Hepcludex (bulevirtide-gmod) / Hepatera, Gilead - LARVOL DELTA

Impacts of HDV Education on Healthcare Provider Knowledge and Practice (ACG 2026) - "Prior to the talk, 53% were uncertain about HDV therapy; 85% and 90% identified bulevirtide and interferon as effective therapies in the post survey... Eight educational programs were conducted; 92 HCPs completed the pre-survey (Fig.1), 57% with >5 years of practice, and 60 completed the post-survey. Geographic awareness of HDV-endemic regions (Africa, Asia, South America) increased from 75-83% (pre-survey) to >90% (post-survey). Awareness of transmission risks (IVDU, blood transfusion, unsafe sex) improved from about 70% to >90%."

Fibrosis • Hepatology • Immunology • Infectious Disease • Liver Cancer • Solid Tumor

Viral Dynamics After Achieving Undetectable HDV RNA With Bulevirtide Monotherapy in Study MYR301 (ACG 2026) - P3 | "Across all arms, 81/149 (54%) pts achieved undetectable HDV RNA during therapy: 13/81 (16%) achieved this by W24, 22/81 (27%) during W24-W48, 14/81 (17%) during W48-W72, 16/81 (20%) during W72-W96, and 16/81 (20%) after W96. Pts with lower baseline (BL) HDV RNA had a shorter time to first undetectability. Pts achieving earlier undetectability were more likely to have undetectable HDV RNA at EOT: 12/13 (92%) of those achieving undetectability by W24 had undetectable HDV RNA at EOT vs 18/22 (82%), 12/14 (86%), 12/16 (75%), and 11/16 (69%) of those who achieved undetectability during W24-W48, W48-W72, and W72-W96 and after W96."

Monotherapy • Hepatology • Inflammation

Comparative Efficacy and Safety of Emerging Therapies for Chronic Hepatitis Delta Virus Infection: A Systematic Review and Network Meta-Analysis (ACG 2026) - "A total of 18 randomized controlled trials involving 4,862 patients with chronic HDV infection were included. Overall, 3,041 patients (62.5%) were male, mean age was 46.8±9.7 years, 38.4% had compensated cirrhosis, and baseline HDV RNA averaged 6.1 log10 copies/mL. Treatment groups included Hepcludex monotherapy (n=1,248), bulevirtide plus pegylated interferon-α (n=962), lonafarnib-based regimens (n=1,031), pegylated interferon monotherapy (n=884), and placebo/standard care (n=737)."

Retrospective data • Review • Fibrosis • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Liver Failure

Influence of Nucleos(t)ide Analogue Use With Bulevirtide on Treatment Outcomes in Chronic Hepatitis Delta (ACG 2026) - P2, P3 | "We included patients in 3 groups: BLV 2 mg/d (n = 49), BLV 10 mg/d (n = 150), and the DT arm (n = 51). Overall, NAs were used in 32/49 (65%), 83/150 (55%), and 32/51 (63%) patients in the BLV 2 mg, 10 mg, and DT groups, respectively. BL characteristics were comparable, except the proportions of patients with cirrhosis, prior interferon use, and mean liver stiffness were higher in those with NAs (54%; 61%; 14.8 kPa) vs without NAs (30%; 41%; 13.4 kPa)."

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

Impact of Prior Interferon Exposure on the Efficacy of Bulevirtide-Based Therapy in Chronic Hepatitis Delta: A Pooled Analysis From Phase 2 and 3 Studies (ACG 2026) - "Of 323 pts included, 168 (52%) received prior IFN for a mean (SD) of 22.9 (21.3) months. Among pts who received BLV mono, BL characteristics were similar with vs without prior IFN exposure: proportion with cirrhosis, 42% vs 47%; mean liver stiffness, 14.0 vs 14.9 kPa; ALT, 105 vs 111 U/L; and HDV RNA, 5.1 vs 5.2 log10 IU/mL. Pts from the BLV + PegIFN groups with prior IFN exposure had higher proportions with cirrhosis (45% vs 22%), mean liver stiffness (14.2 vs 11.0 kPa), and ALT (126 vs 93 U/L) and HDV RNA levels (5.4 vs 4.9 log10 IU/mL) at BL compared to those without prior IFN exposure."

P2 data • Retrospective data • Fibrosis • Hepatology • Immunology • Inflammation

Efficacy of Bulevirtide Monotherapy in Chronic Hepatitis D: A Systematic Review and Meta-Analysis (ACG 2026) - "Ten studies comprising 470 patients contributed to the VR analysis, yielding a pooled response rate of 54% (95% CI, 38%-69%; I²=87.2%). Nine studies (258 patients) contributed to the BR analysis, with a pooled response rate of 53% (95% CI, 41%-64%; I²=62.9%). Ten studies (367 patients) contributed to the CR analysis, with a pooled response rate of 45% (95% CI, 33%-57%; I²=73.3%)."

