A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects with Chronic Hepatitis B Virus Infection
Chronic hepatitis B is a long-lasting infection of the liver caused by the hepatitis B virus. Current standard treatments can keep the virus quiet, but most people have to take daily tablets indefinitely because the infection rarely clears completely. This Phase 2 clinical trial is testing two experimental medicines, named VIR-2218 and VIR-3434. These are being used either together or alongside an existing medicine called peginterferon alfa-2a. Researchers want to find out whether these combinations can safely clear a key viral protein from the blood. Doctors hope this approach might lead to what is known as a 'functional cure'. This means the immune system can keep the virus under control on its own, allowing patients to stop taking daily medicines. Doctors will closely track the health and safety of everyone who takes part.
At a glance
What is this study about?
Chronic hepatitis B is an infection of the liver that lasts for more than six months. Over time, having the virus in your liver can lead to swelling, scarring, and an increased risk of liver damage. Current antiviral tablets do a great job of protecting the liver by keeping the virus at very low levels. However, they rarely clear the virus completely, meaning most people must take daily medicine for the rest of their lives.
This trial is looking at whether newer, experimental treatments can do better. Researchers are combining two new medicines, VIR-2218 and VIR-3434, with or without an established injectable treatment called peginterferon alfa-2a. These experimental treatments are designed to stop the virus from making its key surface proteins and to help the body's natural immune system fight off the infection.
The main goal is to see if these combinations can help patients reach a 'functional cure'. In simple terms, this means the virus's surface protein disappears from the blood and stays undetectable for at least six months after all treatment finishes. If successful, this could pave the way for treatments that allow people with hepatitis B to safely stop taking daily medicines while keeping their liver healthy.
Key takeaways
- Tests new drug combinations aimed at clearing the hepatitis B virus.
- Aims to achieve a 'functional cure' so patients might not need lifelong daily pills.
- Open to adults aged 18 and older living with chronic hepatitis B.
- Involves regular clinic visits, injections under the skin, and routine blood tests.
- Participation is entirely voluntary and does not replace or harm your normal care.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with chronic hepatitis B. Both men and women can take part.
Participants may include people who are already taking regular daily antiviral tablets to keep their virus quiet, as well as some who are not currently on treatment. The study team will look closely at your medical history and run blood tests to see if your viral markers and liver health fit the requirements.
You will not be able to take part if you have severe, advanced liver scarring (known as decompensated cirrhosis) or other major health conditions that might make the treatments unsafe. Women who are pregnant or breastfeeding are also not eligible.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you aged 18 or older?
- Have you been diagnosed with chronic hepatitis B?
- Are you willing to receive regular injections under the skin?
- Are you able to travel to the clinic for planned health checks and blood tests?
- Are you sure you are not pregnant or planning to become pregnant during the study?
What does participation involve?
Taking part in this study involves several stages over roughly one to two years. At the start, you will attend a screening visit where doctors check your overall health and take blood samples. If you join, you will receive the study medicines as injections under the skin at scheduled clinic visits. You will have regular appointments where doctors will check your blood, monitor your liver, and ask how you are feeling. After finishing the treatment period, you will enter a follow-up phase lasting at least 24 weeks. During this time, the team will continue to run tests to see if the virus remains suppressed even after stopping the medicines.
Potential risks and benefits
Locations (2)
- —UnverifiedRomania
- —UnverifiedGermany
Common questions
What is a 'functional cure' for hepatitis B?
A functional cure means the virus is controlled by your own immune system to such low levels that it cannot be detected in routine blood tests, allowing you to stop taking daily antiviral tablets safely.
How are the study medicines given?
The medicines in this trial, including VIR-2218, VIR-3434, and peginterferon, are given as simple injections under the skin by trained clinical staff.
Do I have to pay for the treatments or tests?
No. All trial medicines, clinic visits, and medical tests related to the study are provided free of charge.
What happens if I decide I want to stop taking part?
You are free to leave the trial at any point, for any reason. Your regular doctors will simply continue your standard care as normal.
Will taking part cure my hepatitis B permanently?
This cannot be promised. While the study aims to move towards a cure, it is an early-stage research trial designed to see how safe and effective these new medicine combinations are.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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