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Study in JAMA Concludes That High Level of HBV in Chronic Patients Predicts CA

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Study Reported in JAMA Concludes That High Level of Hepatitis B Virus in

Patients With Chronic Hepatitis B Infection Predicts Increased Risk For

Liver Cancer

TAIPEI, Taiwan and PRINCETON, N.J., Jan. 3 /PRNewswire/ -- Chronic

hepatitis B patients with high levels of circulating hepatitis B virus (HBV)

appear to be at increased risk of developing liver cancer (specifically,

hepatocellular carcinoma), independent of other known risk factors,

according

to a paper published in The Journal of the American Medical Association. The

R.E.V.E.A.L.-HBV Study (Risk Evaluation of Viral Load Elevation and

Associated

Liver Disease/Cancer-HBV Study), one of the largest and longest natural

history studies of hepatitis B, evaluated the relationship between levels of

hepatitis B virus in the blood and risk of liver cancer. Between 1991 and

1992, a total of 3,653 people diagnosed solely with chronic hepatitis B

infection were recruited from seven townships in Taiwan. Patients were

followed until the middle of 2004, for a mean of 11.4 years.

" Our findings suggested a strong relationship between a patient's

hepatitis B virus level and his or her long-term risk of developing liver

cancer, " said Professor Chien-Jen Chen, ScD, Graduate Institute of

Epidemiology, College of Public Health, National Taiwan University.

The rate of liver cancer increased with elevated hepatitis B virus

levels

at study entry independent of other risk factors, including e-antigen

status,

serum alanine aminotransaminase (ALT), and presence of liver damage (or

cirrhosis). The study also confirmed other known risk factors that influence

the probability of HBV-related liver cancer, including: male gender, old

age,

infection with e-antigen positive virus, alcohol consumption, and the

presence

of cirrhosis.

The study demonstrated that the risk of liver cancer started to increase

significantly at virus levels greater than or equal to 10(4) copies/mL.

Patients with hepatitis B virus levels measuring between greater than or

equal

to 10(4) and <10(5) copies/mL at enrollment had more than a two times higher

relative risk of liver cancer compared to study participants with

undetectable

virus levels (cumulative incidence of 3.57 percent versus 1.3 percent,

respectively). Another important conclusion of this study was that patients

with persistently elevated hepatitis B virus levels (i.e., greater than or

equal to 10(5) copies/mL at both study entry and last observation) had a

greater than five times relative risk for liver cancer compared to patients

with hepatitis B virus levels <10(4) copies/mL at study entry. This risk

fell

to less than two times in patients whose hepatitis B virus levels decreased

from 10(5) to <10(4) copies/mL at last observation when compared to patients

with hepatitis B virus levels <10(4) copies/mL at study entry.

Influence of HBV genotype was not evaluated in this study, and is likely

to be addressed in future studies.

Globally, more than 350 million individuals are chronically infected

with

the hepatitis B virus. For those who are infected, the risk of HBV-related

liver cancer ranges from 5 to 98 times higher than those who are not

infected.

Chronic hepatitis B is particularly endemic in Taiwan, where the infection

is

usually acquired at birth or in early childhood. Chronically infected people

are known to be at an increased risk of developing liver cirrhosis, hepatic

decompensation and liver cancer, and 15 to 40 percent of them will develop

these serious disease complications during their lifetime. Data from this

study showed that among all the risk factors assessed, the level of

circulating hepatitis B virus had a strong predictive value for progression

to

liver cancer.

The R.E.V.E.A.L.-HBV study authors are affiliated with the Graduate

Institute of Epidemiology, College of Public Health, National Taiwan

University; Global Epidemiology and Outcomes Research, Bristol-Myers Squibb

Company; Department of Gastroenterology, Kaohsiung Chang-Gung Memorial

Hospital; Department of Internal Medicine, National Taiwan University

Hospital.

National Taiwan University is a leading research university in Taiwan.

Visit National Taiwan University on the World Wide Web at

http://www.ntu.edu.tw.

Bristol-Myers Squibb is a global pharmaceutical and related health care

products company whose mission is to extend and enhance human life. Visit

Bristol-Myers Squibb on the World Wide Web at http://www.bms.com.

SOURCE Bristol-Myers Squibb Company

Web Site: http://www.bms.com http://www.ntu.edu.tw

_________________________________________________________________

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