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HBV, Hepatitis B Advocacy, Hepatitis B Awareness, Liver, Liver Cancer, Liver Health, Living with Hepatitis B

Read about the Hep B Foundation’s Newly Launched Learn the Link Campaign with Dung Hua of the Vital Access Care Foundation

This month, we spoke with Dung Hua of the Vital Access Care Foundation, formerly known as the Vietnamese American Cancer Foundation. Dung and her team continuously work to address the needs of the Vietnamese community in Orange County, California and the surrounding areas. Dung spoke to us about her experiences addressing hepatitis B and liver cancer in this community, as well as her contribution to the Learn the Link campaign, which officially launches in February 2024. Dung shared the challenges she faces, her rewarding experiences and the many ways she works to connect with and educate her community. 

The Learn the Link campaign was created to raise awareness about the link between chronic hepatitis B infection and liver cancer in a culturally appropriate way for communities that are most impacted. It was informed by speaking directly with community members and created with their needs centered and prioritized. The Hepatitis B Foundation held focus groups and assembled an advisory committee to learn about the needs and concerns of the communities for which the educational materials were being created to ensure that the materials were informative and sensitive to the traditions and norms of different cultures.  

Can you introduce yourself and your organization? 

My name is Dung and I work for the Vital Access Care Foundation. We recently underwent a name change because we expanded our services to not only focus on cancer, though The Cancer Continuum of Care, and our liver cancer and hepatitis B programs are the primary focus. We started in 1998 and provided general cancer assistance services, which later developed into a breast cancer focus. In 2003, we started the liver and hepatitis B programs. One of our founders is an oncologist and the other is a gastroenterologist who provides consultation and guidance for our hepatitis B and liver cancer programs. 

Can you tell me about your organization’s programs that address hepatitis B and liver cancer directly? 

Our hepatitis B and liver cancer programs focus on the Vietnamese community. We provide outreach, education, patient navigation and screening. We start with education because many people in this population are not aware of hepatitis B. We host community screenings and bring screenings into the community at churches and cultural events. People are more willing to get screened when we bring screenings to these events. If someone tests positive for hepatitis B, we provide patient navigation and linkage to care. If someone needs to be vaccinated, we provide guidance to link people to the vaccine. If a case is more complicated, we consult with a board member who can provide a professional consultation at no cost. During the pandemic, we tried to tie hepatitis B to COVID-19 and encourage people to get the COVID-19 vaccine and a hepatitis B screen at the same time. We leveraged our hepatitis B vaccine experience and surprisingly, a lot of people were willing to “get poked” twice in one day. 

Can you tell me about the community that your organization serves? 

We focus on the Vietnamese American community in Orange County. This community consists of  immigrants and refugees. In this community, there is still a lot of stigma around hepatitis B. Many people still believe that you can get hepatitis B from sharing a meal with people who are positive. In the Vietnamese community, there’s a saying: “If you sweep the floor, then you find garbage,” which is an idiom for avoiding the doctor; if you don’t go to the doctor, then you won’t know you’re sick. Culturally, you only share what is good. There’s a stigma with seeking help. You’re not supposed to share that you’re weak or struggle, which can lead people to internalize their pain. 

In addition to stigma, many people deal with undiagnosed mental health issues and the challenges of moving to a new country. This community also has lower rates of insurance coverage, which can make receiving routine medical care difficult. The Asian community also deals with the model minority misconception, which can be harmful because many people stereotype Asian people as well educated with a stable income, which isn’t always true.  

Many of the people we serve either speak limited English or no English at all. When people come to the United States (US), they need to immediately find a job and are often classified as low skilled workers. It’s hard for recent immigrants and refugees to have upward mobility. However, many people are motivated by creating better opportunities for their family and children.  

What are some challenges you face in addressing your community’s health concerns? 

The biggest challenges are stigma around disease and having culturally and linguistically appropriate materials. Languages are complicated. Different waves of immigration affect the way that you can communicate with people because languages change over time, which means finding a balance between older and newer languages and dialects is important. It continues to be a learning process for me, as I am exposed more and more to people in my community. It’s important and difficult to be responsive to stigma and all language and cultural barriers, but it is also the most rewarding part of the work.  

Why do you think that hepatitis B and liver cancer educational materials are so important for your community? 

They’re important because knowledge is power. The key to improving is understanding and knowledge, which comes from education. People won’t know what’s best for them if they don’t know the information, which needs to be reinforced through repetition. If people do things and they don’t understand why they are doing them, the behavior won’t last. But if they do understand, they can continue those behaviors and help to spread that information to others. 

What was your experience facilitating the focus groups and serving on the advisory committee that informed the Learn the Link campaign? 

I was there to support and provide observation of the focus group. What I remember is that the community members were very engaged. They have personal experience with hepatitis, which empowered them to engage more. It was a safe space for them to provide feedback. It was empowering for them to be a part of the process and to realize that they are being listened to. The effort of this project to create culturally appropriate materials and seek out feedback from this community allowed people to feel like they made a meaningful contribution to something important. 

While serving on the advisory committee, I remember a number of us were brought together from many different communities and we provided our thoughts and feedback on the project. I enjoyed the opportunity to hear the needs, concerns, and feedback from communities that we don’t typically work with. I found out that many things are similar among diverse communities and it was helpful for me to have the opportunity to learn more about other communities. Seeing everyone at the table providing their perspectives and hearing about the commonalities and the uniqueness was a very interesting experience. 

Why is it important that organizations speak directly with community members when creating campaigns like “Learn the Link”? 

It’s important for any campaign or activity to focus on the community. To be responsive to the community, we must listen to them. We don’t want to create something that we think is the best but doesn’t work for the people that it’s supposed to work for. That direct connection and relationship that allows community members to feel comfortable sharing direct feedback is the key to successful outreach and education.  

