48 week outcomes of maraviroc-containing regimens following the genotypic or Trofile assay in HIV-1 failing subjects: The OSCAR study

Silvia Nozza, Angela Rosa Pignataro, Laura Galli, Valentina Svicher, Claudia Alteri, Enzo Boeri, Marco Ripa, Antonella Castagna, Michela Sampaolo, Massimo Clementi, Carlo Federico Pemo, Adriano Lazzarin

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Abstract

This study assessed the 48-week efficacy of an antiretroviral therapy including maraviroc following the assessment of co-receptor tropism by use of Geno2Pheno algorithm or the Trofile phenotypic assay in failing treatment-experienced HIV-1 patients. This was a multicenter, randomized, open-label, non-inferiority trial. Treatment-experienced subjects with HIV-RNA ≥500 copies/mL were randomized (1:1) to undergo co-receptor tropism testing by the Geno-2Pheno algorithm (with a false positive rate >10%) or the Trofile assay before starting a new antiretroviral treatment which included maraviroc. The primary endpoint was the 48 week proportion of patients with treatment success (TS). Intention-to-treat analyses are also reported. One hundred and fifty-five experienced patients were analysed: 77 patients in the Trofile arm and 78 in the Genotype arm. The 48-week proportion of TS was 87% in the Trofile ami and 89% in the Genotype aim (difference: 1.5%, 95%CI: -8.9% to 11.8%) suggesting non-inferiority. In the Trofile arm, 10 patients had treatment failure: 5 viral rebound, 5 discontinuations. In the Genotype arm, 9 patients had treatment failure: 7 viral rebound, 2 lost to follow-up. CD4+ significantly increased from baseline to week 48 in both arms. 48-week treatment success was similar for maraviroc-including therapy prescribed following the Trofile phenotypic assay or Geno2Pheno algorithm.

Original languageEnglish
Pages (from-to)192-196
Number of pages5
JournalNew Microbiologica
Volume39
Issue number3
Publication statusPublished - Apr 1 2016

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Keywords

  • Failing patients
  • Genotypic tropism assay
  • Maraviroc
  • Trofile

ASJC Scopus subject areas

  • Medicine(all)
  • Microbiology (medical)

Cite this

Nozza, S., Pignataro, A. R., Galli, L., Svicher, V., Alteri, C., Boeri, E., Ripa, M., Castagna, A., Sampaolo, M., Clementi, M., Pemo, C. F., & Lazzarin, A. (2016). 48 week outcomes of maraviroc-containing regimens following the genotypic or Trofile assay in HIV-1 failing subjects: The OSCAR study. New Microbiologica, 39(3), 192-196.