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REGIONAL COMMITTEE
Provisional Agenda item 8.1
Seventieth Session Maldives 6–10 September 2017
SEA/RC70/7 19 July 2017
Hepatitis Scientific advances and breakthroughs, coupled with global solidarity and commitment, have reversed the trend for most communicable diseases but not for viral hepatitis, an infection that is preventable and yet continues to exact a large toll on human lives. Chronic hepatitis B and C claim almost 1.34 million lives each year globally. In the South-East Asia Region, viral hepatitis led to 410 000 deaths in 2015, more than all deaths due to HIV and malaria put together. With 49 million people estimated to be chronically infected with hepatitis B and C, the number of deaths will only increase if our response to viral hepatitis is not strengthened and scaled up. To tackle viral hepatitis, Member States of the WHO South-East Asia Region have endorsed the Global Health Sector Strategy on Viral Hepatitis (2016–2021). In line with this global commitment, the WHO Regional Office for South-East Asia has developed a Regional Action Plan for Viral Hepatitis 2016–2021. The attached working paper was presented to the High-Level Preparatory (HLP) Meeting for its review and recommendations. The HLP Meeting reviewed the paper and made the following recommendations for consideration by the Seventieth Session of the Regional Committee: Actions by Member States (1) Develop national action plans based on the disease burden and cost-effective interventions as per serosurvey/surveillance data. (2) Focus on gaps in the hepatitis B birth dose coverage to ensure at least 95% coverage by 2020.
(3) Ensure that injection safety and other infection-control measures in health-care settings are implemented. Actions by WHO (1) Support Member States in the development and implementation of their national action plans. (2) Support Member States in ensuring access to quality drugs for the treatment of hepatitis C at affordable prices through sharing of information on pricing, and facilitating negotiations through the South-East Asia Regulatory Network. (3) Support and facilitate innovations in the diagnosis of hepatitis B and C, particularly laboratory support for testing and monitoring. (4) Support the development of regional and national systems for surveillance and data management to monitor indicators in real time. (5) Support Member States in increasing community awareness regarding the prevention and control of hepatitis, involving the Goodwill Ambassador for Hepatitis in the South-East Asia Region. This Working Paper and the HLP Meeting recommendations are submitted to the Seventieth Session of the WHO Regional Committee for South-East Asia for its consideration and decision.
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Introduction 1. Viral hepatitis is an important public health problem in the WHO South-East Asia Region, as the number of people who have the disease and deaths due to it are more than those from HIV and malaria combined. Aside from the toll on health and lives, the disease comes with huge financial and social costs. 2. There are five types of hepatitis viruses. Types A and E cause acute infections and are spread by contaminated food and water. Infections due to these are generally reported as outbreaks due to acute infections and are generally self-limiting, though some cases of each type develop acute fulminant hepatitis, which can be fatal. Hepatitis B and C can cause chronic liver disease that can lead to cirrhosis and liver cancer. These viruses are transmitted through contaminated blood, blood products and body secretions, intimate contact, sharing of injecting equipment, unsafe health-care procedures and vertical transmission. Hepatitis D infection occurs only with or as a superinfection with hepatitis B virus. There are effective vaccines against hepatitis A and B; a vaccine for hepatitis E has been developed but is not available outside China; hepatitis D can be prevented by hepatitis B vaccine, and there is no vaccine for hepatitis C.
Rationale 3. Despite the burden of disease and toll on human lives, attention to viral hepatitis as a public health problem was limited until recently to three resolutions by the World Health Assembly and endorsement of the Global Health Sector Strategy for Viral Hepatitis (2016–2021) by all Member States in May 2016. 4. Universal vaccination of all newborns and infants has the highest impact in preventing new hepatitis B infections. It is established that the earlier the infection in life, the higher the odds of developing chronic disease. Point-of-care and rapid diagnostic tests are available for hepatitis B and C infections, although access and costs are limiting factors. There is effective treatment for hepatitis B and newer drugs for hepatitis C can cure the disease in 95% of cases that get access to treatment. Once unaffordable, these medicines are now available at much lower prices in most low- and middle-income countries. Thailand is the only country in the Region with no access to voluntary licensed hepatitis C medicines. 5. With these available tools at hand, efforts towards addressing viral hepatitis in a holistic manner and with a public health approach need to be enhanced. Sustainable Development Goal 3.3 also calls for combating viral hepatitis.
