Clinical Issues in Chronic Liver Disease by Integritas Communications

Presented for attendees of the 69th AASLD Annual Meeting. This event/function is sponsored by Integritas Communications and supported by Gilead Sciences, Inc. This is not an official event/ function of the American Association for the Study of Liver Diseases. This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an independent educational grant from Gilead Sciences, Inc.

MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

FACULTY FACULTY

Stephen A. Harrison, MD, FAASLD Chair

Medical Director, Pinnacle Clinical Research San Antonio, Texas Visiting Professor of Hepatology Radcliffe Department of Medicine University of Oxford, UK Oxford, England Dr. Stephen Harrison earned his medical degree from the University of Mississippi School of Medicine. He completed his internal medicine residency and gastroenterology fellowship at Brooke Army Medical Center and a 4th year advanced liver disease fellowship at Saint Louis University. He is board certified in both Internal Medicine and Gastroenterology. Dr. Harrison served as a Professor of Medicine at the Uniformed Services University of the Health Sciences and is currently a Visiting Professor of Hepatology at the Radcliffe Department of Medicine, University of Oxford. He is a past Associate Editor for Hepatology and is currently an Associate Editor for Alimentary Pharmacology and Therapeutics. He is a peer reviewer for over 20 medical journals and is internationally known for studies in hepatitis C and nonalcoholic fatty liver disease with over 180 peer-reviewed publications in these fields. Dr. Harrison most recently served as a Colonel in the United States Army. Retiring in 2016, he concluded 20 years of dedicated service to his country. During his army tenure, he served as the Director of Graduate Medical Education at Brooke Army Medical Center, Associate Dean for the San Antonio Uniformed Services Health Education Consortium and Gastroenterology Consultant to the Army Surgeon General. Currently, Dr. Harrison serves as the Medical Director for Pinnacle Clinical Research.

Quentin M. Anstee, PhD, FRCP FACULTY

Professor of Experimental Hepatology Deputy-Director of the Institute of Cellular Medicine Newcastle University, United Kingdom Honorary Consultant Hepatologist in the Liver Unit Freeman Hospital Newcastle upon Tyne, England

Dr. Quentin Anstee is Professor of Experimental Hepatology and Deputy-Director of the Institute of Cellular Medicine, Newcastle University, UK. A practicing clinician, he is also an Honorary Consultant Hepatologist in the Liver Unit at the Freeman Hospital, where he leads one of the largest NAFLD clinical services in the UK. He trained in medicine at University College London where he was awarded a First Class Honors degree and won First Prize in Medicine in the final MB BS examination. Dr. Anstee’s translational research has extended from the bench to the bedside with particular focus on the pathogenesis, diagnosis, and treatment of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis (NAFLD/NASH), including the identification of genetic and epigenetic modifiers of disease progression and hepatocellular carcinoma (HCC) risk. Dr. Anstee oversaw the EU FP7–funded ‘FLIP’ Fatty Liver: Inhibition of Progression consortium genetics work-package. He now leads 2 major EU-funded international research consortia that are studying NAFLD pathogenesis and developing/validating biomarkers to assist the diagnosis, riskstratification, and monitoring of patients with NAFLD: ‘LITMUS’ Liver Investigation: Testing Marker Utility in Steatohepatitis (EU IMI2–funded €34 million, 2017-2022) and ‘EPoS’ Elucidating Pathways of Steatohepatitis (EU H2020–funded €6 million, 2015-2019). He is also Chief Investigator of the European NAFLD Registry and several ongoing phase 2/3 clinical trials examining new medical therapies for NAFLD. He has published more than 100 peer-reviewed scientific papers and review articles. Select high-impact publications include studies on NAFLD-associated HCC (Shalapour, Nature 2017), DNA methylation in cell-free DNA (Hardy, Gut 2017), NAFLD natural history (McPherson, J Hepatol 2015), the first publication to demonstrate that variants in the TM6SF2 gene are associated with advanced fibrosis/cirrhosis in NAFLD (Liu, Nat Commun 2014), and a study linking PNPLA3 variants with NAFLD-associated HCC (Liu, J Hepatol 2014).

