The Hepatitis C (HCV) and Hepatitis B (HBV) viruses are leading causes of liver disease. They are the common cause of cirrhosis and hepatocellular carcinoma, as well as the most-prevalent cause for liver transplantation. HCV affects more than 11 million people in the industrialized world. HBV is widely prevalent in other countries, with an estimated number of more than 350 million carriers worldwide.
Determining the degree of fibrosis of the liver is a key parameter in the decision to initiate therapy for hepatitis patients. Liver biopsy is currently the "gold standard"; however, it is invasive, involves a high rate of complications, and is subject to sampling and interpretation error. It is, therefore, not used for ongoing patient management. Serology or specifically elevated ALT levels in the blood are insensitive in assessing liver fibrosis. It is estimated that up to 30% of people infected with HCV have normal ALT levels*. In addition, ALTs do not detect disease progression to cirrhosis. A number of technologies are attempting to provide non-invasive alternative assessments of fibrosis, but despite the clear need, none of them has achieved wide acceptance to date.
BreathID demonstrates a high agreement level with biopsy in detecting significant fibrosis and inflammation.BreathID assesses patients with severe fibrosis (METAVIR > 2) (AUC 0.96; sensitivity 96%, specificity 86%, NPV 97%, and PPV 81%)**. By applying the suggested algorithm for treatment, two-thirds of biopsies can be avoided by using BreathID. ***
BreathID offers significant advantages over existing assessment tools:
* Conry-Cantilena et al. Routes of Infection, viremia and liver disease in blood donors found to have Hepatitis C virus infection. N Eng J Med 1996;334;1691-6
** Lalazar et al., Point of Care Non Invasive 13C Methancetin Breath Testing Accurately Identifies Liver Inflammation and Fibrosis: A Novel Method for Assessing Liver Damage, Presented at DDW 2007
*** Lalazar et al., Accurate Identification of Liver Fibrosis Using the Point-Of-Care Continuous 13C Methacetin Breath Test: A Decision Making Tool in the Treatment of Patients with Chronic HCV Infection, Presented at AASLD 2007