This is a Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection.
The purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body.
This is an open label study and there is no placebo used in this study. All participants will receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.
Age ≥ 18 to ≤65 years
Chronic HBV infection with evidence of HBsAg-positivity x > 6 months
Quantitative HBsAg 300 - 10,000 IU/mL
On stable nucleos(t)ide therapy >1 year
History of cirrhosis as evidenced by prior Liver Elastography (Fibroscan) > 12 kilopascals (kPa), liver biopsy (F4 by METAVIR) or clinical evidence of decompensation (ascites, hepatic encephalopathy)
History of or current hepatocellular carcinoma
Hepatitis C Virus (HCV) RNA or anti-Hepatitis D Virus (HDV) positive
HIV co-infection