W. Ray Kim, MD

FACULTY

Professor and Chief Gastroenterology and Hepatology Stanford University Medical Center Stanford, California

Dr. W. Ray Kim is Professor of Medicine and Chief of the Division of Gastroenterology and Hepatology at Stanford University School of Medicine. He received training in Gastroenterology and Transplant Hepatology at Mayo Clinic in Rochester, Minnesota. He also holds a Master of Science degree in patientoriented research from Seoul National University, Korea and a Master of Business Administration degree from the University of Pennsylvania, Philadelphia. An author of over 200 original articles, Dr. Kim has research interests in epidemiology and outcomes in patients with chronic liver disease, including viral hepatitis and hepatocellular carcinoma. His research program is credited with the seminal achievement of developing the Model for End Stage Liver Disease (MELD) score. At Stanford, he has a specialty practice in viral hepatitis and liver transplantation.

Mark S. Sulkowski, MD FACULTY

Professor of Medicine Medical Director of the Viral Hepatitis Center in the Divisions of Infectious Diseases and Gastroenterology/Hepatology Johns Hopkins University School of Medicine Baltimore, Maryland

Dr. Mark Sulkowski is a Professor of Medicine and the Medical Director of the Viral Hepatitis Center in the Divisions of Infectious Diseases and Gastroenterology/ Hepatology in the Department of Medicine at the Johns Hopkins University School of Medicine in Baltimore, Maryland. He also serves as the Associate Dean for Research in the Capital Region (CAPRES) for Johns Hopkins Medicine. He received his MD from Temple University School of Medicine, Philadelphia, Pennsylvania (1992), pursued training in Internal Medicine at Duke University School of Medicine, Durham, North Carolina (1995), and completed his Fellowship in Infectious Diseases (1998) at the Johns Hopkins University School of Medicine. Dr. Sulkowski has been the principal investigator for more than 100 clinical trials related to the management of viral hepatitis in persons with and without HIV coinfection and has been selected as the global principal investigator on more than a dozen such studies, including the largest clinical trial of agents for the treatment of hepatitis C (N Engl J Med, 2009) and the vanguard study of combination therapy with direct inhibitors of the HCV NS5A and NS5B nonstructural proteins (N Engl J Med, 2014). He is the Chair of the Hepatitis Transformative Sciences Group of the National Institutes of Healthâ&#x20AC;&#x201C;funded adult AIDS Clinical Trials Group (ACTG), leading translational studies of liver disease in persons with HIV infection, namely hepatitis B, hepatitis C, and fatty liver disease. He is an elected member of the American Society for Clinical Investigation (ASCI, 2011) and the American Association of Physicians (AAP, 2017). Dr. Sulkowski is a member of numerous professional societies including the American Association for the Study of Liver Diseases (AASLD), the European Association for the Study of the Liver (EASL), and the Infectious Diseases Society of America (IDSA). He is widely published, with works in Annals of Internal Medicine, The New England Journal of Medicine, Journal of the American Medical Association, Journal of Infectious Diseases, Journal of Hepatology, and Hepatology. In 2017, he was named a Highly Cited Researcher (Clarivate Analytics), defined as being in the top 1% of global researchers in 21 fields of the sciences and social sciences based on the number of citations for papers published between 2005 and 2015. As an invited lecturer, he has frequently presented at major national and international medical congresses and has educated learners in more than 25 countries.

TARGET AUDIENCE

The educational design of this activity addresses the needs of hepatologists, gastroenterologists, and other health care professionals involved in the treatment of patients with hepatitis B virus (HBV), hepatitis C virus (HCV), and/or nonalcoholic steatohepatitis (NASH).

