We should treat more people with hepatitis B, experts say
Researchers make the case to expand treatment for Hep B in Lancet Gastroenterology and Hepatology papers
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Hepatitis B virus
view moreCredit: Courtesy of NIH NIAID
St. Louis -- In a pair of articles published in Lancet Gastroenterology and Hepatology, scientists lay out the case for why we should expand treatment recommendations for people with hepatitis B.
Commissioned by the International Coalition to Eliminate HBV, researchers examine the pros and cons of expanding treatment for the 256 million people chronically infected with the hepatitis B virus (HBV) worldwide. Their conclusion is that hepatitis B drugs are being underused and that expanding the criteria for receiving treatment could save many lives over time.
HBV kills over 3,000 people every day, or over 2 people every minute. Of the people who do not clear the infection and go on to develop a chronic HBV infection, between 20 and 40% will die if they do not receive treatment, usually from liver failure or liver cancer, as the disease progresses over decades. HBV is responsible for half of all liver cancer cases.
Researchers note that current drugs are safe, effective and relatively inexpensive, though they don’t cure people. These medications substantially slow down the disease progression and they can reduce transmission of the virus to other people.
“These medications are good drugs that are being badly underused,” said John Tavis, Ph.D., professor of molecular microbiology and immunology at Saint Louis University School of Medicine and an author on both papers. “Less than 3% of all people infected with HBV are receiving treatment, and the evidence suggests that many more people could benefit from treatment. If we get people on medication earlier, the net disease and death rate is going to be much less.
“In these papers, we go through the scientific and medical evidence,” Tavis said. “We look at how HBV triggers cancers. Treatment significantly slows down the disease progression, and by giving drugs to people earlier, we can limit the cumulative liver damage over the course of a 20 to 30 years long chronic infection that causes liver cancer and liver failure.”
In a second companion article, experts discuss treatment perspectives from a patient and public health perspective.
Researchers note that hepatitis B carries an emotional, mental and social burden that adds to the disease’s impact on quality of life.
“The most common way the infection is passed along is from a mother with HBV to her infant,” Tavis said. “Most mothers don’t know they have the infection. And, the stress of learning that you passed along a deadly illness to your baby is unimaginable.
“In some countries, people with HBV will hide their status because they’ll be fired from their jobs and ostracized by their friends. Despite the fact that the virus does not spread by casual contact, many people suffer in their communities.”
Tavis reflects on the potential benefits of increasing treatment.
“We know these drugs could reduce the incidence of liver cancer by two-thirds, or possibly even three-quarters. That’s a big impact, saving millions of lives over time. Just imagine how many more grandmas will be around to have their grandkids sit on their laps. I’d like to see a lot more of that.”
Bottom line?
“By delaying treatment, you leave people at risk for longer than necessary,” Tavis said. “And, you allow too much damage to the liver before you start treatment. We need to adjust our treatment paradigm for this illness.”
The papers were written on behalf of the International Coalition to Eliminate HBV.
Additional authors on “Scientific and medical evidence informing expansion of hepatitis B treatment guidelines” include Patrick T. Kennedy, M.D., Lena Allweiss, Ph.D., Antonio Bertoletti, M.D., Markus Cornberg, M.D., Adam J. Gehring, Ph.D., Luca G. Guidotti, Ph.D., Hélène A. Kerth, M.D., Maud Lemoine, Ph.D., Massimo Levrero, M.D., Seng Gee Lim, M.D., Barbara Testoni, Ph.D., and Thomas Tu, Ph.D.
Additional authors on “Patient and Public Health Perspectives to Inform Expansion of HBV Treatment Guidelines” include Chari Cohen, DrPH, Thomas Tu, Ph.D. Philippa C. Matthews, M.D., Su Wang, M.D., Jessica Hicks, BCom and Manal El Sayed, MC.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: infectious disease, liver disease, cancer, heart/lung disease, and aging and brain disorders.
As a nationally recognized leader in research and innovation, SLU is an R1 research university, advancing groundbreaking, life-changing discoveries that promote the greater good.
