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

Author

Nozza S, Pignataro AR, Galli L, Svicher V, Alteri C, Boeri E, Ripa M, Castagna A, Sampaolo M, Clementi M, Perno CF, and Lazzarin A

Subjects
Adult, Anti-HIV Agents administration & dosage, Cyclohexanes administration & dosage, Drug Administration Schedule, Female, Humans, Male, Maraviroc, Middle Aged, Treatment Failure, Triazoles administration & dosage, Viral Tropism, Anti-HIV Agents therapeutic use, Cyclohexanes therapeutic use, Genotype, HIV Infections drug therapy, HIV-1 genetics, Triazoles therapeutic use
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.

Published
2016

2. 48 week outcomes of maraviroc-containing regimens following the genotypic or Trofile assay in HIV-1 failing subjects: The OSCAR study

Author

Nozza, S., Pignataro, A. R., Laura Galli, Svicher, V., Alteri, C., Boeri, E., Ripa, M., Castagna, A., Sampaolo, M., Clementi, M., Pemo, C. F., Lazzarin, A., Nozza, Silvia, Pignataro, Angela Rosa, Galli, Laura, Svicher, Valentina, Alteri, Claudia, Boeri, Enzo, Ripa, Marco, Castagna, Antonella, Sampaolo, Michela, Clementi, Massimo, Perno, Carlo Federico, and Lazzarin, Adriano

Subjects
Adult, Male, Genotype, Anti-HIV Agents, Genotypic tropism assay, HIV Infections, Drug Administration Schedule, Settore MED/07, Maraviroc, Failing patients, Cyclohexanes, Cyclohexane, Trofile, Humans, HIV Infection, Treatment Failure, Failing patient, Anti-HIV Agent, Female, HIV-1, Middle Aged, Triazoles, Viral Tropism, Settore MED/07 - Microbiologia e Microbiologia Clinica, Triazole, Human
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.

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