Efficacy and safety of maraviroc vs. efavirenz in treatment-naive patients with HIV-1: 5-year findings.

Academic Article

Abstract

  • 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 300 mg twice daily or efavirenz 600 mg once daily, and zidovudine/lamivudine 300 mg/150 mg 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 re-confirmed 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.
  • Published In

  • AIDS  Journal
  • Keywords

  • Adolescent, Adult, Aged, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, Benzoxazines, CD4 Lymphocyte Count, Cyclohexanes, Double-Blind Method, Drug-Related Side Effects and Adverse Reactions, Female, HIV Infections, HIV-1, Humans, Male, Maraviroc, Middle Aged, Treatment Outcome, Triazoles, Viral Load, Young Adult
  • Digital Object Identifier (doi)

    Author List

  • Cooper DA; Heera J; Ive P; Botes M; Dejesus E; Burnside R; Clumeck N; Walmsley S; Lazzarin A; Mukwaya G
  • Start Page

  • 717
  • End Page

  • 725
  • Volume

  • 28
  • Issue

  • 5