MODAt Trial Simplification to Ritonavir-Boosted Atazanavir - - PowerPoint PPT Presentation

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MODAt Trial Simplification to Ritonavir-Boosted Atazanavir - - PowerPoint PPT Presentation

Simplification to Ritonavir-Boosted Atazanavir Monotherapy MODAt Trial Simplification to Ritonavir-Boosted Atazanavir Monotherapy MODAt: Study Design Study Design: MODAt Background : Randomized, open-label noninferiority trial in adults


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SLIDE 1

Simplification to Ritonavir-Boosted Atazanavir Monotherapy

MODAt Trial

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SLIDE 2

Simplification to Ritonavir-Boosted Atazanavir Monotherapy

MODAt: Study Design

Source: Castagna A, et al. AIDS. 2014;28:2269-79. Monotherapy Group

Ritonavir-boosted Atazanavir

(n = 51) Triple Therapy Group

Ritonavir-boosted Atazanavir+ 2 NRTIs

(n = 52)

Study Design: MODAt

  • Background: Randomized, open-label noninferiority

trial in adults with virologically suppressed HIV infection to evaluate the efficacy of simplification to

  • nce-daily ritonavir-boosted atazanavir monotherapy

versus continuing once-daily ritonavir-boosted atazanavir with two NRTIs

  • Inclusion Criteria (n = 103)
  • Age ≥18
  • On atazanavir + ritonavir + 2 NRTIs for ≥48 weeks
  • HIV RNA <50 copies/ml for ≥24 weeks
  • CD4 nadir ≥100 cells/mm3
  • No previous virologic failure
  • Treatment Arms
  • Atazanavir 300 mg + Ritonavir 100 mg once daily
  • Atazanavir 300 mg + Ritonavir 100 mg once daily

+ 2 NRTIs

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SLIDE 3

Simplification to Ritonavir-Boosted Atazanavir Monotherapy

MODAt: Results

Week 48: Virologic Response by HIV RNA (ITT, re-intensification=failure)

Source: Castagna A, et al. AIDS. 2014;28:2269-79.

73 75 70 85 81 93 20 40 60 80 100 All ≤ 100,000 copies/mL > 100,000 copies/mL Virologic Efficacy (%) Baseline HIV RNA Atazanavir/r Monotherapy Atazanavir/r + 2 NRTIs

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SLIDE 4

Simplification to Atazanavir/r Monotherapy

MODAt: Results

Week 48: Virologic Response by HIV RNA (ITT, re-intensification=success)

Source: Castagna A, et al. AIDS. 2014;28:2269-79.

92 89 96 85 81 93 20 40 60 80 100 All ≤ 100,000 copies/mL > 100,000 copies/ml Virologic Efficacy (%) Baseline HIV RNA Atazanvir/r monotherapy Atazanavir/r + 2 NRTIs

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SLIDE 5

Simplification to Ritonavir-Boosted Atazanavir Monotherapy

MODAt: Conclusions

Source: Castagna A, et al. AIDS. 2014;28:2269-79.

Conclusion: “ATV/r monotherapy treatment simplification showed lower virological efficacy in comparison with maintaining triple therapy; NRTIs reintroduction was effective in all the individuals.”

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SLIDE 6

Acknowledgment

The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program resource funded by the United States Health Resources and Services Administration. The project is led by the University of Washington and the AETC National Coordinating Resource Center.

The content in this slide set does not represent the official views of the U.S. Department of Health and Human Services, Health Resources & Services Administration.