861. Long-Term Efficacy and Safety of EVG/COBI/FTC/TDF Compared to EFV/FTC/TDF in HIV-1-Infected, Treatment-Na´ve, Black Versus Non-Black Subjects
Session: Poster Abstract Session: HIV: Subpopulations
Friday, October 4, 2013
Room: The Moscone Center: Poster Hall C
Posters
  • Hardy 102 W96 STB in Blacks_ IDSA 2013 Poster 861 Final.pdf (439.2 kB)
  • Background:

    Elvitegravir/cobicistat/emtricitabine/tenofovir DF (E/C/F/TDF) demonstrated noninferior efficacy with a favorable and differentiated safety profile compared to efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF) at week 48 and 96 in a randomized, controlled trial of HIV-infected, treatment-naïve subjects. Given that HIV disproportionately affects Blacks in the US, we additionally examined the efficacy and safety of E/C/F/TDF in Black subjects.

    Methods:

    Subgroup analysis of treatment efficacy by FDA snapshot analysis, tolerability and safety of E/C/F/TDF versus EFV/FTC/TDF through week 96 in Black versus Non-Black subjects.

    Results:

    Blacks comprised 30% (106/348) of subjects randomized to E/C/F/TDF and 26% (91/352) of subjects randomized to EFV/FTC/TDF in Study 102. Virologic success in Blacks at week 96 for E/C/F/TDF versus EFV/FTC/TDF was 81% vs. 73% (Difference, 8.6%; 95% confidence interval [CI], -3.4% to 20.6%) and in Non-Blacks was 86% vs. 85% (Difference, 0.9%; 95% CI, -5.4% to 7.2%). Rates of treatment-emergent adverse events leading to study drug discontinuation in Blacks were respectively 1% vs. 10% (p=0.006), and in Non-Blacks, 7% vs. 6% (p=0.71). Median changes in serum creatinine (mg/dL) at week 96 for Blacks on E/C/F/TDF compared to EFV/FTC/TDF were 0.14 vs. 0.01 (p<0.001) and 0.13 vs. 0.01 (p<0.001) for Non-Blacks. Median changes in serum creatinine (mg/dL) at week 96 within the same treatment arm by race were similar for both groups.  At week 96, Blacks on E/C/F/TDF compared to EFV/FTC/TDF had smaller median increases (mg/dL) from baseline in total cholesterol (8 vs. 23, p=0.003) and HDL (7 vs. 9, p=0.011) and similar increases in LDL (8 vs. 13, p=0.094) and triglycerides (1 vs. 5, p=0.88). Increases in lipid parameters within the same treatment arm by race were similar for both groups.

    Conclusion:

    E/C/F/TDF compared to EFV/FTC/TDF may be a durable, well-tolerated, and safe treatment option for Black patients.

    David Hardy, MD1, Peter Ruane, MD2, Kimberly Workowski, MD3, Peter Shalit, MD4, Gordon Crofoot, MD5, Thai Nguyen, MD6, Hiu Liu, PhD6, Martin Rhee, MD7, David Piontkowski, MD6 and Javier Szwarcberg, MD7, (1)Infectious Diseases, Cedars-Sinai Medical Center, Los Angeles, CA, (2)Tower Infectious Diseases, Los Angeles, CA, (3)Infectious Diseases, Emory University School of Medicine, Atlanta, GA, (4)Peter Shalit, MD, Seattle, WA, (5)Gordon Crofoot, MD, Houston, TX, (6)Gilead Sciences, Inc., Foster City, CA, (7)Gilead Sciences, Foster City, CA

    Disclosures:

    D. Hardy, Gilead Sciences, Inc.: Consultant and Investigator, Consulting fee and Research grant
    Bristol Meyers Squibb: Consultant, Consulting fee
    GlaxoSmithKline: Consultant and Investigator, Consulting fee and Research grant
    Pfizer: Consultant, Consulting fee
    Janssen: Consultant, Consulting fee
    Viiv: Consultant and Investigator, Consulting fee and Research grant
    Calimmune: Consultant, Consulting fee
    Bionor: Investigator, Research grant
    Merck: Shareholder, Stocks

    P. Ruane, Gilead Sciences, Inc.: Investigator, Research grant

    K. Workowski, None

    P. Shalit, Gilead Sciences, Inc.: Investigator and Speaker's Bureau, Research grant and Speaker honorarium
    Bristol-Myers Squibb: Speaker's Bureau, Speaker honorarium

    G. Crofoot, Gilead Sciences, Inc.: Investigator, Research grant

    T. Nguyen, Gilead Sciences, Inc.: Employee, Salary

    H. Liu, Gilead Sciences, Inc.: Employee, Salary

    M. Rhee, Gilead Sciences: Employee, Salary

    D. Piontkowski, Gilead Sciences, Inc: Employee, Salary

    J. Szwarcberg, Gilead Sciences, Inc.: Employee, Salary

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