Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial

Inclusion Criteria * Age ≥18, \<70 * MELD 20-35 on day of randomization * Definitive or probable diagnosis as defined by the NIAAA criteria * Onset of jaundice (defined as serum total bilirubin \>3 mg/dL) within the prior 8 weeks * Ongoing consumption of \> 40 gm (for females) and \> 60 gm (for males) alcohol daily for 6 months or more with less than 8 weeks of abstinence before onset of jaundice * AST \> 50 IU/L, * AST: ALT \> 1.5 * ALT and AST values \< 400 IU/L * and/or histological evidence of AH\* \*In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST \< 50 IU/L or \> 400 IU/L, AST/ALT ratio \< 1.5), antinuclear antibody \> 1:160 or SMA \> 1:80, a standard of care liver biopsy may be performed during current hospital admission to confirm AH and exclude competing etiologies. * Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening. Exclusion Criteria * Active listing for liver transplantation before screening * MELD score \<20 or \> 35 * Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy) * Progressive hemodynamic compromise requiring intravenous pressors * Pneumonia as evidenced by clinical and radiological examination * Renal failure defined by estimated GF…