Improving Hepatitis B Clinical Trial Diversity and Participation
Health Equity Forum Podcast: Episode 10 - Transcript
RDML Richardae Araojo: Hello, and welcome to the Health Equity Forum Podcast, hosted by the FDA Office Of Minority Health and Health Equity. I'm your host, Rear Admiral Richardae Araojo, the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at FDA. In this episode, we will be talking about increasing diversity in hepatitis B clinical trials.
Hepatitis B is a viral infection that causes inflammation of the liver. Hepatitis B can be an acute short-term infection or a chronic long-lasting infection. Asian Americans and Pacific Islanders make up over half of the people in the United States living with chronic hepatitis B. African immigrants have the second highest rate of chronic hepatitis B. If you are living with chronic hepatitis B or you think you may have hepatitis B, talk to your healthcare provider about starting a treatment regimen or getting tested.
To learn more about the impact of hepatitis B and the importance of diverse participation in hepatitis B clinical trials, we've invited Dr. Chari Cohen, Senior Vice President and Dr. Yasmin Ibrahim, Public Health Program Manager with the Hepatitis B Foundation.
Dr. Cohen, Dr. Ibrahim, welcome to the Health Equity Forum podcast.
Dr. Cohen: Thank you so much for inviting us.
Dr. Ibrahim: Thank you for inviting us.
RDML Richardae Araojo: Dr. Cohen, can you tell us about the Hepatitis B Foundation?
Dr. Cohen: Sure. I am happy to. The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure and improving the lives of all those impacted by hepatitis B, hepatitis delta, and liver cancer. We have dedicated scientists working to find a cure for hepatitis B and early detection methods for cirrhosis and liver cancer. Our public health team conducts public health research and tests interventions to find strategies for increasing diagnosis, vaccination, care, and treatment.
We also have a robust advocacy program working with hundreds of patients and advocates in the community to end hepatitis B related stigma and discrimination. We lead the national Hep B United and the Coalition Against Hepatitis for People of African Origin, which is our CHIPO coalition. With these coalitions we work with partners in 30 cities across the US to ensure that people in highly impacted communities are provided with culturally appropriate education about hepatitis B and free testing and linkage to healthcare services.
Dr. Cohen: One of the most unique aspects of our organization is our patient engagement programs. We host a consult line where we answer questions and provide social support and navigation to about 10,000 people around the world. We also work with people living with hepatitis B to amplify their voice about the physical and emotional impact of living with the disease, to improve the care they receive through integrating patient reported outcomes and health related quality of life measures into the care continuum.
Dr. Cohen: We also provide support for hepatitis B capacity building and programming in Nigeria, Ghana, and Vietnam. And we partner with outstanding organizations around the world, all of us working to eliminate hepatitis B and saving lives. Finally and most recently, we are working on improving clinical trial diversity and participation. And this is where a lot of our work intersects with the FDA Office Of Minority Health and Health Equity.
RDML Richardae Araojo: Dr. Cohen, can you talk more about the impact of hepatitis B on Asian Americans and other racial and ethnic minority populations?
Dr. Cohen: Sure. Almost 300 million people worldwide have hepatitis B and without appropriate diagnosis and care, up to 25% will die prematurely of cirrhosis or liver cancer. Hepatitis B can be transmitted through sexual contact or needle sharing, but it's mostly transmitted from mother to child due to blood exchange during childbirth. In this way, hepatitis B can devastate generations of families. And the virus is ancient, so in many parts of the world where civilization is also ancient, hepatitis B is more common. In some parts of Asia and Africa, hepatitis B impacts up to 15% of the population. In the US, Asian American, Pacific Islander, and African immigrant communities are disproportionately impacted by hepatitis B and liver cancer. In fact, hepatitis B is the number one health disparity for Asian communities in the US.
Unfortunately, most people who have hepatitis B are not aware of their infection. The communities most impacted are also communities that are underrepresented. They face significant healthcare access challenges, are often marginalized, and are affected by systemic racism. Additionally, hepatitis B is a stigmatized disease. There are many common myths about hepatitis B, and these can serve as barriers. People often don't want to be tested because they don't want to know that they have it. It is so important that we provide culturally and linguistically appropriate information and access to care and treatment. We need to help providers and communities understand that there is a safe and effective vaccine to prevent hepatitis B. And there are good treatments that can help prevent liver damage and liver cancer for people who have hepatitis B.
RDML Richardae Araojo: Dr. Ibrahim, can you please tell us what is the difference is between acute and chronic hepatitis B?
Dr. Ibrahim: Acute hepatitis B happens when a person first gets infected. It may last about six months after becoming infected with the virus. And most people do not have symptoms or their symptoms are mild. However, severe symptoms of acute hepatitis B can also occur that will require hospitalization. Chronic hepatitis B occurs when a person remains infected for more than six months, meaning the virus remains in the body. And chronic hepatitis B can cause serious health problems, including liver damage, cirrhosis, liver cancer, and even death.
