 1, p e52950 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Huijuan Kou Xiaoli Du Yanling Li Jing Xie Zhifeng Qiu Min Ye Qiang Fu Yang Han Zhu Zhu Taisheng Li Comparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients.
description	<h4>Objectives</h4>To investigate the potential of nevirapine 200 mg once-daily regimen and evaluate the influence of patient characteristics on nevirapine concentrations.<h4>Methods</h4>This was a prospective, multicentre cohort study with 532 HIV-infected patients receiving nevirapine as a part of their initial antiretroviral therapy. Plasma samples were collected at trough or peak time at the end of week 2 (lead-in period) and week 4, 12, 24, 36, and 48 (steady-state period), and nevirapine concentrations were determined using a validated HPLC method. Potential influencing factors associated with nevirapine concentrations were evaluated using univariate and multivariate logistic regression.<h4>Results</h4>A total of 2348 nevirapine plasma concentrations were collected, including 1510 trough and 838 peak values. The median nevirapine trough and peak concentration during the lead-in period were 4.26 µg/mL (IQR 3.05-5.61) and 5.07 µg/mL (IQR 3.92-6.44) respectively, which both exceeded the recommended thresholds of nevirapine plasma concentrations. Baseline hepatic function had a moderate effect on median nevirapine trough concentrations at week 2 (4.25 µg/mL v.s. 4.86 µg/mL, for ALT <1.5 × ULN and ≥ 1.5 × ULN, respectively, P = 0.045). No significant difference was observed in median nevirapine trough concentration between lead-in and steady-state periods in patients with baseline ALT and AST level ≥ 1.5 × ULN (P = 0.171, P = 0.769), which was different from the patients with ALT/AST level <1.5ULN. The median trough concentrations were significantly higher in HIV/HCV co-infected patients than those without HCV at week 48 (8.16 µg/mL v.s. 6.15 µg/mL, P = 0.004).<h4>Conclusions</h4>The 200 mg once-daily regimen of nevirapine might be comparable to twice-daily in plasma pharmacokinetics in Chinese population. Hepatic function prior to nevirapine treatment and HIV/HCV coinfection were significantly associated with nevirapine concentrations.
format	article
author	Huijuan Kou Xiaoli Du Yanling Li Jing Xie Zhifeng Qiu Min Ye Qiang Fu Yang Han Zhu Zhu Taisheng Li
author_facet	Huijuan Kou Xiaoli Du Yanling Li Jing Xie Zhifeng Qiu Min Ye Qiang Fu Yang Han Zhu Zhu Taisheng Li
author_sort	Huijuan Kou
title	Comparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients.
title_short	Comparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients.
title_full	Comparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients.
title_fullStr	Comparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients.
title_full_unstemmed	Comparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients.
title_sort	comparison of nevirapine plasma concentrations between lead-in and steady-state periods in chinese hiv-infected patients.
publisher	Public Library of Science (PLoS)
publishDate	2013
url	https://doaj.org/article/1f0bc92babc14af696cd9a24174aab6f
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Comparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients.

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