Information for Focused Action
This strategic direction focuses on the need to understand the viral hepatitis epidemic and response as a basis for advocacy, political commitment, national planning, resource mobilization and allocation, implementation, and programme improvement.
Global leaders have recognized viral hepatitis as an international public health and development priority by explicitly including it under target 3.3 of the 2030 Agenda for Sustainable Development. However, such global recognition has not necessarily resulted in country action. Few countries have national hepatitis strategies, plans and budgets. A robust strategic information system that analyses and translates up to date data on viral hepatitis into usable information can leverage much needed political commitment. Such a system is essential for generating the necessary data to create awareness and advocate for action and resources, to set national targets, to plan for a focused response, to implement programmes most efficiently in order to achieve greatest impact, and to monitor and improve quality and outcomes.
Understanding the Epidemic and the Response – Data for Decisions
With limited resources interventions, services and investments need to be strategically targeted to the local epidemic. Timely and reliable data, with an adequate level of “granularity”, are essential to identify “hotspots”. Such data make it possible to proactively focus high-impact interventions more precisely and effectively, and to deploy or adapt services to reach greater numbers of people in need.
Monitoring and understanding the response to viral hepatitis is critical for informing more strategic investments in hepatitis services, and for maximizing their effectiveness, responsiveness and cost-effectiveness. The hepatitis service continuum provides a good framework for establishing a national hepatitis monitoring and evaluation system, with indicators measuring coverage and performance along each step of the “cascade”. Resources can then be directed to address any significant “leaks” in the cascade, to improve retention in care.
Implement Evidence-Based National Hepatitis Plans
The national hepatitis response should be guided by a national plan with a well-defined governance and management structure that can ensure a coordinated and efficient response and clear accountability.
Strategic planning processes should enable meaningful inputs from all key stakeholders on policy development, service planning and resource allocation.
Informed by current data, national plans and investment cases can be used to mobilize political commitment, define and budget for tailored packages of interventions and services, define responsibilities and allocate resources across the different levels of the health system, and identify potential and reliable sources of funding. Such hepatitis plans, efforts and other activities should be fully aligned and appropriately integrated with broader national health and development strategies and plans, with the goal of achieving universal health coverage. Regular reviews of the national hepatitis response are essential in order to ensure that the national plan is current and “fit for purpose”.
Concerted advocacy efforts, particularly by political and community leaders, and a sound communication strategy are required to increase public and political awareness of the public health importance of viral hepatitis, to generate resources and to mobilize action. World Hepatitis Day provides an opportunity each year to raise public awareness, however, a broader and intensified communication strategy is required to generate the interest required to elevate and accelerate the hepatitis response to reach the global targets.
Interventions for Impact
This strategic direction addresses the first dimension of universal health coverage by describing the essential package of high-impact interventions that need to be delivered along the continuum of hepatitis services to reach country and global targets, and which should be considered for inclusion in national health benefit packages.
Defining an Essential Benefit Package for Viral Hepatitis
Each country needs to define a set of essential viral hepatitis interventions, services, medicines and commodities relevant to the country context, to be included in the national health benefit package.
The benefit package should be covered in whole, or in part, through public funding so as to minimize out-of pocket payments, ensure access to services for all who need them, and cover the entire continuum of hepatitis services, including prevention, diagnosis, treatment and care.
Essential Interventions for Viral Hepatitis
The essential package of viral hepatitis interventions and services should include all five core viral hepatitis interventions: vaccination, particularly for hepatitis B virus, and where appropriate, hepatitis A virus; injection, blood and surgical safety and universal precautions; prevention of mother-to-child transmission of hepatitis B virus; harm reduction services for people who inject drugs; and treatment of chronic hepatitis B virus and hepatitis C virus infection.
In addition, ensuring high levels of sanitation and access to safe food and water is essential for preventing and controlling epidemics of hepatitis A virus and hepatitis E virus. Interventions for prevention of sexual transmission of hepatitis B virus and hepatitis C virus are important for specific populations. Hepatitis prevention interventions also contribute to broader health outcomes, including the prevention of HIV, sexually transmitted and other blood-borne infections described below.
Effective vaccines exist for preventing viral hepatitis A, B and E infections. Hepatitis B virus immunization is a critical intervention for the elimination of hepatitis B virus epidemics. Wider provision of the existing, safe and effective hepatitis B virus vaccine, including through universal childhood vaccination and by delivery of birth-dose, will drastically reduce new hepatitis B infections, reducing rates of chronic illness and death.
