title: The predictive value of core antigen testing for the management of hepatitis C patients receiving pegylated interferon/ribavirin treatment.
abstract: A new quantitative marker of HCV viremia based on the detection of the core antigen of the virus has recently become commercially available in Europe. The usefulness of this test was examined for the management of patients treated with pegylated interferon/ribavirin. One hundred twenty-eight pegylated interferon/ribavirin treated patients were studied. Serum samples were available at baseline, week 4 and week 12 time-points, respectively. Core antigen was quantified using the trak-C assay (Ortho Clinical Diagnostics, Raritan, NJ). For all genotypes at week 4, the positive and negative predictive values of HCV core antigen were 81.4 and 92.9%, respectively, while at week 12 they were 67.9 and 100%, respectively. These predictive values varied substantially according to viral genotype. Among patients with a negative core antigen level (<1.5 pg/ml) at week 12, only 33% of those who were positive at week 4 achieved a sustained virological response whereas 85% of those who were already negative did (P < 0.001). The core antigen assay may be used at week 4 and week 12 to distinguish patients who will achieve a sustained virological response from those who will relapse/breakthrough. This assay is a new reliable alternative for early prediction of virological non-response in patients treated with pegylated interferon/ribavirin.
authors.affiliation: Department of Hepatology, Hôtel-Dieu, Lyon, France. pradat@univ-lyon1.fr
authors.forename: Pierre
authors.initials: P
authors.lastname: Pradat
authors.forename: Marianne
authors.initials: M
authors.lastname: Maynard
authors.forename: Maria
authors.initials: M
authors.lastname: Buti
authors.forename: Pascale
authors.initials: P
authors.lastname: Berthillon
authors.forename: Gaston
authors.initials: G
authors.lastname: Picchio
authors.forename: Hans L
authors.initials: HL
authors.lastname: Tillmann
authors.forename: Johannes
authors.initials: J
authors.lastname: Wiegand
authors.forename: Nicolas
authors.initials: N
authors.lastname: Voirin
authors.forename: Michael P
authors.initials: MP
authors.lastname: Manns
authors.forename: Juan-Ignacio
authors.initials: JI
authors.lastname: Esteban
authors.forename: Michèle
authors.initials: M
authors.lastname: Martinot
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
authors.forename: Christian
authors.initials: C
authors.lastname: Trepo
mesh_terms: D000998:Antiviral Agents / Q000494:pharmacology / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology; D018936:Hepatitis C Antigens / Q000097:blood; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000494:pharmacology / Q000627:therapeutic use*; D011092:Polyethylene Glycols; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D014758:Viral Core Proteins / Q000097:blood*; D014766:Viremia
chemical_list: D000998:Antiviral Agents; D018936:Hepatitis C Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D014758:Viral Core Proteins; C069130:nucleocapsid protein, Hepatitis C virus; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b