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  • Why Is Hepatitis Delta So Hard to Eliminate?

    Forty-five years after Mario Rizzetto discovered the hepatitis D virus (also known as HDV or hepatitis delta), scientists and advocates met for the first ever Delta Cure Meeting to discuss new scientific trends and global advocacy efforts to eliminate this difficult-to-treat disease. This conference included topics ranging from HDV’s global prevalence to new diagnostic methods, and the need for specific and improved efforts to fight this virus. During the Delta Cure Meeting, scientists called for new global strategies to find people living with HDV and have prompted the World Health Organization (WHO) to update their screening guidelines to include HDV tests for all people living with hepatitis B (people who are HBsAg-positive).  Unfortunately, some barriers continue to stand in the way of making this call to action a reality. Dr. Meg Doherty, the Director of Global HIV, Hepatitis, and STI Programmes at the WHO, stated in a recent Healio article that the WHO does not have any prevention recommendations that are specific to HDV. However, the WHO is developing updated guidance for HDV testing, diagnosis, and treatment as a part of hepatitis B (HBV)-focused elimination efforts. While some initial progress has been made, (such as the inclusion of HDV in the 2022-2030 Global Health Sector strategies, which aim to increase knowledge about infections like HIV and viral hepatitis to create effective responses to and advance elimination efforts for these diseases), there is a need to expand elimination strategies to include HDV more broadly. The lack of robust inclusion of HDV disregards people who are currently living with HBV and are at the highest risk of HDV exposure and acquisition. People who have been diagnosed with HDV are overlooked as linkage to appropriate care, diagnostics and treatments (which are important for people living with HDV to stay healthy) continues to be out of reach for many. One of the major challenges with HDV is also the lack of testing and

    http://www.hepb.org/blog/hepatitis-delta-hard-eliminate/
  • What You Need to Know About the 2022 Liver Meeting and How It Relates to Hepatitis Delta

            This year, the annual Liver Meeting, hosted by the American Association for the Study of Liver Diseases (AASLD), was held in Washington, D.C. The featured presentations included new innovations in liver transplant surgery, disease modeling (which is a process that uses cells to show how a disease develops and to test possible treatment approaches), and drug development. While an effective, functional cure for hepatitis B virus (HBV) is still 5-10 years away, researchers, scientists, healthcare providers, and people with lived experience all came together and agreed that more needs to be done to reduce the burden of liver diseases and improve health outcomes now. One highlight of the meeting was Dr. Francis Collins, former director of the U.S. National Institutes of Health and special advisor to President Biden, hosting a special session to introduce a national hepatitis C elimination plan for the U.S. Unfortunately, this plan is focused on hepatitis C. As a response, the Hepatitis B Foundation will soon send an advocacy letter pushing for the inclusion of hepatitis B and hepatitis delta in this plan. Make sure you are signed up for our Action Center alerts to stay engaged with hepatitis B advocacy efforts. Of particular note at this year’s meeting were the presence of many patient advocates and people with lived experience, and an increased focus on hepatitis delta. One important hepatitis delta poster presentation was delivered by Dr. Tatyana Kushner of Mount Sinai Hospital in New York City, entitled “HDV Patient Perspective: The Impact of Disease and Current Unmet Needs.” By including the perspectives of people living with hepatitis delta virus (HDV), this study aimed to empower the patient community. Dr. Kushner and her colleagues collected data on people’s quality of life to identify unmet needs, barriers and gaps in HDV care (including disease management and access-to-care inequities). The researchers found that a person’s

    http://www.hepb.org/blog/aasld2022delta/
  • Results from Hepatitis Delta Clinical Trials Announced at International Liver Congress 2022

