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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Efficacy and safety of Maraviroc vs. Efavirenz in treatment-naive patients with HIV-1: 5-year findings
AIDS, Volume 28, No. 5, Year 2014
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Description
Objective: Maraviroc, a chemokine co-receptor type 5 (CCR5) antagonist, has demonstrated comparable efficacy and safety to efavirenz, each in combination with zidovudine/lamivudine, over 96 weeks in the Maraviroc vs. Efavirenz Regimens as Initial Therapy (MERIT) study. Here we report 5-year findings. Design: A randomized, double-blind, multicenter phase IIb/III study with an open-label extension phase. Methods: Treatment-naive patients with CCR5-tropic HIV-1 infection (Trofile) received maraviroc 300mg twice daily or efavirenz 600mg once daily, and zidovudine/lamivudine 300 mg/150mg twice daily. After the last patient's week 96 visit, the study was unblinded and patients could enter a nominal 3-year open-label phase. Endpoints at the 5-year nominal visit (week 240) included proportion of patients (CCR5 tropism reconfirmed by enhanced sensitivity Trofile) with viral load (plasma HIV-1 RNA) below 50 and 400 copies/ml, and change from baseline in CD4+ cell count, as well as safety. Results: The proportion of patients maintaining viral load below 50 copies/ml was similar between treatment arms throughout the study and at week 240 (maraviroc 50.8% vs. efavirenz 45.9%). Maraviroc-treated patients had a greater increase from baseline in mean CD4+ cell count than efavirenz-treated patients at week 240 (293 vs. 271 cells/μl, respectively). Fewer patients on maraviroc vs. efavirenz experienced treatment-related adverse events (68.9 vs. 81.7%) and discontinued as a result of any adverse event (10.6 vs. 21.3%). Conclusion: Maraviroc maintained similar long-term antiviral efficacy to efavirenz over 5 years in treatment-naive patients with CCR5-tropic HIV-1. Maraviroc was generally well tolerated with no unexpected safety findings or evidence of long-term safety concerns. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Authors & Co-Authors
Cooper, David A.
Australia, Kensington
The Kirby Institute
Heera, Jayvant R.
United States, New York
Pfizer Inc.
Ive, Prudence D.
South Africa, Johannesburg
University of the Witwatersrand
Botes, Mariëtte E.
South Africa, Pretoria
Private Practice
DeJesus, Edwin
United States, Orlando
Orlando Immunology Center
Burnside, Robert
United States, New York
Pfizer Inc.
Clumeck, Nathan N.
Belgium, Brussels
Centre Hospitalier Universitaire Saint Pierre, Brussels
Walmsley, Sharon Lynn
Canada, Toronto
University of Toronto
Lazzarin, Adriano
Italy, Milan
Irccs Ospedale San Raffaele
Mukwaya, Geoffrey
United States, New York
Pfizer Inc.
Saag, Michael S.
United States, Birmingham
The University of Alabama at Birmingham
van der Ryst, Elna
United Kingdom, Tadworth
Pfizer Limited, uk
Statistics
Citations: 34
Authors: 12
Affiliations: 10
Identifiers
Doi:
10.1097/QAD.0000000000000131
e-ISSN:
14735571
Research Areas
Disability
Health System And Policy
Infectious Diseases