Alcohol-Induced Liver Decompensation (AILD)
AILD is a life-threatening form of acute liver failure precipitated by the recent ingestion of alcohol. AILD can occur with or without chronic underlying liver disease and can manifest itself in several clinical patterns depending on the acute response of the liver to alcohol’s toxic effect. One common and well-recognized form of AILD is severe acute alcoholic hepatitis (sAAH), which is characterized by inflammation and enlargement of the liver. Most subjects with sAAH are thought to have some underlying chronic changes to the liver as a result of longer-term alcohol use, although these changes may be reversible on abstention. Because of the frequency with which the AILD population has been found to have some degree of preexisting liver disease, this condition is also often referred to as acute-on-chronic liver failure, or acute-on-chronic hepatitis.
A second form of AILD, which we refer to as non-sAAH AILD, occurs in subjects with underlying stable chronic liver disease who suffer from an episode of acute liver failure due to excessive consumption of alcohol. Current standard-of-care for AILD is defined by the treating facility and typically includes the use of anti-inflammatory drugs, such as corticosteroids, and the treatment of secondary complications such as bleeding, kidney failure and hepatic coma and may include admission to an intensive care unit. Since abstinence from alcohol for six months is generally considered a pre-requisite for inclusion on a liver transplant list, organ transplantation is usually not available for these patients.
The Department of Health and Human Services in the United States estimates that for 2012 the number of hospital admissions related to sAAH in the United States was approximately 95,000, with approximately 14,000 of these admissions identifying sAAH as the primary diagnosis. In addition, approximately 305,000 hospital admissions occurred in 2012 related to alcoholic cirrhosis, alcohol liver damage not-otherwise-specified or alcoholic fatty liver, with approximately 48,000 hospital admissions identifying these conditions as the primary diagnosis. We believe that a subset of these patients have a form of non-sAAH AILD that may be treatable with the ELAD System. Incidence rates for both sAAH and non-sAAH AILD appear to be similar in Europe.