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A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
Hepatitis C virus core antigen testing: role in diagnosis, disease monitoring and treatment
1Hans L Tillmann, GI/Hepatology, Duke Clinical Research Institute and Duke University, Durham, NC 27708, United States.
Insights
Hepatitis C virus (HCV) core antigen testing offers a cost-effective method to confirm active HCV infection and may serve as an alternative to HCV RNA monitoring during treatment.
Area of Science:
- Hepatology
- Virology
- Clinical Diagnostics
Background:
- Hepatitis B virus (HBV) screening uses hepatitis B surface antigen to confirm infection.
- Hepatitis C virus (HCV) screening relies on anti-HCV testing, which cannot distinguish active from past infections.
- HCV RNA testing is currently required to confirm active HCV infection.
Purpose of the Study:
- To evaluate the utility of a newly available HCV core antigen assay for confirming HCV infection.
- To explore the potential of HCV core antigen testing as a cost-effective reflex test.
- To assess the feasibility of using HCV core antigen for monitoring HCV treatment.
Main Methods:
- Evaluation of a commercially available HCV core antigen assay.
- Comparison of HCV core antigen testing with HCV RNA testing in anti-HCV positive individuals.
- Analysis of preliminary data on HCV core antigen for treatment monitoring.
Main Results:
- The HCV core antigen assay can confirm infection in over 50% of anti-HCV positive individuals.
- HCV core antigen testing is less sensitive than HCV RNA assays but offers cost-effectiveness and platform compatibility.
- Early data suggest HCV core antigen may be a viable alternative to HCV RNA for treatment monitoring, potentially superior with direct antivirals.
Conclusions:
- HCV core antigen testing presents a practical and cost-effective option for confirming active HCV infection.
- Further research is needed to establish HCV core antigen assay's role in treatment monitoring.
- HCV core antigen may offer advantages over HCV RNA testing in the era of direct-acting antiviral therapies.
Abstract:
While hepatitis B virus (HBV) screening relies on hepatitis B surface antigen to confirm HBV infection since the early days of hepatitis B disease management, hepatitis C virus (HCV) infection screening is based on anti-HCV testing which does not discriminate active from past infection. Thus to confirm infection HCV RNA testing has been required; recently a HCV core antigen assay became widely commercially available which could serve to confirm infection. That assay is less sensitive than current HCV RNA assays, but as more than 50% of anti-HCV positive persons will be HCV core antigen positive, HCV core antigen testing can be a cost effective and reflex test to confirm HCV infection in anti-HCV positive individuals and will be easier as it can be applied on the same platform. For treatment monitoring, more data need to be generated, but the early data available at present suggest that HCV core antigen may be an alternative to HCV RNA monitoring. With direct antivirals, HCV core antigen could even be superior to HCV RNA testing, as direct antivirals might already prevent virus formation when HCV core antigen is still produced and thereby correlates better with eventual viral clearance.
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