1074. Influence of Age on Outcomes in HIV-infected Adults Initiating Tenofovir Alafenamide Fumarate (TAF) versus Tenofovir Disoproxil Fumarate (TDF) with Elvitegravir, Cobicistat, and Emtricitabine (E/C/F/TAF vs. E/C/F/TDF)
Session: Poster Abstract Session: HIV: New Antiretrovirals
Friday, October 9, 2015
Room: Poster Hall
Posters
  • Daar et al. Age poster IDWeek 2015.pdf (112.9 kB)
  • Background:

    As the HIV-infected population ages and has increasing prevalence of co-morbidities, efficacy and safety of antiretrovirals in older patients is of heightened importance.  In the general population, E/C/F/TAF demonstrated similar efficacy and improved bone and renal safety compared to E/C/F/TDF.

    Methods:

    Treatment na´ve HIV-infected adults were randomized 1:1 to a single tablet regimen of E/C/F/TAF or E/C/F/TDF once daily in two Phase 3 double blind studies. Pre-specified pooled week 48 analyses of efficacy, renal safety, and bone mineral density (BMD) in those ≥ 50 years are described in this analysis.

    Results:

    Of 1,733 patients treated, 203 were ≥ 50 years of age; 89 randomized to E/C/F/TAF and 114 to E/C/F/TDF.  Baseline viral load, CD4 counts, renal laboratories and BMD were similar. Virologic success by FDA snapshot algorithm at week 48 was 94.4% for E/C/F/TAF vs. 91.2% for E/C/F/TDF, similar to efficacy in the entire study population.    Adverse events leading to discontinuation was 1.1% for E/C/F/TAF vs. 3.5% for E/C/F/TDF.   Mean change in estimated glomerular filtration rate at week 48 was -5.8 mL/min for E/C/F/TAF vs. -11.7 mL/min for E/C/F/TDF (p=0.010).  As shown in Figures 1 & 2, subjects ≥ 50 years had significantly improved renal tubular profiles with E/C/F/TAF vs. E/C/F/TDF.  Mean decrease in BMD was significantly less in the E/C/F/TAF vs. E/C/F/TDF arm; spine (-1.47% vs. -2.77%, p=0.011); hip (-0.31% vs. -2.52%, p<0.001).

    Conclusion:

    Among subjects ≥ 50 years of age, those receiving 48 wks of E/C/F/TAF had comparable efficacy and improved bone and renal safety compared to those on E/C/F/TDF, as previously demonstrated in the overall study population.  These findings demonstrate an important safety improvement of TAF relative to TDF in patients 50 years and older, which is of particular importance as the population living with HIV ages and experiences more non-AIDS related comorbidities.


     

     

    Eric S. Daar, MD, Los Angeles Biomedical Research Institute At Harbor-UCLA Medical Center, Torrance, CA, Michael Saag, MD, FIDSA, Medicine, University of Alabama At Birmingham, Birmingham, AL, Benoit Trottier, M.D., Centre D'excellence VIH-Its-Hepatites, Clinique Medicale L'Actuel, Montreal, QC, Canada, Amanda Clarke, M.D., HIV/Gum and Clinical Trials, Royal Sussex County Hospital, Brighton, United Kingdom, Edwin Dejesus, MD, FACP, FIDSA, Orlando Immunology Center, Orlando, FL, David Parks, M.D., Central West Healthcare, St. Louis, MO, Eugenio Teofilo, M.D., Dia Polyva. Bloco Exames Gastro, Centro Hospitalar de Lisboa, Lisboa, Portugal, Cynthia Brinson, M.D., Central Texas Clinical Research, Austin, TX, Hal Martin, M.D., M.P.H., Clinical Research, Gilead Sciences, Foster City, CA, Susan Guo, PhD, Biostatistics, Gilead Sciences, Foster City, CA, Sandra Friborg, B.S., Clinical Operations, Gilead Sciences, Foster City, CA and Marshall Fordyce, MD, HIV Clinical Research, Gilead Sciences, Foster City, CA

    Disclosures:

    E. S. Daar, Bristol Myers Squibb: Consultant and Investigator , Consulting fee and Research support
    Gilead Sciences: Consultant and Investigator , Consulting fee and Research support
    Merck: Investigator , Research support
    Viiv: Consultant and Investigator , Consulting fee and Research support
    Abbvie: Consultant , Consulting fee
    Teva: Consultant , Consulting fee

    M. Saag, Gilead Sciences: Investigator , Research support
    Merck: Investigator , Research support
    BMS: Investigator , Research support
    Abbvie: Investigator , Research support
    Janssen: Investigator , Research support

    B. Trottier, Gilead Sciences: Consultant and Investigator , Consulting fee and Research support
    Abbvie: Consultant and Speaker's Bureau , Consulting fee and Speaker honorarium
    BMS: Consultant and Speaker's Bureau , Consulting fee and Speaker honorarium
    Merck: Consultant and Speaker's Bureau , Consulting fee and Speaker honorarium
    Janssen: Consultant and Speaker's Bureau , Consulting fee and Speaker honorarium
    Theratechnologies: Consultant and Speaker's Bureau , Consulting fee and Speaker honorarium
    ViiV: Consultant and Speaker's Bureau , Consulting fee and Speaker honorarium

    A. Clarke, Gilead Sciences: Investigator , Research support
    Janssen: Travel , Travel bursary
    BMS: Travel , Travel bursary

    E. Dejesus, Achillion: Investigator , Research support
    Boehringer Ingelheim: Investigator , Research support
    Gilead Sciences: Consultant , Investigator and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
    GSK: Investigator , Research support
    Hoffman LaRoche: Investigator , Research support
    Idenix: Investigator , Research support
    Janssen: Consultant , Investigator and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
    Merck: Investigator , Research support
    Novelos: Investigator , Research support
    Pfizer: Investigator , Research support
    Sangamo: Investigator , Research support
    Serono: Investigator , Research support
    Taimed: Investigator , Research support
    Tobira: Investigator , Research support
    Vertex: Investigator , Research support

    D. Parks, Gilead Sciences: Investigator and Speaker's Bureau , Research support and Speaker honorarium
    ViiV: Investigator and Speaker's Bureau , Research support and Speaker honorarium
    BMS: Investigator and Speaker's Bureau , Research support and Speaker honorarium
    Abbvie: Speaker's Bureau , Speaker honorarium

    E. Teofilo, Gilead Sciences: Investigator , Research support

    C. Brinson, Gilead Sciences: Consultant and Speaker's Bureau , Consulting fee and Speaker honorarium
    BMS: Consultant , Consulting fee

    H. Martin, Gilead Sciences: Employee , Salary

    S. Guo, Gilead Sciences: Employee , Salary

    S. Friborg, Gilead Sciences: Employee , Salary

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

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 7th with the exception of research findings presented at the IDWeek press conferences.