University Clinic of Infectious Diseases, University Hospital of Geneva, Switzerland.
AIDS. 2011 Jul 31;25(12):1481-7. doi: 10.1097/QAD.0b013e328348dab0.
Efavirenz (EFV) causes neuropsychiatric side-effects and an unfavorable blood lipid profile. We investigated the effect of replacing EFV with raltegravir (RAL) on patient preference, daytime sleepiness, sleep quality, anxiety, and lipid levels.
Switch-ER was a randomized, double-blind, cross-over study. Patients who tolerated EFV, with less than 50 copies/ml HIV-RNA, were randomized into two groups: the RAL-first group started with RAL (400 mg twice daily) and EFV placebo, and the EFV-first group with EFV (600 mg once daily) and RAL placebo. After 2 weeks, both groups switched to the alternate regimen. The primary endpoint was patient preference for the first or the second regimen, assessed after 4 weeks.
Fifty seven participants were enrolled with a median CD4 cell count 600/μl, and duration of previous EFV therapy 3.4 years. Fifty three participants completed the study. When asked about treatment preference after 4 weeks, 22 preferred RAL and 12 preferred EFV, whereas 19 did not express a preference. A significant difference in anxiety and stress scores favoring RAL (P = 0.04 and 0.03, respectively) was observed. Median plasma cholesterol levels decreased by 0.4 mmol/l (16 mg/dl, P < 0.001), triglycerides by 0.2 mmol/l (18 mg/dl, P = 0.036), and low-density lipoprotein by 0.2 mmol/l (8 mg/dl, P = 0.004) after replacing EFV with RAL. After study completion, 51% of patients switched to RAL.
Half of patients previously on a stable EFV preferred to switch to RAL, after double-blind exposure to RAL for 2 weeks. Substitution of EFV by RAL significantly impacted on lipid levels, stress, and anxiety scores.
依非韦伦（EFV）会引起神经精神副作用和血脂异常。我们研究了用拉替拉韦（RAL）替代 EFV 对患者选择、日间嗜睡、睡眠质量、焦虑和血脂水平的影响。
Switch-ER 是一项随机、双盲、交叉研究。耐受 EFV、HIV-RNA<50 拷贝/ml 的患者随机分为两组：RAL 先组开始服用 RAL（400 mg 每日两次）和 EFV 安慰剂，EFV 先组开始服用 EFV（600 mg 每日一次）和 RAL 安慰剂。2 周后，两组均切换至另一方案。主要终点是 4 周后评估的患者对第一或第二方案的偏好。
57 名参与者入组，中位 CD4 细胞计数为 600/μl，既往 EFV 治疗时间为 3.4 年。53 名参与者完成了研究。4 周后询问治疗偏好时，22 名患者更喜欢 RAL，12 名更喜欢 EFV，19 名患者未表达偏好。RAL 组焦虑和应激评分显著改善（P=0.04 和 0.03）。用 RAL 替代 EFV 后，血浆胆固醇水平中位数降低 0.4mmol/l（16mg/dl，P<0.001），甘油三酯降低 0.2mmol/l（18mg/dl，P=0.036），低密度脂蛋白降低 0.2mmol/l（8mg/dl，P=0.004）。研究结束后，51%的患者转为 RAL。
57 名先前服用稳定 EFV 的患者中，有一半在接受 RAL 双盲治疗 2 周后更喜欢改用 RAL。用 RAL 替代 EFV 显著影响血脂水平、压力和焦虑评分。
