The public health challenge of chronic viral hepatitis: an urgent need for screening

Eurohealth OBSERVER Eurohealth incorporating Euro Observer — Vol.20 | No.4 | 2014 7 THE PUBLIC HEALTH CHALLENGE OF CHRONIC VIRAL HEPATITIS: AN URGENT NEED FOR SCREENING By: Abby Falla, Irene Veldhuijzen and Jan Hendrik Richardus on behalf of the HEPscreen consortium Summary: Hepatitis B and C are stealthy viruses that, if left untreated, silently attack the liver and can cause serious liver disease, decades later. Most viral hepatitis in Europe remains undiagnosed, creating a ‘ticking time bomb’ of liver disease-related ill-health and death. Without screening and treatment, mortality from viral hepatitis associated liver disease in Europe is predicted to increase, peaking around 2030. The HEPscreen Toolkit has been developed through research including pilot studies and aims to motivate and enable others to respond to this public health challenge through the implementation of effective screening, particularly for vulnerable population groups such as migrants. Keywords: Hepatitis B, Hepatitis C, Cross-border Health Threats, Migrant Health, HEPscreen Toolkit Abby Falla is a PhD Researcher at the Department of Public Health, Erasmus University Medical Centre, Rotterdam, The Netherlands; Irene Veldhuijzen is an epidemiologist working at the Municipal Public Health Service, Rotterdam, The Netherlands; Jan Hendrik Richardus is Professor of infectious diseases and public health at Erasmus University Medical Centre, and Principal Investigator of the HEPscreen project. Email: am.falla@rotterdam.nl The HEPscreen consortium partners Hamburg University of Applied Science, Germany, Prof. Dr. Ralf Reintjes, Dr. Amena Ahmad, University of Florence, Italy, Prof. Dr. Paolo Bonnani, Dr. Miriam Levi, Dr. Angela Bechini, Queen Mary University of London, UK, Prof. Dr. Graham Foster, Dr. Jan Kunkel, NHS Grampian in Scotland, UK. Dr. Maria K. Rossi, Public Health Agency of Barcelona, Spain, Dr. Joan Cayla, Dr. Manuel Fernandez, Dr. Sandra Manzanares. National Institute for Public Health and the Environment, The Netherlands, Dr. Susan Hahné, National Center for Epidemiology, Hungary, Dr. Ágnes Csohán, The Hepatitis C Trust, UK, Charles Gore. HEPscreen was co-funded by the EU Health Programme. Responsibility for the information and views set out in this article lies entirely with the authors. The European Commission is not responsible for any use that may be made of the information contained herein. Further information: www.hepscreen.eu Global policy context The urgency and scale of action required on viral hepatitis is recognised in a number of high profile global policy documents, frameworks and guidelines. Spring 2014 was an especially important time as the first World Health Organization (WHO) guidelines dealing with hepatitis C screening and treatment were published in April. 1 In May, the World Health Assembly passed a resolution to improve the prevention, diagnosis and treatment of viral hepatitis as well as ensure equitable access among vulnerable groups including migrants. 2 These build on the WHO’s Framework for Global Action on Viral Hepatitis (2012), which outlined the need for a comprehensive approach to viral hepatitis on a global scale including, obtaining data for evidence-based policy, raising awareness, creating partnerships, and prevention, diagnosis, care and treatment. European policy interest Action on screening for viral hepatitis at the European level contributes to two areas of the European Union (EU) policy agenda. The infectious nature of viral hepatitis and the role of migration in contributing to the burden of disease place the issue within the domain of cross- border health threats. In addition, the disproportionate impact on marginalised populations, and therefore on health inequalities, links to the principles of human rights, dignity and solidarity on which the EU was built. Eurohealth OBSERVER Eurohealth incorporating Euro Observer — Vol.20 | No.4 | 2014 8 The European Centre for Disease Prevention and Control (ECDC), an EU agency with an infectious disease surveillance and coordination mandate, established a viral hepatitis network to improve data quality, bring stakeholders together, share good practices and support Member States to tackle the issue in their populations. A high level meeting in June 2014, under the auspices of the Greek EU Presidency and involving key stakeholders, including the ECDC, examined national approaches, debated new developments and identified public policies that facilitate and improve access to treatment for hepatitis B (HBV) and C (HCV), especially in countries where austerity programmes are in place. Concluding outcomes are for health care systems to develop urgent responses to this simmering public health crisis. The HEPscreen project HEPscreen comprised ten partners in six countries – Germany, Hungary, Italy, the Netherlands, Spain and United Kingdom. The central aim of the project was to assess, describe and communicate good practices in screening among migrant communities for hepatitis B and C. A key area of inquiry concerned the epidemiological evidence on the burden of HBV and HCV among migrants in Europe. Building on this, the project reviewed cost-effectiveness and whether the benefits of screening outweigh the harms. Another line of inquiry focused on recommended (i.e. guidelines) and current practices in screening, counselling, referral and treatment. Another key