使用匹配的安慰剂片剂,评估达芦那韦/考比司他/恩曲他滨/替诺福韦-阿拉非那胺(D/C/F/TAF)固定剂量复方片剂(FDC)在年龄≥6至<12岁的HIV-1感染儿童中的吞咽性和可接受性:随机研究。

IF 1.3 4区 医学 Q4 INFECTIOUS DISEASES
Sandy Van Hemelryck, Erika Van Landuyt, Veerle Hufkens, Simon Vanveggel
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引用次数: 0

摘要

背景:达芦那韦/可比司他/恩曲他滨/替诺福韦-阿拉非那胺(D/C/F/TAF)固定剂量复合制剂(FDC)被开发为每日一次的全套抗逆转录病毒(ARV)疗法,以满足简化蛋白酶抑制剂型抗逆转录病毒疗法的需求。本研究评估了与D/C/F/TAF FDC片剂相匹配的已评分安慰剂片剂在HIV-1感染儿童中的吞咽性和长期使用的可接受性:本研究(NCT04006704)是一项第 1 期、开放标签、随机、单剂量、2 期、2 顺序交叉研究,研究对象为年龄≥6 岁的 HIV-1 儿童:在 24 名注册并完成研究的参与者中,95.8%(23/24)的人在尝试 1 或 2 次后就能吞下整片和分装的对等安慰剂 D/C/F/TAF 药片。大多数参与者(>70%)认为长期每天服用药片的可接受性是可以接受或可以服用的。79.2%(19/24)的护理人员认为掰药片很容易或没问题:结论:经评分的D/C/F/TAF FDC片剂可吞咽(整片比掰开的片剂更受欢迎),对于年龄≥6岁至12岁的HIV-1感染儿童来说,至少可以接受长期每日服用:试验注册:ClinicalTrials.gov Identifier:NCT04006704。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Assessment of swallowability and acceptability of scored darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets in HIV-1-infected children aged ≥6 to <12 years, using matching placebo tablets: A randomized study.

Background: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) was developed as a once-daily, complete antiretroviral (ARV) regimen therapy to address the need for simplified protease inhibitor-based ARV regimens. This study assessed the swallowability and acceptability for long-term use of scored placebo tablets matching the D/C/F/TAF FDC tablets in children living with HIV-1.

Methods: This study (NCT04006704) was a Phase 1, open-label, randomized, single-dose, 2-period, 2-sequence crossover study in children living with HIV-1, aged ≥6 to <12 years and weighing ≥25 to <40 kg, on a stable ARV regimen for ≥3 months. Participants were asked to swallow whole (size, 21 × 11 × 7 mm) and split matching placebo D/C/F/TAF tablets. Swallowability of the matching placebo D/C/F/TAF tablets (primary endpoint) was assessed by observers. Acceptability of taking matching placebo D/C/F/TAF tablets and current ARVs was evaluated by participants using a 3-point questionnaire. Participants rated the acceptability for long-term daily use of the placebo D/C/F/TAF tablets, and observers assessed how easily caregivers could split a scored tablet by hand, using 3-point questionnaires.

Results: Among the 24 participants who enrolled and completed the study, 95.8% (23/24) were able to swallow the whole and split matching placebo D/C/F/TAF tablets after 1 or 2 attempts. Most participants (>70%) rated the acceptability of tablets for long-term daily use as acceptable or good to take. Breaking the tablets was considered easy or OK by 79.2% (19/24) of caregivers.

Conclusion: Scored D/C/F/TAF FDC tablets are swallowable - with whole favoured over split - and considered at least acceptable for long-term daily intake in children living with HIV-1 aged ≥6 to <12 years.

Trial registration: ClinicalTrials.gov Identifier: NCT04006704.

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来源期刊
Antiviral Therapy
Antiviral Therapy 医学-病毒学
CiteScore
2.60
自引率
8.30%
发文量
35
审稿时长
4-8 weeks
期刊介绍: Antiviral Therapy (an official publication of the International Society of Antiviral Research) is an international, peer-reviewed journal devoted to publishing articles on the clinical development and use of antiviral agents and vaccines, and the treatment of all viral diseases. Antiviral Therapy is one of the leading journals in virology and infectious diseases. The journal is comprehensive, and publishes articles concerning all clinical aspects of antiviral therapy. It features editorials, original research papers, specially commissioned review articles, letters and book reviews. The journal is aimed at physicians and specialists interested in clinical and basic research.
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