Study 112 Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study - PowerPoint PPT Presentation

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112: Design Study Design: Study 112 24 Study Week: 0 48 • Background : Open-label, single arm phase 3 trial evaluating switching to once-daily elvitegravir-cobicistat-tenofovir alafenamide- emtricitabine from baseline ART* • Inclusion Criteria (n = 242) EVG-COBI-TAF-FTC - HIV RNA < 50 copies/mL for ≥6 months Baseline ART* (n = 242) - eGFR stable at 30-69 mL/min ≥3 months (n = 242) - CD4 ≥50 cells/mm 3 - No new AIDS conditions in past 30 days - No resistance to EVG, FTC, or TDF • Treatment Arms - Switch to EVG-COBI-TAF-FTC *Baseline ART NRTIs: Tenofovir DF 65%, Abacavir 22%, Other NRTI 7%, No NRTI 5% Third Agent : PI 44%, NNRTI 42%, INSTI 24%, CCR5 Antagonist 3% Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112: Result Week 48 Virologic Response 100 92 80 Participants (%) 60 40 20 7 1 222/242 17/242 0 HIV <50 copies/mL Virologic Failure No Virologic Data EVG-COBI-TAF-FTC Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112: Subgroup Analysis Result Change in Estimated GFR* from Baseline to Weeks 24 and 48 Week 24 Week 48 Median Change (mL/min) in eGFR CG 2 1.2 1 0.6 0.6 0.2 0 -0.4 -0.6 -1 -0.9 -0.90 -1.4 -2 -1.8 -3 ≥50 mL/min Overall <50 mL/min TDF-containing Non-TDF- containing *GFR estimated by Cockcroft Gault Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112: Result Week 48: Changes in General Proteinuria Baseline Week 48 200 161 150 Median (mg/g) 100 50 29 10 5 0 Proteinuria (UPCR) Albuminuria (UACR) Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112: Result Week 48: Changes in Tubular Proteinuria Baseline Week 48 2000 1563 1500 Median (μg/g) 1000 801 500 214 166 0 Retinol Binding Protein:Creatinine Ratio Beta-2 Microalbumin:Creatinine Ratio Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112: Result Week 48: Changes in Bone Mineral Density (BMD) 4 Mean % Change in BMD 3 2.29 2 1.47 1 0 Hip Spine Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112: Result Week 48: Changes in Spine and Hip Bone Mineral Density (BMD) Spine Hip 6% 4% 22% ≥ 3% gain 37% Gain or loss <3% 59% Loss ≥3% 72% Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112: Conclusions Interpretation : “Switch to E/C/F/TAF was associated with minimal change in GFR. Proteinuria, albuminuria and bone mineral density significantly improved. These data support the efficacy and safety of once daily E/C/F/TAF in HIV+ patients with mild or moderate renal impairment without dose adjustment.” Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

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.