Switch from TDF-based to Elvitegravir-Cobicistat-TAF-FTC Study 109

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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 Inclusion Criteria (n = 1443) - HIV RNA < 50 copies/mL on ART for ≥ 96 weeks - CrCl > 50 mL/min - 1 of 4 baseline TDF-containing ART regimens: (a) EVG-COBI-TDF-FTC (n=459) (b) EFV-TDF-FTC (n=376) (c) ATV + RTV + TDF-FTC (n=385) (d) ATV-COBI + TDF-FTC (n=216) Treatment Arms - EVG-COBI-TAF-FTC (Switch group) - Remain on TDF-based ART (No switch group) Switch Group EVG-COBI-TAF-FTC (n=959) 2x 1x No Switch Group TDF-based ART (n = 477) *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 932/ 959 444/ 477 241/ 251 112/125 390/ 402 183/ 199 301/ 306 149/ 153 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) 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 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 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.