Premium
Clinical utility of total HCV core antigen quantification: A new indirect marker of HCV replication
Author(s) -
BouvierAlias Magali,
Patel Keyur,
Dahari Harel,
Beaucourt Stéphanie,
Larderie Patrick,
Blatt Lawrence,
Hezode Christophe,
Picchio Gaston,
Dhumeaux Daniel,
Neumann Avidan U.,
McHutchison John G.,
Pawlotsky JeanMichel
Publication year - 2002
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1053/jhep.2002.34130
Subject(s) - viral load , hepatitis c virus , virology , medicine , antigen , hepacivirus , immunology , hepatitis c , surrogate endpoint , antiviral therapy , viral replication , genotyping , virus , chronic hepatitis , biology , genotype , biochemistry , gene
Hepatitis C virus (HCV) RNA detection, viral load quantification, and HCV genotyping are widely used in clinical practice. Recently, the availability of an anticore antigen (Ag) monoclonal antibody allowed development of an enzyme‐linked immunosorbent assay (ELISA) detecting and quantifying total HCV core Ag in peripheral blood of HCV‐infected patients. The aims of the present study were to investigate the biologic significance of this new marker in HCV infection, to establish the intrinsic performance of the current assay, and to determine its potential utility in the management of HCV‐infected patients. A panel of infected sera calibrated to the World Health Organization International Standard and 657 serum samples from infected patients receiving antiviral treatment were studied. We showed that total HCV core Ag quantification is an accurate, precise, and specific indirect marker of HCV replication. We estimated that 1 pg/mL of total HCV core Ag is equivalent to approximately 8,000 HCV RNA international units (IU)/mL, although minor between‐patient differences may exist. In conclusion, total HCV core Ag quantification can be used in the various indications of viral load monitoring, including the evaluation of baseline viral load before therapy, the assessment of the virologic response to antiviral treatment, and the study of early viral kinetics during therapy. Nevertheless, the total HCV core Ag assay cannot be used as a marker of viral replication for HCV RNA values below 20,000 IU/mL, limiting its use in the monitoring of late events during and after antiviral treatment.