Hepatitis B update: enabling progress towards elimination

SUMMARY

Hepatitis B is a common vaccine-preventable and treatable condition. Chronic hepatitis B is often asymptomatic and can be missed if the diagnosis is not actively considered.

The World Health Organization and the Australian Government have committed to eliminate hepatitis B as a public health threat by 2030. The tools required to achieve this are available: an effective vaccine, accurate blood tests for diagnosis and monitoring, effective antiviral treatments and access to ultrasound to enable early diagnosis of hepatocellular carcinoma.

Risk-based testing approaches are not effective enough to enable Australia to achieve elimination targets; hence, the Fourth National Hepatitis B Strategy 2025–2030 calls for population-wide testing to identify hepatitis B status.

Chronic hepatitis B is a lifelong disease that requires long-term monitoring and follow-up irrespective of the stage of disease or whether an individual is taking antiviral treatment.

Most healthcare for people living with chronic hepatitis B can be provided in primary care. All medical practitioners and authorised nurse practitioners can now prescribe antiviral therapy for hepatitis B; additional accreditation is no longer required.

Holistic care includes the provision of resources in a person’s preferred language, peer and cultural support workers, access to a long-term effective model of care, and appropriate monitoring. Continuity of healthcare providers is desirable and an important enabler of sustained engagement in care.

 

Introduction

One-third of the world’s population has been exposed to hepatitis B, with an estimated 254 million people currently living with chronic hepatitis B (CHB).¹ An estimated 227,000 people are living with CHB in Australia.²

The hepatitis B virus is the second most potent carcinogen after tobacco,³ increasing the risk of hepatocellular carcinoma (HCC) by its very presence. Therefore, unlike other causes of hepatitis, such as hepatitis C, where significant liver fibrosis or cirrhosis needs to be present before HCC risk increases, people living with CHB have an increased risk of HCC irrespective of their cirrhotic status. CHB causes inflammation of the liver that can progress to cirrhosis and HCC. One-quarter of people with untreated CHB will die from either HCC or liver failure.⁴ Although treatment does not cure the infection, it can prevent progression to cirrhosis and reduces the risk of HCC.

In 2016, the World Health Assembly committed to the elimination of hepatitis B as a major public health threat by 2030, and an elimination strategy was developed by the World Health Organization (WHO).⁵ Australia’s ongoing commitment to this elimination goal is reiterated in the Fourth National Hepatitis B Strategy 2025–2030.⁶

Despite having all the necessary tools to eliminate hepatitis B as a public health threat, it is estimated that in Australia, 1 in 3 of the 227,000 people living with CHB are not aware of their diagnosis and only 1 in 4 are receiving guideline-based care. In addition, only small increases in the uptake of antiviral treatment have been seen over the past decade.² Many barriers to accessing testing, diagnosis and care exist, including (but not limited to) the asymptomatic nature of CHB, a lack of knowledge and understanding of risk factors, stigma, remoteness, the logistics of accessing care through tertiary services, English commonly not being a patient’s first language and systematic consequences of a CHB diagnosis, particularly in the immigration system.

Elimination requires a paradigm shift in the care provided to people living with CHB to increase:

• hepatitis B testing through population-wide universal offer of testing, treatment, enabling earlier diagnosis
• primary care provision of hepatitis B testing, follow-up and long-term monitoring of those living with CHB
• the number of people on treatment.

Any changes in the approach to hepatitis B management need to be developed in consultation with affected individuals and communities to ensure stigma and discrimination are addressed and to minimise the personal and social impacts of hepatitis B.⁷

Aboriginal and Torres Strait Islander people in Australia are disproportionately impacted by CHB, with an overall prevalence of 3.4%, compared with 0.8% for Australia as a whole, increasing to more than 6% in some regions.⁸ Aboriginal people in the Northern Territory have a unique subgenotype of hepatitis B virus (HBV/C4) that has genotypic and phenotypic markers of faster progression to cirrhosis and increased risk of HCC, which further increases the urgency for early diagnosis and engagement in care. Some people born overseas are also at higher risk of CHB for many different reasons, predominantly influenced by the prevalence of CHB in the country they were born in and the availability of a hepatitis vaccine as part of the infant vaccine schedule in that country.