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Current situation: global and regional 6. Viral hepatitis is the seventh leading cause of mortality worldwide and is the only communicable disease where mortality is increasing. 7. Viral hepatitis causes at least as many, if not more, deaths annually than TB, AIDS and malaria combined. Around 90% of these are due to hepatitis B and C virus infections. 8. WHO estimates that globally there are an estimated 257 million persons with hepatitis B and every year 900 000 people succumb to hepatitis B-related deaths. An estimated 71 million people are infected with hepatitis C globally, an infection that kills over 400 000 people each year. 9. The WHO South-East Asia Region has an estimated 39 million people with chronic hepatitis B (range 29–77 million) and around 10 million with hepatitis C. Of the estimated 410 000 deaths due to viral hepatitis each year in the Region, 81% are attributed to chronic complications of hepatitis B and C. 10. Hepatitis A and E – which cause acute hepatitis – are amenable to prevention through safe water, hygiene and sanitation, and there is an effective vaccine for hepatitis A. However, countries in the South-East Asia Region of WHO continue to report outbreaks of these diseases – hepatitis A caused 5416 and hepatitis E 31 704 deaths in the year 2015 in the Region, most of which were concentrated in Bangladesh, India and Nepal. 11. People living with HIV coinfected with either hepatitis B virus or hepatitis C virus are at increased risk of treatment failure, complications and death, and are prioritized for management of both conditions. 12. Given that hepatitis B vaccination is highly effective and universal coverage of immunization for newborns (birth dose ideally within 24 hours) followed by two to three doses in infancy can prevent over 90% of transmission, this is one of the key interventions for prevention. As there is an inverse correlation between age of infection and chronicity – the highest for perinatal and childhood infections – the argument in favour of reaching out to all newborns and infants is compelling. Currently, eight out of 11 countries in the Region provide hepatitis B birth dose vaccination. The latest reported coverage for hepatitis B birth dose vaccination in the SEA Region is 55% (Timor-Leste started it in 2016 and Myanmar reintroduced it in late 2016) and that for the three doses of vaccination for hepatitis B is 88%. Large and populous countries such as India, Indonesia and Myanmar need to step up immunization coverage, especially the birth dose. 13. The other major source of infection is horizontal, largely through unsafe health-care interventions, including unsafe injections and transfusions. Hence, there is a need to ensure injection and blood safety, and awareness on overuse and safety of injections in health and nonhealth settings. Equally important is the expansion of harm reduction services for people who inject drugs as they are disproportionately infected with viral hepatitis. Certain population groups at enhanced risk, such as those receiving frequent transfusions (e.g. those with
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thalassaemia and haemophilia), those receiving invasive health procedures such as dialysis, health-care providers, close family contacts of known infected persons, sex workers, and men who have sex with men, should be screened and vaccinated against hepatitis B if not already protected or infected.
Global, regional and country responses 14. With over 1.34 million annual deaths – a burden similar to those due to HIV and tuberculosis – the global momentum for the disease to be recognized as a global public health concern is now on the upswing, thanks to continued advocacy and scientific breakthroughs, especially for the treatment of hepatitis C. 15. The World Health Assembly adopted three resolutions on viral hepatitis, WHA63.18 in 2010 and WHA67.6 in 2014, which called for the development of a global strategy for viral hepatitis. In 2016, the Global Health Sector Strategy on viral hepatitis (2016–2021) promulgated vide resolution WHA69.22 was endorsed by all Member States. 16. At the Regional Committee’s Sixty-seventh session in Dhaka in 2014, viral hepatitis was discussed as an item on the technical Agenda. 17. The Regional Immunization Technical Advisory Group (ITAG) in June 2016 recommended a regional control goal of ≤1% seroprevalence of hepatitis B surface antigen (HBsAg) by 2020 among children less than 5 years of age. As the ITAG also recommended developing an action plan for accelerating hepatitis B immunization to move towards the regional control goal, the newly developed Regional Vaccine Action Plan 2016–2020 (RVAP) details strategic objectives, recommended activities and key monitoring indicators for accelerating hepatitis B control (goal 6). The RVAP also provides frameworks under the goals of strengthening of routine immunization systems (goal 1) and introduction of new vaccines (goal 7) for future hepatitis A and E vaccination as part of comprehensive national hepatitis prevention strategies. 18. To build upon the global and regional momentum on elimination of mother-to-child transmission of HIV and syphilis, and also to think ahead to the 2030 targets of the Global Health Sector Strategy on HIV 2016–2021, the WHO Regional Offices for South-East Asia and the Western Pacific in collaboration with the WHO Region of the Americas and WHO headquarters have developed a conceptual framework for triple elimination of mother-to-child transmission of HIV, syphilis and hepatitis B.
The way forward 19. Based on the Global Health Sector Strategy on viral hepatitis (2016–2021), a Regional Action Plan for Viral Hepatitis in the SEA Region (2016–2021) has been developed in consultation with Member States, partners (including civil society) and academic institutions. It provides an actionable framework governed by the principles of human rights, equity, community involvement, universal health coverage, partnership and evidence-led actions.
