Maraviroc versus Efavirenz in Treatment-Naïve MERIT (A4001026) Trial
Maraviroc versus Efavirenz, both with Zidovudine-Lamivudine MERIT (A4001026): Study Design Study Design: MERIT Study • Background : Randomized, double-blind, double- dummy, phase 2b/3 study evaluating the efficacy and safety of maraviroc versus efavirenz as part of MVC 300 mg twice daily + ART for treatment-naïve persons with HIV infection ZVD-3TC twice daily (n = 360) • Inclusion Criteria (n = 721 treated/analyzed) - Age >16 - Antiretroviral-naïve patients - R5-tropic virus EFV once daily + ZVD-3TC - HIV RNA ≥ 2000 copies/mL twice daily - No resistance to zidovudine, lamivudine, or (n =361) efavirenz • Treatment Arms MVC 300 mg once daily + ZVD-3TC - Maraviroc 300 mg BID + ZVD-3TC BID twice daily arm (n = 174) - Efavirenz 600 mg QD+ ZVD-3TC BID DISCONTINUED at interim analysis MERIT = M araviroc versus E favi r enz i n T reatment-Naive Source: Cooper DA, et al. J Infect Dis. 2010;201:803-13.
Maraviroc versus Efavirenz, both with Zidovudine-Lamivudine MERIT (A4001026): Result Week 48: Virologic Response (Primary Analysis) Maraviroc + ZVD-3TC Efavirenz + ZVD-3TC 100 HIV RNA <50 copies/mL (%) 80 71.6 69.6 69.3 66.0 65.3 59.6 60 40 20 235/360 250/361 142/204 151/211 93/156 99/150 0 All <100,000 copies/mL ≥ 100,000 copies/mL Baseline HIV RNA Source: Cooper DA, et al. J Infect Dis. 2010;201:803-13.
Maraviroc or Efavirenz, both with Zidovudine-Lamivudine MERIT (A4001026): Result Week 48: Virologic Response (Post-hoc Reanalysis*) Maraviroc + ZVD-3TC Efavirenz + ZVD-3TC 100 HIV RNA <50 copies/mL (%) 80 72.1 71.8 68.5 68.3 64.2 62.5 60 40 20 213/311 207/303 127/177 132/183 86/134 75/120 0 All <100,000 copies/mL ≥ 100,000 copies/mL Baseline HIV RNA *Excludes patients with non-R5 virus at screening by the enhanced Trofile assay Source: Cooper DA, et al. J Infect Dis. 2010;201:803-13.
Maraviroc versus Efavirenz, both with Zidovudine-Lamivudine MERIT (A4001026): Conclusions Conclusions : “Twice-daily maraviroc was not noninferior to efavirenz at <50 copies/mL in the primary analysis. However, 15% of patients would have been ineligible for inclusion by a more sensitive screening assay. Their retrospective exclusion resulted in similar response rates in both arms.” Source: Cooper DA, et al. J Infect Dis. 2010;201:803-13.
Maraviroc versus Efavirenz, plus Zidovudine-Lamivudine MERIT (A4001026): Result Week 240 (Year 5): Virologic Response Maraviroc + ZVD-3TC Efavirenz + ZVD-3TC 100 HIV RNA <50 copies/mL (%) 80 60 52.5 50.8 48.5 48.1 45.9 42.5 40 20 158/311 139/303 93/177 88/183 65/134 51/120 0 All <100,000 copies/mL ≥ 100,000 copies/mL Baseline HIV RNA *Excludes patients with non-R5 virus at screening by the enhanced Trofile assay Source: Cooper DA, et al. AIDS. 2014;28:717-25.
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.
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