Hepcludex (bulevirtide) / Hepatera, Gilead - LARVOL DELTA

Modeling of the hepatitis B virus life cycle and the efficacy of antivirals in human iPSC-derived hepatic organoids. (PubMed, Biosci Trends) - "Treatment with tenofovir effectively reduced viral DNA and antigen production without affecting cccDNA levels, whereas bulevirtide resulted in stage-specific inhibition of viral entry, highlighting the model's capacity to resolve mechanism-of-action differences. At the same time, drug-induced hepatotoxicity was assessed within the same system. Collectively, this hiPSC-derived hepatic organoid model provides a scalable and physiologically relevant platform that bridges the gap between conventional cell culture and in vivo systems, offering a powerful tool for studying HBV pathogenesis, host-virus interactions, and preclinical antiviral discovery."

Journal • Fibrosis • Hepatitis B • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • COL1A1 • CYP3A4

Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D (clinicaltrials.gov) - P=N/A | N=25 | Recruiting | Sponsor: Research Center of Periodontal-Systemic Interactions

Biomarker • New trial • Dental Disorders • Hepatitis B • Infectious Disease • Inflammation • Periodontitis

Resolution of Hepatitis Delta Virus-Related Cryoglobulinemic Vasculitis With the Use of Bulevirtide. (PubMed, ACG Case Rep J) - "We present the case of a woman with HBV-HDV coinfection who was referred to our clinic with suspected virus-related CV. One-year treatment with bulevirtide led to complete and durable resolution of CV."

Journal • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Immunology • Infectious Disease • Inflammation • Oncology • Solid Tumor • Vasculitis

Bulevirtide treatment of HBV-HDV coinfected patients: 12 months of real-life experience (ESCMID Global 2026) - No abstract available

Clinical • Hepatitis B • Hepatology

Turkish Real-World Effectiveness and Safety of Bulevirtide in Chronic Hepatitis Delta: A Multicentric Experience with Long-Term Follow Up (APASL 2026) - No abstract available

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Hepatology • Inflammation

Final results of MYR301 Phase 3 study evaluating the efficacy and safety of up to 144 weeks of bulevirtide monotherapy for chronic hepatitis delta and 96 weeks of posttreatment follow-up (APASL 2026) - No abstract available

Clinical • Monotherapy • P3 data • Hepatology • Inflammation

Treatment Efficiency of Bulevirtide in Chronic Hepatitis Delta: Number Needed to Treat Analysis From the MYR301 Phase 3 Trial (APASL 2026) - No abstract available

P3 data • Hepatology • Inflammation

Predictors of undetectable hepatitis delta virus RNA at 48 weeks after end of treatment with bulevirtide monotherapy in the MYR 301 study (APASL 2026) - No abstract available

Monotherapy • Hepatology • Inflammation

Entry Inhibitors (e.g. Bulevirtide) (APASL 2026) - No abstract available

Hepatitis B

Low pre-treatment concentrations of HBV cccDNA transcriptional activity markers – HBcrAg and pre-genomic RNA - can predict response to therapy with pegylated interferon, but not to bulevirtide monotherapy in chronic hepatitis D patients (EASL 2026) - No abstract available

Clinical • Monotherapy • Hepatitis B • Hepatology • Inflammation

Inhibition of hepatic bile salt uptake using Bulevirtide attenuates pre-existing diet-induced metabolic dysfunction-associated steatohepatitis in mice (EASL 2026) - No abstract available

Preclinical • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Correlation of bile acid dynamics with bulevirtide response and disease severity in patients with hepatitis D (EASL 2026) - No abstract available

Clinical • Hepatology • Inflammation

Chemical conjugation of Myrcludex B and Triiodothyronine for liver-specific targeting (EASL 2026) - No abstract available

Metabolic Dysfunction-Associated Steatotic Liver Disease

Bulevirtide monotherapy is safe and well tolerated in chronic hepatitis delta: an integrated safety analysis of bulevirtide clincial trials at week 96 (EASL 2026) - No abstract available

Clinical • Monotherapy • Hepatology • Inflammation

Response to bulevirtide synchronizes HDV RNA and anti-HDV kinetics (EASL 2026) - No abstract available

Hepatology

Controlled bulevirtide discontinuation in chronic hepatitis D: The D-SOLVE BUL-STOP trial (EASL 2026) - No abstract available

Hepatology • Inflammation

Bulevirtide effectiveness in hepatitis delta infection across geographic origins and genotypes: real-world data from Portugal (EASL 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Hepatology • Infectious Disease • Inflammation

National registry of patients with hepatitis D treated with bulevirtide: real-world clinical practice data in Spain (EASL 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Hepatology • Inflammation

Progressive decline of HBcrAg levels in patients with chronic hepatitis Delta long-term treated with Bulevirtide monotherapy (EASL 2026) - No abstract available

Clinical • Monotherapy • Hepatology • Inflammation

Impact of bulevirtide treatment on patient-reported outcomes among patients with hepatitis delta in Europe (EASL 2026) - No abstract available

Clinical • Patient reported outcomes • Hepatology • Inflammation

Therapeutic drug monitoring of Bulevirtide plasma levels in chronic hepatitis Delta patients (EASL 2026) - No abstract available

Clinical • Hepatology • Inflammation

Characterisation of HDV RNA, HBsAg and ALT kinetics in patients treated with bulevirtide and pegylated interferon for 96 weeks in the SEE-D trial (EASL 2026) - No abstract available

Clinical • Hepatology

Virological breakthroughs during long-term Bulevirtide monotherapy in patients with CHD: integrated analysis from the multicenter real-life save-d and d-shield studies (EASL 2026) - No abstract available

Clinical • Monotherapy • Hepatology

Impact of the NTCP rs17556915 polymorphism on disease severity and bulevirtide treatment response in chronic hepatitis D: a multicentre real-world study (EASL 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Hepatology • Inflammation

Bulevirtide monotherapy prevents liver decompensation in patients with hdv-related cirrhosis: a case control study with propensity score weighted analysis (EASL 2026) - No abstract available

Clinical • Monotherapy • Fibrosis • Hepatology • Immunology • Liver Failure