What is the most effective way for organizations to engage with your community? 

The most effective way to engage with the community is meeting them where they are. Being willing to go out of the way and find community members, and being open to understanding their needs and concerns is important. We can’t just work 9-5, we have to go out and find them in the community outside of regular working hours. We try to meet community members at flexible hours, host community meetings on the weekends, meet them at the temple or meet them at the park. We try to listen, understand and build rapport.  

Understanding the cultural and generation differences is important as well. For the Vietnamese population specifically, word-of-mouth is powerful. Information spreads in the community through word-of-mouth and can spread like wildfire.  

Connecting with community leaders and other people and organizations who work with the community directly is another way to connect with people. This stems from the immigrant and refugee background; people who lived through the war have a hard time trusting public entities but have trust in the people that they’ve built a rapport with. 

Do you have any final thoughts or comments about the “Learn the Link” campaign and its potential to improve the health practices of the people in your community? Are there any further materials you hope to see in the future? 

I checked out the materials when they were launched and pulled materials to show to a new employee, and I noticed that all materials were in English. When all the translations are available, it will be great to share with not only the community, but with people who work with the community as well. Hepatitis B may not be people’s priority, but with promotion, these materials can remind people that this silent killer is still around and there are resources available.  

What was your experience in helping to review and edit one of the final peer-reviewed manuscripts that will be submitted for publication from this project? 

There were a lot of words to read! Attending the advisory meetings, attending the focus groups, and reading the manuscript was spread out over a long period of time. But it was great to read the summary of all of the work that has been done. It was a nice refresher and I enjoyed reading quotes that resonated with me personally. Other communities have a lot of things in common with the Vietnamese community. It’s very exciting to collaborate together, since we are all doing this work.  

300 Million Reasons, About Hepatitis B, HBV, Hepatitis B Awareness, Hepatitis B Research, Hepatitis B Treatment, Hepatitis D Drug Development, United States

Podcast Recap: Current Treatments in Development for Hepatitis B with Dr. John Tavis

 

 

 

 

 

 

 

 

 

 

 

 

In a recent B Heppy episode, Dr. John Tavis, a molecular microbiologist at St. Louis University School of Medicine, shared updates on curative therapies for hepatitis B along with insights on how treatments for hepatitis B are researched and approved for use. 

Hepatitis B is a virus that can cause serious liver disease such as liver cancer or liver failure if undiagnosed, unmanaged or without proper intervention and treatment. While there is no cure for hepatitis B at this time, there are treatment options available to manage the virus. Research to find an optimal and functional cure for hepatitis B is ongoing and clinical trials have been very successful in advancing research pertaining to the cure.  

In some experimental studies conducted around the globe, 30% to 40% of patients have achieved functional cure. In smaller studies, approximately 50% of patients have obtained functional cure. However, research on the cure and the progression of these clinical interventions are still ongoing. While the future looks promising for a functional cure for hepatitis B, existing treatments should not be undermined or overlooked as they provide effective protection from serious liver disease such as cirrhosis or liver cancer.  

There are key terms that are important to understand related to drug development and the hepatitis B space. Below we describe complete, functional and partial cure definitions according to researchers.  

Complete, Functional, and Partial Cure 

Complete Cure: Elimination of all traces of hepatitis B including loss of surface antigen and HBV DNA. 

Functional Cure: the loss of hepatitis B surface antigen and undetectable HBV DNA levels, although trace amounts of HBV DNA may persist in the liver.  

Partial Cure: A stable suppression of the virus with undetectable HBV DNA levels. 

The progress on the cure: 

Current progress and research indicate that a combination of drugs will provide the best outcome as it is not likely that only one drug will achieve a functional cure for hepatitis B at this time. There are different types of drugs that are being studied and each treatment focus on a different aspect of the lifecycle of the virus to prevent replication and growth.  

Some of the current options being studied for hepatitis B treatment include: 

Antisense RNA and SiRNA: These drugs work by suppressing and destroying the viral messenger RNA, which is crucial to make proteins and replicate HBV DNA. Current drugs that use this mechanism to target the virus include Bepirovirsen. Clinical trials have shown effective reduction in HBV DNA and viral proteins.  

Suppressing and destroying the viral RNA (destroys proteins—RNA makes proteins,  

CAMs (capsid assembly modifiers): These drugs work by disrupting the formation of capsids. Capsids provide a protective space for the genetic material of the virus to make sure it is able to transfer to the host cell without any complications. By disrupting the formation of the capsids, the virus is unable to replicate itself as the genetic material gets destroyed during the process.  

NAPs (Nucleic Acid Polymers): These drugs work by blocking secretion of the viral surface antigen outside of the cells so the virus is unable to spread to other cells. In the process, the surface antigen drops in the bloodstream and the immune system is alerted to attack the virus.  

Nucleotide Analogues: These drugs are the first-line treatments for hepatitis B. Antiviral treatments like entecavir and tenofovir are incredibly effective in suppressing HBV viremia and preventing progression of the virus from becoming cancerous. Although they are not considered functional cure, these drugs have low toxicity and are effective in treating people living with hepatitis B.  

 

To stay updated on developments in hepatitis B research, check out our Drug Watch page: https://www.hepb.org/treatment-and-management/drug-watch-2/ 

To listen to the full episode on our podcast, B Heppy, click here. https://bheppy.buzzsprout.com/1729790/13238616-current-treatments-in-development-for-hepatitis-b 

HBV, Hepatitis B Awareness, United States

CHIPO Partner Highlight: United States Coalition for African Immigrant Health

The Coalition Against Hepatitis for People of African Origin (CHIPO) is a national community coalition that is co-founded and led by the Hepatitis B Foundation and is comprised of organizations and individuals who are interested in addressing the high rates of hepatitis B infection among African communities in the U.S. Over the past year, CHIPO has grown its membership to include over 50 community-based organizations and federal agencies, all of which are working to meet the common goals of raising awareness about hepatitis B among African immigrant communities, and increasing rates of screening, vaccination, and linkage to care. This month, we are excited to highlight the work of one of our newer national partners, the United States Coalition for African Immigrant Health, Inc., (USCAIH) and their Executive Director, Janet Afoakwah. Please enjoy a recent interview with Janet, as she describes her work, including successes and challenges, and the positive impacts she and USCAIH have had through their annual conferences and upcoming plans for expanding their portfolio and mission.

