Long-term integrated analysis of B/F/TAF in treatment-naïve adults with HIV through five years of follow-up

Title

Long-term integrated analysis of B/F/TAF in treatment-naïve adults with HIV through five years of follow-up

Presenter

Paul Sax

Authors

P. Sax * (1), J. Arribas (2), C. Orkin (3), A. Lazzarin (4), A. Pozniak (5), E. DeJesus (6), F. Maggiolo (7), H.-J. Stellbrink (8), Y. Yasdanpanah (9), R. Acosta (10), H. Huang (10), J. Baeten (10), J. Hindman (10), H. Martin (10), D. Wohl (11)

Institutions

(1) Brigham and Women''s Hospital, Boston, United States, (2) Hospital Universitario La Paz, Madrid, Spain, (3) Queen Mary University of London, London, United Kingdom, (4) San Raffaele Hospital Milan, Milan, Italy, (5) Chelsea and Westminster Hospital, London, United Kingdom, (6) Orlando Immunology Center, Orlandon, United States, (7) Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy, (8) ICH Study Center, Hamburg, Germany, (9) Hôpital Bichat Claude Bernard, Paris, France, (10) Gilead Sciences, Foster City, United States, (11) UNC School of Medicine, Chapel Hill, United States

BACKGROUND: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a guideline-recommended single-tablet regimen for people with HIV-1 (PWH). Week (W) 48 primary and W96 and W144 secondary endpoint results of the blinded phase from two studies established non-inferiority of B/F/TAF to dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) and DTG+F/TAF in treatment-naïve PWH. We present pooled outcomes from a 96W open-label extension (OLE) in participants initially randomized to B/F/TAF for a total follow up of W240.
METHODS: We conducted two randomized, double-blind, phase 3 studies in treatment-naïve adult PWH: Study-1489 (B/F/TAF vs DTG/ABC/3TC) and Study-1490 (B/F/TAF vs DTG+F/TAF). Unblinding occurred after all participants completed W144, after which all were offered B/F/TAF in OLE. Participants originally randomized to B/F/TAF who entered OLE were pooled into B/F/TAF group. An analysis at W240 assessed efficacy as proportion with HIV-1 RNA <50 c/mL using missing=excluded (M=E) and missing=failure analyses; safety assessed adverse events (AEs) and laboratory results.
RESULTS: 634 participants originally randomized/treated with B/F/TAF (506 [80%] treated in OLE), 89% men, 33% Black, median age 32 years (range 18-71). W240 98.6% (426/432) of B/F/TAF participants maintained HIV-1 RNA <50 c/mL (M=E) with a mean CD4 increase of +338 cells/ml from baseline. No B/F/TAF participant in the final resistance analysis developed virologic resistance. Among B/F/TAF group through W240, 28% (178/634) experienced a study drug-related AE, 1% (9/634) were Grade 3 or 4. AEs led to drug discontinuation in <1.6% (n=10/634) of participants. There were no discontinuations due to renal AEs. Lipid changes were similar at W240 to W192, with minimal change in TC:HDL. Median weight change (IQR) from baseline to W240 was +6.1kg (2.0, 11.7), +3kg (0.3, 5.8) occurring during year one.

CONCLUSIONS: Through 5-years of follow-up, B/F/TAF maintained high rates of virologic suppression with no treatment-emergent resistance and rare drug discontinuations due to AEs. These results demonstrate the durability and safety of B/F/TAF in PWH.

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