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Abstract
A multicenter, randomized, double-blind, comparative trial of a novel CCR5 antagonist, maraviroc versus efavirenz, both in combination with Combivir (zidovudine [ZDV]/lamivudine [3TC]), for the treatment of antiretroviral naive patients infected with R5 HIV 1: Week 48 results of the MERIT study
Michael Saag1,
Prudence Ive2, Jayvant Heera3, Margaret Tawadrous3,
Edwin DeJesus4, Nathan Clumeck5, David Cooper6,
Andrej Horban7, Lerato Mohapi8, Horacio Mingrone9,
Gustavo Reyes-Teran10, Sharon Walmsley11, Frances Hackman12,
Elna van der Ryst12, Howard Mayer3
Objectives: To compare the safety and efficacy of maraviroc (MVC) versus efavirenz (EFV), both
administered with Combivir (CBV) in antiretroviral-naive patients.
Methods: Patients with only R5 HIV-1, HIV RNA
≥2,000 copies/mL and no EFV, ZDV, or 3TC resistance were randomized to
CBV plus EFV 600mg QD or MVC 300mg QD or BID. The
primary endpoint was percentage of patients with HIV-1-RNA <400 and <50 copies/mL at week 48;
noninferiority of MVC vs EFV was analyzed. The MVC-QD arm was discontinued in
January 2006.
Results:Overall 721 (29% female) patients received ≥1 dose of
study drug and were included in the analysis. Baseline median CD4+ count (241
and 254 cells/mm3) and mean HIV-1 RNA (4.9 and 4.9 log10
copies/mL) were similar in the MVC-BID and EFV arms, respectively. More
patients discontinued from MVC-BID for lack of efficacy compared with EFV
(11.9% versus 4.2%), whereas fewer patients discontinued MVC-BID due to adverse
events (4.1% versus 13.6%). Key efficacy and safety endpoints are shown in the
following table:
style='border-collapse:collapse;border:none'>
Week 48 results FAS, As Treated
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>MVC BID + CBV (N=360)
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>EFV + CBV (N=361)
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>Difference* (lower bound of 1-sided 97.5% CI)
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HIV RNA <400 copies/mL, %
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70.6
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73.1
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-3.0
(-9.5)
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HIV RNA <50 copies/mL, %
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65.3
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69.3
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-4.2 (-10.9)
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Mean Change from BL in CD4+ count, cells/mm3
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170
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143
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26
(7–46†)
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Patients with Category C Events
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6 (1.7)
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12 (3.3)
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N/A
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*adjusted for randomization strata;
†95% CI
Grade 3/4 AEs were reported by more
patients on EFV compared with MVC-BID. Fewer malignancies occurred on MVC. The
incidence of grade 3/4 transaminase abnormalities was similar between the two
groups.
Conclusions: Non-inferiority
of MVC-BID could be concluded for the <400 but not the <50 copies/mL
endpoint. CD4 cell count increase for MVC-BID was greater than for EFV. MVC-BID
was better tolerated than EFV with fewer discontinuations due to AEs, Category
C events and grade 3/4 adverse events.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no.
WESS104
Suggested Citation
"MichaelSaag, et al.
A multicenter, randomized, double-blind, comparative trial of a novel CCR5 antagonist, maraviroc versus efavirenz, both in combination with Combivir (zidovudine [ZDV]/lamivudine [3TC]), for the treatment of antiretroviral naive patients infected with R5 HIV 1: Week 48 results of the MERIT study.
Special session:
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention:
Abstract no.
WESS104"
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