Defining an approach for therapeutic strategies in metabolic dysfunction-associated steatotic liver disease after liver transplantation

Occurrence of metabolic dysfunction associated steatotic liver (MASLD) is common following liver transplantation (LT). MASLD can be classified as recurrent disease when it occurs in patients receiving LT for metabolic dysfunction associated steatohepatitis (MASH) or as de novo when it occurs in patients transplanted for non-MASH etiologies of liver disease. Fibrosis progression in patients with MASLD is accelerated with progression to cirrhosis occurring more rapidly compared to the general (i.e. non-LT) population. Moreover, the metabolic burden in LT recipients with MASLD is high and synergizes with liver disease to negatively affect clinical course. Despite the oversized clinical burden of MASLD among LT recipients, there is currently a lack of regulatory approach and pathway for therapeutics development in this patient population. The present document, thus, provides guidance for therapeutics development that incorporates nuances of transplant care in patients with post-LT MASLD to facilitate drug development.