Tropifexor plus cenicriviroc combination versus monotherapy in nonalcoholic steatohepatitis: Results from the phase 2b TANDEM study

Editorial Material Gastroenterology & Hepatology

Research in Brief

Holly Baker

LANCET GASTROENTEROLOGY & HEPATOLOGY (2023)

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Article Biochemistry & Molecular Biology

Tropifexor for nonalcoholic steatohepatitis: an adaptive, randomized, placebo-controlled phase 2a/b trial

Arun J. Sanyal et al.

NATURE MEDICINE (2023)

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Article Gastroenterology & Hepatology

Novel therapeutic targets for cholestatic and fatty liver disease

Michael Trauner et al.

Summary: Cholestatic and non-alcoholic fatty liver disease have shared pathophysiological mechanisms that can be targeted for intervention through novel therapeutic concepts. Nuclear receptors play a crucial role in the treatment of these diseases, with high affinity therapeutic ligands being developed for specific or multiple isoforms. In addition, other therapeutic approaches targeting inflammation and fibrosis directly are also available. Combination strategies that target metabolic disturbances, inflammation, and fibrosis may be necessary for successful treatment of these complex disorders.

GUT (2022)

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Article Gastroenterology & Hepatology

Complexity of ballooned hepatocyte feature recognition: Defining a training atlas for artificial intelligence-based imaging in NAFLD

Elizabeth M. Brunt et al.

Summary: The study reveals poor agreement among expert hepatopathologists regarding the number of ballooned hepatocytes seen on the same digitized histology images. This has implications for the diagnosis of nonalcoholic steatohepatitis (NASH) and the requirements for demonstrating 'NASH resolution' in support of drug efficacy in clinical trials. Artificial intelligence-based approaches may offer a more reliable way to assess hepatocyte ballooning.

JOURNAL OF HEPATOLOGY (2022)

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Review Gastroenterology & Hepatology

Breakthroughs in therapies for NASH and remaining challenges

Vlad Ratziu et al.

Summary: Nonalcoholic steatohepatitis (NASH) has become a leading cause of chronic liver disease, and the need for effective treatments is urgent. Recent breakthroughs and progress in understanding the pathogenesis have set the stage for future therapeutic successes in NASH.

JOURNAL OF HEPATOLOGY (2022)

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Article Gastroenterology & Hepatology

Digital pathology with artificial intelligence analyses provides greater insights into treatment-induced fibrosis regression in NASH

Nikolai V. V. Naoumov et al.

Summary: This study demonstrates that digital microscopy with artificial intelligence analyses has greater sensitivity in demonstrating treatment-induced reversal of fibrosis in the liver than current systems. Furthermore, additional details are obtained regarding the pathogenesis of NASH disease and the effects of therapy.

JOURNAL OF HEPATOLOGY (2022)

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Review Gastroenterology & Hepatology

Change in MRI-PDFF and Histologic Response in Patients With Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis

Jonathan G. Stine et al.

Summary: The meta-analysis showed that a >= 30% relative decline in MRI-PDFF is associated with higher odds of histologic response and NASH resolution. These results support the use of MRI-PDFF in monitoring treatment response in early-phase NASH trials and provide helpful data for sample-size estimation for histology-based assessment.

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY (2021)

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Article Gastroenterology & Hepatology

A Machine Learning Approach Enables Quantitative Measurement of Liver Histology and Disease Monitoring in NASH

Amaro Taylor-Weiner et al.

Summary: The study demonstrates that using machine learning can accurately assess liver histopathology in NASH patients and sensitively quantify treatment response. Deep learning methods not only show strong correlations with expert pathologists' evaluations, but also have good predictive value for disease progression in NASH.

HEPATOLOGY (2021)

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Article Gastroenterology & Hepatology

Combination Therapies Including Cilofexor and Firsocostat for Bridging Fibrosis and Cirrhosis Attributable to NASH

Rohit Loomba et al.

Summary: In patients with bridging fibrosis and cirrhosis, 48 weeks of treatment with cilofexor/firsocostat was well tolerated and resulted in improvements in NASH activity, potentially having an antifibrotic effect. This combination offers potential for fibrosis regression with longer-term therapy in patients with advanced fibrosis attributable to NASH.

HEPATOLOGY (2021)

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Article Gastroenterology & Hepatology

Disease burden and economic impact of diagnosed non-alcoholic steatohepatitis in five European countries in 2018: A cost-of-illness analysis

Jorn M. Schattenberg et al.

Summary: This study estimated the disease burden and economic impact of diagnosed NASH in the adult population of France, Germany, Italy, Spain, and the United Kingdom in 2018. The majority of undiagnosed NASH patients were found to have early-stage disease, which may progress to more resource-consuming late-stage liver disease in the future. The results suggest that the majority of economic and wellbeing costs of NASH are experienced in late disease stages, highlighting the importance of earlier diagnosis and care to reduce future healthcare costs.

LIVER INTERNATIONAL (2021)

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Review Pharmacology & Pharmacy

Emerging and Established Therapeutic Approaches for Nonalcoholic Fatty Liver Disease

Emily Brown et al.

Summary: Nonalcoholic fatty liver disease (NAFLD) is a disease spectrum that requires comprehensive treatment considering its hepatic and extrahepatic complications. Treatment options include lifestyle interventions and pharmacologic interventions, with new treatments continuously evolving.

CLINICAL THERAPEUTICS (2021)

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Article Gastroenterology & Hepatology