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Abstract Details
Hepatitis C Virus Core Antigen (HCVAg): an affordable assay to monitor the efficacy of treatment in DAAs era
New Microbiol. 2021 Apr;44(2):89-94. Epub 2021 May 21.
Barbara Rossetti1, Elisabetta Loggi23, Chiara Spertilli Raffaelli4, Simona Mercinelli1, Claudia Gandolfo5, Gianni Gori Savellini5, Silvia Galli6, Giovanni Vitale27, Roberto Di Donato2, Ranka Vukotic2, Elena Grandini2, Marzia Margotti2, Valeria Guarneri2, Giuliano Furlini6, Maria Carla Re6, Andrea De Luca14, Pietro Andreone28, Claudio Galli9, Maria Grazia Cusi5
Author information
1Infectious Diseases Unit, Azienda Ospedaliero-Universitaria Senese, Siena, Italy.
2Department of Medical and Surgical Sciences, Research Center for Hepatitis, Universit degli Studi di Bologna, Bologna, Italy.
3Operational Unit of Clinical Pathology, ASUR4, Fermo, Italy.
4Biotechnologies Department, Siena University, Siena, Italy.
5UOC Microbiologia e Virologia, Universit degli Studi di Siena, and Azienda Ospedaliero-Universitaria Senese, Siena, Italy.
6Microbiology Section, Department of Experimental, Diagnostic and Specialty Medicine, School of Medicine, University of Bologna, Italy.
7Department of Organ Failure and Transplantation, Internal Medicine, Universit degli Studi di Bologna, Bologna, Italy.
8UOC di Medicina Interna Metabolica, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy.
9Global Medical Affairs, Abbott Diagnostics, Roma, Italy.
Abstract
Hepatitis C virus (HCV) Core Antigen (HCVAg) and HCV-RNA were tested in 962 plasma/serum samples from 180 patients during Direct Antiviral Agents (DAAs) treatment and at follow-up. One hundred and eighty individuals were included: 71% carried advanced fibrosis and 43% were treatment-experienced. A Sustained Virological Response (SVR) was achieved in 166/180 (92%) individuals: 96/102 (94.1%) na ve and 70/78 (89.7%) treatment-experienced (p=0.20). The baseline median levels of HCV-RNA and HCVAg were not significantly different between individuals achieving SVR (5.92 x 105 IU/mL, IQR 5.4-6.4, and 3,417 fmol/L, 2,900-3,795) and those without SVR (6.06 x 105 IU/mL, 5.63-6.57, and 3,391 fmol/L, 2,828-4,077). The HCV-RNA vs. HCVAg assays results showed a fair correlation with an overall moderate qualitative agreement (kappa=0.52). Among treatment-failed individuals, at failure 100% of the assays results were positive for both techniques, with HCV-RNA median value 3.09 x 105 IU/mL (2.10-29.09) and HCVAg median value 1570.28 fmol/L (360.15-9317.67). Undetectable HCV-RNA at EOT showed sensitivity 54%, specificity 100%, negative predictive value (NPV) 93% and positive predictive value (PPV) 100%. Undetectable HCVAg at EOT showed sensitivity 74%, specificity 100%, NPV 97% and PPV 100%. The operative and economic advantages of the HCVAg support the alternative use of HCVAg to monitor DAAs treatment outcome.