Presentation Abstract

Session: 184-Antiretrovirals: Efficacy, Safety and Indications
Thursday, Sep 12, 2013, 3:00 PM - 5:30 PM
Presentation Title: H-1464d - 48 Week Study of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF), Each in a Single Tablet Regimen (STR) with Elvitegravir, Cobicistat, and Emtricitabine [E/C/F/TAF vs. E/C/F/TDF] for Initial HIV Treatment
Location: Meeting Room 505
Presentation Number: H-1464d
Pres. Time: Thursday, Sep 12, 2013, 5:15 PM - 5:30 PM
Category: H2
Keywords: tenofovir ; renal function ; HIV-therapy 
Author(s): P. Sax1, I. Brar2, R. Elion3, A. Zolopa4, R. Ortiz5, H. Wang6, C. Callebaut6, H. Martin6, M. Fordyce6, S. McCallister6;
1Brigham and Womens Hosp, Boston, MA, 2Henry Ford Hosp, Detroit, MI, 3George Washington Univ. Hosp., Washington, DC, 4Stanford Univ, Palo Alto, CA, 5Orlando Immunology Ctr., Orlando, FL, 6Gilead Sci., Foster City, CA
Financial Disclosures:  P. Sax,
Gilead Sciences Role(s): Investigator, Scientific Advisor (Review Panel or Advisory Committee).
Abbott Role(s): Scientific Advisor (Review Panel or Advisory Committee).
BMS Role(s): Investigator, Scientific Advisor (Review Panel or Advisory Committee).
GSK Role(s): Investigator, Scientific Advisor (Review Panel or Advisory Committee).
Merck Role(s): Scientific Advisor (Review Panel or Advisory Committee).
Janssen Role(s): Scientific Advisor (Review Panel or Advisory Committee).
I. Brar,
Gilead Sciences Role(s): Investigator, Shareholder (excluding diversitied mutual funds), Speaker's Bureau.
Merck Role(s): Grant Investigator.
GSK Role(s): Grant Investigator.
R. Elion,
Gilead Sciences Role(s): Investigator.
A. Zolopa,
Gilead Sciences Role(s): Investigator.
R. Ortiz,
BMS Role(s): Speaker's Bureau.
Gilead Sciences Role(s): Investigator, Speaker's Bureau.
H. Wang,
Gilead Sciences Role(s): Employee.
C. Callebaut,
Gilead Sciences Role(s): Employee.
H. Martin,
Gilead Sciences Role(s): Employee.
M. Fordyce,
Gilead Sciences Role(s): Employee.
S. McCallister,
Gilead Sciences Role(s): Employee.
Abstract: Background: TAF is a novel tenofovir (TFV) prodrug that has 5-fold higher intracellular TFV diphosphate and 91% lower plasma TFV levels. Week 24 data from a double-blind study comparing the E/C/F/TAF single tablet regimen to E/C/F/TDF (Stribild) showed a high proportion of patients in both arms with undetectable HIV-1 viral load. Methods: Treatment-naïve adults were randomized 2:1 to once daily treatment with E/C/F/TAF or E/C/F/TDF. Week 48 efficacy and safety data are described, including tests of renal function and bone mineral density (BMD). Results: Of 170 patients treated, 88.4% on E/C/F/TAF and 87.9% on E/C/F/TDF had HIV-1 RNA <50 copies/mL (FDA Snapshot, ITT) at Week 48. No virologic failure or resistance occurred in patients on E/C/F/TAF. Nearly all adverse events were of mild to moderate severity and there were no treatment-related SAEs or renal discontinuations in either arm. The median creatinine increase (mg/dL) and eGFR reduction (mL/min) was +0.07 and -5.5 for E/C/F/TAF and +0.10 and -10.1 for E/C/F/TDF (p=0.077, p=0.041). Exploratory markers of proximal renal tubulopathy were different between the arms: urine retinol binding protein/creatinine ratio (µg/g) and urine β-2 microglobulin/creatinine ratio (µg/g) was -0.1 and -33.6 for E/C/F/TAF and +20.7 and +0.4 for E/C/F/TDF (p=0.001, p=0.008). Patients on E/C/F/TAF had less change in BMD at spine (median % change -1.0 vs. -3.37, p<.001) and hip (median % change -0.62 vs. -2.39, p<0.001); there were no pathologic fractures in either arm. Conclusions: These Week 48 data show comparably high efficacy rates for two E/C/F-based STRs containing either TAF or TDF. Patients on E/C/F/TAF had less change in eGFR, in exploratory markers of renal tubulopathy, and in spine and hip BMD. These data are currently being evaluated in Phase 3 clinical trials.




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