Non-alcoholic steatohepatitis: diagnosis, management and challenges in clinical trials: an Indian perspective

Abstract

Non-alcoholic fatty liver disease (NAFLD) is the most prevalent chronic liver disease worldwide and non-alcoholic steatohepatitis (NASH), its progressive form, is rapidly becoming the leading cause of end-stage liver disease and liver transplantation. There is a huge unmet need in the management of NAFLD and NASH. The key challenge is that NAFLD/NASH remains to be an under recognized disease despite its increasing prevalence, and early diagnosis is crucial to reduce the risk of progression and its consequent complications. In India, cases of NAFLD/NASH may go undetected due to lack of awareness and absence of a structured patient referral pathway. Efforts to increase patient and physician awareness along with standardization of local management guidelines for NAFLD and NASH can help improve patient care in India. Another major concern is the lack of approved NASH therapy; in order to address this issue, there has been a global surge in clinical trials. However, many countries, including India, have encountered challenges in the conduct of these trials related to patient recruitment and retention, lack of validated less invasive diagnostic tests, and the effect of placebo response on trial outcomes. Measures to improve the NAFLD and NASH clinical trial environment can help accelerate the approval and availability of better treatment options for NASH.