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A Multicenter, Randomized, Double-Blind, Comparative Trial of a Novel CCR5 Antagonist, Maraviroc Versus Efavirenz, both in Combination with Combivir (Zidovudine/Lamivudine), for the Treatment of Antiretroviral-Naive Subjects Infected with R5 HIV 1: Week 48 Results of the MERIT Study
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Reported by Jules Levin
4th IAS Conference, Juky 22-25, 2007, Sydney, Autralia
Michael Saag1, Prudence Ive2, Jayvant Heera3, Margaret Tawadrous3, Edwin DeJesus4, Nathan Clumeck5, David Cooper6, Andrzej Horban7, Lerato Mohapi8, Horacio Mingrone9, Gustavo Reyes-Teran10, Sharon Walmsley11, Frances Hackman12, Elna van der Ryst12, Howard Mayer3
1University of Alabama at Birmingham, Birmingham, USA
2University of the Witwatersrand, Clinical HIV Research Unit, Johannesburg, South Africa
3Pfizer Global Research and Development, New London, USA
4Orlando Immunology Center, Orlando, USA
5Saint-Pierre University Hospital, Infectious Diseases, Brussels, Belgium
6University of New South Wales, National Centre in HIV Epidemiology and Clinical Research, Sydney, Australia
7Hospital of Infectious Diseases, Warsaw, Poland
8University of the Witwatersrand, Perinatal HIV Research Unit, Johannesburg, South Africa
9HIV Outpatient Care Unit, Mu–iz Hospital, Buenos Aires City, Argentina
10Instituto Nacional de Enfermedades Respiratorias, Center for Research in Infectious Diseases, Tlalpan, Mexico
11University of Toronto, Toronto, Canada
12Pfizer Global Research and Development, Sandwich, UK
AUTHOR SUMMARY
The percentage of subjects discontinuing from the study prior to
Week 48 was similar in the MVC (26.9%) and EFV (25.2%) arms
--The rate of discontinuation due to lack of efficacy was higher with MVC (11.9%) than with EFV (4.2%)
--The rate of discontinuation due to adverse events was lower with MVC (4.2%) than with EFV (13.6%)
Based on the pre-planned statistical analysis (noninferiority margin of
-10%), MVC was:
--Noninferior to EFV based on <400 copies/mL endpoint (70.6% vs 73.1%)
- But not the <50 copies/mL endpoint (65.3% vs 69.3%)
CD4+ cell count increases were higher in patients receiving MVC compared to EFV (+170 vs +144 cells/mm3)
Fewer patients experienced grade 3 or 4 adverse events in the MVC arm than in the EFV arm
Fewer patients experienced Category C events in the MVC arm (n=6) than in the EFV arm (n=12)
--The incidence of AIDS-defining malignancies and malignancies in general was lower in the MVC arm than in the EFV arm
Grade 3/4 transaminase elevations were infrequent and occurred at a similar rate in the two treatment arms
Median lipid increases from baseline were greater in the EFV arm
Patient eligibility criteria:
-- ≥16 years of age
-- Treatment naive
-- R5 HIV-1 infection
-- HIV-1 RNA ≥2,000 copies/mL
-- No evidence of resistance to EFV, ZDV, or 3TC
Patients stratified by:
-- HIV-1 RNA < and ≥100,000 copies/mL at screening
-- Geographic location: Northern Hemisphere and Southern Hemisphere
MVC QD arm discontinued at end of Phase 2b (week 16) for failure to meet
protocol-defined criteria to continue (205 pts completed 16 weeks
--*Patients experiencing toxicity to ZDV or 3TC were permitted to substitute an alternative NRTI
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