A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection

Vir Biotechnology

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatitis B, Chronic

Treatments: Drug: VIR-2218; Drug: PEG-IFNα; Drug: TDF; Drug: VIR-3434

Study type: Interventional

Funder types: Industry

Identifiers

NCT05612581

VIR-MHB1-V200

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 7 patient groups

STRIVE: Cohort 1a (VIR-3434 + TDF)

Experimental group

Description:

Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total

Treatment:

Drug: TDF

Drug: VIR-3434

STRIVE: Cohort 2a (VIR-3434 + TDF)

Experimental group

Description:

Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total

Treatment:

Drug: TDF

Drug: VIR-3434

STRIVE: Cohort 3a (VIR-3434 + TDF)

Experimental group

Description:

Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total

Treatment:

Drug: TDF

Drug: VIR-3434

STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)

Experimental group

Description:

Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total

Treatment:

Drug: TDF

Drug: VIR-3434

Drug: VIR-2218

STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)

Experimental group

Description:

Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total

Treatment:

Drug: TDF

Drug: VIR-3434

Drug: PEG-IFNα

Drug: VIR-2218

THRIVE: Cohort 1b (VIR-3434 + TDF)

Experimental group

Description:

Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks

Treatment:

Drug: TDF

Drug: VIR-3434

THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)

Experimental group

Description:

Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total

Treatment:

Drug: TDF

Drug: VIR-3434

Drug: VIR-2218