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艾维雷韦/考比司他/替诺福韦艾拉酚胺/恩曲他滨单片复方制剂治疗儿童和青少年 HIV 的疗效评价。

An evaluation of elvitegravir plus cobicistat plus tenofovir alafenamide plus emtricitabine as a single-tablet regimen for the treatment of HIV in children and adolescents.

机构信息

a Clinic of Paediatrics , ASST Fatebenefratelli-Sacco , Milano , Italy.

b 1st Division of Infectious Diseases , ASST Fatebenefratelli-Sacco , Milano , Italy.

出版信息

Expert Opin Pharmacother. 2019 Feb;20(3):269-276. doi: 10.1080/14656566.2018.1559299. Epub 2018 Dec 26.


DOI:10.1080/14656566.2018.1559299
PMID:30586314
Abstract

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.

摘要

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。

相似文献

[1]
An evaluation of elvitegravir plus cobicistat plus tenofovir alafenamide plus emtricitabine as a single-tablet regimen for the treatment of HIV in children and adolescents.

Expert Opin Pharmacother. 2018-12-26

[2]
Safety, efficacy, and pharmacokinetics of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in treatment-naive, HIV-infected adolescents: a single-arm, open-label trial.

Lancet HIV. 2016-10-17

[3]
Brief Report: Efficacy and Safety of Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (E/C/F/TAF) in Virologically Suppressed Women.

J Acquir Immune Defic Syndr. 2018-6-1

[4]
Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a multicentre, open-label, phase 3b, randomised trial.

Lancet HIV. 2019-10

[5]
Switching from twice-daily raltegravir plus tenofovir disoproxil fumarate/emtricitabine to once-daily elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate in virologically suppressed, HIV-1-infected subjects: 48 weeks data.

HIV Clin Trials. 2014

[6]
Rare emergence of drug resistance in HIV-1 treatment-naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide.

HIV Clin Trials. 2016-3

[7]
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide: A Review in HIV-1 Infection.

Drugs. 2016-6

[8]
Tenofovir alafenamide, emtricitabine, elvitegravir, and cobicistat combination therapy for the treatment of HIV.

Expert Rev Anti Infect Ther. 2017-3

[9]
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve patients with HIV-1: subgroup analyses of the phase 3 AMBER study.

HIV Res Clin Pract. 2019-2

[10]
Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial.

Lancet. 2012-6-30

引用本文的文献

[1]
Hepatitis B virus drug resistance mutations in HIV/HBV co-infected children in Windhoek, Namibia.

PLoS One. 2020-9-11

[2]
Interventions to Improve Antiretroviral Therapy Adherence Among Adolescents and Youth in Low- and Middle-Income Countries: A Systematic Review 2015-2019.

AIDS Behav. 2020-10

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