Three chronic diseases of the liver—HCV infection, HBV infection, and NASH—are commonly managed by gastroenterologists and hepatologists. Despite the availability of safe and effective treatments for HCV, many chronically infected patients remain unscreened, undiagnosed, and untreated.1 People who inject drugs (PWID) represent a population in particular need of recognition, diagnosis, and treatment; the path to HCV elimination will never be clear without targeting PWID.2 Managing events and comorbidities in patients with HBV can be challenging and requires careful monitoring and treatment selection, particularly for those patients who are coinfected with HCV or HIV.3 Although no medical cure is available for chronic HBV infection, clinicians must remain up to date on current and emerging treatments.3,4 NASH along with its precursor NAFLD represent a growing burden that parallels the increasing prevalence of obesity and diabetes.5 The use of invasive diagnostic modalities is often not feasible, and not all noninvasive diagnostic strategies have been validated or are widely available, which can delay the diagnosis, thereby postponing implementation of necessary lifestyle modifications and treatment.6,7 Clinicians who care for patients who have NASH are further challenged by the lack of US Food and Drug Administration (FDA)-approved therapies to treat this disease.6 Despite these clinical realities, it is important that clinicians suspect and recognize NAFLD/NASH as early in its course as possible, as is true with other chronic liver diseases, to slow progression to fibrosis and cirrhosis. During this Clinical Issues™ program, expert faculty will highlight and discuss challenges posed by these 3 chronic liver diseases, including strategies to eliminate HCV, even in the PWID population; current and future treatments of HBV; and updates on the pathophysiology and diagnosis of NASH.

REFERENCES

1. Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014;9(7):e101554. 2. Alimohammadi A, Holeksa J, Thiam A, Truong D, Conway B. Real-world efficacy of direct-acting antiviral therapy for HCV infection affecting people who inject drugs delivered in a multidisciplinary setting. Open Forum Infect Dis. 2018;5(6):ofy120. 3. Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67(4):1560-1599. 4. Anikhindi SA, Kumar A, Sharma P, Singla V, Bansal N, Arora A. Ideal cure for hepatitis B infection: The target is in sight. J Clin Exp Hepatol. 2018;8(2):188-194. 5. Calzadilla Bertot L, Adams LA. The natural course of non-alcoholic fatty liver disease. Int J Mol Sci. 2016;17(5):E774. 6. Rinella ME. Nonalcoholic fatty liver disease: a systematic review. JAMA. 2015;313(22):2263-2273. 7. Rinella ME, Sanyal AJ. Management of NAFLD: a stage-based approach. Nat Rev Gastroenterol Hepatol. 2016;13(4):196-205.

PREAMBLE

PROGRAM OVERVIEW

EDUCATIONAL OBJECTIVES

PREAMBLE

After completing this activity, the participant should be better able to: •• Consider recent trends in HBV epidemiology and treatment to optimize patient identification and management •• Identify approaches to overcome remaining barriers to HCV elimination •• Discuss data related to new pharmacologic agents under investigation for the treatment of NASH •• Evaluate current standards for diagnosis, staging, and monitoring in chronic liver disease

PROGRAM AGENDA 7:00 pm– 7:05 pm

Opening Remarks, Faculty Introductions, Preactivity Survey Stephen A. Harrison, MD, FAASLD

7:05 pm– 7:20 pm

Persisting Challenges in Chronic Liver Disease Stephen A. Harrison, MD, FAASLD

7:20 pm– 7:45 pm

The Road to HCV Elimination—Goals for 2019 and Beyond Mark S Sulkowski, MD

7:45 pm– 8:05 pm

Emerging Issues in Hepatitis B W. Ray Kim, MD

8:05 pm– 8:50 pm

NASH—The Next Big Challenge for the Liver Specialist Quentin M. Anstee, PhD, FRCP

8:50 pm– 9:00 pm

Audience Q&A Session, Postactivity Survey, Closing Remarks Stephen A. Harrison, MD, FAASLD

PHYSICIAN ACCREDITATION STATEMENT

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group (Global) and Integritas Communications. Global is accredited by the ACCME to provide continuing medical education for physicians.

