hepatitis B surface antigen (HBsAg) quant test enables physicians to assess
a patient’s response to chronic hepatitis B treatment
As chronic hepatitis B remains endemic in many parts of Asia1, experts from
across the region are meeting at the 21st Asian Pacific Association for the
Study of the Liver (APASL) annual congress in Bangkok, Thailand to discuss
advances in the management of this devastating disease, which is a major
cause of liver cirrhosis and cancer.
One key advance is the availability of a new quantitative test for
monitoring a patient’s response to hepatitis B therapy, launched during the
congress by Roche Diagnostics. The test measures the amount of hepatitis B
surface antigen (HBsAg), a marker on the surface of the hepatitis B virus,
in a patient’s blood. This, in combination with HBV DNA testing, enables
clinicians to provide tailored treatment approaches for chronic hepatitis B
“Testing is important for the diagnosis and improved management of chronic
hepatitis B. All too often there are either no symptoms until the liver is
severely damaged or the early symptoms are ignored, allowing the disease to
progress untreated with potentially fatal consequences” said Professor
Teerha Piratvisuth, President of APASL, Director of the NKC Institute of
Gastroenterology and Hepatology, Thailand, and President of Liver Society of
Thailand. “This is a significant problem in Thailand where less than 30
percent of people with chronic hepatitis B are currently being treated and
most do not even know they are infected.”
Almost a third of
the world’s population is, at some time, infected with the Hepatitis B virus
(HBV) and approximately 350 million people (5%) are currently chronically
infected. In Asia, up to 10 percent of the adult population is chronically
infected with the disease2. Every year, 25% to 45% of these HBV carriers die
of HBV-related liver cirrhosis (permanent scarring) or liver cancer1. Liver
cancer is one of the leading causes of cancer death, particularly in Asia.
Treatment for chronic hepatitis B aims for complete clearance of the HBsAg
in the patient. Recent data has shown that HBsAg clearance is associated
with reduced disease progression to liver cirrhosis and liver cancer, and
improved life expectancy as well as quality of life due to the immune
control of the virus and remission of viral activity.
HBsAg quantitative testing represents a simple and reliable means of
assessing how well the body’s own immune system is combating the hepatitis B
virus. It allows clinicians to monitor and assess a patient’s response to
pegylated interferon (PEG-IFN) therapy, thereby confidently predict
sustained treatment success early. This is particularly important as studies
show that one in three respond to the PEG-IFN treatment. In addition, there
is evidence that HBsAg levels in combination with HBV DNA levels, can be
used to distinguish patients who do not require therapy (inactive carriers)
from those who would benefit from treatment6.
“We now have two complementary tests for monitoring chronic hepatitis B
that, when used in combination, enables us to determine how well a patient
is responding to treatment and to tailor it accordingly” said Professor
Henry Chan, Professor of Medicine, Director of Cheng Suen Man Shook Centre
for Hepatitis Research and Director of Centre for Liver Health of The
Chinese University of Hong Kong. “This is a real advance in the management
of chronic hepatitis B as it enables us to respond quicker than we
previously could and, by doing so, reduce the chance of disease
Commenting on the advance, Mr. Pichetpong Srisuwankul, General Manager of
Roche Diagnostics Thailand said; “Given the millions of lives affected by
hepatitis B each year, Roche is proud to be able to make a real difference
in tackling all aspects of managing the disease; from initial diagnosis,
through to treatment and ongoing treatment monitoring. Furthermore, this is
an area where, once again, Roche is facilitating healthcare professionals in
providing tailored treatments to individual patients to significantly
improve their health and wellbeing, a demonstration of Roche leading in
Organization, Hepatitis Factsheet, Retrieved January 28, 2011 from http://www.who.int/mediacentre/factsheets/fs204/en/index.html
Organization, Hepatitis, Retrieved November 12, 2010 from http://www.who.int/topics/hepatitis/en/
Marcellin P et
al. Virological and biochemical response in patients with HBeAg-negative
chronic hepatitis B treated with peginterferon alfa-2a (40KD) with or
without lamivudine: results of 4-year follow-up. Presented at: 43rd Annual
Meeting of the European Association for the Study of the Liver (EASL);
April 23-27, 2008; Milan, Italy.
Fattovich G et
al. Delayed clearance of serum HBsAg in compensated cirrhosis B: relation
to interferon alpha therapy and disease prognosis. Am J Gastroenterol.
Therapy of hepatitis B—viral suppression or eradication? Hepatology.
2006;43(2 suppl 1):S182-S193.
al., Hepatitis B Surface Antigen Serum Levels Help to Distinguish Active
From Inactive Hepatitis B Virus Genotype D Carriers. Gastroenterology
Headquartered in Basel, Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and diagnostics. Roche
is the world’s largest biotech company with truly differentiated medicines
in oncology, virology, inflammation, metabolism and CNS. Roche is also the
world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a
pioneer in diabetes management. Roche’s personalised healthcare strategy
aims at providing medicines and diagnostic tools that enable tangible
improvements in the health, quality of life and survival of patients. In
2010, Roche had over 80’000 employees worldwide and invested over 9 billion
Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs.
Genentech, United States, is a wholly owned member of the Roche Group. Roche
has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
About the Elecsys® HBsAg II quant immunoassay
What is the
Elecsys® HBsAg II quant immunoassay?
HBsAg II quant immunoassay is a new test for assessing the amount of the
hepatitis B surface antigen (HBsAg) in chronic hepatitis B patients.
