Dolutegravir: Clinical and Laboratory Safety in Integrase Inhibitor-Naive Patients
Dolutegravir: Clinical and Laboratory Safety in Integrase Inhibitor-Naive Patients
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DOI：
10.1310/hct1505-199
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发表时间：
2014-09-01
影响因子：
--
通讯作者：
Min, S.
中科院分区：
文献类型：
--
作者：
Curtis, L.;Nichols, G.;Min, S.
背景：在整合酶抑制剂（INI）初治成人人群中进行的5项随机研究证实了度鲁特韦（DTG）的疗效。迄今为止，文献中尚未提供DTG的详细安全性综述。目的：基于5项随机对照试验以及与3种主要抗逆转录病毒（ARV）药物的比较，描述DTG在成人中的安全性和耐受性特征。方法：整合了来自ART初治和ART经验丰富、INI初治成人IIb/III/IIIb期试验的安全性数据。结果如下：在4项ART初治研究（SPRING-1、SPRING-2、SINGLE、FLAMINGO）和1项ART经验丰富的INI初治研究（SAILING）中，1，579例受试者接受了含DTG的方案。DTG治疗组中因不良事件（AE）而退出的个体比例较低（
Background: The efficacy of dolutegravir (DTG) has been demonstrated in 5 randomized studies in integrase inhibitor (INI)-naive adult populations. To date, a detailed safety review of DTG has not been provided in the literature. Objective: To describe the safety and tolerability profile of DTG in adults based on 5 randomized, controlled trials and comparison with drugs in 3 major antiretroviral (ARV) classes. Methods: Safety data from phase IIb/III/IIIb trials in ART-naive and ART-experienced, INI-naive adults were integrated. Results: In 4 ART-naive (SPRING-1, SPRING-2, SINGLE, FLAMINGO) and 1 ART-experienced, INI-naive study (SAILING), 1,579 individuals received a DTG-containing regimen. The proportion of individuals from DTG treatment arms who withdrew due to adverse events (AEs) was low (