Clinical Utility of Enzyme-Linked Immunosorbent Assay for Hepatitis C Core Antigen Quantification in Diagnosis and Monitoring Patients Treated with Direct-Acting Antivirals in A Resource Limited Setting

Abstract

Background: Hepatitis C virus core antigen (HCV-cAg) assay has been proposed as a more economical alternative to HCV RNA detection. Aim of the work: To evaluate the clinical utility of ELISA for HCV-cAg quantification in diagnosis and monitoring treatment outcomes in patients treated with direct acting antivirals (DAAs) for chronic hepatitis C. Patients and Methods: A prospective study on 40 subjects recruited from hepatology department and outpatient clinic in Ain Shams University Hospitals. Group I included 20 patients with positive anti-HCV antibody. Group II included 20 healthy subjects. The patient group received a combination of sofosbuvir 400 mg and daclatasvir 60 mg once daily for 12 weeks. The levels for both HCV-cAg and HCV RNA were evaluated at baseline and 12 weeks after completion of therapy. Results: Baseline HCV-cAg levels showed good correlation with HCV viral load (r=0.808, p 8 IU/ml. Conclusion: ELISA for HCV-cAg can replace the high sensitivity HCV RNA molecular assay to confirm the presence of HCV infection and to monitor treatment outcome.