title: 48 week outcomes of maraviroc-containing regimens following the genotypic or Trofile assay in HIV-1 failing subjects: the OSCAR Study.
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 arm and 89% in the Genotype arm (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.
authors.affiliation: Department of Infectious Diseases, IRCCS San Raffaele, Milan, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Nozza
authors.affiliation: Laboratory of Microbiology and Virology, IRCCS San Raffaele, Milan, Italy.
authors.forename: Angela Rosa
authors.initials: AR
authors.lastname: Pignataro
authors.affiliation: Department of Infectious Diseases, IRCCS San Raffaele, Milan, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Galli
authors.affiliation: Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Svicher
authors.affiliation: Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Alteri
authors.affiliation: Laboratory of Microbiology and Virology, IRCCS San Raffaele, Milan, Italy.
authors.forename: Enzo
authors.initials: E
authors.lastname: Boeri
authors.affiliation: Department of Infectious Diseases, IRCCS San Raffaele, Milan, Italy.|Università Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Ripa
authors.affiliation: Department of Infectious Diseases, IRCCS San Raffaele, Milan, Italy.|Università Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Castagna
authors.affiliation: Laboratory of Microbiology and Virology, IRCCS San Raffaele, Milan, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Sampaolo
authors.affiliation: Laboratory of Microbiology and Virology, IRCCS San Raffaele, Milan, Italy.|Università Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Clementi
authors.affiliation: Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Italy.
authors.forename: Carlo Federico
authors.initials: CF
authors.lastname: Perno
authors.affiliation: Department of Infectious Diseases, IRCCS San Raffaele, Milan, Italy.|Università Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003510:Cyclohexanes / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000235:genetics*; D006801:Humans; D008297:Male; D000077592:Maraviroc; D008875:Middle Aged; D017211:Treatment Failure; D014230:Triazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D056189:Viral Tropism
chemical_list: D019380:Anti-HIV Agents; D003510:Cyclohexanes; D014230:Triazoles; D000077592:Maraviroc
keywords: Failing patients; Genotypic tropism assay; Maraviroc; Trofile