task was the collation and appraisal of translated information materials for people offered testing. Finally, four pilot investigations using both innovative and well-known approaches to screening were conducted in Grampian (Scotland, UK), London, Central Hungary including Budapest and Barcelona. These research and practice questions were especially interesting given the three models of health system organisation found in our participant countries: tax- based National Health Services in the UK, Spain and Italy; social health insurance (SHI) systems in Germany and the Netherlands; and a transitional ‘Semashko’ centralised SHI health care system in Hungary. These six countries also differ with regard to their history and experience of migration. Italy and Spain experienced much more rapid and recent migration than the UK, Germany and the Netherlands, for which migration dating back to the 1950s has been common. Migration to Hungary is also a recent phenomenon and remains less common compared to northern European nations. In this article, we summarise the key findings, recommendations and practical tools developed during the three-year study (see Box 1). Successful preventive measures Public health primary prevention measures, including antenatal HBV screening, HBV vaccination, sterile medical/dental procedures, a safe blood supply and harm reduction activities among people who inject drugs (PWID) have successfully halted much of the transmission of HBV and HCV across Europe. However, variable speed of adoption over time has resulted in distinct geographical variations in prevalence across Europe; prevalence in the general population varies from 0.1% to 5.6% for chronic hepatitis B infection and from 0.4% to 5.2% for chronic hepatitis C. 3 The burden of disease is generally low in the north western countries and higher in the south eastern region of Europe. However, as primary prevention measures do little for those who are already infected, there remains a large undiagnosed burden of chronic viral hepatitis. The impact of migration Over centuries an exporter of people, it is only in the last half century that Europe became a receiver of people. Migration has major impacts on the physical, mental and social dimensions of health, and presents new public health challenges for receiving societies. Indeed, most chronic viral hepatitis infections in Europe are among people born in HBV or HCV endemic countries. In an epidemiological analysis, we found that even though migrants make up a minority (4 – 15%) of the population in the six HEPscreen study countries, the top five most affected migrant communities (defined by country of origin) account for between 10 – 45% of the burden of chronic hepatitis B in these countries. In endemic countries, HBV is most commonly transmitted from mother to child during pregnancy or in early childhood. Unsterile medical, shaving or dental equipment are most common exposure risks in areas where hepatitis C is common. However, as a large proportion of HCV in Europe is also found among PWID, infection is often associated with illicit drug use. This has stigmatised infection and overshadowed the health needs of people from endemic countries. Box 1: Key HEPscreen findings and recommendations • Screening needs to be scaled up. The small-scale, time-limited examples identified are not sufficient to adequately address the public health challenge of chronic viral hepatitis. Guidelines and policy recommendations are urgently needed as a first step. • There are pragmatic yet systematic responses that are relatively simple to implement – for example through routine (but voluntary) registration of country of birth in primary care, as part of a medical history. This can improve access to screening for viral hepatitis-related liver disease among people from endemic areas. • Clear referral pathways need to be central to the design of screening interventions. Highly complex and at times ineffective patient pathways, along with the complex nature of viral hepatitis, compound other health service-related and patient- side barriers facing migrant groups. Effective linkage to specialist care, including antiviral treatment, is crucial to maximise the possible health impact of screening. Eurohealth OBSERVER Eurohealth incorporating Euro Observer — Vol.20 | No.4 | 2014 9 Current action on screening for chronic viral hepatitis in Europe Outside Europe, national guidelines from Canada, the US and Australia recognise the need for screening among people from endemic countries. The project investigated availability of guidelines within Europe via a literature search and an extensive survey among expert clinicians and public health professionals. We also investigated current practices for screening among risk populations, including migrants from endemic areas. In the six HEPscreen European countries, we identified one guideline, from the UK, about screening among people from endemic areas. 