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Taking the Next Steps in the Global Pledge for Hepatitis Eradication
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At the International Liver Congress in April 2016, the presidents of the American Association for the Study of Liver Diseases, European Association for the Study of the Liver, Asian Pacific Association for the Study of the Liver and Latin American Association for the Study of the Liver signed the Joint Society Statement for Elimination of Viral Hepatitis. With so much attention already focused on hepatitis C in light of advances in antiviral therapies, the authors of the statement aimed to draw significant resources to the causes of eradication of both B and C. The proposed inter-continental communication and collaboration could result in improved outcomes and reduced incidence of viral hepatitis worldwide. But eradication is a significant task that requires coordination at the global level, the national level, the community level and the individual doctor–patient relationship level. It is with this in mind that HCV Next asks: We have made this pledge, now what?
Anna Lok, MD, professor of hepatology at the University of Michigan and president-elect of AASLD, said in an interview that in addition to being a roadmap for dealing with viral hepatitis, the pledge is also, largely, a policy statement. “This is a political step,” she said. “It allows WHO to solicit funding, provides countries the opportunity to buy in. The understanding is that the four societies and WHO will receive regional support from the World Health Assembly, the United Nations and other, smaller organizations.”
Support, then, can come from non-governmental organizations and local governments alike, according to Lok. “In the past, WHO had to approach individual countries to solicit resources or discuss strategies,” she said. “When the four regional societies do this together, it’s more impactful. We have drawn attention to the cause.”
Lok was quick to point out, however, that the authors of the document are realistic in their aims. “The organizations have a non-zero target, meaning that they are not attempting total eradication,” she said. “The document we signed basically says that we support the WHO in their effort to eliminate viral hepatitis. That is the ultimate goal.”
Keith D. Lindor, MD, dean of the College of Health Solutions at Arizona State University and current president of AASLD, built on this point. “To ensure we are continuing to work together with other societies to help address shared and individual issues, AASLD is part of the Global Summit Society, which includes AASLD, European Association for the Study of Liver Diseases, Asian Pacific Association for the Study of the Liver, Latin American Association for the Study of the Liver and African Association for the Study of Liver diseases,” he said. “This group meets twice a year to address common issues, specific issues affecting each region, educational agendas and areas for collaboration. We think this group will be very effective in helping one another identify and address key issues as we work toward the goal of eliminating viral hepatitis.”
Strategic Directions, Major Components
The document is comprehensive, stretching to 44 pages and containing macro-level recommendations for international coordination as well as guidelines for vaccine development and harm-reduction programs. “This is going to require a number of steps,” Robert G. Gish, MD, clinical professor of Medicine at the University of Nevada in Las Vegas, senior consultant at St. Joseph’s Medical Center in Phoenix and clinical professor of Medicine at Stanford University, said. “It will differ from region to region and country to country.”
The document outlines five strategic directions to prioritize action. The first, simply, is to gather information. The authors recommend “developing a strong strategic information system to understand viral hepatitis epidemics and focus the response,” according to the statement.
The second direction involves interventions for impact. They suggest that it is necessary to define “essential, high-impact interventions on the continuum of hepatitis services that should be included in health benefit packages.”
The third is delivering for equity, according to the authors. This entails the strengthening of health care systems along with community programs to deliver optimal care to as many patients as possible.
“We understand that each country has different issues to address,” Lindor said. “That is why the WHO resolution urged all countries to develop their own strategies.”
Financial sustainability is the fourth direction. This should focus on reducing cost, improving efficiency of delivery services and minimizing the possibility that hepatitis treatment will lead to financial hardship.
The final direction is innovation. The authors encourage the clinical community to embrace and promote novel approaches that may result in accelerated progress in the elimination of the diseases.
The authors then outlined five major components of the strategy. The first, of course, is the elimination of viral hepatitis. This should involve understanding where viral hepatitis resides and what kind of responses are being mounted in those areas and populations. The authors stress complete understanding of both challenges and opportunities and they argue for increased investment of resources in their goal.
Michael S. Saag, MD, professor of medicine and director of the Center for AIDS research at the University of Alabama at Birmingham, and Co-Chief Medical Editor of HCV Next, put this broad goal into context. “Barrier number one is identifying people who are infected,” he said. “There has to be an all-out universal testing exercise that doesn’t restrict to any particular population or birth cohort. First and foremost, find everyone who has hepatitis C.”
Then the authors recommend framing the strategy in terms of three organizing principles, including “universal health coverage, the continuum of hepatitis services and the public health approach.”
Gish stressed policy initiatives at each government level. “This will lead to pilot and demonstration projects,” he said. “It will also help determine factors involved in the allocation of financial resources.”
The third component is multi-faceted and includes vision, goal, targets and guiding principles. The aim of this component is to outline targets for 2020 and 2030.
