简短报告：在肾功能受损的HIV感染成人中换用与埃替拉韦、考比司他和恩曲他滨联合配方的替诺福韦艾拉酚胺：一项单臂、多中心、开放标签3期研究的96周结果
Brief Report: Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Adults With Renal Impairment: 96-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study.
作者信息
Post Frank A, Tebas Pablo, Clarke Amanda, Cotte Laurent, Short William R, Abram Michael E, Jiang Shuping, Cheng Andrew, Das Moupali, Fordyce Marshall W
机构信息
*Department of Sexual Health, King's College Hospital NHS Foundation Trust, London, United Kingdom; †Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; ‡Department of Sexual Health, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom; §Department of Infectious Diseases, Croix-Rousse Hospital, Hospices Civils de Lyon, France; and ‖Gilead Sciences, Inc., Foster City, CA.
出版信息
J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):180-184. doi: 10.1097/QAI.0000000000001186.
Tenofovir disoproxil fumarate is associated with renal and bone toxicity. In a single-arm, open-label study of 242 virologically suppressed, HIV-infected participants with creatinine clearance 30-69 mL/min who switched to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, participants had stable creatinine clearance, significant and durable improvements in proteinuria, albuminuria, and tubular proteinuria (P < 0.001), and significant increases in hip and spine bone mineral density through 96 weeks (P < 0.001). Eighty-eight percent maintained HIV-1 RNA <50 c/mL at week 96. These longer-term results support the use of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in HIV-infected individuals with mild-moderately impaired renal function.
富马酸替诺福韦二吡呋酯与肾脏和骨骼毒性相关。在一项针对242名病毒学抑制的HIV感染者的单臂、开放标签研究中，这些参与者肌酐清除率为30 - 69 mL/分钟，他们换用了艾维雷韦/考比司他/恩曲他滨/替诺福韦艾拉酚胺，参与者的肌酐清除率保持稳定，蛋白尿、白蛋白尿和肾小管蛋白尿有显著且持久的改善（P < 0.001），并且在96周内髋部和脊柱骨矿物质密度显著增加（P < 0.001）。88%的参与者在第96周时HIV-1 RNA维持在<50拷贝/mL。这些长期结果支持在肾功能轻度至中度受损的HIV感染者中使用艾维雷韦/考比司他/恩曲他滨/替诺福韦艾拉酚胺。
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