Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science

Mohammad Shadab Siddiqui, Stephen A. Harrison, Manal F. Abdelmalek, Quentin M. Anstee, Pierre Bedossa, Laurent Castera, Lara Dimick‐Santos, Scott L. Friedman, Katherine Greene, David E. Kleiner, Sophie Megnien, Brent A. Neuschwander‐Tetri, Vlad Ratziu, Elmer Schabel, Veronica Miller, Arun J. Sanyal, on behalf of the Liver Forum Case Definitions Working Group – 23 October 2017 – Nonalcoholic steatohepatitis (NASH) is an important cause of liver‐related morbidity and mortality.

Systemic regulation of bilirubin homeostasis: Potential benefits of hyperbilirubinemia

Ryoichi Fujiwara, Mathias Haag, Elke Schaeffeler, Anne T. Nies, Ulrich M. Zanger, Matthias Schwab – 23 October 2017 – Neurotoxic bilirubin is the end product of heme catabolism in mammals. Bilirubin is solely conjugated by uridine diphospho‐glucuronosyltransferase 1A1, which is a membrane‐bound enzyme that catalyzes the transfer of glucuronic acid. Due to low function of hepatic and intestinal uridine diphospho‐glucuronosyltransferase 1A1 during the neonatal period, human neonates develop mild to severe physiological hyperbilirubinemia.

Three variants in the nicotinamide adenine dinucleotide phosphate oxidase complex are associated with HCV‐related liver damage

Sandra J. Page, Maria M. Rivera, David E. Kleiner, Xiongce Zhao, Sungyoung Auh, Elaine F. Remmers, Theo Heller – 23 October 2017 – Approximately 71 million people are chronically infected with the hepatitis C virus (HCV), a potentially lethal pathogen. HCV generates oxidative stress correlating with disease severity. HCV proteins increase reactive oxygen species production by stimulating nicotinamide adenine dinucleotide phosphate oxidase (NOX) activity.

Should we treat acute hepatitis C? A decision and cost‐effectiveness analysis

Emily D. Bethea, Qiushi Chen, Chin Hur, Raymond T. Chung, Jagpreet Chhatwal – 23 October 2017 – It is not standard practice to treat patients with acute hepatitis C virus (HCV) infection. However, as the incidence of HCV in the United States continues to rise, it may be time to re‐evaluate acute HCV management in the era of direct‐acting antiviral (DAA) agents. In this study, a microsimulation model was developed to analyze the trade‐offs between initiating HCV therapy in the acute versus chronic phase of infection.

LiverLearning®: Acute on Chronic Liver Failure SIG: Management of the Critically Ill Cirrhotic Patient: Improving Multidisciplinary Care and Avoiding…

Patients with acute-on-chronic liver failure frequently present to the ICU for care, and the mortality rate for cirrhotic patients requiring ICU approaches 50 percent.  Unique physiologic characteristics in the patient population warrant specialized, multidisciplinary, approaches to care.  The goal of this program is to further develop dialog between surgeons, hepatologists and intensive care unit teams to better deliver care to this complex patient population by focusing on the complex physiology of chronic liver failure.  In addition, we will devote special attention to areas of controver

LiverLearning®: Clinical Practice SIG: Best Practices in Clinical Hepatology

Identifying best practices in the difficult management of patients with liver disease in the community outpatient setting is an important topic in clinical hepatology. It is particularly important to look at the approach to patients with non-alcoholic liver disease that are not  candidates for research studies, the management of portal hypertension and portal vein thrombosis, and outpatient intervention and monitoring of patients with cirrhosis and renal insufficiency.

LiverLearning®: Public Health/Healthcare Delivery SIG: Methods for Conducting Healthare Delivery Research

Given recent attention to healthcare reform efforts in the U.S., a greater emphasis is being placed on generating and synthesizing evidence to inform policies affecting the clinical practice of hepatology. In turn, this program will review and teach attendees about the most common research designs and analytic methods associated with the conduct of healthcare delivery research.

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