Hep B Blog

New hepatitis delta drug, Hepcludex, now approved in the U.S.

 

 

 

 

 

What you need to know

| Stella Dlamini

The recent U.S. Food and Drug Administration (FDA) approval of Hepcludex (bulevirtide) marked a major breakthrough in the fight against hepatitis delta. Conservative estimates suggest that approximately 4% of people living with chronic hepatitis B in the United States (U.S.) are also infected with hepatitis delta [1]. This translates to about 80,000 people. For all these people, the drug’s approval represents the first time they can access an effective, FDA-approved treatment for their condition.

What is hepatitis delta?

Discovered nearly 50 years ago, hepatitis delta is a small virus that infects individuals who are living with hepatitis B, or those who acquire both the hepatitis B and hepatitis delta viruses at the same time. The virus is transmitted through exposure to the blood and body fluids of an infected person. Hepatitis delta infection causes the most severe form of viral hepatitis, often leading to rapid disease progression and significantly increasing the risk of severe liver injury and liver cancer if left untreated. In 2025, hepatitis delta was officially classified as a class I carcinogen to humans by the International Agency for Research on Cancer (IARC) [2], owing to its association with increased risk for liver cancer. This classification reflects years of advocacy and evidence showing that people living with hepatitis delta are two-to-six times more likely to develop liver cancer than people living with hepatitis B infection alone.

How does Hepcludex work?

Hepcludex is a viral entry inhibitor and the only FDA-approved treatment for chronic hepatitis delta. Rather than attacking the virus directly, it prevents hepatitis delta from entering liver cells by blocking special protein entry points (known as NTCP receptors) located on the surfaces of liver cells. By preventing new liver cells from becoming infected, the drug helps reduce viral replication and limits ongoing liver injury.

Hepcludex is approved for adults aged 18 and older without cirrhosis or those with compensated cirrhosis, a stage where the liver is injured but continues to retain its functions. Hepcludex is administered as a once-daily subcutaneous injection (injected into the fatty tissue under the skin), typically into the lower abdomen or upper thigh. After appropriate training from a health care professional, many individuals can safely self-administer the medication at home.

Gilead, the manufacturer of Hepcludex, advises that once treatment with Hepcludex has been started, it should not be stopped without first discussing it with a health care provider. Stopping treatment may increase the risk of a ‘flare-up’, where the virus may become active again.

What did clinical trials show?

The FDA approval was supported by Phase 3 clinical trials conducted across the U.S, Germany, Italy, Russia and Sweden.

48% of participants on Hepcludex experienced a significant decline in hepatitis delta viral load (or 2 log reduction in hepatitis delta RNA) and alanine aminotransferase (ALT) normalization, compared to just 2% in the group of participants who had treatment initiation delayed. Importantly, these outcomes were maintained for 144 weeks (approximately three years) for those who received early treatment [3].

While Hepcludex reduces the hepatitis delta viral load, it does not directly affect the hepatitis B viral load, so it is important to maintain standard care for hepatitis B infection when getting treatment for hepatitis delta.

What does this mean for people living with hepatitis B and delta?

Despite hepatitis delta being the most severe form of viral hepatitis, fewer than 11% of people living with chronic hepatitis B are estimated to have ever been tested for the virus in the U.S. [4]. Since hepatitis delta can only occur in people with hepatitis B, anyone living with chronic hepatitis B should discuss hepatitis delta testing with their health care provider. With effective treatment now available, there is a massive opportunity to get tested for hepatitis delta, identify infection and receive treatment early.

Individuals already diagnosed with hepatitis delta should speak with their health care provider to determine whether they are eligible for Hepcludex treatment. Gilead has a Support Path Program created to assist individuals with navigating insurance and financial support for accessing the treatment, including for eligible uninsured individuals.

What does this mean for health care providers?

The availability of an effective drug is also an opportunity to change the approach to hepatitis delta care in clinical practice. Health care providers should proactively identify patients at risk by testing all people living with hepatitis B for hepatitis delta. Hepatitis delta diagnostic capacity has expanded in the U.S., and tests are available to order from multiple labs. Providers should now also make efforts to ensure their eligible patients are started on Hepcludex as soon as possible.

Of course, vaccination against hepatitis B for those who are not infected remains a paramount preventative step, which ensures that individuals are protected from hepatitis B, without which hepatitis delta infection cannot occur.

This approval marks a significant change for everyone involved in hepatitis delta. The next challenge is ensuring that those who stand to benefit from this breakthrough are identified, diagnosed and connected to treatment with no delays. To learn more about hepatitis delta, please visit Hepatitis Delta Connect.

