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Title: Hepatitis C virus core antigen: A simplified treatment monitoring tool, including for post-treatment relapse
Authors: Lamoury, Francois M. J.
Soker, Angelica
Martinez, Danica
Hajarizadeh, Behzad
Cunningham, Evan B.
Cunningham, Philip
Bruggmann, Philip
Foster, Graham R.
Dalgard, Olav
Backmund, Markus
Conway, Brian
Swan, Tracy
Cloherty, Gavin
Marks, Pip
Grebely, Jason
Dore, Gregory J.
Applegate, Tanya L.
Issue Date: 2017
Abstract: Background: Simple, affordable diagnostic tools are essential to facilitate global hepatitis C virus (HCV) elimination efforts. Objectives: This study evaluated the clinical performance of core antigen (HCVcAg) assay from plasma samples to monitor HCV treatment efficacy and HCV viral recurrence. Study design: Plasma samples from a study of response-guided pegylated-interferon/ribavirin therapy for people who inject drugs with chronic HCV genotype 2/3 infection were assessed for HCV RNA (AmpliPrep/COBAS Taqman assay, Roche) and HCVcAg (ARCHITECT HCV Ag, Abbott Diagnostics) during and after therapy. The sensitivity and specificity of the HCVcAg assay was compared to the HCV RNA assay (gold standard). Results: A total of 335 samples from 92 enrolled participants were assessed (mean 4 time-points per participant). At baseline, end of treatment response (ETR) and sustained virological response (SVR) visits, the sensitivity of the HCVcAg assay with quantifiable HCV RNA threshold was 94% (95% CI: 88%, 98%), 56% (21%, 86%) and 100%, respectively. The specificity was between 98 to 100% for all time-points assessed. HCVcAg accurately detected all six participants with viral recurrence, demonstrating 100% sensitivity and specificity. One participant with detectable (non-quantifiable) HCV RNA and non-reactive HCVcAg at SVR12 subsequently cleared HCV RNA at SVR24. Conclusions: HCVcAg demonstrated high sensitivity and specificity for detection of pre-treatment and post-treatment viraemia. This study indicates that confirmation of active HCV infection, including recurrent viraemia, by HCVcAg is possible. Reduced on-treatment sensitivity of HCVcAg may be a clinical advantage given the moves toward simplification of monitoring schedules.
Notes: [Lamoury, Francois M. J.; Soker, Angelica; Martinez, Danica; Hajarizadeh, Behzad; Cunningham, Evan B.; Marks, Pip; Grebely, Jason; Dore, Gregory J.; Applegate, Tanya L.] UNSW Sydney, Kirby Inst, Sydney, NSW, Australia. [Cunningham, Philip] St Vincents Appl Med Res, Sydney, NSW, Australia. [Bruggmann, Philip] Arud Ctr Addict Med, Zurich, Switzerland. [Foster, Graham R.] Queen Mary Univ London, Inst Cell & Mol Sci, London, England. [Dalgard, Olav] Akershus Univ Hosp, Dept Infect Dis, Lorenskog, Norway. [Dalgard, Olav] Univ Oslo, Inst Clin Med, Oslo, Norway. [Backmund, Markus] Munich Schwabing Hosp, Dept Addict Med, Munich, Germany. [Conway, Brian] Univ British Columbia, Dept Pharmacol & Therapeut, Vancouver, BC, Canada. [Robaeys, Geert; Swan, Tracy] Ziekenhuis Oost Limburg, Dept Gastroenterol & Hepatol, Schiepse, Belgium. [Robaeys, Geert] Limburg Clin Res Program, Fac Med & Life Sci, Hasselt, Belgium. [Robaeys, Geert] UZ Leuven, Dept Hepatol, Leuven, Belgium. [Cloherty, Gavin] Abbott Diagnost, Abbott Pk, IL USA.
Keywords: Simplified diagnostic; Core antigen; Viral recurrence; People who inject drugs; Injecting drug use; Hepatitis C virus;simplified diagnostic; core antigen; viral recurrence; people who inject drugs; injecting drug use; Hepatitis C virus
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ISSN: 1386-6532
e-ISSN: 1873-5967
DOI: 10.1016/j.jcv.2017.05.007
ISI #: 000405107800007
Rights: © 2017 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (
Category: A1
Type: Journal Contribution
Validations: ecoom 2018
Appears in Collections:Research publications

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