J Korean Med Sci.  2016 Sep;31(9):1431-1437. 10.3346/jkms.2016.31.9.1431.

Clinical Utility of a New Automated Hepatitis C Virus Core Antigen Assay for Prediction of Treatment Response in Patients with Chronic Hepatitis C

• Kim MN
• Kim HS
• Kim JK
• Kim BK
• Kim SU
• Park JY
• Kim DY
• Ahn SH
• Han KH

• KMID: 2468276
• DOI: http://doi.org/10.3346/jkms.2016.31.9.1431

Abstract

Hepatitis C virus core antigen (HCV Ag) is a recently developed marker of hepatitis C virus (HCV) infection. We investigated the clinical utility of the new HCV Ag assay for prediction of treatment response in HCV infection. We analyzed serum from 92 patients with HCV infection who had been treated with pegylated interferon and ribavirin. HCV Ag levels were determined at baseline in all enrolled patients and at week 4 in 15 patients. Baseline HCV Ag levels showed good correlations with HCV RNA (r = 0.79, P < 0.001). Mean HCV Ag levels at baseline were significantly lower in patients with a sustained virologic response (SVR) than in those with a non SVR (relapse plus non responder) based on HCV RNA analysis (2.8 log10fmol/L vs. 3.27 log10fmol/L, P = 0.023). Monitoring of the viral kinetics by determination of HCV RNA and HCV Ag levels resulted in similarly shaped curves. Patients with undetectable HCV Ag levels at week 4 had a 92.3% probability of achieving SVR based on HCV RNA assay results. The HCV Ag assay may be used as a supplement for predicting treatment response in HCV infection, but not as an alternative to the HCV RNA assay.

Keyword

Chronic Hepatitis C; HCV RNA; HCV Core Antigen; Treatment Response

MeSH Terms

Antigens, Viral/*blood
Antiviral Agents/therapeutic use
Automation
Drug Therapy, Combination
Female
Genotype
Hepacivirus/*genetics/isolation & purification/metabolism
Hepatitis C, Chronic/drug therapy/*virology
Humans
Immunoassay
Interferon-alpha/therapeutic use
Male
Middle Aged
Polyethylene Glycols/therapeutic use
Polymerase Chain Reaction
RNA, Viral/*blood
Reagent Kits, Diagnostic
Recombinant Proteins/therapeutic use
Recurrence
Ribavirin/therapeutic use
Treatment Outcome
Antigens, Viral
Antiviral Agents
Interferon-alpha
RNA, Viral
Reagent Kits, Diagnostic
Recombinant Proteins
Polyethylene Glycols
Ribavirin

Figure

• 

  Fig. 1 HCV Ag levels show good correlation with HCV RNA levels in both genotypes. r = 0.798, P < 0.001 for genotype 1 (A); r = 0.773, P < 0.001 for genotype 2 (B).

• 

  Fig. 2 Baseline HCV levels. (A) RNA levels (log10 IU/mL) in patients with a sustained virologic response (SVR) and non-SVR. The log mean baseline HCV RNA levels are significantly lower in patients with SVR (5.88 IU/mL) than non-SVR (6.13 IU/mL) (P = 0.045). (B) Ag levels (log10 fmol/L) in patients with SVR and non-SVR. The log mean baseline HCV Ag levels are significantly lower in patients with SVR (2.8 fmol/L) than in those with non-SVR (3.27 fmol/L) in logs (P = 0.023).

• 

  Fig. 3 Kinetics of HCV RNA and HCV Ag levels during the 4-week treatment period. Viral kinetics were monitored by determination of HCV RNA and HCV Ag levels. The similarly shaped curves indicate similar kinetics.

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