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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

1Department of Medicine I, University of Bonn, Bonn, Germany 2Orlando Immunology Center, Orlando, FL, USA 3Hennepin County Medical Center, Minneapolis, MN, USA 4Hopital Saint-Louis, AP-HP and University of Paris Sorbonne Cité, INSERM U941, France 5Therapeutic Concepts, Houston, TX, USA 6Gilead Sciences, Foster City, CA, USA.
JAIDS Journal of Acquired Immune Deficiency Syndromes (Impact Factor: 4.39). 01/2013; 62(5). DOI: 10.1097/QAI.0b013e318286415c
Source: PubMed

ABSTRACT This ongoing, randomized, double-blind, active-controlled Phase 3 international trial demonstrated the non-inferior efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF) compared to 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, virologic success (FDA Snapshot) was maintained at Week 96 with EVG/COBI/FTC/TDF and ATV/RTV+FTC/TDF (83% vs 82%, difference 1.1%, 95% CI -4.5% to 6.7%). Study drug discontinuations due to adverse events (AEs) 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 BMD 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.

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Available from: Michael E Abram, Dec 04, 2014
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    ABSTRACT: We report Week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF, n=348) vs efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF, n=352). At Week 48, EVG/COBI/FTC/TDF was non-inferior to EFV/FTC/TDF (88% vs 84%, difference +3.6%, 95% CI -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.
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