References:

1. Gish RG. Delta hepatitis in the United States: epidemiology, testing, and linkage to care. Gastroenterol Hepatol (N Y). 2023 Oct;19(10):603-605. PMID: 38404959; PMCID: PMC10882855.

2. World Health Organization. WHO urges action on hepatitis, announcing hepatitis D as carcinogenic [Internet]. Geneva: World Health Organization; 2025 Jul 28 [cited 2026 Jul 9]. Available from: https://www.who.int/news/item/28-07-2025-who-urges-action-on-hepatitis-announcing-hepatitis-d-as-carcinogenic

3. Gilead Sciences. FDA grants accelerated approval to Gilead’s Hepcludex® (bulevirtide-gmod), the first and only approved treatment for chronic hepatitis delta virus (HDV) [Internet]. Foster City (CA): Gilead Sciences; 2026 May 22 [cited 2026 Jul 9]. Available from: https://www.gilead.com/news/news-details/2026/fda-grants-accelerated-approval-to-gileads-hepcludex-bulevirtide-gmod-the-first-and-only-approved-treatment-for-chronic-hepatitis-delta-virus-hdv

4. B. V. John, M. M. Amoli, D. M. Evon, R. Wong, and B. Dahman, “Hepatitis Delta Testing Trends in a US National Cohort: An Analysis of Patient and Provider- Level Predictive Factors,” Hepatology Communications 8, no. 5 (2024): e0401.

 

Why Primary Care Doctors and Liver Specialists Need to Work Together for Hepatitis B Care

 

 

 

 

 

 

 

 

 

Hepatitis B is a long-term infection that affects the liver. Many people with hepatitis B feel healthy and have no symptoms, sometimes for decades. But even without symptoms, the virus can quietly damage the liver and lead to serious problems such as cirrhosis or liver cancer. Because of this, hepatitis B needs lifelong treatment. That care works best when primary care doctors and liver specialists work together. 

Hepatitis B care is a shared responsibility 

Hepatitis B can be diagnosed in primary care settings. Primary care doctors order blood tests, provide vaccines, manage other health conditions, and often have longstanding relationships with their patients. They are usually the doctors people see regularly and trust the most. 

Liver specialists—such as hepatologists, gastroenterologists, or infectious disease doctors—have deeper training in liver disease. They help decide when treatment is needed, assess liver damage, and guide screening for liver cancer. They are especially important when hepatitis B becomes more active or complications arise. 

What happens when care is not coordinated 

When primary care and specialty care are not connected, people living with hepatitis B can miss critical steps in care. For example: 

  • A patient may not be referred to a specialist when needed. 
  • Blood tests or ultrasounds may be delayed or forgotten. 
  • Liver cancer screening may not happen regularly. 
  • Patients may feel confused about whether their condition is serious. 

Because hepatitis B often causes no pain or has minimal, if any, symptoms, these gaps can go unnoticed. Sadly, some people only learn they have a serious infection when they are diagnosed with advanced liver disease or liver cancer. 

Teamwork leads to better health 

When primary care doctors and liver specialists work as a team, care becomes clearer and safer. Primary care doctors can handle routine visits, manage overall health, and make sure labs and imaging are scheduled. Liver specialists can guide treatment decisions and provide clear plans for monitoring. 

This shared approach helps patients stay on track, reduces duplication of tests, and ensures problems are caught early. 

Collaboration helps reduce health inequities 

Hepatitis B is more common in some communities, especially Asian, Pacific Islander, African and immigrant populations. Many people face language barriers, stigma, or limited access to liver specialists. 

Primary care providers are often closer to these communities, and have a deep understanding of each community’s unique needs. Specialists bring expertise but may not always be easy to reach. Working together helps bridge these gaps, improves education, and supports culturally appropriate care. 

Preventing liver cancer requires ongoing communication 

People with hepatitis B have a higher risk of developing liver cancer, even if they feel fine. Regular screening, usually occurring every six months, can detect cancer early, when treatment works best. Specialists may recommend screening, but primary care doctors often help make sure it actually happens. 

Hepatitis B is a lifelong condition that requires longterm planning and follow up. When primary care doctors and liver specialists work together, patients get better monitoring, receive clearer guidance, and a better chance to stay healthy. Collaboration among primary care providers, liver specialists, and patients is essential for preventing liver disease, reducing disparities, and saving lives. 

