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.
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.
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.
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.
D. A. Wohl,
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