1827 – Testing for hepatitis B virus (HBV) and hepatitis B virus surface antigen (HBsAg) to support the use of PBS subsidised bepirovisen in people with chronic hepatitis B (CHB)

Change to an existing Medicare Benefits Schedule item for codependent application (MSAC and Pharmaceutical Benefits Advisory Committee)

HBV DNA PCR testing is a blood test that checks for hepatitis B virus in the body and measures how much virus is present. This is called the viral load. The test helps doctors decide when to start or change antiviral treatment and to see how well treatment is working. If the virus level falls to an undetectable level, this shows good control of the infection, but it does not mean the infection is cured.

Qualitative hepatitis B surface antigen testing (HBsAg) is a blood test that shows whether the hepatitis B surface antigen is present or not. A positive result means the person currently has a hepatitis B infection.

Quantitative hepatitis B surface antigen testing (qHBsAg) is a blood test that measures the amount of surface antigen in the blood. It is used to follow changes in the infection and treatment response over time.

Both quantitative HBsAg testing and quantitative HBV DNA testing are needed to decide whether a person has reached a functional cure for chronic hepatitis B.

Chronic hepatitis B is a long‑term liver infection caused by the hepatitis B virus. It is usually spread through contact with infected blood or bodily fluids, such as from mother to baby at birth, unprotected sex, or sharing needles. The infection often develops slowly over many years and may cause ongoing liver inflammation. In some people, this can lead to serious problems such as scarring of the liver, liver failure, or liver cancer. Antiviral medicines can control the virus and lower the risk of these problems, and vaccination can prevent hepatitis B infection.

A functional cure of chronic hepatitis B means that the hepatitis B surface antigen is no longer present and the virus cannot be detected in the blood, after the person has stopped treatment for 24 weeks.

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The following consultation deadlines apply:

• Pre-PASC consultation deadline: Friday 10 July 2026 11:59pm AEST
• Pre-MSAC consultation deadline: To be confirmed

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This application will be considered at the following meetings:

• PASC meeting: 13 to 14 August 2026
• ESC meeting: To be confirmed
• MSAC meeting: To be confirmed

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The outcome of this application is pending.

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