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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.

TitleA 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.
Publication TypeJournal Article
Year of Publication2013
AuthorsZolopa A, Sax PE, Dejesus E, Mills A, Cohen C, Wohl D, Gallant JE, Liu HC, Plummer A, White KL, Cheng AK, Rhee MS, Szwarcberg J
Corporate AuthorsGS-US-236-0102 Study Team
JournalJ Acquir Immune Defic Syndr
Volume63
Issue1
Pagination96-100
Date Published2013 May 01
ISSN1944-7884
KeywordsAdenine, Adult, Anti-HIV Agents, Carbamates, Creatinine, Deoxycytidine, Double-Blind Method, Drug Combinations, Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination, Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination, Female, HIV Infections, HIV-1, Humans, Male, Organophosphonates, Oxazines, Quinolones, RNA, Viral, Thiazoles, Treatment Outcome, Young Adult
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.

DOI10.1097/QAI.0b013e318289545c
Alternate JournalJ. Acquir. Immune Defic. Syndr.
PubMed ID23392460
Grant ListP30 AI050410 / AI / NIAID NIH HHS / United States