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300 Million Reasons, About Hepatitis B, Hepatitis B Awareness, Hepatitis B Diagnosis & Monitoring, Hepatitis B Prevention, Research

AGA Publishes New Guidelines on Hepatitis B Reactivation!

 

 

 

 

 

 

 

 

 

The American Gastroenterological Association (AGA) has released updated guidelines to prevent and treat hepatitis B reactivation (HBVr) among at risk populations. Hepatitis B Reactivation is a serious health issue for many people undergoing treatment for cancer or people on other medications. Learn more about HBVr here. 

Immunosuppressive medications are used to treat many different health conditions and most types of cancers. Sometimes, these medications can cause sudden increases in HBV DNA levels and cause reactivation. This can lead to liver failure, severe liver damage and death. Because reactivation can happen to anyone, it is important to test for hepatitis B before starting any kind of immunosuppressive treatment as this can help doctors understand the patient’s previous or current exposure to hepatitis B and prevent reactivation altogether (Ali et al., 2025). If someone is at risk for reactivation, it can be prevented, and this testing helps to ensure that.  

The new guidelines have identified individuals that are most at risk of HBVr according to their hepatitis B status and the immunosuppressive medications they are receiving. 

People who are positive for chronic hepatitis B are at the highest risk if they take the following medications  

  • Anthracycline derivatives, anti-tumor necrosis factor (TNF) agents, or anti-interleukin-6 (IL-6) therapies. 
  • B cell-depleting agents (E.g., rituximab), chimeric antigen receptor (CAR)-T cell therapies, or cytokine/integrin inhibitors. 
  • Tyrosine kinase inhibitor (TKI) therapies or Janus kinase (JAK) inhibitors. 
  • Liver cancer treatment -transarterial chemoembolization (TACE)) 
  • Co-infected with hepatitis C and on direct-acting antiviral (DAA) therapy. 
  • High doses of corticosteroids for longer than a month 

People who were previously exposed to hepatitis B (through a positive anti-HBc) or if they tested negative for surface antigen are at the highest risk if they take rituximab (a cancer treatment drug) but are at a moderate risk if they take any of the above-mentioned medications or treatments (Ali et al., 2025). 

HBVr can progress rapidly, which is why screening for hepatitis B, prior to beginning treatment for cancers is important. If you take any of the mentioned medications, it is best to discuss with your doctor about your risk of reactivation. If you know about your hepatitis B status, you should disclose it to your provider or ask to get tested for hepatitis B to learn about your risk of reactivation. In the United States, all adults over 18 years of age are recommended to get tested for hepatitis B at least once in their lifetime. 

  • Learn more about the updated guidelines here. 
  • Learn more about hepatitis B Reactivation on our B Heppy Podcast here.  

 

References 

Ali, F. S., Nguyen, M. H., Hernaez, R., Huang, D. Q., Wilder, J., Piscoya, A., Simon, T. G., & Falck-Ytter, Y. (2025). AGA Clinical Practice Guideline on the Prevention and Treatment of Hepatitis B Virus Reactivation in At-Risk Individuals. Gastroenterology, 168(2), 267–284. https://doi.org/10.1053/j.gastro.2024.11.008  

Clinical Trials, HDV, Hepatitis D Drug Development, Hepatitis Delta (HDV), Liver, Liver Health, Research

Drug Profile: Three Hepatitis Delta Therapies That We Hope to See Widely Available Soon

 

 

 

 

The full extent of hepatitis delta’s (HDV) global disease burden is still unknown and treatment options for HDV have been limited. However, there are three promising up-and-coming drugs to treat HDV patients. This blog post details the drugs’ current phase of development and testing, how well they work for patients in the real world, and their current path toward regulation and market availability. 

