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Category Archives: Hepatitis D Advocacy

advocacy, HDV, Hepatitis D Advocacy, Hepatitis Delta (HDV)

An Interview with Hepatitis Delta Advocate, Dr. Carla Coffin

Since 2016, the Hepatitis B Foundation has run a program called Hepatitis Delta Connect which aims to increase awareness of hepatitis delta and support for those living with the virus. For this month’s blog post, we sat down with Dr. Carla Coffin, a hepatologist in Canada, who is active in the hepatitis delta space.

Please introduce yourself and describe what you do and where you work.

My name is Dr. Carla Coffin, and I am a hepatologist at the University of Calgary in Alberta, Canada, I am a clinician scientist who does research on hepatitis B and this year I am the president of the Canadian Association for the Study of the Liver. Calgary is the founding/coordinating site for the Canadian Hepatitis B Research Network, which helps lead a collaboration of researchers, scientists, and practitioners across Canada for hepatitis B research and advocacy.

How common is hepatitis delta in your location or nationally?

That is an excellent question because until relatively recently, we didn’t know that much about how common hepatitis delta was in Canada. Most studies were single-site, single-center studies, showing about 1% prevalence overall in people living with hepatitis B. Then the Canadian Hepatitis B Research Network in collaboration with the National Microbiology Lab and the National Reference Lab in Canada did a study, led by Dr. Carla Osiowy, that showed, based on a retrospective screening of cases that were referred for hepatitis delta testing, that the prevalence was about 3% overall. Now, there’s more recent data that is consistent with that approximation of about 3%. We are also conducting a study that shows that for people who are being referred for delta screening, their overall positivity is about 4%. These are specific studies, but if you are just looking at universal screening rates of everyone who is living with hepatitis B who is potentially at risk for hepatitis delta, and not necessarily pre-identified, it’s much lower, maybe only about 1% or 2%.

What are the current screening recommendations and protocols in Canada for hepatitis delta virus (HDV)?

Historically, the recommendations from our major guidelines have been risk-based screening. So, people that are coming from areas where we know hepatitis delta is endemic. People that may have other risk factors such as a history of injection drug use or clinical characteristics that might trigger the clinician to suspect hepatitis delta co-infection. But based on that, I think that people are missed or are not diagnosed, so there’s inaccurate epidemiology just on risk-based screening. Our updated hepatitis B guidelines, which hopefully will be published in 2025, are more consistent with other expert recommendations to do universal screening. So at least a single, one-time test will be recommended for all people living with hepatitis B, to screen for hepatitis delta. And many of our laboratory partners agree with these recommendations. So hopefully there will be a change in the near future for that.

Do you think the reported prevalence is accurate or are people missing?

I would say that the current reported epidemiology of about 2 to 3% is likely to be accurate, but without having a robust universal screening program and robust reporting of hepatitis delta-positive cases, then I can’t say that with 100% confidence. One of the metrics that the Public Health Agency of Canada is advocating for is to have more robust data collection on hepatitis D epidemiology. That’s one of the calls by Action Hepatitis Canada, which is an advocacy group.

So, I think the epidemiology is accurate based on the data we have, but I can’t be 100% confident until we do more robust studies.

What do you think could help to address some of the underdiagnosis of hepatitis delta globally?

We need universal screening to ensure that people are diagnosed and not just rely on risk-based testing. We talk about knowing where hepatitis delta is endemic, but we should also recognize that there are probably countries where the prevalence is higher, but because of a lack of screening, we don’t know where it is actually endemic.

Even in my practice and just this week, we came across a patient that had been followed in our clinic for 15 years with hepatitis B and we only diagnosed this person with hepatitis delta recently, because we hadn’t screened it before.

And I think the other important thing is to increase awareness among health practitioners. A specialist might know about hepatitis delta, but a primary care provider or non-hepatologist would be left less aware. Increase education of healthcare practitioners to say, you know, if your patient has hepatitis B, they should be screened for hepatitis delta.

What do you usually do to help patients manage hepatitis delta?

Well, I think the first thing is you need to explain as clearly as possible exactly what hepatitis delta is and how you get hepatitis delta. How do you prevent it from spreading?

Explain how it’s transmitted by sharing blood and body fluids, highlighting that if you get the vaccine for hepatitis B, that protects you against both B and delta. Then explain what delta can do to your liver and how it can increase your risk of getting liver damage, or liver scarring or cirrhosis, how it increases your risk of getting liver cancer, and the importance of having regular checkups on your liver. So, regular blood tests and regular ultrasounds for monitoring for liver disease and for liver cancer. A lot about management is empowering the patient and giving them educational resources. Then the other thing is to discuss the treatments. There is only one treatment approved for hepatitis B in Canada, and you can use it for hepatitis delta, and that’s interferon. That’s the only thing we can currently use to treat hepatitis delta.

If/when a new drug is approved in Canada, do you think distribution and uptake will be straightforward or do you perceive challenges?

Yes, there will be many challenges. Part of it stems from underappreciation of hepatitis B as well as hepatitis delta. So, if a new drug is approved, it may be a challenge just to raise awareness about it.