 

For patients looking for care and qualified medical providers, check out the Hepatitis B Foundation’s Physician Directory here: https://www.hepb.org/treatment-and-management/physician-directory/ 

What to Know About the New B‑SUPREME Study for Chronic Hepatitis B

 

 

 

 

 

 

 

 

 

Many people living with chronic hepatitis B are hoping for better treatment options, especially medicines that can lead to long-lasting control of the virus. A new research study, called B‑SUPREME, is now enrolling participants to help test a potential new treatment. This study could play an important role in moving HBV research forward.

What Is the B‑SUPREME Study?
B‑SUPREME is a Phase 2 clinical trial. Phase 2 studies focus on learning more about how safe a medicine is and how well it works. The medicine being tested is called ALG‑000184. It is considered investigational, which means it is approved for use in clinical research but is not yet approved for the treatment of chronic hepatitis B infection.

Researchers want to understand how well this study medicine lowers the hepatitis B virus in the blood and how safe the study medicine may be.

Who Can Join the Study?
The study has a few main requirements. Participants must:

  • Be between 18 and 65 years old with a diagnosis of chronic hepatitis B infection,
  • Have either never received hepatitis B treatment or must not have received hepatitis
    B treatment within the last six months before enrolling in the study and
  • Have never received a capsid assembly modulator (CAM), since previous exposure
    could affect study results.

What Does Participation Involve?
If someone qualifies and chooses to join, the entire study lasts about 28 months. That’s a little more than two years. The time is divided into several phases so researchers can understand the medicine from different angles.

The First 48 Weeks
During the first part of the study, participants are randomly assigned to receive either the new study drug, ALG‑000184, or a placebo version of TDF. A placebo looks exactly like real medicine but does not contain any active drug. TDF is a standard treatment for hepatitis B. Using a placebo version helps researchers compare how well the new study drug works.

Everyone takes one pill per day. For the first four weeks, you will visit the study center every two weeks. After that, visits happen once every four weeks until Week 48.

The Next 48 Weeks: Extension Phase
During an extension period of 48 weeks all study participants will take ALG‑000184 only. This part of the study is designed to help researchers learn more about how the medicine works inside the body and how strong its antiviral effects may be.

During this phase, participants return every six to eight weeks until they reach Week 96.

The Long-Term Follow-Up Option
Once participants finish Week 96, they can choose what to do next. One option is to join a long-term follow-up study. This would allow them to continue taking ALG‑000184 for another three to four years. This extra time helps researchers study medicine’s long-term safety and efficacy.

If someone decides not to continue, that is completely fine. They would have just one final visit at eight weeks after taking their last dose.

Costs, Care, and Support
All study-related medication and tests are free for participants. They will also receive reimbursement for travel/transportation. People can leave the study at any time. If participants experience any study-related side effects, the study team will take good care
of them.

If a participant agrees, their treating doctor can also stay informed of their progress, which helps ensure that the person receives support if they decide to leave.

Why This Study Matters
Current treatments help many people but they do not work the same for everyone. Some people may still have virus in their body. The B‑SUPREME study explores whether the study medication could be a future treatment option for chronic hepatitis B. By taking part in the study, participants may help improve understanding of hepatitis B and support future research and care for themselves and others.

Coping With Anxiety Around Liver Cancer Monitoring

 

 

 

 

 

 

 

 

 

For people living with chronic hepatitis B, regular testing is an important part of staying healthy. Blood tests and imaging, such as ultrasounds, help doctors monitor the individual patient’s health and the effectiveness of whatever medications they may be taking and even find liver cancer early, which increases the effectiveness of treatment. Even so, many people feel anxious about monitoring. It is common to worry before appointments or feel stressed while waiting for results. Research shows that this kind of anxiety is very common among people living with hepatitis B (Low et al., 2025). 

The good news is that there are strategies and ways to help reduce the anxiety associated with screening and monitoring liver cancer. These strategies do not eliminate the need for monitoring, but they can make it much easier to manage the worry that comes with it. 

