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NIH Consensus Development Conference: 
Management of Hepatitis B

October 20-22, 2008

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Cosponsors and Partners
Preliminary Agenda
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Program and Abstract Book ( to be released on the first day of the conference)

Hepatitis B is a major cause of liver disease worldwide, ranking as a substantial cause of cirrhosis and liver cancer. In the United States, about 1.25 million people are chronically infected with the virus, resulting in 3,000 to 5,000 deaths each year. However, this condition occurs more frequently in high risk groups, including Asian Americans, emigrants from areas of the world where hepatitis B is common (China, Korea, Southeast Asia, the Indian Subcontinent, Africa, and Micronesia), men who have sex with men, injection drug users, and recipients of blood and blood products before screening procedures with enhanced sensitivity were implemented in 1986. Since routine hepatitis B vaccination of U.S. children began in 1991, new cases of acute hepatitis B among children and adolescents have dropped by more than 95%—and by 75% across all age groups. In non-protected individuals, transmission can result from exposure to infectious blood or body fluids containing blood. A major impediment to diagnosis is that many infected individuals are either asymptomatic or experience only non-specific symptoms of disease, such as fatigue or muscle ache.

For approximately 90% of adults, acute infection with the hepatitis B virus is resolved by the body’s immune system and does not cause long-term problems. The transition from acute to chronic infection appears to occur when the immune system does not effectively destroy and clear virus-infected cells. This leads to high blood levels of both hepatitis B DNA and antigens, as well as antibodies produced by the body in an attempt to combat the infection. The natural history of the disease is not well understood, however, which makes management of this complex disease challenging.

Many factors can influence treatment decisions for an individual patient, including age, ALT (alanine aminotransferase, a liver enzyme) level, viral load, liver biopsy results, and the presence of a co-infecting virus (i.e., HIV). Treatment decisions require in-depth analysis of multiple blood tests results, which are typically repeated at regular intervals to monitor the disease course. There are currently six approved therapeutic agents: interferon-alpha, lamivudine, adefovir dipivoxil, entecavir, pegylated interferon, and telbivudine, which are often used in combination. Generally, these drugs act to decrease the risk of liver damage from hepatitis B by slowing or stopping the replication of the virus.

Questions remain as to which groups of patients benefit from therapy and at which point in the course of their disease. Specific recommendations for hepatitis B therapy are limited by a lack of reliable long-term safety and efficacy information. This is a difficult decision for physicians and patients, as treatments are expensive and may have bothersome, if not harmful, effects on patients; left untreated, however, chronic hepatitis B can lead to liver failure and other serious liver problems. To examine these important issues, the National Institute of Diabetes and Digestive and Kidney Diseases and Office of Medical Applications of Research of the National Institutes of Health will convene a Consensus Development Conference from October 20 to 22, 2008. 

  • What is the current burden of hepatitis B? 

  • What is the natural history of hepatitis B? 

  • What are the benefits and risks of the current therapeutic options for hepatitis B? 

  • Which persons with hepatitis B should be treated? 

  • What measures are appropriate to monitor therapy and assess outcomes? 

  • What are the greatest needs and opportunities for future research on hepatitis B?

Presented by
             
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Medical Applications of Research (OMAR)
The Johns Hopkins University School of Medicine, Educational Provider

Cosponsors

National Cancer Institute  
National Institute of Allergy and Infectious Diseases

Partners

Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)

Preliminary Agenda 
(pdf version)

Monday, October 20, 2008 
8:30 a.m. Opening Remarks
Griffin P. Rodgers, M.D. (pending confirmation)
Director
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
8:40 a.m. Charge to the Panel 
Susan Rossi, Ph.D., M.P.H.
Deputy Director
Office of Medical Applications of Research
Office of the Director
National Institutes of Health
8:50 a.m. Conference Overview and Panel Activities
Michael F. Sorrell, M.D.
Panel and Conference Chairperson
Robert L. Grissom Professor of Medicine
Section of Gastroenterology and Hepatology
University of Nebraska Medical Center
1.    What Is the Current Burden of Hepatitis B?
9:00 a.m. Hepatitis B Virus and the Disease It Causes
T. Jake Liang, M.D.
Chief, Liver Diseases Branch
  National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
9:20 a.m. Evaluation of the Patient With Hepatitis B
Eugene Schiff, M.D., M.A.C.P., F.R.C.P., M.A.C.G.
Chief, Division of Hepatology
Director, Center for Liver Diseases
University of Miami School of Medicine
Miami, FL
 
9:40 a.m. Epidemiology of Hepatitis B
W. Ray Kim, M.D.
Associate Professor of Medicine
Division of Gastroenterology and Hepatology
Mayo Clinic
Rochester, MN
10:00 a.m. Recommendations for Identification and Public Health Management of Persons With Chronic Hepatitis B Virus Infection

Cindy Weinbaum, M.D., M.P.H.

