Maraviroc 150 mg daily plus lopinavir/ritonavir, a nucleoside/nucleotide reverse transcriptase inhibitor-sparing regimen for HIV-infected naive patients: 48-week final results of VEMAN study

Clin Microbiol Infect. 2015 May;21(5):510.e1-9. doi: 10.1016/j.cmi.2014.12.006. Epub 2014 Dec 11.

Abstract

Non-conventional strategies with nucleoside/nucleotide reverse transcriptase inhibitor-sparing regimens in antiretroviral naive human immunodeficiency virus (HIV) -infected patients have been explored in clinical trials. A prospective, open-label, randomized (1:1), multicentre, proof-of-concept trial (VEMAN study, EUDRACT number 2008-006287-11) was conducted assigning HIV-infected naive patients to once-daily maraviroc plus lopinavir/ritonavir (MVC group) or to tenofovir/emtricitabine plus lopinavir/ritonavir (TDF/FTC group). Clinical and laboratory data were collected at baseline, and after 4, 12, 24, 36 and 48 weeks with the objective to evaluate the 48-week virological and immunological efficacy. HIV-1 DNA load and CD4(+) T-cell subsets were analysed on frozen peripheral blood mononuclear cells collected at baseline, 4 and 48 weeks to explore the trend in HIV reservoirs. Fifty patients were randomized and included in the analysis. During follow up, HIV-1 RNA decreased similarly in both groups and, at week 48, all patients in the MVC group and 22/24 (96%) in the TDF/FTC group had < 50 copies/ml of HIV-1 RNA. CD4(+) trend during follow up was higher in maraviroc-treated patients (MVC group: 286 (183-343) versus TDF/FTC group: 199 (125-285); Mann-Whitney U-test: p 0.033). A significant 48-week increase of CCR5(+) CD4(+) T cells and CD4(+) effector memory cells was observed among maraviroc-treated patients (Wilcoxon signed rank test: p 0.016 and p 0.007, respectively). No significant variations were found in naive and central memory CD4(+) T cells. Among naive patients with an R5 virus, treatment with maraviroc and lopinavir/ritonavir was shown to provide a virological response compared to a triple therapy and a greater immunological benefit.

Keywords: Antiretroviral therapy; human immunodeficiency virus; maraviroc; naive patients; nucleoside/nucleotide reverse transcriptase inhibitor-sparing regimen.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents / administration & dosage*
  • Antiretroviral Therapy, Highly Active / methods*
  • CD4 Lymphocyte Count
  • Cyclohexanes / administration & dosage*
  • DNA, Viral / blood
  • Drug Combinations
  • Female
  • HIV Infections / drug therapy*
  • HIV-1 / isolation & purification
  • Humans
  • Lopinavir / administration & dosage*
  • Male
  • Maraviroc
  • Prospective Studies
  • Ritonavir / administration & dosage*
  • Treatment Outcome
  • Triazoles / administration & dosage*
  • Viral Load

Substances

  • Anti-HIV Agents
  • Cyclohexanes
  • DNA, Viral
  • Drug Combinations
  • Triazoles
  • lopinavir-ritonavir drug combination
  • Lopinavir
  • Maraviroc
  • Ritonavir