Improving blood safety
The risk of transmission of viral hepatitis B and C (as well as HIV and other bloodborne infections) through the transfusion of contaminated blood and blood products is extremely high, and, despite being preventable, still occurs because of the absence, or poor quality, of screening in blood transfusion services. Ensuring the availability of safe blood and blood products is a vital public health duty for every national government.
Enhancing infection prevention and control in health care settings
Consistent implementation of infection control practices, including safe injection measures in health care and community settings, will reduce transmission of viral hepatitis and other infections to both users of health care services as well as health care workers. The GHSS strategy sets a target for increasing the percentage of medical injections administered with safety-engineered injection devices from a baseline of 5% in 2015 to 50% in 2020 and 90% in 2030.
Preventing mother-to-child transmission of viral hepatitis
Transmission of hepatitis B virus in highly endemic areas often occurs from infected mothers to their infants during the perinatal period.
Birth-dose vaccination is a key intervention for prevention of hepatitis B virus infection in infants. However, its delivery can be a challenge in communities where a large proportion of births occur outside of health facilities. As a result, global coverage is only around 39%. The GHSS strategy calls for the expansion of interventions to prevent mother-to-child transmission of hepatitis B virus to achieve a coverage of 50% by 2020 and 90% by 2030.
Providing harm reduction services
A package of harm reduction services for people who inject drugs can be highly effective in preventing the transmission and acquisition of viral hepatitis A, B and C, as well as HIV and other blood-borne infections. The hepatitis C virus is more easily transmissible than HIV, therefore harm reduction services should include provision of all injecting paraphernalia, including mixing containers and solutions.
Promoting safer sex
Although sexual transmission of viral hepatitis B and C plays a minor role in most hepatitis epidemics, specific attention should be given to certain populations, particularly men who have sex with men and who have not been vaccinated against hepatitis B virus, and in heterosexual persons with multiple sexual partners.
Ensuring access to safe food and water
An estimated 748 million people lack access to an improved source of drinking water and 2500 million people, more than one third of the global population, live without basic sanitation facilities. Assuring access to safe food, drinking water and sanitation systems can dramatically reduce the transmission of viral hepatitis A and E.
Diagnosing Hepatitis Infection
Early diagnosis of hepatitis infection is critical for effective treatment and care. Yet globally, only 9% of persons living with hepatitis B and 20% of persons living with hepatitis C have been tested and are aware of their status. Awareness is lacking, reliable diagnostics that are appropriate for the setting of intended use and testing services are not sufficiently available, and laboratory capacity is weak. The strategy calls for a major increase in diagnosis of chronic viral B and C infection, with 30% of people infected knowing their status by 2020 and 90% by 2030.
Enhancing Hepatitis Treatment and Chronic Care
Effective antiviral agents against viral hepatitis B and C have the potential to dramatically reduce morbidity and mortality, including among people co-infected with HIV. Not all people with chronic hepatitis infection require, or are eligible for, treatment. Individuals need to be assessed for liver disease to determine whether treatment is indicated, and if not eligible for treatment, regularly monitored to determine when treatment should be initiated.
The GHSS strategy calls for 5 million people with chronic hepatitis B virus infection to be on treatment by 2020, and for 3 million people with chronic hepatitis C virus to have been treated by 2020. By 2030, treatment coverage for both chronic viral hepatitis B and C infection should reach 80% of eligible persons.
Providing chronic care
People with chronic hepatitis infection may require care for a range of health and psychosocial problems. In addition to liver cirrhosis and hepatocellular carcinoma, people with chronic hepatitis infection may experience extra hepatic manifestations of their infection, including insulin resistance and diabetes. Alcohol use, smoking and obesity may complicate chronic infection. An assessment of alcohol intake is recommended for all people with chronic viral hepatitis infection followed by the offer of a behavioural alcohol reduction intervention for those people with moderate-to-high alcohol intake.
In addition to antiviral treatment, chronic care is required for many, including the management of decompensated liver disease and hepatocellular carcinoma. Treatment of advanced liver cirrhosis and hepatocellular carcinoma, including liver transplantation and chemotherapy, is very limited in most low- and middle-income settings, highlighting the need to provide access to good quality palliative and end-of-life care.
Delivering for Equity
This strategic direction addresses the second dimension of universal health coverage by identifying the best methods and approaches for delivering the continuum of hepatitis services to different populations and in different locations, so as to achieve equity, maximize impact and ensure quality.
An effective hepatitis response requires robust and flexible health systems that can sustainably deliver people-centred care across the full continuum of services to those populations, locations and settings in greatest need.