This article aims to provide an update and guidance for healthcare professionals across Australia to play their part in the elimination of CHB.

 

Diagnosis: towards universal testing of all adults

People living with CHB are often asymptomatic and may have normal liver function tests, so an active case-finding approach is needed. A simple and cheap blood test for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) is all that is required to establish hepatitis B immune status, including the need for vaccination, or for the diagnosis of CHB.

Further testing is needed to diagnose and distinguish between acute and chronic infection (IgM anti-HBc) and to assess infectivity and inform decisions about treatment (hepatitis B envelope antigen [HBeAg] and hepatitis B virus [HBV] DNA).

Testing recommendations

Historically, the national testing policy had a risk-based approach to diagnosis except for the universal testing recommendation for pregnant women as a part of antenatal care. High-risk groups identified for routine testing included (but were not limited to) Aboriginal and Torres Strait Islander people, healthcare workers and people born in high CHB-prevalence countries. However, this approach is not effective enough to meet the goal of eliminating hepatitis B by 2030 because, currently in Australia, an estimated 32.6% of people living with CHB are unaware of their diagnosis.² Hence, the Fourth National Hepatitis B Strategy 2025–2030 recommends universal testing for all adults as a priority action to ensure all Australians know their hepatitis B status.⁶ There are clear recommended care pathways for hepatitis B prevention and management for all combinations of hepatitis B antigen and antibody results (Table 1).

Table 1 Interpreting and acting on hepatitis B test results⁹

Test	Result	Interpretation	Hepatitis B status	Action
HbsAg	Negative	Susceptible	Nonimmune	Add hepatitis B status to patient medical summary Offer hepatitis B vaccination If the person requires proof of immunity (i.e. household or sexual contact), repeat serology 4 to 8 weeks after primary course or booster to determine whether anti-HBs is positive. If it is not, give a booster dose and recheck serology 4 to 8 weeks later
Anti-HBc	Negative
Anti-HBs	Negative [NB1]
HBsAg	Negative	Resolved hepatitis B infection	Immune by exposure	Add hepatitis B status to patient medical summary No further action – do not test again If patient becomes immunocompromised or develops unexplained abnormal liver function tests, reassess and retest
Anti-HBc	Positive
Anti-HBs	Positive [NB2]
HBsAg	Negative	Vaccinated	Immune by vaccination	Add hepatitis B status to patient medical summary No further action – do not test again Hepatitis B vaccine booster doses are recommended in immunosuppressed individuals, including those with renal failure or HIV infection
Anti-HBc	Negative
Anti-HBs	Positive [NB2]
HBsAg	Positive	Acute infection This serology pattern can also be seen in people who are living with CHB and are experiencing a flare of hepatitis	Acute infection	Add hepatitis B status to patient medical summary Order further tests as per ‘Clinical care’ row in Table 2 Perform contact tracing Provide counselling and support Repeat serology in 6 months to see whether HBsAg is negative
Anti-HBc	Positive
Anti-HBs	Negative [NB1]
IgM anti-HBc	Positive
HBsAg	Positive	Chronic infection	Chronic infection	Add hepatitis B status to patient medical summary Develop CHB care plan with 6-monthly recalls in patient record for ongoing testing, monitoring and follow-up Initiate antiviral treatment in eligible patients (Table 3) Perform contact tracing Provide counselling and support Ensure that the person has had their diagnosis and care requirements explained in their preferred language
Anti-HBc	Positive
Anti-HBs	Negative [NB1]
IgM anti-HBc	Negative
anti-HBc = hepatitis B core antibody; anti-HBs = hepatitis B surface antibody; CHB = chronic hepatitis B; HBsAg = hepatitis B surface antigen; HIV = human immunodeficiency virus; IgM anti-HBc = hepatitis B IgM core antibody; IgM anti-HBs = hepatitis B IgM surface antibody NB1: Negative anti-HBs = less than 10 mIU/mL NB2: Positive anti-HBs = 10 or more mIU/mL

