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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection
Journal of Infectious Diseases, Volume 201, No. 6, Year 2010
Notification
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Description
Background. 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. Methods. Patients screened for R5 HIV-1 were randomized to receive efavirenz (600 mg once daily) or mar-aviroc (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. Results. 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. 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 Trial registration. ClinicalTrials.gov identifier: (NCT00098293). © 2010 by the Infectious Diseases Society of America. All rights reserved.
Authors & Co-Authors
Cooper, David A.
Australia, Sydney
Unsw Sydney
Heera, Jayvant R.
United States, New London
Pfizer Global Research and Development
Goodrich, James M.
United States, New London
Pfizer Global Research and Development
Tawadrous, Margaret
United States, New London
Pfizer Global Research and Development
Saag, Michael S.
United States, Birmingham
The University of Alabama at Birmingham
DeJesus, Edwin
United States, Orlando
Orlando Immunology Center
Clumeck, Nathan N.
Belgium, Brussels
Centre Hospitalier Universitaire Saint Pierre, Brussels
Walmsley, Sharon Lynn
Canada, Toronto
University of Toronto
Ting, Naitee
United States, New London
Pfizer Global Research and Development
Coakley, Eoin P.G.
United States, San Francisco
Monogram Biosciences
Reeves, Jacqueline D.
United States, San Francisco
Monogram Biosciences
Reyes-Terán, Gustavo
Mexico, Tlalpan
Instituto Nacional de Enfermedades Respiratorias
Westby, Mike
United Kingdom, Tadworth
Pfizer Limited, uk
van Ryst, Elna Der
United Kingdom, Tadworth
Pfizer Limited, uk
Lve, Prudence
South Africa, Johannesburg
University of the Witwatersrand
Mohapi, Lerato
South Africa, Johannesburg
University of the Witwatersrand
Mingrone, Horacio
Argentina
Muñiz Hospital
Horban, Andrzéj
Poland, Warsaw
Medical University of Warsaw
Hackman, Frances
United Kingdom, Tadworth
Pfizer Limited, uk
Sullivan, John F.
United Kingdom, Tadworth
Pfizer Limited, uk
Mayer, Howard B.
United States, New London
Pfizer Global Research and Development
Statistics
Citations: 277
Authors: 21
Affiliations: 12
Identifiers
Doi:
10.1086/650697
ISSN:
00221899
Research Areas
Infectious Diseases
Study Design
Cohort Study