Study of Bepirovirsen in Participants living with HIV and Chronic Hepatitis B Infection
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in Participants living with Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection on Antiretroviral Treatment.
IRAS ID
1010222
Contact name
Joana Norte
Contact email
Sponsor organisation
GSK Research & Development Limited
Eudract number
2023-509588-25
Research summary
Chronic hepatitis B (CHB) infection is caused by the hepatitis B virus (HBV) which infects the liver and can result in lifelong infection that can cause serious liver disease.
Some people infected with HBV are also living with human immunodeficiency virus (HIV). People living with HBV/HIV co-infection are currently offered HBV-active anti-retroviral therapy (ART) to stop both viruses from multiplying.This research study is to test a new HBV treatment, bepirovirsen, which stops HBV making substances which we think prevent the immune system from fighting it. It is the first study of bepirovirsen in people living with HBV/HIV co-infection and is being done to understand whether bepirovirsen, in addition to ART can improve treatment of HBV in people living with HBV/HIV co-infection.
Potential participants will have a screening period to confirm if they are eligible for the study which will involve either 1 or 2 visits. They must be at least 18 years of age and have had CHB and HIV-1 infection for at least 12 months. Blood and urine samples will be collected and other tests (height, weight, temperature, ECG) will be completed at these visits.
Following this, participants will be randomly divided into 2 groups to receive either 24 weeks of bepirovirsen or 24 weeks of placebo along with their usual ART. During this stage of the study, treatment visits will occur. There will be a number of blood tests and other assessments (vital signs, questionnaires, physical exam) during this time. After this, participants will continue to be monitored for another 36 weeks but will only take their usual ART. Visits will again include blood tests and other assessments such as physical exams and questionnaires.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
24/EM/0149
Date of REC Opinion
30 Jul 2024
REC opinion
Further Information Unfavourable Opinion