Hepatitis C virus core antigen in the management of patients treated with new direct-acting antivirals

Alados-Arboledas, Juan Carlos; Guerrero, I Pavón; Rodríguez, María José Blanco; Martos, Eva Torres; Pérez, Ana Belén Macho; Leon, Cristina; Sánchez, Juan; Prieto, María Dolores López; Porcuna, Natalia Chueca; Mochón, María Dolores Ocete; Macı́as, Juan; Salgado, A. De La Iglesia; Granger, Javier Rodríguez; Fernández, Marcial Delgado; Lozano, Irene Iglesias; Reigadas, Elena; Rivero, Antonio; Domínguez, María del Carmen Lozano; Viciana, Isabel; Montemayor, Juan Carlos Galán; García, Féderico

doi:10.1016/j.diagmicrobio.2017.06.006

Cited by 17 publications

(31 citation statements)

References 17 publications

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“…Regarding sensitivity and specificity of HCVcAg for assessment of post-treatment viremia, many studies were nearly parallel to our result; Arboledas et al [31] reported that the sensitivity of HCVcAg test was 86.5% and Daniel et al [32] showed 85.3% sensitivity. Meanwhile, Ergunay et al [33] revealed 75.8% sensitivity.…”

Section: Discussionsupporting

confidence: 86%

Hepatitis C core antigen: a simple predictive marker for treatment response to the new direct-acting antiviral drugs in chronic HCV Egyptian patients

Elbrolosy

El-Hamouly

Eed

et al. 2021

Egypt Liver Journal

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Background Successful eradication of hepatitis C virus (HCV) has great impact on the prognosis of HCV-related complications and the associated mortality. The development of the new direct-acting antiviral drugs (DAAs) has revolutionized the treatment of HCV infection. HCV core antigen (HCVcAg) is a recently developed marker that displayed a good correlation with HCV RNA assays. Our main objectives were to correlate between serum levels of HCVcAg and HCV RNA loads in chronic HCV patients as well as to explore the potential value of HCVcAg assay in predicting treatment response to the new DAAs. The study enrolled a total of 280 chronic HCV-infected patients scheduled to start the new regimen for treatment of chronic HCV by all-oral, interferon-free DAAs. According to the viral load, the studied individuals were arranged into three groups corresponding to mild, moderate, and sever viremia. Serum level of HCVcAg was determined by ELISA technique and HCV RNA viral loads were quantified using the real-time PCR system. The assays were performed three times for all participants: prior to initiation of treatment, at the end of treatment (week 12), and 3 months post-treatment cessation (week 24). Results A statistically significant difference between HCV RNA and HCVcAg baseline levels among different viremia groups was detected (P < 0.001). There was a significant positive correlation between HCV RNA and HCVcAg baseline values among all the studied cases (P < 0.05) with a correlation coefficient of 0.752, 0.976, and 1.00 respectively for mild, moderate, and severe viremia groups. 92.9% (260/280) of the studied patients achieved sustained virologic response, 3.6% (10/280) were non-responders, and 3.6% (10/280) had recurrent viremia/relapse as regards RT-PCR results. Conclusion HCVcAg is a promising alternative to HCV RNA assay. The ELISAs for HCVcAg proved excellent correlations with HCV RNA levels. Moreover, HCVcAg can be introduced as a simple and highly specific tool for monitoring the new DAA regimens particularly in low-resource settings.

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Section: Discussionsupporting

confidence: 86%

Hepatitis C core antigen: a simple predictive marker for treatment response to the new direct-acting antiviral drugs in chronic HCV Egyptian patients

Elbrolosy

El-Hamouly

Eed

et al. 2021

Egypt Liver Journal

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“…The diagnosis of HCV infection commonly involves a two-stage procedure. Antibody screening (anti-HCV) is performed first, followed by the determination of the viral load (VL: HCV-RNA), which allows the differentiation between active and past infection (WHO, 2016;Kuo et al, 2012;Ghany et al, 2009; Centers for Disease Control and Prevention, 2013a; Centers for Disease Control and Prevention, 2013b;Alados-Arboledas et al, 2017). In recent years, a new technique for the detection of the HCV core antigen (HCV-cAg) in blood or plasma samples has been commercialized.…”

Section: Introductionmentioning

confidence: 99%

“…In recent years, a new technique for the detection of the HCV core antigen (HCV-cAg) in blood or plasma samples has been commercialized. HCV-cAg is a highly conserved and antigenic protein of the internal capsid (Hu and Cui, 2016;Kuo et al, 2012;Alados-Arboledas et al, 2017).This structural protein is released and can be detected early, well before the antibodies against the virus, and throughout the complete course of the infection (Freiman, 2016). HCV-cAg has been described as an active marker of infection, thus being an alternative to HCV-RNA, with A1 evidence grading by the European Association for the Study of the Liver (Ross et al, 2010;Ottiger et al, 2013;Chevaliez et al, 2014; European Association for the Study of the Liver, 2018).…”

Section: Introductionmentioning

confidence: 99%

“…HCV-cAg has been described as an active marker of infection, thus being an alternative to HCV-RNA, with A1 evidence grading by the European Association for the Study of the Liver (Ross et al, 2010;Ottiger et al, 2013;Chevaliez et al, 2014; European Association for the Study of the Liver, 2018). The newly described assay (Architect HCV core antigen, Abbott Diagnostics, Wiesbaden, Germany) uses the same platform employed in anti-HCV antibody determination, contributing to the simplification of the diagnosis of active HCV infection to a single step (Alados-Arboledas et al, 2017;Tillmann, 2014). Studies on the use of HCV-cAg in routine laboratory tests for completing the diagnosis of anti-HCV-positive cases and for patient follow-up and treatment monitoring have been conducted (Hu and Cui, 2016;Kuo et al, 2012;Alados-Arboledas et al, 2017;Freiman, 2016;Kesli et al, 2011;Miedouge et al, 2010).…”

