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  • New Hepatitis Delta Treatment Approved by European Commission

    … delta can often be managed and treated, and you are not alone! The most important first step is to know your status. What does this mean for providers? The exact number of people living with hepatitis delta around the world is unknown and estimates range anywhere from 20-70 million. Most of these individuals remain undiagnosed due in large part to a lack of testing and diagnostics. Stephan Urban, one of the researchers leading the effort in the development of Hepcludex has said that, in the United States, fewer than 5% of those tested for hepatitis B are also tested for hepatitis delta (Smith, 2020). It is true that in much of the world diagnostic tools remain unaffordable and so Dr. Urban and his team are developing a much less expensive and rapid test. If the capacity exists, however, testing is crucial for the management of this most severe form of viral hepatitis and all of the subsequent liver conditions that can develop from it. Additionally, as with all infectious diseases, vaccination of ALL people to prevent hepatitis B is critical. Click here for more information on hepatitis delta in general and here for questions and concerns. References German Center for Infection Research. (2020, August 5). First drug for hepatitis D has been approved by European Commission. EurekAlert! https://www.eurekalert.org/pub_releases/2020-08/gcfi-fdf080520.php Highleyman, L. (2019, December 16). Combination therapies show promise against hepatitis D. Retrieved August 31, 2020, from https://www.worldhepatitisalliance.org/latest-news/infohep/3548132/combination-therapies-show-promise-against-hepatitis-d Smith, J. (2020, August 20). Is Hepatitis D Healthcare Being Overlooked? LabioTech https://www.labiotech.eu/medical/hepatitis-d-ema-approval/

    http://www.hepb.org/blog/new-hepatitis-delta-treatment-approved-european-commission/
  • Does Hepatitis Delta Increase My Risk for Liver Cancer?

    … of all HCC globally attributable to hepatitis B (11). People with hepatitis delta coinfection still need to be closely monitored by a liver specialist, as 70% of people with both viruses will develop cirrhosis within 5-10 years (12). Monitoring may be blood testing and a liver ultrasound to screen for HCC every 6 months. Closer monitoring may be required if cirrhosis is already present, or to monitor response to treatment (interferon). For more information about hepatitis delta, visit www.hepdconnect.org. References: Manesis EK, Vourli G, Dalekos G. Prevalence and clinical course of hepatitis delta infection in Greece: A 13-year prospective study. J Hepatol. 2013;59:949–956. Coghill S, McNamara J, Woods M, Hajkowicz K. Epidemiology and clinical outcomes of hepatitis delta (D) virus infection in Queensland, Australia. Int J Infect Dis. 2018;74:123–127. Zhang Z, Filzmayer C, Ni Y. Hepatitis D virus replication is sensed by MDA5 and induces IFN-β/λ responses in hepatocytes. J Hepatol. 2018;69:25–35. Nault JC. Pathogenesis of hepatocellular carcinoma according to aetiology. Best Pract Res Clin Gastroenterol. 2014;28:937–947. Puigvehí, M., Moctezuma-Velázquez, C., Villanueva, A., & Llovet, J. M. (2019). The oncogenic role of hepatitis delta virus in hepatocellular carcinoma. JHEP reports: innovation in hepatology, 1(2), 120–130. Romeo R, Petruzziello A, Pecheur EI, et al. Hepatitis delta virus and hepatocellular carcinoma: an update. Epidemiol Infect. 2018;146(13):1612‐1618. Majumdar A, Curley SA, Wu X. Hepatic stem cells and transforming growth factor β in hepatocellular carcinoma. Nat Rev Gastroenterol Hepatol. 2012;9:530–538. Mendes M, Pérez-Hernandez D, Vázquez J, Coelho AV, Cunha C. Proteomic changes in HEK-293 cells induced by hepatitis delta virus replication. J Proteomics. 2013;89:24–38. Chen M, Du D, Zheng W. Small Hepatitis Delta Antigen Selectively Binds to Target mRNA in Hepatic Cells: A Potential Mechanism by Which Hepatitis D

    http://www.hepb.org/blog/hepatitis-delta-increase-risk-liver-cancer/
  • Eiger BioPharmaceuticals: Developing Two New Hepatitis Delta Treatments