And the second thing is that health care is federally funded, but the funding is then sent to each jurisdiction. The provinces and territories decide how healthcare funding is spent, and then there’s a complex approval process. It starts with Health Canada approval and then there’s this pan-Canadian drug agency called CADTH, the Canadian Agency for Drugs & Technologies in Health, that reviews the medication and sees whether or not they would recommend it. Then each provincial agency looks at the review by CADTH and decides if they want to have it on the formulary.

So, it could be time-consuming, complex, and challenging because of these factors.

Can you describe some of the advocacy efforts in which you have been engaged on hepatitis delta at different levels, and with different stakeholders?

Yeah, so I’m happy to say we’ve been having some success with advocacy. So different stakeholders and partners include Action Hepatitis Canada, the Canadian Liver Foundation, and our professional organization, the Canadian Association for the Study of the Liver. Activities we have done include going to Parliament Hill in Ottawa and holding our Annual Viral Hepatitis Elimination Day on May 9th. We’ve done that now for three years. With the help of all these partners and stakeholders, we have been engaging various governments (so government ministers at the provincial level and at the federal level), and also working with our federal health agencies (so the Public Health Agency of Canada) and having discussions with them to increase the messaging about hepatitis delta.

Are there any messages about hepatitis delta that you would like to share with policy or decision-makers?

I think you need to start with the patient’s voice. What I found most striking when we were meeting with the different policy decision-makers and government officials was that the physicians or the experts could talk about hepatitis B and talk about hepatitis delta and you didn’t see the same impact, but we brought patients with us when we had our meetings and when the patients spoke up and talked about their lived experience, you could really see their story having a strong impact. Then, also try to support the work of our partners.

What are some possible programs or initiatives that can help raise the profile of hepatitis delta and improve participation in the care cascade?

A lot of the people affected by delta are non-Canadian born, so there are a lot of challenges in navigating the healthcare system and language barriers. If we had more in terms of language or translations, I think that would be a good way to increase participation in healthcare and potentially raise the profile. The second is the education of healthcare practitioners, going beyond the specialist, and talking to primary care and family doctors.

Also, perhaps starting at the community level, at a non-academic center to raise more awareness about hepatitis delta and involving people with lived experience. But that’s a bit more difficult because there are so many, at least in Canada, challenges with understanding the language and understanding that patients often have many other challenges that it’s hard for them to think about their health care.

Do you have any final thoughts on hepatitis or hepatitis delta?

There’s been a lot of progress on hepatitis B with the drugs that we have currently, the effective nucleoside analogs, and with the hepatitis B vaccine, of course. It’s a remarkable vaccine, but we need more research and investment in both basic science research to try and find a cure for hepatitis B, and more public health research and investment to reach those that are living with hepatitis B, to provide them treatment and limit financial barriers. Also, more research and investment for hepatitis delta and testing. There’s not even a standardized test for delta. So, my final thought would be that we’ve done a lot, we’ve made progress, but there’s still more work to be done, and we need more government and industry funding.

HDV, Hepatitis D Advocacy, Hepatitis D Drug Development, Hepatitis Delta (HDV)

The Provider’s Perspective on Hepatitis Delta: A Conversation with Ilan Weisberg, MD

Dr. Ilan Weisberg is a highly acclaimed gastroenterologist and hepatologist currently serving as the Chief of Gastroenterology and Hepatology at New York-Presbyterian Brooklyn Methodist Hospital. He shares the Hepatitis B Foundation’s enthusiasm for advocacy and education surrounding hepatitis B and D, and was eager to provide the perspective of a healthcare provider on the current state of hepatitis delta screening and management, as well as some common misconceptions.

A Shift in Provider Awareness and Knowledge

One of the first topics Dr. Weisberg spoke about was how unaware he was about hepatitis delta until recently. He discussed the ongoing issues with a general lack of knowledge about hepatitis delta in the United States, and how this is the most common reason for many of the current challenges seen today. When asked what led to his and other providers’ shift in knowledge, he credited the improvements with hepatitis C awareness and treatment with some of the shift, as well as the potential for new treatments for hepatitis B and D. “Every time there is a promise of a treatment or a cure or intervention, then I think it helps engender more enthusiasm for screening.”

Hepatitis Delta Prevalence and Screening Practices

Dr. Weisberg sees hundreds of patients who are living with hepatitis B virus (HBV). New York, and especially Brooklyn, have so many cultural communities coming from countries where hepatitis B is common. Hepatitis D is a much smaller percentage of his patient population. Dr. Weisberg was a co-author on a study that looked back through electronic medical records (EMRs) for all hepatitis B surface antigen positive (HbSAg+) patients at his former health system to identify how common hepatitis delta virus (HDV) testing and prevalence were. Across the entire health system only about 12% of HbSAg+ patients were tested for delta and among those individuals there was a 4% positive rate for HDV (Nathani et al., 2023).

One particularly concerning part of that study for Dr. Weisberg was the overall low rates of hepatitis delta screening. He notes that it is difficult to keep health care providers motivated to screen when the number of those with hepatitis delta is so low, and that creative solutions like automatic EMR suggestions may increase the likelihood of testing. About three years ago at his former clinic, Dr. Weisberg standardized a protocol for screening every existing and new patient living with hepatitis B for hepatitis delta at least once. This protocol is still being used in his current health system. “Even though the event rate is low, the clinical importance of finding these patients [is] very high” and he hopes that this approach will be widely adopted to more closely align with European Association for the Study of the Liver (EASL) recommendations compared to the current risk-based approach of the American Association for the Study of Liver Disease (AASLD)(EASL, 2023; Terrault et al., 2018). Discussions on changing these American recommendations have been in circulation and plans to update them should be realized in the near future.

