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New test for hepatitis B provides more tailored solutions for patients
 
 

New test for hepatitis B provides more tailored solutions for patients
Roche Press Release

The new 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 patients.

“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 progression.”

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 Personalized Healthcare.”

References:

  1. World Health Organization, Hepatitis Factsheet, Retrieved January 28, 2011 from http://www.who.int/mediacentre/factsheets/fs204/en/index.html

  2. World Health Organization, Hepatitis, Retrieved November 12, 2010 from http://www.who.int/topics/hepatitis/en/

  3. 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.

  4. 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.

  5. Perrillo RP. Therapy of hepatitis B—viral suppression or eradication? Hepatology. 2006;43(2 suppl 1):S182-S193.

  6. Brunetto et al., Hepatitis B Surface Antigen Serum Levels Help to Distinguish Active From Inactive Hepatitis B Virus Genotype D Carriers. Gastroenterology 2010;139:483–490.

About Roche

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?

The Elecsys® 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 decision making. 

What is the role of HBsAg testing?

  • 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.

  • With HBsAg 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

  • Hence, HBsAg testing can also aid in identifying long-term treatment outcomes in patients. 

  • HBV DNA is currently the most widely used diagnostic test in chronic hepatitis B patients.

  • Combined used of HBV DNA and HBsAg quantification tests enable clinicians to tailor therapy options for optimal treatment outcomes in patients.

  • 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 treatment.

What are the advantages of the Elecsys® HBsAg II quant immunoassay?

  • The Elecsys® HBsAg II quant immunoassay is optimized for clinical decision making and has the following advantages:

  • Enhanced convenience: The Elecsys® HBsAg II quant immunoassay has been optimized to reduce retesting through automated features such as onboard dilution.

  • Maximized 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.

  • Excellent precision: The Elecsys® HBsAg II quant immunoassay offers excellent precision across the entire measure range. 

References:
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.

All trademarks used or mentioned in this release are protected by law.

About Hepatitis B

What is hepatitis?

  • Hepatitis is inflammation of the liver, most commonly caused by a virus. [i]

What is hepatitis B?

How is hepatitis B spread?

Hepatitis B is transmitted through contact with infected blood and bodily fluids:

  • from mother to baby at child birth

  • sharing of infected needles

  • receiving infected blood transfusions

  • sexual contact

  • sharing contaminated razors or toothbrushes

  • non-sterile 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

  • dark urine

  • extreme fatigue

  • nausea

  • vomiting

  • abdominal pain

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 year. 3

  • 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 / nucleotide analogs. 

  • 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 LLC

[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:

Patty Lee
Head of Communications, Asia Pacific
Roche Diagnostics Asia Pacific
 Patty.lee@Roche.com
 
 
 
     
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