Large proportions of people at high risk of, or living with, chronic hepatitis infection do not have access to prevention services, remain undiagnosed, do not use or adhere to treatment, and cannot access chronic care services. Furthermore, existing hepatitis services seldom address critical underlying factors that can generate health inequities, such as poverty, discrimination and criminalization, drug dependence and poor mental health.
Interventions and services, where they exist, are often poorly targeted and fail to reach those who are at greatest risk or who are most affected. Such factors lessen the overall impact of interventions and services. The impact of hepatitis responses is also dependent on the quality of hepatitis medicines and diagnostics, interventions and services. When hepatitis services are available, issues of affordability, accessibility and acceptability can prevent their optimal utilization.
Adapting Viral Hepatitis Services
An efficient health system should be able to deliver essential hepatitis services to different populations and settings, reinforce strategic linkages between different health services, ensure quality of the services and actively engage communities.
Tailoring services for different populations and locations
Not all hepatitis interventions and services will be required by all populations and in all locations and settings. Strategic information gathered on affected populations, risk factors and locations should help guide the adaptation and implementation of the essential hepatitis package to specific populations, country settings and contexts.
Linking and integrating hepatitis services with other health services
Greater integration and linking of viral hepatitis services with other relevant health services (including for sexually transmitted infections, HIV, broader sexual and reproductive health, harm reduction and drug use disorders, alcohol use disorders, blood safety, cancer prevention and management, and non-communicable diseases) can speed up progress towards key milestones and targets, and increase efficiency, reach, acceptability and savings.
Strengthening community-based services
Community-based services provide opportunities to reach marginalized groups, improve acceptability and utilization of services, facilitate decentralization of services to provide more equitable access, enhance the quality and impact of services, improve efficiencies and reduce costs. Lessons can be learnt from community-based services addressing other health issues, such as HIV and palliative care.
Involving people living with viral hepatitis
Actively engaging affected populations in developing strategies and programmes should result in better targeted and acceptable services. Affected populations can also act as a powerful force in addressing discrimination, criminalization and harmful socioeconomic and cultural norms that help generate health inequities.
Ensuring the quality of interventions and services
Rapid expansion of programmes to improve coverage should not compromise the quality of services, nor contribute to inequities in access to services and health outcomes. Quality can be optimized by ensuring that interventions and services conform to national and international norms and standards, are continuously monitored and improved, and are made more acceptable and accessible to patients’ needs and preferences.
Strengthening Human Resources for Hepatitis
Many essential viral hepatitis interventions are integrated within broader health services and programmes, such as programmes for child vaccination, blood and injection safety, food safety, water and sanitation, harm reduction for drug users, clinical management of infectious diseases and chronic care for non-communicable diseases.
In all such settings, including primary health care, health workers should be knowledgeable about viral hepatitis risk and infection, and the package of essential hepatitis interventions. They should be competent to work with people living with chronic hepatitis infection and those most affected and at risk.
Ensuring Access to Good Quality and Affordable Hepatitis Vaccines, Medicines, Diagnostics and Other Commodities
Effective hepatitis programmes are dependent on the uninterrupted supply of quality-assured vaccines, medicines, diagnostics and other commodities. Robust procurement and supply management systems are required to ensure that the right products are selected, purchased at a reasonable price and efficiently delivered to the point of care. Disruptions in supply, including stockouts, of hepatitis medicines contribute significantly to the risk of treatment failure.
The demand for affordable treatment for viral hepatitis B and C infection requires comprehensive price reduction strategies for medicines, diagnostics and health commodities, including for those medicines and diagnostics in the development pipeline.
There are also many opportunities to save on procurement of hepatitis commodities and improve efficiencies in supply management, such as bulk procurement with staggered deliveries for short shelf-life commodities, advanced purchasing and improved forecasting to avoid wastage through expired products.
Promoting an Enabling Environment
As with other public health programmes, the hepatitis response requires an enabling environment of policies, laws and regulations that support the implementation of evidence-based policies and programmes, and promote and protect human and health rights, reduce stigma and ensure health equity. The health sector has a compelling obligation to ensure that such an environment exists.
When properly enforced, laws and policies can reduce people’s vulnerability and risk for hepatitis infection, expand access to health services and enhance their reach, quality and effectiveness – especially for most affected populations. However, legal, institutional and other barriers may prevent certain groups of people from accessing effective interventions and using health services such as adolescents, prisoners, people who use drugs, men who have sex with men, sex workers and transgender people.
