Predictors of Liver Cancer or Death among Chronic Hepatitis B Patients

StephenW

*HIV and Hepatitis.com Coverage of the *
*45th Annual Meeting of the European
Association for the Study of the Liver (EASL 2010)**
* April 14 - 18, 2010, Vienna, Austria
  <http://www.hivandhepatitis.com/2010_conference/easl/main.html>

*Predictors of Liver Cancer or Death among Chronic Hepatitis B Patients
Treated with Adefovir (Hepsera) or Entecavir (Baraclude)*
        *SUMMARY:* Chronic hepatitis B patients with decompensated liver
disease have a 10%-20% chance of developing liver cancer and a 20%-30% risk
of death over 2 years despite treatment with nucleoside analogs, according
to a study presented at the 45th Annual Meeting of the European Association
for the Study of the Liver (EASL
2010<http://www.hivandhepatitis.com/2010_conference/easl/main.html>)
last month in Vienna. People with hepatitis B virus (HBV) genotypes B or C
were more likely to develop liver cancer, while those with worse liver
function as indicated by elevated bilirubin or low albumin levels were more
likely to die.

*By Liz Highleyman* <http://www.hivandhepatitis.com/aboutus2.html#liz>

Y.-F. Liaw from Chang Gung Memorial Hospital and an international team of
colleagues analyzed predictors of hepatocellular carcinoma (HCC, a type of
primary liver cancer) and death among participants in Study
ETV-048<http://www.hivandhepatitis.com/2009icr/aasld/docs/110309_b.html>,
a clinical trial comparing entecavir
(Baraclude)<http://www.hivandhepatitis.com/hep_b/news/entecavir.html>versus
adefovir
(Hepsera) <http://www.hivandhepatitis.com/hep_b/news/adefovir.html> in
hepatitis B patients with decompensated liver disease.

Decompensated disease means the liver is unable to carry out its normal
functions such as filtering blood and producing proteins. Prior research
indicates that reported 5-year survival rates of patients with decompensated
cirrhosis is 14%, compared with 84% for those with compensated cirrhosis,
the researchers noted as background. In chronic hepatitis B patients with
compensated disease, antiviral therapy with entecavir or adefovir leads to
durable viral suppression and improved
fibrosis<http://www.hivandhepatitis.com/hep_b/news/liver_fibrosis.html>or
cirrhosis <http://www.hivandhepatitis.com/hep_b/news/liver_cirr.html>, but
outcomes in people with decompensated cirrhosis are not as well understood.

This analysis included 195 chronic hepatitis B patients with decompensated
liver disease and indicated by a Child-Pugh score *>* 7. Most participants
(about 75%) were men, the average age was 52 years, about half were Asian,
and about one-third were white. The mean Child-Pugh score was 8.6 and the
mean MELD score was about 16. About half were hepatitis B "e" antigen
(HBeAg) positive. Participants were randomly assigned to receive 1.0 mg/day
entecavir or 10 mg/day adefovir for up to 96 weeks.

*Results *
  Cumulative rates of hepatocellular carcinoma were 12% among patients on
entecavir and 20% among those on adefovir.  Cumulative mortality rates were
23% and 33%, respectively.  Infection with HBV genotypes B or C was the only
factor significantly associated with a greater risk of developing HCC
(hazard ratio [HR] 3.31, or more than 3 times the risk).  Other factors
previously found to predict HCC in people with compensated liver disease
(e.g., older age, male sex, body mass index, being HBeAg positive) did not
do so in this study.  In a univariate analysis, significant predictors of
mortality were:      Low creatinine level (< 1.5 x upper limit of
normal);  Higher
MELD score (>20);  Higher total bilirubin level (>2.5 x upper limit of
normal);  Low albumin level (< 30 d/dL).    In a multivariate analysis
controlling for other factors, only elevated bilirubin (HR 2.08) and
decreased albumin (HR 4.24) remained significant risk factors.  Virological
response at week 24 was not associated with a significant reduction in
mortality rates (HR 0.73).

Based on these findings, the investigators concluded, "Decreased hepatic
function at baseline (high bilirubin and low albumin) was a significant
predictor of mortality among chronic hepatitis B patients with decompensated
liver disease treated with entecavir or adefovir."

They noted that the 12%-20% 2-year HCC rate was higher than the 2%-5% rates
previously observed in patients who started antiviral treatment with less
advanced liver disease monitored over a comparable period of time.

*Liver Research Unit, Chang Gung Memorial Hospital, Taipei, Taiwan;
Department of Internal Medicine, Aristotle University of Thessalonki,
Thessaloníki, Greece; Universidade Federal Do Rio Grande Do Sul, Porto
Alegre, Brazil; Department of Gastroenterology, G.B. Pant Hospital, New
Delhi, India; Department of Medicine, Siriraj Hospital, Mahidol University,
Bangkok, Thailand; Alice Ho Miu Ling Nethersole Hospital, Hong Kong, China;
China Medical University Hospital, Taichung, Taiwan; Liver Unit, University
of Calgary, Calgary, Canada; Center for Liver Disease and Transplantation,
Columbia University Medical Center, New York, NY; John A. Burns School of
Medicine, University of Hawaii, Honolulu, HI; Department of Infectious
Diseases, Medical University, Lodz, Poland; Research and Development,
Bristol-Myers Squibb Company, Wallingford, CT.*

5/21/10

*Reference*
YF Liaw, M Raptopoulou-Gigi, H Cheinquer, and others. Risk and predictors of
mortality or hepatocellular carcinoma among entecavir- or adefovir-treated
chronic hepatitis B patients with evidence of hepatic decompensation. 45th
Annual Meeting of the European Association for the Study of the Liver (EASL
2010). Vienna, Austria. April 14-18, 2010.
(Abstract<http://www.kenes.com/easl2010/Posters/Abstract898.htm>
).



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