a Clinic of Paediatrics , ASST Fatebenefratelli-Sacco , Milano , Italy.
b 1st Division of Infectious Diseases , ASST Fatebenefratelli-Sacco , Milano , Italy.
Expert Opin Pharmacother. 2019 Feb;20(3):269-276. doi: 10.1080/14656566.2018.1559299. Epub 2018 Dec 26.
Approximately 2.1 million of the estimated 36 million infected with HIV are children or adolescents. International guidelines for HIV-1 Infection suggest starting antiretrovirals (ARV) at the moment of diagnosis. Many factors limit the optimization of antiretroviral therapy in children and adolescents: lack of pediatric formulations, poor adherence, metabolic and pharmacokinetic changes associated withnormal child development and puberty. Areas covered: Three integrase inhibitors are approved by the US Food and Drug Administration and by European Medical Agency for children and adolescents with HIV-1 infection. Raltegravir is approved for children aged 4 weeks to 18 years, while dolutegravir and elvitegravir co-formulated with cobicistat, emtricitabine, and tenofovir alafenamide (E/C/FTC/TAF) are approved for children from 6 years of age. This article evaluates E/C/FTC/TAF as a treatment option. Expert opinion: E/C/FTC/TAF was well tolerated, and the antiretroviral activity and tolerability data of this combination support the use in children and adolescents. However, the studies regarding E/C/FTC/TAF in children and adolescents are scant. Consequently, additional studies investigating its safety and efficacy in children are paramount.
估计有 3600 万艾滋病毒感染者中,约有 210 万是儿童或青少年。国际艾滋病毒 1 型感染指南建议在诊断时即开始使用抗逆转录病毒药物(ARV)。许多因素限制了儿童和青少年抗逆转录病毒治疗的优化:缺乏儿科制剂、依从性差、与儿童正常发育和青春期相关的代谢和药代动力学变化。涵盖领域:三种整合酶抑制剂已获得美国食品和药物管理局以及欧洲药品管理局批准,用于治疗感染艾滋病毒 1 型的儿童和青少年。拉替拉韦获准用于 4 周龄至 18 岁的儿童,而多替拉韦和艾维雷韦与考比司他、恩曲他滨和替诺福韦艾拉酚胺(E/C/FTC/TAF)复方制剂则获准用于 6 岁以上的儿童。本文评估了 E/C/FTC/TAF 作为一种治疗选择。专家意见:E/C/FTC/TAF 具有良好的耐受性,该联合用药的抗病毒活性和耐受性数据支持在儿童和青少年中使用。然而,关于儿童和青少年使用 E/C/FTC/TAF 的研究很少。因此,开展更多研究来评估其在儿童中的安全性和疗效至关重要。
Expert Rev Anti Infect Ther. 2017-3