title: 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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterolgy, Hepatology and Tropical Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
authors.forename: S M
authors.initials: SM
authors.lastname: Kamal
authors.affiliation: Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
authors.forename: S
authors.initials: S
authors.lastname: Kassim
authors.affiliation: Department of Molecular Biology and Biochemistry, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
authors.forename: E
authors.initials: E
authors.lastname: El Gohary
authors.affiliation: Department of Gastroenterolgy, Hepatology and Tropical Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
authors.forename: A
authors.initials: A
authors.lastname: Fouad
authors.affiliation: Department of Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
authors.forename: L
authors.initials: L
authors.lastname: Nabegh
authors.affiliation: Department of Molecular Biology, American University, Cairo, Egypt.
authors.forename: T
authors.initials: T
authors.lastname: Hafez
authors.affiliation: Department of Bioinformatics, Faculty of Computer Science, Ain Shams University, Cairo, Egypt.
authors.forename: K
authors.initials: K
authors.lastname: Bahnasy
authors.affiliation: Department of Clinical Pathology, Cairo University, Cairo, Egypt.|Department of Clinical Pathology, Salman Bin Abdul Aziz University, Riyadh, Saudi Arabia.
authors.forename: H
authors.initials: H
authors.lastname: Hassan
authors.affiliation: Department of Gastroenterolgy, Hepatology and Tropical Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
authors.forename: D
authors.initials: D
authors.lastname: Ghoraba
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000235:genetics*; D018936:Hepatitis C Antigens / Q000097:blood*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D012254:Ribavirin / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D018936:Hepatitis C Antigens; D016898:Interferon-alpha; D012254:Ribavirin