Monotherapy • Retrospective data • Review • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Liver Failure • Solid Tumor

Bulevirtide With or Without Pegylated Interferon-α Versus Delayed Treatment or Pegylated Interferon-α Alone for Chronic Hepatitis Delta: A Bayesian Network Meta-Analysis (ACG 2026) - "Four RCTs (k=4) were included, contributing 6 treatment nodes across 369 participants: BLV 2mg continuous (Node A), BLV 10mg continuous (Node B), BLV 2mg+PegIFNα (Node C), BLV 10mg+PegIFNα (Node D), PegIFNα monotherapy (Node E), and delayed treatment/placebo (Node F). All active regimens were superior to delayed treatment for HDV RNA undetectability at week 48. BLV 10mg+PegIFNα ranked first (P-score 0.99; OR vs delayed treatment 264.19, 95% CI 29.18â2391.71), followed by BLV 2mg+PegIFNα (P-score 0.81; OR 136.73, 95% CI 15.10â1237.84)."

Retrospective data • Hepatology • Infectious Disease • Inflammation

Bulevirtide With or Without Pegylated Interferon Alfa-2a for Chronic Hepatitis D: A Systemic Review and Meta-Analysis of Randomized Controlled Trials (ACG 2026) - "Three RCTs comprising 225 patients were included. At week 24, combination therapy significantly improved virological response (RR 4.81, 95% CI 2.29â10.11), combined virological-biochemical response (RR 1.55, 95% CI 1.02â2.35), and HDV RNA reduction (MD â1.34 log10, 95% CI â1.89 to â0.80; all p< 0.0001). Alanine aminotransferase normalization favored BLV monotherapy (RR 0.38, 95% CI 0.27â0.53; p< 0.00001), likely reflecting interferon-related transaminase fluctuations."

Retrospective data • Review • Fibrosis • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Failure

Beyond Virological Response: Refining the Assessment of Clinical and Patient-Reported Outcomes in Bulevirtide Therapy for Chronic Hepatitis D. (PubMed, J Viral Hepat) - No abstract available

Journal • Inflammation

Advancing Treatment of Hepatitis Delta Virus in the United States (AASLD 2026) - "Non-CME educational program for U.S. HCPs reviewing HDV etiology, epidemiology, disease progression, screening/diagnosis, care-cascade gaps, and a hypothetical patient case, with an overview of bulevirtide as an FDA-approved treatment option for chronic HDV in eligible adults. "Supported by Gilead who provided funding. Gilead has had no input into the content of the materials used at this meeting/conference.""

Hepatology • Inflammation

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection (clinicaltrials.gov) - P=N/A | N=170 | Terminated | Sponsor: Gilead Sciences | Trial completion date: Jul 2028 ➔ Aug 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jul 2028 ➔ Aug 2026; Sponsor decision, no safety concerns.

Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Inflammation

Health Disparities in Hepatitis D Virus Management: A Case Series on Improving Patient Access to Bulevirtide Therapy. (PubMed, Gastro Hep Adv) - "This included initiating therapy at a time that accommodated their personal circumstances, pausing treatment as needed, and working with third-party services to provide practical support that could address medication storage and logistical challenges. By shifting the perception that social circumstances are barriers to adherence, healthcare providers can promote a more inclusive approach to initiating, maintaining, and, where necessary, restarting bulevirtide therapy, ultimately improving health outcomes for patients with HDV."

Journal • Inflammation

Modeling hepatitis D virus kinetics during bulevirtide monotherapy: challenges and solutions. (PubMed, J Theor Biol) - "Lastly, we showed that a model that includes target cell dynamics can explain non-monophasic HDV decline patterns such as biphasic, flat-partial response and viral breakthrough. Including target cell dynamics also predicted a viral rebound once BLV is stopped as observed in clinical studies."

Journal • Monotherapy • Infectious Disease • Inflammation

Integrated Diagnosis of Hepatitis B, C, and D Viruses and HIV in Populations Evaluated for Sexually Transmitted Infections: A Narrative Review and Operational Framework. (PubMed, Viruses) - "Reflex algorithms, multiplex panels, point-of-care assays, dried blood spots, and electronic health record alerts are validated but unevenly implemented. We argue that, alongside persistent resource, political, and equity-related constraints, a substantial share of the remaining barriers is operational rather than purely technological, and propose a practical, STI-clinic-centered framework integrating reflex testing, population-specific periodicity, and explicit linkage pathways toward the WHO 2030 elimination targets."

Journal • Review • Hepatitis B • Hepatitis C • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Hepatology: Emerging Paradigms in MASLD, Viral Hepatitis, Cholestatic Liver Disease, Portal Hypertension and Hepatocellular Carcinoma: Summary of the First Annual Paris International Liver Meeting 2026. (PubMed, Liver Int) - "Resmetirom and semaglutide are now approved for MASH with F2-F3 fibrosis, with a robust pipeline generating anti-fibrotic signals through FGF21 analogs, pan-peroxisome proliferator-activated receptor (PPAR) agonists, and incretin-based dual and triple agonists...In parallel, HDV management is transitioning from a severe disease to one with emerging suppressive and potential curative l through bulevirtide and novel HBsAg-targeting and RNA-silencing therapies, respectively...Finally, for patients with hepatocellular carcinoma (HCC), immunotherapy combinations can achieve unprecedented long-term survival in selected populations of patients. Collectively, these advances define a new era of hepatology centered on precision medicine, earlier intervention, and mechanism-driven therapeutic strategies."

