Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine
Objective: To evaluate the steady state pharmacokinetics of nevirapine (NVP) in HIV-infected children receiving a fixed-dose combination of stavudine, lamivudine and NVP. Methods: This cross-sectional study enrolled 34 children (18 girls) who had received GPO-VIR S30 (30 mg stavudine, 150 mg lamivud...
Saved in:
Main Authors: | , , , , , , , |
---|---|
Other Authors: | |
Format: | Article |
Published: |
2018
|
Subjects: | |
Online Access: | https://repository.li.mahidol.ac.th/handle/123456789/16551 |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Institution: | Mahidol University |
id |
th-mahidol.16551 |
---|---|
record_format |
dspace |
spelling |
th-mahidol.165512018-06-21T15:22:58Z Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine Kulkanya Chokephaibulkit Nottasorn Plipat Tim R. Cressey Koen Frederix Wanatpreeya Phongsamart Edmund Capparelli Teera Kolladarungkri Nirun Vanprapar Mahidol University Harvard School of Public Health Chiang Mai University Médicines Sans Frontières University of California, San Diego Faculty of Medicine, Siriraj Hospital, Mahidol University Immunology and Microbiology Medicine Objective: To evaluate the steady state pharmacokinetics of nevirapine (NVP) in HIV-infected children receiving a fixed-dose combination of stavudine, lamivudine and NVP. Methods: This cross-sectional study enrolled 34 children (18 girls) who had received GPO-VIR S30 (30 mg stavudine, 150 mg lamivudine and 200 mg NVP) for at least 8 weeks. Tablets were divided into quarter fractions (1/4, 1/2, 3/4 or 1 tablet) to attain the NVP dosages of 120-200 mg/m2every 12 h. Plasma NVP levels were measured at predose, and at 2 and 6 h after drug administration. Results: The median age was 8.4 years (range, 3-15). Median CD4 lymphocyte count and percentage at study entry was 576 × 106cells/l and 20.25%, respectively. The median pharmacokinetics parameters were area under the curve at 12 h, 78.4 h × μg/ ml; minimum plasma drug concentration, 5.98 μg/ml; plasma half-life, 25.5 h; apparent oral clearance, 0.079 l/kg per h; and volume of distribution, 2.95 l/kg. Only one child had a minimum plasma drug concentration < 3.4 μg/ml (2.57 μg/ml). Of the 13 children who received GPO-VIR as their first-line regimen, 12 had plasma HIV-1 RNA < 400 copies/ml at 6-18 months, with a median CD4 lymphocyte increase of 216 and 433 × 106cells/l at 6 and 12 months of treatment, respectively. Conclusions: The administration of GPO-VIR S30 fixed-dose combination tablets in fractions or as a whole tablet to children resulted in appropriate NVP exposure and satisfactory virological and immunological benefit. This finding confirms the effectiveness of using a fixed-dose combination as a 'transitional option' while waiting for a paediatric fixed-dose combination drug formulation. © 2005 Lippincott Williams & Wilkins. 2018-06-21T08:15:10Z 2018-06-21T08:15:10Z 2005-09-23 Article AIDS. Vol.19, No.14 (2005), 1495-1499 10.1097/01.aids.0000183625.97170.59 02699370 2-s2.0-25844490364 https://repository.li.mahidol.ac.th/handle/123456789/16551 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=25844490364&origin=inward |
institution |
Mahidol University |
building |
Mahidol University Library |
continent |
Asia |
country |
Thailand Thailand |
content_provider |
Mahidol University Library |
collection |
Mahidol University Institutional Repository |
topic |
Immunology and Microbiology Medicine |
spellingShingle |
Immunology and Microbiology Medicine Kulkanya Chokephaibulkit Nottasorn Plipat Tim R. Cressey Koen Frederix Wanatpreeya Phongsamart Edmund Capparelli Teera Kolladarungkri Nirun Vanprapar Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine |
description |
Objective: To evaluate the steady state pharmacokinetics of nevirapine (NVP) in HIV-infected children receiving a fixed-dose combination of stavudine, lamivudine and NVP. Methods: This cross-sectional study enrolled 34 children (18 girls) who had received GPO-VIR S30 (30 mg stavudine, 150 mg lamivudine and 200 mg NVP) for at least 8 weeks. Tablets were divided into quarter fractions (1/4, 1/2, 3/4 or 1 tablet) to attain the NVP dosages of 120-200 mg/m2every 12 h. Plasma NVP levels were measured at predose, and at 2 and 6 h after drug administration. Results: The median age was 8.4 years (range, 3-15). Median CD4 lymphocyte count and percentage at study entry was 576 × 106cells/l and 20.25%, respectively. The median pharmacokinetics parameters were area under the curve at 12 h, 78.4 h × μg/ ml; minimum plasma drug concentration, 5.98 μg/ml; plasma half-life, 25.5 h; apparent oral clearance, 0.079 l/kg per h; and volume of distribution, 2.95 l/kg. Only one child had a minimum plasma drug concentration < 3.4 μg/ml (2.57 μg/ml). Of the 13 children who received GPO-VIR as their first-line regimen, 12 had plasma HIV-1 RNA < 400 copies/ml at 6-18 months, with a median CD4 lymphocyte increase of 216 and 433 × 106cells/l at 6 and 12 months of treatment, respectively. Conclusions: The administration of GPO-VIR S30 fixed-dose combination tablets in fractions or as a whole tablet to children resulted in appropriate NVP exposure and satisfactory virological and immunological benefit. This finding confirms the effectiveness of using a fixed-dose combination as a 'transitional option' while waiting for a paediatric fixed-dose combination drug formulation. © 2005 Lippincott Williams & Wilkins. |
author2 |
Mahidol University |
author_facet |
Mahidol University Kulkanya Chokephaibulkit Nottasorn Plipat Tim R. Cressey Koen Frederix Wanatpreeya Phongsamart Edmund Capparelli Teera Kolladarungkri Nirun Vanprapar |
format |
Article |
author |
Kulkanya Chokephaibulkit Nottasorn Plipat Tim R. Cressey Koen Frederix Wanatpreeya Phongsamart Edmund Capparelli Teera Kolladarungkri Nirun Vanprapar |
author_sort |
Kulkanya Chokephaibulkit |
title |
Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine |
title_short |
Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine |
title_full |
Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine |
title_fullStr |
Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine |
title_full_unstemmed |
Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine |
title_sort |
pharmacokinetics of nevirapine in hiv-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine |
publishDate |
2018 |
url |
https://repository.li.mahidol.ac.th/handle/123456789/16551 |
_version_ |
1763491413811527680 |