Share

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

Title
Long-term analysis of B/F/TAF in treatment-naïve adults living with HIV through four years of follow-up
Presenter
José Arribas
Authors
J. Arribas * (1), C. Orkin (2), F. Maggiolo (3), A. Antinori (4), A. Lazzarin (5), Y. Yazdanpanah (6), H.-J. Stellbrink (7), A. Pozniak (8), E. DeJesus (9), H. Huang (10), R. Acosta (10), D.M. Brainard (10), J. Hindman (10), H. Martin (10), P.E. Sax (11).
Institutions
(1) Hospital Universitario La Paz, Mardid, Spain, (2) Queen Mary University of London, London, United Kingdom, (3) Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy, (4) National Institute for Infectious Diseases, Lazzaro Spallanzani, Rome, Italy, (5) San Raffaele Hospital Milan, Milan, Italy, (6) Hôpital Bichat Claude Bernard, Paris, France, (7) ICH Study Center, Hamburg, Germany, (8) Chelsea and Westminster Hospital, London, United Kingdom, (9) Orlando Immunology Center, Orlando, United States, (10) Gilead Sciences Inc., Foster City, United States, (11) Brigham and Women's Hospital, Boston, 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 an open-label extension (OLE) in participants initially randomized to B/F/TAF through W192.
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 who were originally randomized to B/F/TAF and entered OLE were pooled into an all-B/F/TAF group. An analysis at W192 assessed efficacy as the proportion with HIV-1 RNA <50 c/mL using missing=excluded (M=E) and missing=failure analyses; safety was assessed by adverse events (AEs) and laboratory results.
RESULTS: Of 634 participants originally randomized to B/F/TAF, 506 (80%) opted for OLE (89% men, 33% Black, median age 32 years [range 18-71]). An on-treatment analysis at W192 revealed 99.2% of B/F/TAF participants maintained HIV-1 RNA <50 c/mL (M=E) and had a median increase in CD4 count of +289 cells/ml from baseline. No participant on B/F/TAF failed with resistance. Among the B/F/TAF group through W192, 79% (471/594) of treatment-emergent AEs were Grade 1 or 2, most commonly diarrhea, nasopharyngitis, headache, upper respiratory tract infection and syphilis. AEs led to drug discontinuation in 1% (n=7) of participants. Median (Q1, Q3) weight change from baseline to W192 was 4.9kg (1.3, 9.9), with 3kg (0.3, 5.8) gain occurring in the first year of treatment.


CONCLUSIONS: Through 4 years of follow-up, B/F/TAF resulted in high rates of virologic suppression with no treatment-emergent resistance, and a low frequency of AEs and few drug discontinuations.