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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

TitleA 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
Publication TypeJournal Article
Year of Publication2013
AuthorsRockstroh JK, Dejesus E, Henry K, Molina J-, Gathe J, Ramanathan S, Wei X, Plummer A, Abram M, Cheng AK, Fordyce MW, Szwarcberg J
Corporate AuthorsGS-236-0103 Study Team
JournalJ Acquir Immune Defic Syndr
Volume62
Issue5
Pagination483-6
Date Published2013 Apr 15
ISSN1944-7884
KeywordsAdenine, Adult, Alanine Transaminase, Anti-HIV Agents, Aspartate Aminotransferases, Atazanavir Sulfate, Bilirubin, Bone Density, Carbamates, Cobicistat, Confidence Intervals, Creatinine, Deoxycytidine, Double-Blind Method, Drug Combinations, Emtricitabine, Female, HIV Infections, HIV-1, Humans, Male, Oligopeptides, Organophosphonates, Pyridines, Quinolones, Ritonavir, RNA, Viral, Tenofovir, Thiazoles, Triglycerides
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.

DOI10.1097/QAI.0b013e318286415c
Alternate JournalJ. Acquir. Immune Defic. Syndr.
PubMed ID23337366