Current and Emerging Treatments for Non-alcoholic Steatohepatitis
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FATTY LIVER DISEASE (V AJMERA, SECTION EDITOR)
Current and Emerging Treatments for Non-alcoholic Steatohepatitis Christian L. Horn 1 & Anvi C. Ta 2 & Nadege T. Gunn 2,3
# Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Introduction Non-alcoholic fatty liver disease (NAFLD) is highly prevalent globally, and its progressive form, non-alcoholic steatohepatitis (NASH), has become a leading cause of cirrhosis, hepatocellular carcinoma, and liver transplantation. Unfortunately, there remains an urgent unmet need for regulatory approved NASH treatments. Purpose of Review This review focuses on the current NASH treatment recommendations and critically discusses investigational agents in clinical development. Recent Findings Most NASH clinical trials are currently in early phase. Many later phase drugs have already failed to meet key endpoints. Obeticholic acid, elafibranor, cenicriviroc, and resmetirom are currently furthest along in the phase 3 development phase. Summary The pursuit to find a treatment for NASH is vital. If one or more agents in late-stage development prove effective, a commercially available medication will help augment the benefits of lifestyle interventions. Keywords Non-alcoholic fatty liver disease . Non-alcoholic steatohepatitis . Current treatments . Emerging treatments . Clinical trials
Introduction Often referenced as the hepatic manifestation of metabolic syndrome, non-alcoholic fatty liver disease (NAFLD) has an estimated global prevalence of 25%. The more progressive form of NAFLD, non-alcoholic steatohepatitis (NASH), is one of the leading causes of cirrhosis, hepatocellular carcinoma, and liver-related mortality [1, 2]. Unfortunately, no pharmacologic therapies are approved by the US Food and Drug Administration (FDA). Traditionally, the mainstay treatment for NASH is weight loss through lifestyle modifications such as diet and exercise [3]. Bariatric surgery may also promote weight loss given the This article is part of the Topical Collection on Fatty Liver Disease * Nadege T. Gunn [email protected] 1
Division of Gastroenterology and Hepatology, Department of Medicine, San Antonio Military Medical Center, Fort Sam Houston, San Antonio, TX, USA
2
Pinnacle Clinical Research, Austin, TX, USA
3
Texas A & M College of Medicine, Bryan, TX, USA
difficulties with behavior modification [4–7]. However, the pathophysiology of NASH is complex, and although weight loss is effective, there is a critical need for medications. Fortunately, several drugs are emerging and aim to hit key endpoints such as resolution of NASH, improvement in noninvasive biomarker prognosticators, and patient outcomes. In this review, we discuss several current and future NASH therapeutics while appraising their inherent successes and challenges.
Current NASH Treatments Promotion of Weight Loss (Fig. 1) Lifestyle modification to achieve weight loss is the foundation for NASH treatment. Histologic features of NASH improve with increased total body weight loss (TBWL). Hepatic steatos
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