US approves a hepatitis B drug aimed at ending treatment for some

In adults with chronic hepatitis B on long-term antivirals, 19% kept the virus controlled six months after stopping all treatment

On 20 October 2026 the US Food and Drug Administration approved bepirovirsen (Hibsago, GSK), given together with existing antiviral therapy, for certain adults with chronic hepatitis B virus infection without cirrhosis: people who have taken antiviral therapy for at least six months, whose virus in the blood is suppressed and whose hepatitis B surface antigen (HBsAg) level is 3,000 IU/mL or less on an FDA-authorised test. It is the first antisense oligonucleotide approved for this infection: a short synthetic strand that targets the genetic instructions the virus uses to copy itself and make its proteins. The approval rests on two replicate double-blind phase 3 trials, B-Well 1 and B-Well 2, published in the New England Journal of Medicine. Adults already taking nucleoside or nucleotide analogue tablets were randomly assigned in a 2:1 ratio to weekly injections under the skin of bepirovirsen or placebo for 24 weeks, and eligible patients stopped their tablets at week 48. At week 72, viral DNA below the lower limit of quantification for at least 24 weeks together with loss of HBsAg was seen in 127 of 650 patients (20%) in B-Well 1 and 106 of 570 (19%) in B-Well 2, and in none on placebo.

For many people with chronic hepatitis B, treatment means taking antiviral tablets for years to keep the virus suppressed. The new drug is a fixed course that gives a minority of patients a chance to keep the virus controlled after all hepatitis B treatment has ended.

Most patients did not get there. In the FDA's summary of the two trials, 24% of those on bepirovirsen met the requirements to stop their existing medicine, against none on placebo, and 19% still had the virus under control with undetectable HBsAg 24 weeks after stopping all treatment. Adverse events were reported in 91% of patients on bepirovirsen and 73% on placebo, serious adverse events in 7% and 4%; during treatment, grade 3 or higher events occurred in 16% and 3%, most often a rise in the liver enzyme ALT. The label carries a boxed warning for serious liver reactions and for low platelet counts, and patients need regular blood tests. The trials reported results up to week 72, not long-term outcomes such as cirrhosis or liver cancer. They were funded by GSK.

Of 154 adults with mismatch-repair-deficient rectal cancer, 110 have so far needed nothing but immunotherapy

On 19 October 2026 the FDA granted accelerated approval to dostarlimab (Jemperli, GSK), an immunotherapy that blocks the PD-1 checkpoint, for adults with stage II or III locally advanced rectal cancer that is mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) on an FDA-authorised test. In AZUR-1, a single-arm, open-label trial in 154 previously untreated patients, participants received nine intravenous cycles every three weeks. Those whose tumour was no longer found on endoscopy, rectal MRI and CT entered close monitoring instead of an operation. In all, 110 patients (71%) were treated with dostarlimab alone, received no other treatment and had no disease progression; 26 (17%) had surgery. Among 116 patients evaluable by independent central review, 47% had a clinical complete response that lasted 12 months, and a further 38 had a complete response with less than 12 months of follow-up at the data cut-off. With a median follow-up of 26.3 months, none of the patients with a complete or near-complete response had disease progression.

For adults whose rectal tumours have this subtype, the approval makes dostarlimab monotherapy an FDA-approved initial option. In AZUR-1, patients without a complete response, or with recurrence or progression, were evaluated for standard care at the investigator's discretion. Of the 15 patients who underwent surgery after dostarlimab alone because imaging suggested an incomplete response, 12 had no cancer left in the removed tissue.

Accelerated approval rests on the rate of sustained complete responses in a trial without a comparison group, not on survival. It covers only dMMR or MSI-H tumours confirmed by a test. Patients managed without surgery are checked with several examinations every four months for the first two years and every six months after that. The FDA also reviewed an earlier investigator-led trial in 50 patients, in which 93% had a complete response lasting 12 months. The label lists warnings for immune-mediated adverse reactions and infusion-related reactions.