4 Our assessment of current practices mirror this: other than antenatal HBV and HBV/HCV blood donor screening, there is no other systematic HBV/HCV screening in the six study countries. We did identify some good practice examples of screening among people from endemic countries, mostly from the UK and the Netherlands, but these examples remain time-limited, small-scale and scarce. Four main ways of screening One objective of the project was to identify and synthesise the fragmented knowledge of effective ways of screening among migrant communities. As part of the HEPscreen Toolkit, we compiled a repository of the good practice examples identified. There are four main ways of screening (see Box 2). Each method has ethical, epidemiological, evaluative and economic implications. General practitioners (GPs), community nurses and sexual health clinics are often in a well-trusted position to raise awareness and offer testing opportunistically to their patients with country of origin- related risk factors. Combining with an existing infectious disease screening programme, such as tuberculosis (TB), builds on existing infrastructure, including appropriately trained staff. Each model varies in its scope and means to raise awareness in the community and to provide information to people offered testing. For example, public awareness information and education sessions and materials are a key part of community outreach screening models. Restricted access to treatment among vulnerable groups Legal and other barriers to health care, such as socio-economic vulnerability and insecure housing or employment conditions, are suggested as partial explanations for the lack of screening among migrants. Previous studies also found lower preventative health care usage 5 and poorer health outcomes from viral hepatitis among migrant groups. 6 The project was interested to find out whether there are formal treatment restrictions in place in the six countries for vulnerable risk groups, such as asylum seekers, undocumented migrants, people without health insurance and PWID. Results from a survey of over 60 gastroenterology or infectious disease specialists involved in the direct clinical care of chronic viral hepatitis patients show a distinct lack of consensus among professionals in the same country about which patients are entitled to which sort of care. This discordance was especially surprising given that the health care system or policy context often defines access to treatment for these specific groups. Our results suggest that health care entitlement guidance is unclear, unavailable or unknown to medical professionals most involved in treating patients. A lack of consensus may also either be an important explanation of, or in fact caused by, the limited existence of screening programmes that target these higher risk populations. Significant restrictions in treatment for undocumented migrants and people without health insurance were reported by the majority in the UK, Germany, the Netherlands, Hungary and Spain; only in Italy did the majority report there to be no or few restrictions. Our results suggest that risk groups such as undocumented migrants, people without health insurance coverage and asylum seekers are rarely screened for viral hepatitis and if found to be chronically infected, do not reliably reach secondary care. Access to antiviral treatment The centralised approval system for pharmaceutical innovations for viral diseases in Europe, through the European Medicines Agency (EMA), appraises applications to grant approval for single marketing authorisation in all EU countries. Decisions on pricing and reimbursement are generally made at the national level however, and differences between Member States in availability, uptake and use of new medication, especially for HCV, have been suggested. 7 Using the same survey of clinical specialists described above, we found that first generation protease inhibitors for HCV, boceprevir and telaprevir, are either significantly or completely restricted for use in Italy, Spain and Hungary despite European-level approval. Epidemiological, health system, clinical and economic factors offer some explanations for this finding. Since our survey in 2012, three new HCV drugs have been approved for use in Europe, with future antiviral development expected. But with expected costs in excess of €60,000 per patient, differences in approval and subsequent use of these expensive options are likely to emerge across Europe. Box 2: The four main implementation models of screening • Outreach-based combining educational/awareness raising with testing either in the community or in a closed/ fixed setting like a workplace or institution. • Offering opportunistic HBV/ HCV testing as part of other health care encounters in primary care such as through GPs, public health services or sexual health clinics. • Extending existing screening initiatives already targeting migrants such as TB screening to include viral hepatitis. • Invitation-based models using municipal population or patient registries as a means to increase access to screening among individuals born in medium/high viral hepatitis endemic countries. Eurohealth OBSERVER Eurohealth incorporating Euro Observer — Vol.20 | No.4 | 2014 10 18 | .1 | 2012 Health information in a linguistically and culturally diverse Europe Providing accurate, appropriate and understandable information to people from endemic countries is a means to raise awareness, improve the acceptability of screening, secure informed choice, normalise testing and alleviate feelings of stigma, shame and fear. To enable health professionals across Europe to provide this in a written format to people offered testing, HEPscreen has developed a tool to create multi-lingual leaflets. The culturally appropriate and simple to understand content is available in 40 languages, from which any combination of two can then be selected to generate a health information leaflet. It has been particularly