Hepatitis B and C Summit Conference Brussels, 14th-15th October, 2010 REPORT
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1 Hepatitis B and C Summit Conference Brussels, 14th-15th October, 2010 REPORT Introduction: The Hepatitis B and C Conference is a new initiative that brings together key stakeholders in a unique partnership whose goal is to curtail the rising epidemic of hepatitis B and C in Europe through innovative evidence-based targeted policies and programmes. This report summarizes the inaugural Summit of the Conference, held in Brussels 14th-15th October, 2010 under the auspices of the Belgian EU Presidency. The Conference presentations will be made available on the website ( 1. Enhanced surveillance of hepatitis B and hepatitis C is urgently needed To date a major obstacle to action in the field of hepatitis B and C in the European Union (EU) has been the lack of reliable and consistent incidence and prevalence data, but both Hepatitis B and C are now beng monitored by the European Centre for Disease Prevention and Control (ECDC) since its creation in Problems with existing data include: - differences in case definition use by countries and researchers; - wide variability in the prevalence rates of hepatitis B and C across the EU that may be in part due different testing and screening practices as well as true differences in epidemiology; - high risk groups such as migrants and intravenous drug users (IDUs) tend to be underrepresented in study samples, many of which are small; - in some EU Member States national statistics on viral hepatitis are simply absent, making cross-country comparisons difficult. The ECDC-enhanced surveillance for hepatitis B and C is thus a welcome initiative which involves the following steps: a. the establishment of a Coordinating Group; b. agreement on a comprehensive framework for hepatitis surveillance including: o case-based data selection
2 o continuous review of results from screening programmes to encourage Member States to do more to evaluate their effectiveness c. annual meetings of the EU Hepatitis Surveillance Network including stakeholders and patient groups; d. implementation of enhanced surveillance for hepatitis B and C including synchronised methods and practices for: o notification and laboratory data o distinction between acute and chronic cases o inclusion of end-stage disease o case definitions (revision of 2002 and 2008 European case definitions). 2. More action on migrants and intravenous drug users (IDUs) A) IDUs There is good evidence from prevalence studies of serological markers that the prevalence of hepatitis B and C is much higher in IDUs than in the general population; on average, 80% of HCV notifications are from IDUs. There nevertheless remain important gaps in our understanding of the dynamics of viral hepatitis spread and injecting drug use: prevalence data on IDUs are very difficult to obtain and diagnostic testing data are likely to be gross underestimates of true prevalence. Better behavioural data (e.g. number of years of infection) and incidence assays data (such as in the HIV field) are urgently needed. Most hepatitis B and C prevention in IDUs has included oral substitution treatment and targeted vaccination, but how this is done varies considerably between EU Member States. From a public health perspective, there are indications that treatment of active IDUs with antiviral therapy may be the most effective and cost-effective, means of reducing the burden of disease. Treatment for prevention is an approach that has long been advocated for HIV/AIDS with its the underlying principle that if the overall viral load in the population can be reduced through effective treatment of those infected the cycle of transmission can be cut. Overall, there is an urgent need for better access to treatment for IDUs, both active and former users. B) Migrants A special report on migration and viral hepatitis B and C was commissioned for the Sumit Conference from the International Centre for Migration, Health and Development. A copy of this report is available on the CD-ROM and in the Report distributed at the Conference. i The report highlights that for the first time in history, Europe has become more of a receiver than an exporter of people and that this change has caught many national policy makers by surprise and unprepared to deal with potential public health ramifications. The paucity of information currently available has been in part due to difficulties identifying and reaching migrants of different categories. Irregular migrants have been especially difficult to reach. Much of the migration into EU Member States involves the movement of people from parts of the world that have high or intermediate levels of hepatitis B and hepatitis C. In addition to the risks associated with this, there is also evidence that migrants and their offspring tend to be targeted by drug dealers and that migrants may be inclined to use narcotic substances as well as alcohol and tobacco as part of their strategies to deal with chronic stress. The fact
