Early decline of the HCV core antigen can predict SVR in patients with HCV treated by Pegylated interferon plus ribavirin combination therapy

Abstract

OBJECTIVE: Pegylated interferon (PEG‐IFN) plus ribavirin (RBV) combination therapy is now a popular treatment for patients with chronic hepatitis C; however, the reported sustained virologic response (SVR) rate remains at nearly 50% in genotype 1b infected patients. Therefore, it is of clinical benefit to be able to predict the effect of combination therapy on individual patients earlier in the treatment. We estimated the predictive serum HCV core antigen levels for SVR in the early therapeutic stage of combination therapy. METHODS: The HCV core antigen in patients with high‐level HCV viremia, in whom standard PEG‐IFNα2b plus RBV combination therapy had been completed, was measured at baseline and at 3, 7, 14, 28 and 84 days of treatment, and their SVR was determined at 24 weeks after treatment. Sixty genotype 1b‐ and 30 genotype 2‐infected patients were included. RESULTS: Thirty (50%) genotype 1b and 27 (90%) genotype 2 patients achieved a SVR. In genotype 1b patients the decline of HCV core antigen levels was statistically different between the SVR and non‐SVR groups. When we defined a separation level at 500 fmol/L, sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for SVR at day 7 was 79.4%, 88.5%, 90%, 76.7%, and 83.3%, respectively. In genotype 2 patients, there was no significant difference in the HCV core antigen values between the SVR and non‐SVR groups. CONCLUSION: In genotype 1b patients, 500 fmol/L of HCV core antigen level at day 7 was the best predictor for therapeutic response in the early stage of treatment.

The clinical significance of HCV core antigen detection during Telaprevir/Peg-Interferon/Ribavirin therapy in patients with HCV 1 genotype infection

“…These findings are in agreement with the observation of Vermehren et al who found that undetectable HCVAg at week 1 of SOC therapy represents a positive predictor for SVR achievement [13]. Similar results had been obtained on SVR prediction using a previous new version of HCV core antigen assay [23][24][25].…”

Quantitative Determination of Hepatitis C Core Antigen in Therapy Monitoring for Chronic Hepatitis C

“…The recent emphasis on the early kinetics of viremia and antigenemia as predictors of sustained response to treatment [4,11,12] may further enhance the usefulness of employing both a serological and a molecular approach for the evaluation of treated patients. Profiles of HCV-RNA (log IU/ml) by RT-PCR and HCV antigen (log pg/ml) in a patient with chronic hepatitis C showing a partial virological response (decrease of 2.7 logs of HCV-RNA after 12 weeks of treatment).…”

Who to test and how to test for chronic hepatitis C infection – 2016 WHO testing guidance for low- and middle-income countries

“…However, the data on HCVcAg in treatment monitoring and assessment of test of cure (SVR) was considered to be too limited to yet recommend its use as a substitute for HCV RNA. The accuracy of two HCVcAg assays for treatment monitoring compared to NAT was assessed by descriptive analysis of five studies [165,[167][168][169][170].…”