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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a (VIR-2218 + VIR-3434) | Experimental | Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total |
|
| Cohort 2a (VIR-2218 + VIR-3434) | Experimental | Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total |
|
| Cohort 3a (VIR-2218 + VIR-3434) | Experimental | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks |
|
| Cohort 4a (VIR-2218 + VIR-3434) | Experimental | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks |
|
| Cohort 5a (VIR-2218 + VIR-3434) | Experimental | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-2218 | Drug | VIR-2218 given by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with treatment-emergent adverse events (TEAEs) | Up to 72 weeks | |
| Proportion of participants with serious adverse events (SAEs) | Up to 72 weeks | |
| Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment | Up to 48 weeks | |
| Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment | Up to 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute serum HBsAg and change from baseline across all timepoints in the study | Up to 110 weeks | |
| Nadir and maximum reduction of serum HBsAg from baseline | Up to 110 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | San Francisco | California | 94143 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41586499 | Derived | Noack J, Anglero-Rodriguez Y, Gall J, Zhou J, LeBlanc S, Liebow A, Bakardjiev A, Hebner CM, Purcell LA, Jadhav V, Corti D, Lempp FA. Combination therapy with tobevibart and elebsiran potently reduces hepatitis B virus surface antigen levels in preclinical in vivo models. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0112725. doi: 10.1128/aac.01127-25. Epub 2026 Jan 26. |
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| Cohort 6a (VIR-2218 + VIR-3434) | Experimental | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks |
|
| Cohort 7a (VIR-2218 + VIR-3434) | Experimental | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks |
|
| Cohort 8a (VIR-2218 + VIR-3434) | Experimental | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks |
|
| Cohort 1b (VIR-3434) | Experimental | Participants will receive multiple doses of VIR-3434 for 44 weeks |
|
| Cohort 2b (VIR-3434) | Experimental | Participants will receive multiple doses of VIR-3434 for 20 weeks |
|
| Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα) | Experimental | Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks |
|
| Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα) | Experimental | Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks |
|
| Cohort 1d (VIR-3434 + PEG-IFNα) | Experimental | Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks |
|
|
| VIR-3434 | Drug | VIR-3434 given by subcutaneous injection |
|
|
| PEG-IFNα | Drug | PEG-IFNα given by subcutaneous injection |
|
| Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs) |
| 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 | Up to 110 weeks |
| For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion | Up to 110 weeks |
| Cmax | Up to 110 weeks |
| AUClast | Up to 110 weeks |
| t1/2 | Up to 110 weeks |
| CL/F | Up to 110 weeks |
| Number of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434 | Up to 110 weeks |
| Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation | Up to 60 weeks |
| Proportion of participants meeting criteria for NRTI retreatment | 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 | Up to 110 weeks |
| Proportion of participants with serum HBsAg < 10 IU/mL at end of treatment | 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 | Up to 72 weeks |
| Proportion of participants with anti-HBs seroconversion | Up to 110 weeks |
| Time to achieve nadir of serum HBsAg | Up to 110 weeks |
| Time to achieve serum HBsAg loss | Up to 110 weeks |
| Miami |
| Florida |
| 33136 |
| United States |
| Investigative Site | Orlando | Florida | 32803 | United States |
| Investigative Site | Baltimore | Maryland | 21218 | United States |
| Investigative Site | Hillsborough | New Jersey | 08844 | United States |
| Investigative Site | Toronto | 2C4 | Canada |
| Investigative Site | Toronto | 3M1 | Canada |
| Investigative Site | Vancouver | 2C7 | Canada |
| Investigative Site | Frankfurt | 60590 | Germany |
| Investigative Site | Hanover | 30625 | Germany |
| Investigative Site | Mannheim | 68167 | Germany |
| Investigative Site | Hong Kong | Shatin | Hong Kong |
| Investigative Site | Hong Kong | Tai Po District | Hong Kong |
| Investigative Site | Hong Kong | Hong Kong |
| Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Investigative Site | Chisinau | MD 2025 | Moldova |
| Investigative Site | Auckland | 1010 | New Zealand |
| Investigative Site | Auckland | 2025 | New Zealand |
| Investigative Site | Hamilton | 3204 | New Zealand |
| Investigative Site | Tauranga | 3110 | New Zealand |
| Investigative Site | Wellington | 6021 | New Zealand |
| Investigative Site | Bucharest | 021105 | Romania |
| Investigative Site | Busan | 49421 | South Korea |
| Investigative Site | Seoul | 03080 | South Korea |
| Investigative Site | Seoul | 05505 | South Korea |
| Investigative Site | Yangsan | 50612 | South Korea |
| Investigative Site | Chiayi City | 60041 | Taiwan |
| Investigative Site | Kaohsiung City | 80756 | Taiwan |
| Investigative Site | Kaohsiung City | 83301 | Taiwan |
| Investigative Site | Taichung | 40705 | Taiwan |
| Investigative Site | Taipei | 100 | Taiwan |
| Investigative Site | Taoyuan City | 33305 | Taiwan |
| Investigative Site | Kyiv | 01135 | Ukraine |
| Investigative Site | Birmingham | B15 2TH | United Kingdom |
| Investigative Site | London | E11FR | United Kingdom |
| Investigative Site | London | SE5 9RS | United Kingdom |
| Investigative Site | Manchester | M8 5RB | United Kingdom |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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