    … host protection during viral infections. By targeting receptors that are localized in the liver, Lambda treatment may reduce side effects and result in improved tolerability . Can you share, in simple terms, the basic results of Eiger phase 3 studies for hepatitis delta trials? Are these drugs equally effective in HBeAg positive and negative HBV patients? The Eiger Phase 2 LOWR program with Lonafarnib has been completed. Over 120 patients were dosed in Phase 2 dose-finding studies to identify combination regimens of lonafarnib (LNF) and ritonavir (RTV) with and without pegylated interferon-alfa (PEG IFN α), with efficacy and tolerability to enable viral load suppression of HDV RNA and ALT normalization at Week 24. Dosing regimens of LNF 50 mg twice daily + RTV 100 mg twice daily with and without PEG IFN-a-2a 180 mcg once weekly were identified with the following reported results: All-oral: Lonafarnib boosted with ritonavir  29% of patients achieved ≥ 2 log decline and ALT normalization  Combination: Lonafarnib boosted with ritonavir + PEG IFN-a-2a  63% of patients achieved ≥ 2 log decline and ALT normalization These dosing arms are being further studied in the global Phase 3 D-LIVR study. Phase 2 studies have not been stratified by HBeAg status. The D-LIVR Study, a Phase 3 pivotal trial, is on-going and evaluating the safety and efficacy of lonafarnib treatments in patients chronically infected with Hepatitis Delta Virus (HDV). Topline Week 48 data will be available in 2021. 2. How will Lambda and Lonafarnib be administered to patients? Lonafarnib capsules are administered orally twice daily by mouth. Lonafarnib is taken in combination with ritonavir, a therapeutic booster that increases the bioavailability of lonafarnib. Ritonavir tablets are administered orally twice daily by mouth. Pegylated interferon-lambda is administered as a self-administered subcutaneous injection once weekly. 3. Do you anticipate combination therapy will be needed and if

    http://www.hepb.org/blog/eiger-biopharmaceuticals-developing-two-new-hep-b-d-treatments/
  • Spotlight on Hepatitis Delta: Renewed Scientific Interest Paves the Way for New Data and Treatments

    … Hawaii. This year has brought many milestones for hepatitis delta data, diagnostics, and clinical trials. With continued scientific research and interest, Hepatitis Delta Connect hopes to continue to support these milestones and drive awareness efforts. References: 1. Zhijiang Miao, Shaoshi Zhang, Xumin Ou, Shan Li, Zhongren Ma, Wenshi Wang, Maikel P Peppelenbosch, Jiaye Liu, Qiuwei Pan, Estimating the global prevalence, disease progression and clinical outcome of hepatitis delta virus infection, The Journal of Infectious Diseases, jiz633. 2. Chen H, Shen D, Ji D, et al. Prevalence and burden of hepatitis D virus infection in the global population: a systematic review and meta-analysis. Gut 2019;68:512-521. 3. Shen D, Ji D, Chen H, et al. Hepatitis D: not a rare disease anymore: global update for 2017–2018. Gut Published Online First: 09 April 2019.

    http://www.hepb.org/blog/spotlight-hepatitis-delta-renewed-scientific-interest-paves-way-new-data-treatment/
  • My Hepatitis B Viral Load is Low (Or Undetectable), Am I Still Infected with Hepatitis Delta?

    … C. R., & Lo, S. J. (2014). Hepatitis D virus infection, replication and cross-talk with the hepatitisB virus. World journal of gastroenterology, 20(40), 14589–14597.  YurdaydınC, Tabak F, Idilman R; Viral Hepatitis Guidelines Study Group. Diagnosis, management and treatment of hepatitis delta virus infection: Turkey 2017 Clinical Practice Guidelines. Turk J Gastroenterol 2017; 28(Suppl 2); S84-S89. Available at: https://www.turkjgastroenterol.org/sayilar/304/buyuk/S84-S89.pdf  Tseng, C. H., & Lai, M. M. Hepatitis delta virus RNA replication.Viruses, 1(3), 818–831.  

    http://www.hepb.org/blog/hepatitis-b-viral-load-low-undetectable-still-infected-hepatitis-delta/
  • Podcasts

