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  ID Week
Wed, Sep 29 -
Sun, Oct 3, 2021
Virtual Conference

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Strong HIV Control for 72 Weeks With B/F/TAF in US Blacks
 
 
  IDWeek, September 29-October 3, 2021
 
Mark Mascolini
 
Despite baseline resistance, blips, and adherence slips, nearly all African Americans taking single-tablet bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for 72 weeks had an undetectable viral load at their last study visit in BRAAVE 2020 [1]. Researchers recorded no new resistance to study drugs throughout follow-up in this 489-person randomized open-label trial.
 
BRAAVE 2020 recruited self-described African Americans with a viral load below 50 copies for at least 6 months on their current regimen [2]. Participants could enter the trial with a history of certain common antiretroviral resistance mutations, but not a primary integrase mutation, the K65R/E/N mutations conferring resistance to TAF or TDF, 3 or more thymidine nucleoside analog mutations, or T69 insertion mutations. Researchers randomized 330 people to switch immediately to B/F/TAF and 165 to continue their current regimen for 24 weeks and then switch. At the 24-week point, 96% who switched immediately to B/F/TAF and 95% who stayed with their baseline regimen had a viral load below 50 copies [2]. After 48 weeks, 95% in the immediate-switch group and 97% in the delayed-switch group had a sub-50-copy viral load.
 
The original group had a median age of 49 years, a median CD4 count around 750, and a median body mass index around 29 kg/m2. One third of participants in both study arms were female at birth. When BRAAVE 2020 began, 15% of participants had a nucleos(t)ide resistance mutation, 11% had M184V/I (conferring resistance to FTC and 3TC), 8% had 1 or more thymidine nucleoside analog mutation, 22% had a primary nonnucleoside mutation, and 13% had a primary protease inhibitor mutation. After randomization in BRAAVE 2020, researchers discovered primary integrase inhibitor mutations in 11 people (2%), all of whom stayed in the study and stayed in viral load computations.
 
The new analysis followed 489 study participants who continued B/F/TAF to week 72. At 48 weeks, 99% (316 of 318) in the immediate-switch group and 100% (127 of 127) in the delayed-switch group kept their viral load below 50 copies. After 72 weeks, 486 of 489 people (99%) who continued B/F/TAF maintained a sub-50 viral load at their last study visit. That response rate did not vary across 9 resistance subgroups, 2 viral blip subgroups, or 3 adherence subgroups:
 
Resistance subgroup number (%) with 72-week viral load below 50 copies
No resistance mutations: 299 of 301 (99%)
Any resistance mutation: 166 of 167 (99%)
Multiclass resistance mutations: 58 of 58 (100%)
NRTI mutations: 68 of 68 (100%)
M184V/I: 50 of 50 (100%)
1 or more thymidine nucleoside analog mutation: 36 of 36 (100%)
Primary nonnucleoside mutation: 100 of 101 (99%)
Primary protease inhibitor mutation: 61 of 61 (100%)
Primary integrase inhibitor mutation: 11 of 11 (100%)
 
Viral blip subgroup number (%) with 72-week viral load below 50 copies
No blip: 464 of 467 (99%)
1 or more blips: 22 of 22 (100%)
 
Adherence subgroup number (%) with 72-week viral load below 50 copies
95% or better adherence: 362 of 363 (100%)
80% to 95% adherence: 102 of 104 (98%)
Less than 80% adherence: 15 of 15 (100%)
 
Blips (a viral load reading above 50 copies followed by an undetectable reading) proved rare after study participants switched to B/F/TAF. Most blips stayed below 200 copies, and adherence did not differ significantly between people with and without blips.
 
Number (%) of blips after switch to B/F/TAF
4 weeks after switch to B/F/TAF

Immediate switch group: 2 of 325 (0.9%)
Delayed switch group: 1 of 161 (0.6%)
 
12 weeks after switch to B/F/TAF
Immediate switch group: 3 of 328 (0.9%)
Delayed switch group: 2 of 159 (1.25%)
 
24 weeks after switch to B/F/TAF
Immediate switch group: 3 of 325 (0.9%)
Delayed switch group: 3 of 159 (1.9%)
 
36 weeks after switch to B/F/TAF
Immediate switch group: 2 of 322 (0.6%)
Delayed switch group: 1 of 150 (0.7%)
 
48 weeks after switch to B/F/TAF
Combined groups: 4 of 318 (1.25%)
 
60 weeks after switch to B/F/TAF
Combined groups: 2 of 279 (0.7%)
 
Three quarters of participants (77%) had at least 95% adherence by pill count during follow-up. Of the 112 people (23%) with less than 95% adherence, 110 of them (98%) had a viral load below 50 copies at their last study visit, including all 14 people with less than 80% adherence.
 
No one dropped out of the study because B/F/TAF lost control of HIV, and no mutations making HIV resistant to study drugs emerged during follow-up.
 
References
1. Andreatta K, D'Antoni ML, Chang S, et al. High efficacy of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in African American adults with HIV including those with preexisting resistance, viral blips, and suboptimal adherence. IDWeek, September 29-October 3, 2021. Abstract 629.
2. Hagins D, Kumar P, Saag M, et al. Switching to bictegravir/emtricitabine/tenofovir alafenamide in black Americans with HIV-1: a randomized phase 3b, multicenter, open-label study. J Acquir Immune Defic Syndr. 2021;88:86-95. doi: 10.1097/QAI.0000000000002731. https://journals.lww.com/jaids/Fulltext/2021/09010/Switching_to_Bictegravir_Emtricitabine_Tenofovir.12.aspx