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20. To better guide actions aimed at prevention and control of viral hepatitis and related morbidity and mortality, there is also an urgent need to take steps for better estimation of the disease burden, raise resources needed for an effective response to viral hepatitis as well as advocate for greater resource allocation from domestic funds by Member States.
Goal of the Regional Action Plan 21. To eliminate viral hepatitis as a major public health threat in the Region by the year 2030.
Purpose 22. To provide an actionable framework of evidence-based, priority interventions to support national responses for prevention, diagnosis and treatment of viral hepatitis. 23. The Regional Action Plan is based on five Strategic Directions, each one of them specifying the areas of intervention. Strategic Direction 1: Information for focused action Strategic Direction 2: Interventions for impact Strategic Direction 3: Delivering for equity Strategic Direction 4: Financing for sustainability Strategic Direction 5: Innovation for acceleration. 24. The detailed priority areas of intervention and actions by countries and WHO under each of the five Strategic Directions are at Annexure 1. 25. The Regional Action Plan will guide the work of WHO on viral hepatitis in the South-East Asia Region and will incorporate guidance and recommendations from related action plans and strategies. The framework for implementation will be guided by principles of universal health coverage (UHC). 26. In order to monitor the response to viral hepatitis, a set of indicators has been finalized and the work will be coordinated with other units and departments such as immunization, water, sanitation and hygiene, and blood and injection safety, etc. The year-wise targets for the different indicators to monitor progress are at Annexure 2. 27. The Regional Committee is requested to review the Regional Action Plan for Viral Hepatitis 2016–2021, offer any recommendations it deems pertinent and consider ratifying the Regional Action Plan for Viral Hepatitis in South-East Asia 2016–2021. (Annexure 3: http://www.searo.who.int/entity/hepatitis/en/)
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Conclusions 28. Viral hepatitis infections are to a large extent amenable to prevention and control; there are effective vaccines against hepatitis A and B, effective treatment against hepatitis B and now a cure for hepatitis C in most cases. 29. Prevention and control of hepatitis needs to be the top priority of Member States with a view toward eliminating viral hepatitis by 2030 as a part of SDG 3.3. 30. The Regional Committee is requested to review the Regional Action Plan for Viral Hepatitis 2016–2021, offer any recommendations it deems pertinent, and consider ratifying the Regional Action Plan for Viral Hepatitis in the South-East Asia Region 2016–2021.
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Annexure 1
Priority areas of and actions for the Regional Action Plan Priority area 1. Information for focused action 1.1 1. Understanding the epidemic and the response 2. Identify a focal point and unit for viral hepatitis, and convene a stakeholder group that includes people living with viral hepatitis for data-driven action for advocacy, planning, policy and programme implementation. Integrate viral hepatitis surveillance activities and indicators within national health information systems and tools, including for outbreak surveillance. 1. Support countries in adapting WHO normative guidance and tools on hepatitis surveillance, and monitoring and evaluation. Country actions WHO actions
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2. Support countries to strengthen health information systems, Assess the national and, where indicated, including target-setting, subnational prevalence and burden of all forms planning, of hepatitis and their sequelae, and develop a implementing, monitoring framework to help assess progress monitoring and and monitor trends over time. evaluating the health Use modelling adapted to the local context for sector response along prioritizing interventions, geographical the cascade of viral locations and populations. hepatitis prevention, care and treatment Monitor access to, uptake and quality of viral services. hepatitis services, disaggregated by different populations and geographical locations to 3. Provide technical guide service improvement. support for the Ensure community participation and development of engagement led by the national programme national estimates, and and key stakeholders to obtain critical assessment of existing sociobehavioural information, and identify and needed health challenges and opportunities for improving system capacity for access to services. scaling up interventions for viral hepatitis. Create or strengthen structures within the national programme to ensure participation of people infected with and affected by viral hepatitis to inform all aspects of service delivery from the perspectives of affected communities. 4. Support countries in modelling, projections, economic analyses and making an investment case for viral hepatitis.
8.
Strengthen or establish a disease registry at national level for liver cirrhosis and hepatocellular carcinoma (HCC; liver cancer).
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Priority area 1.2 Develop and implement evidenceinformed national hepatitis plans 1.
Country actions Convene a stakeholder group led by the Ministry of Health (MoH), and specifically include people with viral hepatitis, to develop and/or revise national plans. Establish a national governance structure and coordination mechanism to oversee the national hepatitis response, integrated within the national health programme. Develop a national plan on viral hepatitis with costing to make a case for securing domestic financing and mobilizing external resources.
WHO actions 1. Provide technical assistance to countries for developing and/or revising their national plans, target-setting and prioritization, and provide support for implementation, monitoring and review.
