Study 109 Switch to Elvitegravir-Cobicistat-TAF-FTC Study 109: - - PowerPoint PPT Presentation

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Mar 16, 2024 154 likes •248 views

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

SLIDE 1

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

Study 109

SLIDE 2

Switch to Elvitegravir-Cobicistat-TAF-FTC

Study 109: Design

Source: Mills A, et al. Lancet Infect Dis. 2016;16:43-52. *NOTE: Between randomization and start of study, 4 participants withdrew consent, 2 withdrew by investigator discretion, and 1 was lost to follow-up.

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)

No Switch Group

TDF-based ART

(n = 477)

Switch Group

EVG-COBI-TAF-FTC

(n=959)

1x 2x

SLIDE 3

97 96 97 98 93 90 92 97

20 40 60 80 100

All prior regimens Prior EFV-TDF-FTC Prior ATV + RTV + TDF-FTC Prior EVG-COBI- TDF-FTC

HIV RNA <50 copies/mL (%)

EVG-COBI-TAF-FTC (Switch) TDF-Based ART (No Switch)

Switch to Elvitegravir-Cobicistat-TAF-FTC

Study 109: Subgroup Analysis Result

Week 48 Virologic Response, by Baseline Regimen

Source: Mills A, et al. Lancet Infect Dis. 2016;16:43-52.

183/ 199 301/ 306 444/ 477 241/ 251 112/ 125 149/ 153 932/ 959 390/ 402

SLIDE 4

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.

1.47 1.56

0.34
0.44
1

1 2 Hip Spine

Mean Change in BMD (%) EVG-COBI-TAF-FTC (Switch) Tenofovir DF-Based ART (No Switch)

SLIDE 5

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.

10 9 18 18

25 50

Proteinuria (UPCR) Albuminuria (APCR) Retinol binding protein β2 microglobulin Median Change from Baseline (%) EVG-COBI-TAF-FTC (Switch) Tenofovir DF-Based ART (No Switch)

SLIDE 6

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.

20 9 2 11 2

1 10 20 30 Total Cholesterol LDL HDL Triglycerides Change in Median Value (mg/dL) EVG-COBI-TAF-FTC (Switch) Tenofovir DF-Based ART (No Switch)

SLIDE 7

Switch to Elvitegravir-Cobicistat-TAF-FTC

Study 109: Conclusions

Source: Mills A, et al. Lancet Infect Dis. 2016;16:43-52.

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.”

SLIDE 8

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.