The goal of this clinical trial is to determine the effectiveness of azathioprine (AZA) versus mycophenolate mofetil (MMF) in inducing remission in treatment-naive patients with autoimmune hepatitis (AIH). The main questions it aims to answer are:
Does MMF combined with prednisolone lead to higher remission rates compared to AZA with prednisolone after 24 weeks? Is MMF associated with fewer adverse events than AZA in these patients? Researchers will compare two treatment arms (MMF vs. AZA) to see if MMF leads to improved remission rates and safety outcomes.
Primary Outcome Measure:
Biochemical remission: The primary outcome is the normalization of liver enzymes (AST, ALT) and IgG levels at 24 weeks.
Secondary Outcome Measures:
Safety and adverse events: Monitoring and comparing the incidence and severity of side effects between the two groups.
Treatment adherence: Evaluating how well patients stick to their assigned treatment regimens.
Improvement in quality of life: Assessing changes in the patient's quality of life using validated questionnaires.
Reversal of fibrosis: Measured by liver stiffness using Fibroscan, aiming for no progression of fibrosis.
Participants will:
Receive either MMF or AZA, alongside a tapering dose of prednisolone. Be monitored regularly through clinic visits, laboratory tests, and safety assessments to track remission and any adverse events.
None
Acute liver failure: Patients presenting with acute liver failure at baseline will be excluded.
Parallel
Mycophenolate Mofetil + Prednisolone Participants will receive mycophenolate mofetil in combination.
DrugParticipants in this arm will receive mycophenolate mofetil (MMF) starting at 1,000 mg/day for the first two weeks, increasing to 2,000 mg/day thereafter. This will be combined with prednisolone, beginning at 40-60 mg/day, with a tapering dose to 5-10 mg/day after 4-8 weeks, depending on the patient's response. MMF works by inhibiting inosine monophosphate dehydrogenase, which decreases lymphocyte proliferation, thereby reducing immune-mediated liver damage in autoimmune hepatitis. Prednisolone, a corticosteroid, is included to control inflammation during the induction phase of treatment. This intervention lasts for 24 weeks, with monitoring for biochemical remission (normalization of liver enzymes and IgG levels) and adverse events to assess the treatment's safety and efficacy.
Azathioprine + Prednisolone
DrugIn this arm, participants will receive azathioprine (AZA) starting at 50 mg/day for the first two weeks, followed by an increase to 100 mg/day. This dose will be combined with prednisolone, starting at 40-60 mg/day, with the dosage tapering to 5-10 mg/day after 4-8 weeks, depending on patient response. Azathioprine works as an immunosuppressive agent by inhibiting DNA synthesis in rapidly dividing immune cells, thereby reducing liver inflammation in autoimmune hepatitis. Prednisolone, a corticosteroid, is included to control inflammation during the initial treatment phase. The intervention lasts for 24 weeks with regular monitoring for biochemical remission, defined as normalization of liver enzymes (AST, ALT) and IgG levels, as well as the occurrence of adverse events to assess safety and tolerability.
Biochemical Remission at 24 Weeks
Definition: Normalization of liver enzymes (ALT, AST) and immunoglobulin G (IgG) levels. Time Frame: Measured at 24 weeks of treatment. Purpose: To evaluate the effectiveness of mycophenolate mofetil (MMF) versus azathioprine (AZA) in achieving biochemical remission in treatment-naive autoimmune hepatitis (AIH) patients.
Incidence and Severity of Adverse Events
Definition: Number and severity (mild, moderate, or severe) of adverse events related to the treatment. Time Frame: Assessed at each follow-up visit (every 4 weeks) during the 24-week treatment period. Purpose: To compare the safety profiles of MMF and AZA.
Treatment Adherence
Definition: Percentage of participants who complete the 24-week treatment without discontinuation due to adverse events or non-compliance. Time Frame: Measured throughout the 24-week period. Purpose: To assess patient adherence to treatment protocols in both groups.
Quality of Life Improvement
Definition: Change in the quality of life score based on a validated patient-reported outcome questionnaire, SF-36, and CLDQ. Time Frame: Measured at baseline and 24 weeks. Purpose: To determine whether improvements in liver function correlate with better quality of life
Change in Liver Fibrosis
Definition: Change in liver fibrosis stage, measured by Fibroscan. Time Frame: Measured at baseline and 24 weeks. Purpose: To evaluate if either treatment leads to a reduction in liver fibrosis or prevents its progression.
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