A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results

被引：95

作者：

Wohl, David ^{[1
]}

Oka, Shinichi ^{[2
]}

Clumeck, Nathan ^{[3
]}

Clarke, Amanda ^{[4
]}

Brinson, Cynthia ^{[5
]}

Stephens, Jeffrey ^{[6
]}

Tashima, Karen ^{[7
]}

Arribas, Jose R. ^{[8
]}

Rashbaum, Bruce ^{[9
]}

Cheret, Antoine ^{[10
]}

Brunetta, Jason ^{[11
]}

Mussini, Cristina ^{[12
]}

Tebas, Pablo ^{[13
,14
]}

Sax, Paul E. ^{[15
,16
,17
]}

Cheng, Andrew ^{[18
]}

Zhong, Lijie ^{[18
]}

Callebaut, Christian ^{[18
]}

Das, Moupali ^{[18
]}

Fordyce, Marshall ^{[18
]}

机构：

[1] Univ N Carolina, Dept Med, CB 7030,Bioinformat Bldg,130 Mason Farm Rd, Chapel Hill, NC 27599 USA

[2] Natl Ctr Global Hlth & Med, AIDS Clin Ctr, Tokyo, Japan

[3] CHU St Pierre Univ Hosp Brussels, Dept Infect Dis, Brussels, Belgium

[4] Brighton & Sussex Univ Hosp NHS Trust, Elton John Ctr, Brighton, E Sussex, England

[5] Cent Texas Clin Res, Austin, TX USA

[6] Mercer Univ, Sch Med, Dept Internal Med, Macon, GA 31207 USA

[7] Brown Univ, Miriam Hosp, Alpert Med Sch, Providence, RI USA

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

[9] Capital Ctr Travel & Trop Med, Washington, DC USA

[10] Ctr Hosp Tourcoing Descartes Univ, Necker Hosp, Le Kremlin Bicetre Hosp, AP HP,Infect Dis Unit,Internal Med Unit, Paris, France

[11] Univ Toronto, Dept Family & Community Med, Maple Leaf Res, Med, Toronto, ON M5S 1A1, Canada

[12] Univ Modena & Reggio Emilia, Clin Malattie Infett & Tropicali, Modena, Italy

[13] Univ Penn, Perelman Sch Med, Dept Med, Philadelphia, PA 19104 USA

[14] Univ Penn, Perelman Sch Med, Ctr AIDS Res, Philadelphia, PA 19104 USA

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

[16] Brigham & Womens Hosp, Dept Med, 75 Francis St, Boston, MA 02115 USA

[17] Harvard Univ, Sch Med, Boston, MA USA

[18] Gilead Sci Inc, 353 Lakeside Dr, Foster City, CA 94404 USA

来源：

JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES | 2016年 / 72卷 / 01期

关键词：

tenofovir alafenamide; integrase inhibitor; randomized controlled trial; HIV; bone mineral density; renal safety; ANTIRETROVIRAL-NAIVE; ABACAVIR-LAMIVUDINE; EFAVIRENZ; THERAPY; DENSITY; SAFETY;

D O I：

10.1097/QAI.0000000000000940

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-blinded Phase 3 trials, 1733 antiretroviral-naive participants were randomized to tenofovir alafenamide (TAF), a tenofovir prodrug versus tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 96 weeks, 86.6% in the TAF arm and 85.2% in the TDF arm had HIV-1 RNA <50 c/mL [difference 1.5%; (95% CI: -1.8% to 4.8%)]. With TAF, there are smaller declines in bone mineral density and more favorable changes in proteinuria, albuminuria, and tubular proteinuria, and no cases of proximal tubulopathy compared with 2 for TDF. These longer-term data support E/C/F/TAF as a safe, welltolerated, and durable regimen for initial HIV-1 treatment.

引用

页码：58 / 64

页数：7

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