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

<p>Article full text</p> <p>The full text of this article can be found at <u>https://link.springer.com/article/10.1007/s40121-016-0110-5</u></p><p><u><br></u></p><p></p> <p>Provide enhanced content for this article</p> <p>If you are an author of this publication and would like to provide additional enhanced content for your article then please contact <a href="http://www.medengine.com/Redeem/”mailto:[email protected]”"><b>[email protected]</b></a>.</p> <p>The journal offers a range of additional features designed to increase visibility and readership. All features will be thoroughly peer reviewed to ensure the content is of the highest scientific standard and all features are marked as ‘peer reviewed’ to ensure readers are aware that the content has been reviewed to the same level as the articles they are being presented alongside. Moreover, all sponsorship and disclosure information is included to provide complete transparency and adherence to good publication practices. This ensures that however the content is reached the reader has a full understanding of its origin. No fees are charged for hosting additional open access content.</p> <p>Other enhanced features include, but are not limited to:</p> <ul> <li>Slide decks</li> <li>Videos and animations</li> <li>Audio abstracts</li> <li>Audio slides</li> </ul

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

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

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

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

Enrollment and patient disposition.

<p>^aOther reasons (more than one reason may apply to a given patient): no final confirmation from the investigator (n = 56); contraindications to therapy (n = 15); HCV RNA-negative at screening/baseline (n = 12); end-stage renal disease (n = 7); major organ transplantation (n = 2); not treated with peginterferon alfa (n = 1) or ribavirin (n = 2); acute hepatitis C (n = 1); co-infection with HIV (n = 115); co-infection with HBV (n = 74); treatment with regimen other than peginterferon alfa-2a/ribavirin or peginterferon alfa-2b/ribavirin (n = 14); treatment-naive and intended treatment duration of 72 weeks (n = 6).</p

SVR rates according to exposure and baseline prediction score in subgroup 2.

<p>SVR rates according to exposure and baseline prediction score in subgroup 2.</p