一项针对高胆固醇血症HIV-1感染个体的随机对照试验：继续使用阿巴卡韦/拉米夫定加依非韦伦，或换用依非韦伦/恩曲他滨/替诺福韦酯。
A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals.
作者信息
Moyle Graeme J, Orkin Chloe, Fisher Martin, Dhar Jyoti, Anderson Jane, Wilkins Edmund, Ewan Jacqueline, Ebrahimi Ramin, Wang Hui
机构信息
Chelsea and Westminster Hospital, London, SW10 9NH, United Kingdom.
St Bartholomew's and Royal London Hospitals, London, United Kingdom.
出版信息
PLoS One. 2015 Feb 6;10(2):e0116297. doi: 10.1371/journal.pone.0116297. eCollection 2015.
BACKGROUND
Drug choice and metabolic changes with antiretroviral therapy contribute to cardiovascular risk in persons with HIV-1 infection.
METHODS
A randomized, 12 week, open-label, comparative study of the impact on lipids of continuation of abacavir/lamivudine (ABC/3TC) plus efavirenz (EFV) or replacement with the single tablet regimen of EFV/emtricitabine/tenofovir DF (EFV/FTC/TDF) in hypercholesterolaemic subjects on successful antiretroviral therapy, with a 12-week extension with all subjects on EFV/FTC/TDF.
RESULTS
157 subjects received study drug, 79 switched to EFV/FTC/TDF and 78 subjects continued ABC/3TC+EFV. At Week 12, 73 subjects on ABC/3TC+EFV switched to EFV/FTC/TDF. The switch was well tolerated and no subject experienced viral rebound. Median baseline fasting total cholesterol was 6.32 mmol/L. 12 weeks following switch, the difference in the means (LSM) between treatment groups (EFV/FTC/TDF minus ABC/3TC+EFV) in total cholesterol change from baseline was -0.74 mmol/l (95% CI -1.00, -0.47, p < 0.001). The median change from baseline in total cholesterol following switch in the EFV/FTC/TDF arm was -0.86 mmol/l (p < 0.001) compared with +0.01 mmol/l (p = 0.45) in the continuation arm at Week 12. Significant (p < 0.001) differences between treatment groups following switch were seen for all lipid fractions from baseline to Week 12: LDL cholesterol (-0.47 mmol/L [-0.70, -0.25]), HDL cholesterol (-0.15 mmol/L [-0.21, -0.08]), triglycerides (-0.43 mmol/L [-0.75, -0.11]), and non HDL cholesterol (-0.56 mmol/L [-0.80, -0.31]). In the extension phase, similar declines in total cholesterol were observed with a median change from Week 12 to Week 24 of -0.73 mmol/L (p < 0.001).
CONCLUSIONS
Switching from ABC/3TC+EFV to EFV/FTC/TDF in persons with hypercholesterolemia maintains virological control and significantly improves key lipid parameters.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00615810.
背景
抗逆转录病毒疗法的药物选择和代谢变化会增加HIV-1感染者的心血管疾病风险。
方法
一项随机、为期12周的开放标签对照研究，旨在观察对于接受抗逆转录病毒疗法治疗成功的高胆固醇血症患者，继续使用阿巴卡韦/拉米夫定（ABC/3TC）加依非韦伦（EFV）或换用依非韦伦/恩曲他滨/替诺福韦酯（EFV/FTC/TDF）单片复方制剂对血脂的影响，并对所有患者使用EFV/FTC/TDF进行为期12周的延长治疗。
结果
157名受试者接受了研究药物治疗，79名换用EFV/FTC/TDF，78名继续使用ABC/3TC+EFV。在第12周时，73名使用ABC/3TC+EFV的受试者换用了EFV/FTC/TDF。换药耐受性良好，无受试者出现病毒反弹。基线空腹总胆固醇中位数为6.32 mmol/L。换药后12周，治疗组（EFV/FTC/TDF减去ABC/3TC+EFV）总胆固醇相对于基线变化的均值（LSM）差异为-0.74 mmol/l（95%CI -1.00，-0.47，p<0.001）。在EFV/FTC/TDF组，换药后总胆固醇相对于基线的中位数变化为-0.86 mmol/l（p<0.001），而在继续使用原方案组，第12周时相对于基线的变化为+0.01 mmol/l（p = 0.45）。从基线到第12周，治疗组之间所有血脂指标均有显著差异（p<0.001）：低密度脂蛋白胆固醇（-0.47 mmol/L [-0.70，-0.25]）、高密度脂蛋白胆固醇（-0.15 mmol/L [-0.21，-0.08]）、甘油三酯（-0.43 mmol/L [-0.75，-0.11]）和非高密度脂蛋白胆固醇（-0.56 mmol/L [-0.80，-0.31]）。在延长治疗阶段，观察到总胆固醇有类似下降，从第12周到第24周的中位数变化为-0.73 mmol/L（p<0.001）。
结论
高胆固醇血症患者从ABC/3TC+EFV换用EFV/FTC/TDF可维持病毒学控制，并显著改善关键血脂参数。
试验注册
ClinicalTrials.gov NCT00615810。
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