3 that the last few years have seen a growing number of people trafficked or otherwise directed into sex work (47% of all female sex workers in Europe are of migrant background) is also a cause for concern. Access to prevention and care remains a significant barrier for migrants. Legal status, poverty, low levels of education, cultural, linguistic and religious differences have been shown to be important factors in determining the extent to which migrants can and do access proper care. Administrative rules and procedures also constitute important barriers to access and use of health care services for migrants with limited understanding of how the health system in host countries functions. Complex, time-consuming processes that require work and residence permits, health insurance papers and permanent addresses which migrants may be unable to provide are all reasons for not continuing with health care seeking. Migrants must be provided with information and education on viral hepatitis B and C in languages and in ways that are attractive and understandable. Screening and facilitating better access to prevention and treatment are some of the steps that call for improvement, and where screening is proposed it will have to be done in an evidence-based way and respectful of the rights of those screened. Particular attention is needed to ensure that individuals are not stigmatised because of their national origin or their viral hepatitis status. 3. Europe is finally realising the toll posed by liver cancer The heavy toll of liver cancer in Europe has become clear over the past years. Worldwide, liver cancer is the third most important cancer in terms of mortality, and the sixth in terms of incidence. According to the World Health Organization, at least 550,000 people die each year from primary liver cancer. Approximately 15 40% of patients infected with the hepatitis B virus, if left untreated, will develop cirrhosis, liver failure, or liver cancer. Up to 80% of liver cancer is caused by hepatitis B and C and hepatitis B is the second most common carcinogen after tobacco. Given the EU s focus on anti-smoking campaigns, it seems natural to increase its focus on information campaigns that address the problem of viral hepatitis and liver cancer in a similar manner. Within the European Union, the risk of death attributed to liver cancer is highest in Southern Europe, both for men and for women. However, differences between Member States may reflect different diagnostic and reporting systems as well as true differences in epidemiology. There is evidence from some Member States such as Spain that mortality from liver cancer is increasing, but more reliable data on the links between viral hepatitis and liver cancer are needed in order to have a clear picture of the real burden of liver disease across Europe. This will only be possible through common definitions, linked databases and systematic monitoring of the outcomes of disease. Such monitoring is being discussed with the framework for enhanced surveillance of hepatitis B and C proposed by the ECDC. A study on the burden of illness associated with hepatitis B and C is also being conducted by ECDC 4. Vaccination remains the most effective preventive approach against hepatitis B Vaccination against hepatitis B is a global success story. Worldwide, 177 countries have universal vaccination. Several hundred million vaccines have been administered, with very high (95-100%) seroprotection rates - close to 100% in healthy children and about 95% in healthy adults. Seroprotection levels are lower in severe smokers, obese, elderly or immunocompromised adults. Clinically significant breakthrough infections are quite rare in vaccinated individuals and protection from HBV lasts up to 20 years. Compelling data have
4 demonstrated a clear impact of vaccination on incidence levels of hepatitis B and as well as liver disease and hepatocellular cancer. As such, the hepatitis B vaccine has been named as the first cancer vaccine in existence. Within Europe, some challenges remain in the field of vaccination against hepatitis B. Polices are not uniform within the European Union, and some Member States have chosen to only adopt targeted (high risk groups) vaccination approach. In the broader European region (as defined by the World Health Organisation), 47 out of 53 countries offer universal vaccination. It is important to consider that there are 11 countries belonging to the Global Alliance for Vaccines and Immunisation within the European region and many of these will now be challenged to sustain the immunisation within their countries which was previously funded by NGOs and international donors. Also, hepatitis B still has some catching up to do in terms of coverage - currently coverage of the 3 rd dose is approximately 76% as compared to 94%-95% for the commonly administered childhood vaccinations. And the impact of migration on the overall epidemiology of hepatitis B needs to be taken into consideration 5. More resources must be devoted to screening programmes for risk groups One of the most consistent