Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results

被引：0

作者：

Arribas, Jose R. ^{[1
]}

Thompson, Melanie ^{[2
]}

Sax, Paul E. ^{[3
]}

Haas, Bernhard ^{[4
]}

McDonald, Cheryl ^{[5
]}

Wohl, David A. ^{[6
]}

DeJesus, Edwin ^{[7
]}

Clarke, Amanda E. ^{[8
]}

Guo, Susan ^{[9
,10
,11
,12
]}

Wang, Hui ^{[9
,10
,11
,12
]}

Callebaut, Christian ^{[9
,10
,11
,12
]}

Plummer, Andrew ^{[9
,10
,11
,12
]}

Cheng, Andrew ^{[9
,10
,11
,12
]}

Das, Moupali ^{[9
,10
,11
,12
]}

McCallister, Scott ^{[9
,10
,11
,12
]}

机构：

[1] Hosp Univ La Paz, Internal Med Serv, Infect Dis Unit, Madrid, Spain

[2] AIDS Res Consortium Atlanta, Atlanta, GA USA

[3] Brigham & Womens Hosp, Div Infect Dis, 75 Francis St, Boston, MA 02115 USA

[4] Gen Hosp Graz West, Internal Med, Graz, Austria

[5] Tarrant Cty Infect Dis Associates, Ft Worth, TX USA

[6] UNC Sch Med, Div Infect Dis, Chapel Hill, NC USA

[7] Orlando Immunol Ctr, Orlando, FL USA

[8] Brighton & Sussex Univ Hosp NHS Trust, Royal Sussex Cty Hosp, Claude Nicol Ctr, Brighton, E Sussex, England

[9] Gilead Sci Inc, Dept Biometr, 353 Lakeside Dr, Foster City, CA 94404 USA

[10] Gilead Sci Inc, Dept Virol, 353 Lakeside Dr, Foster City, CA 94404 USA

[11] Gilead Sci Inc, Dept Clin Operat, 353 Lakeside Dr, Foster City, CA 94404 USA

[12] Gilead Sci Inc, Dept HIV Clin Res, 353 Lakeside Dr, Foster City, CA 94404 USA

来源：

JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES | 2017年 / 75卷 / 02期

关键词：

tenofovir alafenamide; integrase inhibitor; randomized controlled trial; HIV; bone mineral density; renal safety; INFECTED PATIENTS; OPEN-LABEL; TENOFOVIR/EMTRICITABINE; MULTICENTER; PHASE-3; ADULTS;

D O I：

10.1097/QAI.0000000000001350

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

In 2 double-blind phase 3 trials, 1733 antiretroviral-naive adults were randomized to tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 144 weeks, TAF was superior to TDF in virologic efficacy, with 84.2% vs 80.0% having HIV-1 RNA <50 copies/mL (difference 4.2%; 95% confidence interval: 0.6% to 7.8%). TAF had less impact than TDF on bone mineral density and renal biomarkers. No participants on TAF had renal-related discontinuations vs 12 on TDF (P < 0.001), with no cases of proximal tubulopathy for TAF vs 4 for TDF. There were greater increases in lipids with TAF vs TDF, with no difference in the total cholesterol to high-density lipoprotein ratio. For initial HIV therapy, E/C/F/TAF is superior to E/C/F/TDF in efficacy and bone and renal safety.

引用

页码：211 / 218

页数：8

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