Journal
The Lancet Gastroenterology & Hepatology
Article Title
Scientific and medical evidence informing expansion of hepatitis B treatment guidelines
Article Publication Date
23-Jul-2025
Therapeutic vaccine for chronic hepatitis B enters first clinical trial in patients
Helmholtz Munich (Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH))
TherVacB: Over a Decade of Research Reaches the Clinic
“After 13 years of research, seeing TherVacB enter patient trials is exciting as it is a critical step towards providing a potential cure for chronic hepatitis B,” says Prof. Ulrike Protzer, the vaccine's inventor and Director of the Institute of Virology at Helmholtz Munich and Chair for Virology at the Technical University of Munich. “This vaccine aims to activate the natural immune response in a way that could finally enable the body to eliminate the virus,” Protzer adds, who also coordinates the "Hepatitis" research area in German Center for Infection Research (DZIF).
TherVacB uses an innovative heterologous prime-boost strategy: it first introduces proteins that prime the immune system, followed by a modified viral vector (MVA) to boost the cellular immune response. This approach is designed to stimulate both antibody and T-cell responses targeted at the hepatitis B virus. The vaccine is also tailored to cover over 95 percent of global HBV strains, making it potentially effective for the more than 250 million chronically infected humans worldwide.
Sponsored by LMU University Hospital Munich and led by sponsor representative Prof. Michael Hoelscher, Director of the Institute of Infectious Diseases and Tropical Medicine and DZIF Partner Site Speaker Munich, the current trial is being conducted at clinical sites in Germany, Italy, Spain, England, and Tanzania. It aims to evaluate the safety, tolerability, and immune activity of the vaccine in patients with chronic hepatitis B whose infections are currently managed with antiviral medication. 81 patients will participate in two phases. In the first part (phase 1b), participants receive increasing doses of the vaccine components to determine the safest and most effective dose. In the second part (phase 2a), the best dose identified will be tested in a larger group of patients to confirm its safety and determine how well it stimulates the immune system to control the virus. The aim is to determine the optimal dose that is both safe and effective in helping the body fight hepatitis B.
A New Chapter in Hepatitis B Treatment
If successful, TherVacB could represent a breakthrough in the treatment of chronic hepatitis B. The ability to stimulate a functional immune response in already-infected patients could lay the groundwork for a true cure – something no existing therapy offers.
“The outcomes of this trial may not only shape future phases of clinical development but also redefine the global strategy for managing hepatitis B – especially in regions with high disease burden and limited access to existing treatments,” says Michael Hoelscher.
About Chronic Hepatitis B
Chronic hepatitis B is a serious and widespread infectious disease, affecting 254 million people worldwide. It significantly increases the risk of liver damage, cirrhosis, and liver cancer. Although preventive vaccines and antiviral treatments exist, no curative therapy has been developed to date. Current treatments suppress the virus but require lifelong use and are not universally available. According to the World Health Organization (WHO), hepatitis B causes 1.1 million deaths per year, highlighting the urgent need for curative strategies.
Further Information
Find detailed information about the phase 1a/2b clinical trial in patients: https://clinicaltrials.gov/study/NCT06513286?term=thervacb&rank=2
For more information on the therapeutic vaccine TherVacB, visit: https://www.thervacb.eu/
About the Researchers
Prof. Dr. Ulrike Protzer, Deputy Head of the Molecular Targets and Therapeutics Center at Helmholtz Munich, Director of the Institute of Virology at Helmholtz Munich and the Technical University of Munich (TUM), Chair for Virology at the TUM School of Medicine and Health. She invented the TherVacB Vaccine.
Prof. Dr. med. Michael Hoelscher, Director of the Institute of Infectious Diseases and Tropical Medicine, and Chair of Global Health & Infectious Diseases at the Medical Faculty of the LMU Munich, Head of the Unit Global Health (UGH) at Helmholtz Munich, Sponsor Representative of the LMU University Hospital for the TherVacB Phase 1b/2a Trial.
Funding Information
Funding for the study is provided by the European Union through the Horizon 2020 research program.
About Helmholtz Munich
Helmholtz Munich is a leading biomedical research center. Its mission is to develop breakthrough solutions for better health in a rapidly changing world. Interdisciplinary research teams focus on environmentally triggered diseases, especially the therapy and prevention of diabetes, obesity, allergies, and chronic lung diseases. With the power of artificial intelligence and bioengineering, researchers accelerate the translation to patients. Helmholtz Munich has around 2,500 employees and is headquartered in Munich/Neuherberg. It is a member of the Helmholtz Association, with more than 43,000 employees and 18 research centers the largest scientific organization in Germany. More about Helmholtz Munich (Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt GmbH): www.helmholtz-munich.de/en
New study in Ukraine indicates significant lifetime exposure and ongoing transmission of hepatitis B and C viruses among the general population
A nationwide study in Ukraine has found evidence of significant exposure to hepatitis B and C viruses and substantial ongoing circulation among the population, highlighting need for immunisation and regular screening.
