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首页> 外文期刊>The Pediatric infectious disease journal >Pharmacokinetics and 48-week safety and antiviral activity of fosamprenavir-containing regimens in HIV-infected 2- to 18-year-old children
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Pharmacokinetics and 48-week safety and antiviral activity of fosamprenavir-containing regimens in HIV-infected 2- to 18-year-old children

机译：含有磷氨苯那韦的方案在HIV感染的2至18岁儿童中的药代动力学以及48周的安全性和抗病毒活性

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BACKGROUND: Pharmacokinetics, safety and antiviral activity of twice-daily fosamprenavir with or without ritonavir were evaluated in 2- to 18-year-old protease inhibitor-na?ve 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-na?ve 2- to <6-year-old subjects received antiretroviral treatment including unboosted fosamprenavir twice-daily, whereas 89 protease inhibitor-na?ve 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.
机译：背景：在2到18岁的未受过蛋白酶抑制剂治疗的和经验丰富的HIV-1感染儿童中，评估了每天两次含或不含利托那韦的福沙普韦的药代动力学，安全性和抗病毒活性。方法：在第2周收集系列药代动力学样品，每4-12周用药一次。每4-12周监测一次安全性和血浆HIV-1 RNA。结果：20名2至6岁的未使用蛋白酶抑制剂的受试者每天接受两次抗逆转录病毒治疗，包括未加用的fosamprenavir，而89名2至18岁的未使用蛋白酶抑制剂的初学者和2名受试者。每天两次含fosamprenavir / ritonavir的治疗。 fosamprenavir暴露中位数为891天（范围为15-1805天），其中88％暴露于> 48周。每天两次向2岁至<6岁的儿童服用fosamprenavir / ritonavir的剂量为23/3 mg / kg，≥6岁者为18/3 mg / kg的剂量，青少年为700/100 mg，相当于成人每天两次高于700/100 mg，而2至6岁以下儿童每天两次fosamprenavir 30 mg / kg导致成年人每天两次暴露高于1400 mg。在第48周，HIV-1 RNA <400拷贝/ mL的受试者中，fosamprenavir的使用率为60％，而fosamprenavir / ritonavir的使用率为53-74％（意图治疗[暴露]，快照分析）。 fosamprenavir（340细胞/ mm; 8％）和fosamprenavir / ritonavir组（190 cells / mm; 8％）从基线到第48周的绝对和相对（百分比）CD4计数中位数增加。最常见的不良反应是呕吐，咳嗽和腹泻。 18名受试者发生了严重的不良事件，包括9名怀疑阿巴卡韦超敏反应的受试者。结论：对接受过HIV-1感染的2-18岁儿童实施Fosamprenavir方案耐受性良好，并在48周内提供持续的抗病毒活性，血浆氨普那韦暴露量与成人相当或更高。

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