Team Leader

Prevention Branch, Division of Viral Hepatitis
Centers for Disease Control and Prevention
Atlanta, GA 
10:20 a.m. Discussion
2.   What Is the Natural History of Hepatitis B?
11:00 a.m.  Introduction to the Natural History of Hepatitis B
Brian J. McMahon, M.D.
Scientific Program and Clinical Director
Liver Disease and Hepatitis Program
Alaska Native Medical Center 
Anchorage, AK
11:20 a.m. Hepatitis B and Liver Cancer
Adrian M. Di Bisceglie, M.D., F.A.C.P.
Chief of Hepatology, Division of Gastroenterology and Hepatology 
Saint Louis University School of Medicine 
Saint Louis, MO
11:40 a.m. Liver Biopsy Findings in Chronic Hepatitis B 
David E. Kleiner, M.D., Ph.D. 
Chief, Postmortem Pathology and Director of Clinical Operations
Center for Cancer Research
Laboratory of Pathology
National Cancer Institute
National Institutes of Health
12:00 p.m. Lunch
Panel Executive Session
1:00 p.m. HBV DNA Levels and Outcomes of Chronic Hepatitis B
Chien-Jen Chen, Sc.D., M.P.H. 
Minister, Taiwan National Science Council
Executive Yuan
Republic of China
Taipei, Taiwan
1:20 p.m. Evidence-Based Practice Center Presentation I
EPC Speaker
1:40 p.m. Discussion
3.   What Are the Benefits and Risks of the Current Therapeutic Options for Hepatitis B?
2:30 p.m. Overview of the Risks and Benefits of Current Theraputic Options for Hepatitis B
E. Jenny Heathcote, M.D., F.R.C.P.C.
Head, Division of Patient Based Clinical Research
Toronto Western Research Institute
Toronto, Ontario
Canada
2:50 p.m. Benefits and Risks of Interferon Therapy for Hepatitis B
Robert P. Perrillo, M.D. 
Associate Director, Hepatology Division 
Program Director, Transplant Hepatology 
Baylor Universisty Medical Center
Dallas, TX
3:10 p.m. Benefits and Risks of Nucleoside Analogues for Hepatitis B 
Jules L. Dienstag, M.D.
Dean for Medical Education
Carl W. Walter Professor of Medicine 
Harvard Medical School
Boston, MA
3:30 p.m. Benefits and Risks of Combination Therapy for Hepatitis B
Norah A. Terrault, M.D., M.P.H.
Assistant Professor, Medicine and Gastroenterology
UCSF School of Medicine
San Francisco, CA
3:50 p.m. Evidence-Based Practice Center Presentation II
EPC Speaker
 
4:10 p.m. Discussion
5:00 p.m. Adjournment
Tuesday, October 21, 2008
4.    Which Persons With Hepatitis B Should Be Treated?
8:30 a.m. Indications for Therapy in Hepatitis B
Anna S. K. Lok, M.D., M.R.C.P.
Director of Clinical Hepatology
University of Michigan Medical School 
Ann Arbor, MI
8:50 a.m. HIV/HBV Coinfection
Chloe L. Thio, M.D.
Associate Professor of Medicine
Division of Infectious Diseases
Johns Hopkins School of Medicine
Baltimore, MD
9:10 a.m. Special Populations and Hepatitis B
Marion G. Peters, M.D.
John V. Carbone, M.D. Endowed Chair in Medicine
Director of Hepatology Research
UCSF School of Medicine
San Fransisco, CA
9:30 a.m. Prevention of Reactivation of Hepatitis B
Jay H. Hoofnagle, M.D.
Director, Liver Disease Research Branch
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
9:50 a.m. Evidence-Based Practice Center Presentation II 
EPC Speaker
10:10 a.m. Discussion
 
5.   What Measures Are Appropriate To Monitor Therapy of Hepatitis B and Assess Outcomes?
11:00 a.m. Monitoring During and After Antiviral Therapy for Hepatitis B
Ray Chung, M.D.
Assistant Professor of Medicine
Harvard Medical School
Medical Director, Liver Transplant Program
Massachusetts General Hospital
Boston, MA
11:20 a.m. Antiviral Resistance and Hepatitis B Therapy
Mark G. Ghany, M.D.
Investigator, Liver Diseases Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
11:40 a.m. Side Effects of Long-Term Antiviral Therapy for Hepatitis B
Robert J. Fontana, M.D. 
Associate Professor, Department of Internal Medicine
Medical Director of Liver Transplantation
University of Michigan Medical School
Ann Arbor, MI
12:00 a.m. Discussion
12:30 p.m. Adjournment
Wednesday, October 22, 2008
9:00 a.m.  Presentation of the Draft Consensus Statement
9:30 a.m.  Public Discussion
11:00 a.m.  Panel Meets in Executive Session
2:00 p.m.  Press Conference

 

 

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