messages delivered during the Conference is the need for more resources to be devoted to targeted screening programmes of risk groups for hepatitis B and C. Both diseases meet Wilson and Jungner s (1968) criteria for screening: they represent an important public health problem, there is a suitable, acceptable and safe diagnostic test, and effective and established treatments exist. Moreover, data from different studies suggest that screening in certain risk groups, namely migrants and IDUs, is both effective and costeffective. Despite the patchy nature of these data, they point to the same conclusion: screening must become a greater priority in existing hepatitis policies. To be effective, screening programmes must be accompanied by counselling, integrated into existing public health and care practices and connected to treatment programmes. One of the greatest hurdles to screening is lack of awareness of hepatitis B and C by physicians and by patients. Surveys show repeatedly that a large majority of patients infected with hepatitis B and C are unaware of their condition. There is also a misconception amongst the general public (and physicians) that no treatment options exist for those screened positive. Extensive awareness-raising efforts are urgently needed in all Member States to redress these misconceptions and ensure that individuals seek screening as a first step towards proper management of their condition. Training physicians is key to recommending appropriate screening to patients. Screening technologies, like quick tests for screening of HBV and HCV in blood or saliva should be urgently explored. 6. Early diagnosis and treatment are essential There have been considerable advances in the treatment of hepatitis B and C over the past decade, such that today, two critical messages must be communicated: - 95% of chronic hepatitis B cases can be treated, improving survival - 60% of chronic hepatitis C cases can be cured, reversing the natural history. New data and research are emerging that will help improve treatment options for hepatitis B and C. In both cases, the choice of therapy depends on individual patient characteristics. Issues with long-term safety and efficacy as well as ways to induce a long-term cure remain critical. For Hepatitis C, the message must be communicated that this disease is not equivalent to HIV: cure is possible to the level that the virus is actually gone from a patient s body.
5 There have also been important strides made in the treatment of advanced liver disease. Cirrhosis was considered irreversible, but histological evidence now suggests otherwise. It has been shown in patients with HBV, cirrhosis can be reversed. Early detection of viral hepatitis improves the chances of survival after treatment. Liver cancer caused by viral hepatitis infection can be successfully treated if it is diagnosed early by regular screening of chronically infected patients. Cost effectiveness analysis suggests that treatments of chronic HBV and HCV are cost - effective or cost - saving. All of these data point to the need to extend treatment to as many patients as possible because this will have a demonstrable impact on mortality, and reduce infectivity and therefore transmission within the general population. 7. Some successful national/local initiatives have been achieved A number of very successful programmes and policies targeting hepatitis B and/or C have been undertaken across the EU, and the experience of France, Scotland, Netherlands and Italy are worthy of mention. The main messages to emerge from these country experiences are that powerful epidemiological data are essential to drive policy and convince policymakers of the urgency posed by viral hepatitis. Targeted actions in migrant communities have shown positive results as have treatment programmes for active IDUs. And the use of quantifiable goals (e.g. to reduce the prevalence of hepatitis B and C by X%) have shown to provide important motivation for all those involved in programmes and actions to achieve their goals. However, despite these important examples of good practice, the policy landscape on hepatitis B and C is severely lacking. A review of hepatitis policies conducted by the World Hepatitis Alliance ii found that, of the 47 countries within the WHO s definition of Europe, only 8 have a vaccination programme in place. The message that tackling hepatitis B and C requires more than a vaccination policy is still urgently needed: comprehensive policies that encompass all aspects of these two diseases, including prevention, screening, treatment and overall information and awareness raising of all stakeholders are required if their burden is to be reduced in a sustainable way. The situation in the United States was cited as a possibly useful guide: the US Institute of Medicine recently launched a report on hepatitis B and C. The background to viral hepatitis in the US is similar to Europe: there are similar epidemiological trends, data gaps are also critical, awareness is low and stigma is high. And resources devoted to hepatitis are