Hepcludex (bulevirtide) / Hepatera, Gilead - LARVOL DELTA

Influence of Nucleos(t)ide Analogue Use with Bulevirtide on Treatment Outcomes in Chronic Hepatitis Delta (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Vir Biotechnology, Inc.

New P2 trial • Infectious Disease • Inflammation

Achieving Undetectable Hepatitis Delta Virus RNA at End of Therapy With Bulevirtide 10 Mg/day With or Without PegIFNα Is Strongly Associated With Posttreatment Virologic Response in Chronic Hepatitis Delta (ACG 2025) - "Demographics were similar across groups (Table). At EOT, 49% (97/200) achieved undetectable HDV RNA: (A) 70% (35/50), (B) 37% (37/100), and (C) 50% (25/50); 24% (48/200) had < LLOQ, TD: (A) 16% (8/50), (B) 30% (30/100), and (C) 20% (10/50; Figure). At FU48, undetectable HDV RNA was observed in 25% (49/200) overall: (A) 23/50 (46%) of pts receiving combination therapy, (B) 14% (14/100) of pts receiving 2 years of BLV monotherapy, and (C) 24% (12/50) of pts receiving 3 years of BLV monotherapy."

Hepatitis B • Hepatology • Infectious Disease • Inflammation • IFNA1

Predictors of Undetectable Hepatitis Delta Virus RNA at 48 Weeks After End of Treatment With Bulevirtide Monotherapy in the MYR 301 Study (ACG 2025) - "Baseline (BL) characteristics were similar between treatments. Overall, 65/149 (44%) pts achieved HDV RNA undetectability at EOT; 23/64 (36%) with FU data sustained undetectability through FU48. Sustained undetectability rates were higher in the immediate treatment arms (2 mg: 7/14, 50%; 10 mg: 10/25, 40%) vs the DT/10 mg (6/26, 23%) arm."

Monotherapy • Fibrosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation

Final Results of MYR301: A Randomized Phase 3 Study Evaluating the Efficacy and Safety of Up to 144 Weeks of Bulevirtide Monotherapy for Chronic Hepatitis Delta and 96 Weeks of Post-Treatment Follow-Up (ACG 2025) - "Most patients (92%) remained in the study at the end of treatment (EOT); 72% and 57% completed FU48 and FU96, respectively. CR rates in the 2, 10, and DT to 10 mg groups, respectively, declined from 57%, 54%, and 56% at EOT to 24% in each group at FU96. HDV RNA undetectability rates were 29%, 50%, and 52% at EOT and 20%, 22%, and 20% at FU96."

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

Updates on Recent Advancements in Hepatitis D Virus Treatment. (PubMed, Viruses) - "Meanwhile, bulevirtide, an entry inhibitor, became the first agent to be approved for use in chronic HDV infections by the European Medicines Agency (EMA), and several other therapies are currently being investigated as well. In this review, we provide updates on recent advancements in HDV treatment and novel therapies."

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

AGA Clinical Practice Update on Management of Hepatitis Delta: Commentary. (PubMed, Gastroenterology) - "The purpose of this American Gastroenterological Association (AGA) Clinical Practice Update is to facilitate understanding and improve clinical management of patients with hepatitis delta virus infection. This commentary was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Gastroenterology."

Clinical guideline • Journal • Immunology • Infectious Disease • Inflammation

ARISTOTLE: Assessment of Response and Safety of Bulevirtide Treatment in Patients With Chronic Delta Virus Infection (clinicaltrials.gov) - P=N/A | N=160 | Completed | Sponsor: University of Molise

New trial • Infectious Disease • Inflammation

EFFICACY AND SAFETY OF BULEVIRTIDE WITH OR WITHOUT PEGYLATED INTERFERON IN THE TREATMENT OF CHRONIC HEPATITIS D: A SYSTEMATIC REVIEW AND META-ANALYSIS WITH META-REGRESSION (UEGW 2025) - No abstract available

Retrospective data • Review • Hepatology • Inflammation

A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Vir Biotechnology, Inc.

