Policy context

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Policy context

Policy and strategies aimed at controlling major risk factors such as hepatitis B virus (HBV) and hepatitis C virus (HCV) infections have significant potential to reduce Australia's current and future liver cancer burden.

As described in the Prevention and Screening sections of this chapter, the impact of HBV and HCV in Australia has been successfully reduced through ensuring a safe blood supply, implementing a national HBV immunisation program and making treatments for chronic HBV and HCV available through the Pharmaceutical Benefits Scheme.

Low awareness and understanding of viral hepatitis is associated with increased risk of transmission[1], lower likelihood of vaccination[2], underutilisation of treatment options[3] and lower likelihood of cancer screening[4]. As such, increasing awareness of policymakers, healthcare professionals and the public about viral and non-viral risk factors associated with hepatocellular carcinoma is essential to maximise the potential of primary and secondary prevention strategies to reduce the future burden of liver cancer in Australia.

National strategies and guidelines

Australia has a number of national strategies for hepatitis control, and was the first country in the world to have a national strategic response to hepatitis C. These strategies are high level policy documents, outlining priority actions that are to be progressed through partnerships between governments and the community sector, involving people with hepatitis infections, researchers, health professionals and other stakeholders. Major frameworks include:

Implementation of these plans varies throughout the country. Several states and territories have developed strategies or action plans to implement the recommendations of the National Hepatitis C Strategy in their jurisdictions, as listed on the Australasian Society for HIV Medicine website. The West Australian Government has developed an implementation plan in response to the National Hepatitis B Strategy, other state and territory plans are at various stages of development.

Other guidelines include the Gastroenterological Society of Australia's clinical recommendations for the management of hepatitis B in Australia and New Zealand[5] and specific guidelines for hepatitis C prevention, treatment and care in Australian custodial settings were published by the Department of Health and Ageing in 2008[6].

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Monitoring hepatitis incidence and prevalence

Hepatitis B and hepatitis C infections are notifiable conditions in Australia. Cases are routinely notified through public health surveillance systems and data is collated and reported by the Australian Government’s National Notifiable Diseases Surveillance System. Hepatitis notifications are classified as either ‘newly acquired’ (infection acquired within 24 months prior to diagnosis) or ‘unspecified’ (infection acquired more than 24 months prior to diagnosis or not able to be specified), based on serological evidence or evidence of a previously negative test within the 24 months prior to diagnosis.

However, under-diagnosis and under-reporting of HBV and HCV infections mean that hepatitis incidence and hepatitis-related disease burden are underestimated[7][8]. Population-level prevalence studies for HBV and HCV have not been undertaken in Australia. Current prevalence estimates rely on antenatal screening data, opportunistic laboratory surveys, and estimates of at-risk populations.

Furthermore, the surveillance system collects limited demographic information, inadequately recording country of birth and Aboriginal and Torres Strait Islander status. These shortfalls lead to inadequate epidemiological data that hinders the advancement of policy and actions to control hepatitis B and C and reduce the burden of their chronic consequences.

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Hepatitis B vaccination

In Australia during the early 1980s, HBV vaccination was initially administered to at-risk groups such as healthcare workers and Indigenous infants. In 1987, a national strategy for the control of hepatitis B was implemented, targeting infants born to mothers who were positive for hepatitis B surface antigen (HBsAg). In 1996, the National Health and Medical Research Council recommended a universal HBV vaccination program for infants and adolescents. Routine adolescent vaccination was introduced in 1997, and universal infant vaccination began in 2000.

Currently, Australia’s National Immunisation Program includes routine neonatal vaccination (since 2000) and vaccination of adolescents (aged 10–13 years), which will continue until those immunised in the childhood program reach adolescence[9]. Vaccination is also recommended for adults in high-risk groups.

Neonatal vaccination

During the late 1980s, perinatal transmission of HBV was recognised as the major factor leading to viral persistence, chronic liver disease and hepatocellular carcinoma. Prevention of vertical transmission – from infected mother to newborn – is particularly important, because the risk of adverse events and disease progression is greater in those infected as newborns or children (see Natural history of HBV). Routine neonatal vaccination against HBV is effective in preventing both vertical and horizontal transmission.