    London, UK was the host city for this year’s annual International Liver Congress (ILC), the yearly meeting of the European Association for the Study of the Liver (EASL), which took place from June 22nd-26th. This meeting provides an opportunity for those working to address liver diseases around the world to gather in one location and exchange ideas, present research, and work to advance diagnosis, prevention, treatment, and elimination of these serious conditions. This year’s meeting saw significant attention given to hepatitis delta, as new treatments continue to move through the pipeline and more widespread approval for prescription of current treatments is sought. Below is a quick snapshot of some of the presentations! The US-based pharmaceutical company Gilead Sciences, Inc. demonstrated with results from a Phase 3 clinical trial that treatment with Hepcludex (bulevirtide), the first medication ever approved for hepatitis delta (HDV), has been shown to achieve significant response in chronic HDV. After 48 weeks, 48% of study participants who received different doses of treatment with Hepcludex achieved virological response (meaning a decline in hepatitis delta viral load, ALT normalization, and a change in liver stiffness), compared to only 2% of those who had not received any treatment. When compared to results from clinical trials after 24 weeks, response rates to HDV only improved, showing the drug to be even more effective over time. Throughout the clinical trials, there have been no adverse events reported that are attributable to this treatment. Hepcludex has also been found to have a positive impact on the quality of life of individuals living with hepatitis delta, and their overall ability to manage the condition. There were improvements found in health distress, performance of daily activities related to hepatitis, emotional impact of hepatitis, and ability to work. This data reinforces the efficacy and safety of Hepcludex and hopefully strengthens

    http://www.hepb.org/blog/hdv-easl-results/
  • Recent Roundtable Discussion Highlights Hepatitis Delta Virus

    April 21st and 22nd, 2022 marked the occurrence of a roundtable meeting solely focused on hepatitis delta virus (HDV), which was jointly hosted by the American Liver Foundation and the Hepatitis B Foundation. This was one in a series of events taking place this year to raise the profile of hepatitis delta, a serious coinfection of hepatitis B virus (HBV) that is estimated to affect between 5 and 10% of people who are living with HBV. HDV is more severe than HBV alone, with a 70% chance of developing into cirrhosis or liver cancer if unmanaged, compared to an approximately 25% chance for those living with HBV alone. With approval of the first official treatment for hepatitis delta in Europe in July of 2020, expected approval in the United States later in 2022, and other treatments moving through the clinical trial pipeline, more is happening in the world of hepatitis delta than ever before. Despite the promising treatment landscape, the virus still remains significantly under-diagnosed (making estimation of true prevalence difficult), largely due to lack of awareness, low prioritization compared to other health conditions, and limited advocacy, and big questions persist about treatment equity, including access to knowledgeable providers, clinical trials, and available medications. The purpose of this roundtable was to begin a conversation among a diverse group of stakeholders about some of these issues, to bring attention to HDV and its potential consequences, to identify unmet needs in this area, and to prepare calls to action and next steps to address these needs. Participants at the roundtable included individuals living with hepatitis delta, caregivers, healthcare providers, public health professionals, and representatives from community-based organizations. The conversation was very generative and really underscored some of the key issues that exist around hepatitis delta, including gaps in awareness and knowledge among medical and high-risk communities and

    http://www.hepb.org/blog/recent-roundtable-discussion-highlights-hepatitis-delta-virus/
  • 2022 - The Year of Hepatitis Delta

    2022 is shaping up to be a big year for hepatitis delta, the rare but serious virus that can co-infect people who are already living with hepatitis B. As a quick refresher, hepatitis delta is a virus that depends upon the hepatitis B virus in order to survive and replicate - so only those who are already living with hepatitis B can become infected with hepatitis delta. Hepatitis delta virus (HDV) is believed to infect between 5 and 10% of people living with hepatitis B virus (HBV). HDV can occur through either a superinfection or a coinfection. A superinfection occurs when someone who is already living with HBV contracts HDV, in which case there is a very high chance that the individual will develop chronic (lifelong) infections of both HBV and HDV. A coinfection occurs when both HBV and HDV are contracted at the same time - when this happens in adults, both infections tend to clear within six months and there is only a 5% chance that chronic HBV and HDV will occur. Chronic HDV is particularly dangerous because it advances progression to serious liver damage and liver failure much more quickly than HBV alone - 70% of people diagnosed with HDV and HBV will experience serious liver damage within 10 years without intervention, compared to 15-30% of people diagnosed with HBV alone. So, What’s Happening in the World of Hepatitis Delta? The past 18 months have been very important for hepatitis delta research and drug development. In July of 2020, the European Medicines Agency approved Hepcludex, the first-ever drug approved for treatment of hepatitis delta, for prescription in France, Austria, and Germany. Hepcludex works by stopping HDV from entering and infecting liver cells (and is known as an entry inhibitor). In 2021, MYR Pharma, the German company that originally developed Hepcludex, was bought by Gilead Sciences, Inc., which is based in the United States, and which has since filed a Biologics Licensing Agreement for approval of Hepcludex by the US Food and Drug

    http://www.hepb.org/blog/2022-year-hepatitis-delta/
  • Train the Trainer Educational Resources