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2. Convene stakeholders, including communities, civil society, people with viral hepatitis, Set national targets and define indicators to development partners monitor and evaluate, and to report on, the and opinion leaders, for national hepatitis response. ongoing consultation Optimize approaches to ensure a coordinated and dialogue to and integrated framework of action for efficient generate demand and and effective resource use. address stigma and discrimination. Engage with communities and key stakeholders across various national programmes, such as 3. Increase awareness of immunization, infection control, harm viral hepatitis through reduction, drug policy, food, water and blood organizing activities safety, HIV and cancer, for an integrated health such as World Hepatitis sector response. Day. Engage with other sectors, such as education, immigration, police, labour and justice, to reduce stigma and discrimination. Address regulatory issues arising from the registration and use of drugs for improving access to affordable diagnostics and medicines for scaling up the viral hepatitis response. Use modelling for informing priority interventions. 4. Provide technical support for modelling, cost–effectiveness and economic analyses. 5. Support national programmes to strengthen regulatory and procurement issues.
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10. Regularly review the national hepatitis response.
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Priority area 2. Interventions for impact 2.1 Prevention of transmission 2.1.1 Vaccination 1.
Country actions
WHO actions
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5. 6.
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Strengthen routine immunization services to 1. Provide technical achieve and sustain a high coverage of timely support for increasing birth dose followed by 2–3 doses of hepatitis B hepatitis B vaccination vaccine as per national childhood coverage, especially a immunization schedules. timely birth dose, and conducting quality Coordinate with the maternal and child health hepatitis B (MCH) programme to improve access to seroprevalence surveys immunization for births outside of health to measure the impact facilities; and consider catch-up HBV of immunization. vaccination for children and adolescents in areas with low coverage. 2. Update strategies for the control of hepatitis Vaccinate priority adult population groups – B through contacts and families of people with hepatitis immunization, B, health-care workers and other high-risk advocacy materials, groups, such as men who have sex with men, implementation of the transgender people, sex workers, people who birth dose, etc. inject drugs (PWID), recipients of repeated blood/plasma transfusions, etc. 3. Set up regional hepatitis B immunization and Ensure vaccine supply and quality to prevent control goals. vaccine stock-outs, vaccine freezing or heat damage through improved training of staff, and 4. Conduct advocacy to promotion of the use of a controlled promote access to all temperature chain for delivery of the hepatitis hepatitis vaccines B birth dose where available. through expanding coverage of vaccines Improve data collection and mapping to already in the national identify poorly performing areas. schedule, and include Conduct advocacy and social mobilization to additional vaccines in raise awareness among policy-makers, health the national schedule providers, community workers, family where relevant. members and caregivers. 5. Build capacity for Measure programme performance through surveillance of and monitoring of immunization coverage rates, response to adverse including timely birth dose coverage, and effects following impact through hepatitis B seroprevalence immunization (AEFI). surveys. 6. Conduct operational research to identify innovative strategies to increase immunization coverage, especially for home births.
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Priority area 2.1.2 Ensuring blood safety 1.
Country actions Review and strengthen national policies and practices on blood safety that promote the rational use of blood and blood products.
WHO actions
2.
1. Provide technical support to countries for strengthening the management of safe Put in place mechanisms and systems for blood supplies and quality assurance of laboratory testing for viral linkages between blood hepatitis B and C to ensure a reliable supply of transfusion services and quality-assured screening assays. viral hepatitis services. Strengthen systems for surveillance, haemovigilance and monitoring of the incidence and prevalence of viral hepatitis infections in blood donors, and monitor the risk of post-transfusion hepatitis. Advocate for and communicate the need for non-remunerated voluntary blood donation, and rational use of blood and blood products. 2. Support countries with tools and technical assistance to establish systems for surveillance, haemovigilance, and monitoring of supplies of blood and blood products. 3. Communicate and advocate for promoting non-remunerated, voluntary blood donations. 4. Provide technical support and advocacy for rational use of blood and blood products.
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2.1.3 Prevention of viral hepatitis infection in health-care settings
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Establish or strengthen the national infection prevention and control (IPC) regulatory body.
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1. Provide technical support for developing, updating, implementing Strengthen and sustain routine IPC practices in and monitoring health-care settings (public and private), infection prevention including in laboratories, dental clinics, policies in health-care endoscopy clinics and haemodialysis units. settings, including Develop and implement a national safe outreach services. injection policy and practices and, where 2. Provide technical feasible, use WHO prequalified safetysupport for engineered injection devices. implementing WHO’s Ensure health-care provider safety, including injection safety policy, access to immunization and post-exposure introduction of safe prophylaxis (PEP). injection devices, and monitor their Monitor outbreaks of infection in health-care implementation and settings. impact. Allocate adequate resources and build the
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Priority area
Country actions capacity of staff in IPC measures, such as universal precautions and safe biomedical waste management. 7.
