Switch from TDF-based to Elvitegravir-Cobicistat-TAF-FTC Study 109
Switch to Elvitegravir-Cobicistat-TAF-FTC Study 109: Design Study Design: Study 109 • Background : Open-label, randomized study, Phase 3 trial comparing switch to EVG-COBI-TAF-FTC versus continuation of baseline regimen of TDF-based ART Switch Group EVG-COBI-TAF-FTC • Inclusion Criteria (n = 1443) (n=959) - HIV RNA < 50 copies/mL on ART for ≥96 weeks 2x - CrCl >50 mL/min - 1 of 4 baseline TDF-containing ART regimens: 1x (a) EVG-COBI-TDF-FTC (n=459) (b) EFV-TDF-FTC (n=376) No Switch Group (c) ATV + RTV + TDF-FTC (n=385) TDF-based ART (d) ATV-COBI + TDF-FTC (n=216) (n = 477) • Treatment Arms - EVG-COBI-TAF-FTC (Switch group) - Remain on TDF-based ART (No switch group) * NOTE : Between randomization and start of study, 4 participants withdrew consent, 2 withdrew by investigator discretion, and 1 was lost to follow-up. Source: Mills A, et al. Lancet Infect Dis. 2016;16:43-52.
Switch to Elvitegravir-Cobicistat-TAF-FTC Study 109: Subgroup Analysis Result Week 48 Virologic Response, by Baseline Regimen EVG-COBI-TAF-FTC (Switch) TDF-Based ART (No Switch) 100 98 97 97 97 96 HIV RNA <50 copies/mL (%) 93 92 90 80 60 40 20 444/ 241/ 112/ 183/ 301/ 932/ 390/ 149/ 125 959 477 251 402 199 306 153 0 All prior regimens Prior EFV-TDF-FTC Prior ATV + RTV + Prior EVG-COBI- TDF-FTC TDF-FTC Source: Mills A, et al. Lancet Infect Dis. 2016;16:43-52.
Switch to Elvitegravir-Cobicistat-TAF-FTC Study 109: Result Week 48: Changes in Bone Mineral Density (BMD) EVG-COBI-TAF-FTC (Switch) Tenofovir DF-Based ART (No Switch) 2 1.56 1.47 Mean Change in BMD (%) 1 0 -0.34 -0.44 -1 Hip Spine Source: Mills A, et al. Lancet Infect Dis. 2016;16:43-52.
Switch to Elvitegravir-Cobicistat-TAF-FTC Study 109: Result Week 48: Changes in Quantitative Proteinuria EVG-COBI-TAF-FTC (Switch) Tenofovir DF-Based ART (No Switch) Median Change from Baseline (%) 50 25 18 18 10 9 0 -25 -18 -21 -33 -50 -52 -75 β2 microglobulin Proteinuria Albuminuria Retinol binding (UPCR) (APCR) protein Source: Mills A, et al. Lancet Infect Dis. 2016;16:43-52.
Switch to Elvitegravir-Cobicistat-TAF-FTC Study 109: Result Week 48: Change in Plasma Lipids from Baseline EVG-COBI-TAF-FTC (Switch) Tenofovir DF-Based ART (No Switch) 30 Change in Median Value (mg/dL) 20 20 11 9 10 2 2 1 0 -2 -2 -10 Total Cholesterol LDL HDL Triglycerides Source: Mills A, et al. Lancet Infect Dis. 2016;16:43-52.
Switch to Elvitegravir-Cobicistat-TAF-FTC Study 109: Conclusions Interpretation : “Switching to a tenofovir alafenamide -containing regimen from one containing tenofovir disoproxil fumarate was non-inferior for maintenance of viral suppression and led to improved bone mineral density and renal function. Longer term follow-up is needed to better understand the clinical impact of these changes.” Source: Mills A, et al. Lancet Infect Dis. 2016;16:43-52.
Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $800,000 with 0% financed with non-governmental sources. This project is led by the University of Washington’s Infectious Diseases Education and Assessment (IDEA) Program. The content in this presentation are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government.
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