A Randomized Double-Blind Comparison of Coformulated Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate for Initial Treatment of HIV-1 Infection: Analysis of Week 96 Results

被引：125

作者：

Zolopa, Andrew ^{[1
]}

Sax, Paul E. ^{[2
]}

DeJesus, Edwin ^{[3
]}

Mills, Anthony ^{[4
]}

Cohen, Calvin ^{[5
]}

Wohl, David ^{[6
]}

Gallant, Joel E. ^{[7
]}

Liu, Hui C. ^{[8
]}

Plummer, Andrew ^{[8
]}

White, Kirsten L. ^{[8
]}

Cheng, Andrew K. ^{[8
]}

Rhee, Martin S. ^{[8
]}

Szwarcberg, Javier ^{[8
]}

机构：

[1] Stanford Univ, Div Infect Dis & Geog Med, Palo Alto, CA 94304 USA

[2] Harvard Univ, Brigham & Womens Hosp, Sch Med, Div Infect Dis, Boston, MA 02115 USA

[3] Orlando Immunol Ctr, Orlando, FL USA

[4] Anthony Mills MD Inc, Los Angeles, CA USA

[5] Community Res Initiat New England, Boston, MA USA

[6] Univ N Carolina, Div Infect Dis, Chapel Hill, NC USA

[7] Johns Hopkins Univ, Sch Med, Div Infect Dis, Baltimore, MD 21205 USA

[8] Gilead Sci Inc, Foster City, CA 94404 USA

来源：

JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES | 2013年 / 63卷 / 01期

关键词：

HIV; stribild; cobicistat; phase 3 randomized trial; efficacy; safety; CO-FORMULATED ELVITEGRAVIR; NON-INFERIORITY TRIAL; TREATMENT-NAIVE; EFAVIRENZ; LOPINAVIR/RITONAVIR; COBICISTAT; TENOFOVIR; RITONAVIR; EFFICACY; PHASE-3;

D O I：

10.1097/QAI.0b013e318289545c

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF, n = 352). At week 48, EVG/COBI/FTC/TDF was noninferior to EFV/FTC/TDF (88% vs 84%, difference + 3.6%, 95% confidence interval: -1.6% to 8.8%). Virologic success (HIV-1 RNA <50 copies/mL) was maintained at week 96 (84% vs 82%, difference +2.7%, 95% CI: -2.9% to 8.3%). Discontinuation due to adverse events was low (5% vs 7%). Median changes in serum creatinine (mg/dL) at week 96 were similar to week 48. These results support the durable efficacy and long-term safety of EVG/COBI/FTC/TDF.

引用

页码：96 / 100

页数：5

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