Bulevirtide (Hepcludex) 

Gilead Sciences Inc. has been seeking approval from the U.S. Food and Drug Administration (FDA) for bulevirtide, or Hepcludex, since 2021. In 2020, Gilead acquired MYR, a German pharmaceutical company that had developed the hepatitis delta virus (HDV) drug. At the time that it was acquired, Hepcludex had already been conditionally authorized for use in Germany, France, and Austria (MYR Pharmaceuticals, 2020). Gilead, which is based in California, in the U.S., hoped to accelerate the global launch of Hepcludex. Since then, however, Hepcludex remains in regulatory limbo. In October 2022, the FDA announced the rejection of Hepcludex, citing concerns around the manufacturing and delivery of the drug. Gilead responded by stating that they plan to resubmit Hepcludex for approval as soon as possible (Dunleavy, 2022). Six months after the FDA rejection, the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA’s) committee responsible for conveying its opinions on medicinal products to the public, stated that it recommends Hepcludex for full marketing authorization in Europe. Since its conditional approval, a Phase 3 trial (which utilized data from patients in Germany, Italy, Russia, Sweden, and the U.S.) has shown it to be safe and effective for HDV patients. If the European Commission fully approves Hepcludex, it will be the only authorized HDV treatment available in Europe (Dunleavey, 2023).  

Lonafarnib 

At the end of 2022, Eiger Biopharmaceuticals announced that lonafarnib reached an important milestone in its phase 3 trial.  

The trial includes two regimens in patients with chronic HDV:  

  1. 1. Lonafarnib boosted with ritonavir, a protease inhibitor, which interferes with the ability of certain enzymes to break down proteins, often used in combination with other therapies for antiviral activity (this is an all-oral therapy), and
  2. 2. Lonafarnib in combination peginterferon alfa, an antiviral and immunosuppressive, which either completely or partially suppresses the immune system, often used to treat hepatitis B (HBV) and hepatitis C (HCV) patients (this is a combination therapy).

Both treatment arms showed statistical significance over the placebo arm of the trial. The placebo arm is used as a control in drug testing and has no therapeutic effect on patients. The results showed three noteworthy findings: 1. After 48 weeks (about 11 months) of treatment with the all-oral regimen, a small number of patients may achieve reduced viral load and improved liver function. 2. Combining lonafarnib and ritonavir with peginterferon alfa showed the potential to almost double the effectiveness of the drugs. 3. Combination treatment may lead to significant liver tissue improvement. Researchers found that most adverse symptoms related to treatment were either mild or moderate in severity, with gastrointestinal issues being the most frequent (Eiger Biopharmaceuticals, 2022). 

Peginterferon Lambda 

In June 2023, the results of a phase 2 trial looking at the safety and efficacy of peginterferon lambda (also an Eiger Biopharmaceuticals product) in HDV patients were published. Previously, peginterferon lambda showed a good tolerability profile (or the degree to which patients can tolerate negative treatment symptoms) in patients with HBV and HCV when compared to peginterferon alfa. In this trial, patients received 120-mcg or 180-mcg peginterferon lambda injections over 48 weeks, followed by 24 weeks of post-treatment follow-up. Researchers found that 180-mcg injections were more effective in HDV patients compared to the 120-mcg injections group. Results showed that with 48 weeks of 180 mcg treatment, patients showed a significant reduction in HDV RNA, the molecules responsible for perpetuating the virus in HDV patients. 36% of patients’ HDV RNA levels were undetectable. Some of the adverse symptoms patients experienced were flu-like symptoms and elevated transaminase levels, or enzymes that are related to a fatty liver. Most adverse symptoms were mild or moderate in nature and were resolved without additional treatment (Etzion et al, 2023). 

These three drug therapies show promise for HDV patients. Hepcludex is well on its way to becoming fully authorized in Europe after its three-year conditional approval and recent Phase 3 trial results. Lonafarnib’s phase 3 trial results are encouraging and Eiger, its manufacturer, plans to begin meeting with regulatory agencies, such as FDA and EMA, to discuss regulatory submissions (Eiger Biopharmaceuticals, 2022). Peginterferon lambda has shown a higher tolerability in patients with a lower adverse event rate than peginterferon alfa, which has been modestly used for the treatment of HDV over the past several decades (Etzion et al, 2023). Peginterferon lambda still has a ways to go before regulatory discussions, considering that results have just been published from its Phase 2 trial. Typically, in Phase 2 trials, researchers seek to learn whether the treatment they are studying is effective in fighting the disease. Phase 3 will test whether peginterferon lambda is more effective than already available, standard treatments. Hopefully, these three drugs continue to show positive results for HDV patients and will become widely available over the next few years. There are a number of other HDV drugs currently in development, but these are still in the early stages of clinical trial testing. You can stay up to date on the latest developments of these drugs by checking out the Hepatitis Delta Connect Drug Watch page. 