Could you please introduce yourself and your organization?

My name is Janet Afoakwah, and I am now the Executive Director of the United States Coalition for African Immigrant Health (USCAIH), previously known as the United States Conference on African Immigrant Health. USCAIH began as the National African Immigrant Project in 2005, supported by the U.S. Office of Minority Health, which provided a platform for national and regional conferences focused on African immigrant (AI) health. These conferences continue to be held on a yearly basis and attract a broad range of attendees, including federal agencies, academicians, researchers, policy makers, public health officials, students, community organizations, and a variety of other stakeholders. We are very excited because this year, in addition to hosting our annual conferences, we are going to be broadening the scope and focus of our work to include other services.

Could you tell me a little bit about what some of USCAIH’s programs are that specifically address hepatitis and other health concerns in African communities?

As we move forward into 2023 and beyond, USCAIH is going to be working toward achievement of some broader goals, including coalition-building; providing technical support to organizations working with AI communities; offering trainings and support in cultural sensitivity for direct-service organizations, especially those working in the areas of HIV and hepatitis, since this is such a crucial component of engaging with AI communities; organizing and expanding our website with important and relevant resources; collaborating and forming partnerships with like-minded organizations; inviting researchers to share their work with the community via a new podcast format; and providing a database where researchers working on AI health can consolidate their findings for direct use and application within communities. Data and research about African immigrants often are not disaggregated from that about African American and Black populations, so getting a clear picture of the health and health disparities impacting AI communities can often be difficult.

Is USCAIH focused in a specific geographic area or does it have more of a national reach?

Our conferences are both regional and national, and we also try to include researchers and organizations from many countries within Africa itself. The other services that we are hoping to expand will be focused on AI communities within the U.S., but all around the country.

Which countries are primarily represented in the African diaspora that USCAIH serves?

We work with folks from all countries and communities. We have been able to reach some communities a bit more effectively, due to existing relationships that our staff has with community members, but our hope is to eventually reach all AI communities within the U.S.

What are some of the biggest challenges in addressing hepatitis and other health concerns at the community level? How have you worked to overcome these? Are there any additional resources that would be helpful to have?

The biggest missed opportunities are in vaccination and screening for both hepatitis B and liver cancer. This gap is due to a variety of reasons, including general lack of health insurance and lack of funding for supportive programs, as well as inequities in healthcare access in general for many immigrant communities, which contribute to greater health disparities. Another large barrier is the lack of provider knowledge about the high risk of hepatitis B in AI communities.

The best ways to overcome some of these challenges are in the creation and sustainability of programs that are centered on AI communities and are culturally and linguistically competent – this is SO important. Another key element in breaking some of the barriers around cultural humility and especially provider awareness is in establishing partnerships and effective collaborations. Building awareness among trusted community and faith leaders, who in turn can pass this on to community members, is also critical. We have been able to launch and disseminate a podcast that covers health issues affecting AI communities, and we try to feature researchers and guests with lived experience of different health challenges, including hepatitis B, in order to raise awareness, dispel myths and misperceptions, and bring the severity of different health concerns into perspective. We are also working to consolidate resources on our website and to have all partners providing direct services around the country listed on there for easy navigation and connection.

Other more broad-sweeping, policy-level changes that need to happen include making hep B screening recommendations universal for all adults; and improving and centralizing linkage to care systems.

What do you think are some of the biggest barriers in raising awareness and addressing rates of hepatitis screening and linkage to care at the local, state, and federal levels? Do you think more could be done in these spheres to address this problem?

This is a big concern and one of the steps we have recently taken to address this is hosting a roundtable discussion intended to educate healthcare providers and professionals about hepatitis B and how to care for community members who might be living with HBV. Better provider education and linkage to care needs to be the order of the day. Community-based organizations should be supplementing the services that providers are offering. One big important change that can occur is for electronic medical records to include an automatic question about hepatitis B screening for all patients. All of this can be done with additional funding and support from the federal and state levels.

Do you see this issue as being connected to other concerns facing African immigrant communities?

Yes, there are a variety of health concerns that face AI communities in the U.S, many of which require similar approaches of cultural sensitivity and community and provider awareness to address. These include diabetes, heart disease, hypertension, and various forms of cancer.

What are your favorite parts about your job? What got you interested in this work?

I am passionate about hepatitis B and that is what actually got me into public health. I came into this work having previously led an HIV project at another organization. I love every aspect of my work! My favorite moments are in organizing conferences because they move so fast, have many moving parts, and are SO rewarding! These conferences are widely recognized as the premier gathering for discussing AI health – many organizations of all types are interested in presenting and sharing their work. The conference planning is tremendously collaborative and is an all-volunteer effort. Now, as Executive Director, I can see the whole picture of the conferences and the organization as a whole and am so excited to continue to be working on our old and new endeavors. Hosting the podcast has been a great experience as well, and a wonderful tool to interview a variety of people working in AI health, to raise awareness about important health topics like hepatitis B and to amplify the mission of USCAIH.

Any other thoughts or ideas you’d like to share for improving health and closing health disparities among African immigrant communities in the U.S.?

