At the 58th European Association for the Study of the Liver (EASL) Annual Meeting (EASL 2023) and EASL Congress 2023, Doctor Philippa Easterbrook, Senior Scientist at the Global Hepatitis Programme of the Department of HIV at the World Health Organization (WHO) headquarters in Geneva, attended the WHO-ECDC Joint Forum. She discussed the new directions being drafted in WHO’s updated Hepatitis B guidelines, focusing on expanding simplified treatment criteria, service delivery, and innovative diagnostics. Hepatology Digest had the privilege to interview Doctor Philippa Easterbrook about WHO’s 2030 goals, the progress of the new Hepatitis B guidelines, essential information, and the global challenges and opportunities in addressing Hepatitis B prevention and control.
Hepatology Digest: Hepatitis B is a significant global public health issue. WHO has set a goal to eliminate the public health threat of viral hepatitis by 2030. How are countries progressing towards this goal, based on current statistical data?
Doctor Philippa Easterbrook: Understanding some background information is essential to grasp the significance of WHO’s hepatitis elimination strategy. In 2016, WHO first released a global elimination strategy aimed at eliminating the public health threat of hepatitis B and C viruses by 2030. The elimination targets include a 90% reduction in new infection incidence and a 65% reduction in mortality. In 2021, we released a new elimination strategy, extending to 2030, which, for the first time, includes HIV, viral hepatitis, and sexually transmitted infections/diseases (STIs). In the same year, we provided guidelines to countries on how to demonstrate that they have achieved the goal of eliminating the public health threat of viral hepatitis.
The guidance we provide involves countries setting targets for mortality and new infection rates, as well as program targets for immunization, testing, and treatment. Crucially, we’ve set thresholds, absolute targets that, when met, demonstrate that a country has achieved elimination. One of the measures to reduce transmission is to have the proportion of children under 5 years old who are hepatitis B surface antigen-positive below 0.1%. Additionally, it needs to be demonstrated that the diagnosed rate of infections exceeds 90%, and 80% of eligible patients are receiving treatment, with over 90% of infants or those born later being vaccinated.
Hepatology Digest: It has been reported that WHO is in the process of developing a new version of guidelines for hepatitis B. Could you please provide an update on the progress of these new guidelines and any new recommendations or directions that are expected to be proposed?
Doctor Philippa Easterbrook: One of WHO’s primary responsibilities is to develop normative global guidelines that are applicable across various regions of the world. Over the past eight years, WHO’s global hepatitis program has released several guidelines, including the 2015 Hepatitis B Testing Guidelines, the 2017 Hepatitis B and C Testing Guidelines, and the 2022 Hepatitis C Guidelines. Additionally, we published guidelines in 2020 on the use of antiviral drugs to prevent mother-to-child transmission of hepatitis B. Currently, we are still actively engaged in this work and have convened the first major meeting related to the update of the Hepatitis B guidelines.
Firstly, I’d like to highlight some key characteristics of WHO guidelines. Compared to national guidelines, guidelines from organizations like the American Association for the Study of Liver Diseases (AASLD), and the European Association for the Study of the Liver (EASL), WHO guidelines have three important distinctions. First, WHO places special emphasis on low- and middle-income countries, with the target audience for guideline publication extending beyond just doctors and clinicians to include project leaders within health departments—those responsible for overseeing hepatitis prevention and control programs within governments. Second, our guidelines adopt a public health approach, favoring simplified standardized drug regimens as the preferred option. In contrast, EASL or AASLD guidelines provide multiple individualized treatment options for high-income settings. Third, we employ the GRADE methodology, considering not only medical evidence but also the balance of benefits and harms of specific recommendations, program feasibility, acceptability and preferences of patients or healthcare providers for specific recommendations, and resource use.
In the new version of the Hepatitis B guidelines, we’ve identified several key themes and posed questions around these themes. These themes include expanding indications for treatment, viral load threshold, and whether antiviral prophylaxis should be used for HBsAg-positive women when they cannot access HBV DNA testing. We are also discussing the recommendation of tenofovir alafenamide (TAF) in addition to the already recommended tenofovir disoproxil fumarate (TDF) and entecavir. We are exploring the use of point-of-care viral load testing, reflex viral load testing, and simplified diagnostic pathways for the detection of hepatitis B co-infected with hepatitis D, which is crucial for promoting testing for this condition. Finally, we are considering ways to streamline the delivery of healthcare services.
We conducted a meeting in May, followed by a follow-up meeting in June, and plan to release the guidelines in October. The key message is that we are expanding the indications for treatment, allowing more HBsAg-positive patients to receive treatment. We provide four different treatment options to meet the requirements for treatment indications, with three of them not requiring viral load testing. We are also taking into account the limitations in viral load testing in sub-Saharan Africa and exploring ways to make the pathway for patients to receive treatment more convenient. We particularly emphasize the importance of delivering good healthcare services.
