Encore Presentations
Tuesday, November 14, 2023
08:30 AM–10:00 AM
Abstract
Background: People with HIV (PWH) who are initiated on guidelines-recommended first-line INSTI-based antiretroviral therapy routinely achieve rapid virologic suppression; however, those with a high baseline (BL) HIV-1 RNA and/or low CD4 count may be more challenging to manage in the short- and long-term. To further characterize long-term outcomes over 5 years in select subgroups, we analyzed results from two studies examining B/F/TAF as initial treatment stratified by BL HIV-1 RNA and/or CD4 count.
Methods: Adults with HIV were randomized to receive blinded initial treatment with B/F/TAF versus dolutegravir [DTG]/abacavir/lamivudine (Study 1489) or DTG+F/TAF (1490) for 144 weeks (W) of blinded treatment followed by an optional open-label B/F/TAF for 96W. We present virologic response (HIV-1 RNA <50 c/mL, missing=excluded and missing=failure) and study drug-related adverse events (DRAE) from a pooled analysis of participants originally randomized to B/F/TAF who had BL HIV-1 RNA 100,00-400,000 copies(c)/mL, HIV-1 RNA >400,000 c/mL and/or CD4 count <200 cells/µL through W240.
Results: 634 adults (median age 32 years, 89% men, 33% Black/African descent, 24% Hispanic/LatinX) originally randomized to B/F/TAF were included for analysis. At BL, 80 participants had a BL CD4 count <200 cells/µL and 119 participants had HIV-1 RNA >100,000 c/mL, of whom, 20 had HIV-1 RNA >400,000 c/mL. At W240, virologic suppression was high for the low CD4 count and/or high HIV-1 RNA subgroups (Table). No participant in the final resistance analysis developed virologic resistance to any component of B/F/TAF. Across the subgroups, the most common DRAEs were nausea, headache and diarrhea and there were no serious DRAEs. There was only one discontinuation due to a DRAE in the low CD4 count subgroup, and none in the high HIV-1 RNA subgroup.
Conclusion: Initial treatment with B/F/TAF was safe and efficacious over 5 years of follow-up in people with a high BL HIV-1 RNA and/or low CD4 count. These outcomes provide additional evidence that B/F/TAF is an effective and durable regimen for a broad range of PWH, including those with advanced disease.
Table: Pooled B/F/TAF Efficacy and Safety Data at 240 weeks*
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All B/F/TAF (N=634 originally randomized to B/F/TAF)
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BL HIV-1 RNA <100,000 c/mL (N=515)
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BL HIV-1 RNA 100,000-400,000 c/mL
(N=99)
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BL HIV-1 RNA >400,000 c/mL
(N=20)
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BL CD4 count <200 cells/µL
(N=80)
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BL HIV-1 RNA >100,000 c/mL AND CD4 count <200 cells/µL
(N=39)
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Efficacy at Week 240, n/N (%)
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HIV-1 RNA <50 c/mL (M=E)
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350/353 (99%)
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63/65 (97%)
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13/14 (93%)
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49/50 (98%)
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20/21(95%)
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HIV-1 RNA <50 c/mL (M=F)§
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350/515 (68%)
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76/99 (64%)
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13/20 (65%)
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49/80 (61%)
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20/39 (51%)
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Safety at Week 240, n (%)
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Any DRAE
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144 (28%)
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30 (30%)
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4 (20%)
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20 (25%)
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8 (21%)
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DRAE > 2%
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Nausea
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24 (5%)
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4 (4%)
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0
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3 (4%)
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1 (3%)
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Headache
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22 (4%)
|
7 (7%)
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2 (10%)
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6 (8%)
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4 (10%)
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Diarrhea
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21 (4%)
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7 (7%)
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2 (10%)
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5 (6%)
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3 (8%)
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Fatigue
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13 (3%)
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4 (4%)
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0
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2 (3%)
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1 (3%)
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Insomnia
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12 (2%)
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1 (1%)
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0
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2 (3%)
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1 (3%)
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Dizziness
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11 (2%)
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3 (3%)
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1 (5%)
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0
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0
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Serious DRAE
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5 (1%)
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0
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0
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0
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0
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AE Leading to Premature Study Drug Discontinuation
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9 (2%)
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1 (1%)
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0
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2 (3%)
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0
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Drug-Related
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5 (0.8%)
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0
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0
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1 (1%)
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0
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AE: adverse event; BL: baseline; DRAE: Drug-Related Adverse Event; LTFU: lost to follow-up; M=E: missing = excluded; M=F: missing = failure; OLE: open-label extension
*Includes only participants originally randomized and treated with B/F/TAF. Of 634, 115 prematurely discontinued study-drug during randomized phase: 13 did not enter OLE, 62 prematurely discontinued study drug during OLE (LTFU 28, participant decision 22, AE 4, investigator’s discretion 3, non-compliance with study-drug 2, death 1, lack of efficacy 1, protocol violation 1)
Presenting Author
Nathan Unger PharmDGilead Sciences
Authors
Kristin Andreatta MSc
Gilead Sciences
Jared Baeten MD
Gilead Medical Affairs
Axel Baumgarten MD
MIB Infectious Disease Medical Center
Mezgebe Berhe MD
North Texas Infectious Diseases Consultants
Hal Martin MD, MPH
Gilead Sciences
Debbie Hagins MD
Chatham County Health Department
Jason Hindman PharmD, MBA
Gilead Sciences
Hailin Huang PhD
Gilead Sciences
Chloe Orkin MBBCH
Queen Mary University of London
Olayemi Osiyemi MD
Triple O Research Institute
Anton Pozniak MD
Chelsea and Westminster Hospital
Juan Manuel Tiraboschi PhD
Bellvitge University Hospital
Anson Warupa MD
Infectious Disease Specialists of Atlanta
Moti Ramgopal MD
Midway Research Center and Specialty Care