Universal testing in practice

The Fourth National Hepatitis B Strategy 2025–2030⁶ states healthcare professionals need to ‘ensure all adults in Australia know their hepatitis B status’ and a universal testing approach has been shown to be cost effective in the Australian context.¹⁰

Testing can be done opportunistically when arranging blood tests for a patient in any healthcare setting for any reason by considering ‘Do we know this person’s hepatitis B status?’ If the answer is no, then, with the patient’s consent, HBsAg, anti-HBs, anti-HBc and liver function tests can be added to the request form. Testing should be considered for everyone who does not have their hepatitis B status documented, irrespective of their vaccination history.

 

Clinical care: creating an enabling environment

Historically, treatment of CHB has been provided in tertiary care settings or by general practitioners (GPs) and nurse practitioners (NPs) with additional prescribing training through the section 100 (s100) access scheme. After years of advocacy to increase the number of prescribers and improve access to treatment, specialist accreditation requirements for prescribing hepatitis B antiviral drugs in Australia were removed on 1 September 2026.¹¹ All medical practitioners and authorised nurse practitioners can now prescribe subsidised hepatitis B antiviral treatments for eligible patients under the Pharmaceutical Benefits Scheme, addressing a longstanding barrier to the delivery of CHB care. Prescriber education and support continue to be available through ASHM (the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine), including the Hepatitis B Advanced Management and Prescribing Course (formerly the s100 prescriber accreditation course).

Despite the availability of effective antiviral treatments, only around 13% of people with CHB are on antiviral treatment, representing approximately one-third of those who would benefit from treatment according to current Australian guidelines.² Newer international guidelines have expanded treatment recommendations to include a much broader group of those living with CHB.^1,12 Where care has been decentralised and provided predominantly in primary care, the number of people on treatment has increased significantly. For example, a highly collaborative program developed in the Northern Territory, the Hep B PAST program, achieved engagement in CHB care for 86% of people with CHB, with 24% on treatment,¹³ using the same definitions as the national hepatitis B mapping project.²

The main principles of the Hep B PAST model are as follows:

1.    Systematically identify everyone in a practice who is living with CHB by testing and documenting hepatitis B status in the health record of all patients.

2.    Offer vaccination to those people who are not immune.

3.    Enable holistic care to be provided to those people who are living with CHB as per current Australian guidelines.

The Fourth National Hepatitis B Strategy 2025–2030 recommends models of care, such as Hep B PAST, be rolled out to other parts of Australia.

Baseline assessment and ongoing care following diagnosis

Once a diagnosis of CHB has been established, a holistic baseline assessment and a plan for ongoing care are needed.

Assessment may require several consultations and, in some patients, may require the use of interpreters and peer workers, where available. This assessment can be split into 4 main sections (Table 2):

1.    Patient understanding – education and explanation of hepatitis B diagnosis in the patient’s preferred language

2.    Clinical care – assessment and associated investigations to identify the extent of liver damage and comorbidities, identify those who are eligible for antiviral treatment and formulate a comprehensive care plan