Routine HBV vaccination for all Australian infants has been provided as part of the National Immunisation Program since May 2000. The program includes a single dose of hepatitis B vaccine at birth or up to eight days of age, followed by three doses of the vaccine at two months, four months and either six or 12 months of age. Uptake in Australian children is very good: 94% of children aged 24–27 months of age at 30 June 2012 had received the full course (three doses)[10].

In newborn infants of mothers with HBV infection, vaccination combined with administration of ‘hyperimmune’ hepatitis B immunoglobulin (HBIG) at birth is around 85–95% effective in preventing vertical transmission[11][12][13][14]. HBV vaccine and HBIG, must be administered within 12 hours of birth, as efficacy decreases markedly if administration is delayed beyond 48 hours after birth[9].

Vaccination of adolescents

Vaccination of adolescents 10–13 years of age is recommended for those who have not received the hepatitis B vaccine[9]. This is administered on a State and Territory level. The adolescent program will continue until those immunised against HBV in the childhood program reach adolescence[9].

Adolescents can receive either a two-dose schedule (adult dose vaccine) administered at baseline and four (or six) months; or a three-dose schedule (paediatric dose vaccine) at baseline, one month and six months, predominantly through school-based programs. Randomised controlled trials have demonstrated that in adolescents the adult (two-dose) schedule is an effective alternative to the standard three-dose regimen of the paediatric formulation[15][16]. The two-dose schedule is recommended in this age group to improve compliance[9].

Vaccination of high-risk groups

Hepatitis B vaccination is recommended for susceptible adults in high-risk groups who would not have been targeted by universal infant and childhood immunisation because of their age. Adults receive a three-dose schedule of hepatitis B vaccine administered at baseline, one month and six months[9]. Testing of susceptibility to infection is recommended prior to vaccination[9].

In Australia, hepatitis B vaccination is recommended in adults in the following at-risk groups[9]:

  • Household or other close (household-like) contacts of persons with hepatitis B;
  • Sexual contacts of persons with hepatitis B;
  • Migrants from hepatitis B endemic countries;
  • Aboriginal and Torres Strait Islander people;
  • Adult haemodialysis patients and patients with severely impaired renal function in whom dialysis is anticipated;
  • Solid organ and haematopoietic stem cell transplant recipients;
  • HIV-positive adults and other immunocompromised adults;
  • Persons with chronic liver disease and/or hepatitis C;
  • Persons who inject drugs;
  • Recipients of certain blood products;
  • Persons with developmental disabilities;
  • Inmates of correctional facilities;
  • Sex industry workers;
  • Persons at occupational risk; and
  • Travellers to hepatitis B endemic areas.

‘Catch up’ hepatitis B vaccination of Aboriginal and Torres Strait Islander children and adolescents was introduced in the late 1990s, but coverage appears to be incomplete. A survey of vaccination status among adolescents in an Indigenous community in Queensland found only 44% were fully vaccinated and more than 90% of the incompletely vaccinated adolescents had a HBV infection[17].

Despite good vaccine coverage through neonatal and adolescent immunisation programs, hepatitis B vaccination has been consistently underused by adults in high-risk groups who would not have been targeted by universal infant and childhood immunisation because of their age[18]. Low uptake of vaccination by high-risk groups has been attributed to a lack of awareness, failure by health professionals to identify and offer vaccination to at-risk persons, the cost of accessing the hepatitis B vaccine (the vaccine is free in some jurisdictions, but there is often a consultation fee) and failure to complete the vaccine course.

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Screening programs

Australia does not have population hepatitis screening programs for HCV, HBV or hepatocellular carcinoma. With the exception of antenatal screening, case finding has not been promoted.

Mandatory or compulsory hepatitis testing is required under policy or legislation for people wanting to participate in certain activities or have access to certain services, e.g. as a condition of blood, tissue and organ donation; to enter armed forces training or service; and before performing exposure-prone procedures in some healthcare settings.

