The B-Together Study

About the Study

Infection with hepatitis B virus, especially chronic infection, is a significant global health problem. Clinical research studies are looking for potential treatments that may be more effective than current treatments and may lead to results that continue after treatment ends.

The B-Together study is being done to help us learn more about how two study drugs might work together as a treatment for CHB. These two drugs are GSK3228836 and pegylated interferon, also known as Pegasys. In a previous study, people living with CHB received GSK3228836 for 4 weeks. The B-Together study will test longer treatment with GSK3228836, followed by Pegasys to see what effects this may have on viral substances in the body.

The intention is that all participants will receive GSK3228836 followed by Pegasys. After you have finished treatment with GSK3228836, your doctor will check if it is appropriate for you to start treatment with Pegasys. If it is not appropriate, you may not receive Pegasys at all. At the beginning of the study, you will be assigned by chance to 1 of 2 groups. Each group will receive the study drugs for different lengths of time. You will know which group you are in.

The B-Together study lasts about 79 weeks for each participant. This includes a screening period, a study treatment period, and a follow-up period.

Although your participation is completely voluntary and you may choose to leave the study at any time, it is important to know that your ongoing commitment to the B-Together study is a key element in helping researchers find potential treatment options for people living with CHB around the world.

What are the study drugs?

GSK3228836 (one of the study drugs) is an investigational drug being tested as a potential treatment for CHB, meaning it is not yet approved for this purpose. There are medicines available to treat CHB, but they only stop the virus from multiplying; the body is not able to fully control the infection, so patients have to keep taking the medicines. The study drug is designed to stop the virus from making substances that may prevent the immune system from fighting the virus. By stopping the virus from making those substances, the study drug may potentially allow the body to gain control over the infection.

The other drug used in this study, Pegasys, is a medicine that is already used on its own by doctors to treat CHB. Pegasys works by enhancing your body’s immune response to viral infections such as HBV.

What will happen during the study?

Screening period

At a screening visit, the study doctor will give you a physical examination, ask about your medical history, and conduct medical tests. The screening period may last up to about 6.5 weeks while the study doctor reviews the results of your screening visit to determine if you meet all requirements for participation.

Study treatment period

While receiving GSK3228836, you will visit the clinic for either 12 or 24 weeks. For the first two weeks of your treatment with GSK3228836, you will visit twice per week, for the remaining weeks you will visit the clinic once per week.

When you have finished treatment with GSK3228836, your doctor will assess if it is appropriate for you to start treatment with Pegasys. If it is appropriate for you to start then you will then receive treatment for up to 24 weeks.

In some countries, it will be possible for you to self-inject Pegasys at home after discussion and training from your study doctor. This could reduce the amount of times you have to visit the clinic.

Other study activities will vary from visit to visit and may include:

• Discussions about your health and medications you may take outside the study
• Measurement of vital signs
• Collection of blood or urine samples
• Physical examination
• Questionnaires about your health and well-being

Follow-up period

During the 24-week follow-up period, you will not receive injections of study treatment, but you will complete other study visit activities as scheduled. There are 8 visits scheduled in the follow-up period. Your study participation will end about 72 weeks after your first dose of the study drug.

What will be expected of me during the study?

If you qualify for and decide to participate in the B-Together clinical research study, you will be responsible for:

• Following instructions from the study doctor and study staff
• Coming to your study visits and completing all scheduled activities
• Having study treatment as assigned and scheduled
• Reporting any changes in your health, even if you don’t think the changes are important or related to the study
• Following all requirements related to lifestyle issues, including contraception, as explained by the study doctor or staff
• Following all requirements related to lifestyle issues, including contraception and alcohol and nicotine use, as explained by the study doctor or staff
• Keeping your contact information current with the study staff
• Understanding the commitment to participating in this study, including weekly visits during treatment with GSK3228836 or Pegasys
• Talking with the study doctor or staff before you begin taking any new medications or supplements during this study
• Telling the study doctor or staff if you no longer want to be in the study