1508. Efficacy and Safety of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate in HIV-infected, Virologically Suppressed Black and Non-Blacks Adults Through Week 48: Subgroup Analysis of a Randomized Switch Study
Session: Poster Abstract Session: HIV: Antiretroviral Therapy
Friday, October 28, 2016
Room: Poster Hall
  • DeJesus IDWeek 2016 Poster 1508.pdf (2.2 MB)
  • Background: Black adults are disproportionately affected by HIV.

    Methods: We conducted a 48-week subgroup analysis by race (Black vs. non-Black) for efficacy (pre-specified) and safety (post-hoc) from a randomized, double blind, active-controlled study in virologically suppressed HIV-infected individuals who switched to emtricitabine/tenofovir alafenamide (FTC/TAF) from FTC/tenofovir disoproxil fumarate (FTC/TDF) vs continuing FTC/TDF while remaining on the same third agent.

    Results: Of the 663 treated, 136 (20.5%) self-identified as Black (FTC /TAF n=69, FTC /TDF n=67). Baseline viral load, CD4 counts, renal laboratory parameters, and bone mineral density (BMD) were similar between the two arms within Blacks and non-Blacks. For Blacks, virologic success by FDA snapshot algorithm at Week 48 was FTC /TAF 94.2% vs. FTC /TDF 89.6%; for non-Blacks, it was 94.3% vs 93.9%. Few participants discontinued study drug due to adverse events in either subgroups (Black, FTC /TAF 0 vs. FTC /TDF 1.5%; non-Black, 2.7% vs. 0.8%). In assessment of renal and bone safety using estimated glomerular filtration rate (eGFR), renal biomarkers, and BMD, there were differences between two arms that generally favored FTC/TAF over FTC/TDF (Table 1). No cases of Fanconi syndrome or proximal renal tubulopathy were reported in the overall population.

    Conclusion: In virologically suppressed Black adults, FTC/TAF demonstrated improvements in renal and bone safety over FTC/TDF with similar high-level efficacy at Week 48. These results support switching to FTC/TAF from FTC/TDF for the treatment of HIV-1 infection in Black adults.

    Edwin Dejesus, MD1, Richard Elion, MD2, Moti Ramgopal, MD, FACP, FIDSA3, Barbara H. Wade, MD, FIDSA4, Louis Sloan, MD5, Howard Edelstein, MD6, Gerald Pierone Jr., MD7, Jihad Slim, MD8, Jeffrey Stephens, MD9, Mingjin Yan, PhD10, Cecilia Tran-Muchowski, BS11 and Martin Rhee, MD11, (1)Orlando Immunology Center, Orlando, FL, (2)Whitman-Walker Health, Washington DC, DC, (3)Midway Immunology and Research Center, Fort Pierce, FL, (4)Center for the Prevention and Treatment of Infections, Pensacola, FL, (5)North Texas Infectious Diseases Consultants PA, Dallas, TX, (6)Alameda Health System- Highland Hospital, Oakland, CA, (7)AIDS Research and Treatment Center of the Treasure Coast, Vero Beach, FL, (8)Saint. Michael's Medical Center, Newark, NJ, (9)Mercer University School of Medicine, Macon, GA, (10)Biostatistics, Gilead Sciences, Inc., Foster City, CA, (11)Gilead Sciences, Foster City, CA


    E. Dejesus, Gilead Science: Board Member , Consultant , Investigator and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
    Janssen Pharmaceuticals: Board Member , Investigator and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
    Glaxo-SmitKline: Investigator , Research support
    Bristol Meyer Squibb: Investigator , Research support
    Merck: Investigator , Research support

    R. Elion, Gilead: Consultant , Consulting fee and Speaker honorarium
    ViiV: Consultant , Consulting fee and Speaker honorarium
    Merck: Consultant , Consulting fee and Speaker honorarium
    BMS: Speaker , Speaker honorarium
    Jannsen: Speaker , Speaker honorarium

    M. Ramgopal, None

    B. H. Wade, Gilead: Investigator and Speaker , Research support and Speaker honorarium

    L. Sloan, None

    H. Edelstein, Alameda Health System: Investigator , Research support

    G. Pierone Jr., None

    J. Slim, ViiV: Investigator and Scientific Advisor , Consulting fee and Grant recipient

    J. Stephens, Mercer University School of Medicine: Grant Investigator , Research grant

    M. Yan, Gilead: Employee , own stock and Salary

    C. Tran-Muchowski, Gilead: Employee , owns stock and Salary

    M. Rhee, Gilead: Employee , Owns stocks/options and Salary

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