WHO actions 3. Provide technical support for investigation of infection outbreaks.
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Raise awareness and advocate among health workers and auxiliaries on viral hepatitis 4. Provide technical transmission, and the importance of safety and support for setting up infection prevention. and maintaining adequate regulatory Address disinfection and sterilization practices structures for IPC. in non-health settings, e.g. tattoo clinics, barber shops. Raise awareness and advocate among the public to reduce the demand for unnecessary injections. Introduce and improve coverage of a timely birth dose of hepatitis B vaccine, including coverage of births taking place outside of health-care facilities, followed by immunization of infants with 2–3 doses as per national schedule. In collaboration with the MCH department, update national policies and guidelines on maternal and neonatal health, based on evolving WHO guidance on elimination of mother-to-child transmission of viral hepatitis. 1. Provide technical support for advocacy and implementation of the hepatitis B birth dose followed by 2–3 doses of the vaccine as per the national immunization schedule. 2. Conduct implementation science research for improving access to vaccination for home births, including the use of a controlled temperature chain. 3. Provide technical support to countries for implementation of an evidence-based package of interventions to eliminate mother-tochild transmission of hepatitis B, and coordination and collaboration with the MCH and immunization programmes.
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2.1.4 Prevention of mother-tochild transmission
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Priority area 2.1.5 Prevention of transmission through injecting drug use 1. 2.
Country actions Ensure access to harm reduction services for people who use drugs.
WHO actions
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1. Provide technical support for designing, implementing and Address HBV- and HCV-related stigma and monitoring a discrimination while providing harm reduction comprehensive services. package of harm Accelerate implementation of a comprehensive reduction interventions harm reduction programme, which has been for prevention of expanded to cover the prevention of and hepatitis B and C. testing for hepatitis B and C among vulnerable 2. Advocate for and populations. ensure political Review and modify laws that restrict or commitment to criminalize activities of drug users and address facilitate access to harm institutional barriers for expanding harm reduction interventions, reduction services. and a review of restrictive policies and Link hepatitis and harm reduction services to institutional barriers. facilitate integrated prevention, treatment and care for people who use drugs. Ensure community engagement to reach unreached populations, facilitate access to services and reduce stigma. Ensure access to opioid substitution therapy (OST) for opioid-dependent individuals, including in closed settings. Ensure access to safe injections and needles such as low dead-space syringes. Collaborate with communities to develop service delivery models to reach PWID with viral hepatitis prevention, screening, treatment and care services. 3. Advocate for political commitment to and resource allocation for programmes targeting PWID. 4. Provide technical support for assessing barriers to the implementation of effective harm reduction interventions and health service provision for PWID.
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10. Implement integrated services for PWID, linking with services for viral hepatitis, TB, HIV, substance use and mental health. 2.1.6 Prevention of sexual transmission 1. Ensure access to comprehensive and evidence- 1. Provide technical support for and based sexual and reproductive health services. guidance on These should include health promotion, comprehensive STI education, prevention and management of prevention and sexually transmitted infections (STIs) for all, treatment services, with a specific focus on key and vulnerable especially for key and populations. vulnerable populations.
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Priority area 2.
Country actions
WHO actions
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Strengthen the involvement and management 2. Support countries in reducing barriers to of sexual partners, ensuring confidentiality and access to STI services, access to counselling, testing and treatment of including condoms and STIs. lubricants for key Conduct advocacy and communication for populations. consistent condom use, especially for key populations, and ensure continuous and quality supply of condoms and lubricants. Engage with community organizations and networks for increasing the demand for STI services and reaching out to key populations. Ensure intersectoral collaboration with the water, sanitation and agriculture departments to ensure access to safe water, safe food, hygiene and sanitation. Advocate for and communicate the need for safe food, water, hygiene and sanitation. Improve access to safe sanitation facilities and educate the public on safe disposal of human faeces. 1. Support risk assessment and management of water supplies, food safety, sanitation and hygiene. 2. Provide technical support for intersectoral collaboration to improve water and food quality.
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2.1.7 Ensuring access to safe water and food
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Put in place effective surveillance and outbreak 3. Provide technical response systems, and reporting systems for support for outbreak hepatitis A virus (HAV) and hepatitis E virus investigation, reporting (HEV). and monitoring actions on the Engage and communicate with communities recommendations. on prevention of transmission and early case reporting of outbreaks. Develop evidence-based viral hepatitis testing guidelines and testing algorithms at the national level. 1. Provide technical support for developing and validating national diagnostic algorithms for testing.