New P3 trial • Infectious Disease • Inflammation

Improving Virological Monitoring of HDV Infection: A Proof-of-Concept Comparative Study of Bosphore and AltoStar® Assays in Patients Treated with Bulevirtide. (PubMed, Biomedicines) - "However, our findings suggest that differences in assay sensitivity could impact the evaluation of virological response, highlighting the risk of false-negative results in chronically HDV-infected patients with low-level viremia. This emphasizes the need for careful assay selection to accurately monitor treatment outcomes."

Journal • Fibrosis • Gastroenterology • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis • Oncology • Solid Tumor

Single-cell analysis of mature hepatocytes reveals an IRF1-driven restriction of HDV infection. (PubMed, JHEP Rep) - "This work improves our understanding of mature cell culture models for HDV, needed to decipher its host-pathogens interactions. Identification of antiviral effector genes opens the way to the development of new host targeted antiviral strategies, particularly for targeting cell division-mediated spread that is not inhibited by currently used entry inhibitors (Hepcludex)."

Journal • Hepatocellular Cancer • Infectious Disease • Inflammation • Liver Cancer • Solid Tumor • IRF1

Comparative Efficacy of Treatment Regimens for Chronic Hepatitis D Virus Infection: A Systematic Review and Network Meta-Analysis. (PubMed, Liver Int) - "Bulevirtide plus PEG-IFN-alpha combination therapy was superior in achieving virological response, both in magnitude and duration, compared to bulevirtide or PEG-IFN-alpha monotherapies in patients with chronic HDV infection."

Clinical • Journal • Retrospective data • Review • Infectious Disease • Inflammation • IFNA1

Hope on the horizon: Emerging therapies for hepatitis D. (PubMed, World J Hepatol) - "Pegylated interferon lambda acts on interferon-lambda (Type III) receptors predominantly expressed in hepatocytes. In 2023, bulevirtide was approved in the European Union and Russia for treating chronic hepatitis D. This drug works by binding to and inhibiting the sodium taurocholate co-transporting polypeptide receptor on liver cells, which is the primary entry point for the virus...Two more viral entry inhibitors are HH003 and tobevibart. Other agents include nucleic acid polymers (REP 2139-Mg), prenylation inhibitors (lonafarnib), and RNA interference-based therapies (elebsiran)...The efficacy and safety of these drugs will further be evaluated in ECLIPSE 1, 2, and 3 trials. With these new treatments on the horizon, the prospects for improved HDV patient outcomes are promising."

Journal • Review • Hepatitis B • Infectious Disease • Inflammation • IFNA1

Advances in treatment of hepatitis delta virus infection: Update on novel investigational drugs. (PubMed, World J Virol) - "Significant unmet medical needs remain in the treatment of HDV, and recent advances in drug development offer hope for meaningful advances in drug therapy which may improve virologic response rates and clinical outcomes. This review summarizes trial design and available efficacy data from key phase 2 and 3 trials for investigational therapies including entry inhibitors (bulevirtide), prenylation inhibitors (lonafarnib), novel IFNs (peginterferon lambda), RNA interference molecules (JNJ-3989, elebsiran), monoclonal antibodies (tobevibart), and nucleic acid polymers (REP2139), and addresses future directions in HDV pharmacotherapy."

Journal • Review • Fibrosis • Gastroenterology • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Liver Failure • Oncology • Solid Tumor

HBV, HCV, and HDV Triple-Infection-A Therapeutic Challenge. (PubMed, Diseases) - "Compared to patients with a single hepatotropic viral infection, those with a double or triple infection had more severe hepatic damage. Concomitant therapy with Bulevirtide, DAAs, and NUCs is possible and the therapeutic results from clinical studies, with single-infection patients showing great potential for improving the prognosis of these patients."

Journal • Fibrosis • Hepatitis B • Hepatitis C • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Hepatitis D Virus Infection: Pathophysiology, Epidemiology and Treatment. Report From the Third Delta Cure Meeting 2024. (PubMed, Liver Int) - "The improved knowledge of the HDV life cycle has led to the development and approval of the first HDV-direct antiviral, Bulevirtide (BLV)...Despite recent advances in antiviral treatment, strategies to achieve HBsAg loss, which most closely resembles HDV cure, are not available and antiviral treatment for patients with advanced liver disease is limited. The third international Delta Cure meeting, held in Milan in October 2024, aimed to share the latest findings, and this review highlights key takeaways from the lectures and research on HDV."

