Hep B Blog

2022 Advocacy Year in Review

As we wrap up 2022, we hope you’ll take some time to look back and celebrate the exciting and important hepatitis B policy and advocacy achievements of the past year! Community partners and grassroots advocates around the world came together to advance our shared advocacy goals and working toward the elimination of hepatitis B.  

  

 

 

 

 

 

 

 

 

 

 

 

This year we celebrated big wins in the U.S. including:  

Congressional Funding for Pennsylvania Center of Public Health Excellence  

With the passage of the Fiscal Year (FY) 2022 Omnibus Appropriations Act in March, the Hepatitis B Foundation received $475,000 to create a Center of Public Health Excellence focused on hepatitis B elimination by providing expert resources, advice, training, capacity building and technical assistance for state and local partners on how to best prevent, treat and control hepatitis B, and to increase the rate of adult vaccination and testing for hepatitis B. The Center of Public Health Excellence was one of nine community projects that Congressman Brian Fitzpatrick secured funding for in the FY 2022 Omnibus. 

 

Implementing Universal Hepatitis B Recommendations   

In April, universal hepatitis B vaccination for adults aged 19-59 became official recommendation. HBF immediately embarked on a dissemination campaign to raise awareness of the new guidelines amongst various stakeholder groups. HBF also launched the Hepatitis B Vaccination and Screening Advisory Council, which is comprised of key stakeholders from the provider and patient advocate communities and hepatitis B experts. The Council held a two-day meeting in June to develop implementation strategies for universal hepatitis B vaccination and screening (expected in 2023) and will publish its findings in a white paper. 

 As our network of grassroots advocates and storytellers continues to grow, we have also expanded our involvement in state/local advocacy and global advocacy. Our ongoing advocacy efforts in the U. S. include calling on Optum to restore the hepatitis B treatment Vemlidy back to their health insurance formulary. Globally we continue to put pressure on Gavi to move forward with implementation of hepatitis B birth dose in member countries, urging members of Congress and President Biden to help end hepatitis B discrimination in the U.S. military, recognizing National African Immigrant and Refugee HIV and Hepatitis Awareness (NAIRHHA) Day in the U.S., advocating for universal adult hepatitis B screening, and increasing funding for hepatitis B and liver cancer. 

 

Updated U.S. Public Health Service Corps Medical Standards  

The U.S. Public Health Service (USPHS) Commissioned Corps announced in December that it is updating its medical standards to accept future applicants living with chronic hepatitis B and HIV. Previously, HIV and hepatitis B infection were both considered disqualifying medical conditions. The Hepatitis B Foundation became aware of this issue in late 2020, when an individual with hepatitis B applied to serve but was denied due to their hepatitis B infection. Working alongside partners, we successfully advocated for a change in this policy by meeting with senior administration official and Congressional champions, and getting language included in the FY 2022 House Labor-HHS Appropriations report urging the USPHS to allow officers with hepatitis B to serve in the Commissioned Corps.  

  

Check out the report to learn more!  

https://www.hepbunited.org/assets/Advocacy/5d40b3bcc9/2022-HBU-Year-in-Review-Final.pdf 

  

From all of us at the Hepatitis B Foundation and Hep B United, THANK YOU for your continued support and dedication to advocating for hepatitis B awareness, prevention, treatment, and research and combatting stigma and discrimination. We are so proud of what the hepatitis B advocacy community achieved this year, and we look forward to continuing to work together to build on the momentum of these accomplishments in 2023! 

What You Need to Know About the 2022 Liver Meeting and How It Relates to Hepatitis Delta

 

 

 

 

This year, the annual Liver Meeting, hosted by the American Association for the Study of Liver Diseases (AASLD), was held in Washington, D.C. The featured presentations included new innovations in liver transplant surgery, disease modeling (which is a process that uses cells to show how a disease develops and to test possible treatment approaches), and drug development. While an effective, functional cure for hepatitis B virus (HBV) is still 5-10 years away, researchers, scientists, healthcare providers, and people with lived experience all came together and agreed that more needs to be done to reduce the burden of liver diseases and improve health outcomes now. One highlight of the meeting was Dr. Francis Collins, former director of the U.S. National Institutes of Health and special advisor to President Biden, hosting a special session to introduce a national hepatitis C elimination plan for the U.S. Unfortunately, this plan is focused on hepatitis C. As a response, the Hepatitis B Foundation will soon send an advocacy letter pushing for the inclusion of hepatitis B and hepatitis delta in this plan. Make sure you are signed up for our Action Center alerts to stay engaged with hepatitis B advocacy efforts.