2.2 Diagnosing hepatitis infection
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Integrate viral hepatitis testing into health settings where feasible, e.g. HIV, antenatal care 2. Develop a regional (ANC), key population intervention sites, network of qualitynoncommunicable diseases, cancer screening assured laboratories for and treatment services, etc. expanding quality Prioritize populations and locations for testing, assurance, capacityand modify testing approaches and strategies building and horizontal according to these. collaboration.
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Priority area 4.
Country actions Strengthen the national laboratory system to ensure quality assurance for testing, including laboratory and point-of-care diagnostics, and confidentiality of test results. Improve the availability of affordable, quality diagnostic test kits for the diagnosis of viral hepatitis. Increase awareness and capacity-building among primary care providers on testing for HBV and HCV. Establish and strengthen linkages between testing and other services. Engage with communities, raise public awareness and advocate for increasing the demand for testing, especially for key and vulnerable populations. Develop and implement a national testing policy detailing the roles and responsibilities of people diagnosing viral hepatitis, particularly in informing people that they are infected. Ensure access to clinical management for hepatitis B and treatment for hepatitis C in the public sector.
WHO actions 3. Provide technical support for developing testing guidelines, including decentralized testing approaches and establishing quality assurance mechanisms. 4. Facilitate access to quality-assured diagnostics, including point-of-care rapid tests and viral load testing. 5. Develop a best practice model of testing for viral hepatitis.
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2.3 Enhancing hepatitis treatment and care of chronic liver disease
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1. Provide technical assistance and support to countries for developing and Ensure the availability of diagnostics for staging updating standard of chronic liver disease to prioritize and plan treatment guidelines treatment and clinical management. and protocols. Ensure registration and licensing of newer 2. Identify the barriers to medicines and necessary national legislations management and care to improve access to affordable medicines for services for people with treating viral hepatitis. viral hepatitis. Make effective use of flexibilities in the 3. Provide technical Agreement on Trade-Related Aspects of assistance for capacityIntellectual Property Rights (TRIPS) to improve building in affordable access to oral antiviral medicines for decentralized service treating hepatitis B and C. delivery. Develop standard guidelines, plans and 4. Conduct protocols for treatment of various forms of implementation science hepatitis, in line with the latest evidence and research for innovations guidance from WHO. in diagnostics and
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Priority area 6.
Country actions Build the capacity of health-care providers in the use of newer medicines and follow up of patients on treatment. Review the infrastructure of existing health systems and strengthen them where necessary to implement and scale up treatment for viral hepatitis. Conduct research to identify the barriers to access to these services. Prioritize and focus on designing phased implementation of treatment programmes. Engage with the private sector for implementation of national standards, reporting and price regulation.
WHO actions service delivery. 5. Expand partnerships and collaborations, including with communities and civil society organizations (CSOs), for advocacy and resource mobilization for hepatitis. 6. Provide technical support for registration of newer medicines and devices, price negotiations and use of TRIPs flexibilities for improved and affordable access to medicines.
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10. Expand access to quality standard treatment through decentralization and public–private partnerships. 11. Strengthen monitoring and evaluation for timely treatment initiation, response to treatment, drug toxicity and adverse event monitoring. 12. Monitor the cascade of treatment and care to identify and address barriers to early linkage and retention in care. 13. Address common comorbidities, such as HIV infection and risk factors that may accelerate progression of liver disease, and improve access to palliative and end-of-life care. 14. Post treatment/cure, monitor patients for cirrhosis and HCC, including the need for liver transplantation. 3. Delivering for equity 3.1 Improving viral hepatitis services 1. Identify and prioritize most affected populations and locations to expand access to services and service delivery. Ensure community engagement and involvement of people infected with and affected by viral hepatitis to inform policymaking, programme implementation and monitoring for impact.
2.
1. Provide technical support for implementation research on community involvement and decentralized service delivery. 2. Provide technical support for developing
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Priority area 3.
Country actions Conduct implementation research on community engagement in policy-making and developing innovative service delivery models. Ensure quality assurance through implementation and monitoring of evidencebased norms and standards in the public and private sectors.
WHO actions innovative service delivery models to raise awareness, expand access to testing and treatment for viral hepatitis, and reach hard-to-reach population groups.
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Strengthen monitoring and information systems 3. Provide technical to include indicators that capture the quality support for monitoring and equity of services, including access and the continuum and service use by different populations and in quality of care for different settings. prevention, control, diagnosis and treatment Initiate a dialogue with key stakeholders such of viral hepatitis. as industry, the Global Fund to Fight AIDS, Tuberculosis and Malaria, the Vaccine Alliance 4. Provide technical (GAVI) to improve access to viral hepatitis support for evaluating prevention, care and treatment services. the use of existing diagnostic platforms for Optimize and rationalize distribution of testing expanding diagnostics and treatment services to reach all those in for viral hepatitis. need. Use existing diagnostic platforms in other disease control programmes, such as exploring the use of GeneXpert machines from TB or HIV programmes for diagnosis of hepatitis. Include viral hepatitis services in the universal benefit package.