People with viral hepatitis and those at risk may be exposed to stigmatization, discrimination and social marginalization, further impeding their access to hepatitis services. Many of these barriers can be overcome if existing models of service delivery are reviewed and adapted to meet the needs of affected populations. Others may require the reform or removal of certain laws, regulations and policies.
Financing for Sustainability
This strategic direction addresses the third dimension of universal health coverage by identifying sustainable and innovative models for financing of hepatitis responses and approaches for reducing costs so that people can access the necessary services without incurring financial hardship.
People should receive the hepatitis services they need without experiencing financial hardship.
Adequate investment in the full continuum of hepatitis services is necessary to achieve the targets for 2020 and 2030, and to promote universal health coverage. Increasing access to high quality and affordable medicines and diagnostics for viral hepatitis B and C infection, coupled with standardized and simple treatment protocols, is critical.
Financing for a sustainable hepatitis (and broader health) response requires action in three areas:
- Revenue raising to pay for viral hepatitis interventions and services.
- Financial risk protection and pooling, including establishing equitable mechanisms to pool funds across the health system to ensure adequate coverage along the hepatitis services continuum.
- Improving efficiency in the use of health system resources to enable greater effective coverage of hepatitis services.
The national health financing systems should address viral hepatitis along with all other priority national health issues, avoiding fragmented funding channels while aiming to achieve health equity.
Increasing Investments Through Innovative Financing and New Funding Approaches
Unlike the other major communicable diseases, such as HIV, tuberculosis and malaria, there has been very little external development assistance funding for comprehensive viral hepatitis responses. Similarly, most countries do not have dedicated hepatitis budgets or programmes. Therefore, new sources of funding will be required for countries to launch, accelerate and sustain public health responses to viral hepatitis, and these resources will need to be substantial if the ambitious global targets are to be realized.
Strategies to increase investment in hepatitis need to be part of broader efforts to increase overall investments in health, so that all priority health services can be scaled up towards universal health coverage. Public, domestic funding will be central to funding essential viral hepatitis services in all countries and to ensure the long-term sustainability of such services. Public spending on health can be increased either by raising more tax revenues (increasing a government’s fiscal capacity) or by allocating a greater share of overall government funds to health (giving health a greater priority in the public budget).
Many low- and lower middle-income countries will rely on external funding to expand their hepatitis responses over the period of the strategy. Revenue flows from such sources need to be fully aligned with national hepatitis and broader health sector priorities, programmes and plans. Stability and predictability of these revenue flows are essential to minimize the risk of service interruption.
Addressing Financial and Other Barriers to Access and Provide Financial Risk Protection
Health financing systems that minimize out-of-pocket payments for all essential health services increase access to these services and prevent impoverishment. To minimize catastrophic health payments, out-of-pocket spending should be limited to less than 15–20% of the total health spending.
Treating chronic hepatitis infections, especially new treatments for hepatitis C, and care for cirrhosis and cancer is currently unaffordable for many people.
Essential viral hepatitis interventions, across the continuum of hepatitis services, should be included in the national health benefit package and be provided free of charge. In addition, the provision of supportive arrangements (such as decentralizing services or offering transport vouchers) to minimize the indirect costs for people using services can improve service uptake and impact.
Financial risk protection and access to needed services for people at risk and living with hepatitis will depend on a broader, robust and fair national health financing system. Public financing systems for health, involving predominant reliance on revenues raised from general taxation and/or payroll taxes for compulsory health insurance, are the most equitable and efficient systems. Such prepayment mechanisms should be based on an ability to pay, with broad pooling of the revenues to enable benefits to be provided to those in need, including those who cannot afford to contribute to the system.
Reducing Prices and Costs, and Removing Inefficiencies
Fiscal constraints require that countries select the most effective interventions and approaches, target those activities to the populations and settings where they will have greatest impact, reduce the prices of medicines and other health commodities, and increase the efficiency of services. Programmes that can demonstrate “value for money” and efficiency gains are better positioned to argue for fair allocation of resources and external financial support. The potential for efficiency gains across programmes needs to be explored.
Good programme management can improve the efficient flow, allocation and utilization of resources from national budgets or external sources to service delivery. This includes better coordination of donor funding and alignment with national plans and the broader health system, pooling of resources, performance-based funding and increased accountability at all levels and across all stakeholders, including implementers and funders.
Innovation for Acceleration
This strategic direction identifies where there are major gaps in knowledge and technologies, where innovation is required to shift the trajectory of the viral hepatitis response in order for those responses to be accelerated and in order for the 2020 and 2030 targets to be achieved.