Dunleavy, K. (2022, October 28). Gilead hits surprise FDA rejection for hepatitis D drug already authorized in Europe for 2 Years. Fierce Pharma. https://www.fiercepharma.com/pharma/gilead-gets-fda-rejection-hepatitis-d-drug-already-authorized-europe-two-years 

Dunleavy, K. (2023, May 5). After FDA rejection, Gilead’s Hepcludex looks set for full EU NOD. Fierce Pharma. https://www.fiercepharma.com/pharma/gileads-hdv-drug-hepcludex-gets-thumbs-chmp 

Eiger announces both lonafarnib-based treatments in pivotal phase 3 D-LIVR trial in Hepatitis Delta virus (HDV) achieved statistical significance against Placebo in composite primary endpoint. Eiger BioPharmaceuticals. (n.d.). https://ir.eigerbio.com/news-releases/news-release-details/eiger-announces-both-lonafarnib-based-treatments-pivotal-phase-3 

Etzion, O., Hamid, S., Lurie, Y., Gane, E. J., Yardeni, D., Duehren, S., Bader, N., Nevo-Shor, A., Channa, S. M., Cotler, S. J., Mawani, M., Parkash, O., Dahari, H., Choong, I., & Glenn, J. S. (2023). Treatment of chronic hepatitis D with peginterferon lambda-the phase 2 LIMT-1 clinical trial. Hepatology (Baltimore, Md.), 77(6), 2093–2103. https://doi.org/10.1097/HEP.0000000000000309  

MYR Pharmaceuticals. (2020, September 17). Myr Pharmaceuticals launches HEPCLUDEX® in Germany, France and Austria. PR Newswire: press release distribution, targeting, monitoring and marketing. https://www.prnewswire.com/news-releases/myr-pharmaceuticals-launches-hepcludex-in-germany-france-and-austria-301133006.html 

300 Million Reasons, About Hepatitis B, HBV, Hepatitis B Awareness, Hepatitis B Prevention, Liver, Liver Health

Team Helpatitis: Students and Teachers Come Together to Raise Awareness of Hepatitis B in India! 

 

Hepatitis B is a critical public health crisis in India.  With over 40 million HBV carriers, it is estimated that over 115,000 people die each year from hepatitis B related causes and one million newborn babies are at risk of developing hepatitis B in India. 1 

In an effort to raise awareness for hepatitis B and contribute to the World Health Organization’s (WHO) viral hepatitis elimination plan, teachers and students at Amity International School in New Delhi, India launched Team Helpatitis to promote hepatitis B education.. Science teachers have integrated hepatitis B education in their extra-curricular activities to teach students about chronic hepatitis and liver health. School events and festivals have provided unique opportunities for students, teachers, and parents to come together and learn about the importance of prevention strategies like hepatitis B screenings in making India hepatitis free!  

Diwali Lamps Bring Hope and Awareness to the hepatitis B Cause in India 

During the month of Diwali, a religious festival of lights, Team Helpatitis students designed liver shaped oil lamps to promote awareness. These lamps are made from clay pots and are lit every year on Diwali to represent the transition from darkness into light in the coming new year. Students and teachers hope to combat the stigma and misconceptions associated with hepatitis B though these lamps. The lamps were distributed to school students and teachers to bring home and share the important message of hope and resilience with their friends and families. 

 

 

 

 

 

The liver shaped lamps were sculpted, packaged, and distributed by the students and teachers to raise awareness of hepatitis B during the Diwali festivities at their school.

Pin-O-Liv: Dart Throwing Competition to Understand the Difference between Good and Bad Liver Habits! 

The Winter Carnival at Amity International provided a platform for students to showcase their learning outside of the classroom and educate attendees about healthy and unhealthy habits for their liver. The students chose an interactive sport to keep the players informed and entertained. They created a dartboard with pictures representing good and bad lifestyle habits and their impact on the liver. Before the game, players were briefed on liver health and ways to keep the liver healthy and safe. Players were given five darts and challenged to hit the images with unhealthy habits.