I just want to emphasize the importance of practicing cultural and linguistic competency, and of working in collaboration and establishing relationships with a variety of partners (including community- and faith-based organizations, health centers, and providers) and how important this is for community work. Establishing trust (which requires time and patience) and providing appropriate resources also cannot be overstated. Continuing to host conferences in order to have a space where ideas can be shared and collaborations can happen is key, and hopefully we can all work together to develop and execute a strategic plan of sorts for improving health and eliminating disparities in African immigrant communities in the U.S.

Thank you so much for taking the time to speak with me today and for sharing more about the great work USCAIH has done and will continue into the future!

 Thank you!

Clinical Trials, HBV, Hepatitis B Research, Hepatitis B Treatment

GlaxoSmithKline Recruiting for B-Together Hep B Clinical Trials

The company GlaxoSmithKline (GSK) is launching a new clinical trial, called B-Together, that will investigate how two study drugs might work together to treat chronic hepatitis B (CHB). Researchers are hoping to find new potential treatments that could be more effective than those that are currently available and could lead to positive results that last long after the treatment ends. Participants in this trial could play a role in shaping science and changing the landscape of CHB treatment around the world, and will have an opportunity to learn more about the disease itself.

The two drugs that will be investigated in this trial are GSK3228836 and pegylated interferon, also known as Pegasys. In a previous Phase 2 trial, people living with CHB received GSK3228836 for 4 weeks. The Phase 2b B-Together trial will test longer treatment with GSK3228836, followed by Pegasys, to see what effects this may have on viral antigens (such as HBsAg) in the body. 

About the Study Drugs

GSK3228836 is an investigational drug being tested as a potential treatment for CHB, meaning it is not yet approved for this purpose. Current medicines available to treat CHB only stop the virus from multiplying – they do not enable the body to fully clear the infection, so people have to keep taking these medicines. GSK3228836 is designed to stop the virus from producing proteins that may prevent the immune system from fighting the virus. Thus, the study drug may potentially allow the body to gain control over the infection.

The other drug used in this study, Pegasys, is a medicine that is already used on its own by doctors to treat CHB. Pegasys works by enhancing the body’s immune response to viral infections such as hepatitis B.

What Will Happen During This Trial?

During this trial, all participants will receive GSK3228836 followed by Pegasys. After you have finished treatment with GSK3228836, your doctor will check if it is appropriate for you to start treatment with Pegasys. If it is not appropriate, you may not receive Pegasys at all. At the beginning of the trial, you will be assigned by chance to one of two groups. Each group will receive the study drugs for different lengths of time. You will know which group you are in. The B-Together trial lasts about 79 weeks for each participant. This includes a screening period, a study treatment period, and a follow-up period.

Screening Period

At a screening visit, the study doctor will give you a physical examination, ask about your medical history, and conduct medical tests. The screening period may last up to about 6.5 weeks while the study doctor reviews the results of your screening visit to determine if you meet all requirements for participation.

Trial Treatment period

While receiving GSK3228836, you will visit the clinic for either 12 or 24 weeks. For the first two weeks of your treatment with GSK3228836, you will visit twice per week and for the remaining weeks you will visit the clinic once per week.

When you have finished treatment with GSK3228836, your doctor will assess if it is appropriate for you to start treatment with Pegasys. If it is appropriate, then you will then receive treatment  with Pegasys once a week for up to 24 weeks.

In some countries, it will be possible for you to self-inject Pegasys at home after discussion and training from your study doctor. This could reduce the number of times you have to visit the clinic.

Other study activities will vary from visit to visit and may include:

  •         Discussions about your health and medications you may take outside the trial
  •         Measurement of vital signs (i.e. blood pressure, pulse, weight)
  •         Collection of blood or urine samples
  •         Physical examination
  •         Questionnaires about your health and well-being

Follow-Up Period

During the 24-week follow-up period, you will not receive injections of study treatment, but you will complete other study visit activities as scheduled. There are eight visits scheduled in the follow up period. Your study participation will end about 72 weeks after your first dose of the trial drug.

Who Can Participate?

You may be eligible to participate in this trial if you are at least 18 years old, have been living with documented CHB for at least six months, and have also been receiving stable nucleos(t)ide treatment (not telbivudine) with no changes for at least six months prior to screening and no planned changes for the duration of the study. There are other eligibility requirements that the study doctor will review with you. Individuals who have a current co-infection with or past history of hepatitis C virus, HIV or hepatitis D virus are not eligible to participate in this trial. 

Where Is This Trial Taking Place?

This trial is ongoing in the UK, Spain, Russia, Poland, Italy, Korea, Japan, China, the US, Canada, and South Africa.

You can play a role in shaping your own health and the science of tomorrow! To learn more about this trial and check your eligibility to participate, visit https://clinicaltrials.gov/ct2/show/NCT04676724. 

About Hepatitis B, HBV, Hepatitis B Research, Liver, Liver Health, Living with Hepatitis B, United States

Announcing the New Current Patient Opportunities Page on the HBF Website

A new page has been created on the Hepatitis B Foundation’s website that contains a compilation of various opportunities available for people living with hepatitis B. These opportunities can be for clinical trials, other types of research, or toolkits with information and resources for those living with hepatitis B and their loved ones and community members. All of these postings are produced or organized by entities external to HBF, but all are related to improved quality of life and liver health. The first two of these opportunities are listed below.

New Tool from CME Outfitters

A new HBV Patient Education Hub has been compiled by continuing medical education company CME Outfitters. The hub includes a great deal of valuable information, such as an overview of hepatitis B, a list of questions to ask your healthcare provider, a patient guide, information about hepatitis B co-infection, doctors’ advice on what to expect from treatment, and many other resources. All information is in an engaging and accessible format. Check it out today!

