Autoimmune hepatitis (AIH) is a chronic liver disease characterised by immune-mediated liver inflammation that can lead to liver failure or cirrhosis if untreated. The current standard treatments involve immunosuppressive therapies in the form of prednisolone in combination with azathioprine, but due to inadequate and variable response and high toxicity, there is ongoing debate about the most effective induction therapy for treatment-naive patients. MMF is used for refractory, relapsed cases or azathioprine intolerant cases for AIH. Few of the studies showed better responses in patients with MMF, but all the available data is not free of biases. This study aims to compare the efficacy and safety of azathioprine (AZA) versus mycophenolate mofetil (MMF) in inducing remission in patients with treatment-naive autoimmune hepatitis.

This double-blind, randomized controlled trial (RCT) will enrol treatment-naive AIH patients randomly assigned to receive either azathioprine or mycophenolate mofetil, along with steroids. The primary endpoint is the induction of remission, defined by normalizing liver enzymes and IgG after six months of treatment. Secondary endpoints include assessing safety, adverse events, quality of life measures, and the need for additional immunosuppressive therapy.

Patients will be closely monitored through regular clinic visits, laboratory tests. Safety and tolerability will be assessed to ensure patient well-being. This trial aims to provide robust evidence on the comparative effectiveness of AZA and MMF, potentially guiding future treatment protocols for AIH.