Clifford David B, Evans Scott, Yang Yijun, Acosta Edward P, Ribaudo Heather, Gulick Roy M
Washington University School of Medicine, St. Louis, MO 63110, USA.
HIV Clin Trials. 2009 Nov-Dec;10(6):343-55. doi: 10.1310/hct1006-343.
Efavirenz (EFV) is an antiretroviral (ARV) drug associated with neuropsychological effects. Limited data describing the long-term impact of EFV-based regimens on neuropsychological performance over more than 3 years are available.
We enrolled a subset of participants from a large initially EFV placebo-controlled trial of therapies for HIV subjects naïve to ARV treatment (A5095). Clinical follow-up continued for 184 weeks of study. Subjects were assessed with brief neuropsychological testing, a symptom questionnaire of EFV-associated symptoms, the Pittsburgh Sleep Index, Center for Epidemiologic Studies-Depression Scale, and an anxiety rating interview.
Over 184 weeks on EFV, the median NPZ3 score in 86 evaluable patients improved from baseline by +0.5 (p < .01); all components improved, although higher EFV levels were associated with slightly lower responses. Overall symptom scores did not change, while EFV-associated CNS symptoms increased (p = .01). Median change of bad dream sleep scores and anxiety increased from the baseline while global depression score decreased.
In participants who continued EFV-based regimens, neuropsychological performance improvement from baseline was maintained over 3 years. EFV-based treatment was generally well tolerated, but small increases from baseline in EFV-associated symptoms, bad dreams, and anxiety were detected.
依非韦伦（EFV）是一种与神经心理效应相关的抗逆转录病毒（ARV）药物。目前关于基于EFV的治疗方案对神经心理表现超过3年的长期影响的数据有限。
我们从一项最初针对未接受过ARV治疗的HIV受试者的大型EFV安慰剂对照治疗试验（A5095）中招募了一部分参与者。临床随访持续了184周的研究。受试者接受了简短的神经心理测试、EFV相关症状的症状问卷、匹兹堡睡眠指数、流行病学研究中心抑郁量表和焦虑评级访谈。
在接受EFV治疗的184周内，86名可评估患者的NPZ3评分中位数较基线提高了+0.5（p <.01）；所有组成部分均有改善，尽管较高的EFV水平与稍低的反应相关。总体症状评分没有变化，而与EFV相关的中枢神经系统症状增加（p =.01）。噩梦睡眠评分和焦虑的中位数变化较基线增加，而总体抑郁评分下降。
在继续接受基于EFV治疗方案的参与者中，神经心理表现较基线的改善在3年内得以维持。基于EFV的治疗总体耐受性良好，但检测到与EFV相关的症状、噩梦和焦虑较基线有小幅增加。