Dr. Weisberg believes that one of the reasons for the low testing is that hepatitis delta is considered a “rare disease” in the United States. He notes that the major differences in the number of cases among different countries means that one study in a specific geographic area cannot be generalized to the entire global prevalence.  He hypothesizes that if there was true and accurate prevalence data across the globe, the number of cases would be higher than those estimated in the U.S.  and globally today. One of the challenges in providing accurate prevalence data is knowledge about appropriate testing, which Dr. Weisberg recalls encountering in his clinical career. When he arrived at his former health system, they were only testing for hepatitis delta antigen rather than the hepatitis delta antibody (anti-HDV), which is the appropriate initial test to perform. True prevalence rates are important for improving our understanding of who is affected by hepatitis delta, and with new therapeutics on the horizon, it is vital to identify patients who are hepatitis delta-positive so that they can participate in trials and be ready to receive treatments once approved.

Thoughts on Universal Reflex Testing

Dr. Weisberg mentioned that his current health system does not have the HDV test set up as a reflex test (automatic testing for HDV when one tests positive for HBV, using the same blood sample) straight from HbSAg+ to anti-HDV and from anti-HDV to confirmatory HDV RNA, but they are working on getting that established. “In a place like Brooklyn where we have enormous populations from hot spots of endemicity for delta, like Moldova and Mongolia, it might be very cost-effective, but in other parts of the country it may not be, and it is hard to have a universal strategy that is not universally cost-effective.” He also highlighted the need to be able to reliably check across databases to avoid repeated testing upon new emergency room visits, providers, etc.

Risk Factors for Hepatitis Delta

According to the AASLD, identified risk factors for hepatitis delta include persons born in regions with reported high HDV endemicity, persons who have ever injected drugs, men who have sex with men, individuals living with hepatitis C (HCV) or human immunodeficiency virus (HIV), persons with multiple sexual partners or history of sexually transmitted disease, and those with persistently elevated levels of the liver enzymes ALT and AST, despite low levels of HBV DNA. Based on Dr. Weisberg’s experience he has not found these risk factors to be entirely representative of his hepatitis delta patient population. The same study he conducted on hepatitis delta screening found that, by following the AASLD risk-based screening guidelines alone, about 18% of positive cases would have been missed. Of those positive cases, the patients tended to be younger and had significantly notable increase in liver disease progression and incidence of liver cancer. Dr. Weisberg encourages the testing of all hepatitis B-positive individuals to ensure the capture of all cases and linkage to appropriate care.

One major misconception among providers that Dr. Weisberg noted is that hepatitis delta is commonly referenced as a virus only seen in people living with HIV and people who use injection drugs (PWID). This translates to higher screening rates in those groups and leaves out a focus on those immigrant communities from highly endemic countries that can be very heavily affected by the virus.

Case Management Recommendations

Management of hepatitis delta patients requires a uniquely tailored approach for each case, but Dr. Weisberg outlined some of the general recommendations that he makes for his HDV+ patients. Since hepatitis D is so damaging to the liver, a main concern is keeping their liver as healthy as possible. This means reducing alcohol consumption to avoid developing alcohol-related liver disease and completing liver cancer surveillance (ongoing screening using non-invasive methods to detect early-stage hepatocellular carcinoma (HCC)). Dr. Weisberg recommends seeing your hepatologist once or twice a year and he personally checks patient labs and viral loads every six months, and transient elastography (FibroScans) every three years or so to check the stiffness and fat  changes in the liver. Other screening tools such as ultrasounds, alpha fetoprotein (AFP) markers, and Fibrosis-4 values are appropriate ways to stay updated on the liver health of all hepatitis delta-positive individuals. Most importantly, Dr. Weisberg stresses the need for a strong relationship between the hepatologist and the primary care provider in the long-term management of viral hepatitis patients, and a team-based approach with other providers in the clinical setting.

In terms of treatment options for hepatitis delta, the only currently available therapeutic is pegylated interferon alpha, which in Dr. Weisberg’s experience has not been effective in reducing his patients’ viral loads and tends to cause a lot of additional difficulties for his patients in their daily lives. He recommends careful consideration of which patients should be put on interferon treatment. In cases of contraindications such as diagnosis of autoimmune disease or severe risk of progressive disease, there is a possibility to appeal for compassionate use therapy for some treatments not yet fully approved in the United States. One such therapy is Hepcludex, the recently available treatment, which is presently only approved for prescription in Europe.

Finally, Dr. Weisberg’s management approach always involves the family of affected individuals, and discussions of how to keep transmission low for any who may be vulnerable to hepatitis B and D. One commonly cited reason for low delta screening rates for providers is “Why screen for people without a treatment?” Since hepatitis delta is highly transmissible, knowing one’s status allows the patient to be mindful about preventing exposure and infection of other household members, sexual partners, etc. Dr. Weisberg is a strong advocate for promoting hepatitis B vaccination in immigrant and adult populations (the vaccine also prevents hepatitis delta) and testing for the presence of hepatitis surface antibody (HbSAb) among close contacts of individuals living with hepatitis B and delta, to ensure low transmission rates.

