Abstract：
Background: Biktarvy is approved for use in HIV-1 infection in both treatment-naïve and treatment-experienced individuals, after a series of successful phase III trials. However, studies on real-world evidence on its efficacy, safety and tolerability are limited. Purpose: The study aims to collate real-world evidence on the use of Biktarvy in clinical practice to identify gaps in knowledge. Research Design: Scoping review was undertaken using PRISMA guidelines and a systematic search strategy. The final search strategy used was (Bictegravir* OR biktarvy) AND (efficac* OR safe* OR effect* OR tolerab* OR \'side effect*\' OR \'adverse effect*\'). The last search was performed on the 12th of August 2021. Study Sample: Studies were eligible if they reported on the efficacy, effectiveness, safety or tolerability of bictegravir-based ART. Data Collection and/or Analysis: Data were collected from 17 studies that met the inclusion and exclusion criteria and summarised using a narrative synthesis. Results: The efficacy of Biktarvy in clinical practice is comparable to phase III trials. However, adverse effects and discontinuation rates were found to be higher in real-world studies. Conclusions: The cohorts in the included real-world studies showed more demographic diversity when compared to the drug approval trials, further prospective studies are required on under-represented groups such as women, pregnant people, ethnic minorities and older adults.
摘要：
背景：Biktarvy被批准用于初治和有治疗经验的个体的HIV-1感染，在一系列成功的III期试验之后.然而,关于其功效的真实世界证据的研究，安全性和耐受性有限。目的：该研究旨在整理有关在临床实践中使用Biktarvy的真实证据，以确定知识差距。研究设计：使用PRISMA指南和系统的搜索策略进行范围审查。使用的最终搜索策略是（Bictegravir*ORbiktarvy）和（efficac*ORsafe*OReffect*ORterialab*OR\'或\'副作用*\'）。最后一次搜索是在2021年8月12日进行的。研究样本：如果研究报告了疗效，则研究合格，有效性,基于bictegravir的ART的安全性或耐受性。数据收集和/或分析：从符合纳入和排除标准的17项研究中收集数据，并使用叙述性综合进行总结。结果：Biktarvy在临床实践中的疗效与III期试验相当。然而,在真实世界的研究中发现不良反应和停药率较高.结论：与药物批准试验相比，纳入的真实世界研究中的队列显示出更多的人口统计学差异，需要对妇女等代表性不足的群体进行进一步的前瞻性研究，孕妇,少数民族和老年人。