3.    Contact tracing – consideration of who else needs to be tested within the patient’s family and close networks

4.    Social and cultural needs – active consideration of cultural, social and legal needs, and stigma, as appropriate

Table 2 Assessment of people diagnosed with chronic hepatitis B

Care domain	What is required	How can it be provided
1.      Patient understanding of the diagnosis	Education	Explain diagnosis and the need for lifelong follow-up in the patient’s preferred language
2.      Clinical care (assessment and associated investigations to enable the formulation of a comprehensive care plan)	Holistic assessment history examination Diagnostics to assess viral status liver status Consideration of other comorbidities that can impact liver health, specifically assessment for diabetes, MAFLD, dyslipidaemia, hypertension, alcohol and other drug use, as well as co-infections HCC surveillance if cirrhotic family history Asian-Pacific male aged 40 years or older Asian-Pacific female aged 50 years or older people from sub-Saharan Africa aged 20 years or older Aboriginal and Torres Strait Islander aged 50 years and older or 40 years and older if living in an area with a high-risk genotype (e.g. Northern Territory)	Viral status tests    hepatitis B envelope antigen and antibody (to assess eligibility for treatment)    hepatitis B viral load    hepatitis A serology    hepatitis C serology    hepatitis D serology    HIV serology Liver status and other tests    liver function tests    full blood count    urea, creatinine, renal function    INR    alpha-fetoprotein (if HCC surveillance is required)    APRI score or fibrosis-4 test    HbA1c    lipids    liver ultrasound    elastography (FibroScan) if available Refer to specialist hepatitis B services if any of the following are present    cirrhosis    hepatitis C or D or HIV co-infection    chronic kidney disease stage 3 or above    mass lesion identified on ultrasound    suspected HCC (urgent review required)    decompensated liver disease (urgent review required) Initiate antiviral treatment in eligible patients (Table 3)
3.      Contact tracing	Explanation and assessment of who else requires testing family and household contacts children sexual partners	–
4.      Social and cultural needs	This will vary significantly depending on the patient’s cultural background, visa status, employment and financial situation This may include the use of interpreters, the provision of support letters and a specific focus on dispelling myths around hepatitis B transmission	Tailor support and care to the individual and use all available resources to assist with this, including support workers, peer workers, Aboriginal Health Workers, nurses and social workers where appropriate. If unsure how to support the patient, liaise with HepLink National Hepatitis information line
APRI = aspartate aminotransferase to platelet ratio index; HbA1c = glycated haemoglobin; HCC = hepatocellular carcinoma; HIV = human immunodeficiency virus; INR = international normalised ratio; MAFLD = metabolic dysfunction–associated fatty liver disease

The information collected from the baseline assessment can be collated to answer 3 key questions about the ongoing CHB-related care for each person living with CHB:

• Does this person meet the criteria for antiviral treatment, based on HBeAg, viral load and liver status (Table 3)?
• -  If yes, initiate antiviral treatment or refer to a specialist hepatitis B service. Drug choices are entecavir or tenofovir disoproxil, depending on renal function, pregnancy potential and other clinical factors.
• Does this person have cirrhosis, based on the aspartate aminotransferase to platelet ratio index, fibrosis-4 test or elastography (FibroScan)?
• -  If yes, refer to a specialist hepatitis B service.
• Who else within this person’s contacts (family, household, sexual partners) requires testing and possible vaccination?
• -  In consultation with the patient, work through how to achieve this in a culturally safe way.

Table 3 Pharmaceutical Benefits Scheme criteria for chronic hepatitis B antiviral treatment in Australia¹⁴

Scenario	PBS eligibility criteria
1	HBeAg positive AND HBV DNA greater than 20,000 IU/mL AND ALT greater than 19 U/L (women) or ALT greater than 30 U/L (men) AND/OR cirrhosis
2	HBeAg negative AND HBV DNA greater than 2000 IU/mL AND ALT greater than 19 U/L (women) or ALT greater than 30 U/L (men) AND/OR cirrhosis
3	HBeAg negative or positive AND any detectable HBV DNA AND cirrhosis
ALT = alanine aminotransferase; HBeAg = hepatitis B envelope antigen; HBV = hepatitis B virus

People living with CHB require lifelong review at least every 6 months, as well as guideline-based management of identified comorbidities. Each 6-monthly review requires assessment of the individual’s liver status and hepatitis B virus status with repeat investigations to assess the need for hepatitis B treatment and any change in progression to, or degree of, fibrosis. If cirrhosis is suspected or diagnosed, referral to specialist hepatitis B care is recommended and assessment of variceal status and bone health is required, in addition to HCC surveillance, if not already part of the person’s care plan. Other triggers for referral to specialist care include hepatitis C or D or HIV co-infection, chronic kidney disease stage 3 or above, concern about HCC or detection of a mass on ultrasound, and evidence of decompensated liver disease.

