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Maraviroc versus Efavirenz, Both in Combination with Zidovudine‐Lamivudine, for the Treatment of Antiretroviral‐Naive Subjects with CCR5‐Tropic HIV‐1 Infection

2010; Oxford University Press; Volume: 201; Issue: 6 Linguagem: Inglês

10.1086/650697

1537-6613

David A. Cooper, Jayvant Heera, James Goodrich, Margaret Tawadrous, Michael S. Saag, Edwin DeJesus, Nathan Clumeck, Sharon Walmsley, Naitee Ting, Eoin Coakley, Jacqueline D. Reeves, Gustavo Reyes‐Terán, Mike Westby, Elna van der Ryst, Prudence Ive, Lerato Mohapi, Horacio Mingrone, Andrzej Horban, Frances Hackman, John Sullivan, Howard Mayer,

HIV/AIDS Research and Interventions

The MERIT (Maraviroc versus Efavirenz in Treatment-Naive Patients) study compared maraviroc and efavirenz, both with zidovudine-lamivudine, in antiretroviral-naive patients with R5 human immunodeficiency virus type 1 (HIV-1) infection.Patients screened for R5 HIV-1 were randomized to receive efavirenz (600 mg once daily) or maraviroc (300 mg once or twice daily) with zidovudine-lamivudine. Coprimary end points were proportions of patients with a viral load <400 and <50 copies/mL at week 48; the noninferiority of maraviroc was assessed.The once-daily maraviroc arm was discontinued for not meeting prespecified noninferiority criteria. In the primary 48-week analysis (n = 721), maraviroc was noninferior for <400 copies/mL (70.6% for maraviroc vs 73.1% for efavirenz) but not for <50 copies/mL (65.3% vs 69.3%) at a threshold of -10%. More maraviroc patients discontinued for lack of efficacy (11.9% vs 4.2%), but fewer discontinued for adverse events (4.2% vs 13.6%). In a post hoc reanalysis excluding 107 patients (15%) with non-R5 screening virus by the current, more sensitive tropism assay, the lower bound of the 1-sided 97.5% confidence interval for the difference between treatment groups was above -10% for each end point.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 Trial registration. ClinicalTrials.gov identifier: (NCT00098293) .