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Priority area 3.2 Strengthening human resources for hepatitis 1.
Country actions
WHO actions
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Review and strengthen pre-service and in1. Provide technical service curricula of health-care cadres to guidance and support include knowledge, skills and capacity-building for training health-care for managing viral hepatitis at various levels of workers. health-care service delivery. 2. Provide technical Identify opportunities for task-shifting and tasksupport for designing, sharing to extend the capacity of the health implementing and workforce, including community health monitoring workers, while ensuring supportive supervision decentralized service of and mentoring for front-line service delivery. delivery. Implement measures to reduce the risk of transmission of viral hepatitis in health-care settings, and ensure the safety and security of health-care providers. 3. Support national accreditation bodies for reviewing and updating pre-service and inservice curricula to Ensure access to PEP and treatment for healthinclude knowledge and care providers infected with viral hepatitis B skills on viral hepatitis. and C. 4. Advocate for reducing Raise awareness and conduct training of stigma and health-care workers to reduce stigma and discrimination against discrimination in health-care settings. health workers living with viral hepatitis. Strengthen the national hepatitis procurement and supply management structures and processes by ensuring that they are integrated into the broader national procurement and supply management system. Ensure the procurement of quality-assured hepatitis vaccines, medicines, diagnostics, condoms, and other hepatitis-related commodities, including through the use of WHO prequalification. 1. Support innovative strategies to reduce the prices of vaccines, medicines, diagnostics and other commodities for viral hepatitis. 2. Provide technical support to countries to forecast the need for essential commodities related to viral hepatitis.
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3.3 Ensuring access to good-quality and affordable hepatitis vaccines, medicines, diagnostics and other commodities
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Plan and implement a hepatitis medicines and commodities access strategy to reduce the prices of hepatitis-related commodities, and 3. Support national include fast-tracking registration of new regulatory authorities in medicines, price negotiations and use of TRIPs pre-market assessment flexibilities. and registration of new medicines and diagnostics for viral hepatitis, with postmarket surveillance.
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Priority area
Country actions
WHO actions 4. Provide technical support for quality assurance of diagnostics and medicines. 5. Give technical advice on joint procurement mechanisms and access to generic medicines. 6. Promote informationsharing on the prices of medicines and diagnostics across Member States through online price reporting systems.
3.4 Promoting an enabling environment
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Review laws, policies and institutional mechanisms that restrict access to hepatitis prevention and treatment interventions for most affected and vulnerable groups. Address stigma and discrimination in settings such as health care, education and employment.
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1. Provide technical support for review of laws and policies in line with WHO guidelines on gender, equity and human rights.
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2. Provide technical support for measuring Include indicators in the monitoring and equity and quality of evaluation (M&E) plans to measure quality and service delivery, and equity (including gender equity) of services. stigma and Collaborate and partner with CSOs and other discrimination faced by stakeholders to create an enabling affected communities, environment for effective, equitable and including in health-care efficient programme scale up. settings. Develop a national investment case for viral hepatitis to advocate and make a case for adequate resource allocation. 1. Provide technical assistance and support to develop investment cases.
4. Financing for sustainability Sustainability 1.
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Include essential interventions for hepatitis prevention and clinical management within the 2. Advocate for inclusion universal benefit package. of essential prevention, diagnostics and clinical Ensure sustainable financing for harm management of viral reduction interventions. hepatitis in the Explore alternative and innovative financing universal benefit mechanisms to reduce catastrophic health package. expenditure.
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Priority area 5.
Country actions Identify opportunities for resource-sharing, including infrastructure, human resources and finances in other related programmes for scaling up implementation of viral hepatitis interventions effectively and efficiently, e.g. coinfection management with the HIV programme, MCH and immunization programme for vaccination and prevention of mother-to-child transmission (PMTCT), harm reduction services, blood and injection safety, infection prevention services, surveillance and M&E.
WHO actions 3. Support countries in assessing and monitoring health service costs and cost– effectiveness. 4. Advocate for increased political commitment to allocation of domestic resources and resource mobilization from external development partners. 5. Review and assess existing resources, including infrastructure and human resources within national health systems, which could be leveraged for implementing the national viral hepatitis strategy and plan.
5. Innovation for acceleration Innovations 1. Promote viral hepatitis as an important research area and allocate or raise necessary resources. Embed implementation research in implementation plans to answer questions on scaling up coverage with quality and equity, and ensuring financial protection. Ensure intersectoral collaboration across programmes for integrated service delivery models. Interlink monitoring systems for strengthening viral hepatitis data capture, analysis and use. Disseminate and use research findings to better inform programme planning and implementation. 1. Provide technical support for designing implementation research projects within national plans. 2. Provide technical support for monitoring, and documenting and disseminating results. 3. Facilitate intercountry and interinstitutional collaboration. 4. Advocate for and facilitate innovations and implementation research within and across countries. 5. Ensure knowledge
2.