IO biomarker • Journal • Review • Cardiovascular • Cholestasis • Dermatology • Fatigue • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Oncology • Portal Hypertension • Primary Biliary Cholangitis • Pruritus • Solid Tumor • FGF21

Bulevirtide approved by FDA for chronic hepatitis D. (PubMed, Lancet Microbe) - No abstract available

FDA event • Journal • Inflammation

FDA approval of hepcludex: a milestone in the treatment of chronic hepatitis delta virus infection. (PubMed, Ann Med Surg (Lond)) - No abstract available

FDA event • Journal • Infectious Disease • Inflammation

Bulevirtide (Hepcludex) for Chronic Hepatitis Delta: A Milestone Achievement Demanding Real-World Evaluation. (PubMed, Ann Pharmacother) - No abstract available

HEOR • Journal • Real-world evidence • Inflammation

The Impact of Chronic Hepatitis D Virus Infection on Health-Related Quality of Life and Fatigue: A Real-World International Study. (PubMed, J Viral Hepat) - "Patients who had received bulevirtide for hepatitis B or treatment licensed for HDV were excluded...HDV infection significantly impacts patients' HRQoL and fatigue, particularly for patients at later disease stages. Treatments that slow disease progression, reducing the burden of HDV infection, are needed."

HEOR • Journal • Real-world evidence • Fatigue • Fibrosis • Gastroenterology • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Oncology • Solid Tumor

Fate of hepatitis D virus-specific CD8+ T cells during bulevirtide monotherapy in patients with chronic hepatitis delta☆. (PubMed, JHEP Rep) - "Albeit based on small patient numbers, antiviral treatment with bulevirtide could ameliorate exhausted HDV-specific CD8+ T cells targeting conserved HDV epitopes. However, as the majority of HDV-specific CD8+ T-cell responses target escaped viral epitopes, this does not translate to a substantial improvement in overall HDV-specific CD8+ T-cell immunity. Our findings may explain in part why long-term bulevirtide treatment is required to prevent viral relapse."

Journal • Monotherapy • Infectious Disease • Inflammation • Liver Cirrhosis • CD8 • HLA-B

An Exploratory Cost-Utility Analysis of Screening and Treating Immigrants in Canada for Hepatitis D. (PubMed, J Viral Hepat) - "Nevertheless, HDV screening and treatment with pegylated interferon alfa-2a monotherapy was the only cost-effective strategy (ICER: $23,177/QALY). While monotherapy with pegylated interferon alfa-2a proved cost-effective, combination therapy with bulevirtide is likely more clinically effective and may be cost-effective if treatment costs decrease significantly."

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

Mathematical Modeling of HDV RNA, HBsAg, and ALT Kinetics in Patients with Compensated Cirrhosis: Insights from 96 Weeks of Bulevirtide Monotherapy. (PubMed, Antiviral Res) - "The HDV FPR and VB observed in patients during 96 weeks of BLV are consistent with modeling prediction that BLV 2 mg/day is suboptimal (η≤ηc) in a high percentage of patients (84%) with compensated cirrhosis and CSPH and therefore is unlikely to achieve cure even with prolonged duration of therapy."

Journal • Monotherapy • Cardiovascular • Fibrosis • Hypertension • Immunology • Infectious Disease • Inflammation • Portal Hypertension

Pegylated interferon for chronic hepatitis delta: does it still have a role in the bulevirtide era? (PubMed, Rev Esp Enferm Dig) - "Our results confirm the considerable toxicity and limited efficacy of PegIFNα, but also its capacity to induce a sustained virological response and HBV functional cure in a subgroup of patients. In the bulevirtide era, PegIFNα remains a valid treatment option in selected patients given its curative potential."

Journal • Hematological Disorders • Infectious Disease • Inflammation • Psychiatry • IFNA1

ECLIPSE 2: A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (clinicaltrials.gov) - P3 | N=150 | Active, not recruiting | Sponsor: Vir Biotechnology, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Inflammation

Improving hepatitis D virus diagnosis and streamlining management pathways through double reflex testing (BSG 2026) - "The aim was to accelerate HDV case- finding and streamline linkage to specialist care, including access to licensed therapy, bulevirtide (BLV), and recruitment into clinical trials of novel therapies for HDV...This approach is scalable and could serve as a model for wider NHS adoption to improve access to HDV diagnosis and treatment nationally. Download figure Open in new tab Download powerpoint Abstract P75 Figure 1 ALT and HDV RNA levels in HDV RNA-positive patients"

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