 

 

 

 

 

 

 

 

 

Students participate in the dart-throwing competition to “kill” the bad habits that destroy our liver

Livbola: Students reinvent tambola to promote hepatitis B education among children and adults 

Tambola is a slightly different version of Bingo and is a beloved pastime of south Asian communities. The students were given a short presentation on hepatitis B and liver cancer. They were then introduced to the rules of the game and were quizzed on questions related to hepatitis and liver health. Prizes were distributed to players to encourage participation. The players included students, school staff, and community members.

 

 

 

 

 

 

School staff, students, and parents play the Livbola game during their annual winter carnival

The Hepatitis B Foundation was recently approached by the teachers at Team Helpatitis for a live session on hepatitis B. The Foundation met with the students and teachers via zoom a few weeks ago and discussed the physical, social, and financial impact of hepatitis B.  We also discussed the importance of preventative strategies like vaccines in promoting positive health outcomes for all communities.  

 

 

 

 

 

The students and teachers of Amity International School met with the Foundation for an introductory session on hepatitis B on zoom.

 

By participating in these activities, projects, and festivities with the help of their school’s leadership and administration, Team Helpatitis has expanded their reach beyond the classroom and amplified the voices of public health workers, advocates, and people living with hepatitis B! Check out Team Helpatitis’ social media channels to stay updated! 

Team Helpatitis’ Instagram:  https://www.instagram.com/helpatitis_aisv1_yppteam/ 

 

References: 

chrome extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.who.int/docs/default-source/searo/india/health-topic-pdf/factsheet-b-hepatitisday2016.pdf?sfvrsn=da61ef0_2#:~:text=In%20India%2C%20the%20prevalence%20of,D%2C%20followed%20by%20Aand%20C. 

Premkumar, M., & Kumar Chawla, Y. (2021). Chronic Hepatitis B: Challenges and Successes in India. Clinical liver disease, 18(3), 111–116. https://doi.org/10.1002/cld.1125 

 

300 Million Reasons, About Hepatitis B, Hepatitis B Awareness, Hepatitis B Diagnosis & Monitoring, Hepatitis B Prevention, Hepatitis B Treatment, Liver, Liver Cancer, Liver Cancer Awareness Month, Living with Hepatitis B

Ignore it till it goes away! A hepatitis B vignette.

The Scenario:

Woman is sick on couch, her husband is giving her an ice pack

Aroha Kawai just started a new job as a medical interpreter for Pacific Islander patients diagnosed with COVID-19. As a critical source of communication for the providers and the patients, she is often called to work night and weekend shifts. Aroha had a difficult conversation with the family members of a critical COVID-19 patient on whether they should discontinue ventilation support for the ailing grandmother. During this time, Aroha’s family noticed changes in her behavior. She stopped eating regularly, lost weight and repeatedly cancelled plans to go out. Aroha dismissed her family’s concerns as physical manifestations of the emotional burnout from work.

People are at a free hepatitis B screening event in a park.

Recently she attended a health fair hosted by her department at work. She approached a viral hepatitis screening booth and decided to get tested for hepatitis B. The following week, she received her results in the mail. Her results indicated that she had tested positive for hepatitis B. She shared her diagnosis with her mother who informed her that her grandfather died from liver cancer.  

Inside a doctor's office. A doctor is showing information about the liver. A woman with hepatitis B sits with her husband.

Aroha then followed up with her primary care doctor.  She discovered that she had chronic hepatitis B. Even though the ultrasound did not show any evidence of cirrhosis, her doctor ordered an imaging test (U/S, CT, MRI) to screen for liver cancer. Unfortunately, Aroha was diagnosed with early-stage liver cancer.  

Inside a hospital room. A man and child visit a woman with hepatitis B in a hospital bed.

Fortunately, the cancer had not spread and did not infect nearby blood vessels. Her doctor suggested a partial hepatectomy to remove the tumor safely as the rest of the liver was still healthy. Aroha decided to adhere to her doctor’s advice and successfully underwent the surgery. She has taken some time off from work to focus on recuperating from the surgery and spending time with loved ones.  

