复方新药Biktarvy®在中国HIV抗病毒治疗中的临床价值

摘要/Abstract

摘要： 2018年,欧美地区主要的循证治疗指南均对人类免疫缺陷病毒（human immunodeficiency virus,HIV）治疗的首选抗反转录病毒治疗（antiretroviral therapy,ART）方案进行了更新,加入了最新的基于整合酶抑制剂（integrase strand transfer inhibitor,INSTI）的三合一复方单片制剂（single tablet regimen,STR）Biktarvy®（bictegravir/恩曲他滨 /丙酚替诺福韦）。Biktarvy®也被美国指南推荐为快速启动治疗的首选方案之一。此方案的临床试验数据显示其疗效不劣于既往首选ART方案,且安全性与耐药屏障较高。Biktarvy®已在欧美及亚洲部分地区获批上市并投入临床使用。本文旨在综述Biktarvy®在关键性临床试验中的疗效和安全性,并结合我国HIV患者的情况分析其在我国HIV治疗中的潜在临床价值。

关键词: Bictegravir, 整合酶抑制剂, 人类免疫缺陷病毒, 抗反转录病毒治疗

Abstract: Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide), a new integrase strand transfer inhibitor (INSTI)- based single tablet regimen (STR), has been recommended as a first-line antiretroviral therapy (ART) by European and American guidelines in 2018. It has also been recommended by American guidelines as one of the first-line options for rapid initiation of ART. Biktarvy® a good safety profile and a high resistance barrier in clinical trials is demonstrated non-inferior efficacy to existing first-line ART regimens, a good safety profile and a high resistance barrier in clinical trials. It has been approved and used clinically in the European Union (EU), the United States of America (USA) and some regions in Asia. This paper reviews the efficacy and safety data from Biktarvy’s pivotal trials, and discusses the potential clinical significance of this novel regimen for the treatment of Chinese patients with human immunodeficiency viruses (HIV) infection.

Key words: Bictegravir, Integrase strand transfer inhibitor, HIV, Antiretroviral therapy

王辉. 复方新药Biktarvy®在中国HIV抗病毒治疗中的临床价值[J]. 新发传染病电子杂志, 2019, 4(2): 85-90.

WANG Hui. The potential clinical value of Biktarvy® in HIV treatment in China[J]. Electronic Journal of Emerging Infectious Diseases, 2019, 4(2): 85-90.

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