Journal • Review • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Oncology • Solid Tumor • IFNA1 • KEAP1

HERACLIS_BLV_D: Increasing Response Rates During 2-Year Bulevirtide Real-Life Therapy in Chronic Hepatitis D. (PubMed, Liver Int) - "BLV monotherapy is safe and effective for the treatment of CHD patients followed at Greek tertiary liver centres offering increasing rates of VRHDV RNA undetectability and BR or combined response exceeding 90%, 80% and 70%, respectively, at 2 years of therapy."

Journal • Fibrosis • Immunology • Inflammation

Update on the management of HDV infection: current events and perspectives. (PubMed, Microb Pathog) - "Bulevirtide not only offered a novel therapeutic option for HDV but also marked a milestone in the history of HDV treatment. However, while this new drug represents a significant advance, there are still several aspects that need further clarification and exploration."

Journal • Review • Fibrosis • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis

BUL-STOP: Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Hannover Medical School | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Hepatology • Infectious Disease • Inflammation

Clinical Trials for Hepatitis Delta Virus in the WHO African region: A neglected virus among neglected viruses. (PubMed, J Infect) - "HDV-focused CT are needed in the WHO African region, as the region with the highest disease burden, and unique genotypes (5-8); to evaluate efficacy of novel anti-HDV compounds and to ensure that new treatments can be distributed and deployed as they become available."

Journal • Review • Inflammation

Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis (Businesswire) - "New data to be presented at EASL will include a subgroup analysis from ASSURE, an ongoing open-label study, and an analysis of the Phase 3 RESPONSE trial and the open-label extension. Data will reinforce the effectiveness of Livdelzi (seladelpar), known as Lyvdelzi in the European Union, in reducing pruritus (chronic itch), a debilitating common symptom of primary biliary cholangitis (PBC). Moreover, the results will highlight seladelpar’s ability to deliver a sustained biochemical response regardless of prior treatment history, and as an option for a broad range of people with PBC....Key findings from 29 accepted abstracts will include two oral presentations showcasing new data on the critical goal of maintained virologic response following treatment with 2 mg and 10 mg bulevirtide in people living with hepatitis delta virus (HDV). These findings build on the wealth of long-term data for the treatment of chronic HDV."

Clinical data • Hepatitis B • Primary Biliary Cholangitis

EFFICACY AND SAFETY OF TREATMENTS FOR CHRONIC HEPATITIS D: A SYSTEMATIC REVIEW AND META-ANALYSIS OF 19 RANDOMIZED CONTROLLED TRIALS (DDW 2025) - "Objective: This meta-analysis evaluates the efficacy and safety of pharmacological treatments for chronic HDV, including Lamivudine, Peg-IFN, Ribavirin, IFN alfa-2a, Adefovir, Bulevirtide, Lonafarnib, TDF, and Entecavir... Bulevirtide with Peg-IFN is the most effective and safest treatment for chronic HDV, particularly in cirrhotic patients. TDF shows potential but requires further study in larger, long-term trials. Adverse effects from therapies like Peg-IFN and Lonafarnib emphasize the need for careful monitoring."

Retrospective data • Review • Anemia • Fatigue • Gastrointestinal Disorder • Hematological Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Liver Cirrhosis • Pain

HEPATITIS D; AN ORPHAN DISEASE THAT NEEDS EARLY DIAGNOSIS AND TREATMENT (DDW 2025) - "She was able to obtain bulevirtide (2 mg) from Russia but had no virological or biochemical response after 4 months... With increased awareness of HDV screening since 2011, the overall HDV screening rate in our tertiary Liver Center was 50% among CHB patients. In this predominantly foreign CHB cohort, 1.35% were anti-HDV(+) and >40% had cirrhosis at the time of diagnosis. Early diagnosis and effective therapeutic options are urgently needed for this challenging disease."

Fibrosis • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

MPR_BD: Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment (clinicaltrials.gov) - P=N/A | N=192 | Recruiting | Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Inflammation