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

Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

Baseline ART*

(n = 242)

Study Design: Study 112

• 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)
• HIV RNA < 50 copies/mL for ≥6 months
• eGFR stable at 30-69 mL/min ≥3 months
• CD4 ≥50 cells/mm3
• No new AIDS conditions in past 30 days
• No resistance to EVG, FTC, or TDF
• Treatment Arms
• Switch to EVG-COBI-TAF-FTC

EVG-COBI-TAF-FTC

(n = 242)

48 24 Study Week:

*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%

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment

Study 112: Result

Week 48 Virologic Response

Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

92 7 1 20 40 60 80 100 HIV <50 copies/mL Virologic Failure No Virologic Data

Participants (%) EVG-COBI-TAF-FTC

222/242

17/242

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment

Study 112: Subgroup Analysis Result

Change in Estimated GFR* from Baseline to Weeks 24 and 48

Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

• 0.4

1.2

• 0.9

0.6

• 0.90
• 0.6

0.6

• 1.4

0.2

• 1.8
• 3
• 2
• 1

1 2

Overall <50 mL/min ≥50 mL/min TDF-containing Non-TDF- containing Median Change (mL/min) in eGFRCG

Week 24 Week 48

*GFR estimated by Cockcroft Gault

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment

Study 112: Result

Week 48: Changes in General Proteinuria

Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

161 29 5 10

50 100 150 200

Proteinuria (UPCR) Albuminuria (UACR) Median (mg/g)

Baseline Week 48

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment

Study 112: Result

Week 48: Changes in Tubular Proteinuria

Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

801 1563 166 214 500 1000 1500 2000

Retinol Binding Protein:Creatinine Ratio Beta-2 Microalbumin:Creatinine Ratio

Median (μg/g)

Baseline Week 48

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment

Study 112: Result

Week 48: Changes in Bone Mineral Density (BMD)

Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

1.47 2.29

1 2 3 4 Hip Spine

Mean % Change in BMD

37% 59% 4%

Spine

22% 72% 6%

Hip

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment

Study 112: Result

Week 48: Changes in Spine and Hip Bone Mineral Density (BMD)

Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

≥ 3% gain Gain or loss <3% Loss ≥3%

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment

Study 112: Conclusions

Source: Pozniak A, et al. J Acquir Immune Defic Syndr. 2016;71:530-7.

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

• nce daily E/C/F/TAF in HIV+ patients with mild or moderate renal

impairment without dose adjustment.”

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.