1073. Safety and Efficacy of TAF vs. TDF Single-Tablet Regimen in HIV-1 Treatment-Na´ve Black and non-Black Patients through Week 48
Session: Poster Abstract Session: HIV: New Antiretrovirals
Friday, October 9, 2015
Room: Poster Hall
Posters
  • Bio Wohl IDWeek 88x44@275-PrintReady1.pdf (421.1 kB)
  • Background:

    Black adults are disproportionately affected by HIV and chronic kidney disease. We report 48 week efficacy and safety data of tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in Black and non-Black subjects from two phase 3 treatment-na´ve trials.

    Methods:

    Treatment-na´ve HIV-1-infected adults with eGFR ≥50 mL/min were randomized 1:1 to a single tablet regimen (STR) of elvitegravir/cobicistat/emtricitabine/TAF (E/C/F/TAF) or elvitegravir/cobicistat/emtricitabine/TDF (E/C/F/TDF) in both studies. A pre-specified analysis of efficacy and a post-hoc analysis of safety of TAF vs. TDF by race were conducted.

     

    Results:

    Of the 1733 subjects treated, 436 (25%) self-identified as Black. Baseline characteristics among Blacks were balanced between treatment arms. At Week 48, rates of virologic success were numerically (though not statistically) higher for Blacks on TAF vs. TDF (88% vs. 83%), but significantly lower than in non-Blacks (94% TAF vs. 93% TDF). In the TAF arm, the overall lower rate of success in Blacks was primarily driven by lack of virologic data (6.7% Black vs. 3.1% Non-black, p=0.018), with most discontinuing study drug due to reasons other than adverse events. In the TDF arm, both virologic failure (p=0.003) and missing virologic data were higher in Blacks vs. non-Blacks (p=0.005). Pill-count adherence was also lower in Blacks vs. non-Blacks in both the TAF (mean 95.4% vs. 97.3%; p<0.001) and TDF groups (95.1% vs. 97.6%; p<0.001). Both STRs were well-tolerated and proximal renal tubulopathy was not observed. Among Blacks, decline in median eGFR was significantly less and median decreases in proteinuria were numerically greater in the TAF group. Blacks experienced similar bone mineral density declines compared with non-Blacks, while those on TAF had less spine and hip BMD loss vs. TDF in both populations.

    Conclusion:

    In treatment-na´ve Black adults, E/C/F/TAF demonstrates significant improvements in renal and bone safety over E/C/F/TDF with similar high-level efficacy at Week 48. Rates of virologic success and adherence were high for Blacks but were lower than those for non-Blacks. These results support the use of E/C/F/TAF for the initial treatment of HIV-1 in Black and non-Black adults.

    David Alain Wohl, MD, University of North Carolina at Chapel Hill, Chapel Hill, NC, Joseph Gathe, MD, The Cure C Consortium, Houston, TX, Melanie Thompson, MD, AIDS Research Consortium of Atlanta, Atlanta, GA, Robert Grossberg, MD, Montefiore Medical Center, Bronx, NY, Sorana Segal-Maurer, MD, Infectious Disease, New York Hospital Queens, Flushing, NY, Laurent Cotte, MD, Infectious Diseases, Hospices Civils de Lyon, Hopital de la Croix-Rousse, Lyon, France, Indira Brar, MD, Infectious Diseases, Henry Ford Hospital, Detroit, MI, Susan Guo, PhD, Biostatistics, Gilead Sciences, Foster City, CA, Devi Sengupta, MD, HIV Clinical Research, Gilead Sciences, Inc., Foster City, CA and Marshall Fordyce, MD, HIV Clinical Research, Gilead Sciences, Foster City, CA

    Disclosures:

    D. A. Wohl, Gilead Sciences: Investigator and Scientific Advisor , Research support

    J. Gathe, None

    M. Thompson, Gilead Sciences: Investigator , Research support
    Bristol Myers Squibb, Inc.: Investigator , Research support
    Geo Vax, Inc: Investigator , Research support
    Kowa Research Institute: Investigator , Research support
    Pfizer Inc: Investigator , Research support
    Janssen/Tibotec Therapeutics: Investigator , Research support
    Merck & Co: Investigator , Research support
    Tobira Therapeutics: Investigator , Research support
    ViiV Healthcare: Investigator , Research support

    R. Grossberg, Gilead: Investigator , Research support

    S. Segal-Maurer, Gilead Sciences: Investigator , Research support

    L. Cotte, ViiV, MSD: Grant Investigator , Research grant
    BMS, Janssen, Gilead, MSD, ViiV: inscription to congress and travel accomadations , non financial support
    Mylan: Board Member , Consulting fee

    I. Brar, Gilead: Investigator and Speaker's Bureau , Grant recipient and Speaker honorarium
    Janssen: Investigator and Speaker's Bureau , Grant recipient
    Viiv: Investigator , Research grant

    S. Guo, Gilead Sciences: Employee , Salary

    D. Sengupta, Gilead Sciences: Employee and Shareholder , Salary

    M. Fordyce, Gilead Sciences, Inc.: Employee and Shareholder , Salary

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