{"title":"Efficacy, safety and tolerability of Biktarvy in HIV-1 infection: A scoping review.","authors":"Ellen Peters, And Collins Iwuji","doi":"10.1177/13596535231159030","DOIUrl":null,"url":null,"abstract":"<p><p><b>Background: </b>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. <b>Purpose: </b>The study aims to collate real-world evidence on the use of Biktarvy in clinical practice to identify gaps in knowledge. <b>Research Design: </b>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. <b>Study Sample: </b>Studies were eligible if they reported on the efficacy, effectiveness, safety or tolerability of bictegravir-based ART. <b>Data Collection and/or Analysis: </b>Data were collected from 17 studies that met the inclusion and exclusion criteria and summarised using a narrative synthesis. <b>Results: </b>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. <b>Conclusions: </b>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.</p>","PeriodicalId":8364,"journal":{"name":"Antiviral Therapy","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Antiviral Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/13596535231159030","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 2
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.
背景:Biktarvy在一系列成功的III期试验后,被批准用于treatment-naïve和有治疗经验的HIV-1感染患者。然而,关于其有效性、安全性和耐受性的真实证据研究有限。目的:本研究旨在整理临床实践中使用Biktarvy的真实证据,以确定知识差距。研究设计:使用PRISMA指南和系统搜索策略进行范围审查。最后使用的搜索策略是(Bictegravir* OR biktarvy)和(efficac* OR safe* OR effect* OR tolerance * OR side effect* OR adverse effect*)。最后一次搜索是在2021年8月12日。研究样本:如果研究报告了双替尼韦为基础的抗逆转录病毒治疗的疗效、有效性、安全性或耐受性,则该研究是合格的。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,并使用叙述性综合方法进行总结。结果:Biktarvy在临床实践中的疗效与III期试验相当。然而,在现实世界的研究中,发现副作用和停药率更高。结论:与药物批准试验相比,纳入的现实世界研究的队列显示出更多的人口多样性,需要对代表性不足的群体(如妇女、孕妇、少数民族和老年人)进行进一步的前瞻性研究。
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.