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

共 20 条

[1]

[Anonymous], 11 INT C DRUG THER H

[2]

[Anonymous], STRIB ELV COB EMTR T

[3] Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial [J].

Cohen, Calvin J. ;

Andrade-Villanueva, Jaime ;

Clotet, Bonaventura ;

Fourie, Jan ;

Johnson, Margaret A. ;

Ruxrungtham, Kiat ;

Wu, Hao ;

Zorrilla, Carmen ;

Crauwels, Herta ;

Rimsky, Laurence T. ;

Vanveggel, Simon ;

Boven, Katia .

LANCET, 2011, 378 (9787) :229-237

[4] Atazanavir Plus Ritonavir or Efavirenz as Part of a 3-Drug Regimen for Initial Treatment of HIV-1 [J].

Daar, Eric S. ;

Tierney, Camlin ;

Fischl, Margaret A. ;

Sax, Paul E. ;

Mollan, Katie ;

Budhathoki, Chakra ;

Godfrey, Catherine ;

Jahed, Nasreen C. ;

Myers, Laurie ;

Katzenstein, David ;

Farajallah, Awny ;

Rooney, James F. ;

Pappa, Keith A. ;

Woodward, William C. ;

Patterson, Kristine ;

Bolivar, Hector ;

Benson, Constance A. ;

Collier, Ann C. .

ANNALS OF INTERNAL MEDICINE, 2011, 154 (07) :445-456

[5] Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial [J].

DeJesus, Edwin ;

Rockstroh, Juergen K. ;

Henry, Keith ;

Molina, Jean-Michel ;

Gathe, Joseph ;

Ramanathan, Srinivasan ;

Wei, Xuelian ;

Yale, Kitty ;

Szwarcberg, Javier ;

White, Kirsten ;

Cheng, Andrew K. ;

Kearney, Brian P. .

LANCET, 2012, 379 (9835) :2429-2438

[6] Evaluation of efficacy, safety, pharmacokinetics, and adherence in HIV-1-infected, antiretroviral-naive patients treated with ritonavir-boosted atazanavir plus fixed-dose tenofovir DF/emtricitabine given once daily [J].

Elion, Richard ;

Cohen, Calvin ;

Ward, Douglas ;

Ruane, Peter ;

Ortiz, Roberto ;

Reddy, Y. Sunila ;

Ebrahimi, Ramin ;

McColl, Damian ;

Kearney, Brian ;

Fisher, Alvan ;

Flaherty, John .

HIV CLINICAL TRIALS, 2008, 9 (04) :213-224

[7] Effect of Cobicistat on Glomerular Filtration Rate in Subjects With Normal and Impaired Renal Function [J].

German, Polina ;

Liu, Hui C. ;

Szwarcberg, Javier ;

Hepner, Mischa ;

Andrews, Jessica ;

Kearney, Brian P. ;

Mathias, Anita .

JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, 2012, 61 (01) :32-40

[8] Raltegravir Versus Efavirenz Regimens in Treatment-Naive HIV-1-Infected Patients: 96-Week Efficacy, Durability, Subgroup, Safety, and Metabolic Analyses [J].

Lennox, Jeffrey L. ;

DeJesus, Edwin ;

Berger, Daniel S. ;

Lazzarin, Adriano ;

Pollard, Richard B. ;

Ramalho Madruga, Jose Valdez ;

Zhao, Jing ;

Wan, Hong ;

Gilbert, Christopher L. ;

Teppler, Hedy ;

Rodgers, Anthony J. ;

Barnard, Richard J. O. ;

Miller, Michael D. ;

DiNubile, Mark J. ;

Nguyen, Bach-Yen ;

Leavitt, Randi ;

Sklar, Peter .

JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, 2010, 55 (01) :39-48

[9] Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial [J].

Lennox, Jeffrey L. ;

Dejesus, Edwin ;

Lazzarin, Adriano ;

Pollard, Richard B. ;

Ramalho Madruga, Jose Valdez ;

Berger, Daniel S. ;

Zhao, Jing ;

Xu, Xio ;

Williams-Diaz, Angela ;

Rodgers, Anthony J. ;

Barnard, Richard J. O. ;

Miller, Michael D. ;

DiNubile, Mark J. ;

Nguyen, Bach-Yen ;

Leavitt, Randi ;

Sklar, Peter .

LANCET, 2009, 374 (9692) :796-806

[10]

McGrath D, 2008, 17 INT AIDS C AUG 3

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