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Switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults aged 65 years or older: week 96 results from an international, Phase 3b, open-label trial

Title
Switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults aged 65 years or older: week 96 results from an international, Phase 3b, open-label trial
Presenter
Franco Maggiolo
Authors
F. Maggiolo * (1), G. Rizzardini (2), J.-M. Molina (3), F. Pulido (4), S. De Wit (5), L. Vandekerckhove (6), J. Berenguer (7), M. D'Antoni (8), C. Blair (8), S. Chuck (8), H. Martin (8), I. McNicholl (8), R. Haubrich (8), J. Gallant (8)
Institutions
(1) Division of Infectious Diseases, ASST Papa Giovanni XXIII, Bergamo, Italy, (2) Division of Infectious Diseases, Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy, (3) Saint Louis Hospital, University Paris Diderot, Department of Infectious Diseases, Paris, France, (4) Unidad VIH, Hospital Universitario 12 de Octubre, imas12, UCM, Madrid, Spain, (5) St Pierre University Hospital, Université Libre de Bruxelles, Brussels, Belgium, (6) University Hospital, Ghent, Belgium, (7) Infectious Diseases, Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Spain, (8) Gilead Sciences, Foster City, United States

BACKGROUND: Studies are needed to assess the safety and efficacy of antiretroviral therapy in older individuals. This is the largest, international, Phase 3b study enrolling HIV-1-infected participants '¥65 years. We report the efficacy and safety of switching to B/F/TAF at Week(W) 96.
METHODS: Virologically suppressed (VL <50 copies/mL) participants '¥65 years receiving either E/C/F/TAF or a TDF-based regimen at baseline switched to B/F/TAF. W96 VL <50 copies/mL was measured by Snapshot (secondary endpoint) and missing=excluded (M=E) analyses.
RESULTS: 86 participants were enrolled. Median age was 69 years (IQR 67, 72); 13% were female; 99% were white; 92% were receiving E/C/F/TAF at baseline. At W96 (M=E), 100% had VL <50 copies/mL with no virologic failures at W96 by M=E analysis. Snapshot results are presented in the Table. Median CD4 counts were stable. Median changes from baseline in lipid parameters were: total fasting cholesterol (-15 mg/dL), LDL (-10 mg/dL), HDL (-1 mg/dL), triglycerides (-19 mg/dL) and total cholesterol:HDL (-0.2). Median weight change from baseline was 0.0 kg. There were 2 (2.3%) Grade 3-4 study drug-related AEs, 11 (13%) Grade 3-4 laboratory abnormalities and 3 (3.5%) AEs leading to study drug discontinuation (drug-related). There were no discontinuations for renal, bone or hepatic AEs and no study drug-related serious AEs occured. Two deaths occurred that were not attributed to study drug by the site investigator.

Table 1 Efficacy at W96 (Snapshot)# participants (%)
HIV-1 RNA <50 copies/mL
64/86 (74%)
HIV-1 RNA >50 copies/mL
0
No virologic data in W96 window22 (26%)
discontinued study drug with last available HIV-1 RNA <50 copies/mL
 9
visit after W96 window with HIV-1 RNA <50 copies/mL
 2
missed W96 with no RNA assessments after W84 due to COVID-19 restrictions but W84 HIV-1 RNA <50 copies/mL
 11

CONCLUSIONS: Through W96, high rates of virologic suppression were maintained in older participants who switched to B/F/TAF. The COVID-19 pandemic affected in-person visits affecting W96 data; however, study teams were able to keep participants in care through telehealth. The safety and efficacy data support the switch to B/F/TAF in virologically suppressed, HIV-infected individuals aged '¥65 years.