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Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e3182a1126a
HIV Reports

Pharmacokinetics and 48-week Safety and Antiviral Activity of Fosamprenavir-containing Regimens in HIV-infected 2- to 18-year-old Children

Fortuny, Claudia MD*; Duiculescu, Dan MD; Cheng, Katharine MD; Garges, Harmony P. MD§; Cotton, Mark MD; Tamarirt, Desamparados Pérez MD; Ford, Susan L. PharmD§; Wire, Mary Beth PharmD§; Givens, Naomi MSc; Ross, Lisa L. MS§; Lou, Yu MS§; Perger, Teodora MD; Sievers, Jörg DPhil

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Abstract

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/mm3; 8%) and fosamprenavir/ritonavir group (190 cells/mm3; 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.

© 2014 by Lippincott Williams & Wilkins, Inc.

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