PHYSICIAN CREDIT DESIGNATION

Global Education Group designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

GLOBAL CONTACT INFORMATION

For information about the accreditation of this program, please contact Global at 303-395-1782 or cme@globaleducationgroup.com.

INSTRUCTIONS TO RECEIVE CREDIT

In order to receive credit for this activity, the participant must submit a completed evaluation form at the conclusion of the program. You will be emailed a certificate within 4 weeks. If you do not receive your credit at that time, please contact cme@globaleduationgroup.com.

PREAMBLE

FEE INFORMATION

There is no fee for this educational activity.

DISCLOSURE OF CONFLICTS OF INTEREST

Global Education Group (Global) requires instructors, planners, managers, and other individuals and their spouses/life partners who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations. The faculty reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Stephen A. Harrison, MD, FAASLD Consultant/Independent Contractor: Akorn Inc., Chronic Liver Disease Foundation (CLDF), Cirius Therapeutics, Civ., ConSynance Therapeutics, Inc., Corcept Pharmaceuticals Incorporated, CymaBay Therapeutics, Echosens, Galectin Therapeutics, Inc., GENFIT SA, Shenzen HighTide Biopharmaceutical Ltd., Histoindex Pte. Ltd., Innovate Biopharmaceuticals Inc, Intercept Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Metacrine, Inc., NGM Biopharmaceuticals Inc., Perspectum Diagnostics Ltd., Terns Pharmaceuticals, Inc., Viking Therapeutics Inc. Grant/Research Support: Bristol-Myers Squibb, Cirius Therapeutics, Civ., Conatus Pharmaceuticals Inc., CymaBay Therapeutics, Galmed Pharmaceuticals Ltd., GENFIT SA, Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., NGM Biopharmaceuticals Inc., Pfizer Inc. Honoraria: AbbVie Inc., Alexion Pharmaceuticals Inc. Speakers Bureau: AbbVie Inc., Alexion Pharmaceuticals Inc. Stock Shareholder: Cirius Therapeutics, Civ., Galectin Therapeutics, Inc., GENFIT SA, Madrigal Pharmaceuticals, Inc., Metacrine, Inc.

PREAMBLE

Quentin M. Anstee, PhD, FRCP Consultant/Independent Contractor: (performed on behalf of Newcastle University) Abbott Laboratories, Acuitas Medical Ltd., Allergan/Tobira, E3Bio Limited, Eli Lilly & Company Ltd., Galmed Pharmaceuticals Ltd., GENFIT SA, Gilead Sciences, Inc., GrĂźnenthal, Imperial Innovations, Intercept Pharma Europe Ltd., Inventiva Pharma, Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals Inc., MedImmune, LLC, NewGene, NGM Biopharmaceuticals, Inc., Novartis International AG, Novo Nordisk A/S, Pfizer Ltd., Raptor Pharma, Servier Laboratories. Grant/Research Support: Research Grant Funding: AbbVie Ltd., Allergan/Tobira, AstraZeneca plc, GlaxoSmithKline, Novartis International AG, Pfizer Ltd., Vertex Pharmaceuticals; Active Research Collaborations (including research supported through the EU IMI2 LITMUS Consortium): AbbVie Ltd, Antaros Medical AB, Allergan/Tobira, AstraZeneca plc, Boehringer Ingelheim International GMBH, Ellegaard GĂśttingen Minipigs AS, Eli Lilly & Company Ltd., Exalenz Bioscience Ltd., GENFIT SA, GlaxoSmithKline, Intercept Pharma Europe Ltd., iXscient Ltd., Nordic Bioscience A/S, Novartis International AG, Novo Nordisk A/S, One Way Liver Genomics SL, Perspectum Diagnostics Ltd., Pfizer Ltd., Sanofi-Aventis Deutschland GMBH, SomaLogic, Inc., Takeda Pharmaceuticals International AG. Honoraria: Abbott Laboratories, Allergan/Tobira, Bristol-Myers Squibb, Clinical Care Options, Falk, GENFIT SA, Gilead Sciences, Inc., Kenes Group. Speakers Bureau: Abbott Laboratories, Allergan/Tobira, Bristol-Myers Squibb, Clinical Care Options, LLC, Dr Falk Pharma UK Ltd, GENFIT SA, Gilead Sciences, Inc., Kenes Group. Other/Royalty: Elsevier W. Ray Kim, MD Grant/Research Support: Gilead Sciences, Inc. Mark S. Sulkowski, MD Consultant/Independent Contractor: AbbVie Inc., Gilead Sciences, Inc., Merck & Co. Inc. Grant/Research Support: (paid to Johns Hopkins) AbbVie Inc., Assembly Biosciences, Inc., Gilead Sciences, Inc., Proteus Digital Health, Inc. The planners and managers reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Lindsay Borvansky Andrea Funk Liddy Knight Gena Dolson Julia Muino Jim Kappler, PhD