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Choropleth maps of the anti-HCV (A), anti-HBc (B) and HBsAg (C) prevalence and absolute number of cases in Ukraine during June–July 2021.
view moreCredit: Eurosurveillance
A study just published on Eurosurveillance has found evidence of substantial lifetime exposure to hepatitis B and C viruses in Ukraine in a 2021 nationwide, representative sample of the population, with findings also suggesting significant ongoing circulation of these viruses.
Ahead of World Hepatitis Day 2025, viral hepatitis remains a major global health concern, and is one of the priority infectious diseases under the United Nations’ Sustainable Development Goal 3. [1][2] The World Health Organization (WHO) Global Hepatitis report 2024 estimated an overall hepatitis B virus (HBV) prevalence of 1.2% for the WHO European Region and identified Ukraine as one of six focus countries in the region for its viral hepatitis response. [3]
Diagnostic tests to detect Hepatitis C virus (HCV) core antigen (HCcAg) in the study were interrupted by the Russian invasion of Ukraine. With the war still ongoing and the disruption in public health infrastructure and surveillance, it is difficult to estimate its inevitably negative effect on global efforts to reach the goal of eliminating viral hepatitis as a public health threat by 2030. This was the first population-based serological study in Ukraine to assess HBV and HCV prevalence among the general adult population, despite the pressing need for such data.
Men and older adults more likely to test positive for hepatitis B and C
Researchers from the Public Health Centre of the Ministry of Health of Ukraine and the medical laboratory DILA used blood samples collected in mid-2021 through a nationwide and representative cross-sectional, household-based SARS-CoV-2 serosurvey. The samples from the adult population were tested for hepatitis C virus (HCV) antibodies, total antibodies against hepatitis B virus (HBV) core antigen (HBc), hepatitis B surface antigen (HBsAg) and hepatitis D virus (HDV) antibodies. Researchers then calculated crude and weighted proportions for anti-HCV, anti-HBc and HBsAg positivity, adjusting the data to ensure it reflected actual Ukrainian demographics. Weighted regional estimates and proportions positive for anti-HDV were also calculated among HBsAg-positive cases.
The study found a 3.3% prevalence of hepatitis C antibodies and 11.6% of hepatitis B antibodies, which indicate current or past infection for these viral infections. A prevalence of 0.9% was found for HBsAg, which indicates a current, mainly chronic HBV infection. Among those with HBsAg, 7.5% were anti-HDV positive.
Odds of having anti-HBc increased with age and was highest among those over 60. The prevalence of anti-HCV, anti-HBV and HBsAg was found to be higher in southern regions of Ukraine. Anti-HCV markers were more prevalent among men, in urban areas, and in the eastern and southern regions.
Significant challenges in Ukraine to achieve viral hepatitis elimination targets
These findings emphasise the need of hepatitis B virus (HBV) vaccination among infants and risk groups as well as regular HBV and hepatitis C virus (HCV) screening, treatment, and awareness raising to decrease transmission.
Ukraine joined the WHO’s Global Strategy for the Elimination of HBV and HCV in 2019 [4], and has since expanded HBV screenings in primary care, ensured public funding for diagnosis and treatment, and decentralised care by involving family and non-infectious disease doctors. It has also improved access to HBV services.
Ukraine introduced HBV vaccination in the national childhood immunisation schedule in 2002, achieving vaccination coverage of 88% in 2024. However, the vaccination rate remains below the WHO target of 90% and national surveillance is not fully established. Ukraine’s strategy to eliminate viral hepatitis includes reducing new cases and associated deaths, which requires effective surveillance.
The war on Ukraine has resulted in large-scale internal displacement as well as refugee migration to neighbouring countries, disrupted treatment for Ukrainians in the occupied territories, and hampered healthcare infrastructure, adding to existing challenges in addressing viral hepatitis.
Journal
Eurosurveillance
Subject of Research
People
Article Title
National representative seroprevalence of viral hepatitis B, C, and D seromarkers in Ukraine, 2021
Article Publication Date
24-Jul-2025
