TITLE: Efficacy and safety of B/F/TAF in Hispanic/Latine adults with HIV-1 initiating first-line therapy: 5-year follow-up from two Phase 3 studies

Authors: Claudia Martorell,¹ Olayemi Osiyemi,² Mezgebe Berhe,³ Lizette Santiago,⁴ Christopher Rosero,⁵ Fang Fang,⁵ Nathan Unger,⁵ Jason T. Hindman,⁵ Moti Ramgopal⁶

Affiliations [one affiliation allowed per author]:

1. The Research Institute, Springfield, USA
2. Triple O Research Institute, West Palm Beach, USA
3. North Texas Infectious Diseases Consultants, Dallas, USA
4. HOPE Clinical Research, San Juan, Puerto Rico
5. Gilead Sciences, Inc., Foster City, USA
6. Midway Immunology and Research Center, Fort Pierce, USA
   
   

Abstract content; Word limit: 343/350 (including table [=50], excluding section headings)

Background: Hispanic/Latine people are disproportionately affected by HIV-1 and may have a greater risk of comorbidities compared with non-Hispanic/Latine people with HIV (PWH). However, this population has historically been underrepresented in HIV clinical studies. Here we assess the efficacy and safety of first-line therapy with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) over 5 years in Hispanic/Latine PWH.

Methods: Studies 1489 (NCT02607930; B/F/TAF vs. dolutegravir/abacavir/lamivudine [DTG/ABC/3TC]) and 1490 (NCT02607956; B/F/TAF vs. DTG+F/TAF) were randomized, double-blind, multicenter Phase 3 studies in adult PWH initiating first-line therapy. We present a pooled analysis of participants who received B/F/TAF in the 144-week (W) randomization phase and in the 96W open-label extension. Outcomes were compared between Hispanic/Latine and non-Hispanic/Latine participants. Baseline demographics and clinical characteristics, proportion of participants with HIV‐1 RNA <50 copies/mL (missing=excluded), change in CD4 cell count, changes in metabolic parameters, adherence and treatment-emergent adverse events (TEAEs) are presented.

Results: In total, 155 (24.5%) Hispanic/Latine and 477 (75.5%) non-Hispanic/Latine participants (61.9% and 68.1% from the U.S., respectively) received B/F/TAF over 240W. At baseline, median age was 30 and 33 years, 89.0% and 89.1% were male at birth, 11.6% and 21.2% had HIV-1 RNA >100,000 copies/mL, 10.3% and 13.4% had CD4 <200 cells/µL, and 4.5%/12.9%/10.3% and 6.5%/16.4%/14.7% had a history of diabetes mellitus/hypertension/hyperlipidemia, respectively. Outcomes are shown in the Table. At W240, 100.0% of Hispanic/Latine participants and 98.1% of non-Hispanic/Latine participants had HIV-1 RNA <50 copies/mL. Change in CD4 count, changes in metabolic parameters including body weight and estimated glomerular filtration rate, adherence rate and TEAEs were similar between groups.

Conclusions: Through 5 years of follow-up in Hispanic/Latine PWH, B/F/TAF maintained high rates of virologic suppression and was well tolerated, with similar metabolic (including treatment-emergent diabetes/hypertension) and safety outcomes compared with non-Hispanic/Latine PWH. These results demonstrate the durability and safety of B/F/TAF in Hispanic/Latine PWH.

Table. Outcomes at Week 240