    This video provides an overview of hepatitis delta virus, including what it is, who is affected, testing, prevention, treatment, management, and challenges. This video is for anyone who would like to learn more about hepatitis delta and share this information out with their community (healthcare providers, community and faith leaders, caregivers, people with lived expeerience, advocates - the list goes on!) Greater awareness can help to bring this hidden epidemic out of the shadows!  [embed width="418" height="236" class="leftAlone" thumbnail="https://i.ytimg.com/vi/LIKwmOPfVME/hqdefault.jpg?r"]http://www.youtube.com/watch?v=LIKwmOPfVME[/embed]You can find the slides from the presentation here (PowerPoint format) and here (PDF format). Additionally, the link for the HDV assessment quiz can be found here.  

    https://www.hepb.org/research-and-programs/hepdeltaconnect/resources/train-the-trainer-educational-resources/
  • World Hepatitis Day

    Every year on July 28th, we celebrate World Hepatitis Day in honor of Dr. Baruch Blumberg’s birthday. Dr. Blumberg discovered the hepatitis B virus in 1967 and subsequently developed the hepatitis B vaccine two years later in 1969. We commemorate World Hepatitis Day by raising awareness about viral hepatitis. With almost 300 million individuals living with hepatitis B worldwide, it is so important to bring awareness to this preventable and treatable disease. If you can support our efforts to bring awareness and find a cure, please donate here.  This year we echo the World Hepatitis Alliance in their call to action, "We can't wait for a world without hepatitis. #ICantWait" You can read more about their campaign here.  For our part we are focusing on hepatitis B storytellers. Join us on July 28 at 10:30 a.m. EDT for a facebook live with three of our #justB storytellers here. And get to know our new #BtheVoice storytellers right now! We have new #BtheVoice videos from real patients living in Nigeria. These audio recordings were captured by Catherine Freeland, MPH, Program Director of Public Health at the Hepatitis B Foundation during a recent trip to Nigeria where she helped to bring awareness to mother-to-child transmission and the need for timely birth dose.  We believe that elevating the voices of those who have hepatitis B is the best way to spread awareness for the need to find a cure, provide screening and treatment and work to fight stigma and discrimination.  Hear these moving stories here:  Sonia: #ICantWait to vaccinate my baby.  Ismail: #ICantWait for a world without stigma.  John: #ICantWait to get treated for hepatitis B. Gold: #ICantWait to tell my friends to get tested and vaccinated.  Dayo's Story: #ICantWait to get tested.   You can help support programs like #BtheVoice and other outreach projects as well as work toward a cure with a donation here.     

    https://www.hepb.org/news-and-events/world-hepatitis-day/
  • Find Your Why on World Hepatitis Day

