Anti-HCV Core Protein Monoclonal antibody, Clone 7B2

We are entering a new era in the treatment of hepatitis C virus (HCV) infection and almost all patient groups in high-income countries have the potential to be cured with all-oral, highly potent combinations of direct-acting antiviral drugs. Soon the main barrier to curing hepatitis C, even in wealthy countries, will be the high price of these all-oral regimens. The gulf between the advances in HCV drug development and access to treatment for individual patients will be even greater in low- and middle-income countries (LMIC) where 80% of the global burden of HCV infection and mortality exists. Ensuring that people in LMIC have access to regimens against HCV will require a similar level of advocacy and public-private partnerships as has transformed the control of other global diseases such as HIV. Numerous challenges will need to be overcome. These include improving low-cost diagnostic tests, especially in sub-Saharan Africa where the false-positive rate is unacceptably high, reducing iatrogenic spread of HCV, addressing transmission among people who inject drugs (PWID), and ensuring affordable access to antiviral treatment for all people living with HCV infection in LMIC. This article forms part of a symposium in Antiviral Research on "Hepatitis C: next steps toward global eradication." (C) 2015 The Authors. Published by Elsevier B.V.

Background: The aim of the evaluation was to investigate the relevance of the HCV-core antigen testing for the diagnosis and monitoring of HCV infections in the daily routine. Up to now, most of the serological diagnostics was performed as determination of antibodies while the determination of activity and the monitoring of antiviral therapy were checked by HCV RNA PCR. Methods: The routine requests for HCV-core antigen of a private laboratory were analyzed for a period of two years. Results: The determination of HCV antigen highly correlates with the quantitative measurement of HCV RNA (r = 0.73), p = 0.0003). The diagnostic window is comparable with that of the HCV PCR (27.1 +/- 12.8 d vs. 23.9 +/- 9.2 d, p = 0.11). The sensitivity of the HCV antigen assay was 99.0 % with a specificity of 99.2 %. 54.3 % of the confirmed antibody positive samples were also antigen positive. Only in 3 of 560 HCV-RNA positive samples HCV antigen was not detectable, but 3 samples without HCV antibodies were confirmed positive for HCV antigen. Conclusions: The HCV antigen assay is a suitable tool for the detection of chronic active HCV infections, for the early diagnosis of acute infections and for testing of HCV in patient with immunodeficiency. The HCV antigen assay valuable completion of serological testing for HCV.