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A Randomized, Double-Blind Comparison of Coformulated Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF vs Ritonavir-Boosted Atazanavir Plus Coformulated Emtricitabine and Tenofovir DF for Initial Treatment of HIV-1 Infection: Analysis of Week 96 Results

Rockstroh, Jürgen K. MD*; DeJesus, Edwin MD; Henry, Keith MD; Molina, Jean-Michel MD§; Gathe, Joseph MD; Ramanathan, Srinivasan PhD; Wei, Xuelian PhD; Plummer, Andrew; Abram, Michael PhD; Cheng, Andrew K. MD, PhD; Fordyce, Marshall W. MD; Szwarcberg, Javier MD, MPHfor the GS-236-0103 Study Team

JAIDS Journal of Acquired Immune Deficiency Syndromes: April 15th, 2013 - Volume 62 - Issue 5 - p 483–486
doi: 10.1097/QAI.0b013e318286415c
Rapid Communication

Abstract: This ongoing, randomized, double-blind, active-controlled phase 3 international trial demonstrated the noninferior efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF) compared with atazanavir boosted by ritonavir (ATV/RTV) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) at 48 weeks. Here, we report the week 96 results. Of 708 treated subjects, virological success (Food and Drug Administration snapshot) was maintained at week 96 with EVG/COBI/FTC/TDF and ATV/RTV + FTC/TDF (83% vs 82%, difference 1.1%, 95% confidence interval −4.5% to 6.7%). Study drug discontinuations due to adverse events were low (4% vs 6%). Median increases from baseline in serum Cr (mg/dL) in EVG/COBI/FTC/TDF vs ATV/RTV + FTC/TDF at week 96 (0.12 vs 0.08) were similar to those at week 48 (0.12 vs 0.08). EVG/COBI/FTC/TDF showed similar mean decreases (%) in bone mineral density from baseline vs ATV/RTV + FTC/TDF (hip: −3.16 vs −4.19, P = 0.069; spine: −1.96 vs −3.54, P = 0.049). Overall, week 96 results support durable efficacy and safety of EVG/COBI/FTC/TDF in HIV-1–infected patients.

*Department of Medicine I, University of Bonn, Bonn, Germany;

Orlando Immunology Center, Orlando, FL;

Department of Infectious Diseases, Hennepin County Medical Center, Minneapolis, MN;

§Department of Infectious Diseases, Hopital Saint-Louis, AP-HP and University of Paris Sorbonne Cité, INSERM U941, Paris, France;

Therapeutic Concepts, Houston, TX;

Gilead Sciences, Foster City, CA.

Correspondence to: Jürgen K. Rockstroh, MD, Department of Medicine I, University of Bonn, Sigmund-Freud-Str. 25, Bonn 53127, Germany (e-mail:

Supported by Gilead Sciences.

Portions of this study were presented at the 11th International Congress on Drug Therapy in HIV Infection, November 11–15, 2012, Glasgow, United Kingdom.

J.K.R. has received lecture fees and advisory board honoraria from Abbott, Bristol-Myers Squibb, Gilead Sciences, Boehringer Ingelheim, GlaxoSmithKline, ViiV, Tibotec, Janssen, Merck and Pfizer. E.DJ. has received research grant support from Abbott Laboratories, Achillion Pharmaceuticals, Avexa, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Hoffmann LaRoche, Idenix, Janssen, Merck, Pfizer, Sangamo, Taimed, Tobira, and Vertex; and consulting fees as a member of advisory boards for Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, and Vertex. K.H. has received research grant support from Gilead Sciences, GlaxoSmithKline, US Centers for Disease Control, and the US National Institutes of Health; consulting fees as an advisory board member for Gilead Sciences. J-M.M. has acted as a consultant, participated in advisory boards, has received speaker fees, and has been an investigator for clinical trials for Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Merck, Tibotec, and ViiV Healthcare. J.G. has received research grant support from Abbott Laboratories, Boehringer Ingelheim, Gilead Sciences, GlaxoSmithKline, Janssen, and receives consulting fees from Abbott Laboratories and Boehringer Ingelheim. S.R., X.W., A.P., M.A., A.K.C., M.W.F., and J.S. are employees of Gilead Sciences.

Received October 24, 2012

Accepted January 04, 2013

© 2013 Lippincott Williams & Wilkins, Inc.