Evidence‑Based Coping Strategies 

  • Learn what monitoring is for and what results mean.
    People feel less anxious when they understand why tests are done and what different results mean. Clear explanations from health care providers, such as explaining that unclear or abnormal results do not always mean cancer, can reduce fear and stress (Hui et al., 2026). 
  • Ask direct questions during appointments.
    Questions like “What is this test checking for?” or “What happens if something looks different?” can help replace worry with facts and reduce uncertainty (Hui et al., 2026). 
  • Use mental health tools to manage worry.
    Research shows that cognitive behavioral therapy (CBT) and mindfulness practices help people notice anxious thoughts and calm their reactions. Simple steps such as deep breathing, guided relaxation, or focusing on the present moment can help during scan weeks (Low et al., 2025). 
  • Plan ahead for testing days.
    Having a plan helps people feel more in control. This may include scheduling something relaxing after an appointment, choosing a friend or family member to talk to, or limiting time spent searching online for alarming information (Low et al., 2025). 
  • Lean on social support.
    Talking with others who understand—such as support groups, patient programs, or trusted loved ones–can reduce feelings of isolation and anxiety. Feeling supported makes coping easier (Low et al., 2025). 
  • Treat mental health as part of liver health.
    Experts recommend screening for anxiety and depression as part of hepatitis B care. Counseling or emotional support can improve quality of life and help people stay engaged in important monitoring (Low et al., 2025). 

Studies show that even though monitoring can be stressful, most patients still want to continue because it helps save lives (Hui et al., 2026). The goal is not to stop testing, but to support emotional well‑being along the way. 

Liver cancer monitoring helps catch problems early, but living with constant check‑ups can be stressful. With clear information, mental health support and simple coping strategies, patients can stay connected to care while also protecting their well‑being. 

When Policies Don’t Match Science: Confronting Hepatitis B Stigma in Education

 

 

 

 

 

 

 

 

 

Guest Writer: H. Grady SwicordDMD, Birmingham Family Dental Services 

My dental assistant knocked and entered my office, looking ashen. She was holding a letter from the Dental Board. “They aren’t going to let me in,” she said quietly. 

“What do you mean? Why not?” I asked, reaching for the letter. My assistant was fully qualified, and we had been expecting her admission letter to the Board’s Dental Hygiene Program for weeks. Becoming a Dental Hygienist was one of her lifelong goals. She handed me the certified letter, visibly ashamed. 

REF: Denial of 2023–2024 ADHP Application 

…Due to your diagnosed chronic hepatitis B, you will not be able to participate in… 

The letter was as poorly written as it was unfair. My student had been born overseas to a mother with asymptomatic chronic hepatitis B and was chronic hepatitis B positive herself. She had answered truthfully on the application a question that should not have even been on the form. The Dental Board told me they were simply following state law. I knew they actually were violating federal law. This marked the beginning of a long journey. 

My student was eventually admitted that year, 2023, but only after I hired a lawyer. Even then, her participation came with restrictions, such as not being allowed to have her teeth cleaned in the Alabama Dental Hygiene Program. I realized this scenario would continue for the next hepatitis B positive student, as well as for the many other students who were excluded each year, I did not want this to happen again. 

I began speaking at the Dental Board’s monthly meetings in late 2023 and continued into 2024. At each meeting, I delivered the same message: the state law the Dental Board was relying on was based on outdated 1991 CDC guidelines and should instead be following the 2012 CDC guidelines, which did not permit denial, delay or restrictions based on any hepatitis B blood test results, and the newer guidelines must be followed. The Board refused to budge, insisting they had to follow state guidelines. The next elected Board president for 2025 had the same mindset. 

Finally, I spoke to the president of the Alabama Department of Public Health, which oversees the Dental Board on state health regulations. The president was certain they were aligned with CDC recommendations. At this point, two Dental Board presidents, two dental specialists on the Dental Board, and the president of the Alabama Department of Public Health had told me I was wrong. I needed to give up or become very determined. I chose the latter. 

I reached out to various organizations for help, support and clarification. I got none of that and until I reached out to Dr. Chari Cohen, president of the Hepatitis B Foundation. I had looked up their website and then, why not, I reached out to the president, Chari Cohen. On the phone, Dr. Cohen was engaging, assured me I was correct and explained they were very familiar with outdated guidelines being entrenched in various administrations. She confirmed the arbitrary discrimination based on hepatitis B status or vaccine response violated federal law. Over the months, Chari continued to provide me with supportive information and much needed encouragement. 

After I had a series of communications with the Alabama Department of Public Health, they agreed to a Zoom call with me. I requested that everyone who needed to make the decision to be present on the call. 

During the call, the general counsel and officers were courteous and professional and had done their homework. They agreed with my position and outlined the process for them to change state law, which would take nearly a year. I acknowledged the timeline and expressed appreciation for their swift decision to move forward in the process. Unfortunately, this lengthy process meant another admissions cycle would pass. Several more students with dreams of a career as a dental hygienist were denied entry. 