New Study Opportunity Available for People Living with Itching (Cholestatic Pruritus) Due to Liver Disease or Injury

A new paid opportunity has become available for those experiencing itching caused by hepatitis B, hepatitis C, drug-induced liver injury, auto-immune hepatitis, or primary sclerosing cholangitis (PSC). If you live in Canada or the US and have this condition, you may be eligible to participate in an interview to help researchers better understand your lived experience. The new research study is seeking participants ages 12-80 living in the US and Canada who are living with this itch. This is an opportunity to be involved in research and help advance scientific understanding! Contact the research coordinator for more information and to check if you are eligible. 

Please note that this study does not include treatment and pruritus must be at an intensity level of 4 on a scale of 1-10 for at least the past 8 weeks in order to participate. Patients cannot be pregnant or breastfeeding or have a diagnosis of primary biliary cholangitis. 

We are very excited to unveil this new section of our website and hope it will be a useful resource for many going forward! Please check back often, as more opportunities will be posted as they arise.

HBV, Hepatitis B Advocacy, Hepatitis B Treatment, Liver Health, Living with Hepatitis B

CVS Caremark : Re-Add Vemlidy To Your Formulary

UPDATE: The Hepatitis B Foundation and Hep B United, along with our network of patients, providers and partners, has successfully advocated for improved access to the hepatitis B medication Vemlidy in the US.! In July 2019 CVS Caremark – a subsidiary of CVS Health and one of the nation’s leading pharmacy benefit managers – stopped providing coverage for Vemlidy. This decision impacted thousands of Americans who rely on this life-saving drug to manage their hepatitis B.

Our members took swift action. Together, we sent over 20 letters from partner organizations and gathered over 250 individual signatures for a petition encouraging CVS Caremark to provide coverage for this essential medication. 
The company announced last week that they will resume coverage of Vemlidy for their plan members as early as October 2019! Thank you to everyone who helped us to advocate for this important change. We firmly believe that all FDA-approved medications should be available for doctors to prescribe to their patients, and this change will ensure that those on CVS Caremark plans have access to this life-saving drug.
What’s Next:
On October 1, 2019, Vemlidy will be processed for those under the Advanced Control Specialty Formulary. For those with a Value Formulary, Vemlidy will be covered beginning on January 1, 2020.
Until January 1st, Gilead Sciences – the creators of Vemlidy – will provide $1,000 a month (for up to $5,000) to offset the costs of treatment. Those interested can go to Gilead’s website and apply for a co-pay card; insurance is not needed.
Thank you to everyone who signed the petition, wrote a letter, or simply shared the information. Because of you, those who rely on Vemlidy now have one less barrier to accessing their needed treatment!

A few months ago, CVS Caremark – a subsidiary of CVS Health – announced their intentions to remove Vemlidy from their list of covered medications, or formulary. With over 2.2 million individuals in the United States living with chronic hepatitis B, this decision impacts thousands of Americans who rely on this life-saving drug to prevent cirrhosis and liver cancer.

CVS Caremark is the second-largest Pharmacy Benefits Manager (PBM) in the United States. As a PBM, Caremark manages prescription drug benefit plans for payers including health insurers and large employers. One of their main tasks is to negotiate drug prices with manufacturers and develop and maintain formularies on behalf of health insurers, which influence which drugs are available to patients on their prescription drug plan and determine out-of-pocket costs. Negotiations between PBMs and drug companies are common. However, they create a dangerous, unstable health and financial situation for those suffering from chronic illnesses.

When it comes to the treatment of chronic illnesses like hepatitis B, medical decisions are best made based upon knowledgeable and informed discussions between the doctor and the patient. After all, doctors have been tracking and monitoring how the virus impacts an individual for many months, if not years, and a patient is aware of how their body reacts to certain medications. CVS Caremark’s decision to remove Vemlidy from their formularies limits the ability of providers to make the best treatment choice for their individual hepatitis B patients.

Vemlidy is one of just three first-line hepatitis B treatments. First-line treatments are medications that have been proven to be highly effective with the least amount of side effects. For some individuals, this drug is the best option, as other FDA treatments can increase their risk of kidney disease and bone density loss. Hepatitis B expert and Medical Director of the Hepatitis B Foundation Robert G Gish, MD, notes two separate studies where tenofovir alafenamide (TAF) (Vemlidy) had lower amounts of bone density loss and kidney impairment than tenofovir disoproxil fumarate (entecavir), another first-line treatment. In order to properly help their patients, doctors need to have a full range of tools at their disposal. All FDA approved medications should be available for doctors to choose from.

The Hepatitis B Foundation’s Medical and Scientific Advisory Board is also concerned about the negative health impacts of Caremark’s decision. “TAF is less likely to cause adverse bone mineral density and renal dysfunctions than Tenofovir disoproxil fumarate (TDF). This is true not only for patients at risk of these complications but the overall hepatitis B patient population as demonstrated in clinical studies comparing TAF and TDF. By removing Vemlidy from the formulary plan, CVS Caremark is implementing a significant barrier to thousands of Americans who may need and/or rely on this drug to manage their hepatitis B….We are not advocating that all hepatitis B patients have to be treated with TAF. We believe that this decision should be made by the patient’s doctor with the patient.”

What Does This Mean: 

Now that Vemlidy has been removed from Caremark’s list of covered treatments, those living with chronic hepatitis B will either have to pay the full price or switch to another medication. To put this into perspective, the average retail price of Vemlidy is $1,350 USD a month. The average cash price reached $1,650 USD in July. There is no generic version of the drug. Like other hepatitis B treatments, Vemlidy must be taken daily over the course of several years to be effective; an individual paying the average retail price would have to pay approximately $16,200 a year to access their medication.

Others will be forced to change from Vemlidy to a similar treatment that is cheaper, but may be less effective with safety issues. This practice is known as non-medical switching: when insurers or PBMs make changes to a formulary primarily due to financial negotiations with manufacturers, in exchange for greater market share.