In Chinese adults, two scores of 14 blood proteins tracked faster growth of artery calcium and plaque

On 20 October 2026 PLOS Medicine published a cohort study led by researchers at Fuwai Hospital in Beijing. In a community cohort of 903 people who had coronary artery calcium or carotid plaque measured twice, in 2008–2009 and again in 2013–2014, the team selected two scores of 14 proteins each from a panel of 117 blood proteins: one for growth of coronary calcium and one for carotid plaque. The scores explained 17.1% and 18.4% of the variation in progression. In a separate case-cohort of 1,835 people followed for a median of 10.4 years, each standard-deviation increase in the scores was associated with a 36% and 38% higher risk of atherosclerotic cardiovascular disease (hazard ratios 1.36 and 1.38). Added to a guideline-recommended risk score, they improved classification (net reclassification improvement 0.127): 18.6% of people at intermediate risk moved to the high-risk group, where the 10-year event rate was 10.9%.

The authors' starting point is that existing risk tools do not identify well the people with silent, early atherosclerosis who could benefit from earlier prevention. In this Chinese research cohort, the protein scores were associated with progression measured on repeated scans; they have not been shown to replace scans in practice.

The study is observational: it shows associations, not that these proteins cause plaque growth or that acting on the score changes outcomes. The scores are a research tool built and tested in Chinese cohorts, and the authors name large-scale external validation as the main thing still missing.

People with inherited high cholesterol reached a marker of thymus ageing about six years earlier than healthy peers

On 20 October 2026 the European Heart Journal published a study from Beijing in 562 people with heterozygous familial hypercholesterolaemia, an inherited condition with high LDL cholesterol throughout life (236 untreated and 326 on lipid-lowering therapy), and 295 healthy controls of the same age. The researchers measured how many new T cells the thymus releases, using recent thymic emigrants among naive CD4 T cells and T-cell receptor excision circles. Untreated patients had a lower share of recent thymic emigrants than controls, especially at ages 18 to 30 and in carriers of highly pathogenic LDLR variants. Patients reached the controls' median level about six years earlier: in men at 19.12 against 25.51 years, in women at 19.18 against 25.58 years. Their T-cell repertoire was skewed towards a few highly expanded clones, and statin-treated patients, especially women, had higher levels of recent thymic emigrants than those not taking statins.

The thymus is where new T cells mature, and the study ties cholesterol exposure from birth not only to the arteries but also to this source of the immune system, expressed as an age.

This is a cross-sectional study in one Chinese cohort, with one measurement per person. The difference between statin users and non-users is an observation, not evidence that statins restore thymic output; the reported results concern immune-cell markers rather than clinical outcomes.

This material is for information only and does not replace a consultation with a doctor. Nothing in it is a recommendation to start, stop or change treatment.

Sources

• Hou J, et al. Phase 3 Results of Bepirovirsen Treatment for Chronic Hepatitis B Virus Infection. N Engl J Med. 2026. PMID 42206582

• U.S. Food and Drug Administration. FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment. 20 October 2026. fda.gov

• Study of Bepirovirsen in Nucleos(t)ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1). ClinicalTrials.gov. NCT05630807

• Study of Bepirovirsen in Nucleos(t)ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2). ClinicalTrials.gov. NCT05630820

• U.S. Food and Drug Administration. FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer. 19 October 2026. fda.gov

• A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer (AZUR-1). ClinicalTrials.gov. NCT05723562

• Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors. ClinicalTrials.gov. NCT04165772

• Huang Y, et al. Plasma proteomic signatures of subclinical atherosclerosis progression for cardiovascular risk stratification: A cohort study. PLoS Med. 2026. PMID 42900662

• Li F, et al. Familial hypercholesterolaemia and thymic ageing in a Chinese cohort. Eur Heart J. 2026. PMID 42900678