Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection.

Academic Article

Abstract

  • 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 maraviroc (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) .
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    Keywords

  • Adolescent, Adult, Aged, Anti-HIV Agents, Anti-Retroviral Agents, Antiviral Agents, Benzoxazines, CCR5 Receptor Antagonists, Cyclohexanes, Double-Blind Method, Drug Combinations, Drug Resistance, Viral, Drug Therapy, Combination, Female, HIV Infections, HIV-1, Humans, Lamivudine, Male, Maraviroc, Middle Aged, Receptors, CCR5, Treatment Outcome, Triazoles, Viral Load, Viral Tropism, Young Adult, Zidovudine
  • Digital Object Identifier (doi)

    Author List

  • Cooper DA; Heera J; Goodrich J; Tawadrous M; Saag M; Dejesus E; Clumeck N; Walmsley S; Ting N; Coakley E
  • Start Page

  • 803
  • End Page

  • 813
  • Volume

  • 201
  • Issue

  • 6