The 3-year renal safety of a tenofovir disoproxil furnarate vs. a thymidine analogue-containing regimen in antiretroviral-naive patients
The 3-year renal safety of a tenofovir disoproxil furnarate vs. a thymidine analogue-containing regimen in antiretroviral-naive patients
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DOI：
10.1097/qad.0b013e3283112b8e
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发表时间：
2008-10-18
期刊：
影响因子：
3.8
通讯作者：
Enejosa, Jeffrey V.
中科院分区：
文献类型：
--
作者：
Gallant, Joel E.;Winston, Jonathan A.;Enejosa, Jeffrey V.
背景：有报道称，接受富马酸替诺福韦酯（TDF）治疗的患者发生肾功能不全。我们分析了TDF与含胸苷类似物（对照）方案在两项抗逆转录病毒初治HIV感染患者中进行的144周临床试验的肾脏安全性。（TDF，n=556;对照组，n=555），对照试验（研究903和934）比较TDF与司他夫定或齐多夫定联合依法韦仑和拉米夫定或恩曲他滨。这些研究包括患者血清肌酐低于1.5毫克/分升，血清磷至少2.2毫克/分升和估计肾小球滤过率的Cockcroft-Gault至少60和至少50毫升/分钟在筛选。TDF组中没有患者因肾脏异常而停药。在144周内，血清肌酐（>1.5 mg/dl）或血清磷（
Background: Cases of renal dysfunction in patients receiving tenofovir disoproxil fumarate (TDF) have been reported. We analyzed the renal safety of TDF compared with thymidine analogue-containing (control) regimens through 144 weeks from two clinical trials in anti retroviral-naive HIV-infected patients.Methods: We evaluated the changes in renal parameters in 1111 patients (TDF, n=556; control, n=555) who were enrolled in two randomized, controlled trials (Studies 903 and 934) comparing TDF vs. either stavudine or zidovudine in combination with efavirenz and either lamivudine or emtricitabine. The studies included patients with serum creatinine less than 1.5 mg/dl, serum phosphorus at least 2.2 mg/dl and estimated glomerular filtration rate by Cockcroft-Gault at least 60 and at least 50 ml/min at screening.Results: Baseline characteristics were similar between groups. No patient discontinued due to renal abnormalities in the TDF arm. Through 144 weeks, the proportion of patients who experienced confirmed abnormalities in serum creatinine (>1.5 mg/dl) or serum phosphorus (