Efficacy and safety of maraviroc versus efavirenz, both with zidovudine/lamivudine: 96-week results from the MERIT study.
Author(s): Sierra-Madero J, Di Perri G, Wood R, Saag M, Frank I, Craig C, Burnside R, McCracken J, Pontani D, Goodrich J, Heera J, Mayer H
Affiliation(s): Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, CIFBIOTEC Medica Sur, Tlalpan, Mexico.
Publication date & source: 2010-05, HIV Clin Trials., 11(3):125-32.
Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't
BACKGROUND: The MERIT study evaluated maraviroc versus efavirenz, both with zidovudine/lamivudine, in treatment-naive patients with CCR5-tropic (R5) HIV-1. Post hoc analyses previously assessed week 48 outcomes in patients rescreened with R5 virus by a more sensitive tropism assay. METHODS: Week 96 efficacy (post hoc, n = 614) and safety (n = 721) were assessed. RESULTS: Proportions of subjects <50 copies/mL (58.8% maraviroc, 62.7% efavirenz) and time to loss of virologic response (TLOVR) responders (<50 copies/mL: 60.5% vs 60.7%) were similar. Maraviroc recipients had greater CD4 increases (+ 212 vs + 171 cells/mm(3)) and fewer adverse event discontinuations (6.1% vs 15.5%), malignancies, and category C events. CONCLUSION: Week 96 data confirm week 48 observations in MERIT.