Plain language summary of the efficacy and safety of bepirovirsen in patients with chronic hepatitis B infection

Abstract

This is a summary for the hepatitis B community providing straightforward information on the results of a study called ‘B-Clear’. Hepatitis B is an infection of the liver caused by a virus. Chronic hepatitis B is a long-lasting infection and occurs when the body is unable to fight off the virus and it persists in the blood and liver. Chronic hepatitis B virus infection is a major global health problem affecting approximately 296 million people. Current standard therapies, such as nucleotide analogs (antiviral therapy), rarely lead to a cure. This study investigated a new treatment for chronic hepatitis B virus infection, called bepirovirsen, alone or in combination with nucleotide analogs (antiviral therapy), in participants with chronic hepatitis B virus infection. The duration of treatment was 6 months. In this study, bepirovirsen was tested to see if it could decrease the levels of hepatitis B surface antigen and viral DNA to the point where they cannot be detected anymore in the blood and whether participants would maintain undetectable levels for 6 months after the end of treatment. Six (9%) participants who were currently on nucleotide analogs (antiviral therapy) and also received bepirovirsen and 7 (10%) participants who only received bepirovirsen, achieved undetectable levels of hepatitis B surface antigen and viral DNA for 6 months after the end of treatment. These results show that bepirovirsen could be an effective treatment for chronic hepatitis B virus infection. The loss of hepatitis B surface antigen seen in some participants means that bepirovirsen has the potential to reduce the risk of liver complications, such as liver failure and liver cancer and provide patients with an alternative option to lifelong treatment. Achieving undetectable levels of hepatitis B surface antigen and viral DNA may also have a positive impact on the quality of life of participants by reducing stigma and discrimination related to hepatitis B and offer relief from the hopelessness that often comes with a chronic hepatitis B virus infection diagnosis and need for lifelong therapy. Larger and longer studies are needed to confirm the results of the B-Clear study and to further evaluate how well bepirovirsen works in treating chronic hepatitis B virus infection as well as to assess its safety. Clinical Trial Registration: NCT04449029 (B-Clear study) ( ClinicalTrials.gov )