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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

Zolopa, Andrew MD*; Sax, Paul E. MD; DeJesus, Edwin MD; Mills, Anthony MD§; Cohen, Calvin MD, MSc; Wohl, David MD; Gallant, Joel E. MD, MPH#; Liu, Hui C. MD, PhD**; Plummer, Andrew BS**; White, Kirsten L. PhD**; Cheng, Andrew K. MD, PhD**; Rhee, Martin S. MD**; Szwarcberg, Javier MD, MPH**for the GS-US-236-0102 Study Team

JAIDS Journal of Acquired Immune Deficiency Syndromes: May 1st, 2013 - Volume 63 - Issue 1 - p 96–100
doi: 10.1097/QAI.0b013e318289545c
Brief Report: Clinical Science

Abstract: 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.

*Division of Infectious Diseases and Geographic Medicine, Stanford University, Palo Alto, CA;

Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, MA;

Orlando Immunology Center, Orlando, FL;

§Anthony Mills MD Inc., Los Angeles, CA;

Community Research Initiative of New England, Boston, MA

Division of Infectious Diseases, University of North Carolina, Chapel Hill, NC;

#Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD; and

**Gilead Sciences, Foster City, CA.

Correspondence to: Andrew Zolopa, MD, Division of Infectious Diseases and Geographic Medicine, Stanford University, 300 Pasteur Dr, Rm S-156 Grant Bldg, Stanford, CA 94305 (e-mail: azolopa@stanford.edu).

This work has previously been presented at the 11th International Congress on Drug Therapy in HIV Infection, November 11–15, 2012, Glasgow, United Kingdom.

Conflicts of interest for all authors: A.Z. has received research grant support from Gilead Sciences, consulting fees as an advisory board member for Bristol-Myers Squibb, Gilead Sciences, and Janssen Therapeutics. P.E.S. has received research support from Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Laboratories, and Tibotec; consulting fees from Abbott Laboratories, Aeliron Scientific, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Laboratories, and Janssen Therapeutics. E.D.J. has received research grant support from Abbott Laboratories, Achillion Pharmaceuticals, Avexa, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Hoff mann 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. A.M. has received research support from Boehringer Ingelheim, Gilead Sciences, GlaxoSmithKline, Janssen Therapeutics, Kowa, Merck, Pfizer, Tobira, and ViiV; and consulting fees for speakers bureaux and advisory boards from Bristol-Myers Squibb, Gilead Sciences, Janssen Therapeutics, and Merck. C.C. has received research grant support from Gilead Sciences, Bristol-Myers Squibb, Merck, Janssen, and Viiv; and receives consulting fees from Gilead Sciences, Bristol-Myers Squibb, Merck, Janssen, Viiv, and Tobira. D.W. has received research grant support from Merck and GlaxoSmithKline, and receives consulting fees from Janssen Therapeutics and Gilead Sciences. JEG has received research support from Gilead Sciences; and consulting fees from Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck, and Janssen Therapeutics. D.W. has received grant support from Merck & Co, and GlaxoSmithKline; and has been on advisory boards for Janssen Therapeutics and Gilead Sciences. H.C.L., A.P., K.L.W., A.K.C., M.S.R., and J.S. are employees of Gilead Sciences. A.Z., P.E.S., E.D.J., A.M., C.C., and D.W. are all principal investigators. H.C.L., A.P., K.L.W., A.K.C., M.S.R., and J.S. are employees of the Sponsor of this study, Gilead Sciences; and were the scientific, medical, and operational leaders responsible for this study’s design, conduct, oversight, and analyses.

All authors have reviewed the results of this study and the article.

Received October 18, 2012

Accepted January 22, 2013

© 2013 Lippincott Williams & Wilkins, Inc.