“Can we eradicate by 2030?” Saag said. “It is possible, but if we are going to set that as a goal, we needed a document that says how we should do it. This may be that document.”
The fourth component involves prioritizing actions. Individual nations and WHO are encouraged to assess which actions from the five strategic directions should be undertaken.
Finally, the authors suggest that “leadership, partnerships, accountability, monitoring and evaluation” are critical to implementation of the strategy.
Javier Brahm, MD, professor of Medicine at the University of Chile and president of the Latin American Association for the Study of the Liver, spoke about how the document may impact his region in terms of putting leadership into action. “The first step was to disseminate information about this to all Latino-American hepatology societies through our web page,” he said. “We signed the document at the WHO/Pan American Health Organization meeting in Buenos Aires earlier this year. We will next cover this topic at the ALEH Congress in Santiago, Chile in September and October of this year.”
These strides highlight Lok’s point that the document is as much a political statement as a clinical one. “The four societies document was signed in front of a big audience from several countries and given to a WHO authority,” Brahm said.
Intervention Areas
In terms of clinical approaches, the authors outlined “five core intervention areas.” The first is the widespread implementation of effective vaccines, particularly for hepatitis A, B and E. “With hepatitis C, we don’t have a vaccine, so we really can’t prevent it,” Lok said. “This makes it that much more challenging.”
Prevention of vertical transmission is another clinical approach, while enhanced safety to reduce nosocomial transmission is a third. The authors zeroed in on injection, blood-related and surgical safety as the key components of reducing health care-related transmission of the diseases.
Harm reduction programs are the fourth intervention area. Access to sterile injection equipment should be universal, as should effective addiction programs.
Finally, the authors suggest that treatment should be available for all patients with viral hepatitis. Significant steps should be made to reduce cost and other barriers to therapy.
For Lok, however, treatment can only occur when patients are found. “Treatment means you have to find people with infection, then get them into care,” she said. “After that, the problem then becomes how do you figure out how to offer them very expensive treatment. Of course the treatments are safe and highly effective. However, you still have new infections ongoing because there is no way of preventing it. It is all connected.”
Barriers
The authors acknowledged the myriad barriers that prevent improvements in any health care initiative. They wrote that leadership and commitment is “uneven” from country to country, and within each nation.
Part of the issue is budgetary. Resources are limited in many of the countries most impacted by viral hepatitis. But there are also failures in guidance and coordination that inhibit forward progress in the fight against the diseases, the authors state.
“Now we must work together to join forces,” Brahm said. “Each Latin American country should use this document for pressing locally to political authorities.”
Variability in resources and political will can, in turn, lead to inadequate data, which is another barrier to implementation of the strategies, according to the document. “The true public health dimensions and impact of hepatitis epidemics are poorly understood in many countries,” the authors wrote. Specifically, surveillance is often insufficient, which presents a stumbling block right at the outset of the development of a national strategy.
Another issue is limitation of prevention programs and preventive services due to coverage. The authors wrote that despite reductions, unsafe hospital injections still cause upward of 1.7 million hepatitis B cases and hundreds of thousands of HCV cases worldwide. Harm reduction programs remain sparse for injection drug users, and coverage for hepatitis B vaccination at birth is just 38%.
Lack of awareness of hepatitis status is another barrier, according to the authors. They suggested that this is because there is still no simple and effective hepatitis testing apparatus. The result is that patients present to the health care system with advanced disease and poor liver function, requiring significant resources for treatment and cure.
Access limitations present another barrier. This includes both diagnostics and treatment and is a function of structural barriers and individual inability to afford services.
“Even for HCV in the Americas, where there are more resources than in other parts of the world, access to these drugs is limited,” Saag said.
More broadly, the authors added that a public health approach to viral hepatitis intervention is lacking. “A reorientation of hepatitis program towards a comprehensive public health approach will be critical if hepatitis elimination is to be achieved,” they wrote. “This will require people-centered health services that can reach those populations most affected, well-functioning laboratories to ensure high-quality testing and treatment monitoring, a secure supply of affordable medicines and diagnostics, an appropriately trained health workforce, adequate public funding for essential interventions and services and active involvement of affected communities.”
“For this goal to be reached, it will take many groups working in collaboration with shared vision,” Lindor said. “From WHO to hepatology societies and governments worldwide, we need to focus on championing the recommendations in this statement. Meaning, recognition of viral hepatitis as a public health threat, prevention and education, elimination of healthcare-related transmission of hepatitis, creation of practice guidelines, funding of research, and ensuring tests and treatments are available and affordable. If we do this, we will reach our ambitious, but attainable goal.”
