Meta-analysis: diagnostic accuracy of hepatitis C core antigen detection during therapy with direct-acting antivirals

Area of Science:

• Hepatology
• Virology
• Diagnostic Assay Development

Background:

• Direct-acting antivirals (DAAs) are standard for treating hepatitis C virus (HCV) infection.
• Monitoring treatment efficacy typically involves assessing plasma HCV-RNA levels.
• Hepatitis C virus core antigen (HCVcAg) detection is explored as a potential alternative monitoring marker.

Purpose of the Study:

• To evaluate the diagnostic performance and clinical utility of HCVcAg assays for monitoring DAA treatment efficacy in HCV-infected patients.
• To compare the diagnostic accuracy of HCVcAg detection against the gold standard HCV-RNA test at various time points during and after treatment.

Main Methods:

• A systematic literature search was conducted across multiple electronic databases up to July 6, 2022.
• Included studies evaluated HCVcAg detection in plasma or serum compared to HCV-RNA testing.
• Pooled diagnostic performance metrics, including sensitivity, specificity, PLR, NLR, and AUC, were calculated at 2 and 4 weeks post-treatment initiation, end-of-treatment (EOT), and sustained virological response (SVR).

Main Results:

• 16 studies involving 3237 patients and 8958 samples (2016-2022) were analyzed.
• HCVcAg assay performance was poor at week 2 (AUC=0.57) and fair at week 4 (AUC=0.79).
• Performance was acceptable at EOT (AUC=0.97) and excellent for SVR (AUC=0.99).

Conclusions:

• The HCVcAg assay demonstrates poor diagnostic performance for monitoring DAA treatment efficacy at early time points (weeks 2 and 4).
• HCVcAg testing is a valuable tool for assessing treatment effectiveness at the end of therapy (EOT).
• The assay is highly effective for documenting sustained virological response (SVR) 12 weeks post-treatment.