Of particular note at this year’s meeting were the presence of many patient advocates and people with lived experience, and an increased focus on hepatitis delta. One important hepatitis delta poster presentation was delivered by Dr. Tatyana Kushner of Mount Sinai Hospital in New York City, entitled “HDV Patient Perspective: The Impact of Disease and Current Unmet Needs.” By including the perspectives of people living with hepatitis delta virus (HDV), this study aimed to empower the patient community. Dr. Kushner and her colleagues collected data on people’s quality of life to identify unmet needs, barriers and gaps in HDV care (including disease management and access-to-care inequities).

The researchers found that a person’s care is affected in two ways: In the care they receive for their clinical diagnosis and their emotional journey after diagnosis. The participants’ experience of care was often negatively impacted by having a delayed HDV diagnosis, and limited access to specialized care and tolerable treatment options. Findings describe that the lack of specific and acceptable treatment options for hepatitis delta left people with little hope, which put an emotional burden on their life post-diagnosis. Due to the gaps in providers’ knowledge of HDV, participants held little trust in their healthcare providers. The study participants also shared that they suffered emotionally due to the stigma attached to their diagnosis.

Dr. Kushner and her colleagues call for an increased effort to educate healthcare providers on hepatitis delta, as their lack of HDV-specific knowledge drives health disparities or differences between groups, where one group is more burdened by a disease than the other. These are driven by unequal opportunities to achieve good health (CDC, 2020). Health disparities are preventable, and educating providers is the first step to overcoming these inequalities. Educating providers on HDV will lead to more rapid identification of the disease, as they will have a better understanding of the signs, symptoms and risk factors for hepatitis delta. Increasing advocacy efforts for point-of-care testing for both HBV and HDV in the U.S. will increase levels of testing and earlier identification of people at risk for the diseases. Timely diagnosis allows for people to be linked to specialty care earlier, ultimately improving health outcomes. Improving community awareness of HDV will combat stigma and likely reduce testing hesitancy, which can improve health outcomes. The researchers call for drug developers to meet the needs of the patient community by developing tolerable and hepatitis delta-specific treatments.

In terms of drug development, researchers presented on antiviral treatments for people living with HDV and discussed preferred outcomes of treatment, based on what they believed to be most helpful to each individual’s physical health. To understand these treatment considerations, it is important to review how HDV functions. Hepatitis delta virus (HDV) uses a person’s RNA (ribonucleic acid) to produce and replicate the virus, so high HDV RNA levels in the blood indicate severe infection, and low or undetectable HDV RNA levels indicate that the virus is not rapidly reproducing (Stephenson-Tsoris & Casey, 2022). A virological response is defined as a long-term period of low-level replication that leads to undetectable HDV RNA levels in the blood six months after stopping treatment, and this indicates viral suppression (Yamashiro et al., 2004). A biochemical response is defined as normalization of alanine aminotransferase (ALT) levels after antiviral treatment (Kim et al., 2022). When liver cells are damaged, they release ALT into the bloodstream, so high levels of ALT indicate that one’s liver is diseased or damaged (MedlinePlus, n.d.). ALT normalization is considered a good indicator that antiviral therapy is working because it means that there is less liver damage, liver disease is less severe, and people living with HBV/HDV are at less risk of harm (Kim et al., 2022).

One study of interest from the meeting was the D-LIVR study by Eiger BioPharmaceuticals, Inc.: Lonafarnib Global Study in Chronic Hepatitis Delta. This study consisted of 400 participants, who were all on treatment for 48 weeks, then followed up with researchers 24 weeks after treatment. In total, 50 participants received pegylated interferon (Peg IFN) treatment for 48 weeks; 125 participants received a combination of Lonafarnib, Ritonavir and Peg IFN; and 175 participants received the oral antiviral therapy Lonafarnib and Ritonavir. There were also 50 people on a placebo treatment. A placebo is a harmless pill that has no effect on a person, and is often used in clinical trials to test the effectiveness of a specific treatment being studied, in this case, Peg IFN, Lonafarnib and Ritonavir (Harvard Health Publishing, 2021). The researchers decided that they wanted to see a decline in HDV RNA (virologic response) and normalization of ALT (biochemical response) at week 48 as their study’s main outcome or proof that the treatment could work. In this study, an acceptable virologic response was defined as a “2log decline of HDV RNA levels,” which means they wanted to see HDV RNA levels decrease by 99% from the original levels that were measured before starting treatment (Wikipedia, n.d.).

Pegylated interferon (Peg IFN) is a protein-based medication that prompts the body to activate its natural immune system (induce innate antiviral response) (Zhang & Urban, 2021; Drugbank, n.d.). For Peg IFN-based treatments, researchers determine that undetectable HDV RNA six months after stopping treatment is desirable. However, researchers emphasize the importance of yearly HDV RNA post-treatment screening to monitor for viral relapses after treatment. For long-term treatment (over 48 weeks), a 99% reduction of HDV RNA concentration levels is an appropriate virologic response for non-interferon-based treatments, but more studies must be done to establish whether a person living with hepatitis delta is actually benefiting from the treatment (this is called clinical benefit). When establishing the clinical benefits for non-interferon-based treatments (or any new treatment), researchers can measure delays in disease progression or improvement of signs and symptoms of the disease, which includes symptom relief, improved functioning and improved survival rates (Lee, n.d).

