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Use of B/F/TAF in Elderly HIV Patients: Phase 3b Trial Results

Explore the safety and efficacy of B/F/TAF in HIV patients aged 65 years and older. Results show promising tolerability and viral suppression. Study included 86 older patients across multiple countries.

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Use of B/F/TAF in Elderly HIV Patients: Phase 3b Trial Results

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  1. Switching to Bictegravir/Emtricitabine/TenofovirAlafenamide (B/F/TAF) in Adults Aged ≥ 65 Years: Week 24 Results from a Phase 3b, Open-Label Trial (GS-US-380-4449) MaggioloF1, Rizzardini G2, Molina JM3, Pulido F4, De Wit S5, Vandekerckhove L6, Berenguer J7, Blair C8, Chuck S8, Piontkowsky D8, Martin H8, McNicholl I8, Haubrich R8, Gallant J8 1Division of Infectious Diseases, ASST Papa Giovanni XXIII, Bergamo, Italy; 2Division of Infectious Diseases, Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy; 3Department of Infectious Diseases, Saint Louis Hospital, University Paris Diderot, France; 4Unidad VIH, Hospital Universitario 12 de Octubre, imas12, UCM, Madrid, Spain; 5St Pierre University Hospital, UniversitéLibre de Bruxelles, Brussels, Belgium; 6University Hospital Ghent, Belgium; 7Infectious Diseases, Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Spain; 8Gilead Sciences, Foster City, CA, USA Presented at 10th IAS Conference on HIV Science (IAS 2019) 21-24 July 2019 Mexico City, Mexico Presentation MOPEB238

  2. Background Maggiolo, IAS, 2019, Presentation #MOPEB238 Because almost 50% of people living with HIV are > 50 years old, collecting and evaluating data on long term safety in older patients is important Older individuals are at increased risk of co-morbidities and polypharmacy, so ensuring the safety and convenience of ART in this population is critical B/F/TAF is a small single-tablet regimen with few drug-drug interactions and a high barrier to resistance Tenofoviralafenamide (TAF) is a prodrug of tenofovir associated with 90% lower tenofovir plasma levels than tenofovirdisoproxilfumarate (TDF), resulting in less renal and bone toxicity

  3. Study Design (GS-US-380-4449) Multicenter, open-label, 96-week single arm Primary Endpoint- W24 HIV-infected Stable ART for ≥ 3 months Prior enrollment in E/C/F/TAF studies 1823 or 1826 or currently on E/C/F/TAF (or FTC/TDF + 3rd agent B/F/TAF N = 86 Study sites in Belgium, France, Italy, Spain, and United Kingdom 96 weeks • Primary endpoints: • HIV RNA < 50 copies/mL at Week 24 by Food and Drug Administration (FDA) Snapshot algorithm • Secondary endpoints: • HIV-1 RNA <50 copies/mL at Week 48 and Week 96 • Safety and tolerability of B/F/TAF at through 96 weeks

  4. Key Inclusion Criteria • Age ≥ 65 years at screening • Currently receiving an ARV regimen of E/C/F/TAF FDC (or FTC/TDF + 3rd agent if currently or previously participated in GS-US-292-1826) for ≥ 3 months • Documented plasma HIV-1 RNA < 50 copies/mL on current regimen for the last 2 visits preceding the Screening Visit • Transient detectable viremia or “blips” (HIV-1 RNA ≥ 50 and < 400 copies/mL) were acceptable • Estimated GFR ≥ 30 mL/min (Cockcroft-Gault formula)

  5. Key Exclusion Criteria • Use of immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study • Malignancy within 5 years of screening other than cutaneous Kaposi’s sarcoma, completely resected non-melanoma skin cancer or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3) • The following medications were not permitted • carbamazepine, cisapride, dofetilide, Echinacea, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St. John’s wort

  6. Analysis • Primary endpoint: • HIV-1 RNA <50 copies/mL at Week 24 - defined by the FDA Snapshot • ŒSecondary endpoints: • HIV-1 RNA <50 copies/mL at Week 48 - defined by the FDA Snapshot • HIV-1 RNA <50 copies/mL at Week 96 - defined by the FDA Snapshot

  7. Baseline Characteristics * 3 participants had race that was not permitted to be disclosed

  8. Baseline Characteristics (Cont’d)

  9. Virologic Outcomes at Week 24 (Snapshot Analysis) N=2 N=0 N=84 Median change in CD4 count was -7 cells/mm3(IQR: -80, 90) by W24.

  10. Virologic Outcomes at Week 24 by FDA Snapshot *1) abdominal discomfort (Grade 2, drug-related) 2) benzodiazepine withdrawal c/mL=copies/mL, DC=discontinued

  11. Median Change in Weight from Baseline through Week 24 B/F/TAF 0 0 0 0 Median (Q1, Q3) change in weight (kg) Week Median change in weight at Week 24 was 0.0 kg (IQR -1, 2)

  12. Renal Biomarker Changes (%) at Week 24 RBP:Cr β2m:Cr B/F/TAF N Baseline (ug/g) 86 72.0 86 139.3 Median percent change (Q1, Q3) 92% of participants switched from a TAF-based regimen to B/F/TAF

  13. Estimated Glomerular Filtration Rate: Median Changes from Baseline through Week 24 B/F/TAF Median (Q1, Q3) change from Baseline in eGFRCG (mL/min) Week eGFRCG, estimated glomerular filtration rate calculated with Cockcroft-Gault equation

  14. Changes in Fasting Lipids at Week 24 B/F/TAF Median Change from Baseline, mg/dL 3.9 Baseline, mg/dL 191 117 51 131 • Participants on lipid-modifying medication • At baseline: 35 (41%) • Initiated during study: 2 (2.3%)

  15. Treatment-Emergent Adverse Events through Week 24 *1) abdominal discomfort (Grade 2, drug-related) 2) alcohol withdrawal 3) benzodiazepine withdrawal

  16. Conclusions Maggiolo, IAS, 2019, Presentation #MOPEB238 • Twenty-four weeks after switching to B/F/TAF • Virologic suppression was high at 98% with no virologic failures • There was no change in weight from baseline through Week 24 • No Grade 3 or 4 drug-related AEs were reported • There were no study drug-related SAEs or deaths • Fasting lipids decreased • B/F/TAF was safe, effective and well tolerated in virologically suppressed adults ≥ 65 years through 24 weeks

  17. Acknowledgments • F Ajana, A Antinori, J Berenguer, JI Bernardino de la Serna, A Bonjoch, E Cua, S de Wit, A Di Biagio, G Di Perri, C Duvivier, PM Girard, E Lazaro, G Madeddu, F Maggiolo, J MallolasMasferrer, GM Mateo García, B Menzaghi, JM Molina, P Morlat, C Mussini, J Navarro, E Ong, G Parruti, B Payne, J Perez Stachowski, P Philibert, L Piroth, F Pulido, T Quirino, F Raffi, G Rizzardini, JD Ross, D Salmon-Ceron, L Vandekerckhove, L Waters • This research was funded by Gilead Sciences, Inc. Yant, IAS, 2019, Presentation #TUPEA075 We extend our thanks to the participants, their partners and families, and all GS-US-380-4449 Investigators

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