Week 72 outcomes and COVID-19 impact from The BRAAVE 2020 study: a randomized switch to B/F/TAF in African American adults living with HIV


BACKGROUND: Black Americans are disproportionately impacted by HIV. The BRAAVE 2020 study demonstrated that guideline-recommended bictegravir/emtricitabine/tenofovir alafenamide(B/F/TAF) was non-inferior to continuing current HIV treatment in Black adults through week (W) 48. Participants could continue B/F/TAF until W72. We present final W72 results, subgroup analyses, and COVID-19 impact.
METHODS: Black American adults living with HIV and virologically suppressed on 2 NRTIs plus a 3rd agent, were randomized (2:1) to switch to open-label B/F/TAF or stay on baseline regimen (SBR). Efficacy and safety at W24&W48 were previously presented. SBR participants switched to B/F/TAF at W24 with follow-up until W72. Virtual visits started after W48 due to COVID-19. Subgroup analyses were performed (age <50& '¥50 and sex at birth [SAB]).
Table 1: Duration of Exposure, HIV1 RNA, CD4, Body Weight Changes and Subgroup Analyses



Duration of B/F/TAF exposure in weeks, median (Q1, Q3)
72 (71.4, 72.3)
48 (47.3, 48.3)
HIV-1 RNA < 50 copies/mL at Study W72 (Missing = Excluded), n/N (%)
246/248 (99.2)
127/127 (100)
CD4 change from baseline at Study W72, cells/mm3 mean, (SD)
+28 (205; n= 218)
+7 (174; n=117)
Body weight change from baseline at W72 in kg
median (IQR), (n=229 B/F/TAF)

1.8 (-1.4, 4.8)

Body weight change from baseline at W72 in kg (females vs male), median (IQR):
Female, n (%) (n=79 B/F/TAF)
Male, n (%) (n=150 B/F/TAF)

1.7 (-1.4, 4.6)
1.9 (-1.5, 5.1)

Treatment-emergent AEs by age (< 50 vs '¥ 50 years old), n/N (%)

< 50 (n=170 B/F/TAF; n = 84 SBR to B/F/TAF)
144/170 (84.7)
61/84 (72.6)
'¥ 50 (n=160 B/F/TAF; n=79 SBR to B/F/TAF)
131/160 (81.9)
52/79 (65.8)

493 were treated with B/F/TAF including 163 of the165 randomized to SBR who switched to B/F/TAF at W24 (SBR to B/F/TAF): 32% female, median age 49y (range 18-79). 124 (25%) participants completed virtual visit(s) in lieu of site visits, 6(1%) missed visits (in person and/or virtual) due to COVID-19-related challenges. The last participant visit was 18-Aug-2020. Five participants were reported to have COVID-19 and two died. 99% were suppressed (HIV-1 RNA <50 c/mL, Missing=Excluded) at W72. No treatment-emergent resistance was detected. Study drug-related AEs occurred in 10% of participants, mostly grade 1. Twelve (2.4%) participants discontinued due to an AE. One study-drug-related SAE of vomiting occurred (resolved in one day); three participants had grade 3/4 study-drug related AEs. Body weight change from baseline was similar regardless of SAB. The number of participants experiencing AEs by age group or by SAB were similar regardless of subgroup (table 1). Median study drug adherence was 98%.
CONCLUSIONS: Switching to B/F/TAF was highly effective and safe for Black adults regardless of age or SAB. Participants had high study engagement with few missed visits and high adherence despite the COVID-19 pandemic.