The risk of developing chronic hepatitis B infection is directly related to the age at which a person is first exposed to the virus. The younger a person is when they are infected, the more likely they will develop a chronic hepatitis B infection. For example, more than 90% of infants that are infected will develop a chronic hepatitis B infection. Up to 50% of young children between one and five years old who are infected will develop a chronic hepatitis B infection.
Whereas five to 10% of healthy adults, 19 years and older who are infected will develop a chronic hepatitis B infection, so 90% will recover from an exposure. Most pregnant women don't know whether they are infected and can infect their babies during childbirth. And that's why the Centers for Disease Control and Prevention and the World Health Organization recommend that all infants receive the first dose of the hepatitis B vaccine within 12 to 24 hours after birth. Vaccinating infants and children as early as possible is so important because of the high risk they have of developing chronic hepatitis B.
RDML Richardae Araojo: Thank you, Dr. Ibrahim. Dr. Cohen, can you tell us about the #justB campaign?
Dr. Cohen: Sure. JustB, real people sharing their hepatitis B stories, is our patient storytelling program that provides training, support, and opportunities to people living with hepatitis B. It helps them share their stories widely, educating their communities and advocating for people living with hepatitis B. There are over 50 storytellers right now in three countries in 12 languages. Listeners can see the stories on our website at www.hepb.org.
RDML Richardae Araojo: Your organization is working on a collaborative research project with the FDA Office of Minority Health and Health Equity on improving clinical trial diversity and participation among people living with chronic hepatitis B. What can you tell us about this research project?
Dr. Ibrahim: And we are very excited to be partnering on this study with your office. The goal is to better understand the knowledge, attitudes, perceptions, and challenges and barriers to clinical trial participation among diverse people living with chronic hepatitis B. We are collecting this information from people in the United States and around the world in multiple languages through surveys, interviews, and focus groups. We are also collecting information from drug developers and healthcare providers.
This study will broaden our understanding of how people perceive clinical trials, potential challenges to participation, and ideas for improving future hepatitis clinical trial participation. What we learn can inform drug development and clinical trial design and improve future strategies that promote diversity and inclusion in clinical trials for chronic hepatitis B. Ultimately, we can improve hepatitis B clinical trial participation among diverse populations leading to enhanced information about safety and efficacy and increase the likelihood of having better treatment options in the future.
We are still collecting data, but so far from our U.S. data, the data we have from the United States, we have learned that most people living with hepatitis B who are aware of their disease, are willing to participate in clinical trials or at least to consider participating. So we know that in the future, we need to focus on systemic access challenges to help people get connected with clinical trial opportunities.
Hepatitis B is particularly challenging because as we mentioned earlier, many of those living with the disease are undiagnosed and unaware of their status. And because the communities impacted are so diverse, our strategies need to be diverse as well. We also learned that healthcare providers in the United States who serve racial and ethnic minority populations may lack equitable access to clinical trial knowledge and experience, and that drug developers can play an important role in improving this.
RDML Richardae Araojo: Dr. Ibrahim, can you talk more about why it's important for diverse populations to participate in hepatitis B clinical trials?
Dr. Ibrahim: Sure. There is a responsibility to ensure that clinical trials adequately reflect the communities that are most impacted by a disease or a condition. It is one way that we can make sure that all communities, especially those that are underrepresented or hard to reach, benefit from new treatments and technologies. This is particularly important for people living with hepatitis B because it impacts such diverse communities. If we want to improve health outcomes for Asian American, Pacific Islander, and African/Black communities and other communities, then we need people from these communities to participate in clinical trials. Ensuring diversity in clinical trials also help us promote health equity, giving every person with hepatitis B the opportunity to attain full health, and will ultimately help us reduce health disparities associated with this disease.
RDML Richardae Araojo: And where can listeners find more information about the Hepatitis B Foundation?
Dr. Cohen: Our website, hepB.org has information in 15 languages, including videos, fact sheets, and patient navigation resources. We also have a podcast Be Heppy, H-E-P-P-Y, available on our website and on most podcast apps. From our website you can also link to our social media, so you can check us out on Facebook, Twitter, Instagram, and YouTube.
RDML Richardae Araojo: Dr. Cohen and Dr. Ibrahim, thank you so much for joining us today and for bringing attention to this important topic. And of course, thank you for the incredible work the Hepatitis B Foundation is doing to improve the health of people living with hepatitis B.
Dr. Cohen: Thank you so much for having us.
Dr. Ibrahim: Thank you for having us.
RDML Richardae Araojo: For more information about the Health Equity Forum Podcast series, visit our website at www.fda.gov/healthequity. While you are there, check out our library of resources and sign up for our newsletter. Also, don't forget to follow us on Twitter @FDAHealthEquity. Remember, together we can create a world where health equity is a reality for all.
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