On Jan. 10, 2026, the Alabama Department of Public Health officially updated the state law, which now aligned Alabama with the current federal law on hepatitis B guidelines. 

At the January 2026 Dental Board meeting, I spoke about the state law changing. The Board decided to vote the following month on a proposal to update their hepatitis B guidelines for their Dental Hygiene Program. On Feb. 13, 2026, I addressed the Board again, emphasizing the fairness of the update and reminding them that with proper sterilization techniques, no healthcare worker practicing with Standard Precautions has transmitted hepatitis B to a patient anywhere in the world in the last 38 years. We needed to update our hepatitis B guidelines. 

The Board then voted on the proposal I had helped draft, which eliminated denials, delays, and restrictions for students based on hepatitis B status or vaccine response status. It passed, and the Dental Board came into compliance. Two weeks later, the 2026–2027 Dental Hygiene Program applications were released—with the new hepatitis B guidelines prominently displayed on the front page. No student would be denied, delayed or restricted in their education due to hepatitis B status or vaccine response. 

There were no bad actors in this process, just uninformed professionals with wrong concerns. In the end, everyone came around. And my hygienist is enjoying her wonderful career. A deeply satisfying journey. 

If you or someone you know has faced discrimination related to hepatitis B, explore our Discrimination Registry and Know Your Rights Guide to learn about the protections available to you. 

How artificial intelligence (AI) technology is helping doctors understand liver cancer

 

 

 

 

 

 

 

 

 

Liver cancer is a serious disease that can be difficult to detect early. When a patient’s symptoms raise a concern, physicians usually use medical images, such as CT scans or MRIs, to look for signs of cancer or abnormal growth in the liver. But sometimes, these images are challenging to read, and small tumors can be missed. That’s where artificial intelligence (AI) comes in. 

A recent study looked at how AI is being used to help doctors find and understand liver cancer better. 

What is AI? 

AI stands for artificial intelligence, which means computer programs that can learn from data and make decisions or predictions. In medicine, AI can look at lots of information, such as diagnostic images of the body, lab test results and patient history, and find patterns that might show signs of disease. 

How is AI used in liver cancer? 

In liver cancer, AI can be used to: 

  • Find tumors: AI can scan medical images and spot areas that look unusual (this can indicate abnormal tissue growth or cancer cells), even if they’re very small. 
  • Measure tumors: It can outline the shape and size of a tumor, which helps doctors plan treatment. 
  • Predict risks: AI can estimate how likely it is that the cancer will come back or spread. 
  • Help choose treatments: Based on the available data, AI can suggest which treatments might work best for a patient. 

What kinds of AI tools are there? 

Researchers are using different types of AI tools to help study liver cancer. Each tool works in its own way, but they all have the same goal: to look at medical data and help doctors understand what’s going on inside the body. 

Here are the main types:

Machine Learning (ML):  

  • Machine learning is a type of computer program that learns from examples. For liver cancer, it might look at thousands of patient records and medical images to learn what cancer looks like. Once it’s trained, ML can analyze new cases and predict whether someone might have cancer or how serious it is. 
  • Think of it like teaching a computer to recognize patterns, just like how you might learn to spot different dog breeds by looking at lots of pictures. 

 Deep Learning (DL) 

  • Deep learning is a more advanced kind of machine learning. It’s especially good at looking at pictures, such as CT scans or MRIs, and finding tiny details that might be hard for a human to see. These tools use a neural network, which is a system that works kind of like a human brain; it connects lots of pieces of information to make decisions. 
  • Deep learning is often used to find small tumors, measure their size and even tell if they’re likely to grow or spread. 

Multi-Modal Systems 

  • “Multi-modal” means using more than one type of information at the same time. These systems combine medical images with lab test results, patient history and other health data. By looking at everything together, AI can give a more complete picture of the patient’s condition and medical needs. 
  • It’s like solving a puzzle; you need all the pieces to see the full image. These tools help doctors understand not just where the cancer is, but how it might behave and what treatments could work best. 

What are the challenges? 

Even though AI is helpful, it’s not perfect. It needs a lot of good-quality data to work well. If the data is missing or not diverse, AI can make mistakes. Also, many AI tools are still being tested and aren’t used in hospitals yet. Doctors still need to understand how AI makes its decisions, which isn’t always easy. While it’s still being developed, artificial intelligence is helping researchers learn more about liver cancer and how to treat it. 

