%0 Generic %A Kou, Huijuan %A Du, Xiaoli %A Li, Yanling %A Xie, Jing %A Qiu, Zhifeng %A Ye, Min %A Fu, Qiang %A Han, Yang %A Zhu, Zhu %A Li, Taisheng %D 2013 %T Comparison of Nevirapine Plasma Concentrations between Lead-In and Steady-State Periods in Chinese HIV-Infected Patients %U https://plos.figshare.com/articles/dataset/Comparison_of_Nevirapine_Plasma_Concentrations_between_Lead_In_and_Steady_State_Periods_in_Chinese_HIV_Infected_Patients__/154221 %R 10.1371/journal.pone.0052950 %2 https://plos.figshare.com/ndownloader/files/478175 %2 https://plos.figshare.com/ndownloader/files/478177 %K nevirapine %K plasma %K concentrations %K lead-in %K steady-state %K periods %K chinese %K hiv-infected %K patients %X

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.

Registration

Clinicaltrial.gov ID: NCT00872417

%I PLOS ONE