written for people with limited health literacy or people from cultures where norms and values about unsafe sex and illicit drug use heighten stigma when viral hepatitis is explicitly associated with these routes of transmission. The Toolkit – practical support for implementation The HEPscreen Toolkit builds on the increasing recognition of the need for systematic action on viral hepatitis. Epidemiological HEPscreen tools can assist public health planners and other professionals to estimate the burden among people from endemic countries, as well as to understand which communities are most at risk of viral hepatitis-related liver disease. Focusing screening on higher risk groups increases the chance of finding positive cases and makes more effective use of scarce health care resources. Knowledge of which communities are most affected can add to local community expertise and be used to tailor approaches to specific cultural, linguistic, and social norms and values. To complement this, culturally appropriate, understandable pre-test information leaflets are available in over 40 languages. A pre-test discussion checklist, compiled through a literature review and survey can aid health professionals offering testing to discuss viral hepatitis with culturally and linguistically diverse populations. Practical guides and case studies of the different ways of screening can help to design evidence-based screening programmes. An indicator can help to monitor screening programmes after implementation. These are a few examples of how aspects of the HEPscreen Toolkit can raise awareness, improve knowledge and motivate action to tackle the simmering public health crisis of viral hepatitis in Europe (see Box 3). Scientific consensus – time for action The Global Burden of Disease study (2010) ranked viral hepatitis ninth in the list of causes of mortality, with a larger disease burden in Europe than HIV and TB. 8 Studies also show that screening in populations with an expected prevalence of 2% or higher is likely to be cost- effective. 9 Yet, viral hepatitis receives much less public health, policy or political attention in comparison to HIV. The complex epidemiology and natural history, insufficient advocacy in the field, the global economic crisis and the immense pressure on health care expenditure are important explanations. 10 The current climate of economic austerity, rumbling xenophobia and an increasing demand for health care resources is not ideal to advocate for resource allocation to the secondary prevention of a condition mostly limited to some of the most marginalised and vulnerable members of society. But in the midst of this noisy, highly politicised debate it is our responsibility as public health professionals to articulate the case for evidence-based disease prevention and health promotion. As Da Vinci once said: “Knowing is not enough; we must apply. Being willing is not enough; we must do”. References 1 World Health Organization. Guidelines for the  screening, care and treatment of persons with  hepatitis C infection. Geneva: WHO, 2014. 2 World Health Assembly (WHA). Hepatitis (WHA67.6), 2014. 3 European Centre for Disease Prevention and Control (ECDC). Hepatitis B and C in the EU  neighbourhood: prevalence, burden of disease and  screening policies. A Literature Review. ECDC, 2010. 4 National Institute for Health and Care Excellence. Hepatitis B and C: ways to promote and offer testing  to people at increased risk of infection. London: NICE 2012. 5 Uiters E, Deville W, Foets M, et al. Differences between immigrant and non-immigrant groups in the use of primary medical care; a systematic review. BMC Health Services Research 2009;9:76. Epub 2009/05/12. 6 Antonucci G, Mazzotta F, Puoti M, et al. Factors associated with access to antiviral treatment in a multicentre cross-sectional study of patients with chronic hepatitis B in Italy. Journal of Viral Hepatititis 2012;19(12):881 – 9. Epub 2012/11/06. 7 Lettmeier B, Muhlberger N, Schwarzer R, et al. Market uptake of new antiviral drugs for the treatment of hepatitis C. Journal of Hepatology 2008;49(4):528 – 36. Epub 2008/08/07. 8 Cowie BC, Carville KS, MacLachlan JH. Mortality due to viral hepatitis in the Global Burden of Disease Study 2010: new evidence of an urgent global public health priority demanding action. Antiviral Therapy 2013;18(8):953 – 4. Epub 2013/06/13. 9 Hahne SJ, Veldhuijzen IK, Wiessing L, et al. Infection with hepatitis B and C virus in Europe: a systematic review of prevalence and cost- effectiveness of screening. BMC Infectious  Diseases 2013;13:181. Epub 2013/04/20. 10 The Economist Intelligence Unit. The Silent  Pandemic: tackling hepatitis C with policy innovation. 2012. Available at: www.economistinsights.com/ sites/default/files/Thesilentpandemic.pdf Box 3: Key aspects of the HEPscreen Toolkit • Videos and animations about the public health challenge of chronic viral hepatitis • Epidemiological tools to assess the burden of chronic viral hepatitis among migrants • ‘How-to’ guides, case studies and videos about the different ways of screening • A repository of good practice screening projects • A tool to create multi-lingual leaflets for people offered hepatitis B/C screening – with over 40 languages available • Tools to support primary care to offer testing to their patients from endemic areas, including a pre-test discussion checklist • Good practice recommendations for post-test counselling and linkage to specialist care.