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在真实环境中,从富马酸替诺福韦二吡呋酯转换为替诺福韦艾拉酚胺会显著恶化血脂谱。

Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide Significantly Worsens the Lipid Profile in a Real-World Setting.

机构信息

Department of Infectious Diseases, Inflammation Center, Helsinki, Finland.

University of Helsinki, Helsinki, Finland.

出版信息

AIDS Patient Care STDS. 2019 Dec;33(12):500-506. doi: 10.1089/apc.2019.0236. Epub 2019 Nov 19.

Abstract

Tenofovir disoproxil fumarate (TDF) has increasingly been replaced by tenofovir alafenamide (TAF) because of reduced kidney and bone toxicity with TAF. This switch has, however, caused worsening of lipid concentrations in clinical trials, but data from any real-world setting are scarce. The objective of this study was to characterize the effect of TDF to TAF switch on plasma lipid concentrations in a real-world clinic population. This is a retrospective study comparing lipid concentrations and other laboratory parameters between the last visit on TDF and the first visit after at least a 2-month exposure to TAF. A total of 490 HIV-positive subjects were included in the study. The median (interquartile range) increase was 23.2 (0-38.7) mg/dL in total cholesterol ( < 0.001) and 15.5 (0-30.9) mg/dL in low-density lipoprotein (LDL) cholesterol ( < 0.001). The ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol increased by 0.2 (-0.2 to 0.6),  < 0.001. The proportion of patients having optimal LDL cholesterol concentration by National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) decreased from 30.8% to 17.8% and proportion having dyslipidemia or severe dyslipidemia increased from 30.2% to 50.3% after the switch. Demographic characteristics, antiretroviral agents, or comedication did not affect the changes in lipid concentrations. Plasma creatinine decreased by 0.03 (-0.09 to 0.03) mg/dL ( < 0.001) and estimated glomerular filtration rate increased by 0.5 (-2.3 to 3.2) mL/min ( = 0.009). Switching from TDF to TAF caused a statistically significant worsening of the lipid profile that may have clinical relevance. The benefit of the lipid-lowering effect of TDF should be considered in selected patients with low risk for kidney and bone toxicity.

摘要

富马酸替诺福韦二吡呋酯(TDF)因其肾毒性和骨毒性较低,已逐渐被替诺福韦艾拉酚胺(TAF)取代。然而,这种转换在临床试验中导致了血脂浓度的恶化,但在任何真实环境中的数据都很稀缺。本研究的目的是描述 TDF 转换为 TAF 对真实世界临床人群血浆脂质浓度的影响。这是一项回顾性研究,比较了 TDF 最后一次就诊和至少 2 个月暴露于 TAF 后的第一次就诊时的血脂浓度和其他实验室参数。共有 490 名 HIV 阳性患者纳入本研究。总胆固醇中位数(四分位距)增加了 23.2(0-38.7)mg/dL( < 0.001),低密度脂蛋白(LDL)胆固醇增加了 15.5(0-30.9)mg/dL( < 0.001)。总胆固醇与高密度脂蛋白(HDL)胆固醇的比值增加了 0.2(-0.2 至 0.6), < 0.001。根据国家胆固醇教育计划成人治疗专家组 III(NCEP ATP III),具有最佳 LDL 胆固醇浓度的患者比例从 30.8%下降到 17.8%,而具有血脂异常或严重血脂异常的患者比例从 30.2%增加到 50.3%。转换后,人口统计学特征、抗逆转录病毒药物或合并用药并未影响血脂浓度的变化。血浆肌酐降低 0.03(-0.09 至 0.03)mg/dL( < 0.001),估算肾小球滤过率增加 0.5(-2.3 至 3.2)mL/min( = 0.009)。从 TDF 转换为 TAF 会导致血脂谱的统计学显著恶化,这可能具有临床意义。应考虑在具有低肾毒性和骨毒性风险的患者中使用 TDF 的降脂作用。

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