MONARCH Trial Darunavir + RTV Monotherapy versus Triple Therapy - - PowerPoint PPT Presentation

Darunavir + RTV Monotherapy versus Triple Therapy

MONARCH Trial

Darunavir + RTV Monotherapy versus Triple Therapy

MONARCH: Study Design

Source: Guaraldi G, et al. HIV Clin Trials. 2013;14:140-8.

Darunavir 800 mg QD + Ritonavir 100 mg QD

(n = 15)

Darunavir 800 mg QD + Ritonavir 100 mg QD + 2 NRTIs

(n = 15)

Study Design: MONARCH

• Background: Randomized, phase II, open label trial

evaluate change in cardiometabolic and endothelial function in patients with HIV infection switching to ritonavir-boosted darunavir (monotherapy) versus ritonavir-boosted darunavir + 2NRTIs (triple therapy)

• Inclusion Criteria (n = 30)
• HIV RNA <50 copies/mL x 24 weeks on 3-drug ART
• CD4 count >200 cells/mm3
• CD4 count nadir >100 cells/mm3
• No PI resistance or history of virologic failure
• Treatment Arms
• Darunavir 800 mg QD + RTV 100 mg QD
• Darunavir 800 mg QD + RTV 100 mg QD + 2 NRTIs

Darunavir +RTV Monotherapy versus Triple Therapy

MONARCH: Result

Week 48: Virologic Response (Intent-to-Treat)

Source: Guaraldi G, et al. HIV Clin Trials. 2013;14:140-8.

93 100 20 40 60 80 100 HIV RNA <40 copies/mL Darunavir + Ritonavir Darunavir + Ritonavir + 2NRTIs

14/15 15/15

Darunavir +RTV Monotherapy versus Triple Therapy

MONARCH: Result

Weeks 24 and 48: Change in Brachial Artery FMD

Source: Guaraldi G, et al. HIV Clin Trials. 2013;14:140-8.

• 4.8
• 4.4
• 0.6
• 3.0
• 10
• 5

5 10

Week 24 Week 48

Median Reduction in *FMD (%)

Study Week

Darunavir + Ritonavir Darunavir + Ritonavir + 2NRTIs

*FMD = Flow-mediated dilation

Darunavir + RTV Monotherapy versus Triple Therapy

MONARCH: Conclusions

Source: Guaraldi G, et al. HIV Clin Trials. 2013;14:140-8.

Conclusions: “In the MONARCH trial, switching from triple combination treatment to DRV/r, with or without nucleoside analogues, did not translate into clinically meaningful reductions in endothelial function as measured by FMD.”

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.