    Listen to our podcasts to learn more about all things hepatitis delta! Bright and Evangeline sit down with Dan to talk about his experience with hepatitis Delta. We talk about his initial feelings surrounding the diagnosis, his treatment, how he got involved with the Hepatitis B Foundation, and his hope for the future of all people living with hepatitis B and Delta. Listen here today!  Join us for a podcast in which researchers from the Hepatitis B Foundation in the United States and the University of New South Wales in Australia come together to discuss the profound impacts stigma can have on the lives of people living with hepatitis B. Click here to listen! Listen to the latest episode of B Heppy, the Hepatitis B Foundation's monthly podcast, all about hepatitis delta! B Heppy host Evangeline chats with Dr. Robert Gish to discuss what hepatitis delta is, how it is related to hepatitis B, how to manage it, and what future treatment options look like. Listen here today!

    https://www.hepb.org/research-and-programs/hepdeltaconnect/resources/podcasts/
  • German scientist, inventor of new, first-in-class treatment for hepatitis D, to receive the 2023 Baruch S. Blumberg Prize

    Prof. Stephan Urban led development of the first treatment for hepatitis D, an often-fatal infection for millions of people worldwide. Doylestown, Pa., Nov. 14, 2022 – The Hepatitis B Foundation, a global nonprofit organization, today announced that Stephan Urban, PhD, distinguished professor and globally recognized virologist, has been chosen to receive its 2023 Baruch S. Blumberg Prize. Prof. Urban developed bulevirtide (brand name Hepcludex), a new and effective first-in-class drug approved in Europe treat hepatitis D, which is a serious coinfection that only exists in combination with hepatitis B. Developed by Prof. Urban and his team at Heidelberg University Hospital, bulevirtide blocks the entry of the hepatitis B and hepatitis D viruses into the liver cell. Hepcludex, the first commercial formulation of bulevirtide, was approved by the European Commission in July 2020. Studies have estimated that 12 to 74 million people carrying the hepatitis B virus have been coinfected with hepatitis D virus (HDV) worldwide. Chronic HDV infection results in often fatal complications and a higher risk of liver cancer. “Prof. Urban’s innovative research has helped us understand key components of hepatitis B and D virology, and he is a pioneer in the development of new therapeutics for hepatitis B and D,” Hepatitis B Foundation President Chari A. Cohen, DrPH, MPH, said. “The hepatitis B and D communities owe him a debt of gratitude.” The Baruch S. Blumberg Prize is the Hepatitis B Foundation’s highest honor. It is named for Baruch S. Blumberg, MD, DPhil, who received the Nobel Prize in Medicine and Physiology in 1976 for discovering the hepatitis B virus. He was a faculty member at the Fox Chase Cancer Center in Philadelphia at the time. Dr. Blumberg was instrumental in the creation of the Foundation, served on our Scientific and Medical Advisory Board and was the Foundation’s Distinguished Scholar from 1992 until his death in 2011. The Foundation’s research arm was renamed the Baruch S. Blumberg Institute in his honor. A committee of former Blumberg Prize recipients annually selects a new honoree. Past recipients include Dr. Harvey Alter, who was among the winners of the 2020 Nobel Prize in Medicine and Physiology; Dr. Anna Lok, assistant dean for clinical research, University of Michigan Medical School; and Dr. John Taylor, professor emeritus, Fox Chase Cancer Center. The Blumberg Prize will be presented to Prof. Urban at the 2023 Hepatitis B Foundation Gala, which will be held on March 10 at the Warrington in Warrington, Pa. Timothy M. Block, PhD, co-founder of the Hepatitis B Foundation and a virologist who is one of the world’s leading experts on hepatitis B, said: “Prof. Urban is one of the world’s most innovative and creative scientists, taking an idea for a drug from concept all the way to practice, where it’s now being used to treat people. Honoring this kind of accomplishment is exactly what we intended for the Blumberg Prize.” Prof. Urban is head of Translational Virology in the Department of Infectious Diseases, Molecular Virology, at Heidelberg University Hospital. He also is Project Coordinator for the DZIF (German Center for Infection research) TTU Hepatitis Program. Prof. Urban was awarded with the DZIF Research Award in 2014, received the Pettenkofer Prize in 2011, the distinguished award in Hepatitis B Virus research in 2021 and the Wolfgang Gerok prize in 2022. Prof. Urban’s research interests include molecular mechanisms of hepatitis B and hepatitis D virus/host interactions with a focus on the early and late events of viral infection; identification of hepadnaviral receptors and structural analyses of virus receptor interactions; development of novel cell culture systems for HBV and HDV; clinical development of entry inhibitors for HBV and HDV infection; and analyses of innate immune responses upon HBV and HDV infection. Prof. Urban completed his Diploma in Biochemistry at the University of Tübingen in 1991 and was awarded a doctorate in 1995 under Prof. P.H. Hofschneider at the Max-Planck-Institut für Biochemie, Martinsried. He conducted postdoctoral research at the Centre for Molecular Biology, Heidelberg University, with Prof. H. Schaller and became an independent group leader in the department of molecular virology headed by Prof. Ralf Bartenschlager.

