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 Study Design: MONARCH • Background : Randomized, phase II, open label trial evaluate change in cardiometabolic and endothelial Darunavir 800 mg QD function in patients with HIV infection switching to + Ritonavir 100 mg QD ritonavir-boosted darunavir (monotherapy) versus (n = 15) 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/mm 3 Darunavir 800 mg QD - CD4 count nadir >100 cells/mm 3 + Ritonavir 100 mg QD - No PI resistance or history of virologic failure + 2 NRTIs (n = 15) • Treatment Arms - Darunavir 800 mg QD + RTV 100 mg QD - Darunavir 800 mg QD + RTV 100 mg QD + 2 NRTIs Source: Guaraldi G, et al. HIV Clin Trials. 2013;14:140-8.

Darunavir +RTV Monotherapy versus Triple Therapy MONARCH: Result Week 48: Virologic Response (Intent-to-Treat) Darunavir + Ritonavir Darunavir + Ritonavir + 2NRTIs 100 100 HIV RNA <40 copies/mL 93 80 60 40 20 14/15 15/15 0 Source: Guaraldi G, et al. HIV Clin Trials. 2013;14:140-8.

Darunavir +RTV Monotherapy versus Triple Therapy MONARCH: Result Weeks 24 and 48: Change in Brachial Artery FMD Darunavir + Ritonavir Darunavir + Ritonavir + 2NRTIs 10 Median Reduction in *FMD (%) 5 0 -0.6 -3.0 -5 -4.4 -4.8 -10 Week 24 Week 48 Study Week *FMD = Flow-mediated dilation Source: Guaraldi G, et al. HIV Clin Trials. 2013;14:140-8.

Darunavir + RTV Monotherapy versus Triple Therapy MONARCH: Conclusions 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.” Source: Guaraldi G, et al. HIV Clin Trials. 2013;14:140-8.

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.