According to the Alliance for Patient Access, non-medical switching is associated with poor health outcomes. One of their recent studies found that patients who had been switched off their preferred medication experienced complications from the new medication. One in 10 reported being hospitalized for complications after the switch, approximately 40% stopped taking their medication completely, and 60% reported side effects from the new medication. These complications are extremely dangerous for individuals taking hepatitis B medication, as stopping suddenly and without consulting an expert can cause the virus to flare and increase the risk of liver disease, and liver cancer.

Taking Action

Hep B United (HBU) – a program of the Hepatitis B Foundation and a national coalition of over 40 organizations – has started a petition and will be sending a letter to CVS Caremark.

Individuals can ask CVS Caremark to reinstate Vemlidy by signing this petition! Organizations can add their names to HBU’s official letter commenting on Caremark’s decision. We hope that CVS Caremark will honor their commitment to the health of Americans and add Vemlidy back on their formularies!

About Hepatitis B, Hepatitis B Prevention

Hepatitis B is NOT A Genetic Disease – And Here’s Why

There are many misconceptions about the hepatitis B virus. One recurring one is the myth that hepatitis B is a genetic or hereditary disease. The belief is that because multiple family members can be infected by hepatitis B, it must be a virus that runs in families. This is not true. Hepatitis B is NOT genetic. Hepatitis B is spread through direct contact with infected blood. Although transmission can occur a number of different ways, it does not happen at conception or while the child is developing in the uterus. 

Let’s start by breaking down what it means for something to be genetic or hereditary: 

A genetic disease is caused by an error in a person’s genes and is   carried by an individual in their genes. This type of disease may be passed on to a person’s child (which means it is hereditary) or it can occur spontaneously as a result of a gene mutation while a child is growing in the womb. Genes – which make up each of our unique DNA strands – are passed on to a child from both the mother and the father. Therefore, if a mother or father carries a certain hereditary disease or genetic trait, such as brown hair or green eyes, the child has the ability to have that as well. 

Hepatitis B is not a genetic disease because it does not exist in a person’s genes. It is not carried in the egg of a woman or the sperm of a man. The hepatitis B virus exists in the liver cells and circulates in the bloodstream. Unlike a genetic disease, a person is not born with the hepatitis B virus already in their bodies. Instead, the virus is passed from mother to baby during childbirth through infected blood passing from the mother to the child during the physical delivery process. If a pregnant woman tests positive for hepatitis B, she can pass the virus to her newborn through infected blood and tiny tears in the skin that occur during childbirth. Oftentimes, these tears are unable to be seen by the human eye but can still allow for the virus to pass through and make direct contact with mucous membranes (“wet skin”) of the eyes, ears, nose, and mouth of the infant

A number of different factors play a role in determining if a newborn will contract hepatitis B from their mother: the mother’s viral load levels, the mother’s knowledge of her infection, and if the newborn receives post-exposure prophylaxis. Post-exposure prophylaxis is the key to preventing mother-to-child transmission and consists of two parts: the first dose of the hepatitis B vaccine and hepatitis B immunoglobulin (HBIG). Both shots need to be administered 1) in two different limbs and 2) within 12 hours of birth in order to be as effective as possible. Once the shots have been given, the infant should complete the standard hepatitis B vaccine schedule in order to ensure that they are protected for life! *Please note that HBIG is not recommended by WHO, so it may not be recommended or available in all countries.

Commonly Asked Questions: 

It can be difficult to understand facts when they do not align with what you have been told for many years, so we’ve answered some of the most common responses to our information below: 

  1.  If it is not genetic, how is it sexually transmitted? 

 This question goes back to the topic of genes. A genetic disease differs from a sexually transmitted disease because of where the virus is hosted during transmission from one individual to another. A genetic disease is given to a person via cellular DNA while a baby is developing in the mother’s womb. Sexual transmission occurs because the virus is present in blood and sexual fluids and can be transmitted through very tiny, microscopic tears as a result of sexual intercourse.

2.  If it’s not genetic, why do multiple members of my family have it? 

Families tend to share objects – and that’s okay! However, sharp objects like earrings and body jewelry or personal care items like razors, nail clippers, or toothbrushes, can make tiny, microscopic cuts and abrasions in our skin that bleed. Sometimes, we don’t even notice! When a family member uses an object with trace amounts of infected blood and they also have a wound, such as a mouth sore,  cut, or freshly shaved skin, the virus can spread to the uninfected individual. Because hepatitis B is so infectious (at least 50 times more infectious than HIV!), even small amounts of infected blood can cause a person to become infected. Therefore, it is recommended that personal items and sharp objects are not shared – even between family members, or ensure all family members are properly vaccinated for hepatitis B and confirm they are protected

Accidents also occur frequently in households, and sometimes blood is spilled. The virus can live on surfaces outside of the body, so it is essential to properly clean up any blood spills. The key to safely cleaning up blood and killing the virus is to wear gloves and use a fresh diluted bleach solution of 1 part bleach mixed with 9 parts water. 

It’s extremely important to note that infected blood must come into contact with uninfected blood or a mucous membrane for transmission to occur. A person cannot become infected from skin-to-skin contact such as shaking hands or hugging, sharing utensils or food prepared by an infected individual, or even kissing.

Prevention: 

The best thing to remember is that hepatitis B is preventable, even if a child is born to a mother living with chronic hepatitis B! Always remember to wash your hands thoroughly with soap and hot water after any possible exposure to blood. In addition, any family members and loved ones who test negative for the hepatitis B surface antigen (HBsAg) and did not recover from a past infection (HBcAb total negative) should get vaccinated to prevent any possible transmission. The vaccine is one of the most effective vaccines in the world! 

