[Federal Register Volume 73, Number 157 (Wednesday, August 13, 2008)]
[Notices]
[Page 47199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18656]



[[Page 47199]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


NIH Consensus Development Conference: Management of Hepatitis B; 
Notice

    Notice is hereby given of the National Institutes of Health (NIH) 
``NIH Consensus Development Conference: Management of Hepatitis B'' to 
be held October 20-22, 2008, in the NIH Natcher Conference Center, 45 
Center Drive, Bethesda, Maryland 20892. The conference will begin at 
8:30 a.m. on October 20 and 21, and at 9 a.m. on October 22, and will 
be open to the public.
    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 
percent--and by 75 percent across all age groups. In nonprotected 
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 nonspecific symptoms of disease, such as fatigue or muscle ache.
    For approximately 90 percent 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 test 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 
the Office of Medical Applications of Research of the National 
Institutes of Health will convene a Consensus Development Conference 
from October 20 to 22, 2008, to assess the available scientific 
evidence related to the following questions:
     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?
    An impartial, independent panel will be charged with reviewing the 
available published literature in advance of the conference, including 
a systematic literature review commissioned through the Agency for 
Healthcare Research and Quality. The first day and a half of the 
conference will consist of presentations by expert researchers and 
practitioners and open public discussions. On Wednesday, October 22, 
the panel will present a statement of its collective assessment of the 
evidence to answer each of the questions above. The panel will also 
hold a press conference to address questions from the media. The draft 
statement will be published online later that day, and the final 
version will be released approximately six weeks later. The primary 
sponsors of this meeting are the NIH National Institute of Diabetes and 
Digestive and Kidney Diseases and the NIH Office of Medical 
Applications of Research.
    Advance information about the conference and conference 
registration materials may be obtained from American Institutes for 
Research of Silver Spring, Maryland, by calling 888-644-2667, or by 
sending e-mail to [email protected]. American Institutes for 
Research's mailing address is 10720 Columbia Pike, Silver Spring, MD 
20901. Registration information is also available on the NIH Consensus 
Development Program Web site at http://consensus.nih.gov.

    Please Note: The NIH has instituted security measures to ensure 
the safety of NIH employees and property. All visitors must be 
prepared to show a photo ID upon request. Visitors may be required 
to pass through a metal detector and have bags, backpacks, or purses 
inspected or x-rayed as they enter NIH buildings. For more 
information about the security measures at NIH, please visit the Web 
site at http://www.nih.gov/about/visitorsecurity.htm.


    Dated: August 4, 2008.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
[FR Doc. E8-18656 Filed 8-12-08; 8:45 am]
BILLING CODE 4140-01-P