As you know, clinical trials play an important role in the development and approval of treatments for hepatitis B. Clinical trials can tell how well new medicines work in people and can compare new medicines with current treatment options. Clinical trials provide a great opportunity to help advance hepatitis B research and give people with hepatitis B access to new treatments!
There are new phase 3 clinical trials starting for people living with chronic hepatitis B infection. GlaxoSmithKline (GSK) is launching two new phase 3 clinical trials called B Well-1 and B Well-2, which will test an experimental drug, bepirovirsen, as a potential treatment for hepatitis B.
Bepirovirsen, which has not yet been approved for treatment, is designed to stop the hepatitis B virus from making substances that may prevent a person’s immune system from fighting the virus. This can potentially allow the body to gain control over the infection.
Researchers are hopeful that bepirovirsen may be more effective than current treatment options and may lead to results that continue after treatment ends. Phase 2 clinical trial results showed that treatment with bepirovirsen reduced HBsAg and hepatitis B virus (HBV) DNA after 24 weeks of treatment in people with chronic hepatitis B.
In the B Well phase 3 studies, participants will be randomized into different study groups. Some people will receive bepirovirsen, and some people will receive a placebo. All people will remain on their nucleoside/nucleotide analogue (NA, such as tenofovir or entecavir) treatment. The studies are designed to see if combination treatment with bepirovirsen and an NA results in greater reduction of HBsAg and HBV DNA – and to see if this reduction is sustained after treatment ends. People in the study have a 2 in 3 chance of receiving bepirovirsen and a 1 in 3 chance of receiving placebo. The entire study lasts 78-102 weeks. Participants will not know whether they are receiving bepirovirsen or placebo, and neither will the doctor (until after the study ends). Participants will have medical visits throughout the study, where the doctor will check on hepatitis B viral activity and each participant’s overall health.
To participate in the new phase 3 B Well studies, people need to be at least 18 years old (although the minimum age requirement may be higher in some countries); have a documented hepatitis B infection for at least six months; and have been on antiviral therapy with an NA for at least 6 months.
The B Well study is being run in many countries, so there is opportunity for people in many areas of the world to participate! To find out more information and see if you might be eligible, please visit www.bwellstudy.com.