Comparison of HIV Treatments in Women Study: EVG-COBI-TDF-FTC vs ATV+RTV+TDF-FTC
The WAVES study compared the efficacy and safety of EVG-COBI-TDF-FTC versus ATV+RTV+TDF-FTC in antiretroviral-naive women with HIV. Results at Week 48 showed virologic response rates and discontinuation due to adverse events. Common adverse events were also noted. Sources: Lancet HIV 2016. Images provide visual data on the study outcomes.
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EVG-COBI-TDF-FTC versus ATV + RTV + TDF-FTC in Women Study 128 (WAVES)
EVG-COBI-TDF-FTC versus ATV + RTV + TDF-FTC (in Women) WAVES Study: Design Background: Randomized, double-blind, phase 3 trial comparing elvitegravir-cobicistat- tenofovir-emtricitabine with atazanavir + ritonavir + tenofovir DF-emtricitabine in women EVG-COBI-TDF-FTC (n = 289) Inclusion Criteria (n = 575) - Antiretroviral-na ve women - Age 18 years - HIV RNA 500 copies/mL - Any CD4 count Atazanavir + Ritonavir + TDF-FTC (n = 286) Treatment Arms - Elvitegravir-Cobicistat-TDF-FTC - Atazanavir + Ritonavir + TDF-FTC Source: Squires L, et al. Lancet HIV. 2016;3:e410-20.
EVG-COBI-TDF-FTC versus ATV + RTV + TDF-FTC (in Women) WAVES Study: Result Week 48 Virologic Response Elvitegravir-Cobicistat-TDF-FTC Atazanavir + Ritonavir + TDF-FTC 100 HIV RNA <50 copies/mL (%) 90 87 80 86 82 81 78 60 40 20 252/289 231/286 189/220 175/214 62/69 56/72 0 All >100,000 copies/mL 100,000 copies/mL Baseline HIV RNA Source: Squires L, et al. Lancet HIV. 2016;3:e410-20.
EVG-COBI-TDF-FTC versus ATV + RTV + TDF-FTC (in Women) WAVES Study: Result Week 48 Virologic Response Elvitegravir-Cobicistat-TDF-FTC Atazanavir + Ritonavir+ TDF-FTC 100 HIV RNA <50 copies/mL (%) 90 87 80 86 82 81 78 60 Discontinuation of therapy due to adverse events Elvitegravir-Cobicistat-TDF-FTC: 2% Atazanavir + Ritonavir + TDF-FTC: 7% 40 20 252/289 231/286 189/220 175/214 62/69 56/72 0 All >100,000 copies/mL 100,000 copies/mL Baseline HIV RNA Source: Squires L, et al. Lancet HIV. 2016;3:e410-20.
EVG-COBI-TDF-FTC versus ATV + RTV + TDF-FTC (in Women) WAVES Study: Common Adverse Events Treatment Emergent Adverse Events in 10% of Subjects in Either Group EVG-COBI-TDF-FTC (n = 289) ATV + RTV + TDF-FTC (n= 286) Headache 16% 15% Upper Respiratory Tract Infection 16% 15% Malaria 11% 8% Nausea 15% 14% Vomiting 10% 6% Jaundice <1% 11% Icterus <1% 12% Source: Squires L, et al. Lancet HIV. 2016;3:e410-20.
EVG-COBI-TDF-FTC versus ATV + RTV + TDF-FTC (in Women) WAVES Study: Conclusions Interpretation: WAVES shows that clinical trials of ART regimens in global and diverse populations of treatment-naive women are possible. The findings support guidelines recommending integrase inhibitor based regimens in first-line antiretroviral therapy. Source: Squires L, et al. Lancet HIV. 2016;3:e410-20.
Acknowledgments The National HIV Curriculum is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling $1,021,448 with 0% financed with non-governmental sources. The contents 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. For more information, please visit HRSA.gov. This project is led by the University of Washington s Infectious Diseases Education and Assessment (IDEA) Program.
