Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium

CASES: Heavy drinkers with alcoholic hepatitis

Inclusion criteria

• The diagnosis of AH will be established on published criteria this is based on:

• Average daily ethanol consumption of > 40 grams/day for women and > 60 grams/day for men for a minimum of 6 months and within the 6 weeks prior to study enrolment. Judgment regarding daily and yearly alcohol use will be made by the site investigator
• Clinical evaluation and appropriate laboratory testing as defined by total bilirubin > 2 mg/dL and AST > 50 U/L. When the diagnosis of AH remains in question, a liver biopsy (if clinically feasible and that subject has no contra-indications) will be required.
• Subjects with HBV, HCV and/or HIV will be eligible for enrollment

Exclusion criteria

• Evidence of other liver diseases such as autoimmune or drug-induced
• Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure
• Abstinence of alcohol use > 6 weeks immediately preceding enrollment
• Hemochromatosis
• Wilson Disease
• Active intravenous drug use

CONTROLS: Heavy drinkers without alcoholic hepatitis

Inclusion criteria

• Average daily ethanol consumption of > 40 grams /day for women and > 60 grams/day for males for a minimum of 6 months and within the 6 weeks prior to study enrollment. In addition, heavy drinkers who have just become abstinent within prior 2 weeks are eligible to be enrolled. Judgment regarding daily and yearly alcohol use will be made by the site investigator
• AST and ALT ≤ 50 and total bilirubin levels within normal range. If bilirubin is increased due to a suspected Gilbert's Syndrome, patient may be enrolled if the direct bilirubin is within normal limits

Exclusion criteria

• Evidence of liver disease
• Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure
• Abstinence of alcohol use > 2 weeks immediately preceding enrollment
• Hemochromatosis
• Wilson Disease
• Active intravenous drug use
• Prior history of known alcoholic liver disease
• Presence of hepatosplenomegaly from the physical examination/radiographic imaging or stigmata of liver disease