Nothing to disclose Nothing to disclose Nothing to disclose Nothing to disclose Nothing to disclose Nothing to disclose

DISCLOSURE OF UNLABELED USE

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Global Education Group (Global) and Integritas Communications do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER

PREAMBLE

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturerâ&#x20AC;&#x2122;s product information, and comparison with recommendations of other authorities.

SLIDES

CLINICAL PRACTICE GUIDELINES »»Hepatitis C guidance 2018 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. American Association for the Study of Liver Diseases (AASLD)-Infectious Diseases Society of America (IDSA). Clin Infect Dis. 2018;67(10):1477-1492. https://academic.oup.com/cid/article/67/10/1477/5095352

»»The diagnosis and management of nonalcoholic fatty liver disease: practice guidance from the American Association for the Study of Liver Diseases. Chalasani N, et al. Hepatology. 2018;67(1):328-357. http://onlinelibrary.wiley.com/doi/10.1002/hep.29367/epdf

»»EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. European Association for the Study of the Liver. J Hepatol. 2017;67(2):370-398. https://www.journal-of-hepatology.eu/article/S0168-8278(17)30185-X/fulltext

»»EASL recommendations on treatment of hepatitis C 2018. European Association for the Study of the Liver (EASL). J Hepatol. 2018;69(2):461-511. https://www.journal-of-hepatology.eu/article/S0168-8278(18)31968-8/fulltext

»»EASL–EASD–EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease.

RESOURCE CENTER

European Association for the Study of the Liver (EASL), European Association for the Study of Diabetes (EASD), and European Association for the Study of Obesity (EASO). J Hepatol. 2016;64(6):1388-1402. http://www.journal-of-hepatology.eu/article/S0168-8278(15)00734-5/pdf

»»Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Terrault NA, et al. Hepatology. 2018;67(4):1560-1599. https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep.29800

CLINICAL RESOURCES »»Histological Scoring System for Nonalcoholic Fatty Liver Disease. Transplant Pathology Internet Services, 2009. http://tpis.upmc.com/changebody.cfm?url=/tpis/schema/NAFLD2006.jsp

»»MELD Score (Model for End-Stage Liver Disease) (12 years and older). MD+CALC online calculator, 2016. https://www.mdcalc.com/meld-score-model-end-stage-liver-disease-12-older

»»NAFLD (Non-Alcoholic Fatty Liver Disease) Fibrosis Score. MD+CALC online calculator. https://www.mdcalc.com/nafld-non-alcoholic-fatty-liver-disease-fibrosis-score

PATIENT RESOURCES »»American College of Gastroenterology (ACG) Patient Education and Resource Center. The ACG website provides a basic overview of chronic liver disease that includes patient-centered podcasts. http://patients.gi.org/

»»American Liver Foundation. The American Liver Foundation website offers broad-based information and links to additional educational resources and support services for patients living with liver disease. http://www.liverfoundation.org/

The CDC provides an overview of all forms of viral hepatitis and how to get tested for both hepatitis C virus (HCV) and hepatitis B virus (HBV). https://www.cdc.gov/hepatitis/

»»National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Health Information Center. The NIDDK website for NAFLD and nonalcoholic steatohepatitis (NASH) provides comprehensive patient-centered information and resources, including an overview of clinical trial participation. https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash

RESOURCE CENTER

»»Centers for Disease Control and Prevention (CDC).

