Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. More than 290 million people worldwide live with chronic hepatitis B. Current treatments suppress the virus but rarely eliminate it, leaving people at risk for cirrhosis and liver cancer.
What's actually going on in research
Trials are testing direct antiviral drugs that target different parts of the virus lifecycle, therapies that boost immune response to clear infected cells, and combination approaches that aim for functional cure. Approved nucleos(t)ide analogues like tenofovir and entecavir suppress viral replication, but researchers are pursuing treatments that could eliminate the virus entirely.
Functional cure approaches
Several drugs aim to achieve functional cure, where the virus remains undetectable without ongoing treatment. These include capsid inhibitors, RNA interference therapies, and therapeutic vaccines that train the immune system to control the virus.
Combination therapy
Researchers are testing combinations of antivirals with immune modulators, based on the idea that suppressing the virus while stimulating immunity may lead to cure. Early trials are evaluating which combinations work best.
Entry inhibitors
New drugs aim to block hepatitis B from entering liver cells in the first place. These may work alongside existing treatments to reduce the pool of infected cells.
What to know before you search
Eligibility typically depends on hepatitis B status (chronic or acute), viral load, liver function tests, degree of liver scarring, and whether you're currently taking antiviral medication.
What types of trials are currently open
- Antiviral trials — Testing new direct-acting antivirals, including capsid inhibitors and entry inhibitors, that target different stages of the virus lifecycle.
- Immune therapy trials — Testing therapeutic vaccines, checkpoint inhibitors, and other treatments that help the immune system recognize and clear infected liver cells.
- Combination trials — Testing whether combining antivirals with immune therapies can achieve functional cure, where the virus stays suppressed without ongoing medication.
- Prevention trials — Testing new vaccines and post-exposure treatments to prevent infection, especially in high-risk populations.
- Liver disease trials — Studies focused on preventing or reversing cirrhosis and reducing liver cancer risk in people with chronic hepatitis B.
Recently added Hepatitis B trials
Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection
Hepatitis D virus (HDV) is a major global health issue, with an estimated 12 million people living with the infection worldwide. HDV infection requires the presence of hepatitis B virus (HBV), as it relies on hepatitis B virus for replication within the liver cells. Treatment options for HDV are limited and cannot cure the infection. The combination of concurrent HBV and HDV increases the risk of developing severe liver disease, including cirrhosis and liver cancer. This risk would significantly decrease if HDV is eliminated or reduced. Consequently, there is a need for the development of new treatment options. Colleagues at Rockefeller University in New York have identified the antibody HepB mAb19, which effectively reduces the amount of circulating HBV antigens. Since HDV depends on HBV to replicate, we will test this antibody as a potential treatment for HDV. The trial design is a phase 1b open-label aiming at including 15 study participants with chronic hepatitis D infection. All study participants will receive two or three dosis of the antibody, HepB mAB19, and will be followed for 60 weeks after the first HepB mAb19 infusion. This study will evaluate the safety and pharmacokinetics of this antibody, as well as its potential effects on viral levels of HDV RNA and antiviral immune responses in individuals living with chronic HDV infection.
Hep Mec Cohort in Zambia
Observational cohort of adults with acute and chronic hepatitis B infection in Zambia, with and without HIV coinfection. Participants join the study at the time of diagnosis and before or at the time when they are starting antiviral treatments and then they are followed up over multiple years to assess changes to their liver and evolution of HBV (and HIV if applicable) infection. All treatments for HBV and HIV are standard per local Ministry of Health guidelines.
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