Overview
This is a Phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic hepatitis B virus infection.
Description
VIR-SHB1-V201 (STRIVE) Sub-Protocol A is a Phase 2 study under the PREVAIL platform trial. This is a multi-center, open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434, VIR-2218, PEGASYS (PEG-IFNα), and nucleotide reverse transcriptase inhibitors (NRTI) in noncirrhotic adult participants with chronic HBV infection that have not received prior NRTI or PEGASYS treatment.
VIR-SHB1-V202 (THRIVE) Sub-Protocol B is a Phase 2 study under the PREVAIL platform trial. This is a multi-center open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434 and NRTI with or without VIR-2218 in noncirrhotic adult participants with low viral burden of chronic HBV infection.
Eligibility
Inclusion Criteria:
- Male or female ages 18 or older
- Chronic HBV infection for >/= 6 months
- Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2 occasions at least 6 months apart based on previous or current laboratory documentation
- STRIVE: HBeAg positive or negative, HBV DNA > 2,000 IU/mL, ALT > ULN and ≤ 5x ULN
- THRIVE: Must be/have the following, within the 1-year period prior to screening: HBeAg negative, HBV DNA ≤ 2,000 IU/mL, ALT ≤ ULN
Exclusion Criteria:
- Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation
- History of clinically significant liver disease from non-HBV etiology
- History or current evidence of hepatic decompensation
- Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV).
- History or clinical evidence of alcohol or drug abuse
- STRIVE and THRIVE: Significant fibrosis or cirrhosis
- STRIVE and THRIVE: History of immune complex disease
- STRIVE and THRIVE: History of autoimmune disorder
- STRIVE and THRIVE: History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434
- STRIVE: Prior NRTI or PEG-IFN therapy
- STRIVE: History of known contraindication to any interferon product
- THRIVE: Prior NRTI therapy < 24 weeks of study or any prior PEG-IFN therapy
