Dataset Information

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

ABSTRACT:

Objectives

To investigate the potential of nevirapine 200 mg once-daily regimen and evaluate the influence of patient characteristics on nevirapine concentrations.

Methods

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.

Results

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).

Conclusions

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.

SUBMITTER: Kou H

PROVIDER: S-EPMC3554734 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

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

Kou Huijuan H Du Xiaoli X Li Yanling Y Xie Jing J Qiu Zhifeng Z Ye Min M Fu Qiang Q Han Yang Y Zhu Zhu Z Li Taisheng T

PloS one 20130124 1

<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 c ...[more]

PMID: 23359265

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Project description:Background:The regular assessment of hormonal and mood state parameters in professional soccer are proposed as good indicators during periods of intense training and/or competition to avoid overtraining. Objective:The aim of this study was to analyze hormonal, psychological, workload and physical fitness parameters in elite soccer players in relation to changes in training and match exposure during a congested period of match play. Methods:Sixteen elite soccer players from a team playing in the first Tunisian soccer league were evaluated three times (T1, T2, and T3) over 12 weeks. The non-congested period of match play was from T1 to T2, when the players played 6 games over 6 weeks. The congested period was from T2 to T3, when the players played 10 games over 6 weeks. From T1 to T3, players performed the Yo-Yo intermittent recovery test level 1 (YYIR1), the repeated shuttle sprint ability test (RSSA), the countermovement jump test (CMJ), and the squat jump test (SJ). Plasma Cortisol (C), Testosterone (T), and the T/C ratio were analyzed at T1, T2, and T3. Players had their mood dimensions (tension, depression, anger, vigor, fatigue, confusion, and a Total Mood Disturbance) assessed through the Profile of Mood State questionnaire (POMS). Training session rating of perceived exertion (sRPE) was also recorded on a daily basis in order to quantify internal training load and elements of monotony and strain. Results:Significant performance declines (T1 < T2 < T3) were found for SJ performance (p = 0.04, effect size [ES] ES1 - 2 = 0.15-0.06, ES2 - 3 = 0.24) from T1 to T3. YYIR1 performance improved significantly from T1 to T2 and declined significantly from T2 to T3 (p = 0.001, ES1 - 2 = 0.24, ES2 - 3 = -2.54). Mean RSSA performance was significantly higher (p = 0.019, ES1 - 2 = -0.47, ES2 - 3 = 1.15) in T3 compared with T2 and T1. Best RSSA performance was significantly higher in T3 when compared with T2 and T1 (p = 0.006, ES2 - 3 = 0.47, ES1 - 2 = -0.56), but significantly lower in T2 when compared with to T1. T and T/C were significantly lower in T3 when compared with T2 and T1 (T: p = 0.03, ES3 - 2 = -0.51, ES3 - 1 = -0.51, T/C: p = 0.017, ES3 - 2 = -1.1, ES3 - 1 = -1.07). Significant decreases were found for the vigor scores in T3 when compared to T2 and T1 (p = 0.002, ES1 - 2 = 0.31, ES3 - 2 = -1.25). A significant increase was found in fatigue scores in T3 as compared to T1 and T2 (p = 0.002, ES1 - 2 = 0.43, ES2 - 3 = 0.81). A significant increase was found from T1 < T2 < T3 intension score (p = 0.002, ES1 - 2 = 1.1, ES2 - 3 = 0.2) and anger score (p = 0.03, ES1 - 2 = 0.47, ES2 - 3 = 0.33) over the study period. Total mood disturbance increased significantly (p = 0.02, ES1 - 2 = 0.91, ES2 - 3 = 1.1) from T1 to T3. Between T1-T2, significant relationships were observed between workload and changes in T (r = 0.66, p = 0.003), and T/C ratio (r = 0.62, p = 0.01). There were significant relationships between performance in RSSAbest and training load parameters (workload: r = 0.52, p = 0.03; monotony: r = 0.62, p = 0.01; strain: r = 0.62, p = 0.009). Between T2-T3, there was a significant relationship between ?% of total mood disturbance and ?% of YYIR1 (r = -0.54; p = 0.04), RSSAbest (r = 0.58, p = 0.01), SJ (r = -0,55, p = 0.01), T (r = 0.53; p = 0.03), and T/C (r = 0.5; p = 0.04). Conclusion:An intensive period of congested match play significantly compromised elite soccer players' physical and mental fitness. These changes were related to psychological but not hormonal parameters; even though significant alterations were detected for selected measures. Mood monitoring could be a simple and useful tool to determine the degree of preparedness for match play during a congested period in professional soccer.

Dataset Information

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

Objectives

Methods

Results

Conclusions

Publications

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

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