This is a phase 2 study in which participants with chronic hepatitis B virus (HBV) infection will receive VIR-2218, VIR-3434 and/or PEG-IFNα and be assessed for safety, tolerability, and efficacy
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Proportion of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 72 weeks
Proportion of participants with serious adverse events (SAEs)
Time frame: Up to 72 weeks
Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment
Time frame: Up to 48 weeks
Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment
Time frame: Up to 72 weeks
Absolute serum HBsAg and change from baseline across all timepoints in the study
Time frame: Up to 110 weeks
Nadir and maximum reduction of serum HBsAg from baseline
Time frame: Up to 110 weeks
Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs)
Time frame: Up to 110 weeks
For hepatitis B e-antigen (HBeAg)-positive participants: Proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
Time frame: Up to 110 weeks
For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
Time frame: Up to 110 weeks
Cmax
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Investigative Site
San Francisco, California, United States
Investigative Site
Miami, Florida, United States
Investigative Site
Orlando, Florida, United States
Investigative Site
Baltimore, Maryland, United States
Investigative Site
Hillsborough, New Jersey, United States
Investigative Site
Toronto, Canada
Investigative Site
Toronto, Canada
Investigative Site
Vancouver, Canada
Investigative Site
Frankfurt, Germany
Investigative Site
Hanover, Germany
...and 27 more locations
Time frame: Up to 110 weeks
AUClast
Time frame: Up to 110 weeks
t1/2
Time frame: Up to 110 weeks
CL/F
Time frame: Up to 110 weeks
Number of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434
Time frame: Up to 110 weeks
Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation
Time frame: Up to 60 weeks
Proportion of participants meeting criteria for NRTI retreatment
Time frame: Up to 110 weeks
Proportion of participants achieving undetectable HBsAg and sustained suppression of HBV DNA [below the LLOQ, target not detected (TND)] >/= 24 weeks after discontinuation of all treatment, including NRTIs
Time frame: Up to 110 weeks
Proportion of participants with serum HBsAg < 10 IU/mL at end of treatment
Time frame: Up to 48 weeks
Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment
48 weeks treatment + 24 weeks post-end of treatment
Time frame: Up to 72 weeks
Proportion of participants with anti-HBs seroconversion
Time frame: Up to 110 weeks
Time to achieve nadir of serum HBsAg
Time frame: Up to 110 weeks
Time to achieve serum HBsAg loss
Time frame: Up to 110 weeks