    Will you join us on World Hepatitis Day, July 28, by asking yourself an important question:  “Why should I give to The Hepatitis B Foundation?” Please donate here once you've found your why!  Here are some examples of reasons why to give: The nearly 300 million people living with hepatitis B today A person you love who has the disease Fighting the stigma against those with hepatitis B Finding a cure Supporting life-changing research Finding improved treatment options for those living with hepatitis B Some of our organization's dearest friends had this to say about their personal Why: Catharine Williams, a member of our Board of Directors, says: “Hepatitis B should not derail anyone’s life. The Hep B Foundation and the Blumberg Institute are changing the outcomes for people living with the disease. They are the change agents for this disease.” Alan Brownstein, one of our most-valued advisors, says: “I support the Hepatitis B Foundation and the Baruch S. Blumberg Institute because I have seen firsthand how hepatitis B has affected people I love. The amazing work being done at HBF and the Blumberg Institute is leading the way towards curing hepatitis B and meeting the needs of millions living with hepatitis B.” Jane Blumberg, a greatly valued Foundation supporter and daughter of the late Dr. Baruch S. Blumberg, says: "I support the Blumberg Institute and Hepatitis B Foundation to continue my father’s work and to build on the amazing legacy that Joan and Tim Block have created. All of us together will beat hepatitis B and eradicate it –- finally and for good." Please Find Your Why and donate today! Click here to donate now. Or contact Jean Holmes: jean.holmes@hepb.org, 215-489-4946. Or mail your check to Hepatitis B Foundation, 3805 Old Easton Road, Doylestown, PA 18902 Our goal is to welcome 30 new donors to help fund the life-changing work that is made possible at the Hepatitis B Foundation and Blumberg Institute. Please give from the heart to save someone else’s liver. Thank you!    

    https://www.hepb.org/research-and-programs/find-your-why-on-b-day/
  • News Archive

