Cohort 2c (VIR-2218 + VIR-3434) for Hepatitis B, Chronic

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hepatitis B, Chronic+6 More
VIR-2218 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing new drugs to treat hepatitis B. The drugs will be given to people who have the virus and researchers will see how well they work, how safe they are, and how well they are tolerated.

Eligible Conditions
  • Hepatitis B, Chronic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hepatitis B, Chronic

Study Objectives

5 Primary · 24 Secondary · Reporting Duration: Up to 116 weeks

Up to 110 weeks
Absolute serum HBsAg and change from baseline across all timepoints in the study
For HBeAg-positive subjects: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
For hepatitis B e-antigen (HBeAg)-positive subjects: Proportion of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
Number of subjects with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434
Proportion of subjects achieving undetectable hepatitis B surface antigen (HBsAg) and sustained suppression of HBV DNA [target not detected (TND)] >/= 24 weeks after discontinuation of all treatment, including NRTIs
Proportion of subjects meeting criteria for NRTI retreatment
Proportion of subjects with anti-HBs seroconversion
Proportion of subjects with serum HBsAg loss (defined as undetectable HBsAg)
Proportion of subjects with treatment-emergent adverse events (TEAEs)
Time to achieve the nadir and maximum reduction of serum HBsAg from baseline
Up to 116 weeks
Number of subjects with post-treatment lab abnormalities as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint
Proportion of subjects with serious adverse events (SAEs)
Up to 48 weeks
Proportion of subjects with HBsAg loss at end of treatment
Hepatitis B Surface Antigens
Up to 60 weeks
Proportion of subjects meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation
Up to 64 weeks
%AUCexp
AUCinf
AUClast
CL/F
Clast
Cmax
Tlast
Tmax
Vz/F
t1/2
λz
Up to 72 weeks
Proportion of subjects with HBsAg loss at 24 weeks post-end of treatment
Proportion of subjects with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Hepatitis B, Chronic

Trial Design

12 Treatment Groups

Cohort 2c (VIR-2218 + VIR-3434)
1 of 12
Cohort 1a (VIR-2218 + VIR-3434)
1 of 12
Cohort 8a (VIR-2218 + VIR-3434)
1 of 12
Cohort 1b (VIR-3434)
1 of 12
Cohort 2a (VIR-2218 + VIR-3434)
1 of 12
Cohort 7a (VIR-2218 + VIR-3434)
1 of 12
Cohort 1c (VIR-2218 + VIR-3434)
1 of 12
Cohort 4a (VIR-2218 + VIR-3434)
1 of 12
Cohort 6a (VIR-2218 + VIR-3434)
1 of 12
Cohort 2b (VIR-3434)
1 of 12
Cohort 5a (VIR-2218 + VIR-3434)
1 of 12
Cohort 3a (VIR-2218 + VIR-3434)
1 of 12
Experimental Treatment

260 Total Participants · 12 Treatment Groups

Primary Treatment: Cohort 2c (VIR-2218 + VIR-3434) · No Placebo Group · Phase 2

Cohort 2c (VIR-2218 + VIR-3434)Experimental Group · 3 Interventions: VIR-2218, PEG-IFNα, VIR-3434 · Intervention Types: Drug, Drug, Drug
Cohort 1a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 8a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 1b (VIR-3434)
Drug
Experimental Group · 1 Intervention: VIR-3434 · Intervention Types: Drug
Cohort 2a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 7a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 1c (VIR-2218 + VIR-3434)Experimental Group · 3 Interventions: VIR-2218, PEG-IFNα, VIR-3434 · Intervention Types: Drug, Drug, Drug
Cohort 4a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 6a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 2b (VIR-3434)
Drug
Experimental Group · 1 Intervention: VIR-3434 · Intervention Types: Drug
Cohort 5a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 3a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIR-2218
2020
Completed Phase 2
~110

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 116 weeks

Who is running the clinical trial?

Vir Biotechnology, Inc.Lead Sponsor
23 Previous Clinical Trials
12,670 Total Patients Enrolled
7 Trials studying Hepatitis B, Chronic
685 Patients Enrolled for Hepatitis B, Chronic

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.