    https://www.hepb.org/news-and-events/news-2/german-scientist-inventor-of-worlds-first-treatment-for-hepatitis-d-to-receive-the-2023-baruch-s-blumberg-prize/
  • Hepatitis B Foundation creates two Global Community Advisory Boards

    People living with and affected by hepatitis B and hepatitis delta will provide input to industry, government and nonprofits working on drug development. Doylestown, Pa., July 18, 2022 – To further its work as the world’s leading nonprofit dedicated to hepatitis B and liver cancer, the Hepatitis B Foundation has formed two new Global Community Advisory Boards. At the Foundation’s invitation, 81 people worldwide, primarily people living with hepatitis B and delta infections, applied to serve on the advisory boards. One board, which has 14 members, is dedicated to hepatitis B and the other, with nine members, is devoted to hepatitis delta, or hepatitis D. Members represent Albania, Australia, Canada, Cameroon, Ghana, India, Israel, Mongolia, Nigeria, Philippines, Romania, Senegal, Taiwan, Tanzania, Uganda, the U.K. and the U.S. The Foundation will work to share the board members’ perspectives, experience and expertise with those engaged in drug development and clinical research in hepatitis B and D. A primary goal is to ensure that the voices of those living with HBV and HDV are central to decision-making by industry, government and nonprofits, and to drive progress toward cures for hepatitis B and D. “The Hepatitis B Foundation always has placed a high value on the voices of people with hepatitis B and D, and their loved ones,” Chari A. Cohen, DrPH, MPH, president of the Foundation, said. “We believe that no major strides can be made without understanding the lived experience of those affected by these diseases. We are extremely grateful that so many people agreed to serve on the advisory boards and contribute their time, energy and ideas.” Chari A. Cohen, DrPH, MPH, president, Hepatitis B Foundation   Advisory board members will participate in discussions with drug and clinical trial developers, represent the advisory boards at public events and conferences, and contribute to outreach and education in their home communities. The boards’ meetings, to be held quarterly, will be online due their worldwide membership. About Hepatitis B: Hepatitis B is the most common serious liver infection in the world. It is caused by the hepatitis B virus that attacks and injures the liver. Each year up to 1 million people die from hepatitis B worldwide, even though it is preventable and treatable. Hepatitis B is a “silent epidemic” because most people do not have symptoms when they are newly or chronically infected. Thus, they can unknowingly infect others and continue the spread of hepatitis B. For people who are chronically infected and asymptomatic, liver damage can still occur silently and can develop into more serious liver disease, such as cirrhosis or liver cancer. About Hepatitis Delta: Hepatitis delta, also known as hepatitis D or HDV, is a liver infection caused by the hepatitis delta virus that results in the most severe form of viral hepatitis known to humans. Only those already infected with hepatitis B can acquire hepatitis delta, as it is dependent on the hepatitis B virus to reproduce. Of the more than 296 million people living with hepatitis B, an estimated 15-20 million are also infected with hepatitis delta. Coinfections lead to more serious liver disease than hepatitis B infection alone. They are associated with faster progression to liver fibrosis, increased risk of liver cancer, and early decompensated cirrhosis and liver failure.  

    https://www.hepb.org/news-and-events/news-2/hepatitis-b-foundation-creates-two-global-community-advisory-boards/
  • Hepatitis Delta Trials

    Click here for more information on clinical trials for hepatitis delta.

    https://www.hepb.org/treatment-and-management/clinical-trials/hepatitis-d-trials-2/
  • Welcome to Hepatitis Delta Connect!

