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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
Author(s) -
Kamal S. M.,
Kassim S.,
EL Gohary E.,
Fouad A.,
Nabegh L.,
Hafez T.,
Bahnasy K.,
Hassan H.,
Ghoraba D.
Publication year - 2015
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.13261
Subject(s) - ribavirin , medicine , pegylated interferon , viral load , hepatitis c virus , virology , hepatitis c , immunology , antigen , chronic hepatitis , genotype , virus , biology , biochemistry , gene
Summary Background Quantitative hepatitis C ( HCV ) polymerase chain reaction (qt HCV ‐ 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 qt HCV RNA PCR and HCV core Ag assay protocol to the standard All‐qt HCV ‐ 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.