LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis

Inclusion Criteria: * Men and women at least 18 years of age with a diagnosis of definite or probable AIH defined by the revised International Autoimmune Hepatitis Group (IAIHG) criteria * Elevation of serum ALT ≥ 1.5 times the upper limit of normal * Liver biopsy showing chronic hepatitis consistent with AIH * Patients able to swallow the study medication * Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study * Women of childbearing potential must have a negative serum pregnancy test within seven days prior to receiving study medication and agree to use contraceptive measures to avoid pregnancy during participation in the trial. Exclusion Criteria: * Patients with other concurrent liver disease * Patients with cirrhosis on liver biopsy with a MELD score \> 15 * Patients with a history or presence of decompensated liver disease * Patients with serum creatinine ≥ 1.5 mg/dL prior to enrollment * Patients positive for HCV RNA or Hepatitis B surface antigen (HBsAg) * Patients with a history of alcohol intake \> 25 g/day within the past six months * Patients with TSH outside normal range accompanied by an abnormal T4 * Patients with alpha-fetoprotein ≥ 20 ng/mL * Patients with severe anemia (hemoglobin \< 8 g/dL), leukopenia (WBC \< 4000/mm3), or thrombocytopenia (platelet count \< 100,000/mm3) * Patients with a history of recent exposure to hepatotoxic drugs * Patients who require therapy with any immunosuppressive agent other than those prescribed in the study * Patients unable or unwilling to provide informed consent * Pregnant or nursing women * Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception * Patients who have been treated with another investigational agent in the three months prior to enrollment * Patients receiving any drug interfering with tacrolimus metabolism * Patients with current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully * Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives * Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus * Patients with a known hypersensitivity to azathioprine, corticosteroids or tacrolimus * Patients with any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator * Patients who are recipients of an organ transplant or who require treatment with immunosuppressives or corticosteroids for any disease other than AIH.