1383. Efficacy and Safety of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate in HIV-infected, Virologically Suppressed Black and Non-Blacks Adults Through Week 96: Subgroup Analysis of a Randomized Switch Study
Session: Poster Abstract Session: HIV: Antiretroviral Therapy
Friday, October 6, 2017
Room: Poster Hall CD
  • Flamm IDWeek 2017 88x43@100%-PrintRead.pdf (972.0 kB)
  • Background: Black adults are disproportionately affected by HIV.

    Methods: We conducted a 96-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 663 treated patients, 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 96: FTC /TAF 87.0% vs. FTC /TDF 88.1%; for non-Blacks 89.0% vs 89.7%. Few participants discontinued study drug due to adverse events in either subgroups (FTC/TAF vs FTC/TDF: Black 0 vs. 1.5%; non-Black, 3.0% vs. 1.1%). 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). In the overall population, no cases of Fanconi syndrome or proximal renal tubulopathy occurred with FTC/TAF; one FTC/TDF participant discontinued study drug due to proximal tubulopathy.

    Conclusion: In virologically suppressed Black adults, FTC/TAF demonstrated improvements in renal and bone safety over FTC/TDF with similar sustained efficacy at week 96. These results support switching to FTC/TAF from FTC/TDF for the treatment of HIV-1 infection in Black adults.

    Jason A Flamm, MD, Kaiser Permanente, Sacramento, CA, Thanes Vanig, MD, Spectrum Medical Group, Phoenix, AZ, Joseph Gathe, MD, Therapeutic Concepts, Houston, TX, Clifford Kinder, MD, AHF Kinder Medical Group, Miami, FL, Michael Para, MD, FIDSA, The Ohio State University, Columbus, OH, Bruce Rashbaum, MD, Capital Medical Associates, Washington DC, DC, Sorana Segal-Maurer, MD, The Dr James J Rahal Jr. Division of Infectious Disease, NewYork-Presbyterian Queens, Flushing, NY, David Shamblaw, MD, La Playa Medical Group, San Diego, CA, Michael Wohlfeiler, JD, MD, AIDS Healthcare Foundation, Los Angeles, CA, Benjamin Young, MD, PhD, APEX Research, Denver, CO, Christine Zurawski, MD, FACP, Atlanta Infectious Disease Group PC, Atlanta, GA and Martin S Rhee, MD, Gilead Sciences Inc., Foster City, CA


    J. A. Flamm, Gilead: Investigator , Research support

    T. Vanig, Gilead: Consultant , Investigator and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium

    J. Gathe, Gilead: Investigator , Research support

    C. Kinder, Gilead: Investigator , Research support

    M. Para, Gilead: Investigator , Research grant and Research support

    B. Rashbaum, Gilead: Investigator and Shareholder , Research support and Speaker honorarium

    S. Segal-Maurer, Gilead Sciences: Consultant , Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
    Janssen Therapeutics: Speaker's Bureau , Speaker honorarium

    D. Shamblaw, Gilead: Investigator , Research support

    M. Wohlfeiler, Gilead: Investigator , Research support

    B. Young, Gilead Sciences: Independent Contractor , Investigator , Research Contractor and Scientific Advisor , Consulting fee , Research support and Speaker honorarium
    Merck & Co: Scientific Advisor and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
    ViiV Healthcare: Scientific Advisor , Research grant

    C. Zurawski, Gilead: Investigator , Research grant

    M. S. Rhee, Gilead: Employee and Shareholder , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 4th with the exception of research findings presented at the IDWeek press conferences.