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

Garbuglia, Anna Rosa; Lionetti, Raffaella; Lapa, Daniele; Taibi, Chiara; Visco-Comandini, Ubaldo; Montalbano, Marzia; D’Offizi, Gianpiero; Castiglione, Filippo; Capobianchi, Maria Rosaria; Paci, Paola

doi:10.1016/j.jcv.2015.06.002

Cited by 12 publications

(10 citation statements)

References 23 publications

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“…In TVR treatment, the antigen level at week 1 and antigen negativity at week 2 allowed distinction of the groups achieving different outcomes. Similar to the present study, Garbuglia and co-workers have reported the inability to detect HCVcAg one week after starting therapy is predictive of the likelihood to achieve SVR in TVR treatment [ 46 ]. Tamai and colleagues found no association between HCVcAg level and SVR of HCV specific genotype 1b and high viral loads [ 18 ], although in their previous study of interferon-based therapy, antigen levels within two weeks showed usefulness in predicting outcomes [ 10 ].…”

Section: Discussionsupporting

confidence: 84%

The Role of Hepatitis C Virus Core Antigen Testing in the Era of Direct Acting Antiviral Therapies: What We Can Learn from the Protease Inhibitors

et al. 2016

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Direct-acting antiviral (DAA) therapies have revolutionised the treatment of hepatitis C virus (HCV). The financial cost of DAAs however is significant, and first generation protease inhibitors (PIs) also require frequent monitoring of viral RNA levels to guide treatment. In this context, we examined the relevance of HCV antigen testing to evaluate the potential role in monitoring virological response to HCV antiviral treatment with the PI-based triple therapies, telaprevir (TVR) and boceprevir (BOC). Chronic HCV-infected individuals (n = 152) enrolled in the Irish Hepatitis C Outcomes Research Network (ICORN) study were prospectively analysed for baseline markers and the early viral kinetics associated with SVR. The sustained virological response (SVR) rates in the cohort receiving TVR and BOC were 87.3% and 73.8%, respectively. Baseline factors associated with successful outcome in TVR therapy were age (P = 0.0098), IFNL3 genotype (P = 0.0330) and viral load (P = 0.0456). RNA level at week 4 (P = 0.0068) and viral antigen negativity at week 2 (P = 0.0359) were predictive of SVR for TVR-based therapy. In BOC therapy, prior interferon treatment (P = 0.0209) and IFNL3 genotype (P = 0.0410) were baseline predictors of SVR. Evidence of viraemia based either on viral RNA or antigen at week 4 predicted SVR in these patients. Our data showed that rapid decline of HCV antigen to negative level at week 2 in TVR treatment and <0.96 log fmol/l in BOC treatment after commencement of PI triple therapy were associated with SVR. HCV antigen measurement should be considered as a potential alternative for monitoring treatment response during DAA-based regimens.

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Section: Discussionsupporting

confidence: 84%

The Role of Hepatitis C Virus Core Antigen Testing in the Era of Direct Acting Antiviral Therapies: What We Can Learn from the Protease Inhibitors

et al. 2016

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“…This study is the first to prospectively evaluate the clinical performance of HCVcAg in plasma to monitor HCV treatment and viral recurrence among an international cohort of recent PWID and people receiving OST with chronic HCV infection. While limited to genotype 2/3 HCV infection, this study supports previous studies indicating HCVcAg can be used to identify active HCV infection at baseline/screening among those with chronic HCV infection [9,[21][22][23] and identify those with a sustained virological response at 12 weeks post treatment [10,24]. While these data confirm a previous study by Chevaliez et al [10] that HCVcAg can accurately detect viral recurrence 12 or 24 weeks post-treatment, this study provides additional comprehensive longitudinal profiles from individuals with recurrent viraemia.…”

Section: Discussionsupporting

confidence: 83%

Hepatitis C Virus Core Antigen: A Simplified Treatment Monitoring Tool, including for Post-Treatment Relapse

Lamoury¹,

Soker²,

Martinez³

et al. 2016

Journal of Hepatology

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Background: Simple, affordable diagnostic tools are essential to facilitate global hepatitis C virus (HCV) elimination efforts. Objectives: This study evaluated the clinical performance of core antigen (HCVcAg) assay from plasma samples to monitor HCV treatment efficacy and HCV viral recurrence. Study design: Plasma samples from a study of response-guided pegylated-interferon/ribavirin therapy for people who inject drugs with chronic HCV genotype 2/3 infection were assessed for HCV RNA (AmpliPrep/COBAS Taqman assay, Roche) and HCVcAg (ARCHITECT HCV Ag, Abbott Diagnostics) during and after therapy. The sensitivity and specificity of the HCVcAg assay was compared to the HCV RNA assay (gold standard). Results: A total of 335 samples from 92 enrolled participants were assessed (mean 4 time-points per participant). At baseline, end of treatment response (ETR) and sustained virological response (SVR) visits, the sensitivity of the HCVcAg assay with quantifiable HCV RNA threshold was 94% (95% CI: 88%, 98%), 56% (21%, 86%) and 100%, respectively. The specificity was between 98 to 100% for all time-points assessed. HCVcAg accurately detected all six participants with viral recurrence, demonstrating 100% sensitivity and specificity. One participant with detectable (non-quantifiable) HCV RNA and non-reactive HCVcAg at SVR12 subsequently cleared HCV RNA at SVR24. Conclusions: HCVcAg demonstrated high sensitivity and specificity for detection of pre-treatment and posttreatment viraemia. This study indicates that confirmation of active HCV infection, including recurrent viraemia, by HCVcAg is possible. Reduced on-treatment sensitivity of HCVcAg may be a clinical advantage given the moves toward simplification of monitoring schedules.

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“…Furthermore, in consideration of the high costs of DAAs, less expensive tests to assess on-treatment responses are needed. Recent studies have demonstrated the clinical utility of monitoring HCV Ag in patients with CHC taking DAAs ( 33 34 35 ). Aghemo et al ( 33 ) investigated the accuracy of the HCV Ag assay in predicting which patients receiving DAAs would achieve SVR at week 12 (SVR12).…”

Section: Discussionmentioning

confidence: 99%

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

Kim

et al. 2016

J Korean Med Sci

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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.

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

Cited by 12 publications

References 23 publications

The Role of Hepatitis C Virus Core Antigen Testing in the Era of Direct Acting Antiviral Therapies: What We Can Learn from the Protease Inhibitors

The Role of Hepatitis C Virus Core Antigen Testing in the Era of Direct Acting Antiviral Therapies: What We Can Learn from the Protease Inhibitors

Hepatitis C Virus Core Antigen: A Simplified Treatment Monitoring Tool, including for Post-Treatment Relapse

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

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