Background: Black adults are disproportionately affected by HIV.
Methods: We conducted a 48-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 the 663 treated, 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 48 was FTC /TAF 94.2% vs. FTC /TDF 89.6%; for non-Blacks, it was 94.3% vs 93.9%. Few participants discontinued study drug due to adverse events in either subgroups (Black, FTC /TAF 0 vs. FTC /TDF 1.5%; non-Black, 2.7% vs. 0.8%). 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 1). No cases of Fanconi syndrome or proximal renal tubulopathy were reported in the overall population.
Conclusion: In virologically suppressed Black adults, FTC/TAF demonstrated improvements in renal and bone safety over FTC/TDF with similar high-level efficacy at Week 48. These results support switching to FTC/TAF from FTC/TDF for the treatment of HIV-1 infection in Black adults.
Janssen Pharmaceuticals: Board Member , Investigator and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
Glaxo-SmitKline: Investigator , Research support
Bristol Meyer Squibb: Investigator , Research support
Merck: Investigator , Research support
ViiV: Consultant , Consulting fee and Speaker honorarium
Merck: Consultant , Consulting fee and Speaker honorarium
BMS: Speaker , Speaker honorarium
Jannsen: Speaker , Speaker honorarium
M. Ramgopal, None
B. H. Wade, Gilead: Investigator and Speaker , Research support and Speaker honorarium
L. Sloan, None
H. Edelstein, Alameda Health System: Investigator , Research support
G. Pierone Jr., None
J. Slim, ViiV: Investigator and Scientific Advisor , Consulting fee and Grant recipient
J. Stephens, Mercer University School of Medicine: Grant Investigator , Research grant
M. Yan, Gilead: Employee , own stock and Salary
C. Tran-Muchowski, Gilead: Employee , owns stock and Salary
M. Rhee, Gilead: Employee , Owns stocks/options and Salary