Rilpivirine-Tenofovir alafenamide-Emtricitabine ( Odefsey ) Prepared - - PowerPoint PPT Presentation

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Rilpivirine-Tenofovir alafenamide-Emtricitabine ( Odefsey ) Prepared - - PowerPoint PPT Presentation

May 03, 2023 35 likes •235 views

Rilpivirine-Tenofovir alafenamide-Emtricitabine ( Odefsey ) Prepared by: Brian R. Wood, MD David H. Spach, MD Last Updated: December 22, 2019 Rilpivirine-Tenofovir Alafenamide-Emtricitabine ( Odefsy) Odefsy [oh-DEF-see] Rilpivirine-Tenofovir

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SLIDE 1

Rilpivirine-Tenofovir alafenamide-Emtricitabine (Odefsey)

Prepared by: Brian R. Wood, MD David H. Spach, MD

Last Updated: December 22, 2019

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SLIDE 2

Rilpivirine-Tenofovir Alafenamide-Emtricitabine (Odefsy)

NNRTI NRTI NRTI

Odefsy

[oh-DEF-see]

Rilpivirine-Tenofovir alafenamide-Emtricitabine

Dose: 1 tablet once daily with a meal 25 mg 25 mg 200 mg

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SLIDE 3
  • Phase 3 Switch/Simplification Trials
  • STUDY 1160: Switch to RPV-TAF-FTC from EFV-TDF-FTC
  • STUDY 1216: Switch to RPV-TAF-FTC from RPV-TDF-FTC

Rilpivirine-Tenofovir alafenamide-Emtricitabine Summary of Key Studies

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SLIDE 4

Rilpivirine-Tenofovir Alafenamide-Emtricitabine

SWITCH STUDIES

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SLIDE 5

Switch to RPV-TAF-FTC from EFV-TDF-FTC

Study GS-366-1160

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SLIDE 6

Switch to RPV-TAF-FTC from EFV-TDF-FTC

Study GS-366-1160: Design

Source: DeJesus E, et al. Lancet HIV. 2017;4:e205-e213. *NOTE: of 881 participants randomized, 6 were never treated (875 individuals treated)

Study Design: Study GS-366-1160

  • Background: Phase 3b, multinational, randomized,

double-blind, placebo controlled, non-inferiority trial investigating the tolerability of switching to the single tablet regimen rilpivirine-tenofovir alafenamide-emtricitabine (RPV-TAF-FTC)

  • Inclusion Criteria (n = 881 randomized)
  • HIV-1-infected adults
  • HIV RNA <50 copies/mL for ≥6 months on EFV-TDF-FTC
  • Creatinine clearance at least 50 mL/min
  • No resistance to EFV, RPV, TDF, or FTC
  • Treatment Arms
  • Switch to RPV-TAF-FTC (Switch group)
  • Remain on EFV-TDF-FTC (No switch group)

No Switch Group

EFV-TDF-FTC

(n = 437)

Switch Group

RPV-TAF-FTC

(n= 438)

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SLIDE 7

Switch to RPV-TAF-FTC from EFV-TDF-FTC

Study GS-366-1160: Results

Week 48 Virologic Response (FDA Snapshot Analysis)

Source: DeJesus E, et al. Lancet HIV. 2017;4:e205-e213.

90 92 50 60 70 80 90 100 HIV RNA <50 copies/mL (%) RPV-TAF-FTC (Switch) EFV-TDF-FTC (No Switch)

394/438 402/437

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SLIDE 8

Switch to RPV-TAF-FTC from EFV-TDF-FTC

Study GS-366-1160: Results

Week 48: Changes in Bone Mineral Density (BMD)

Source: DeJesus E, et al. Lancet HIV. 2017;4:e205-e213.

1.65 1.28

  • 0.05
  • 0.13
  • 1

1 2 3 Hip Spine

Mean Change in BMD (%)

RPV-TAF-FTC (Switch) EFV-TDF-FTC (No Switch)

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SLIDE 9

Switch to RPV-TAF-FTC from EFV-TDF-FTC

Study GS-366-1160: Results

Week 48: Changes in Markers of Proximal Tubulopathy

Source: DeJesus E, et al. Lancet HIV. 2017;4:e205-e213.

  • 30
  • 14
  • 28
  • 41
  • 2

12 29 17

  • 75
  • 50
  • 25

25 50

Proteinuria (UPCR) Albuminuria (APCR) Retinol binding protein β2 microglobulin Median Change from Baseline (%)

RPV-TAF-FTC (Switch) EFV-TDF-FTC (No Switch)

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SLIDE 10

Switch to RPV-TAF-FTC from EFV-TDF-FTC

Study GS-366-1160: Results

Week 48: Change in Plasma Lipids from Baseline

Source: DeJesus E, et al. Lancet HIV. 2017;4:e205-e213.