 

 

The Challenge:
  1. Dismissal of Symptoms:
    • Aroha initially ignored the physical symptoms of liver cancer. It is true that signs and symptoms may not necessarily be present.
    • However, it is crucial to take care of one’s health and never ignore warning signs. Fatigue, unintended weight loss, and loss of appetite are a few of the symptoms of liver cancer. 
  2. Cancer without Cirrhosis: 
    • It is possible to get liver cancer without cirrhosis. Therefore, it is always important to screen for liver cancer if you have chronic hepatitis B infection. 
  3. Importance of Screening
    • Liver cancer screening is a highly effective method to detect malignant tumors and prevent cancer for those living with hepatitis B.
    • Early intervention increases the survival rate significantly and stops the cancer from spreading to other vital organs. 
What can you do?
  1. Get Help!
    • If you experience pain or discomfort of any kind, it is important to reach out for help. Set up an appointment with your doctor and discuss your concerns.
    • There is a good chance you might be misunderstanding an important health issue for side effects of stress or emotional burnout. Do not ignore your symptoms or feelings.  
  2. Get Screened!
    • Hepatitis B is a leading cause of liver cancer, most of the time it is because someone did not know they were infected with hepatitis B or were not managing their hepatitis B infection.
    • Everyone should be tested for hepatitis B to know their status. Ask your doctor for a hepatitis B screening today.  
  3. Stay on track!
    • If you have hepatitis B, it is critical to manage the progression of the virus in your liver. For this reason, it is important to go through liver cancer surveillance regularly. Discuss with your doctor if you are at high-risk and how often you should get screened.
    • It is recommended to get an ultrasound with blood work every 6 months to check how the virus is impacting the liver.  This includes the alpha-fetoprotein (AFP) blood test to measure the levels of AFP in your blood as it may indicate the presence of cancer cells in your liver. This can also help detect any scarring or tumors. 

Don't ignore it until it goes away. Get help. Get screened for hepatitis B. Stay on track.

Resources and Acknowledgements:
  1. https://www.cancer.org/cancer/liver-cancer/detection-diagnosis-staging/signs-symptoms.html 
  2. https://www.cancer.org/cancer/liver-cancer/treating/by-stage.html 
  3. https://www.hepb.org/research-and-programs/liver/prevention-of-liver-cancer/ 

Hepatitis B Advocacy, Hepatitis B Diagnosis & Monitoring, Living with Hepatitis B

Learn Which Cancer, Arthritis or Asthma Drugs Can Reactivate Hepatitis B – Even If You’ve Cleared the Infection

Courtesy of Pixabay.
Courtesy of Pixabay.

By Christine Kukka

Drugs that suppress your immune system in order to treat cancers, rheumatoid arthritis, psoriasis, COPD and asthma can cause a life-threatening reactivation of your hepatitis B.

This dangerous viral rebound can occur if you are currently infected or even if you cleared the infection and now test negative for the hepatitis B surface antigen (HBsAg) and positive for the surface antibody (HBsAb).

These drugs weaken the immune system, which allows your infection to rebound with a vengeance, spiking your viral load and causing life-threatening liver damage within weeks of starting chemotherapy or high-dose steroids.

What’s behind this reactivation risk? Think herpes or chicken pox (shingles). You might get rid of the infections and the ugly blisters, but small amounts of virus remain and as we age and our immune systems weaken, they can reappear.

The hepatitis B virus (HBV) behaves similarly. When we lose HBsAg and/or develop surface antibodies, there are still small amounts of HBV lurking in our bodies. When we’re healthy, our immune systems effectively contain these trace amounts of virus, but old age, another serious medical condition or immune-suppressing drugs allow hepatitis B to reactivate.

Today, medical guidelines require doctors to test everyone they plan to treat with any immune-suppressing drugs for the hepatitis B core antibody (HBcAb) so they know who has been infected with hepatitis B. If a patient tests positive, doctors must run more tests to determine what risk the new drug will pose. When a patient is at risk of reactivation, doctors will simultaneously treat them with antivirals (either tenofovir or entecavir) and continue antiviral treatment for six more months after the immune-suppressing therapy ends to prevent reactivation.

