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April 2012: Hepatitis B surface antigen quantification now available

Chronic hepatitis B (CHB) is a major cause of liver disease worldwide, ranking as the first cause of cirrhosis and hepatocellular carcinoma. Hepatitis B surface antigen (HBsAg) is one qualitative marker for the diagnosis of hepatitis B virus (HBV) infection1. Clearance of HBsAg during the natural course of CHB is associated with improved long-term clinical outcome, including reduced incidence of cirrhosis and hepatocellular carcinoma, and longer survival2, 3. HBsAg clearance is, therefore, considered to be the best definition of virologic response to treatment and the closest outcome to clinical cure in CHB4.

For the treatment of CHB, two different strategies are applicable: treatment for a finite period with pegylated interferon (PEG-IFN) and long-term treatment with nucleoside/nucleotide analogs (NUCs). Studies have shown that the degree and timing of reductions in HBsAg levels during PEG-IFN-based therapy may predict sustained response in both hepatitis B 'e' antigen (HBeAg)-positive and HBeAg-negative CHB5-10 and may also predict response to treatment with some nucleos(t)ide analogs11, 12. In addition, HBsAg levels may also indicate disease state, and so differentiate between patients with inactive and active disease13, 14.

Based on these findings, there is increasing interest in the role of quantitative HBsAg in the individualization of CHB management and therapy, and therefore a need for accurate, simple, standardized and widely available quantitative HBsAg assays to ensure optimal clinical decision making. The Elecsys® HBsAg II quant assay is a quantitative electrochemiluminescence immunoassay which uses onboard dilution and has a broad linear range reflecting clinically relevant HBsAg titers. The assay is standardized against the WHO Second International Standard for HBsAg.

  1. HBsAg seroclearance: prognostic value for the response to treatment and the long-term outcome. Moucari R, Marcellin P. Gastroenterol Clin Biol. 2010 Sep; 34 Suppl 2:S119-25.
  2. AASLD guidelines. Chronic hepatitis B: update 2009. Lok AS and McMahon BJ. Hepatology 2009; 50:1-36
  3. EASL Clinical Practice Guidelines: Management of chronic hepatitis B.
  4. European Association for the Study of the Liver. J Hepatol 2009; 50:227-242 3. Diagnostic markers of chronic hepatitis B infection and disease. Bonino F et al. Antivir Ther 2010; 15(Suppl 3):35-44
  5. On-treatment HBsAg decline during peginterferon alpha-2a (40KD) + lamivudine in patients with HBeAg-positive CHB as a potential predictor of durable off-treatment response. Lau GK et al. Hepatolology 2008; 48:A910
  6. In patients with HBeAg-negative chronic hepatitis B HBsAg serum levels early during treatment with peginterferon alfa-2a predict HBsAg clearance 4 years post-treatment. Marcellin P et al. Hepatolology 2008; 48:A919
  7. Hepatitis B surface antigen serum levels help to distinguish active from inactive hepatitis B virus genotype D carriers. Brunetto MR et al. Gastroenterology 2010; 139:483-490
  8. High rates of HBsAg seroconversion in HBeAg-positive chronic hepatitis B patients responding to interferon: A long-term follow-up study. Moucari R et al. Hepatology 2009; 49:1151-1157
  9. On-treatment decline in serum HBsAg levels predicts sustained immune control 1 year post-treatment and subsequent HBsAg clearance in HBeAg-negative hepatitis B virus-infected patients treated with peginterferon alfa-2a [40KD] (PEGASYS). Marcellin P et al. Hepatol Int 2010; 4:151, abstract PP209
  10. On-treatment decline in serum HBsAg levels predicts sustained immune control 6 months post-treatment and subsequent HBsAg clearance in HBeAg-positive hepatitis B virus-infected patients treated with peginterferon alfa-2a [40KD] (PEGASYS). Piratvisuth T et al. Hepatol Int 2010; 4:152, abstract PP21
  11. Three-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B. Heathcote EJ et al. Gastroenterology 2011; 140:132-143
  12. Kinetics of hepatitis B surface antigen decline during 3 years of telbivudine treatment in hepatitis B e antigen-positive patients. Wursthorn K et al. Hepatology 2010; 52:1611-1620
  13. Hepatitis B surface antigen (HBsAg) levels in the natural history of hepatitis B virus (HBV)-infection: a European perspective. Jaroszewicz J et al. J Hepatol 2010; 52:514-522
  14. Quantitative HBsAg: A new specific marker for the diagnosis of HBsAg inactive carriage. Martinot-Peignoux M et al. J Hepatol 2010; 52(Suppl 1):S282

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