  • 9
  • 3
  • 4
  • 4
  • 3
  • 2
  • 1
  • 2
  • 15
  • 5

5 Total Cholesterol LDL HDL Triglycerides Change in Median Value (mg/dL)

RPV-TAF-FTC (Switch) EFV-TDF-FTC (No Switch)

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SLIDE 11

Switch to RPV-TAF-FTC from EFV-TDF-FTC

Study GS-366-1160: Conclusion

Source: DeJesus E, et al. Lancet HIV. 2017;4:e205-e213.

Interpretation: “Switching to rilpivirine, emtricitabine, and tenofovir alafenamide from efavirenz, emtricitabine, and tenofovir disoproxil fumarate was non-inferior in maintaining viral suppression and was well tolerated at 48 weeks. These findings support guidelines recommending tenofovir alafenamide-based regimens, including coformulation with rilpivirine and emtricitabine, as initial and ongoing treatment for HIV-1 infection.”

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SLIDE 12

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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SLIDE 13

Switching to TAF from TDF, each with RPV and FTC

Study GS-366-1216

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SLIDE 14

Switch from TDF to TAF, each with RPV and FTC

Study GS-366-1216: Design

Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204. *NOTE: of 632 participants randomized, 2 were never treated (630 individuals treated)

Study Design: Study GS-366-1160

  • Background: Phase 3b, multinational, randomized,

double-blind, placebo controlled, non-inferiority trial to investigate safety, and tolerability of switching to the single tablet regimen rilpivirine-tenofovir alafenamide- emtricitabine (RPV-TAF-FTC)

  • Inclusion Criteria (n = 632 randomized)
  • HIV-1-infected adults
  • HIV RNA <50 copies/mL ≥6 months on RPV-TDF-FTC
  • Creatinine clearance at least 50 mL/min
  • No resistance to RPV, TDF, or FTC
  • Treatment Arms
  • Switch to RPV-TAF-FTC (Switch group)
  • Remain on RPV-TDF-FTC (No switch group)

No Switch Group

RPV-TDF-FTC

(n = 314)

Switch Group

RPV-TAF-FTC

(n= 316)

1x 1x

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SLIDE 15

Switch to TAF from TDF, each with RPV and FTC

Study GS-366-1216: Design

Week 48 Virologic Response (FDA Snapshot Analysis)

Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204.

94 94 50 60 70 80 90 100 HIV RNA <50 copies/mL (%) RPV-TAF-FTC (Switch) RPV-TDF-FTC (No Switch)

296/316 294/313

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SLIDE 16

Switch to TAF from TDF, each with RPV and FTC

Study GS-366-1216: Results

Week 48: Changes in Bone Mineral Density (BMD)

Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204.

1.04 1.61

  • 0.25

0.08

  • 1

1 2 Hip Spine

Mean Change in BMD (%)

RPV-TAF-FTC (Switch) RPV-TDF-FTC (No Switch)

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SLIDE 17

Switch to TAF from TDF, each with RPV and FTC

Study GS-366-1216: Results

Week 48: Changes in Markers of Proximal Tubulopathy

Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204.

  • 19
  • 8
  • 18
  • 29

7 17 22 12

  • 40
  • 20

20 40

Proteinuria (UPCR) Albuminuria (APCR) Retinol binding protein β2 microglobulin Median Change from Baseline (%)

RPV-TAF-FTC (Switch) RPV-TDF-FTC (No Switch)

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SLIDE 18

Switch to TAF from TDF, each with RPV and FTC

Study GS-366-1216: Results

Week 48: Change in Plasma Lipids from Baseline

Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204.

16 10 2 5

  • 2
  • 1
  • 6
  • 10

10 20 Total Cholesterol LDL HDL Triglycerides Change in Median Value (mg/dL)

RPV-TAF-FTC (Switch) RPV-TDF-FTC (No Switch)

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SLIDE 19

Switch to TAF from TDF, each with RPV and FTC

Study GS-366-1216: Interpretation

Source: Orkin C et al. Lancet HIV. 2017;4:e195-e204.

Interpretation: “Switching to rilpivirine, emtricitabine, and tenofovir alafenamide was non-inferior to continuing rilpivirine, emtricitabine, tenofovir disoproxil fumarate in maintaining viral suppression and was well tolerated at 48 weeks. These findings support guidelines recommending tenofovir alafenamide-based regimens, including coformulation with rilpivirine and emtricitabine, as initial and ongoing treatment for HIV-1 infection.”

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SLIDE 20

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.