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JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0b013e318286415c
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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

Rockstroh, Jürgen K. MD*; DeJesus, Edwin MD; Henry, Keith MD; Molina, Jean-Michel MD§; Gathe, Joseph MD; Ramanathan, Srinivasan PhD; Wei, Xuelian PhD; Plummer, Andrew; Abram, Michael PhD; Cheng, Andrew K. MD, PhD; Fordyce, Marshall W. MD; Szwarcberg, Javier MD, MPH; for the GS-236-0103 Study Team

Erratum

Erratum

In the article by Rockstroh et al., appearing in the Journal of Acquired Immune Deficiency Syndromes, Vol. 62, No. 5, pp. 483-486, entitled “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,” the statement in the Results sections that reads “Of the 6 subjects with resistance to EVG/COBI/FTC/TDF, 5 occurred during the first 48 weeks and 1 occurred during the second 48 weeks of treatment, 2 which failed with M184V but no integrase resistance” is incorrect. The statement should read: “Of the 6 subjects with resistance to EVG/COBI/FTC/TDF, 5 occurred during the first 48 weeks as previously described2 and 1 occurred during the second 48 weeks of treatment developing both M184V in reverse transcriptase and E92Q in integrase.”

JAIDS Journal of Acquired Immune Deficiency Syndromes. 63(5):e171, August 15, 2013.

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Abstract

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.

© 2013 Lippincott Williams & Wilkins, Inc.

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