Reference: 

Wang, L., Fatemi, M., & Alizad, A. (2024). Artificial intelligence techniques in liver cancer. Frontiers in Oncology, 14, 1415859. https://doi.org/10.3389/fonc.2024.1415859 

Beyond the Liver: The broader impact of living with chronic hepatitis B

 

 

 

 

 

 

 

 

 

When we talk about chronic hepatitis B virus (HBV) infection, the focus is usually on the liver and for good reason. HBV is a leading cause of liver cirrhosis and liver cancer. However, new research shows that HBV’s impact goes far beyond the liver. It can increase the risk of other cancers in the body.  

Hepatitis B and non-liver cancers 

A major population-based study in China found that people with chronic hepatitis B had significantly higher risks of several types of cancer beyond liver cancer. These included stomach, colorectal, pancreatic, oral cancers, and lymphoma (a type of cancer that affects the immune system). For example, the risk of lymphoma was nearly double in HBV-positive individuals compared to those without the virus (Song et al., 2019). This suggests that HBV may play a role in cancer development outside the liver, possibly through long-term inflammation or high viral load that affects other tissues and nearby cells. 

How hepatitis B affects other organs 

Hepatitis B isn’t limited to liver cells. It can also be found in the pancreas, kidneys, and blood cells, where it may cause inflammation and target the immune system (Tang, 2020). Long-term inflammation, especially without proper treatment or management, caused by hepatitis B can raise the risk of cancer, and, because the virus can stay in different parts of the body, not just the liver, it may help explain why it’s linked to other types of cancers.  

In addition to cancer, hep B can also cause inflammation in other organs. One example is kidneys. Some people with HBV develop a condition called glomerulonephritis, which is a type of kidney inflammation. Over time, this can lead to serious kidney damage if not treated. 

HBV may also be linked to certain blood disorders and metabolic issues, especially when combined with other health problems such as diabetes or MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease. These conditions can make it harder for the body to stay balanced and healthy (Karayiannis, 2017). 

Mental and emotional health 

Living with chronic hepatitis B often can affect a person’s mental health. Some people feel anxious, stressed, or even depressed because of the stigma, the fear of passing the virus to others, or worries about their future health. These feelings can make it more challenging to stay on top of treatment and care. 

What Can Be Done? 

Fortunately, hepatitis B is manageable. Antiviral medications can suppress the virus, which may reduce the risk of complications and help with inflammation of not just liver cells but also other cells and tissues in the body. Regular monitoring and early treatment are key, not just for liver health, but for preventing other health issues linked to hepatitis B. Learn more about hepatitis B management and updated recommendations here. Check out our Liver Cancer Connect program to learn more about liver cancer prevention and management. 

While liver cancer is one of the most serious outcomes of chronic hepatitis B, the virus can also harm other parts of the body, including the stomach, pancreas, and even the immune system. That’s why managing hepatitis B isn’t just about protecting the liver; it’s about protecting your whole health. Staying connected to care, getting regular checkups, and following treatment plans are key to detecting problems early and living well with hepatitis B.  

References: 

Song, C., Lv, J., Liu, Y., et al. (2019). Associations between hepatitis B virus infection and risk of all cancer types. JAMA Network Open, 2(6), e195718. https://doi.org/10.1001/jamanetworkopen.2019.5718  

Tang, H. (2020). Hepatitis B Virus Infection: Molecular Virology to Antiviral Drugs. Springer. https://doi.org/10.1007/978-981-13-9151-4  

Karayiannis, P. (2017). Hepatitis B virus: virology, molecular biology, life cycle and intrahepatic spread. Journal of Gastroenterology, https://doi.org/10.1007/s12072-017-9829- 

Should hepatitis B screening be mandatory for jobs or immigration? Let’s talk ethics

 

 

 

 

 

 

 

 

 

Hepatitis B (HBV) is a virus that affects the liver and can lead to serious health problems like liver cancer. Because it can spread through blood and other body fluids, some governments and employers have considered making HBV screening mandatory, especially for people applying for jobs or immigration. But is that fair? Let’s break down the ethical issues. 

Hepatitis B screening is a simple blood test that checks if someone has the virus. The U.S. Centers for Disease Control and Prevention (CDC) now recommends that all adults get screened at least once, even if they don’t have symptoms (Schillie et al., 2023). That’s because many people don’t know they have it, and early treatment can prevent serious illness. 

The problem with making it mandatory 

While screening can help protect public health, forcing people to get tested—especially for employment- or immigration related reasons can harm communities and increase stigma and discrimination.  

  1. It can take away personal choice.

Mandatory screening means people don’t get to decide for themselves if they want to be tested. Often people are not even informed of the testing taking place or why it is occurring. That goes against the idea of informed consent, which is a basic principle of medical ethics. People should be able to choose whether to get tested, especially when it involves sensitive health information. 

