Worldwide, 240 million people are chronically infected with the Hepatitis B Virus leading to over 600,000 deaths a year. Despite the existence of an effective vaccine for decades, global immunization coverage remains around 38%. The vast majority of Hepatitis B related mortality is not due to acute infection, but results from cirrhosis and liver cancer that often develops from longstanding Chronic Hepatitis B (CHB) infection. This, combined with the fact that CHB often remains outwardly asymptomatic for long stretches of time makes identifying patients who are at the highest risk of serious complications especially difficult. The WHO estimates that only 5% of those with CHB are aware of their infection status and less than 1% have ever accessed antiviral therapy. The high cost of CHB diagnostics and medications is undoubtedly a large factor in the severe lack of disease awareness. In an effort to establish an effective response to the Hepatitis B pandemic the WHO has cited, among other factors, a need for advances in affordable and reliable CHB diagnostics.
Research within the laboratory aims to develop the first assay capable of rapid lateral flow detection of elevated Hepatitis B core-related antigen, HBcrAg, a novel serum marker that has been shown to independently correlate with intrahepatic disease status in CHB patients in ways that can be clinically useful. HBcrAg levels above certain thresholds can, often independent of other existing diagnostic tests, be predictive of development of hepatocellular carcinoma later in life and viral relapse after cessation of treatment. A commercially produced laboratory-based assay for detection of HBcrAg is currently used in Japan to help physicians determine the ideal time to discontinue antiviral treatment. However, there are no approved assays for detection of HBcrAg in the United States. Moreover, the costs associated with laboratory-based diagnostic tests are often prohibitive.
A rapid test for detection of HBcrAg could fill a diagnostic gap that currently exists in the management of CHB, especially in resource poor settings. This research effort includes a collaboration with physicians at U.C. Davis, who will provide valuable clinical samples from CHB patients. This collaboration strengthens development efforts and allows for the valuable flow of information between R&D efforts and the physicians in need of better CHB diagnostic capabilities.
Project investigators: David AuCoin, Ph.D. (Principal Investigator)