Context

PoC-HCV will capitalise and translate promising discoveries made in the context of the SPHINX FP7 project (http://www.sphinx-hcv.eu), which identified biomarkers useful in the management of patients infected by hepatitis C virus (HCV), thus establishing a foundation for the migration of assays onto Point-of-Care (PoC) technologies. As detailed herein, genetic and protein biomarkers tested on PoC devices, will be united by new predictive mathematical algorithms, taking advantage of leading-edge biomarker discoveries to help overcome challenges for patient management in resource-poor countries. In Western settings the new PoC tests will assist health agencies and physicians, allowing for cost optimised treatment strategies while minimising adverse side-effects of new therapies.

Viral hepatitis C

Hepatitis C is an infectious disease affecting the liver, caused by the hepatitis C virus (HCV). Chronic infection may result in life-threatening liver failure or cancer. About 170 million people worldwide are chronically infected with hepatitis C virus, representing a 15 billion euro / year economic burden. More than 350 000 people die every year from hepatitis C-related liver diseases. In Europe alone, estimates for hepatitis C incidence are 8.7 per 100 000, with much higher prevalence in injecting drug users (reference: European Centre for Disease Prevention and Control).

Current treatment options against HCV

Clinical management decisions include questions of whether, when, and how to treat patients with chronic HCV. Until recently, and still the case in resource limited settings, treatment for chronic hepatitis C involves the a combination of pegylated interferon and ribavirin. The effectiveness of this therapy depends on many factors, and only achieves a 50% response rate. New direct acting anti-viral drugs, called protease inhibitors, have recently been approved for clinical use. Protease inhibitors block the effects of enzymes that viral cells need to reproduce and when combined with conventional bi-therapy give increased cure rates. Next generation direct anti-virals targeting other viral proteins promise even more effective cure rates.

Point of Care assays to implement personalized medicine

Personalised medicine (PM), a strategy for customization of healthcare based on individual phenotyping of profiles rather than the long established ‘one-size-fits-all’ approach, identifies elements that predict the individuals’ response to treatment and their predisposition to disease. Personalized medicine approaches are already been utilized for the management of HCV patients, for example the Fibrotest and FibroMax biomarker panels and viral genotype help to influence treatment decisions. The PoC-HCV project will extend this approach combining well established genetic and protein biomarkers to help predict patient outcome when required. These point of care tests will be performed from single blood droplets with results delivered in 30 minutes enabling real time treatment decisions. The point of care technologies will also be applied to monitor in treatment responses and to identify early indicators of adverse reactions. In addition they may enable the detection and diagnosis of previously undetectable HCV infected cases. The newly developed PoC assays will enable maximisation of health resources in all clinical settings. 


europe  

PoC-HCV is a European research project supported
by the European Commission (Grant agreement n° 601851).