BACKGROUND: Virologic response-monitoring is essential for determining therapy duration in patients with chronic hepatitis C virus (HCV) infection. This is usually performed using highly sensitive HCV-RNA assays. However, HCV-RNA assays are time-consuming, expensive and require highly trained personnel. Quantitative determination of HCV core-antigen (HCVAg) levels may be used to supplement treatment monitoring. OBJECTIVES: The clinical utility of the ARCHITECT HCV Ag assay (Abbott Diagnostics) for response-guided therapy was investigated. STUDY DESIGN: We analyzed serum from 160 patients with HCV genotype 1 infection who had been treated with peg-interferon alfa-2b/ribavirin. HCVAg levels were determined at baseline, weeks 1, 2, 4 and 12. HCVAg levels were compared to those obtained with HCV-RNA assays: VERSANT HCV Quantitative 3.0 (bDNA) and Qualitative (TMA, both Siemens Healthcare) assay and the Abbott RealTime HCV assay (ART; Abbott Diagnostics). RESULTS: Baseline HCVAg levels correlated well with HCV-RNA as assessed by bDNA (r=0.91; p<0.0001) and ART (r=0.92; p<0.0001), respectively. Patients with undetectable HCVAg levels at week 1 had a 90.9% probability (positive predictive value) to achieve a rapid virologic response (HCV-RNA undetectable at week 4) based on TMA and 86.4% based on ART, respectively. Patients with less than 1 log(10) reduction in HCVAg between baseline and week 12 had a 90% probability (negative predictive value) to achieve a nonresponse (<2 log(10) decline in HCV-RNA between baseline and week 12) based on bDNA and 100% based on ART, respectively. CONCLUSIONS: Determination of HCVAg may be useful for antiviral response-monitoring in patients with HCV genotype 1 infection.
BACKGROUND: Virologic response-monitoring is essential for determining therapy duration in patients with chronic hepatitis C virus (HCV) infection. This is usually performed using highly sensitive HCV-RNA assays. However, HCV-RNA assays are time-consuming, expensive and require highly trained personnel. Quantitative determination of HCV core-antigen (HCVAg) levels may be used to supplement treatment monitoring. OBJECTIVES: The clinical utility of the ARCHITECT HCV Ag assay (Abbott Diagnostics) for response-guided therapy was investigated. STUDY DESIGN: We analyzed serum from 160 patients with HCV genotype 1 infection who had been treated with peg-interferon alfa-2b/ribavirin. HCVAg levels were determined at baseline, weeks 1, 2, 4 and 12. HCVAg levels were compared to those obtained with HCV-RNA assays: VERSANT HCV Quantitative 3.0 (bDNA) and Qualitative (TMA, both Siemens Healthcare) assay and the Abbott RealTime HCV assay (ART; Abbott Diagnostics). RESULTS: Baseline HCVAg levels correlated well with HCV-RNA as assessed by bDNA (r=0.91; p<0.0001) and ART (r=0.92; p<0.0001), respectively. Patients with undetectable HCVAg levels at week 1 had a 90.9% probability (positive predictive value) to achieve a rapid virologic response (HCV-RNA undetectable at week 4) based on TMA and 86.4% based on ART, respectively. Patients with less than 1 log(10) reduction in HCVAg between baseline and week 12 had a 90% probability (negative predictive value) to achieve a nonresponse (<2 log(10) decline in HCV-RNA between baseline and week 12) based on bDNA and 100% based on ART, respectively. CONCLUSIONS: Determination of HCVAg may be useful for antiviral response-monitoring in patients with HCV genotype 1 infection.
Authors: Syria Laperche; C Micha Nübling; Susan L Stramer; Ewa Brojer; Piotr Grabarczyk; Hiroshi Yoshizawa; Vytenis Kalibatas; Magdy El Elkyabi; Faten Moftah; Annie Girault; Harry van Drimmelen; Michael P Busch; Nico Lelie Journal: Transfusion Date: 2015-05-27 Impact factor: 3.157
Authors: J Morgan Freiman; Trang M Tran; Samuel G Schumacher; Laura F White; Stefano Ongarello; Jennifer Cohn; Philippa J Easterbrook; Benjamin P Linas; Claudia M Denkinger Journal: Ann Intern Med Date: 2016-06-21 Impact factor: 25.391
Authors: Nikolien van de Ven; Joe Fortunak; Bryony Simmons; Nathan Ford; Graham S Cooke; Saye Khoo; Andrew Hill Journal: Hepatology Date: 2015-02-09 Impact factor: 17.425