Hepatitis B screening

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists guidelines state that all pregnant women should be screened for HBV and, if positive, undergo further testing to determine the risk of transmission to the infant and degree of infectivity[19]. If unknown, a pregnant woman’s hepatitis B status is determined upon presentation during labour. Routine antenatal screening enables intervention to prevent transmission to newborn infants, referral of the woman for treatment and an opportunity for vaccination of household contacts.

The National Hepatitis B Testing Policy lists indications for HBV testing, including people from the following ‘priority populations’[20]:

  • persons born in, or born to parents from, countries of high and intermediate prevalence rates for HBV (identified in the policy) including immigrants and adopted children;
  • Aboriginal and Torres Strait Islander people;
  • all patients undergoing chemo- or immune-suppressive therapy; and
  • unvaccinated adults at higher risk of infection, including:
    • partners and other household and sexual contacts of people with acute or chronic hepatitis B,
    • people who have ever injected drugs,
    • men who have sex with men,
    • people with multiple sex partners,
    • people in custodial settings or who have ever been in custodial settings,
    • people with HIV or HCV, or both,
    • patients undergoing dialysis, and
    • sex workers.

Globally, national screening programs are rare, particularly in countries with endemic HBV infection, because of the considerable resources needed to screen (primarily due to the cost of HBV DNA assays) and to provide long-term follow-up of identified people with chronic hepatitis B. HBV screening programs exist in New Zealand, Shanghai, Taiwan, Alaska and many American states.

Australian modelling has shown that a program of chronic hepatitis B screening, follow-up and treatment is both feasible and cost-effective, compared to current practice; it could significantly reduce cases of cirrhosis by 52%, hepatocellular carcinoma diagnoses by 47% and chronic hepatitis B-related deaths by 56%[21]. Internationally two studies of the cost-effectiveness of screening high-risk groups for viral hepatitis have been conducted, both of which found that screening of migrant groups for HBV and HCV was clinically effective and cost-effective[22][23].

Hepatitis C screening

According to Australia’s Hepatitis C Testing Policy, testing is indicated for people who have risk factors associated with transmission of HCV, including[24]:

  • a history of injecting drug use;
  • current or past incarceration;
  • having received organs, tissues, blood or blood products before February 1990 in Australia (or at any time in countries where screening of such products does not occur);
  • tattoos or skin piercings;
  • being born in a country with high HCV prevalence;
  • having a sexual partner with HCV;
  • being born to an HCV-positive mother;
  • Aboriginal and Torres Strait Islander heritage;
  • working in a healthcare setting (following occupational exposure to blood or body substances); and
  • receiving regular haemodialysis.

Both the HBV and HCV testing policies note that a person who requests a test should not be denied one if they choose not to disclose risk factors[20][24].

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Treatment of hepatitis

The B Positive pilot program represents the first population-based Australian initiative aimed at addressing the burden of hepatitis B and liver cancer. Research conducted by the Victorian Infectious Disease Research Laboratory and Australasian Society for HIV Medicine in 2012 found that the uptake of antiviral treatment in the program area (while still only 50% of the intended target) was the highest in the country, as evidence of the program’s impact in a low socioeconomic status area of Sydney (see Medicare Locals Planning Project).

Given the limited capacity of existing specialist hepatitis treatment services, extending therapy to a greater number of patients would require an expansion of capacity in the primary healthcare sector.

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Barriers to prevention and treatment uptake

In Australia the groups at highest risk of hepatocellular carcinoma due to hepatitis B and C infection also face the greatest barriers to healthcare services. Particularly among Indigenous and migrant groups, issues related to cultural, linguistic and/or religious differences, poverty, distance and transportation, literacy rates, and poor access to healthcare services adversely impact prevention and management uptake.

Addressing these barriers requires targeted strategies that recognise the diversity of needs of high-risk groups. Culturally and linguistically appropriate public education and awareness campaigns are necessary to increase uptake of hepatitis B vaccination and access to healthcare services for screening and treatment in communities at highest risk for liver cancer.

A recent study found that the major barriers to uptake of hepatitis C treatment in a tertiary hospital setting were related to drug and alcohol use, hence improved co-management of drug and alcohol dependence and better infrastructure for treatment delivery could increase uptake and reduce hepatitis C-related morbidity[25]. The proportion of people who inject drugs (PWID) who receive treatment remains very low, although recent data confirm PWID can be treated successfully with current standard of care[26].