U.S. CDC.
U.S. CDC.

This mandatory testing is important because some people don’t know they should tell their doctors about their past infection, and many don’t know they’re infected. Here is what happened to one person who contacted the Hepatitis B Foundation after her doctor failed to test her for hepatitis B:

“I recently had my first dose of chemotherapy and I did not mention (to) my oncologist that I was a carrier of hepatitis B, (because) I knew that it was not active. Then, after a week of chemo, I was really sick and got a high temperature. Then, my blood test came back (indicating) that my hepatitis B was reactivated. My liver doctor gave me medicine (an antiviral) to take to deactivate the virus.”

Her oncologist immediately stopped chemotherapy and monitored her HBV DNA (viral load) and liver enzymes (ALT/SGPT) to make sure the antiviral lowered her viral load before restarting chemotherapy. This example shows why it’s important to tell all doctors, including specialists, about a current or resolved hepatitis B infection. No one wants to be battling cancer and a reactivated hepatitis B infection at the same time.

According to experts, about 4.3 percent of people who have cleared hepatitis B will experience a reactivation when treated with immune-suppressing drugs.

Which drugs reactivate hepatitis B? Below is a summary of drugs that can reactivate your hepatitis B and require monitoring and preventive use of antivirals to reduce reactivation risk, according to American Gastroenterological Association (AGA) guidelines:

High-risk Drugs:

More than 10 percent of people with current or resolved hepatitis B infections will experience a dangerous reactivation if treated with:

  • Rituximab for non-Hodgkins lymphoma, or
  • Ofatumumab for chronic lymphocytic leukemia

Anyone with a current infection (HBsAg positive) treated with the following is also at high risk of reactivation:

  • Anthracycline derivatives (such as doxorubicin, epirubicin) used to treat cancers, including breast or bladder cancer, Kaposi’s sarcoma, lymphoma or acute lymphocytic leukemia, or,
  • Moderate-doses of prednisone/corticosteroids (10 to 20 mg daily) or high doses (more than 20 mg daily or equivalent) for four or more weeks. This steroid is used to treat inflammatory diseases including asthma, COPD, rheumatic disorders, ulcerative colitis, Crohn’s disease, MS, tuberculosis, shingles side effects, lupus, poison oak and tuberculosis among others.

Moderate-risk Drugs:

 Anyone with a resolved or current infection treated with the following drugs is at moderate risk of reactivation:

  • Tumor necrosis factor alpha inhibitors, such as etanercept, adalimumab, certolizumab, infliximab, for arthritis, inflammatory bowel disease, psoriasis and asthma;
  • Other cytokine or integrin inhibitors (such as abatacept, ustekinumab, natalizumab, vedolizumab), or
  • Tyrosine kinase inhibitors (such as imatinib, nilotinib)

 Also with a current infection treated is at moderate risk if treated with:

  • Low-dose (less than 10 mg prednisone daily or equivalent) corticosteroids for four or more weeks.

Also, anyone with a resolved infection treated with:

  • Moderate-dose (10—20 mg prednisone daily or equivalent) or high-dose (more than 20 mg prednisone daily or equivalent), or
  • Corticosteroids daily for four or more weeks, or anyone treated with anthracycline derivatives (eg, doxorubicin, epirubicin).

Low-risk Drugs:

Drugs that reactivate hepatitis B in fewer than 1 percent of patients include:

Current or previously-infected people treated with:

  • Traditional immunosuppressive drugs such as azathioprine, 6-mercaptopurine or methotrexate, or
  • Intra-articular corticosteroids
  • Any dose of oral corticosteroids daily for a week or less.

Previously-infected patients treated with:

  • Low-dose (less than 10 mg prednisone or equivalent) corticosteroids for four weeks or longer.

To see the entire list of immune-suppressing drugs, read the AGA guidelines.

Hepatitis B reactivation following successful hepatitis C treatment: New antivirals (such as Harvoni), used to cure hepatitis C do not suppress the immune system, but they leave coinfected people at risk of HBV reactivation once the dominant hepatitis C virus disappears. Coinfected patients need to be monitored carefully and treated with antivirals if their HBV rebounds.

Baruch S. Blumberg Institute