Living with Hepatitis B, Relationships

Valentine’s Day: Dating, Love, and Hepatitis B

Valentine’s Day is a day of celebration, but it can also bring about worries and stress. Some might feel pressure about buying the right gifts for their loved ones. Maybe you’re wondering if it’s too soon in your relationship to celebrate the holiday. We may not be able to help you figure out what type of candy your partner likes the most, but we can help you navigate the holiday if you or a loved one is living with hepatitis B!

Can my partner and I have sex if one of us is infected and the other is not?

One way that hepatitis B is spread is through unprotected sex. This means that certain precautions need to be taken if your partner is uninfected, has not been vaccinated, or has not completed their vaccine series yet. Precautions include using a condom correctly. Using condoms can also prevent other sexually transmitted infections, like hepatitis C and HIV, that can be harmful to everyone, but especially to those who have chronic hepatitis B. Please keep in mind that certain sexual activities carry higher risks of transmission because of tiny, often microscopic tears in the membrane that may occur and increase the chances of direct blood contact! If you believe your partner has been accidentally exposed, they should contact their doctor or a local physician to begin post-exposure prophylaxis (PEP) as soon as possible. PEP can prevent chronic hepatitis B if caught early enough, so it is very important to inform the doctor of a possible exposure soon after it occurs.

If your partner has already completed the 2 dose (where available) or 3 dose vaccine series, there is nothing to worry about! They are not at risk for transmission! The recommended schedule for the three-dose vaccine consists of a dose at 0, 1 and 6 months, and the two-dose adult vaccine is at 0 and 1 month.  Some individuals may be interested in an accelerated vaccine schedule. Please understand that an accelerated schedule entails four shots, not three. The fourth shot would be administered at one year and would provide long term protection. Those that choose a shortened schedule will not have long term protection from hepatitis B if they do not complete the fourth dose. And your partner should have their blood tested 4 weeks after their last vaccine dose to confirm that they are protected.

I’m scared to tell my partner that I have hepatitis B.

It can be intimidating to tell a person something so personal, especially if you are uncertain about how they will react. However, it is extremely important! Even if you are using condoms, it is necessary to let your partner know your status before becoming intimate. Once you tell them, it will be a huge relief!

So, how can you prepare for the conversation?

  1. Research: hepatitis B can be confusing, so it is important that you both are familiar with the infection, including how it is transmitted! Apart from HBF’s website, the Centers for Disease Control and Prevention (CDC) has great information and handouts (in multiple languages!) on the infection. Consider printing one or two fact sheets out for your partner to look over.
  2. Take a deep breath: Don’t rush into the conversation. Take a moment to think about what you want to say. This will help you to stay calm and allow the conversation to progress. Remember to let your partner talk as well!
  3. Speak confidently: Don’t let hepatitis B speak for you! Let your partner know what you’ve learned about your infection and inform them that you are regularly visiting the doctor to monitor the infection. Speaking confidently can help keep them calm as well, and assure them that there is nothing to worry about!

If they react badly to the news at first, don’t worry! Everybody processes things at different rates and many people fear what they don’t understand. Try giving them some space and let them think about the information they’ve been given. You can also show them Heng’s #justB video; it tells the story of a man who fell in love and married a woman who is living with chronic hepatitis B and how he still supports her today! Also, remind your partner that hepatitis B is vaccine preventable! Three simple shots can protect them for life and they will never have to worry about the risk of transmission again!

Some people will never react kindly to the news, and that’s okay too! It may be disappointing, but don’t let it keep you down! You deserve someone who will accept and love you for who you are! Your chronic hepatitis B infection does not define you; it is just a small part of who you are.

For Partners of Chronic Hepatitis B Patients:

Valentine’s Day is a  time of love, and what better way is there to show love than by being supportive? If your partner is living with hepatitis B, you can show them you care in small ways! Perhaps it’s skipping the alcohol once in a while when you two go out with friends so they don’t feel alone. You can also try cooking healthy meals with them or exercising together a few times a week. Small gestures can say big things!

Hepatitis B Diagnosis & Monitoring

Newly Diagnosed with Hepatitis B? How Did I Get this? Learning the HBV Transmission Basics

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If you have just been diagnosed with hepatitis B virus (HBV) then you need to understand how HBV is transmitted. This is important whether you have an acute or chronic infection.  You must understand you are infectious and can transmit the virus to others.

How is hepatitis B transmitted?

Hepatitis B is transmitted through direct contact with infected blood or certain bodily fluids. The virus is most commonly transmitted from an infected pregnant person to their baby during childbirth, due to the blood exchange that happens between mother and baby. It is also transmitted through unsterile medical or dental equipment, unprotected sex, or unsterile needles. For kids, pediatric experts report that the fluid that oozes from cuts and open sores is also highly infectious, so keep those open cuts covered. Hepatitis B can also be transmitted inadvertently by the sharing of personal items such as razors, toothbrushes, nail clippers, body jewelry and other personal items that have small amounts of blood on them.

Hepatitis B is not transmitted casually by sneezing or coughing, shaking hands, hugging or sharing or preparing a meal. In fact, the virus is not contracted during most of life’s daily activities. You don’t need to keep cups, bowls, plates or utensils separate. Hugging, or even kissing won’t cause infection unless there are bleeding gums or open sores during the exchange. It’s really all about trace amounts of infected blood, though the virus is in other bodily fluids in lower concentrations. For example, it’s not the saliva on the toothbrush that is a big concern, but rather the potential for trace amounts of blood that could be exchanged with a shared toothbrush.

How did I get this? If you have been diagnosed with hepatitis B virus you are likely racking your brain trying to figure out how you could have gotten HBV.  Some can immediately track their likely exposure to a recent event, or perhaps a time period in their life where they were more likely to have been exposed. They may fit into an at-risk category for hepatitis B due to lifestyle choices, country of origin, frequent travel and exposure in endemic areas of the world, or an unsafe blood transfusion, or medical or dental procedures performed without proper infection control. Some may never know how they were infected. What is important is that you are now aware.

