A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants With Chronic Hepatitis B Infection (PREVAIL)

简要总结

详细描述

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.

主要结局

次要结局

• STRIVE and THRIVE: Proportion of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Up to 96 weeks)
• STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at End of Treatment(Up to 48 weeks)
• STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at 24 Weeks Post-end of Treatment(Up to 72 weeks)
• STRIVE and THRIVE: Serum HBsAg Levels and Change From Baseline Across Timepoints in the Study(Up to 96 weeks)
• STRIVE and THRIVE: Serum HBsAg Level at Nadir During the Study(Up to 96 weeks)
• STRIVE and THRIVE: Time to Achieve Nadir of Serum HBsAg During the Study(Up to 96 weeks)
• STRIVE and THRIVE: Time to Achieve Serum HBsAg Loss (< 0.05 IU/mL)(Up to 96 weeks)
• STRIVE and THRIVE: Proportion of Participants With HBsAg Loss With Anti-HBs Seroconversion at End of Treatment and at 24 Weeks Post-end of Treatment(Up to 76 weeks)
• STRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) After Discontinuation of All Treatment at 24 Weeks and at the F48 Follow-Up Visit(Up to 96 weeks)
• STRIVE: Proportion of Participants With HBsAg Loss (<0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment(Up to 72 weeks)
• STRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) After Discontinuation of All Treatment at 24 Weeks and at the F48 Follow-Up Visit(Up to 96 weeks)
• STRIVE: For HBeAg-positive Participants: Proportion of Participants With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion(Up to 72 weeks)
• STRIVE: Incidence and Titers of Anti-drug Antibodies (ADA; if Applicable) to VIR-3434(Up to 96 weeks)
• STRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study(Up to 96 weeks)
• STRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ) Across Timepoints in the Study(Up to 96 weeks)
• STRIVE: Proportion of Participants Achieving ALT ≤ ULN Across Timepoints in the Study(Up to 96 weeks)
• THRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) After Discontinuation of All Treatment at 24 Weeks and at 48 Weeks(Up to 92 weeks)
• THRIVE: Proportion of Participants Achieving HBsAg Loss (< 0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment(Up to 44 weeks)
• THRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) After Discontinuation of All Treatment at 24 Weeks and at 48 Weeks(Up to 68 weeks)
• THRIVE: Incidence and Titers of ADA (if Applicable) to VIR-3434(Up to 92 weeks)
• THRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study(Up to 92 weeks)
• THRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ)(Up to 92 weeks)