Comparative safety of B/F/TAF versus other antiretroviral therapy regimens for treatment-naïve people with HIV-1: a systematic literature review and network meta-analysis.

IF 1.9 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES
Tristan Curteis, Lucy A Eddowes, Megan Chen, Bhumi Gandhi-Patel, Andrei Karlsson, Hannah Luedke, Manon Rubinstein, Mathias Hempfling, Ernesto G Scerpella, Paresh Chaudhari, James Jarrett
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引用次数: 0

Abstract

Aim: Bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) is a single-tablet regimen approved for the treatment of HIV-1 in treatment-naive (TN) and virologically suppressed people with HIV-1 (PWH). While the efficacy of antiretroviral therapy (ART) regimens in TN PWH is well established, regimen selection is often influenced by safety and tolerability concerns. This systematic literature review and network meta-analysis compares the safety outcomes of B/F/TAF with other ART regimens in TN PWH, addressing a key aspect of therapeutic decision-making. Materials & methods: A systematic literature review was performed to identify phase III and IV RCTs assessing B/F/TAF and comparator regimens in TN adults (≥18 years) with HIV-1. MEDLINE, Embase, Cochrane Database of Systematic Reviews and CENTRAL databases were last searched on 14 June 2023. Study design, population and outcome definitions were evaluated to ensure consistency across studies. Bayesian network meta-analyses were conducted where feasible, following key methodological guidelines. Results: Nineteen studies were included in indirect comparisons following assessments of heterogeneity and network connectivity. B/F/TAF performed better than the majority of interventions in safety and tolerability outcomes, notably discontinuation due to adverse events (AEs), treatment-related AEs and nausea. Additionally, with comparable risk of experiencing grade 3/4 treatment-emergent AEs, diarrhea and all-cause discontinuation rates to other interventions, B/F/TAF was non-inferior to any other regimen for all outcomes. B/F/TAF typically outperformed interventions containing non-nucleoside reverse transcriptase inhibitor third agents in terms of treatment-related AEs, nausea, and discontinuation due to AEs, although treatment class effects were not estimated separately. Conclusion: This analysis highlights the favorable safety profile of B/F/TAF compared with other ART regimens in TN PWH, demonstrating that B/F/TAF remains a safe and well-tolerated ART option for most TN PWH.

B/F/TAF与其他抗逆转录病毒治疗方案对treatment-naïve HIV-1患者的安全性比较:系统文献综述和网络荟萃分析
目的:Bictegravir, emtricitabine and替诺福韦alafenamide (B/F/TAF)是一种被批准用于治疗HIV-1 (TN)和病毒学抑制的HIV-1 (PWH)患者的单片方案。虽然抗逆转录病毒治疗(ART)方案在TN PWH中的疗效已经确立,但方案的选择往往受到安全性和耐受性问题的影响。本系统文献综述和网络荟萃分析比较了B/F/TAF与其他ART方案在TN PWH中的安全性结果,解决了治疗决策的关键方面。材料与方法:通过系统的文献综述,确定评估B/F/TAF和比较方案的III期和IV期随机对照试验(rct),用于TN成人(≥18岁)HIV-1。MEDLINE、Embase、Cochrane系统评价数据库和CENTRAL数据库最后检索时间为2023年6月14日。评估研究设计、人群和结果定义以确保研究的一致性。贝叶斯网络元分析在可行的情况下进行,遵循关键的方法学指导方针。结果:在评估异质性和网络连通性后,19项研究被纳入间接比较。B/F/TAF在安全性和耐受性方面优于大多数干预措施,特别是因不良事件(ae)、治疗相关ae和恶心而停药。此外,与其他干预措施相比,B/F/TAF发生3/4级治疗性不良事件、腹泻和全因停药的风险相当,在所有结果中,B/F/TAF并不逊于任何其他方案。B/F/TAF在治疗相关不良事件、恶心和因不良事件而停药方面通常优于含有非核苷类逆转录酶抑制剂第三剂的干预措施,尽管治疗类效应没有单独估计。结论:该分析强调了B/F/TAF与其他ART方案相比在TN PWH中的良好安全性,表明B/F/TAF仍然是大多数TN PWH的安全和耐受性良好的ART选择。
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来源期刊
Journal of comparative effectiveness research
Journal of comparative effectiveness research HEALTH CARE SCIENCES & SERVICES-
CiteScore
3.50
自引率
9.50%
发文量
121
期刊介绍: Journal of Comparative Effectiveness Research provides a rapid-publication platform for debate, and for the presentation of new findings and research methodologies. Through rigorous evaluation and comprehensive coverage, the Journal of Comparative Effectiveness Research provides stakeholders (including patients, clinicians, healthcare purchasers, and health policy makers) with the key data and opinions to make informed and specific decisions on clinical practice.
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