MARCH study
Research type
Research Study
Full title
A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of VIR-2218 + VIR-3434 in Subjects with Chronic Hepatitis B Virus Infection.
IRAS ID
1003766
Contact name
Daniel Cloutier
Contact email
Sponsor organisation
Vir Biotechnology, Inc.
Eudract number
2021-001033-39
Research summary
This is a phase 2 study to evaluate the safety, tolerability, and efficacy of VIR-2218 + VIR-3434 in patients with chronic hepatitis B viral (HBV) infection. The sponsor conducting this study is Vir Biotechnology Inc.
Chronic HBV infection remains an important global public health problem with significant morbidity and mortality. Chronic HBV infection is associated with the inability of the immune system to suppress the virus. The presence of HBV surface antigen (a foreign substance which induces an immune response in the body; HBsAg) is a hallmark of the disease. Elimination of HBsAg, called a functional cure, is associated with improved outcomes. However, functional cure is rare with currently available treatments.
A combination of multiple therapies may be necessary to achieve functional cure in the majority of patients with chronic HBV infection. High levels of HBsAg are thought to contribute to immune dysfunction. Therefore, development of functional cure is likely to require a reduction or elimination of HBsAg in conjunction with the induction of host immunity against the infection.
VIR-2218 is a synthetic small interfering ribonucleic (siRNA) therapeutic which suppresses the production of viral proteins, and VIR-3434 is a monoclonal antibody that neutralizes HBsAg and may stimulate an immune response against the virus. The combination of VIR-2218 + VIR-3434 is anticipated to result in deep, sustained reductions in HBsAg and may produce a durable immune response to the infection.
For this study, patients must be aged 18-65 and have a diagnosis of chronic HBV infection without cirrhosis (a type of liver disease) and be on NRTI (nucleoside reverse transcriptase inhibitor, a type of antiviral drug) therapy. A total of up to 120 patients will be enrolled to 1 of 6 groups. The regimen of each drug, including the overall duration, differs between the groups. All patients will be followed up for at least 48 weeks if they have received study drug.REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0464
Date of REC Opinion
28 Jul 2021
REC opinion
Further Information Favourable Opinion