Usefulness of a New Immunoradiometric Assay of HCV Core Antigen to Predict Virological Response during PEG-IFN/RBV Combination Therapy for Chronic Hepatitis with High Viral Load of Serum HCV RNA Genotype 1b

Sasase, Noriko; Kim, Soo Ryang; Kim, Ke Ih; Taniguchi, Miyuki; Imoto, Susumu; Mita, Keiji; Hotta, Hak; Shouji, Ikuo; El-Shamy, Ahmed; Kawada, Norifumi; Kudo, Masatoshi; Hayashi, Yoshitake

doi:10.1159/000122601

Cited by 8 publications

(12 citation statements)

References 40 publications

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“…Assays for HCV core antigen have been proposed in the early '90s, mainly for detecting early infections [7] ; a quantitative approach to HCV antigen determination has been proposed soon thereafter as an adjoint or even a replacement to HCV-RNA testing during the monitoring of chronic hepatitis C treatment [3,4] . The main disadvantages of these earlier tests for HCV antigen were represented by the need of a manual pretreatment of the samples, to free the antigen from immune complexes and to release it from circulating virions, and the relative lack of sensitivity, even more evident as the new real-time PCR assays for HCV-RNA became available.…”

Section: Discussionmentioning

confidence: 99%

“…The main disadvantages of these earlier tests for HCV antigen were represented by the need of a manual pretreatment of the samples, to free the antigen from immune complexes and to release it from circulating virions, and the relative lack of sensitivity, even more evident as the new real-time PCR assays for HCV-RNA became available. Studies carried out with the earlier versions of HCV antigen assays have demonstrated that this antigen can be detected in the serum of most HCV-infected individuals concurrent with viremia and that the levels correlate quite well with HCV RNA levels [3,4,6] .…”

Section: Discussionmentioning

confidence: 99%

“…The recommended timing for assessing the virological response during therapy monitoring is at baseline, after 4 and 12 weeks, at the end of treatment (24 or 48 weeks according to the schedule) and every 3 months during the follow-up: additional controls at earlier time points (i.e. 1-2 days and/or 1-2 weeks after the start of treatment) have been suggested in order to achieve a higher predictive value for therapy outcomes [3][4][5] . However, since HCV-RNA testing is expensive and technically demanding, these alternatives for a closer follow-up are not adopted in practice.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2010

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The correlation and kinetics of hepatitis C virus (HCV) RNA and HCV core antigen levels in chronic hepatitis C patients treated with pegylated interferon + ribavirin were evaluated in order to envision a combined use of the two assays in therapy monitoring. HCV core antigen levels by a chemiluminescent immunoassay (Abbott ARCHITECT) and HCV-RNA levels by branched DNA (bDNA) or real-time PCR have been evaluated on plasma specimens from 32 patients treated for chronic hepatitis C. An early virological response (undetectable levels of HCV-RNA 4 weeks after start of treatment) was found in 10/23 subjects (43.5%) followed up for 5 months or more. The response was linked to the HCV genotype (20% in genotype 1B vs. 61.5% in other genotypes; p < 0.05). HCV RNA and HCV antigen showed a good correlation (r = 0.814); HCV antigen was still detectable in 3 samples with undetectable (<615 IU/ml) RNA by bDNA, while no differences in clinical sensitivity were recorded in comparison with real-time PCR. These findings suggest that HCV-RNA and HCV antigen may be used at different time points in order to tailor therapy monitoring to individual needs.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2010

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“…A new IRM assay of HCV core antigen is very useful in predicting virological response during PEG-IFN/RBV combination therapy for chronic hepatitis with a high viral load of serum HCV RNA, genotype 1b [26]. Our patient demonstrated a rapid virological decrease in HCV core antigen during 4 weeks after the start of therapy, as revealed by the new IRM assay.…”

Section: Discussionmentioning

confidence: 79%

Pegylated Interferon plus Ribavirin Combination Therapy for Chronic Hepatitis C with High Viral Load of Serum Hepatitis C Virus RNA, Genotype 1b, Discontinued on Attaining Sustained Virological Response at Week 16 after Onset of Acute Pancreatitis

