This session provides a synthesis of new data on the treatment of viral hepatitis presented at The Liver Meeting®.Michael W. Fried Insook Kim Insook Kim, PhD is a clinical pharmacology team leader for gastroenterology and hepatology products in the Office of Clinical Pharmacology at FDA. Since she joined FDA as a clinical pharmacology reviewer in 2007, she has been involved in numerous IND and NDA review and has provided regulatory and scientific guidance for product development in the areas of gastroenterology, hepatology, and inborn errors of metabolism.

Evaggelia Liaskou, Gideon M. Hirschfield – 24 October 2017

This session will highlight recent key studies in the field of cholestatic and autoimmune liver diseases. Speakers will review data on new therapies for the treatment of PBC and discuss the role of risk stratification in the management of this disease. Additionally, recent studies evaluating new biomarkers and surveillance strategies in PSC will be reviewed to determine their usefulness and applicability. Finally, the session will evaluate the evidence underlying the use of specific second line therapies in autoimmune hepatitis and a treatment algorithm will be proposed.Christopher L.

Drug-induced liver injury (DILI) remains the leading cause of acute liver failure in the U.S. This session will review methods that are used by clinical and regulatory scientists to gather information about the hepatotoxicity of a drug or biological agent, during each phase of its life cycle.  The session will highlight the diverse clinical signatures and mechanisms that underlie DILI and discuss critical challenges when analyzing drug-related risk for serious liver toxicity.James L. Boyer James L.

This program will include discussions of recently approved regimens and challenging patient populations.  The emphasis in these lectures will be on clinical knowledge and application to individual patient management decisions, the AASLD-IDSA Guidance Panel treatment recommendations, and global perspectives on disease eradication strategies.Andrew J. Muir Andrew Muir, MD, FAASLD is a gastroenterologist whose research activitiesare focused on developing innovative treatments for a variety of liverdiseases. Through his work at the Durham Veterans Administration MedicalCenter, Dr.

This program provides a timely review of the mechanistic and clinical information relevant to HCC occurring in HCV by addressing the relevance of the problem and treatment effects. The program will also discuss key basic concepts with relevance to HCC in HCV.Gregory J. Gores Gregory J. Gores, M.D.

NAFLD affects 24% of the adult population worldwide. Additionally, about 10% of children and adolescents may have NAFLD. NAFLD is closely associated with type 2 diabetes and obesity. A proportion of subjects with NAFLD and non-alcoholic steatohepatitis (NASH) can develop progressive liver disease, cirrhosis and liver cancer. There are extensive efforts to develop non-invasive tests for NASH. Although no approved therapeutic options for NASH are yet available, a large number of clinical trials are underway.

The intestinal microbiota and the human body have a symbiotic relationship, and a dysbalance of this delicate homeostasis can lead to disease. Liver diseases are associated with changes in the gut microbiota. Intestinal dysbiosis is characterized by bacterial overgrowth and changes in the microbiota composition. In addition, most chronic liver diseases are associated with intestinal barrier dysfunction. The contribution of intestinal dysbiosis to chronic liver disease goes beyond disruption of the intestinal barrier.

The Symposium will provide a broad overview on the diversity of noninvasive diagnostic approaches for assessing chronic liver disease in the U.S. and Europe. Experts will discuss the role and interpretation of noninvasive diagnostic test strategies in assessing the severity of disease associated with NAFLD, cirrhosis, and portal hypertension. These lectures — in conjunction with a panel discussion — will benefit all healthcare professionals using these novel tools in their clinical practice.Jayant A. Talwalker Sumeet K.

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.