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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Pharmacokinetics and 48-week safety and antiviral activity of fosamprenavir-containing regimens in HIV-infected 2- to 18-year-old children
Pediatric Infectious Disease Journal, Volume 33, No. 1, Year 2014
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Description
BACKGROUND: Pharmacokinetics, safety and antiviral activity of twice-daily fosamprenavir with or without ritonavir were evaluated in 2- to 18-year-old protease inhibitor-naïve and -experienced HIV-1-infected children. METHODS: Serial pharmacokinetic samples were collected at week 2 and predose samples every 4-12 weeks. Safety and plasma HIV-1 RNA were monitored every 4-12 weeks. RESULTS: Twenty protease inhibitor-naïve 2- to <6-year-old subjects received antiretroviral treatment including unboosted fosamprenavir twice-daily, whereas 89 protease inhibitor-naïve and -experienced 2- to 18-year-old subjects received fosamprenavir/ritonavir-containing therapy twice-daily. Median fosamprenavir exposure was 891 days (range 15-1805 days), with 88% exposed >48 weeks. Twice-daily doses of fosamprenavir/ritonavir 23/3 mg/kg in 2- to <6-year olds, 18/3 mg/kg in ≥6-year olds and 700/100 mg in adolescents achieved plasma amprenavir exposures comparable with or higher than 700/100 mg twice-daily in adults while fosamprenavir 30 mg/kg twice-daily in 2- to <6-year olds led to exposures higher than 1400 mg twice-daily in adults. The proportion of subjects with HIV-1 RNA <400 copies/mL at week 48 was 60% for fosamprenavir and 53-74% for fosamprenavir/ritonavir (intent-to-treat [exposed], snapshot analysis). Median increases in absolute and relative (percentage) CD4 counts from baseline to week 48 occurred in both the fosamprenavir (340 cells/mm; 8%) and fosamprenavir/ritonavir group (190 cells/mm; 8%). The most common adverse events were vomiting, cough, and diarrhea; 18 subjects experienced serious adverse events, including 9 with suspected abacavir hypersensitivity. CONCLUSIONS: Fosamprenavir regimens administered to HIV-1-infected children aged 2-18 years were generally well-tolerated and provided sustained antiviral activity over 48 weeks, with plasma amprenavir exposures comparable with or higher than adults. Copyright © 2013 by Lippincott Williams & Wilkins.
Authors & Co-Authors
Fortuny, Clàudia
Spain, Esplugues de Llobregat
Hospital Sant Joan de Déu Barcelona
Duiculescu, Dan Constantin
Romania, Bucharest
Victor Babes National Institute
Cheng, Katharine Y.
United Kingdom, Brentford
Glaxosmithkline Plc.
Garges, Harmony P.
United States, Philadelphia
Glaxosmithkline, Usa
Cotton, Mark Fredric
South Africa, Tygerberg
Tygerberg Hospital
Tamarirt, Desamparados Pérez
Spain, Valencia
Hospital Infantil la fe
Ford, Susan L.
United States, Philadelphia
Glaxosmithkline, Usa
Wire, Mary Beth
United States, Philadelphia
Glaxosmithkline, Usa
Givens, Naomi
United Kingdom, Brentford
Glaxosmithkline Plc.
Ross, Lisa L.
United States, Philadelphia
Glaxosmithkline, Usa
Lou, Yu
United States, Philadelphia
Glaxosmithkline, Usa
Perger, Teodora
United Kingdom, Brentford
Glaxosmithkline Plc.
Sievers, Jörg
United Kingdom, Brentford
Glaxosmithkline Plc.
Statistics
Citations: 13
Authors: 13
Affiliations: 6
Identifiers
Doi:
10.1097/INF.0b013e3182a1126a
ISSN:
08913668
e-ISSN:
15320987
Research Areas
Infectious Diseases
Maternal And Child Health