· The Elecsys® HBsAg II quant immunoassay is optimized for clinical
What is the role
of HBsAg testing?
quantitative testing represents a simple and reliable means of assessing
how well the body’s own immune system is combating the hepatitis B virus.
quant testing, clinicians can monitor and assess patients’ response to
anti-viral therapy. This allows clinicians to predict treatment success
early during pegylated-interferon (PEG-IFN) treatment.
Recent data has
shown that HBsAg clearance is associated with greatly reduced liver
cancer, liver cirrhosis and improved life expectancy due to the immune
control of the virus and its remission. 1, 2, 3
testing can also aid in identifying long-term treatment outcomes in
HBV DNA is
currently the most widely used diagnostic test in chronic hepatitis B
of HBV DNA and HBsAg quantification tests enable clinicians to tailor
therapy options for optimal treatment outcomes in patients.
evidence that HBsAg levels in combination with HBV DNA levels, can be used
to distinguish patients who do not require therapy (inactive carriers)
from those who would benefit from treatment.
What are the
advantages of the Elecsys® HBsAg II quant immunoassay?
HBsAg II quant immunoassay is optimized for clinical decision making and
has the following advantages:
convenience: The Elecsys® HBsAg II quant immunoassay has been optimized to
reduce retesting through automated features such as onboard dilution.
reliability: The Elecsys® HBsAg II quant immunoassay is traceable to the
WHO second international standard for HBsAg and offers accurate and
validated exact results as well as enhanced safety through the onboard
dilution feature. It is also suitable for quantifying HBsAg samples with
all major hepatitis B genotypes.
precision: The Elecsys® HBsAg II quant immunoassay offers excellent
precision across the entire measure range.
1) Marcellin P et al. Virological and biochemical response in patients with
HBeAg-negative chronic hepatitis B treated with peginterferon alfa-2a (40KD)
with or without lamivudine: results of 4-year follow-up. Presented at: 43rd
Annual Meeting of the European Association for the Study of the Liver (EASL);
April 23-27, 2008; Milan, Italy.
2) Fattovich G et al. Delayed clearance of serum HBsAg in compensated
cirrhosis B: relation to interferon alpha therapy and disease prognosis. Am
J Gastroenterol. 1998;93(6):896-900.
3) Perrillo RP. Therapy of hepatitis B—viral suppression or eradication?
Hepatology. 2006;43(2 suppl 1):S182-S193.
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About Hepatitis B
What is hepatitis B?
How is hepatitis
Hepatitis B is
transmitted through contact with infected blood and bodily fluids:
from mother to
baby at child birth
infected blood transfusions
contaminated razors or toothbrushes
equipment such as for dental work, tattooing and body piercing
What are the symptoms of hepatitis B?
Some patients with hepatitis B do not experience any
symptoms until the liver is severely damaged
Some of the common hepatitis B symptoms include:
jaundice - yellowing of the skin or eyes
How prevalent is hepatitis B?
Almost a third of the world’s population is, at some time,
infected with the hepatitis B virus (HBV) and approximately 5% (350
million people) are currently chronically infected.[iv]
50 million new cases of hepatitis B are diagnosed every
25-45% of all the HBV carriers (1 million people annually)
will develop serious consequences including liver cirrhosis, liver
decompensation (where the liver is unable to function normally) and/or
cancer of the liver (hepatocellular carcinoma(HCC)). 3
In Asia, up to 10 per cent of the adult population is
chronically infected with HBV. [v] Hepatitis B is endemic in China, which
accounts for one third of the worldwide chronic hepatitis B sufferers.
How is hepatitis B diagnosed?
Hepatitis B can be detected via blood tests, even in
patients without symptoms.
HBsAg test, which tests for the presence of the hepatitis B
surface antigen (HBsAg), a protein produced by the hepatitis B virus that
reflects the presence of the virus in the liver, are used to diagnose
hepatitis B. Quantitative measure of HBsAg can assess the body’s
elimination of the virus from the liver, thereby determines whether the
patient is responding to certain treatment.
HBV DNA tests are conducted to establish the viral load
within the body. The viral load refers to the quantity of the hepatitis B
virus within the body. A HBV DNA test will also indicate how quickly the
virus is reproducing in the liver.[vi]
What is the treatment for hepatitis B?
There are two main types of treatment for people with
chronic hepatitis B, interferons / pegylated interferons and nucleoside /
Interferons / pegylated interferons stimulate the immune
system and inhibit virus replication; the treatment course is finite.
Nucleoside / nucleotide analogs prevent viral replication;
the treatment course is indefinite.
World Health Organization, Hepatitis,
Retrieved November 12, 2010 from http://www.who.int/topics/hepatitis/en/
2World Health Organization, Global Alert and Response, Hepatitis
B, Retrieved November 12, 2010 -http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index1.html
[iii] Pan et al. Current Hepatitis B Reports. 2008. Current Medicine Group
[iv] The Global Alliance for Vaccines & Immunization, Hepatitis B, Retrieved
November 12, 2010 -http://www.who.int/immunization_delivery/adc/gavi_hepb_factsheet.pdf
[v] World Health Organization, Hepatitis B, Retrieved November 12, 2010 - http://www.who.int/mediacentre/factsheets/fs204/en/index.html
[vi] Hepatitis B Foundation, What Is HBV DNA and How Is It Measured,
Retrieved November 12, 2010 - http://www.hepb.org/pdf/hbv_dna.pdf
For additional information please contact:
Head of Communications, Asia Pacific
Roche Diagnostics Asia Pacific