Since HBV is a silent infection there can be years before it is detected.  Many individuals born in endemic parts of the globe find out later in life that they are hepatitis B positive, even though they have likely had HBV since birth or early-childhood. Children are especially vulnerable to chronic HBV. Greater than 90% of babies and up to 50% of young children infected with HBV will remain chronically infected, and most will have no symptoms.  Often it remains undetected until it is caught in routine blood work, blood donation, or later in life after there is liver inflammation or disease progression. In Asia, vertical transmission from mother to child is particularly common; whereas in Africa, horizontal transmission at a young age may be more likely.

Although not casually transmitted, there are inadvertent opportunities for exposure to hepatitis B. If you are from an area where HBV is very common, then the odds of exposure, transmission, and infection will be higher. Many are surprised when family is tested, and they learn hepatitis B appears to “run in their family”.  Hepatitis B is NOT genetic! It is not carried on the sperm of a man or the egg of a woman, but it is very easily passed from an HBsAg positive mom to her baby at birth. Hep B is a vaccine preventable disease, but not all moms living with the virus have access to the birth dose for their baby or able to complete the vaccine series, or they have a high viral load resulting in failure of HBV birth prophylaxis. The good news is that today we can prevent the transmission of hepatitis B to the next generation.

If you do, or have participated in high-risk activities at some point in your life, you are also at greater risk. This is not a time to judge or be judged.

Time to move forward. Unless your infection is acute and you can definitively identify your exposure, I would advise that you let it go and move forward. I spent a number of years wondering about the details of my daughter’s infection, but ultimately, it really didn’t matter. What is important is seeing a doctor to learn more about your infection, getting treatment if you need it, preventing transmission to others, and moving forward with your life.

Hepatitis B Diagnosis & Monitoring, Living with Hepatitis B

Recently Diagnosed with Hepatitis B? Getting Through the Next Months Waiting to Confirm if Your Infection is Acute or Chronic

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Have you recently been told you have hepatitis B?  Dealing with the diagnosis and waiting out the next six months to determine if your infection will resolve itself or learning that it is a chronic infection can be nerve-wracking.

Fortunately, greater than 90 percent of healthy adults who are newly infected will clear or resolve an acute hepatitis B infection.  On the hand, greater than 90% of babies and up to 50% of children infected with hepatitis B will have lifelong, chronic infection. Sometimes people are surprised to learn they have a chronic infection. It can be confusing since there are typically few or no symptoms for decades. If a person continues to test hepatitis B positive for longer than 6 months, then it is considered a chronic infection. Repeat testing is the only way to know for sure.

Acute hepatitis B patients rarely require hospitalization, or even medication.  If you are symptomatic, (some symptoms include jaundice, dark urine, abdominal pain, fever, general malaise)  you may be anxiously conferring with your doctor, but if you are asymptomatic, you might not feel compelled to take the diagnosis seriously.  Ignoring your diagnosis can be very serious. If you have concerning symptoms like jaundice (yellow eyes and skin), a bloated abdomen or severe nausea and vomiting, please see your doctor immediately. Your doctor will be monitoring your blood work over the next few months to see if you clear the virus, or monitoring your liver if there are concerning symptoms.

Your job is to start loving your liver …today.  STOP drinking alcoholic beverages.  Refrain from smoking cigarettes.  Your liver is a non-complaining organ, but you cannot live without it.  Make your diet liver-friendly and healthy filled with a rainbow of vegetables and fruits, whole grains, fish and lean meats. Minimize processed foods, saturated fats and sugar.  Drink plenty of water.

Talk to your doctor before taking prescription medications, herbal remedies, supplements or over-the-counter drugs.  Some can be dangerous to a liver that is battling hepatitis B.  Get plenty of rest, and exercise if you are able.

Don’t forget that you are infectious during this time, and that loved ones, sexual partners and household contacts should be tested to see if they need to be vaccinated to protect against hepatitis B.  Sometimes family members or close household contacts may find that they have a current infection or have recovered from a past HBV infection.  If anyone fears exposure, ensure them that hepatitis B is not transmitted casually. They should get tested, and vaccinated if needed, and take simple precautions. Remind them that 1/3 of the world’s population will be infected with the hepatitis B virus during their lifetime.

On the flip-side… Do not let this new hepatitis B diagnosis consume you.  As the weeks and months pass, you might find that the infection is not resolving, and you might worry that you have a chronic infection.  The associated stress and anxiety can be challenging, even overwhelming.  It can contribute to physical symptoms you may be experiencing.  Find a family member, friend, or health care professional with whom you can share your concerns.

If you are told you have recovered from an acute HBV infection (you are now HBsAg negative, HBcAb positive and HBsAb positive) be sure to get copies of your lab reports to ensure there are no mistakes. Compare them with our easy to use blood tests chart.   If something looks wrong, or if you’re confused, speak up and ask your doctor. Once confirmed, be sure to include hepatitis B as part of your personal health history. This is important in case you have conditions requiring treatment later in life that might once again warrant monitoring of your hepatitis B. It is possible for a past HBV  infection to reactivate if a person requires longterm immune suppressing drugs .

No one wants to learn they have chronic hepatitis B but it is a manageable disease. You’ll want to see a doctor with experience treating chronic HBV so they can run additional tests. There are very effective treatments available, though not everyone with chronic HBV needs treatment. All people living with chronic HBV benefit from regular monitoring since things can change with time. Please do not panic or ignore a chronic hepatitis B diagnosis. Take a deep breath and get started today learning more about your HBV infection and the health of your liver.  Things are going to be okay!

If you are confused about your diagnosis, please feel free to contact the Hepatitis B Foundation at info@hepb.org.

Baruch S. Blumberg Institute