Rokx Casper, Verbon Annelies, Rijnders Bart J A
Department of Internal Medicine and Infectious Diseases, Erasmus University Medical Center , Rotterdam, the Netherlands .
AIDS Res Hum Retroviruses. 2015 Apr;31(4):363-7. doi: 10.1089/AID.2014.0278. Epub 2015 Feb 26.
Antiretroviral therapy-related dyslipidemia increases the risk of cardiovascular disease (CVD) and is less frequently observed with nevirapine. Whether substituting rilpivirine for nevirapine has dyslipidemic consequences and alters CVD risk is unknown. The aim of this prospective open-label clinical trial was to evaluate serum lipids, cardiovascular risks, and lipid treatment goals over 48 weeks after switching from nevirapine to rilpivirine. Fifty HIV-1-suppressed patients on stable once-daily nevirapine plus emtricitabine/tenofovir-DF were switched to single-tablet rilpivirine/emtricitabine/tenofovir-DF. Lifestyle, weight, systolic blood pressure (SBP), ≥6 h overnight fasting lipids, 10-year Framingham risk scores (FRS), and Adult Treatment Panel III (ATP-III) lipid goals were evaluated over 48 weeks. Patients were 82% males, were a median of 45 years of age, and were on nevirapine for a median of 66 months. Diets, exercise levels, body mass index, and smoking status did not change during follow-up. At week 24, significant changes (p<0.001) were seen in mean [95% confidence interval (CI)] total cholesterol (-0.67 mmol/liter, CI: -0.50 to -0.83), low-density lipoprotein cholesterol (-0.36, CI: -0.21 to -0.51), and high-density lipoprotein cholesterol (-0.28, CI: -0.20 to -0.35). The total cholesterol/high-density lipoprotein cholesterol ratio increased 0.20 (CI: 0.02 to 0.37; p=0.029). Triglycerides did not change and the SBP decreased 6 mmHg (CI: -1.7 to -10.3; p=0.007). Week 48 lipid profiles and SBP were similar to week 24. The median FRS did not change during follow-up (-0.7%, p=0.119). More patients achieved ATP-III low-density lipoprotein cholesterol (+14.9%; p=0.016) and total cholesterol goals (+25.5%; p<0.001). The lipid profile changes after substituting rilpivirine for nevirapine did not significantly influence FRS, although SBP and the ATP-III low-density lipoprotein and total cholesterol goals improved.
抗逆转录病毒疗法相关的血脂异常会增加心血管疾病（CVD）的风险，而奈韦拉平导致这种情况的频率较低。用利匹韦林替代奈韦拉平是否会产生血脂异常后果并改变心血管疾病风险尚不清楚。这项前瞻性开放标签临床试验的目的是评估从奈韦拉平换用利匹韦林48周后的血脂、心血管疾病风险和血脂治疗目标。50名接受稳定的每日一次奈韦拉平加恩曲他滨/替诺福韦酯治疗且HIV-1得到抑制的患者换用利匹韦林/恩曲他滨/替诺福韦酯单片制剂。在48周内评估生活方式、体重、收缩压（SBP）、≥6小时空腹血脂、10年弗明汉风险评分（FRS）以及成人治疗专家组III（ATP-III）血脂目标。患者中82%为男性，中位年龄45岁，接受奈韦拉平治疗的中位时间为66个月。随访期间饮食、运动水平、体重指数和吸烟状况未发生变化。在第24周时，平均[95%置信区间（CI）]总胆固醇（-0.67毫摩尔/升，CI：-0.50至-0.83）、低密度脂蛋白胆固醇（-0.36，CI：-0.21至-0.51）和高密度脂蛋白胆固醇（-0.28，CI：-0.20至-0.35）出现显著变化（p<0.001）。总胆固醇/高密度脂蛋白胆固醇比值增加0.20（CI：0.02至0.37；p=0.029）。甘油三酯未发生变化，收缩压下降6毫米汞柱（CI：-1.7至-10.3；p=0.007）。第48周时的血脂谱和收缩压与第24周相似。随访期间中位FRS未发生变化（-0.7%，p=0.119）。更多患者实现了ATP-III低密度脂蛋白胆固醇目标（增加14.9%；p=0.016）和总胆固醇目标（增加25.5%；p<0.001）。用利匹韦林替代奈韦拉平后的血脂谱变化虽未显著影响FRS，但收缩压以及ATP-III低密度脂蛋白和总胆固醇目标有所改善。