  1. It can lead to discrimination.

HBV is more common in certain parts of the world, such as Asia and Africa. So, if screening is required for immigrants, it could unfairly target people from those regions. That can lead to stigma and even racism. In fact, studies show that people in Asian and Black communities in the U.S. are more likely to die from HBV-related illnesses than White communities (Schillie et al., 2023). Many communities in parts of Africa and East Asia are unfairly targeted through these mandatory screening tests which limit economic opportunities and lead to social isolation and stigma.  

  1. What happens after the test?

Another issue is what happens if someone tests positive. Will they be denied a job or visa? Will they get access to treatment or linkage to care? If screening is mandatory, there should also be support systems in place—such as affordable health care and protection from discrimination. Otherwise, it’s not just unfair—it’s harmful.  

  1. Privacy matters.

Health information is personal. If employers or immigration officers have access to someone’s HBV status, that could well be a privacy violation. People might lose jobs or face rejection just because of a medical condition that’s manageable with treatment. 

A better way forward 

Instead of making HBV screening mandatory, experts suggest offering it as part of routine health care. That way, people can get tested without feeling singled out. Universal screening also helps reduce stigma because it treats everyone equally. Additionally, people who test positive or need the hepatitis B vaccine should have easy access to medical care and vaccination options. 

In short, HBV screening is important, but it should be done in a way that respects people’s rights and reduces stigma and discrimination.  

References: 

Schillie, S., Wester, C., & Vellozzi, C. (2023). Universal adult hepatitis B screening: Updated recommendations from the CDC. Morbidity and Mortality Weekly Report, 72(6), 145–150. https://doi.org/10.15585/mmwr.mm7206a1 

 

Microbiome matters: What your gut says about your liver

 

 

 

 

 

 

 

 

 

Did you know that the tiny organisms living in your gut, called the microbiome, can have a strong impact on your liver? Recent research shows that the bacteria and fungi in your digestive system play a major role in keeping your liver healthy and may even affect how hepatitis B progresses. 

The gut-liver connection 

Your gut and liver are closely connected through something called the gut-liver axis. When your gut microbiome is balanced, it helps protect your liver by producing helpful substances such as butyrate and tryptophan. These can reduce inflammation and support liver function. But when the microbiome is out of balance (a condition called dysbiosis), harmful bacteria and toxins can leak into the bloodstream and reach the liver, causing damage (Zhang et al., 2024). 

What happens in hepatitis B 

Hepatitis B virus (HBV) can lead to serious liver problems, including cirrhosis. A 2025 study found that people with HBV-related cirrhosis had fewer good bacteria such as alistipes and lachnospira, and more harmful ones including Fusobacterium and Enterococcus in their gut (Chen et al., 2025). These changes were linked to lower levels of important nutrients like tocopherol, which help protect the liver. 

Another study looked at how the mix of bacteria in the gut changes as hepatitis B gets worse. Researchers found that people with chronic hepatitis B had a wider variety of bacteria compared to people without hepatitis B. They also noticed changes in the balance between two major groups of bacteria (firmicutes and bacteroidetes) that are important for digestion and immune health. These shifts in gut bacteria could help doctors understand any changes or advances in hepatitis B and possibly even predict how it might develop over time (Wang et al., 2023). 

Bile acids and bacteria 

Bile acids, which help digest fats, also interact with gut bacteria. In HBV-related liver disease, high bile acid levels were linked to more lactobacillales and fewer clostridiales, which suggests another kind of imbalance (Zhou et al., 2025). This connection could lead to new treatments that target both bile acids and bacteria. 

Your gut microbiome does a lot more than help you digest food. It’s deeply connected to your liver and can influence how hepatitis B develops and changes over time. As scientists learn more, we may see new treatments that focus on fixing the microbiome to protect and promote liver health. 

 

References: 

Chen, Y., et al. (2025). Gut microbiota and metabolomic profiles in HBV-related cirrhosis. Journal of Hepatology Research. 

Li, X., et al. (2024). Gut mycobiome and liver disease: Emerging insights. Liver International. 

Wang, J., et al. (2023). Microbiota diversity across HBV disease stages. Microbiome Medicine. 

Zhang, L., et al. (2024). Gut microbiota and chronic liver disease: Mechanisms and interventions. Hepatology Reviews. 

Zhou, H., et al. (2025). Microbiota–bile acid crosstalk in HBV-induced cirrhosis. Clinical Gastroenterology. 

