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Lippincott, Williams & Wilkins, Journal of Acquired Immune Deficiency Syndromes, 5(62), p. 483-486, 2013

DOI: 10.1097/qai.0b013e318286415c

Lippincott, Williams & Wilkins, Journal of Acquired Immune Deficiency Syndromes, 5(63), p. e171

DOI: 10.1097/qai.0b013e3182a1fe0f

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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

Journal article published in 2013 by Jürgen K. Rockstroh, Edwin DeJesus, Keith Henry, Jean-Michel Molina, Joseph Gathe, Srinivasan Ramanathan, Xuelian Wei, Andrew Plummer, Michael Abram ORCID, Andrew K. Cheng, Marshall W. Fordyce, Javier Szwarcberg
This paper was not found in any repository, but could be made available legally by the author.
This paper was not found in any repository, but could be made available legally by the author.

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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.