Boceprevir Plus Peginterferon Alfa-2a/Ribavirin in Treatment-Naïve Hepatitis C Virus Genotype 1 Patients: International Phase IIIb/IV TriCo Trial

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Correlation of IL28B polymorphism with progression-free and overall survival.

<p>A) Kaplan-Meier curve of progression-free survival according to IL28B polymorphism. No significant difference in progression-free survival could be observed for patients with CC or non-CC genotype (p = 0.176). Survival time on the x-axis is depicted in years. B) Kaplan-Meier curve of overall survival according to IL28B polymorphism. No significant difference in overall survival could be observed for patients with CC or non-CC genotype (p = 0.727). Survival time on the x-axis is depicted in years.</p

Univariate Cox regression analysis of risk factors associated with progression-free and overall survival.

<p>A) Risk factors associated with progression-free survival (univariate Cox regression analysis) B) Risk factors associated with overall survival (univariate Cox regression analysis).</p

Real-Time PCR Assays for the Quantification of HCV RNA: Concordance, Discrepancies and Implications for Response Guided Therapy

<div><p>Background and Aims</p><p>Monitoring of chronic Hepatitis C (CHC) treatment relies on HCV RNA quantification by means of real-time PCR methods. Assay specific analytical sensitivities may impact therapy management.</p><p>Methods</p><p>Comparative analysis between three commercial assays (Roche COBAS AmpliPrep/COBAS TaqMan Version 1 (CAP/CTM Ver. 1), Version 2 (CAP/CTM Ver. 2) and the Abbott RealTime HCV (ART) assay) was performed on 247 available samples taken at key decision time points during antiviral therapy of 105 genotype 1 patients (triple therapy: n = 70; dual therapy: n = 35).</p><p>Results</p><p>Overall concordance of HCV RNA measurements was high between the two Roche systems (89%; n = 220/247) but lower between the Roche assays and the ART (CAP/CTM Ver. 1 vs ART: 77.3%; n = 191/247 and CAP/CTM v.2 vs ART: 80.1%; n = 198/247). Most discrepancies were noted in week 4/8 samples with residual viremia (</p><p>Conclusion</p><p>An abbreviated course of treatment can safely be applied in patients with residual viremia (</p></div

Baseline characteristics of patients.

<p>Baseline characteristics of patients.</p

Multivariate Cox regression analysis of risk factors associated with progression-free and overall survival.

<p>A) Risk factors associated with progression-free survival (multivariate Cox regression analysis) B) Risk factors associated with overall survival (multivariate Cox regression analysis).</p

Distribution of IL28B genotype in study cohort and correlation with expected distribution according to Hardy-Weinberg equilibrium.

<p>Distribution of IL28B genotype in study cohort and correlation with expected distribution according to Hardy-Weinberg equilibrium.</p

Quantitative HCV RNA at specific RGT timepoints during antiviral therapy.

<p>Comparison of HCV RNA results of the Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative assay Version 1 (CAP/CTM Ver. 1), the Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative assay Version 2 (CAP/CTM Ver. 2) and the Abbott RealTime HCV (ART) assay in serum samples taken at (A) week 4/8 (n = 102), (B) week 12 (n = 73) and (C) week 24 (n = 72) during antiviral therapy. TND: Target not detected. </p

Risk factors like sex, age, type of melanoma, tumour thickness and AJCC stage did not differ between CC and non-CC genotype.

<p>Risk factors like sex, age, type of melanoma, tumour thickness and AJCC stage did not differ between CC and non-CC genotype.</p

Shortening of antiviral therapy (triple therapy regimen) according to assay specific detection of HCV RNA (n = 13).

<p>According to the routine assay for guidance of treatment response (Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative assay Version 1 (CAP/CTM Ver. 1) 13 patients underwent an abbreviated course of antiviral therapy (24 weeks). In comparison: number and therapy outcome of patients who would have been eligible for a shortening of antiviral treatment according to the results of the Roche COBAS AmpliPrep/COBAS TaqMan HCV quantitative assay Version 2 (CAP/CTM Ver. 2), according to the Abbott RealTime HCV assay (ART) and the adapted version of the ART Abbott RealTime HCV assay (column ART adapted: shortening of antiviral treatment also in cases where HCV RNA was detected but </p