Section: Introductionmentioning

confidence: 99%

“…The newly described assay (Architect HCV core antigen, Abbott Diagnostics, Wiesbaden, Germany) uses the same platform employed in anti-HCV antibody determination, contributing to the simplification of the diagnosis of active HCV infection to a single step (Alados-Arboledas et al, 2017;Tillmann, 2014). Studies on the use of HCV-cAg in routine laboratory tests for completing the diagnosis of anti-HCV-positive cases and for patient follow-up and treatment monitoring have been conducted (Hu and Cui, 2016;Kuo et al, 2012;Alados-Arboledas et al, 2017;Freiman, 2016;Kesli et al, 2011;Miedouge et al, 2010). However, prospective comparison of the two techniques in different clinical situations in real-life scenarios are needed.…”

Section: Introductionmentioning

confidence: 99%

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Hepatitis C core antigen: Diagnosis and monitoring of patients infected with hepatitis C virus

Pérez‐García

Aguinaga

Navascués

et al. 2019

International Journal of Infectious Diseases

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Introduction: New efficient strategies are needed for the assessment of active hepatitis C virus (HCV) infection. The aim of this study was to evaluate the ability of HCV core antigen (HCV-cAg) as a marker of active HCV infection in newly diagnosed patients, for treatment monitoring, and for the detection of therapeutic failure. Materials and methods: A prospective study was conducted at a regional reference hospital in Spain. HCV-cAg and viral load (RNA-HCV) were tested in plasma or serum samples from three patient groups: new diagnosis, treatment monitoring, and treatment failure. The treatment monitoring group was tested at the beginning of treatment, at 4 weeks post-initiation, at the end of treatment, and at 12 weeks posttreatment completion. The Architect HCV core antigen assay was performed for HCV-cAg testing, and viral load was quantified with the Cobas 6800 system. Results: A total of 303 samples from 124 patients were analyzed. Excellent correlation was seen between HCV-cAg and HCV-RNA (R 2 = 0.932). The optimal cut-off value was 3 fmol/l in the receiver operating characteristics curve analysis, and the area under the curve was 0.987 (95% confidence interval 0.972-1.000). HCV-cAg sensitivity and specificity were 97% and 95%, respectively. Most diverging results were observed in the treatment follow-up group. Conclusions: HCV-cAg demonstrated good sensitivity and specificity as a marker for active HCV infection, new diagnosis, detection of antiviral therapeutic failure, and treatment monitoring.

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Diagnostic performance of hepatitis C core antigen assay to identify active infections: A systematic review and meta‐analysis

Sepúlveda‐Crespo

Treviño‐Nakoura

Bellón

et al. 2023

Reviews in Medical Virology

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Hepatitis C virus (HCV) core antigen (HCVcAg) assay is an alternative for diagnosing HCV infection in a single step. This meta‐analysis aimed to evaluate the Abbott ARCHITECT HCV Ag assay's diagnostic performance (validity and utility) for diagnosing active hepatitis C. PubMed, EMBASE, Scopus, Web of Science, and Cochrane Library were searched until 10 January 2023. The protocol was registered at the prospective international register of systematic reviews (PROSPERO: CRD42022337191). Abbott ARCHITECT HCV Ag assay was the test for evaluation, and nucleic acid amplification tests with a cut‐off ≤50 IU/mL were the gold standard. Statistical analysis was performed using STATA with the MIDAS module and random‐effects models. The bivariate analysis was conducted on 46 studies (18,116 samples). The pooled sensitivity was 0.96 (95% CI = 0.94–0.97), specificity 0.99 (95% CI = 0.99–1.00), positive likelihood ratio 141.81 (95% CI = 72.39–277.79), and negative likelihood ratio 0.04 (95% CI = 0.03–0.06). The area under the summary receiver operating characteristic curve was 1.00 (95% CI = 0.34–1.00). For active hepatitis C prevalence values of 0.1%–15%, the probability that a positive test was a true positive was 12%–96%, respectively, indicating that a confirmatory test should be necessary, particularly with a prevalence ≤5%. However, the probability that a negative test was a false negative was close to zero, indicating the absence of HCV infection. The validity (accuracy) of the Abbott ARCHITECT HCV Ag assay for screening active HCV infection in serum/plasma samples was excellent. Although the HCVcAg assay showed limited diagnostic utility in low prevalence settings (≤1%), it might help diagnose hepatitis C in high prevalence scenarios (≥5%).

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Hepatitis C virus core antigen in the management of patients treated with new direct-acting antivirals

Cited by 17 publications

References 17 publications

Hepatitis C core antigen: a simple predictive marker for treatment response to the new direct-acting antiviral drugs in chronic HCV Egyptian patients

Hepatitis C core antigen: a simple predictive marker for treatment response to the new direct-acting antiviral drugs in chronic HCV Egyptian patients

Hepatitis C core antigen: Diagnosis and monitoring of patients infected with hepatitis C virus

Diagnostic performance of hepatitis C core antigen assay to identify active infections: A systematic review and meta‐analysis

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