sorely lucking. If one looks at the US Centers for Disease Prevention and Control (CDC) budgets 69%target domestic HIV, 15% target STI, 14% target tuberculosis and only 2% target hepatitis. Similarly, for every research dollar spent on hepatitis by National Institutes of Health (NIH), there are more dollars spent on HIV/AIDS. These figures should act as a wake-up call to policymakers around the world that the balance needs to be redressed and more attention must be given to hepatitis B and C. 8. Patient groups play a critical role in advancing policy and patient care A report on the role of patient groups for hepatitis B and C in Europe was commissioned by the Conference from the European Liver Patients Association (ELPA). This report is available in the Conference report and on the CD-ROM distributed at the Conference. iii
6 The report found that despite chronic shortage of funds and limited manpower patient groups, are doing an excellent job across the EU in raising the profile of hepatitis B and C among many stakeholders including policy makers. Patient groups are leaders of awareness-raising campaigns, and fill a very important gap through counselling and offering psychological support to patients. This direct interaction and support of patients and their families is critical as this aspect of the diseases is largely neglected by medical centres and hospitals. The most important challenges faced by patient groups are: lack of good quality data on both the scientific and economic aspects of hepatitis B and C; a high level of stigma surrounding these diseases, and a general lack of interest or incentive on the part of health professionals and in particular, general practitioners (GPs), to become better informed about the condition. Low interest and awareness of viral hepatitis B and C among GPs remains a particular concern. So far, the impact of awareness campaigns targeting GPs has been poor and most patients eventually seek treatment out of their own motivation without a good understanding of the fact that their disease is treatable. This is reflected in the low percentage of screened patients who actually go on to treatment. In many cases patients fear treatment and its sideeffects, and currently GPs seem to lack the knowledge to reassure patients that effective treatment options exist and thus guide them to the appropriate course of care. The challenge now is thus to raise awareness amongst GPs of the significance of viral hepatitis B and C and to communicate the message that if they screen their patients, they can also offer them effective treatments. This message was not possible a decade ago. Conclusion: Europe must recognise the importance of viral hepatitis B and C and make resources available to deliver policies. 1. There is urgent need for broad-reaching, cohesive European-level policies on hepatitis B and C. European institutions are making important moves to this end. For example, the ECDC is establishing an enhanced surveillance programme for hepatitis B and C, and within the European Commission, DG Health and Consumers and DG Research are funding efforts which target viral hepatitis. The WHO-European Region is also adopting a regional strategy for viral hepatitis. Expert at the Summit Conference nevertheless made it clear that much more work and more funding is called for if the epidemic of hepatitis B and C is to be fought, and EU Member States need to respond to European leadership and make viral hepatitis a priority in their national plans and budgets. 2. More data are needed but as MEP Alojz Peterle stated in his address to the Summit Conference, policymakers must not hide behind the need for data to make concrete policy recommendations. Available data already point to the urgent need to act to deal with hepatitis B and C in national and European level policies, programmes and actions. 3. This is a new era for hepatitis B and C. Europe is faced with a paradox that the means to test and treat patients with hepatitis B and C are at our disposal, but as many as 90% of people infected with the virus do not even know they have the disease. 4. The October 2010 Conference is not a one-off. The momentum will be maintained at a European and at national levels by the Steering Group and participants all expressed a strong desire to see the multi-stakeholder engagement achieved during the Summit reflected at national levels.
7 5. A critical factor for success will be to follow advances in EU policy with policies, actions and programmes in all the EU Member States. The activities at EU level will only be useful if Member States are willing to implement the policy recommendations from the Call to Action in their national healthcare plans. i Please contact the Hepatitis Summit Conference Secretariat should you wish to obtain a copy. ii For further information and a copy of the report, contact the World Hepatitis Alliance at contact@worldhepatitisalliance.org. iii Pl ease contact the Hepatitis Summit Conference Secretariat should you wish to obtain a copy.
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