Improved therapies with lower toxicity and shorter treatment regimens have the potential to increase access and adherence to treatment. Increasing access maximised by making therapies available outside tertiary centres i.e. in primary and community-based practices as well as methadone clinics and other settings has further potential to increase treatment uptake in a number of high risk groups.

The removal of liver biopsy as a mandatory requirement for access to funded hepatitis B treatment (as of November 2011) eliminated a significant barrier, particularly for patients in remote communities where biopsy was not available, and for some migrant communities whose cultural beliefs were in conflict with biopsy. Treatment is now available to patients with elevated HBV DNA levels (>20,000 IU/mL if HBeAg positive, or >2,000 IU/mL if HBeAg negative) and evidence of chronic liver injury as determined by either elevated alanine transaminase or liver biopsy.

There is a need to raise public and health practitioner awareness of the impact of risk factors such as obesity, diabetes and alcohol consumption, and the importance of making healthy lifestyle choices to prevent progression to hepatocellular carcinoma, especially among people infected with viral hepatitis.

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  8. Australian Government Department of Health and Ageing. Third national hepatitis C strategy 2010–2013. Canberra: DoHA; 2010 Available from: http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-national-strategies-2010-hcv/$File/hcv.pdf.
  9. 9.0 9.1 9.2 9.3 9.4 9.5 9.6 9.7 Australian Government Department of Health and Ageing. The Australian immunisation handbook. 10th edition. Canberra: DoHA; 2013 Available from: http://health.gov.au/internet/immunise/publishing.nsf/Content/EE1905BC65D40BCFCA257B26007FC8CA/$File/handbook10.pdf.
  10. Australian Childhood Immunisation Register. Childhood immunisation coverage report. Canberra: Australian Government Department of Human Services; 2012 Jun [cited 2012 Aug] Available from: http://www.medicareaustralia.gov.au/provider/patients/acir/statistics.jsp.
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  19. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Hepatitis B. Melbourne: RANZCOG; 2012. Report No.: College statement: C-Gen 3.
  20. 20.0 20.1 National HBV Testing Policy Expert Reference Committee. National hepatitis B testing policy. Canberra: Australasian Society for HIV Medicine; 2012 Available from: http://www.ashm.org.au/images/HBV/HBV_TESTING_POLICY_FORMATTED_V1.1_PRINT.pdf.
  21. Robotin MC, Kansil M, Howard K, George J, Tipper S, Dore GJ, et al. Antiviral therapy for hepatitis B-related liver cancer prevention is more cost-effective than cancer screening. J Hepatol 2009 May;50(5):990-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/19303657.
  22. Hutton DW, Tan D, So SK, Brandeau ML. Cost-effectiveness of screening and vaccinating Asian and Pacific Islander adults for hepatitis B. Ann Intern Med 2007 Oct 2;147(7):460-9 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/17909207.
  23. Veldhuijzen IK, Toy M, Hahné SJ, De Wit GA, Schalm SW, de Man RA, et al. Screening and early treatment of migrants for chronic hepatitis B virus infection is cost-effective. Gastroenterology 2010 Feb;138(2):522-30 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/19879275.
  24. 24.0 24.1 National HCV Testing Policy Expert Reference Committee. National HCV testing policy. Sydney: Australian Society for HIV Medicine; 2012 [cited 2012 Aug]. Sponsored by Australian Government Department of Health and Ageing. Available from: http://testingportal.ashm.org.au/hcv.
  25. ACHOS investigator team, Gidding HF, Law MG, Amin J, Macdonald GA, Sasadeusz JJ, et al. Predictors of deferral of treatment for hepatitis C infection in Australian clinics. Med J Aust 2011 Apr 18;194(8):398-402 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21495939.
  26. Hellard ME, Jenkinson R, Higgs P, Stoové MA, Sacks-Davis R, Gold J, et al. Modelling antiviral treatment to prevent hepatitis C infection among people who inject drugs in Victoria, Australia. Med J Aust 2012 Jun 4;196(10):638-41 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/22676879.

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