Share
 
Title
B/F/TAF versus ABC/DTG/3TC or DTG + F/TAF in treatment-naïve adults with high baseline viral load or low baseline CD4 count in 2 Phase 3 randomized, controlled clinical trials
Presenter
Daniel Podzamczer
Authors
D. Podzamczer1, H.-J. Stellbrink2, C. Orkin3, A. Pozniak4, J.R. Arribas5, E. Koenig6, M. Ramgopal7, A. Baumgarten8, X. Wei9, A. Cheng9, D. Sengupta9, H. Martin9, E. Quirk9
Institutions
1Hospital Universitari de Bellvitge, HIV and STD Unit Infectious Disease Department, Barcelona, Spain, 2ICH Study Center, Hamburg, Germany, 3Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre, London, United Kingdom, 4Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom, 5Hospital Universitari de Bellvitge, Barcelona, Spain, 6Instituto Dominicano de Estudios Virologicos IDEV, Santo Domingo, Dominican Republic, 7Midway Immunology and Research Center, Fort Pierce, United States, 8Zibp Zentrum fur Infektiologie Berlin Prenzlauer Berg, Berlin, Germany, 9Gilead Sciences Inc., Foster City, United States

Background: Treatment-naïve, HIV-1-infected individuals with high viral load and/or low CD4 count may be difficult to treat. In two Phase 3 studies of fixed-dose combination bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) vs. dolutegravir comparators, there were no treatment differences between arms for subgroups with HIV-1 RNA >100,000 copies (c)/mL or CD4 < 200 cells/ µL at baseline. No participant failed with resistance. To further characterize efficacy of B/F/TAF, we analyzed pooled results from these trials for those with high HIV-1 RNA or low CD4 count at baseline.
Methods: Treatment-naïve, HIV-1-infected adults were randomized 1:1 to receive blinded treatment with B/F/TAF (50/200/25 mg) vs. dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) (study 1489) or DTG (50 mg) + F/TAF (200/25 mg) (study 1490). Participants were recruited in North America, Europe, and Australia. To evaluate the efficacy of B/F/TAF specifically in these populations, we conducted a per-protocol (PP) analysis, which included participants randomized who received ≥1 dose of study medication but excluded those without on-treatment results in the week (W) 48 window (unless discontinued for lack of efficacy) or who had low medication adherence (< 2.5th percentile). We present W48 virologic responses by FDA snapshot algorithm for participants with baseline HIV-1 RNA >100,000 c/mL or CD4 count < 200 cells/µL using the PP analysis set.
Results: 629 adults were randomized in study 1489 (B/F/TAF n=314, DTG/ABC/3TC n=315) and 645 in study 1490 (B/F/TAF n=320, DTG+F/TAF n=325). Pooled, 198 participants (PP analysis set) had baseline HIV-1 RNA >100,000 copies/mL (B/F/TAF n=103/634 [16%], DTG/ABC/3TC n=46/315 [15%], DTG+F/TAF n=49/325 [15%]), and 132 (B/F/TAF n=73/634 [12%], DTG/ABC/3TC n=27/315 [9%], DTG+F/TAF n=32/325 [10%]) had baseline CD4 count < 200 cells/µL. For both high VL and low CD4 subgroups, rates of participants with HIV-1 RNA < 50 c/mL at W48 were similarly high for B/F/TAF, DTG/ABC/3TC, and DTG+F/TAF (table). No participant failed with resistance to any components of study drug.
Conclusions: B/F/TAF demonstrated potent viral suppression with no treatment-emergent resistance in treatment-naïve adults with high baseline HIV-1 RNA or low CD4 count. These data provide further evidence that B/F/TAF is an appropriate treatment for a wide range of patients, including late presenters who have been historically more difficult to treat.


Baseline HIV-1 RNA >100,000 c/mLB/F/TAF (n=103)DTG/ABC/3TC (n=46)DTG + F/TAF (n=49)
HIV-1 RNA < 50 c/mL99% (102/103)98% (45/46)98% (48/49)
HIV-1 RNA ≥ 50 c/mL1% (1/103)2% (1/46)2% (1/49)
Discontinued due to lack of efficacy000
    
Baseline CD4 count <200 cells/µLB/F/TAF (n=73)DTG/ABC/3TC (n=27)DTG + F/TAF (n=32)
HIV-1 RNA < 50 c/mL99% (72/73)96% (26/27)100% (32/32)
HIV-1 RNA ≥ 50 c/mL1% (1/73)4% (1/27)0
Discontinued due to lack of efficacy000
[Week 48 Outcomes by Baseline HIV-1 RNA >100,000 c/mL and CD4 count <200 cells/ µL (PP Analysis Set)]

Download the e-Poster