Comparative effectiveness of tenofovir in treatment-naïve HIV-infected patients: systematic review and meta-analysis.

Q2 Medicine

HIV Clinical Trials Pub Date : 2015-10-01 DOI:10.1179/1945577115Y.0000000004

Lars G Hemkens, Hannah Ewald, Marilia Santini-Oliveira, Julian-Emanuel Bühler, Danielle Vuichard, Stefan Schandelmaier, Marcel Stöckle, Matthias Briel, Heiner C Bucher

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引用次数: 23

Abstract

Introduction: Benefits and harms of tenofovir disoproxil fumarate (TDF) in HIV-infected, antiretroviral treatment (ART)-naïve patients of any age have not been systematically reviewed since recent milestone trials were published.

Methods: We searched MEDLINE, EMBASE, CENTRAL, SCI, LILACS, WHO GHL, and ClinicalTrials.gov for randomized controlled trials (RCTs) comparing TDF-based treatments with any other ART-regimen (last search 01/2015). Trial characteristics and results were extracted, risks of bias systematically assessed, and treatment effects synthesized in meta-analyses using random-effects models.

Results: We included 22 RCTs (8297 patients). We found no differences between groups for mortality, AIDS, fractures, CD4 cell count, and virological failure; and inconclusive information due to inadequate reporting for cardiovascular events, renal failure, proteinuria, rash, and quality of life. Tenofovir disoproxil fumarate-based regimens significantly reduced total cholesterol (mean difference -18.42 mg/dl; 95% confidence interval [CI] -22.80 to -14.0), LDL-cholesterol (-9.53 mg/dl; -12.16 to -6.89), HDL-cholesterol (-2.97 mg/dl; -4.41 to -1.53), and triglycerides (-29.77 mg/dl; -38.61 to -20.92), bone mineral density (BMD) (hip: -1.41%; -1.87 to -0.94), and glomerular filtration rate (eGFR) (-3.47 ml/minute; -5.89 to -1.06) over 48 weeks of follow-up. Effects were similar in trials comparing fixed-dose TDF/FTC-based regimens with ABC/3TC-based regimens. We found no influence of baseline viral load on virological failure.

Discussion: Moderate-quality evidence suggests similar effects of TDF-based treatment regimens and other ART on virological failure. Tenofovir disoproxil fumarate-based regimens are associated with a more favorable lipid profile, but with increased risk of reduced BMD and eGFR. Improved reporting quality is vital to allow assessment of clinical outcomes in future trials.

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替诺福韦在treatment-naïve hiv感染患者中的比较疗效:系统评价和荟萃分析。

简介:富马酸替诺福韦二氧吡酯(TDF)对任何年龄的hiv感染抗逆转录病毒治疗(ART)-naïve患者的益处和危害自最近里程碑式试验发表以来尚未进行系统评价。方法:我们检索MEDLINE、EMBASE、CENTRAL、SCI、LILACS、WHO GHL和ClinicalTrials.gov，检索比较tdf治疗与其他art治疗方案的随机对照试验(rct)(上次检索于2015年1月1日)。提取试验特征和结果，系统评估偏倚风险，并在使用随机效应模型的meta分析中综合治疗效果。结果:我们纳入22项随机对照试验(8297例患者)。我们发现两组在死亡率、艾滋病、骨折、CD4细胞计数和病毒学失败方面没有差异;由于对心血管事件、肾衰竭、蛋白尿、皮疹和生活质量的报道不足，信息不确定。以富马酸替诺福韦二氧吡酯为基础的方案显著降低总胆固醇(平均差值-18.42 mg/dl;95%可信区间[CI] -22.80 ~ -14.0)，低密度脂蛋白胆固醇(-9.53 mg/dl;-12.16至-6.89)，高密度脂蛋白胆固醇(-2.97毫克/分升;-4.41至-1.53)，甘油三酯(-29.77 mg/dl;-38.61 ~ -20.92)，骨密度(BMD)(髋部:-1.41%;-1.87 ~ -0.94)，肾小球滤过率(eGFR) (-3.47 ml/分钟;-5.89至-1.06)，随访48周。在比较以固定剂量TDF/ ftc为基础的方案与以ABC/ 3c为基础的方案的试验中，效果相似。我们发现基线病毒载量对病毒学失败没有影响。讨论:中等质量的证据表明，基于tdf的治疗方案和其他抗逆转录病毒治疗方案对病毒学失败的影响相似。以富马酸替诺福韦二氧吡酯为基础的方案与更有利的脂质谱相关，但BMD和eGFR降低的风险增加。提高报告质量对于评估未来试验的临床结果至关重要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

HIV Clinical Trials 医学-传染病学

CiteScore

1.76

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： HIV Clinical Trials is devoted exclusively to presenting information on the latest developments in HIV/AIDS clinical research. This journal enables readers to obtain the most up-to-date, innovative research from around the world.