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.
J. A. Flamm,
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