Based on a variety of extensive studies (not just D-LIVR), the researchers decided to combine virologic and biochemical responses to try to demonstrate the clinical benefit of using ongoing antiviral treatment as a functional cure for hepatitis delta. They concluded that acceptable endpoints for HDV treatment studies include undetectable HDV RNA six months after stopping treatment, the loss of the hepatitis B surface antigen (HBsAg), and ALT normalization in people living with chronic hepatitis delta. This can also be considered a functional cure since there are undetectable levels of HBsAg and HDV RNA in the blood for a sustained period of time, even after finishing treatment (Wong et al., 2022).

While there is still time before we overcome the burden of hepatitis delta, the presentations from The Liver Meeting show us that researchers and scientists are constantly working to improve the lives of people living with hepatitis delta. Development toward a functional cure is progressing, and advocates are incorporating peoples’ lived experiences and perspectives into drug development and education. Collaboration between all these groups is the best way to move forward in the fight against hepatitis delta.

For more information on hepatitis delta, you can visit the Hepatitis Delta Connect website or review this hepatitis delta fact sheet.

References

Centers for Disease Control and Prevention. (2020). Health disparities. Centers for Disease Control and Prevention, Division of Adolescent and School Health, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. https://www.cdc.gov/healthyyouth/disparities/index.htm 

Drugbank. (n.d.). Peginterferon alfa-2a. Drugbank. https://go.drugbank.com/drugs/DB00008

Harvard Health Publishing. (2021, December 13). The power of the placebo effect. Harvard Health Publishing, Harvard Medical School. https://www.health.harvard.edu/mental-health/the-power-of-the-placebo-effect 

Kau, A., Vermehren, J., & Sarrazin, C. (2008). Treatment predictors of a sustained virologic response in hepatitis B and C. Journal of Hepatology, 49(4), 634-651. https://doi.org/10.1016/j.jhep.2008.07.013

Kim, S. H., Cho, E. J., Jang, B. O., Lee, K., Choi, J. K., Choi, G. H., Lee, J. H., Yu, S. J., Kim, Y. J., Lee, Y. B., Yoon, J. H., Kim, J. W., Jeong, S. H., & Jang, E. S. (2022). Comparison of biochemical response during antiviral treatment in patients with chronic hepatitis B infection. Liver International: Official Journal of the International Association for the Study of the Liver, 42(2), 320–329. https://doi.org/10.1111/liv.15086 

Lee, J. (n.d.). Defining Clinical Benefit in Clinical Trials: FDA Perspective [Presentation]. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. https://celiac.org/main/wp-content/uploads/2015/04/great3-07.pdf 

MedlinePlus. (n.d.). ALT blood test. National Library of Medicine (U.S.). [updated August 3, 2022]. https://medlineplus.gov/lab-tests/alt-blood-test/ 

Raman, S. (2022 October 25). Administration eyes national hepatitis C treatment plan. Roll Call: Policy. https://rollcall.com/2022/10/25/administration-eyes-national-hepatitis-c-treatment-plan/ 

Stephenson-Tsoris, S., & Casey, J. L. (2022). Hepatitis delta virus genome RNA synthesis initiates at position 1646 with a nontemplated guanosine. Journal of Virology, 96(4), e0201721. https://doi.org/10.1128/JVI.02017-21 

Wikipedia. (n.d). Log reduction. https://en.wikipedia.org/wiki/Log_reduction

Wong, G. L. H., Gane, E., & Lok, A. S. F. (2022). How to achieve functional cure of HBV: Stopping NUCs, adding interferon or new drug development?. Journal of Hepatology, 76(6), 1249–1262. https://doi.org/10.1016/j.jhep.2021.11.024

Yamashiro, T., Nagayama, K., Enomoto, N., Watanabe, H., Miyagi, T., Nakasone, H., Sakugawa, H., & Watanabe, M. (2004). Quantitation of the level of hepatitis Delta virus RNA in serum, by real-time polymerase chain reaction—and its possible correlation with the clinical stage of liver disease. The Journal of Infectious Diseases, 189(7), 1151–1157. https://doi.org/10.1086/382133

Zhang, Z., & Urban, S. (2021). New insights into HDV persistence: The role of interferon response and implications for upcoming novel therapies. Journal of Hepatology, 74(3), P686-699. https://doi.org/10.1016/j.jhep.2020.11.032