The Promise of Future Treatments

“Every patient with [hepatitis] delta should be treated for [hepatitis] delta” but the major missing component is available treatments. Dr. Weisberg believes this to be the largest unmet need for his patients, but he emphasized hope for approval of treatments in the future. The availability of compassionate use therapy is a strong indicator for future approval since this was not always an option. Additionally, bulivertide (Hepcludex) is approved in the European Economic Area but is not yet approved by the Food and Drug Administration (FDA) in the United States. Dr. Weisberg explained that most information suggests that the delay in approval is more likely related to the need for reliable manufacturing and supply chain efficiency rather than a concern about the safety of the drug itself. (The FDA has not requested any further clinical trials, which is promising.) One common misconception in the provider community is that there will never be a cure for hepatitis B, but Dr. Weisberg remains confident in the progress being made towards both treatments for hepatitis D and a cure for hepatitis B.

Dr. Weisberg is one of many compassionate and knowledgeable physicians that manage people living with hepatitis B and D. If you need a provider, use our Physician Directory to find one near you!

References

European Association for the Study of the Liver (2023). EASL Clinical Practice Guidelines on hepatitis delta virus. Journal of hepatology, 79(2), 433–460. https://doi.org/10.1016/j.jhep.2023.05.001

Nathani, R., Leibowitz, R., Giri, D., Villarroel, C., Salman, S., Sehmbhi, M., Yoon, B. H., Dinani, A., & Weisberg, I. (2023). The Delta Delta: Gaps in screening and patient assessment for hepatitis D virus infection. Journal of viral hepatitis, 30(3), 195–200. https://doi.org/10.1111/jvh.13779

Terrault, N. A., Lok, A. S., McMahon, B. J., Chang, K., Hwang, J. P., Jonas, M. M., Brown, R. S., Bzowej, N., & Wong, J. B. (2018). Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology, 67(4), 1560–1599. https://doi.org/10.1002/hep.29800

World Health Organization: WHO. (2023, July 20). Hepatitis D. https://www.who.int/news-room/fact-sheets/detail/hepatitis-d

HDV, Hepatitis D Advocacy, Hepatitis Delta (HDV), Research

Why Is Hepatitis Delta So Hard to Eliminate?

Forty-five years after Mario Rizzetto discovered the hepatitis D virus (also known as HDV or hepatitis delta), scientists and advocates met for the first ever Delta Cure Meeting to discuss new scientific trends and global advocacy efforts to eliminate this difficult-to-treat disease. This conference included topics ranging from HDV’s global prevalence to new diagnostic methods, and the need for specific and improved efforts to fight this virus.

During the Delta Cure Meeting, scientists called for new global strategies to find people living with HDV and have prompted the World Health Organization (WHO) to update their screening guidelines to include HDV tests for all people living with hepatitis B (people who are HBsAg-positive). 

Unfortunately, some barriers continue to stand in the way of making this call to action a reality. Dr. Meg Doherty, the Director of Global HIV, Hepatitis, and STI Programmes at the WHO, stated in a recent Healio article that the WHO does not have any prevention recommendations that are specific to HDV. However, the WHO is developing updated guidance for HDV testing, diagnosis, and treatment as a part of hepatitis B (HBV)-focused elimination efforts.

While some initial progress has been made, (such as the inclusion of HDV in the 2022-2030 Global Health Sector strategies, which aim to increase knowledge about infections like HIV and viral hepatitis to create effective responses to and advance elimination efforts for these diseases), there is a need to expand elimination strategies to include HDV more broadly. The lack of robust inclusion of HDV disregards people who are currently living with HBV and are at the highest risk of HDV exposure and acquisition. People who have been diagnosed with HDV are overlooked as linkage to appropriate care, diagnostics and treatments (which are important for people living with HDV to stay healthy) continues to be out of reach for many. One of the major challenges with HDV is also the lack of testing and surveillance to identify those individuals living with delta and to understand the true burden of the disease. 

The WHO affirms that HDV elimination efforts must start with raising awareness of the virus and increasing advocacy efforts. The scientists at the Delta Cure Meeting are doing just that. Here are some solutions that scientists and researchers have identified to address the challenges surrounding HDV elimination:

Barrier: Overly complicated screening guidelines present a major barrier to the elimination of HDV. It was only in March 2023 that the Centers for Disease Control and Prevention (CDC) introduced new guidelines recommending universal HBV screening for all adults in the United States. A recommendation for universal HDV reflex testing (automatic testing for HDV when one tests positive for HBV) for all individuals living with HBV has still not been implemented in the US. Additionally, the American Association for the Study of Liver Diseases (AASLD) has screening guidelines for HDV that are still risk-based, meaning that only people who have certain risk factors are recommended to be tested for HDV (high-risk groups include people who inject drugs and men who have sex with men, among others). Conversely, the European Association for the Study of the Liver (EASL) and the Asian-Pacific Association for the Study of the Liver (APASL) have moved away from risk-based screening. Both EASL and APASL recommend that providers perform the HDV antibody total (anti-HDV total) test in all HBsAg-positive patients to identify whether someone has recovered from or is currently infected with delta antibodies (Palom et al., 2022; Hepatitis B Foundation, 2023).

