• Claudia Fortuny, Dan Duiculescu, Katharine Cheng, Harmony P Garges, Mark Cotton, Desamparados Pérez Tamarirt, Susan L Ford, Mary Beth Wire, Naomi Givens, Lisa L Ross, Yu Lou, Teodora Perger, and Jörg Sievers.
• From the *Sant Joan de Déu Hospital, Barcelona, Spain; †Dr. Victor Babes Hospital for Infectious and Tropical Diseases, Bucharest, Romania; ‡GlaxoSmithKline, Uxbridge, United Kingdom; §GlaxoSmithKline, Research Triangle Park, NC; ¶Tygerberg Children's Hospital, Tygerberg, South Africa; and ‖Hospital Infantil La Fe, Valencia, Spain.
• Pediatr. Infect. Dis. J. 2014 Jan 1; 33 (1): 50-6.

BackgroundPharmacokinetics, 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.MethodsSerial 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.ResultsTwenty 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.ConclusionsFosamprenavir 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.

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