Hibsago (bepirovirsen) / GSK, Ionis, Sino Biopharm - LARVOL DELTA

Bepirovirsen Treatment for Chronic Hepatitis B Virus Infection. (PubMed, N Engl J Med) - No abstract available

Journal • Hepatitis B • Infectious Disease • Inflammation

Bepirovirsen Treatment for Chronic Hepatitis B Virus Infection. (PubMed, N Engl J Med) - No abstract available

Journal • Hepatitis B • Infectious Disease • Inflammation

Bepirovirsen Treatment for Chronic Hepatitis B Virus Infection. Reply. (PubMed, N Engl J Med) - No abstract available

Journal • Hepatitis B • Infectious Disease • Inflammation

MTE #6: New Hepatitis B Virus and Hepatitis D Virus Treatments Including Drugs in Development (Ticketed) (AASLD 2026) - "This expert session focuses on new treatments for HBV monoinfection and HBV/HDV coinfection including: Capsid assembly modulators (CAMs; eg, pevifoscorvir) Small interfereing RNA (SiRNA; eg, elebsiran) and antisense oligonucleotides (ASO; eg, bepirovirsen) Monoclonal hepatitis B surface (HBs) antibodies (eg, tobevibart) Gene editing nucleases (eg, PBGENE-HBV) Other novel therapies Discussion leaders present a representative case and integrate new clinical trial data to illustrate the role of newer therapies for persons living with HBV or HBV/HDV infection. Evaluate agents in combination for the treatment of HBV/HDV coinfection. List the remaining barriers to HBV and HDV infection cure."

Hepatitis B • Hepatology • Infectious Disease • Inflammation

EFFICACY AND SAFETY OF BEPIROVIRSEN AS ADD-ON THERAPY TO NUCLEOS(T)IDE ANALOGUES IN CHRONIC HEPATITIS B: A SYSTEMATIC REVIEW AND META-ANALYSIS (UEGW 2026) - No abstract available

Retrospective data • Review • Hepatitis B • Hepatology • Infectious Disease • Inflammation

GSK Obtains First Global Approval for Chronic Hepatitis B Drug Hibsago (Yahoo Finance) - "The UK-based pharmaceutical group used data from the phase 3 B-well trials to support the application for Hibsago in Japan, where the drug had also received a SENKU fast-track designation prior to approval in recognition of its potential to address high unmet medical need."

Japan approval • Hepatitis B • Infectious Disease

Bepirovirsen induces innate immune proteins independent of HBV. (PubMed, Hepatol Int) - P1, P2 | "These findings strengthen the association between bepirovirsen treatment and changes in innate immune-related proteins and indicate that this effect does not require the presence of HBV. The kinetic patterns of protein expression suggest that there are multiple waves of protein induction, which could impact recruitment and activation of innate and adaptive immune cell types."

Journal • Hepatitis B • Infectious Disease • Inflammation

Bepirovirsen Brings Functional Cure Closer to Reality in Chronic Hepatitis B. (PubMed, Gastroenterology) - No abstract available

Journal • Hepatitis B • Infectious Disease • Inflammation

B-Well1: Phase 3 Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1) (clinicaltrials.gov) - P3 | N=534 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

B-UNITED: A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - P2 | N=280 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

B-UNITED: A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - P2 | N=264 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Infectious Disease • Inflammation

B-UNITED: A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - P2 | N=280 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2) (clinicaltrials.gov) - P3 | N=859 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • Inflammation

CLINICALLY-MEANINGFUL RATES OF FUNCTIONAL CURE IN PATIENTS WITH CHRONIC HEPATITIS B INFECTION TREATED WITH BEPIROVIRSEN: B-WELL PHASE 3 TRIALS (UEGW 2026) - No abstract available

Clinical • P3 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2) (clinicaltrials.gov) - P3 | N=857 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Infectious Disease • Inflammation

GSK Biopsy: Bepirovirsen Liver Biopsy Study (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: National University Health System, Singapore

New P2 trial • Hepatitis B • Infectious Disease • Inflammation

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2) (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: GlaxoSmithKline | N=534 ➔ 900

Enrollment change • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Phase 3 Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2) (clinicaltrials.gov) - P3 | N=534 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Phase 3 Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2) (clinicaltrials.gov) - P3 | N=534 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

B-Well1: Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1) (clinicaltrials.gov) - P3 | N=941 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • Inflammation

B-UNITED: A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - P2 | N=280 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Oct 2027 ➔ Jul 2027 | Trial primary completion date: Oct 2027 ➔ Jul 2027

Trial completion date • Trial primary completion date • Hepatitis B • Infectious Disease • Inflammation

B-Well1: Phase 3 Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1) (clinicaltrials.gov) - P3 | N=534 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

B-Well1: Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1) (clinicaltrials.gov) - P3 | N=981 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Infectious Disease • Inflammation

B-Well1: Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1) (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: GlaxoSmithKline | N=534 ➔ 900

Enrollment change • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure) (clinicaltrials.gov) - P2 | N=360 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Infectious Disease • Inflammation