SUGGESTED READING »»96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. Agarwal K, et al. J Hepatol. 2018;68(4):672-681. https://www.sciencedirect.com/science/article/abs/pii/S0168827817324911

»»Non-alcoholic fatty liver disease: an expanded review. Benedict M, Zhang X. World J Hepatol. 2017;9(16):715-732. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5468341/

»»NAFLD: a multisystem disease. Byrne CD, Targher G. J Hepatol. 2015;62(suppl 1):S47-S64. http://www.journal-of-hepatology.eu/article/S0168-8278(14)00933-7/fulltext

»»Long-term pioglitazone treatment for patients with nonalcoholic steatohepatitis and prediabetes or type 2 diabetes mellitus: a randomized trial. Cusi K, et al. Ann Intern Med. 2016;165(5):305-315. https://www.ncbi.nlm.nih.gov/pubmed/27322798

»»Increased risk of mortality by fibrosis stage in non-alcoholic fatty liver disease: systematic review and meta-analysis. Dulai PS, et al. Hepatology. 2017;65(5):1557-1565. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5397356/

RESOURCE CENTER

»»Non-alcoholic fatty liver disease: non-invasive investigation and risk stratification. Dyson JK, et al. J Clin Pathol. 2013;66(12):1033-1045. https://jcp.bmj.com/content/66/12/1033?utm_source=TrendMD&utm_ medium=cpc&utm_campaign=JCP_TrendMD-%25SPONSORED%25

»»Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. Feld JJ, et al. N Engl J Med. 2014;370(17):1594-1603. http://www.natap.org/2014/EASL/nejmoa1315722.pdf

»»A randomized, placebo-controlled trial of cenicriviroc for treatment of nonalcoholic steatohepatitis with fibrosis. Friedman SL, et al. Hepatology. 2018;67(5):1754-1767. http://onlinelibrary.wiley.com/doi/10.1002/hep.29477/pdf

»»Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial. Grebely J, et al. Lancet Gastroenterol Hepatol. 2018;3(3):153-161. http://www.natap.org/2018/HCV/PIIS2468125317304041.pdf

»»Noninvasive imaging methods to determine severity of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Hannah WN Jr, Harrison SA. Hepatology. 2016;64(6):2234-2243. https://www.ncbi.nlm.nih.gov/pubmed/27338123

»»Expansion of treatment for hepatitis C virus infection by task shifting to community-based nonspecialist providers: a nonrandomized clinical trial. Kattakuzhy S, et al. Ann Intern Med. 2017;167(5):311-318. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5736381/

»»Prediction models of long-term cirrhosis and hepatocellular carcinoma risk in chronic hepatitis B patients: risk scores integrating host and virus profiles. Lee MH, et al. Hepatology. 2013;58(2):546-554. https://aasldpubs.onlinelibrary.wiley.com/doi/full/10.1002/hep.26385

»»Hepatitis B cure: from discovery to regulatory approval. Lok AS, et al. Hepatology. 2017;66(4):1296-1313. https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep.29323

»»The ASK1 inhibitor selonsertib in patients with nonalcoholic steatohepatitis: a randomized, phase 2 trial.

