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­NASH: An Evolving Landscape of
Opportunities
AGENDA
Disclosures
The Continuum of NASH: A Global
Epidemic
NAFLD and NASH in Children in the United
States:
A Serious Threat
NAFLD: Risk Factors, Comorbidities,
and Potential Consequences Across the
Lifespan
NAFLD Among the Elderly in the United
States
An NHANES-III Analysis
Burden of NAFLD and NASH: US
Perspective
Polling Question
Obesity: The Main Driver of NAFLD/NASH
Polling Question
The NAFL  Cirrhosis Continuum
Clinical Outcomes
Polling Question
Patients With NAFLD/NASH at High Risk of
Developing Advanced Liver Disease
NAFLD Is a Serious Disease: Liver-Related
Mortality
Polling Question
Long-Term Outcomes in NAFLD
Cirrhosis, HCC, Liver Transplant, and Liver Mortality
Nonhepatic Diseases Associated With
NAFLD
Polling Question
NASH: Burden of Illness in the United States
The Continuum of NASH: A Global
Epidemic
Clinical Conundrums:
Evaluation, Diagnosis, and Management
Defining Risk
NAFLD: Is it NAFL or NASH?
Serum-Based Single Tests for Identifying Patients With NAFLD at
Increased Risk for Worse Outcomes
Imaging Tests to Identify Patients Likely to
Have Advanced Fibrosis
To Biopsy or Not to Biopsy?
Current Management of NASH
The Weight Loss Pyramid
Exercise Mobilizes Hepatic Fat Mobilization in Patients
With NAFLD: Lifestyle Modifications Are Beneficial
Use It or Lose It
Physical Activity Makes a Difference
Aerobic Exercise and Improvement in
Fibrosis in NAFLD
Treatment of NASH
Multidisciplinary Treatment Approach to
NAFLD
Off-Label Pharmacologic Treatment of NAFLD and NASH
Case 1: How Much Fibrosis Does This Patient
Really Have?
Case 1 (cont)
NFS and FIB-4 Reference Values
Polling Question
Case 1 (cont)
Polling Question
Meta-Analysis of Noninvasive Modalities to
Detect Fibrosis in NAFLD
Case 1 (cont)
Case 1 (cont)
Case 1 (cont)
Case 2: Management of NAFLD and Obesity
in the Presence of "Pre-Diabetes"
Case 2 (cont)
Polling Question
Case 2 (cont)
Liraglutide (GLP-1 Receptor Agonist) for NASH
Case 3
Case 3 (cont)
Vitamin E: Guideline Recommendations
Vitamin E Studies in NASH
Vitamin E or Pioglitazone for NASH: PIVENS Trial
Vitamin E: Safety Concerns
Pioglitazone for NASH
Pioglitazone for NASH: AASLD Guidance
Polling Question
Vitamin E in Patients with Advanced Fibrosis
We can no Longer say "No Studies"
Vitamin E in Patients With Advanced Fibrosis
Case 4: Bariatric Surgery for Obesity:
Excellent Treatment for NASH, But How
Limited by Fibrosis?
Case 4 (cont)
Case 4 (cont)
Case 4 (cont): Liver Biopsy 11/2017
Polling Question
Case 4 (cont)
Case 4 (cont)
Bariatric Surgery: An Option for Patients
With NASH
Laparoscopic Sleeve Gastrectomy: A
Promising Treatment for NASH?
Outcomes of Bariatric Surgery in Patients With Cirrhosis
Emerging Therapies for NASH:
An Active Pipeline
Case 5
Case 5 (cont)
Cardiometabolic Management of the Patient
With NASH
Pioglitazone Plus Vitamin E Better Than Placebo in Patients With
NASH and T2D
Effect of Liraglutide in Patients With T2D
Emerging Therapies for NASH: An Active
Pipeline
Pathogenesis of NASH: Targets for Treatment
Partial List of Drugs in Phase 2 Trials for
NASH
FXR Agents in Development
Current Ongoing Phase 3 Trials for NASH
Obeticholic Acid
Breakthrough Therapy Designation by FDA
REGENERATE: Phase 3 International, Randomized, Placebo-
Controlled Study Evaluating OCA for Treatment
of NASH
REGENERATE: Results
REGENERATE: Results (cont)
Concluding Remarks
Audience Q&A
Does Vitamin E, Alone or Combined With Pioglitazone, Improve
Histology in Patients With T2D and NASH?
Abbreviations
Abbreviations (cont)
Abbreviations (cont)