3.
4. 5.
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Priority area
Country actions
WHO actions management and create a repository of best practices and lessons learnt in innovations and use of newer technologies.
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Annexure 2
Targets for the Regional Action Plan Priority area 1. Information for focused action Understanding All Member States with a high burden of viral hepatitis have the epidemic and completed national disease burden estimates. the response All Member States have surveillance and M&E systems aligned with WHO guidance. Develop and implement evidenceinformed national hepatitis plans All high-burden Member States have developed national action plans for viral hepatitis. All high-burden Member States have started implementation of national action plans that include a communication and advocacy strategy. 2018 2020 2018 2020 Targets Timeline
2. Interventions for impact Prevention of transmission All Member States have included and scaled up implementation of the hepatitis B birth dose up to 75% and Hep B3 dose up to 90%. All Member States that have a policy of providing birth dose vaccination have reached 90% coverage with the birth dose and 95% coverage with Hep B3. All Member States have started implementation of routine Hep B vaccination among high-risk groups, including health-care workers. All Member States in the Region have haemovigilance systems in place, and all donated blood is tested for HBV and HCV. All Member States have 100% non-remunerated voluntary blood donations. All Member States have adopted and implemented safe injection and infection prevention and control (IPC) policies. 50% of all injections in Member States are administered with safety-engineered devices. 75% of newborns are covered with the Hep B birth dose within 24 hours of birth in all Member States implementing this policy. 75% of pregnant women screened for hepatitis B and postexposure prophylaxis (PEP) provided to exposed newborns in 2018
2020
2020
2018 2020 2018 2020 2018 2018
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Priority area
Targets Member States implementing such policies. 95% of newborns in Member States are covered with the birth dose within 24 hours. All Member States with a high burden of viral hepatitis have developed and implemented comprehensive and expanded harm reduction services for PWID. All Member States have achieved the target of at least 200 syringes/PWID, and at least 40% of opioid-dependent PWID have received OST. All Member States have programmes in place to provide comprehensive STI services, including access to condoms, lubricants, HIV and viral hepatitis testing, and linkage to care. All Member States have effective outbreak response and surveillance systems in place to monitor HAV and HEV outbreaks and outcomes.
Timeline 2020 2018
2020
2020
2020
Diagnosing hepatitis infection
All Member States with a high burden of viral hepatitis have national viral hepatitis testing policies aligned with WHO guidelines. 50% of all persons with HBV and HCV know their status.
2018
2020 2018
Enhancing hepatitis treatment and care of chronic liver disease
All Member States with a high burden of viral hepatitis have updated clinical treatment guidelines for HBV and HCV that are aligned with WHO guidelines. All Member States with a high burden of viral hepatitis have included recommended medical products for HBV and HCV treatment in the National Essential Medicines list and Essential Diagnostics List, based on updated clinical treatment guidelines (essential medicines and diagnostics). National disease burden and treatment needs are estimated in all high-burden Member States. 75% of all patients diagnosed with chronic hepatitis and eligible begin treatment. 90% of HCV patients treated achieve viral suppression and cure.
2019
2018 2020 2020
3. Delivering for equity Improving viral hepatitis services All high-burden Member States have expanded services for prevention, control and treatment of viral hepatitis to the district level. 2018
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Priority area
Targets 50% of Member States have included viral hepatitis services in the UHC benefit package.
Timeline 2020 2018 2019
Ensuring access to good-quality and affordable hepatitis vaccines, medicines, diagnostics and other commodities Promoting an enabling environment
All high-burden Member States have registered the medicines for HBV and HCV, and have negotiated the prices for medicines. All Member States with a high burden of viral hepatitis have included recommended medical products for HBV and HCV treatment in the National Essential Medicines list and Essential Diagnostics list, based on updated clinical treatment guidelines (medicines and diagnostics) or relevant national formularies to allow public procurement or health insurance coverage. All high-burden Member States have identified regulatory barriers, and reviewed and revised restrictive laws and policies limiting the full participation of people with viral hepatitis in society.
2020
4. Financing for sustainability Sustainability At least 50% of high-burden Member States have developed national investment cases for viral hepatitis. All Member States implementing UHC have included viral hepatitis services in the national benefit package. 5. Innovation for acceleration Innovations All high-burden Member States have implementation science research projects for innovations in programme planning and service delivery. 2020 2018 2020
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Annex 3
Regional Action Plan for Viral Hepatitis 2016–2021
Regional Action Plan will be annexed.