Data show that many clinics are not monitoring patients to ensure they take their medication on time and monitor viral load to ensure it is controlled. Therefore, we will strongly advocate for providing good adherence support, tracking patients to ensure they do not get lost to follow-up. Additionally, more people will be eligible for treatment, which means more women of childbearing age can receive treatment, contributing to preventing transmission to children.
WHO updates the progress of countries towards elimination every few years. We first updated based on 2015 data, then on 2019 data, and we are currently undergoing a new round of data updates. According to the 2019 data, the diagnosed rate for hepatitis B virus (HBV) infections was only 10%. Globally, only 2% of infected individuals were receiving treatment. The situation is generally suboptimal worldwide, particularly in sub-Saharan Africa. So, we have a long way to go. Currently, countries are working towards achieving the 2030 goal by increasing testing and treatment efforts, such as China’s large-scale diagnosis and treatment initiatives. While progress has been slow on a global scale so far, the goal of elimination and clear guidance provide countries with a clear path forward.
Hepatology Digest: From a global perspective, what challenges and opportunities does the current prevention and control of hepatitis B face? How do you think countries can address these challenges and seize these opportunities?
Doctor Philippa Easterbrook: I believe that compared to HIV/AIDS or previously hepatitis C, there are two main opportunities and advantages in the prevention and control of hepatitis B. First, we have a highly effective and low-cost hepatitis B vaccine, which is one of the great successes in 20th-century public health, while effective vaccines are not available for HIV/AIDS or hepatitis C. This is a significant advantage as it can prevent many new infections, and China has been particularly successful in implementing this highly effective vaccine intervention. Secondly, there is treatment available for hepatitis B. Tenofovir disoproxil fumarate (TDF) is an effective, low-cost, and readily accessible drug that can also be used to treat HIV. Currently, hepatitis B treatment drugs are easily accessible globally, with treatment costs as low as $30 per year. These two advantages are crucial for the management of hepatitis B.
However, there are several challenges facing the global prevention and control of hepatitis B and hepatitis C. Firstly, there is a lack of global funding mechanisms. Unlike HIV/AIDS, which has the support of the Global Fund to Fight AIDS, Tuberculosis, and Malaria or PEPFAR, hepatitis B and C do not have similar global funding mechanisms. This means that governments and national programs need to rely on their own resources to address this challenge. For the countries most heavily affected by hepatitis, such as in sub-Saharan Africa, governments are faced with many other competing priorities and limited resources, adding to the complexity of the challenge.
Another challenge is the lack of systematic testing and case finding for hepatitis B and C. Additionally, there is a lack of community awareness. For example, in sub-Saharan Africa, there is widespread awareness of HIV/AIDS, but very little knowledge about hepatitis B. Despite there being more hepatitis B patients in Africa than HIV patients, awareness of hepatitis B is low. This lack of awareness leads to confusion and uncertainty about the disease, making people hesitant to get tested. Even when people receive treatment, they often interrupt it due to their lack of understanding of the disease. Healthcare workers also face similar issues, including a lack of awareness, knowledge of the disease, confidence in treatment, and inadequate training.
Regarding future key opportunities, I believe they mainly exist in certain regions of sub-Saharan Africa and Asia by leveraging existing HIV infrastructure. These infrastructures include clinics, personnel, laboratories, drug supplies, and pharmacies. While not all countries have well-established infrastructure, linking and utilizing existing HIV infrastructure can provide substantial support.
Many hepatitis B patients require the same drug treatment, such as tenofovir disoproxil fumarate (TDF), and they need adherence support, just as with HIV. Laboratory monitoring to ensure viral load suppression is also necessary, as with HIV. Therefore, I believe this is an opportunity that has not been fully exploited.
Furthermore, I think COVID-19 has brought about other opportunities. One thing we’ve learned from COVID-19 is the feasibility of telemedicine. China has made significant progress in this regard, providing support, adherence support, and disease education through telephone consultations, offering additional support to patients. Additionally, COVID-19 has shown us the potential for self-testing, and there is an increasing availability of laboratory capacity to expand molecular testing, with self-testing becoming more common in Africa. Point-of-care viral load testing instruments are also becoming more accessible, and these instruments can be used for hepatitis B testing. Therefore, I believe we should draw from these experiences, and COVID-19 has shown us the possibility of testing large populations in a short time. China conducted testing in many community cities, and Egypt achieved success in hepatitis C by testing 67 million people within six months. These examples demonstrate the feasibility of testing and case finding and connecting patients to treatment.
In summary, hepatitis B and hepatitis C face challenges but also opportunities. Leveraging successful experiences, strengthening community awareness and education, drawing from the telemedicine and testing experiences of COVID-19, and establishing links with HIV infrastructure are all key opportunities moving forward. By fully harnessing these opportunities, we can better manage and control hepatitis B.