For the Individual Clinician
A big question for all of this is how the individual clinician will be impacted. “It will take time to impact day-to-day clinicians treating HCV,” Brahm said. “This is because there is a shortage of specialists in our region.” He added that the daily activities of doctors are impacted by decisions made in the political arena, but that those decisions have not been made. There is still discussion of how to approach the goals in a climate of limited resources.
For Saag, it is a matter of enough warm bodies to treat patients. “Eradication will require that we have enough treaters,” he said. “There simply are not enough hepatologists, gastroenterologists and infectious disease doctors. So the brunt of the treatment will fall to primary care providers.”
This presents its own set of challenges. “These providers have to be trained and enthusiastic, and they have to understand how this disease works,” Saag said. “But then we are confronted with the question of how to do mass education of these primary care providers who don’t think about the liver every day like a hepatologist does. What are the key messages that they need to think about?”
There is good news, though. “With more pangenotypic drugs hitting the market, treatment, overall, will be easier,” Saag said. “They will not have to make those clinical decisions.”
Gish also acknowledged that PCPs will play a significant role, and not just in treatment. “Each clinician will need to be part of the screening and education program,” he said.
A key component is how these higher level policies take into account and interact with individual doctors. “The joint statement itself serves as a sign to clinicians that AASLD sees viral hepatitis as a public health threat and is partnering not only in the United States, but globally, to ensure more resources from bench to bedside,” Lindor said. “As we move forward to drafting U.S.-specific strategies with the National Academies of Sciences, Engineering and Medicine, I expect there to be actions clinicians can take as well as specific outcomes that will positively impact their daily practice.”
Moving Forward
“The joint statement is a great first step, but there will be many other steps to take to ultimately hit the goal of eliminating viral hepatitis,” Lindor added, and again referenced the work being done to create strategies specific to the U.S. “We expect this to be published early next year.”
For Lok, it comes back to a vaccine. “With hepatitis B, there is a vaccine that is highly effective,” she said. “So if we do a good job at getting all newborns vaccinated, then two generations from now, it won’t be a problem.”
But even with such a comprehensive inoculation strategy in place, there are political hurdles to clear, according to Lok. “How can I look at the 250 million people who are currently infected and say, ‘Once you’re all dead, then there will be no more problem,’” she said. “We have to deal with the people who are chronically infected.”
Improved therapies for HCV are the answer to that question for that disease. But that, of course, brings the argument back to one of access. Many believe that the increased role of WHO will be critical to increased availability of drugs worldwide.
“WHO has a big role as an umbrella to countries all over the world,” Brahm said. “They are independent from the liver societies.”
This, then, can have practical implications, according to Gish. “WHO will have a major role in implementation of these strategies,” he said. “Although other NGOs and expert organizations will have to assist.”
In the end, Saag believes that this step can’t be underestimated. “Putting it together into one focus piece was really important,” he said. “Global eradication may be possible, and we are now beginning to understand what it will take.”
- For more information:
- Please review the statement at: http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_32-en.pdf?ua=1
- Javier Brahm, MD, can be reached at Santos Dumont 999, Independencia, Santiago, Chile; email: jbrahm@hcuch.cl.
- Robert G. Gish, MD, can be reached at 6022 La Jolla Mesa Drive, San Diego, CA 92037; email: rgish@robertgish.com.
- Keith D. Lindor, MD, can be reached at the College of Health Solutions at Arizona State University, Health North Bldg., 550 North 3rd Street, Phoenix, AZ 85004-0698; email: Keith.Lindor@asu.edu.
- Anna Lok, MD, can be reached at Taubman Center, Floor 3, Reception D,1500 E Medical Center Drive, Ann Arbor, MI 48109; email: aslok@med.umich.edu.
- Michael S. Saag, MD, can be reached at Center for AIDS Research at the University of Alabama at Birmingham, BBRB 256, 1720 2nd Avenue S, Birmingham, AL 35294-2107; email: msaag@uab.edu.
Disclosures: Brahm reports being a researcher and/or lecturer and/or national/international board member of Roche, Bristol-Myers Squibb, Gilead, MSD, Janssen and AbbVie. Gish reports various financial relationships with AbbVie, Akshaya, Alexion, Arrowhead, Astra-Zeneca, Bayer, Benitec, Bristol-Myers Squibb, Contravir, Eiger, Enyo, Genentech, Gilead Sciences, Hoffmann-LaRoche Ltd., HumAbs, Intellia, Intercept, Ionis Pharmaceuticals, Isis, Janssen, MedImmune, Merck, Nanogen, Novira, Salix/Valeant, Quest and shareholder interest in Kinex, Synageva, RiboSciences, CoCrystal. Lindor serves on the advisory boards of Intercept (not paid and does not meet) and Shire (not paid). Lok reports no relevant financial disclosures. Saag reports no relevant financial disclosures