Effectiveness, safety, and patient-reported outcomes of emtricitabine/tenofovir alafenamide-based regimens for the treatment of HIV-1 infection: Final 24-month results from the prospective German TAFNES cohort study.

IF 2.8 3区 医学 Q2 INFECTIOUS DISEASES HIV Medicine Pub Date : 2024-10-30 DOI:10.1111/hiv.13728
Christoph Stephan, Christoph D Spinner, Ansgar Rieke, Stefan Christensen, Stefan Mauss, Sandra Schreiber, Boris Albuquerque, Marion Heinzkill, Heribert Ramroth, Hans-Jürgen Stellbrink
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Abstract

Background: Tenofovir alafenamide (TAF) was introduced in the European Union in 2015 as a novel prodrug of tenofovir showing similar efficacy in clinical trials and a more favorable safety profile than tenofovir disoproxil fumarate (TDF). The German TAFNES cohort study (2016-2019) was conducted to generate real-world evidence.

Methods: Treatment-naïve (TN) and treatment-experienced (TE) people with HIV (PWH) receiving elvitegravir/cobicistat/emtricitabine/TAF (E/C/F/TAF), rilpivirine/F/TAF (R/F/TAF) or F/TAF + 3rd agent were included. Month (M) 24 outcomes included virologic effectiveness (HIV RNA <50 copies/mL), treatment persistence, adverse drug reactions (ADRs) and patient-reported outcomes, using the HIV Symptom Index (HIV-SI), 36-Item Short Form Health Survey (SF-36) and HIV Treatment Satisfaction (HIVTSQ) questionnaires.

Results: The study included 767 PWH (92% men, median age 46 years; 301 TN, 466 TE; E/C/F/TAF [n = 318], R/F/TAF [n = 192], F/TAF + 3rd agent [n = 257]). Among TN, 35% had late HIV diagnosis (CD4 < 350/μL and/or AIDS). Of TE, 95% were on suppressive antiretroviral therapy (ART) before switching. D:A:D (Data Collection on Adverse Effects of Anti-HIV Drugs) 5-year risks for chronic kidney disease were high for about 1 in 10 TN and 4 in 10 TE. Overall treatment persistence at M24 was 81% (E/C/F/TAF: 88%; R/F/TAF: 86%; F/TAF + 3rd agent: 70%, with ART simplification of multiple-tablet regimens in 13%). M24 viral suppression (missing = excluded) was 96% (479/501). Discontinuations due to virologic failure or ADRs were rare, 2% (12/767) and 4% (30/767), respectively. HIV-SI and SF-36 summary scores improved in TN; HIVTSQ change scores showed an improvement in treatment satisfaction in TE.

Conclusion: Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.

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基于恩曲他滨/替诺福韦-阿拉非那胺的方案治疗 HIV-1 感染的有效性、安全性和患者报告结果:德国 TAFNES 前瞻性队列研究 24 个月的最终结果。
背景:替诺福韦-阿拉非那胺(TAF)作为一种新型替诺福韦原药于2015年引入欧盟,在临床试验中显示出与富马酸替诺福韦二吡呋酯(TDF)相似的疗效和更有利的安全性。德国TAFNES队列研究(2016-2019年)旨在获得真实世界的证据:方法:纳入接受埃替拉韦/考比司他/恩曲他滨/TAF(E/C/F/TAF)、利匹韦林/F/TAF(R/F/TAF)或F/TAF+第3种药物治疗的艾滋病病毒感染者(PWH)。第 24 个月的结果包括病毒学有效性(HIV RNA 结果):研究纳入了 767 名 PWH(92% 为男性,中位年龄 46 岁;301 名 TN,466 名 TE;E/C/F/TAF [n = 318],R/F/TAF [n = 192],F/TAF + 第 3 种药物 [n = 257])。在 TN 患者中,35% 的人晚期确诊了 HIV(CD4 结论):真实世界的数据证实,基于 F/TAF 的抗逆转录病毒疗法具有良好的安全性、高病毒学有效性和高治疗满意度。
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来源期刊
HIV Medicine
HIV Medicine 医学-传染病学
CiteScore
5.10
自引率
10.00%
发文量
167
审稿时长
6-12 weeks
期刊介绍: HIV Medicine aims to provide an alternative outlet for publication of international research papers in the field of HIV Medicine, embracing clinical, pharmocological, epidemiological, ethical, preclinical and in vitro studies. In addition, the journal will commission reviews and other feature articles. It will focus on evidence-based medicine as the mainstay of successful management of HIV and AIDS. The journal is specifically aimed at researchers and clinicians with responsibility for treating HIV seropositive patients.
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