 

Why Postpartum Women Struggle with HBV Treatment Adherence and What We Can Do About It

 

 

 

 

 

 

 

 

 

Hepatitis B remains a global health challenge.. There are strategies to prevent perinatal (mother to child) transmission of hepatitis B. Prevention includes testing all pregnant persons for the marker of hepatitis B infection (HBsAg), if the pregnant person is positive, then assessment is needed throughout pregnancy. If the pregnant person’s viral load becomes high, antiviral treatment (TDF) might be recommended during the second trimester taken throughout pregnancy. Data shows this is safe and effective, and reducing the viral load can reduce the risk of transmission.  

Additionally, making sure that all infants get hepatitis B birth dose as soon as possible after delivery, ideally within the first 24 hours of birth followed by at least two subsequent doses of hepatitis B vaccine (usually part of global childhood immunization series ex: the pentavalent vaccination). However, for many individuals, adhering to these guidelines in many parts of the world can be a challenge. Recent research sheds light on the barriers and opportunities to improve treatment adherence during this important period. Treatment adherence means taking your medicine the right way, at the right time, in the right amount, and for as long as your doctor tells you. It’s about sticking to your treatment plan to maintain your health.  

The postpartum drop-off: a hidden risk 

A study published in the Journal of the Pediatric Infectious Diseases Society explored adherence to tenofovir disoproxil fumarate (TDF), a medication used to treat HBV, among pregnant individuals. While adherence during pregnancy was relatively high, many women discontinued treatment postpartum. A mix of factors contributed to the drop in HBV treatment adherence following delivery including:  

  • Lack of follow-up care after delivery 
  • Low awareness about health risks that may come from stopping medication 
  • Limited knowledge about the long-term benefits of continued treatment 
  • Healthcare system gaps, especially in low-resource settings, making access to care and medication difficult 

What the numbers say?

In a broader context, a study from Israel found that only about 67% of chronic HBV patients maintained high adherence (defined as taking at least 80% of the prescribed medication). Many women stopped taking their medication after giving birth or were not consistent with their medication routines (Mor et al., 2022). A 2025 pilot study published in Virology Journal looked at what happens when women with chronic hepatitis B stop taking antiviral medication after giving birth. Among 88 women who discontinued treatment postpartum, nearly 29% experienced liver inflammation (ALT flares)—a sign that the virus was becoming elevated (Tang et al., 2025).  

What can be done? 

Improving postpartum adherence to HBV treatment requires a holistic approach and strategies can include: 

  • Integrated care models that link obstetric and hepatology services, making it easier for women to stay on track with their hepatitis B care and medication 
  • Patient education that emphasizes the importance of continued treatment beyond pregnancy 
  • Support from community health workers to provide follow-up and encouragement to stay connected with hepatitis B care 
  • Mobile health tools (like SMS reminders) to help new mothers stay on track after delivery 

The postpartum period is a time of immense change—and often, medical follow-up takes a backseat. But for women living with HBV, taking efforts to prevent perinatal transmission is crucial not just for their own health, but for preventing the future generation from hepatitis B. With better systems, education, and support, we can close the adherence gap and protect more lives. 

To learn more about prevention of perinatal transmission of hepatitis B, you can also visit the Hepatitis B Foundation’s Informed Training Hub, which includes modules on perinatal prevention. 

References: 

Greenup, A. J., Tan, J., Nguyen, V., & Visvanathan, K. (2020). Adherence to antiviral therapy for chronic hepatitis B during pregnancy and postpartum: A prospective cohort study. Journal of the Pediatric Infectious Diseases Society, 9(3), 289–295. https://doi.org/10.1093/jpids/piz064 

Mor, Z., Grotto, I., & Anis, E. (2022). Adherence to antiviral therapy among patients with chronic hepatitis B in Israel. Israel Journal of Health Policy Research, 11(1), 1–9. https://doi.org/10.1186/s13584-022-00527-2 

Tang, Q., Wang, C., Li, H., Chen, Z., Zhang, L., Zhang, J., Liu, X., Xue, Y., Qiu, Y., Peng, M., Zeng, Y., & Hu, P. (2025). Unexpected HBsAg decrease after nucleoside analogues retreatment among HBeAg positive postpartum women: A pilot study. Virology Journal, 22, Article 36. https://doi.org/10.1186/s12985-025-02632-x 

World Health Organization. (2024). Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection (WHO Guidelines). https://www.who.int/publications/i/item/9789240090903