Research and innovation provide opportunities to change the trajectory of the global hepatitis response, improve efficiency and quality of services and maximize impact. It is unlikely that the ambitious targets set for 2020 and 2030 can be achieved if we are limited to existing medicines, technologies and service delivery approaches. Innovations are required along the entire continuum of prevention, diagnosis, treatment and care services.
They need to be backed with operational research and collaboration between researchers and policy-makers to ensure that research findings are translated into practice rapidly and on a scale sufficient to have the desired impact.
This strategic direction outlines areas where research and innovation will play a key role in accelerating the hepatitis response. Whereas WHO has an important role in convening partners and promoting and shaping a global research agenda, much leadership will rest with others, including research institutions and private industry.
WHO also has a responsibility to monitor the development of new vaccines, medicines, diagnostics, other commodities and service delivery approaches, and, where appropriate, to rapidly integrate them into WHO guidelines. Countries have a critical role in defining priorities for innovation, facilitating research, documenting early implementation experiences and leading on operational research. Given the 15-year time horizon for achieving the 2030 targets, short-, medium- and long-term research priorities should be considered. This strategy focuses on the short and medium-term priorities.
In addition to the existing technologies for preventing viral hepatitis infections, there are major opportunities for improving and expanding the package of prevention interventions for viral hepatitis.
Injection equipment: Effective implementation of the WHO injection safety policy and global campaign will require innovations in safety-engineered injection equipment, that is affordable, to prevent re-use.
Hepatitis vaccines: Hepatitis B virus vaccination programmes would be greatly enhanced by the development of a more heat-stable and freeze-stable vaccine and simplified delivery systems for hepatitis B virus birth-dose. The development of an effective hepatitis C vaccine would be a powerful addition to the hepatitis prevention intervention portfolio and would complement new advances in hepatitis C virus treatment.
Using antiviral medicines for prevention: The potential role of pre-exposure and post-exposure-prophylaxis for preventing viral hepatitis B and C acquisition should be considered, noting the experience from the HIV response.
Prevention benefits of treatment: Assess the potential prevention benefits of expanded coverage of viral hepatitis B and C treatment on viral hepatitis B and C transmission.
Optimizing Testing and Diagnostics
There are huge opportunities to improve viral hepatitis diagnostics technologies, strategies and approaches, essential for rapidly expanding viral hepatitis testing services and ensuring accurate and reliable diagnosis, clinical assessment and patient monitoring.
Optimizing Medicines and Treatment Regimens
The development of highly effective medicines to treat chronic hepatitis C infection has been a “game-changer” in tackling hepatitis C epidemics. There is also an impressive pipeline of new medicines, combinations and candidate molecules under development that promise to offer more effective, potent, tolerable and safer oral drugs and treatment regimens.
The development of long-acting treatment formulations should improve treatment adherence. In addition, new medicines and other treatments are required to improve the management of complications of chronic viral hepatitis infection, including treatments for chronic liver disease, liver failure and hepatocellular carcinoma.
Optimizing Service Delivery
Few countries have public health programmes that deliver comprehensive hepatitis services, apart from childhood hepatitis B virus vaccination programmes. Various obstacles exist in the efficient delivery of hepatitis B virus vaccine at birth, a key intervention for preventing mother-to- child transmission of hepatitis B virus. Harm reduction services that have been effective in preventing HIV epidemics among people who inject drugs have been less successful in preventing hepatitis C virus epidemics, even though the key interventions are the same.
Early diagnosis and staging of chronic hepatitis disease is compromised by both the lack of simple and reliable diagnostics and effective testing services that can reach those populations and locations most affected. In 2015, less than 1% of people with chronic hepatitis infection were receiving treatment, mostly though individual clinical care. Gaps in the response, such as those outlined above, highlight challenges in service delivery that require careful analysis and new service delivery approaches.
In 2015, less than 1% of people with chronic hepatitis infection were receiving treatment.
Large-scale treatment and care of people with chronic hepatitis will require a new public health approach to service delivery, including simplified and standardized treatment regimens and protocols, and decentralized care, including at the primary health care level and in the community. Investment in operational research is required to assess different service delivery models and opportunities for improving service delivery quality.
Expanded treatment, particularly for lifelong hepatitis B virus treatment, will require strategies and approaches to maximize treatment adherence and retention in care, monitor patients for treatment outcomes and failure, and monitor for drug toxicity and the emergence of drug resistance.