The Australian Pharmaceutical Benefits Scheme (PBS) has recently rejected an application for a new drug, bulevirtide, to be be available at subsidised rates for for treatment of hepatitis D, despite submissions from community and health organisations.
Hepatitis D is the most severe form of viral hepatitis carrying with it a 70 to 80 per cent risk of cirrhosis in five to ten years, and liver cancer within ten years. If only infects people already with hepatitis B, putting them at a significantly higher risk of serious disease and death. About a quarter of people who develop cirrhosis from hepatitis D will die of liver failure.
In Australia, hepatitis B prevalence is highest among migrant communities from countries or regions of higher prevalence, as well as First Nations communities and hepatitis D is significantly under diagnosed. We were significantly behind in our efforts to reach the 2022 national hepatitis B targets, and also behind in reaching 2030 global targets. Having a subsidised, effective treatment for hepatitis D will greatly improve outcomes for people living with hepatitis B.
Hepatitis D is spread when infectious body fluids (blood, saliva, semen and vaginal fluid) come into contact with body tissues beneath the skin (for example, through needle punctures or broken skin) or mucous membranes (the thin moist lining of many parts of the body such as the mouth, throat and genitals). There is no vaccine for hepatitis D.
The current treatment for hepatitis B/hepatitis D chronic infection is a 48-week course of pegylated interferon, which is effective for only 20-25 per cent of patients and has significant adverse side-effects. There is also often a relapse after treatment.
For the first time, a new targeted treatment, bulevirtide, will be available for people living with hepatitis D. It has a much higher efficacy and is more well tolerated. Buleviritide works by blocking the hepatitis D virus’s access to regenerated liver cells, letting the immune system eliminate infected cells. This can result in prevention of viral replication, and subsequent reduction in inflammation and associated liver damage.
…those most affected by hepatitis B—and therefore vulnerable to hepatitis D—already face barriers to healthcare…
Considering the fact that those most affected by hepatitis B—and therefore vulnerable to hepatitis D—already face barriers to healthcare, removing the cost barrier to accessing this more effective treatment is surely vital to managing this deadly form of hepatitis. Its rejection for listing on the PBS is no doubt disappointing to those in the sector who have lobbied for it.
The peak body for health professionals in the field, ASHM, recommends that people living with hepatitis B automatically receive a hepatitis D antibody test—REFLEX testing is a straightforward and simple way to do this—and anyone testing positive should then have a hepatitis D PCR test to confirm active infection and inform clinical care. For those who commence treatment, twice-yearly monitoring via hepatitis D PCR tests is then extremely important.
Unfortunately, the cost of the medication itself is just one of the barriers to clinical management faced by people living with hepatitis D. We also need to remove the costs associated with the hepatitis D PCR tests, which are an essential component of determining eligibility to commence treatment, and to monitor the clinical benefits, and consequently the duration, of treatment.
The hepatitis D virus can only live in people already infected with hepatitis B, because it doesn’t have its own cellular “machinery” for reproduction, and relies on making use of that provided by the cells of hepatitis B. It is the smallest known pathogenic virus in humans, partly because of this lack.
Most people living with hepatitis B (and thus hepatitis D) in Australia were born outside of Australia, adding an extra burden to those already dealing with the barriers in place to people who migrate to Australia, especially given that a large number of people living with hepatitis D are also affected by other socio-economic barriers (poorer literacy, education, employment opportunities and access to transportation, as well discrimination, racism, trauma, etc., not to mention all of the extra stigma and health difficulties for people who inject drugs). All of this leads inevitably to poorer health outcomes due to difficulties navigating health systems.
Add to that the burden of dealing simultaneously with two different chronic liver conditions (since, by its very nature, everyone living with hepatitis D must also be coping with hepatitis B), and it is easy to see the huge value that will come from making access to hepatitis D testing and treatment cheaper and easier. Furthermore, the more people tested and treated, the more further transmission of hepatitis B and hepatitis D is limited, giving a tremendously powerful flow-on effect to any health investment made now.
See our special issue on Hepatitis D here.
ASHM (2020). National Hepatitis B Testing Policy v 1.2, Commonwealth of Australia, Barton. ACT. https://testingportal.ashm.org.au/files/ASHM_TestingPolicy_2020_HepatitisB_07_2.pdf
Posted 20 March 2025
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