The accuracy and cost-effectiveness of hepatitis C core antigen assay in the monitoring of anti-viral therapy in patients with chronic hepatitis C genotype 4

Abstract

Background Quantitative hepatitis C (HCV) polymerase chain reaction (qtHCV-PCR), the gold standard for monitoring HCV therapy, is an expensive, time-consuming procedure that requires equipped laboratories and trained personnel. Aims To assess the accuracy and cost-effectiveness of the automated Abbott ARCHITECT HCV Ag assay (Wiesbaden, Germany) in monitoring response to pagylated interferon (PEG-IFN) and ribavirin therapy for chronic HCV genotype 4 (G4). Methods This longitudinal, non-inferiority study compared the efficacy and cost benefit of an All-HCV core antigen assay protocol and a hybrid qtHCV RNA PCR and HCV core Ag assay protocol to the standard All-qtHCV-PCR protocol in chronic HCV G4 patients treated with pegylated interferon (PEG IFN) and ribavirin. Results Four hundred and ten patients with chronic hepatitis C genotype 4 met inclusion criteria and were enrolled in the study. The sustained virological response rate (SVR) was 66.34%. The All-HCV core antigen and hybrid monitoring assays resulted in the significant cost savings without compromising performance. A good correlation existed between HCV viral load and HCV core antigen levels (r = 0.944; P < 0.0001). Baseline HCV RNA values <600 IU/mL, baseline HCV core Ag levels <2000 fmol/L, rapid virological response, rapid decline in HCV core antigen were strong predictors of SVR. Conclusion Hepatitis C core Ag assay is a point-of-care, reproducible, reliable, cost-effective monitoring tool with rapid turnaround time that, which can effectively replace or adjunct to qRT-PCR in monitoring interferon based or interferon-free anti-viral therapy in chronic hepatitis genotype 4 patients in resource-limited countries with a high burden of hepatitis C.