Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.

Inclusion Criteria:

• Male or female aged 18-60.
• Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
• Chronic HBV infection for ≥ 6 months.
• On NRTI therapy for at least 6 months.

Exclusion Criteria:

• Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
• Significant liver fibrosis or cirrhosis.
• History or evidence of drug or alcohol abuse.
• History of intolerance to SC injection.
• History of chronic liver disease from any cause other than chronic HBV infection.
• History of hepatic decompensation.
• Contraindications to the use of Peg-IFNα.