Risk-based screening burdens both providers and patients alike. As part of risk-based testing, providers must ask questions about risk factors that are not necessarily part of a regular health screening and must know which factors indicate a need for HDV testing. Providers are often hesitant to ask their patients these questions, as talking about risk factors can be uncomfortable and overwhelming. But if providers do not ask, then the patient must know their own risk factors and ask for the test themselves (which can be very uncomfortable). A guideline to test everyone who is positive for hepatitis B (HBsAg-positive) for HDV would eliminate this confusion and hesitation. In light of this barrier, and the fact that risk-based testing is not evidence-based, the Hepatitis B Foundation recommends that all people living with HBV ask their doctors about getting tested for hepatitis delta.

Call to Action: Introduce new screening guidelines, including screening all adults who are HBsAg-positive for HDV. As the US does not have universal HDV screening guidelines, people who test positive for the hepatitis B surface antigen (HBsAg) but do not fall into a “high risk” category are not recommended to be screened for HDV, so they may be living with hepatitis delta and unaware of their infection. This puts these individuals at a much higher risk of having unmanaged hepatitis delta and developing liver cirrhosis or other advanced liver diseases at a more rapid pace. HBV is also already significantly underdiagnosed in the US and, as Dr. Nancy Reau neatly summarized “If you aren’t thinking about B, you’re not thinking about D.” 

Barrier: HDV is not a nationally notifiable or reportable condition in the United States. This means that healthcare providers are not required to report cases of HDV to local and state health departments or to the CDC. Because of this, the actual number of people living with HDV in the US remains underestimated, and without accurate prevalence data, prioritization of this neglected disease is made all the more difficult. 

Call to Action: Make HDV a reportable and notifiable disease in the US and beyond. Dr. Doherty of the WHO agrees that efforts to identify the populations most at risk for HDV are needed in the fight for HDV elimination, and specifically mentions the need for epidemiological surveys (different study designs of various sizes to better understand the burden of disease). A new survey method was discussed at the 2022 Delta Cure Meeting by Dr. Saeed Hamid in his presentation, “Epidemiology of HDV: From Low to High Endemic Countries.” Dr. Hamid called for new national surveys to be distributed to people with advanced liver disease because this population is one in which HDV is most likely to be found. He believes this monitoring method can be used in any country to advance elimination efforts.

Barrier: There are currently no standard HDV diagnosis methods, which makes HDV elimination very difficult to achieve. Professor Maurizia Brunetto, who presented “Diagnosis of HDV: Clinical Virology and New HBV Biomarkers,” explained that there is likely an underestimation of HDV infection in general, due to misdiagnosis (when someone is incorrectly diagnosed) and challenges accessing the diagnostic testing for hepatitis delta. When Dr. Doherty of the WHO was asked about what needs to be done to improve HDV elimination efforts (specifically in the US), she mentioned improving diagnostic testing tools.

Call to Action: Simplify testing and introduce point-of-care testing to increase HDV detection and diagnosis. Prof. Brunetto explained that point-of-care testing (getting rapid results within 20 minutes of being tested rather than waiting for up to 48 hours for results of a traditional blood test) can improve overall HDV diagnostics around the world. She believes it is especially important to introduce point-of-care testing in countries with less developed medical infrastructure. Having this point-of-care testing method will be easier to maintain and can identify people living with HDV earlier and link them to treatment before their disease becomes more severe. Dr. Stephen Urban, who led the discovery and creation of the first ever drug for HDV (bulevirtide), has been developing a point-of-care test to find delta antibodies from one single drop of blood. While only in the experimental phase, Dr. Urban and colleagues have published two journal articles that provide evidence for the test’s potential effectiveness in identifying people living with HDV (Lempp et al., 2021). While still more than two years away from using this method at a larger scale, Dr. Urban believes that this method can lead to faster HDV diagnostics.

As new HBV screening guidelines are introduced and new diagnostic tools are being developed, we have to advocate for universal HDV screening in individuals with hepatitis B by raising public awareness of the importance of screening and raising the voices of people who are living with HDV around the world. 

References

American Association for the Study of Liver Diseases [AASLD]. (2021, November). Hepatitis d (delta) at AASLD 2021.  https://www.natap.org/2021/AASLD/AASLD_136.htm 

Centers for Disease Control and Prevention [CDC]. (n.d.). Interpretation of hepatitis B serologic test results [Fact Sheet]. U.S. Department of Health & Human Services. https://www.cdc.gov/hepatitis/hbv/pdfs/serologicchartv8.pdf 

CDC. (2022). Nationally notifiable diseases. U.S. Department of Health & Human Services. https://www.cdc.gov/healthywater/statistics/surveillance/notifiable.html 

CDC. (2023, March 10). Screening and testing for hepatitis B virus infection: CDC recommendations — United States, 2023. MMWR | Recommendations and Reports, 72(1);1–25. https://www.cdc.gov/mmwr/volumes/72/rr/rr7201a1.htm?s_cid=rr7201a1_w 

Delta Cure. (2022, October). Program. https://www.deltacure2022.com/pages/program/index.php 