Kim

Imoto²,

Mita³

et al. 2009

Digestion

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Recent clinical trials have shown that pegylated interferon-α (PEG-IFN-α) in combination with ribavirin (RBV) improves the rate of sustained virological response (SVR), with over 50% of patients demonstrating a positive response to treatment. However, no SVR has been reported when PEG-IFN/RBV combination therapy is discontinued by week 16, especially in cases of chronic hepatitis with a high viral load of serum hepatitis C virus (HCV) RNA, genotype 1b. Here, we describe SVR in a 67-year-old woman whose PEG-IFN/RBV combination therapy for chronic hepatitis C with a high viral load of serum HCV RNA, genotype 1b, was discontinued after 16 weeks because of the onset of PEG-IFN plus RBV-induced acute pancreatitis. Among viral factors, substitution of amino acid 70 (Arg) and 91 (Leu) in the core region and HCV RNA negativity were observed after 8 weeks. Host factors including low body weight, no alcohol consumption, no coinfection with hepatitis B virus, slight fibrosis, and viral factors including early viral clearance, double wild type in the core region, may have contributed to the SVR irrespective of the discontinuation of the combination therapy at week 16. Moreover, PEG-IFN plus RBV-induced acute pancreatitis might have been related to the SVR.

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“…The amount of HCV core antigen was assessed by the IRM assay (Ortho Clinical Diagnostics, Tokyo, Japan), which provides a good correlation between the amount of HCV core antigen and the amount of HCV RNA, as shown in our previous study [9] . The HCV core antigen was measured on days 0, 1 (24 h), 7 (1 week) and 14 (2 weeks) according to the detection limit of 20 fmol/l established by the manufacturer.…”

Section: Methodsmentioning

confidence: 80%

Outcome and Early Viral Dynamics with Viral Mutation in PEG-IFN/RBV Therapy for Chronic Hepatitis in Patients with High Viral Loads of Serum HCV RNA Genotype 1b

Sasase¹,

Kim

Kudo

et al. 2010

Intervirology

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We investigated whether sustained virological response (SVR) and non-SVR by chronic hepatitis C patients to pegylated interferon plus ribavirin (PEG-IFN/RBV) combination therapy are distinguishable by viral factors such as the IFN/RBV resistance-determining region (IRRDR) and by on-treatment factors through new indices such as the rebound index (RI). The first RI (RI-1st; the viral load at week 1 divided by the viral load at 24 h) and the second RI (RI-2nd; the viral load at week 2 divided by the viral load at 24 h) were calculated. The subject patients were divided into 3 groups based on RI-1st and RI-2nd: an RI-A group (RI-1st ≤1.0), an RI-B group (RI-1st >1.0 and RI-2nd <0.7) and an RI-C group (RI-1st >1.0 and RI-2nd ≧0.7). The SVR rate was 71.4% (10/14) in the RI-A group, 46.2% (6/13) in the RI-B group and 20.0% (3/15) in the RI-C group (p = 0.005 between the RI-A group and the RI-C group). In IRRDR ≧6 and IRRDR ≤5 the SVR rate was 81.3% (13/16) and 23.1% (6/26) (p = 0.0002), respectively. By combining RI and IRRDR as a predicting factor, the SVR rate was 87.5% (7/8) in the RI-A group (≧6 mutations in the IRRDR) and 7.7% (1/13) in the RI-C group (≤5 IRRDR mutations) (p = 0.0003).

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Usefulness of a New Immunoradiometric Assay of HCV Core Antigen to Predict Virological Response during PEG-IFN/RBV Combination Therapy for Chronic Hepatitis with High Viral Load of Serum HCV RNA Genotype 1b

Cited by 8 publications

References 40 publications

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

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

Pegylated Interferon plus Ribavirin Combination Therapy for Chronic Hepatitis C with High Viral Load of Serum Hepatitis C Virus RNA, Genotype 1b, Discontinued on Attaining Sustained Virological Response at Week 16 after Onset of Acute Pancreatitis

Outcome and Early Viral Dynamics with Viral Mutation in PEG-IFN/RBV Therapy for Chronic Hepatitis in Patients with High Viral Loads of Serum HCV RNA Genotype 1b

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