Second Generation of the Automated Cobas Amplicor HCV Assay Improves Sensitivity of Hepatitis C Virus RNA Detection and Yields Results That Are More Clinically Relevant

Doglio, Alain; Laffont, C.; Caroli-Bosc, François-Xavier; Rochet, Pascale; Lefébvre, Jean-Claude

doi:10.1128/jcm.37.5.1567-1569.1999

Cited by 78 publications

(32 citation statements)

References 10 publications

(10 reference statements)

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“…Serum HCV RNA was assessed by qualitative PCR assay (COBAS Amplicor HCV Monitor Test v2.0, Chugai-Roche Diagnostics), with a detection limit of 50 IU/mL [12].…”

Section: Virological Testsmentioning

confidence: 99%

Factors affecting efficacy in patients with genotype 2 chronic hepatitis C treated by pegylated interferon alpha-2b and ribavirin: reducing drug doses has no impact on rapid and sustained virological responses

Inoue

Hiramatsu

Oze

et al. 2010

Journal of Viral Hepatitis

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Reducing the dose of drug affects treatment efficacy in pegylated interferon (Peg-IFN) and ribavirin combination therapy for patients with hepatitis C virus (HCV) genotype 1. The aim of this study was to investigate the impact of drug exposure, as well as the baseline factors and the virological response on the treatment efficacy for genotype 2 patients. Two-hundred and fifty patients with genotype 2 HCV who were to undergo combination therapy for 24 weeks were included in the study, and 213 completed the treatment. Significantly more patients who achieved a rapid virological response (RVR), defined as HCV RNA negativity at week 4, achieved a sustained virological response (SVR) (92%, 122/133) compared with patients who failed to achieve RVR (48%, 38/80) (P < 0.0001). Multivariate logistic-regression analysis showed that only platelet counts [odds ratio (OR), 1.68; confidence interval (CI), 1.002-1.139] and RVR (OR, 11.251; CI, 5.184-24.419) were independently associated with SVR, with no correlation being found for the mean dose of Peg-IFN and ribavirin for RVR and SVR. Furthermore, in the stratification analysis of the timing of viral clearance, neither mean dose of Peg-IFN (P = 0.795) nor ribavirin (P = 0.649) affected SVR in each group. Among the patients with RVR, the lowest dose group of Peg-IFN (0.77 +/- 0.10 microg/kg/week) and ribavirin (6.9 +/- 0.90 mg/kg/day) showed 100% and 94% of SVR. Hence, RVR served as an important treatment predictor, and drug exposure had no impact on both SVR and RVR in combination therapy for genotype 2 patients.

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“…Serum HCV RNA was assessed by qualitative PCR assay (COBAS Amplicor HCV Monitor Test v2.0, Chugai-Roche Diagnostics), with a detection limit of 50 IU/mL [12].…”

Section: Virological Testsmentioning

confidence: 99%

Factors affecting efficacy in patients with genotype 2 chronic hepatitis C treated by pegylated interferon alpha-2b and ribavirin: reducing drug doses has no impact on rapid and sustained virological responses

Inoue

Hiramatsu

Oze

et al. 2010

Journal of Viral Hepatitis

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“…Structural proteins Non-structural proteins studies between a standardized RT±PCR assay for the detection and quanti®cation of HCV RNA (AMPLICOR HCV MONITOR ä ) and the bDNA assay (Quantiplex ä HCV assay) have shown that the AMPLICOR HCV Test is more sensitive and, in some rare cases, more predictive of long-term response to IFN therapy, than bDNA [20]. A second-generation AMPLICOR HCV assay, which has greater sensitivity, has been introduced [27]. The problem remains, however, that as each assay uses different standard values, the assays cannot be directly compared with each other.…”

Section: Hcv Diagnosticsmentioning

confidence: 99%

Genotype and viral load as prognostic indicators in the treatment of hepatitis C

Trépo

2000

Journal of Viral Hepatitis

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Interferon-alpha (IFN-alpha), either alone or in combination with ribavirin, is the standard treatment for patients with hepatitis C. However, most patients do not achieve a sustained remission with this treatment regimen. A number of studies have demonstrated that genotype, baseline viral load and/or a decrease in viral load early after treatment induction are the major predictive factors for response to treatment with IFN. Patients with hepatitis C virus (HCV) genotype 1 are more resistant to treatment with IFN, whereas low viral load at baseline and a marked decline in the HCV RNA level during the first 2-12 weeks of IFN therapy are associated with enhanced treatment efficacy. These variables could potentially be used to develop treatment algorithms that tailor therapies for specific clinical situations. Continued development and refinement of such algorithms would facilitate both the selection of patients who are most likely to benefit from therapy and the development of optimal treatment regimens for different patient groups. Predictive factors will also enable clinicians to identify subsets of patients who are not expected to respond well to current treatment. The development of new delivery methods for IFN that produce sustained antiviral pressure may provide a means of treating these previously difficult-to-treat patient groups.

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“…As shown in the present study, 204 (95.8%) of 213 cases were detectable by the second-generation assay, providing evidence that sensitivity was indeed significantly improved. The sensitivity of this assay was comparable with that of the COBAS v2.0 assay, a well-calibrated, sensitive and non-serotype-dependent assay (8,(17)(18)(19)(20)(24)(25)(26).…”

Section: Figmentioning

confidence: 73%

“…The quantification of HCV has become an important issue because low viral load is a strong predictor of sustained response to interferon (IFN) monotherapy for chronic hepatitis C (13-15). Among the assays for quantification of HCV load, combined reverse transcription PCR assay, the AM-PLICOR HCV MONITOR assay version 2.0 (CO-BAS v2.0) (Roche Molecular Systems, Branchburg, NJ), is now one of the most sensitive and reliable assays (16)(17)(18)(19)(20).…”

mentioning

confidence: 99%

Evaluation of clinical usefulness of second‐generation HCV core antigen assay: comparison with COBAS AMPLICOR HCV MONITOR assay version 2.0

Yokosuka

Kawai

Suzuki

et al. 2005

Liver International

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Second Generation of the Automated Cobas Amplicor HCV Assay Improves Sensitivity of Hepatitis C Virus RNA Detection and Yields Results That Are More Clinically Relevant

Cited by 78 publications

References 10 publications

Factors affecting efficacy in patients with genotype 2 chronic hepatitis C treated by pegylated interferon alpha-2b and ribavirin: reducing drug doses has no impact on rapid and sustained virological responses

Factors affecting efficacy in patients with genotype 2 chronic hepatitis C treated by pegylated interferon alpha-2b and ribavirin: reducing drug doses has no impact on rapid and sustained virological responses

Genotype and viral load as prognostic indicators in the treatment of hepatitis C

Evaluation of clinical usefulness of second‐generation HCV core antigen assay: comparison with COBAS AMPLICOR HCV MONITOR assay version 2.0

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