Rosenblatt Lisa, Broder Michael S, Bentley Tanya G K, Chang Eunice, Reddy Sheila R, Papoyan Elya, Myers Joel
a Bristol-Myers Squibb , Lawrenceville , NJ , USA.
b Partnership for Health Analytic Research, LLC , Beverly Hills , CA , USA.
AIDS Care. 2017 Aug;29(8):1067-1073. doi: 10.1080/09540121.2017.1280123. Epub 2017 Feb 1.
Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor indicated for treatment of HIV-1 infection. Despite concern over EFV tolerability in clinical trials and practice, particularly related to central nervous system (CNS) adverse events, some observational studies have shown high rates of EFV continuation at one year and low rates of CNS-related EFV substitution. The objective of this study was to further examine the real-world rate of CNS-related EFV discontinuation in antiretroviral therapy naïve HIV-1 patients. This retrospective cohort study used a nationally representative electronic medical records database to identify HIV-1 patients ≥12 years old, treated with a 1st-line EFV-based regimen (single or combination antiretroviral tablet) from 1 January 2009 to 30 June 2013. Patients without prior record of EFV use during 6-month baseline (i.e., antiretroviral therapy naïve) were followed 12 months post-medication initiation. CNS-related EFV discontinuation was defined as evidence of a switch to a replacement antiretroviral coupled with record of a CNS symptom within 30 days prior, absent lab evidence of virologic failure. We identified 1742 1st-line EFV patients. Mean age was 48 years, 22.7% were female, and 8.1% had a prior report of CNS symptoms. The first year, overall discontinuation rate among new users of EFV was 16.2%. Ten percent of patients (n = 174) reported a CNS symptom and 1.1% (n = 19) discontinued EFV due to CNS symptoms: insomnia (n = 12), headache (n = 5), impaired concentration (n = 1), and somnolence (n = 1). The frequency of CNS symptoms was similar for patients who discontinued EFV compared to those who did not (10.3 vs. 9.9%; P = .86). Our study found that EFV discontinuation due to CNS symptoms was low, consistent with prior reports.
依非韦伦（EFV）是一种非核苷类逆转录酶抑制剂，用于治疗HIV-1感染。尽管在临床试验和实践中对依非韦伦的耐受性存在担忧，特别是与中枢神经系统（CNS）不良事件相关，但一些观察性研究显示，一年时依非韦伦的持续使用率较高，而与中枢神经系统相关的依非韦伦替代率较低。本研究的目的是进一步检查初治HIV-1患者中与中枢神经系统相关的依非韦伦停药的实际发生率。这项回顾性队列研究使用了一个具有全国代表性的电子病历数据库，以识别2009年1月1日至2013年6月30日期间年龄≥12岁、接受基于依非韦伦的一线治疗方案（单一或联合抗逆转录病毒片剂）治疗的HIV-1患者。在6个月基线期内无依非韦伦使用记录（即初治抗逆转录病毒治疗）的患者在开始用药后随访12个月。与中枢神经系统相关的依非韦伦停药定义为改用替代抗逆转录病毒药物的证据，以及用药前30天内有中枢神经系统症状记录，且无病毒学失败的实验室证据。我们识别出1742例一线使用依非韦伦的患者。平均年龄为48岁，22.7%为女性，8.1%既往有中枢神经系统症状报告。第一年，依非韦伦新使用者的总体停药率为16.2%。10%的患者（n = 174）报告有中枢神经系统症状，1.1%（n = 19）因中枢神经系统症状停用依非韦伦：失眠（n = 12）、头痛（n = 5）、注意力不集中（n = 1）和嗜睡（n = 1）。与未停用依非韦伦的患者相比，停用依非韦伦的患者中枢神经系统症状的发生率相似（10.3%对9.9%；P = 0.86）。我们的研究发现，因中枢神经系统症状导致的依非韦伦停药率较低，与既往报告一致。