Treatment may also be considered for pregnant women to prevent mother-to-child transmission, especially pregnant women who are HBsAg positive with a high viral load (more than 200,000 IU/mL or 5.3 log₁₀ IU/mL). Tenofovir disoproxil is the drug of choice and is started in the third trimester (28 to 32 weeks gestation) and continued until 4 weeks after delivery.¹⁵ All babies of HBsAg-positive mothers should receive a birth dose of hepatitis B immunoglobulin and vaccine, as well as the further 3 doses of vaccine as per the infant immunisation schedule.

It is important to consider treatment for all people living with CHB undergoing any kind of significant immunosuppression. Joint guidelines from relevant medical colleges are available to guide who requires prophylaxis based on their specific immunosuppression regimen, which should also be discussed with their treating specialist.¹⁶ People with past hepatitis B who are HBsAg-negative but anti-HBc-positive may also require prophylactic antiviral therapy during significant immunosuppression, irrespective of anti-HBs titre.

 

Moving towards elimination: new WHO guidelines

In March 2024, the WHO launched new hepatitis B guidelines¹ aimed at simplifying care, improving equity in areas of the world where access to hepatitis B viral load testing is limited and supporting progress towards hepatitis B elimination. These guidelines take a more inclusive approach to offering treatment with antiviral agents, either entecavir or tenofovir disoproxil, and, although not advocating for universal offer of treatment, they now encourage the treating clinician to ask the question ‘Is there a reason why I shouldn’t offer this person treatment?’ as opposed to the traditional approach of ‘Who should I treat?’ The need to allocate a phase of disease and the absolute requirement of having a hepatitis B viral load available to enable someone to meet the treatment criteria have been removed. Instead, these guidelines recommend that those with significant fibrosis, liver or other comorbidity or co-infection have access to treatment irrespective of the viral load or alanine aminotransferase level (Figure 1).

In order for Australia to reach hepatitis B elimination, treatment eligibility needs to be reconsidered, and the number of people diagnosed, treated, monitored and accessing care needs to increase. Resources and services should be linguistically and culturally appropriate. Since the WHO guidelines were published, recent updates in European guidelines have adopted this broader approach to treatment,¹² which is also anticipated in Australian consensus recommendations that are currently being updated.

 

Conclusion

People living with CHB experience significant morbidity and mortality, which can be prevented and managed within an already publicly funded toolkit of vaccination, testing, diagnosis, management and treatment options. Removing the barriers to accessing this care is an urgent priority if Australia is going to meet the elimination targets it has committed to. The foundation step is for everyone to know their hepatitis B status through universal testing; only then can holistic care be provided to those who are living with CHB through decentralised models of care tailored to community and culture.

This article was finalised on 2 September 2026.

Conflicts of interest: Jane Davies is a Board Director for Hepatitis Australia. She has received funding from the Commonwealth Department of Health and Ageing and the National Health and Medical Research Council for research related to hepatitis B testing and management in First Nations people; the Australian Centre for Disease Control for a community hepatitis B education program; and Roche for attendance at an advisory committee meeting related to liver cancer testing. Jane has been on hepatitis B advisory committees for the World Health Organization and ASHM (the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine). She was a working group member for the Australian hepatitis B consensus statement and contributes to the ASHM section 100 prescriber course.

Marilou Capati is a principal investigator of the REACH-B (real-world assessment of people living with chronic hepatitis B in Australia) study. Marilou is a member of the Northern Territory viral hepatitis steering group and clinical panel for Hepatitis B Voices Australia.

Nicole Allard was a working group member for the Australian hepatitis B consensus statement and is an honorary hepatitis B advisor for ASHM.

This article is peer reviewed.

 

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