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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Steady-state pharmacokinetics of nevirapine extended-release tablets in HIV-1-infected children and adolescents: An open-label, multiple-dose, cross-over study
Pediatric Infectious Disease Journal, Volume 33, No. 7, Year 2014
Notification
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Description
BACKGROUND: To compare steady-state (ss) pharmacokinetic targets of nevirapine extended-release (NVP-XR) tablets once-daily (QD) with immediate-release (NVP-IR) tablet or oral suspension twice-daily in HIV-1-infected children and adolescents. METHODS: Phase I, open-label, multidose, cross-over study with optional extension phase, in 85 patients 3 to <18 years of age, previously on an NVP-IR-based regimen for ≥18 weeks with baseline viral load <50 copies/mL. Patients were stratified by age, treated with NVP-IR twice-daily for 11 days, then NVP-XR QD for 10 days. C pre,ss (steady-state, predose concentrations) was obtained from all, and 12-hour NVP-IR and 24-hour NVP-XR steady-state pharmacokinetic profiles were obtained in the pharmacokinetic substudy. Viral loads, CD4 counts and adverse events (AEs) were monitored. RESULTS: Eighty patients completed the trial. Adjusted geometric mean (gMean) Cpre,ss for NVP-XR and NVP-IR exceeded the target of 3000 ng/mL, and the adjusted gMean NVP-XR:NVP-IR ratio (90% confidence interval) for QD normalized and un-normalized Cpre,ss were 91.2% (83.5-99.6%) and 91.8% (83.7-100.7%). gMean 24-hour area under the curve at steady-state NVP-XR:NVP-IR for un-normalized dose was 90.4% and un-normalized Cpre,ss NVP-XR:NVP-IR were 91.0%, 81.9% and 103.7% for the 3 age groups, 3 to <6, 6 to <12 and 12 to <18 years, respectively. gMean values indicated no exposure to subtherapeutic NVP concentrations and viral suppression was adequate and maintained in all QD groups. Most AEs were mild and similar between age groups. No serious or Division of AIDS Grade 4 AEs or AE related treatment discontinuations occurred. CONCLUSIONS: NVP-XR exhibited adequate trough concentrations with equivalent area under the curve at steady-state relative to NVP-IR. NVP-XR was well-tolerated and is a valuable treatment option for HIV-infected children and adolescents. Copyright © 2014 by Lippincott Williams & Wilkins.
Authors & Co-Authors
Giaquinto, Carlo
Italy, Padua
Università Degli Studi Di Padova
Anabwani, Gabriel Misango
Botswana, Gaborone
Botswana Baylor Children's Clinical Center of Excellence
Feiterna-Sperling, Cornelia
Germany, Berlin
Charité – Universitätsmedizin Berlin
Nuttall, James J.C.
South Africa, Cape Town
University of Cape Town
Mompati, Kgosidialwa F.
Botswana
Tati River Clinics
Königs, Christoph H.
Germany, Frankfurt am Main
Goethe-universität Frankfurt am Main
Mensa, Federico J.
United States, Ridgefield
Boehringer Ingelheim Pharmaceuticals, Inc.
Sabo, John P.
United States, Ridgefield
Boehringer Ingelheim Pharmaceuticals, Inc.
Yong, Chan Loi
United States, Ridgefield
Boehringer Ingelheim Pharmaceuticals, Inc.
Macgregor, Thomas R.
United States, Ridgefield
Boehringer Ingelheim Pharmaceuticals, Inc.
Nguyen, Thuy Nhien Thanh
United States, Ridgefield
Boehringer Ingelheim Pharmaceuticals, Inc.
Quinson, Anne Marie
United States, Ridgefield
Boehringer Ingelheim Pharmaceuticals, Inc.
Statistics
Citations: 12
Authors: 12
Affiliations: 7
Identifiers
Doi:
10.1097/INF.0000000000000241
ISSN:
08913668
e-ISSN:
15320987
Research Areas
Health System And Policy
Infectious Diseases
Maternal And Child Health