    A dedicated program of the Hepatitis B Foundation to increase awareness about hepatitis delta - a serious virus that coinfects hepatitis B patients - and to promote screening and testing, and provide information and support for those affected.      Clinical Trial Finder - Find A Clinical Trial Near You!                                                                                                         Check Out Our Latest Podcast! Bright and Evangeline sit down with Dan to talk about his experience with hepatitis Delta. We talk about his initial feelings surrounding the diagnosis, his treatment, how he got involved with the Hepatitis B Foundation, and his hope for the future of all people living with hepatitis B and Delta. Listen here today! Join us for our next hepatitis delta webinar in June! This will be a two-part series. Part 1, happening on June 8th, 2023 at 10am Eastern Time, will feature a panel discussion about hepatitis delta in the European context, the status of approvals of Hepcludex (bulevirtide) around the continent, and how the medication is changing the HDV landscape. We will be joined by panelists from the UK, Spain, Romania, France, and Italy. Part 2, taking place on June 15th, 2023 at 10am Eastern Time, will explore the epidemiology of hepatitis delta in areas of the world in which bulevirtide has not yet been approved, as well as challenges with diagnostics and management of the virus in different contexts. We will be joined by panelists in North America, Africa, Asia, and Australia. Hope to see you there! Please click here to register for part 1 and click here to register for part 2! We would love to hear from you! Complete the survey to sign up! Please note: This survey link is specifically for those living with hepatitis delta, or those who are caretakers of people living with hepatitis delta. Take our brief survey & sign up to receive updates on clinical trials, info about hepatitis delta monitoring, management & care + more! Sign up today! Please note: This survey link is specifically for healthcare providers caring for people living with hepatitis delta. We've educated 13,000 people in 111 countries!   News & Updates March 2023 Blog Post: Why Is Hepatitis Delta So Hard to Eliminate? December 2022 Blog Post: What You Need to Know About the 2022 Liver Meeting and How it Relates to Hepatitis Delta September 2022 Blog Post: What's the Difference? Herbal Remedies and Supplements vs. Western Medicine July 2022 Blog Post: Results from Hepatitis Delta Clinical Trials Announced at 2022 International Liver Congress View our webinar, "The Lived Experience of Hepatitis Delta" recording here. 05/17/2023: The Many Functions Of The Hepatitis D Antigen Proteins 05/16/2023: Hundreds of NHS patients in England and Wales offered access to first treatment conditionally licensed for the most aggressive form of viral hepatitis 05/15/2023: With NICE nod, Gilead clears another regulatory hurdle in Europe for Hepcludex 05/10/2023: RNA Gymnastics: How Does Hepatitis Delta Virus Replicate? 05/05/2023: After FDA rejection, Gilead's Hepcludex looks set for full EU nod 04/06/2023: Molecular and Clinical Features of Hepatocellular Carcinoma in Patients with HBV-HDV Infection 04/06/2023: Hepatitis D double reflex testing of all hepatitis B carriers in low HBV and high HBV/high HDV prevalence countries 03/20/2023: Real-world studies show efficacy, safety of BLV monotherapy in patients with HDV-related compensated cirrhosis 03/17/2023: Hepatitis Delta, Aisf and Simit specialists present joint and updated document 03/14/2023: Scottish Medicines Consortium accepts treatment for chronic hepatitis delta virus 03/2023: Improved hepatitis delta virus genome characterization by single molecule full-length genome sequencing combined with VIRiONT pipeline 01/21/2023: Bulevirtide in the Treatment of Hepatitis Delta: Drug Discovery, Clinical Development and Place in Therapy 01/11/2023: Identifying and Screening At-Risk Patients for Hepatitis Delta Virus: A Case Report 01/03/2023: A 3-Year Course Of Bulevirtide Monotherapy May Cure HDV Infection In Cirrhotics 01/2023: Effect of variants in LGP2 on MDA5-mediated activation of interferon response and suppression of hepatitis D virus replication 01/2023: D is for Diagnosis, Whom to Screen for hepatitis Delta virus Get Connected   

    https://www.hepb.org/research-and-programs/hepdeltaconnect/