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- 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.
- Authors
Kamal, S. M.; Kassim, S.; EL Gohary, E.; Fouad, A.; Nabegh, L.; Hafez, T.; Bahnasy, K.; Hassan, H.; Ghoraba, D.
- 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, costeffective 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.
- Subjects
HEPATITIS C; COST effectiveness; CHRONIC diseases; GENOTYPES; ANTIVIRAL agents
- Publication
Alimentary Pharmacology & Therapeutics, 2015, Vol 42, Issue 3, p307
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/apt.13261