Delta Cure. (2022, October). Poster Exhibition. https://www.deltacure2022.com/pages/posterExhibition/index.php 

European Association for the Study of the Liver. (2017, April 17). EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection. Journal of Hepatology, Clinical Practice Guidelines, 67(2), P370-398. DOI: https://doi.org/10.1016/j.jhep.2017.03.021

Hepatitis B Foundation [HBF]. (2023). Testing and diagnosis. https://www.hepb.org/research-and-programs/hepdeltaconnect/testing-and-diagnosis/ 

HBF (2023). Treatment. https://www.hepb.org/research-and-programs/hepdeltaconnect/treatment/ 

Lempp, F. A., Roggenbach, I., Nkongolo, S., Sakin, V., Schlund, F., Schnitzler, P., Wedemeyer, H., Le Gal, F., Gordien, E., Yurdaydin, C., & Urban, S. (2021). A Rapid point-of-care test for the serodiagnosis of hepatitis delta virus infection. Viruses, 13(12), 2371. https://doi.org/10.3390/v13122371 

Michael, E. (2022, October 31). Q&A: Expert discusses current state of hepatitis D, challenges in elimination efforts. Healio. https://www.healio.com/news/hepatology/20221031/qa-expert-discusses-current-state-of-hepatitis-d-challenges-in-elimination-efforts 

Palom, A., Rando-Segura, A., Vico, J., Pacin, B., Vargas, E., Barreira-Diaz, A., Rodriguez-Frias, F., Riveiro-Barciela, M., & Esteban, R. (2022, October). Implementation of anti-HDV reflex testing among HBsAg-positive individuals increases testing for hepatitis D. Journal of Hepatology, 4(10), 100547. https://doi.org/10.1016/j.jhepr.2022.100547 

Sarin, S. K., Kumar, M., Lau, G. K., Abbas, Z., Chan, H. L., Chen, C. J., Chen, D. S., Chen, H. L., Chen, P. J., Chien, R. N., Dokmeci, A. K., Gane, E., Hou, J. L., Jafri, W., Jia, J., Kim, J. H., Lai, C. L., Lee, H. C., Lim, S. G., Liu, C. J., … Kao, J. H. (2016). Asian-Pacific clinical practice guidelines on the management of hepatitis B: A 2015 update. Hepatology International, 10(1), 1–98. https://doi.org/10.1007/s12072-015-9675-4

TheBMJ. (n.d.). Chapter 5. Planning and conducting a survey. https://www.bmj.com/about-bmj/resources-readers/publications/epidemiology-uninitiated/5-planning-and-conducting-survey

World Health Organization. (2022, July 18). Global health sector strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections for the period 2022-2030. https://www.who.int/publications/i/item/9789240053779 

Hepatitis B Awareness, Hepatitis D Advocacy, Living with Hepatitis B

Elevate Your Voice

Almost 300 million people worldwide live with chronic hepatitis B, but most of their stories remain untold. Often this is due to the negative stigma surrounding the virus, fear of discrimination, lack of community awareness or understanding of the disease and lack of support for those who wish to speak out publicly about hepatitis B.

No one knows hepatitis B better than the people living with the virus. Elevating the voice of people who live with hepatitis B is so important to bring awareness to hepatitis, help fight discrimination, and keeping up the momentum to find a cure for hepatitis B. Storytelling is an important to way to talk about an individual’s journeys with hepatitis B.

Since 2017, the Hepatitis B Foundation has partnered with StoryCenter to host six #justB digital storytelling workshops for over 40 participants from more than 20 U.S. states and Canadian provinces. The #justB campaign empowers people with lived experience to share their stories with the goals of increasing awareness and advocacy around hepatitis B, decreasing stigma and discrimination, and promoting testing, vaccination and linkage to care and treatment.

The latest #justB workshop was held in Berkeley, Calif., from March 18-20, 2022. It brought together five highly motivated adults living with hepatitis B who wanted to learn how to share their stories to educate communities and inspire action.

We will be highlighting these patient advocates and their stories over the next few months. Here are overviews of Adama and Chelle’s stories:

Adama, who was born in West Africa and immigrated to the U.S. decades ago, recalls when he tested positive for hepatitis B and how he soon realized that the illness his mother suffered from must have also been hepatitis B. “As I began to learn about the virus, I realized, ‘Oh, I think that’s what killed my mom.” Having lost his mother to the disease, Adama knows the importance of testing, early detection and monitoring for those who are living with hepatitis B. “I take treatment, I learned how to take care of myself… But what about the people around me, in my community, who won’t even get tested? Everyone talks about HIV, about how to protect ourselves, but this hepatitis virus is too much ignored.”

Chelle, a Utah resident, speaks candidly in her story about the stigma she encountered after being diagnosed with hepatitis B in the 1980s. “I felt so isolated. I couldn’t even talk to my family… Sometimes I thought about all the stomach problems I had complained of as a kid. I had been adopted from the Philippines in the 1970s. I was tested for this and that, but not for hepatitis B. Testing for the virus wasn’t widespread at that time. I was called a hypochondriac when the doctors couldn’t figure out what was wrong.” Chelle is grateful that things have improved since then and that she was able to pursue a career in the medical field. But her experience still motivates her to continue speaking out and fighting against hepatitis B related stigma that persists around the world.

