Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Notices 47199 

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 virusinfected 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 indepth 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 

consensus@mail.nih.gov. 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Listing of Members of the 

National Institutes of Health’s Senior 

Executive Service 2008 Performance 

Review Board 

The National Institutes of Health 

(NIH) announces the persons who will 

serve on the National Institutes of 

Health’s Senior Executive Service 2008 

Performance Review Board. This action 

is being taken in accordance with Title 

5, U.S.C., Section 4314(c)(4), which 

requires that members of performance 

review boards be appointed in a manner 

to ensure consistency, stability, and 

objectivity in performance appraisals, 

and requires that notice of the 

appointment of an individual to serve as 

a member be published in the Federal 

Register. 

The following persons will serve on 

the NIH Performance Review Board, 


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