»»Farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic, nonalcoholic steatohepatitis (FLINT): a multicentre, randomised, placebocontrolled trial. Neuschwander-Tetri BA, et al. Lancet. 2015;385(9972):956-965. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4447192/pdf/nihms672595.pdf

RESOURCE CENTER

Loomba R, et al. Hepatology. 2018;67(2):549-559. http://onlinelibrary.wiley.com/doi/10.1002/hep.29514/epdf

»»Improved bone and renal safety at 1 year after switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF): results from 2 phase 3 studies in HBeAg-positive and HBeAg-negative patients with chronic hepatitis B (CHB). Pan CQ, et al. Hepatology. 2017; 66(suppl 1):482A. https://aasldpubs.onlinelibrary.wiley.com/doi/epdf/10.1002/hep.29501

»»The risk of hepatocellular carcinoma decreases after the first 5 years of entecavir or tenofovir in Caucasians with chronic hepatitis B. Papatheodoridis GV, et al. Hepatology. 2017;66(5):1444-1453. https://aasldpubs.onlinelibrary.wiley.com/doi/abs/10.1002/hep.29320

»»The therapeutic landscape of non-alcoholic steatohepatitis. Perazzo H, Dufour JF. Liver Int. 2017;37(5):634-647. https://onlinelibrary.wiley.com/doi/full/10.1111/liv.13270

»»Elafibranor, an agonist of the peroxisome proliferator-activated receptor-α and -δ, induces resolution of nonalcoholic steatohepatitis without fibrosis worsening. Ratziu V, et al. Gastroenterology. 2016;150(5):1147-1159. http://www.gastrojournal.org/article/S0016-5085(16)00140-2/pdf

»»Cenicriviroc treatment for adults with non-alcoholic steatohepatitis: year 2 analysis of the phase 2b CENTAUR study. Ratziu V, et al. J Hepatol. 2018;68(suppl 1):S1-S2. https://ilc-congress.eu/wp-content/uploads/2018/04/Abstract-book2018EASL_14.04.2018.pdf

RESOURCE CENTER

»»Management of NAFLD: a stage-based approach. Rinella ME, Sanyal AJ. Nat Rev Gastroenterol Hepatol. 2016;13(4):196-205. https://www.ncbi.nlm.nih.gov/pubmed/26907882

»»Recommendations for diagnosis, referral for liver biopsy, and treatment of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Spengler EK, Loomba R. Mayo Clin Proc. 2015;90(9):1233-1246. https://www.mayoclinicproceedings.org/article/S0025-6196(15)00510-8/fulltext

»»The performance of vibration controlled transient elastography in a US cohort of patients with non-alcoholic fatty liver disease. Tapper EB, et al. Am J Gastroenterol. 2016;111(5):677-684. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4860094/

»»Noninvasive imaging biomarker assessment of liver fibrosis by elastography in NAFLD. Tapper EB, Loomba R. Nat Rev Gastroenterol Hepatol. 2018;15(5):274-282. https://www.nature.com/articles/nrgastro.2018.10

»»Challenges to a cure for HBV infection. Testoni B, et al. Semin Liver Dis. 2017;37(3):231-242. https://www.thieme-connect.com/products/ejournals/ abstract/10.1055/s-0037-1606212

»»Marked reduction in the prevalence of hepatitis C viremia among people who inject drugs during 2nd year of the Treatment as Prevention (TraP HepC) program in Iceland. Tyrfingsson T, et al. J Hepatol. 2018;68(suppl 1):S52. https://ilc-congress.eu/wp-content/uploads/2018/04/Abstract-book2018EASL_14.04.2018.pdf

»»Diagnosis of fibrosis and cirrhosis using liver stiffness measurement in nonalcoholic fatty liver disease. Wong VW, et al. Hepatology. 2010;51(2):454-462. https://aasldpubs.onlinelibrary.wiley.com/doi/full/10.1002/hep.23312

»»Global epidemiology of nonalcoholic fatty liver disease- Meta-analytic assessment of prevalence, incidence, and outcomes.

RESOURCE CENTER

Younossi ZM, et al. Hepatology. 2016;64(1):73-84. https://aasldpubs.onlinelibrary.wiley.com/doi/full/10.1002/hep.28431

NOTES

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