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Hepatitis BNovember 2022

What the B-Clear Trial Found — Bepirovirsen for Chronic Hepatitis B

B-Clear tested bepirovirsen, a weekly antisense injection that lowers hepatitis B viral proteins, in 457 adults with chronic hepatitis B. About one in ten reached a sustained loss of the surface antigen — a major step toward functional cure.

What the trial was testing

The B-Clear enrolled 457 patients with hepatitis b. The study was sponsored by GlaxoSmithKline and tracked outcomes across the full group of patients who matched the trial's eligibility profile.

It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.

What the results showed

9-10% achieved sustained surface antigen loss after 24 weeks of treatment.

New England Journal of Medicine · 2022 · NCT04449029

These findings — that achieved sustained loss of hepatitis B surface antigen — a marker of functional cure — were published in the New England Journal of Medicine and represent the headline result of the study.

Researchers tracked outcomes across 457 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.

What this means for patients

For patients with hepatitis b, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.

What you can do now

Bepirovirsen is still in development and not yet FDA-approved. A larger Phase 3 program is underway. Standard chronic hepatitis B treatment with daily entecavir or tenofovir is FDA-approved and effective at suppressing the virus. Ask a liver specialist about approved options or open trials.

Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.

Open hepatitis b trials

RecruitingObservational study

The Role and Regulatory Mechanism of Germinal Center Immune Response in Hepatitis B Virus Infection

The purpose of this observational study is to investigate the structure and composition of germinal centers in individuals with chronic HBV infection. The primary questions it aims to address are: What are the phenotypes, functions, and complexity of B cell clones of the immune cells within the germinal centers of chronic HBV-infected individuals? Do chronic HBV-infected individuals have ectopic germinal centers in the liver? This will be studied by collecting peripheral blood and discarded liver, lymph node, and tonsil tissues from chronic HBV patients undergoing lymph node surgery, hepatectomy, and tonsillectomy.

Guangzhou, Guangdong, China
RecruitingObservational study

Acceptability and Feasibility of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users and Vulnerable Populations, in Non-conventional Structures "Outside the Walls" by Dual Screening Method RTDs and FibroScan®

The "Scanvir" concept aims to achieve barriers to HCV screening and treating of marginalized patients. The concept is applicable to other various populations and territories and should effectively improve HCV patient's health outcomes. The main objective of the SCANVIR project was to evaluate the feasibility, acceptability and reproducibility of a "test, treat and cure" strategy for PWIDs and vulnerable populations during dedicated days in addiction care centers.

Limoges, France