To watch the new #justB stories by Adama, Chelle, Wendy, DHE and FK, and to access the complete #justB video library with more information, please visit: www.hepb.org/justb.

How to Elevate Your Voice

Are you interested in sharing your journey with hepatitis B? The Hepatitis B Foundation has the B the Voice Story Bank which provides an online platform for people living with hepatitis B, their families, community health workers and health care providers to share their firsthand knowledge and experiences with a global audience. You can submit your stories using an online form, along with any photos and personal details you wish to share. Submissions are confidential and can be made without disclosing a person’s full identity.

We encourage you to share stories about your diagnosis, living with hepatitis B, access to care and treatment, stigma and discrimination, education and advocacy, support and caregiving, services and programs and other related topics to not only help raise awareness for hepatitis B, eliminate stigma and discrimination, but to also inspire others to be brave in their diagnosis.

How Can Providers Elevate Individual’s Voices?

It is important for providers to also help elevate peoples’ who are living with hepatitis B voices. Healthcare institutions, organizations, and departments must develop relationships with people living with hepatitis B to establish trust and listen to what they want to see be done in the hepatitis B world. Their opinions are critical to develop effective programming around hepatitis B education, vaccination, testing, and eventually elimination. 

HDV, Hepatitis D Advocacy, Hepatitis Delta (HDV)

Recent Roundtable Discussion Highlights Hepatitis Delta Virus

April 21st and 22nd, 2022 marked the occurrence of a roundtable meeting solely focused on hepatitis delta virus (HDV), which was jointly hosted by the American Liver Foundation and the Hepatitis B Foundation. This was one in a series of events taking place this year to raise the profile of hepatitis delta, a serious coinfection of hepatitis B virus (HBV) that is estimated to affect between 5 and 10% of people who are living with HBV. HDV is more severe than HBV alone, with a 70% chance of developing into cirrhosis or liver cancer if unmanaged, compared to an approximately 25% chance for those living with HBV alone. With approval of the first official treatment for hepatitis delta in Europe in July of 2020, expected approval in the United States later in 2022, and other treatments moving through the clinical trial pipeline, more is happening in the world of hepatitis delta than ever before. Despite the promising treatment landscape, the virus still remains significantly under-diagnosed (making estimation of true prevalence difficult), largely due to lack of awareness, low prioritization compared to other health conditions, and limited advocacy, and big questions persist about treatment equity, including access to knowledgeable providers, clinical trials, and available medications. The purpose of this roundtable was to begin a conversation among a diverse group of stakeholders about some of these issues, to bring attention to HDV and its potential consequences, to identify unmet needs in this area, and to prepare calls to action and next steps to address these needs.

Participants at the roundtable included individuals living with hepatitis delta, caregivers, healthcare providers, public health professionals, and representatives from community-based organizations. The conversation was very generative and really underscored some of the key issues that exist around hepatitis delta, including gaps in awareness and knowledge among medical and high-risk communities and limited access to and availability of HDV screening and care. These factors lead to under-diagnosis and under-surveillance, making the production of accurate data difficult, which in turn complicates advocacy efforts, since compelling data is often a key ingredient for policy change that might make screening, treatment, and linkage to care more available and accessible.

The ultimate planned outcome of this virtual event will be production of a white paper that will highlight key takeaways from the discussion, clearly outline unmet needs and priority issues for people living with HDV, and detail calls to action for stakeholders at every level to meet these needs and overcome some of the significant barriers and challenges that persist in diagnosing, managing, and treating HDV.

Another goal of the meeting was to begin to develop resources that can better support and engage the larger community around HDV awareness and advocacy – a first step toward this goal will be creation and dissemination of a visually appealing infographic, which will provide at-a-glance information about HDV and its estimated prevalence, transmission, prevention, testing, and treatment.

The white paper and infographic are expected to be complete by early summer 2022. The organizers of this roundtable meeting are hopeful that its outcomes will bring hepatitis delta virus more into focus for various stakeholder communities and generate more engagement and energy around this dangerous virus that has long been neglected and is not receiving the attention it deserves.

Clinical Trials, HDV, Hepatitis D Advocacy, Hepatitis D Drug Development, Hepatitis Delta (HDV), News

2022 – The Year of Hepatitis Delta

2022 is shaping up to be a big year for hepatitis delta, the rare but serious virus that can co-infect people who are already living with hepatitis B. As a quick refresher, hepatitis delta is a virus that depends upon the hepatitis B virus in order to survive and replicate – so only those who are already living with hepatitis B can become infected with hepatitis delta. Hepatitis delta virus (HDV) is believed to infect between 5 and 10% of people living with hepatitis B virus (HBV). HDV can occur through either a superinfection or a coinfection. A superinfection occurs when someone who is already living with HBV contracts HDV, in which case there is a very high chance that the individual will develop chronic (lifelong) infections of both HBV and HDV. A coinfection occurs when both HBV and HDV are contracted at the same time – when this happens in adults, both infections tend to clear within six months and there is only a 5% chance that chronic HBV and HDV will occur. Chronic HDV is particularly dangerous because it advances progression to serious liver damage and liver failure much more quickly than HBV alone – 70% of people diagnosed with HDV and HBV will experience serious liver damage within 10 years without intervention, compared to 15-30% of people diagnosed with HBV alone.

