title: HCV core antigen as an alternate test to HCV RNA for assessment of virologic responses to all-oral, interferon-free treatment in HCV genotype 1 infected patients.
abstract: In light of the advances in HCV therapy, simplification of diagnosis confirmation, pre- treatment diagnostic workup and treatment monitoring is required to ensure broad access to interferon-free therapies. HCV core antigen (HCV cAg) testing is rapid, giving results in approximately 60min, and less expensive than HCV RNA methods. While extensive data on the analytical performance of HCV cAg relative to RNA or comparisons in longitudinal studies of patients on interferon based (response guided) therapy there is very limited data on the relative performance of HCV cAg in diagnosis and monitoring patients receiving all-oral interferon free regimens. Furthermore, there is no data in the literature that describes the specificity of HCV cAg in patients with resolved HCV infection i.e. anti-HCV positive/HCV RNA negative. In this study a total of 1201 plasma samples from the 411 HCV genotype 1 subjects with a HCV RNA viral load >50,000IU/ml who enrolled in a clinical trial with ombitasvir, ritonavir-boosted paritaprevir and dasabuvir, with or without ribavirin were retrospectively tested in a blinded fashion with HCV cAg test and results were compared to HCV RNA levels. The specificity of the HCV cAg test was also evaluated in anti-HCV positive but HCV RNA negative samples. Overall concordance between HCV cAg and HCV RNA was 98.6% while concordance in pre-treatment samples was 99.5% (409/411; n=2 HCV RNA pos. with viral loads>3 Mill IU/ml but HCV cAg neg.) and 99.24% in post treatment week 12 samples (391/394; n=2 HCV RNA pos.<25IU/ml and n=1 HCV RNA pos. 2180IU/ml). Specificity in anti-HCV positive HCV RNA negative samples tested was 100%.
authors.affiliation: University Hospital Bonn, Bonn, Germany.
authors.forename: Jürgen Kurt
authors.initials: JK
authors.lastname: Rockstroh
authors.affiliation: Toronto Centre for Liver Disease McLaughlin-Rotman Centre for Global Health University of Toronto, Toronto, ON, Canada.
authors.forename: Jordan J
authors.initials: JJ
authors.lastname: Feld
authors.affiliation: National Reference Center for Viral Hepatitis B C and D Department of Virology Hôpital Henri Mondor Université Paris-Est and INSERM U955, Créteil, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Chevaliez
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Cheng
authors.affiliation: Klinik für Gastroenterologie Hepatologie und Endokrinologie Medizinische Hochschule Hannover, Hannover, Germany.
authors.forename: Heiner
authors.initials: H
authors.lastname: Wedemeyer
authors.affiliation: Medizinische Klinik 1 Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Sarrazin
authors.affiliation: Medizinische Klinik 1 Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Maasoumy
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Herman
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA.
authors.forename: John
authors.initials: J
authors.lastname: Hackett
authors.affiliation: Abbvie, North Chicago, IL, USA.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Cohen
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA.
authors.forename: George J
authors.initials: GJ
authors.lastname: Dawson
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA. Electronic address: gavin.cloherty@abbott.com.
authors.forename: Gavin
authors.initials: G
authors.lastname: Cloherty
authors.affiliation: National Reference Center for Viral Hepatitis B C and D Department of Virology Hôpital Henri Mondor Université Paris-Est and INSERM U955, Créteil, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Pawlotsky
mesh_terms: D015081:2-Naphthylamine; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology*; D018936:Hepatitis C Antigens / Q000097:blood*; D019698:Hepatitis C, Chronic / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy / Q000821:virology; D006801:Humans; D007372:Interferons / Q000009:adverse effects / Q000627:therapeutic use; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011392:Proline / Q000031:analogs & derivatives; D012367:RNA, Viral / Q000097:blood*; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use; D019438:Ritonavir / Q000627:therapeutic use; D012680:Sensitivity and Specificity; D013449:Sulfonamides / Q000627:therapeutic use; D014498:Uracil / Q000031:analogs & derivatives / Q000627:therapeutic use; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D003521:Cyclopropanes; D018936:Hepatitis C Antigens; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds; D012367:RNA, Viral; D013449:Sulfonamides; D012254:Ribavirin; D014498:Uracil; D007372:Interferons; D011392:Proline; D015081:2-Naphthylamine; C588260:dasabuvir; D019438:Ritonavir; C585405:paritaprevir