So, What’s Happening in the World of Hepatitis Delta?

The past 18 months have been very important for hepatitis delta research and drug development. In July of 2020, the European Medicines Agency approved Hepcludex, the first-ever drug approved for treatment of hepatitis delta, for prescription in France, Austria, and Germany. Hepcludex works by stopping HDV from entering and infecting liver cells (and is known as an entry inhibitor). In 2021, MYR Pharma, the German company that originally developed Hepcludex, was bought by Gilead Sciences, Inc., which is based in the United States, and which has since filed a Biologics Licensing Agreement for approval of Hepcludex by the US Food and Drug Administration, which is expected later this year. At this time, there is not a timeline for when Hepcludex approval will be expanded to more countries and parts of the world. Prior to Hepcludex, the only drug available for hepatitis delta management, which was never officially approved, was called pegylated interferon alpha. This drug, still in use today, is only effective in controlling HDV in about 25% of people living with the virus and has challenging side effects that can negatively impact quality of life.

In addition to Hepcludex, two other promising drugs are in clinical trials, both developed by Eiger BioPharma in the United States. The first of these is called Lonafarnib, which is being evaluated for how well it works to target the protein assembly process, which keeps new viruses from being created (it is known as a prenylation inhibitor). Lonafarnib, in combination with another drug called Ritonavir, is currently in Phase III clinical trials (the phase in which the safety and effectiveness of a drug is compared to that of currently available treatments). These trials are fully enrolled, and data is expected by the end of 2022. Additionally, Eiger is currently enrolling phase III clinical trials for Pegylated Interferon Lambda, which works by stimulating the body’s own immune system to fight the virus. For a full list of drugs under investigation for hepatitis delta, including one from Janssen Research and Development and one from Antios Therapeutics, visit our Drug Watch page.

Are There Other Clinical Trials Happening for Hepatitis Delta?

 Yes! There are clinical trials happening worldwide to test many of the drugs listed above and more. You can check out our clinical trials page here. This page includes a detailed description of each clinical trial, along with information about where it is being conducted and how to contact the principal investigator (or person leading the clinical trial). This page also includes a helpful graphic describing the clinical trial process and what it takes for a drug to move from an idea into the real world. It is important to note that not all of the trials listed here are for the purpose of testing a medication – some are observational studies to monitor what are called disease biomarkers, which are physical measures used to monitor the progress of a disease and could include tests of blood or liver function, for example. Clinical trials are currently happening in Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, France, Georgia, Germany, Greece, Israel, Italy, Japan, Mongolia, New Zealand, Pakistan, Republic of Moldova, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, the United Kingdom, the United States, and Vietnam.

When Will HDV Drugs and Clinical Trials Be More Accessible in More Parts of the World?

 This is unfortunately a difficult question to answer. Even though up to 10% of people who are living with hepatitis B are also living with hepatitis delta, there are not good systems in place to make sure that everyone who is living with HBV or who is at increased risk for HDV is tested and diagnosed, so there are not very accurate numbers about how many people in the world are living with HDV. Indeed, of the nearly 300 million people around the world who are living with hepatitis B alone, only 10% are aware of their diagnosis, so this number is undoubtedly far lower than even 10% for hepatitis delta. Without accurate information about how many people are living with the virus, it is difficult for drug and clinical trial developers to invest resources into studying or pursuing drug development or clinical trials for HDV.

Another problem is the many resources of time, money, and labor that are necessary for developing drugs, and preparing and running clinical trials. The development process for a single drug can take anywhere from 5-15 years and a much larger number of drugs fail to complete this process than succeed. Additionally, there needs to be some degree of existing infrastructure in a particular country in order to both support a clinical trial and ultimately to get a drug approved. Unfortunately, this kind of infrastructure is generally already established and easier to navigate in wealthier countries, so these are the countries in which clinical trials are generally held and in which drug approvals tend to happen first. Public health and clinical infrastructure is slowly developing and becoming more prioritized in different parts of the world and hopefully this trend will continue, but for the time being, the locations of clinical trials and approvals for important treatments point to the much larger issues of lack of access to health and healthcare in much of the world, that in turn stem from deep-seated poverty and inequity. Again, as health equity continues to be a focus of the public eye, these trends will hopefully begin to change, paving the way for greater access to healthcare for hepatitis delta, hepatitis B, and countless other health conditions.

What Is Hep Delta Connect’s Role?

 This year, Hep Delta Connect will continue its work to raise the profile of hepatitis delta, both in the United States and around the world. We are committed to building awareness through partnerships with community-based organizations, healthcare providers, and governmental agencies around the world and through dissemination of educational materials and programming. We hope to foster greater engagement of those living with and affected by hepatitis delta globally, more focused advocacy efforts to bring HDV into the spotlight, and increased screening, diagnosis, and management of HDV. We keep our website and social media channels updated regularly with program news and events – make sure to follow us on Facebook, Twitter, and Instagram and check out our website frequently! You are always welcome to connect with us anytime at connect@hepdconnect.org. We look forward to an exciting year of work on HDV!

Baruch S. Blumberg Institute