    12/2022: Low Performance of Hepatitis Delta Virus Testing Among 2 National Cohorts of Chronic Hepatitis B Patients in the United States 12/8/2022: Eiger Announces Both Lonafarnib-based Treatments in Pivotal Phase 3 D-LIVR Trial in Hepatitis Delta Virus (HDV) Achieved Statistical Significance Against Placebo in Composite Primary Endpoint 11/11/2022: Bulevirtide Improves Health-Related Quality of Life (Phase 3 Clinical Trial Presentation at AASLD) 11/04/2022: Assembly Biosciences Presents New Data at AASLD The Liver Meeting® Highlighting Breadth of Virology Portfolio and Potential of Next-Generation Core Inhibitors in HBV 10/27/2022: Gilead Receives Complete Response Letter from U.S. FDA for Bulevirtide for the Treatment of Adults with Hepatitis Delta Virus. 10/27/2022: COVID-19 Impacts HDV Screening, Patient Outcomes 10/17/2022: Identification of a novel interaction site between the large hepatitis delta antigen and clathrin that regulates the assembly of genotype III hepatitis delta virus 09/2022: Presentation from International HBV Meeting: Combined results from the clinical trials MYR203 and MYR301, in patients with chronic hepatitis D 09/25/2022: Replicor Inc. has updated clinical data on the compassionate use program for treating chronic HBV/HDV co-infection in cirrhotic patients 09/22/2022: Vir Biotechnology Announces First Patient Dosed in the Phase 2 SOLSTICE Trial for the Treatment of Chronic Hepatitis D Virus Infection 09/13/2022: Safety and efficacy of bulevirtide in combination with tenofovir disoproxil fumarate in patients with hepatitis B virus and hepatitis D virus coinfection 09/2022: Diagnosing and Screening for Hepatitis D Viral Infection 06/2022: EASL Presentation - Peginterferon Lambda combined with Lonafarnib diminished triphasic HDV kinetic pattern seen under PEG-IFN Lambda monotherapy 06/2022: EASL Presentation - Mathematical modeling of HDV RNA kinetics suggests high peginterferon lambda efficacy in blocking viral production 06/2022: EASL Presentation - Rising Clinical and Economic Burden Among Hepatitis D Patients Who Attended Spanish Hospitals 06/2022: EASL Presentation - Provider Factors Shaping Hepatitis Delta Screening 06/2022: EASL Presentation - Hepatitis delta virus reflex testing in patients with hepatitis B dramatically improves the HDV screening cascade: 10 years of real-world experience  06/27/2022: Eiger BioPharmaceuticals Announces Results from Multiple Presentations at EASL 2022 06/27/2022: Vir Biotechnology Inc. (VIR) Announces New Clinical Data From its Broad Hepatitis B Program 06/23/2022: Treatment With Hepcludex® (Bulevirtide) Meets Primary Endpoint and Achieves Significant Response in Chronic Hepatitis Delta Virus at 48 Weeks 06/16/2022: Review shines a light on the overlooked virus, hepatitis D 06/08/2022: Eiger BioPharmaceuticals Announces Multiple Presentations at EASL 2022 05/12/2022: Research Article Examining the Different Evolutionary Dynamics of the hepatitis B and hepatitis D virus 04/27/2022: Vir Biotechnology Unveils New Hepatitis D Clinical Program 03/23/2022: New Hepatitis D Central Resource Available from Healio 02/17/2022: Four Questions with Professor Maria Buti: Understanding Hepatitis D 02/11/2022: New Hepatitis Delta Podcast Episode: Viral Hepatitis: On the Road to Elimination 02/04/2022: Patient Perspective: Living with HBV and HDV Coinfection in Pandemic Times 01/20/2022: Hepatitis D Changing Context Global Prevalence 01/04/2022: New Slideset Updated on Don't Delay with Delta: Best Practices and Calls to Action in HDV 12/21/2021: Bulevirtide Improves Quality of Life in Chronic HDV 12/21/2021: Eiger BioPharmaceuticals Announces First Patient Enrolled in LIMT-2: A Phase 3 Study of Peginterferon Lambda in Patients with Chronic Hepatitis Delta Virus (HDV) Infection 12/20/2021: Medical Minutes Podcasts on HDV Epidemiology and Universal Screening 12/16/2021: UN Adopts Resolution on Rare Diseases 12/13/2021: Bulevirtide Shows Real-World Efficacy Versus HDV 12/03/2021: Should We Screen All Patients with Hepatitis B for Hepatitis Delta? 12/01/2021: Hepatitis Delta Presentations from the 2021 AASLD Liver Meeting Now Available 12/01/2021: Ethnic Variations in Clinical Presentation and Treatment Eligibility for HDV Infection at a US Referral Center 11/19/2021: Gilead Files BLA for Bulevirtide to Treat Chronic HDV Infection 11/12/2021: Prevalence and Characteristics of Hepatitis Delta in the United States: An Analysis of All-Payer Claims Databases 09/29/2021: The Kinesin KIF4 Mediates HBV/HDV Entry Through Regulation of Surface NTCP Localization and Can Be Targeted by RXR Agonists in vitro 08/24/2021: The Highly Complementary Model of Hepatitis D and Hepatitis B, Described by Scientists, Can Broadly Cover the HDV Replication Cycle 07/28/2021: Hepatitis D: Neglected Disease in the Race to Eliminate Viral Hepatitis by 2030 07/27/2021: Risk of Hepatocellular Carcinoma in Hepatitis B & D Virus Co-Infected Patients: A Systematic Review and Meta-Analysis of Longitudinal Studies 07/12/2021: Significant Disruptions in the International Incidence of Hepatitis Delta Virus 06/25/2021: Gilead Preps Filing for Hepatitis D Therapy Hepcludex in US 06/24/2021: Treatment With Hepcludex® (Bulevirtide) Was Shown to Achieve Significant Response in Chronic Hepatitis Delta Virus After 24 Weeks 04/01/2021: Hepatitis Delta Infection Among Persons with HIV in Europe 11/30/20: New Insights into Hepatitis D Virus Persistence: The Role of Interferon Response and Implications for Upcoming Novel Therapies 11/17/20: Eiger Announces Positive Peginterferon Lambda-Lonafarnib Combination End-of-Study Results from Phase 2 LIFT HDV Study at the Liver Meeting Digital Experience 2020 11/16/20: Eiger Announces Case Studies Demonstrating Regression of Liver Fibrosis Following 48 Weeks of Therapy with Peginterferon Lambda in Patients with Chronic HDV Infection at the Liver Meeting Digital Experience 2020 10/7/20: Risk Factors for Delta Hepatitis in a North American Cohort: Who Should Be Screened?  9/17/20: Hepcludex Launched in Germany, France, and Austria 8/31/20: End of Treatment Results Presented for Lambda-Interferon + Lonafarnib Combination Phase 2 LIFT Study at International Liver Congress, 2020 8/5/20: Hepcludex Approved by European Commission 6/2/20: MYR Pharmaceuticals Receives Positive Opinion from EMA for Hepcludex for the Treatment of Chronic Hepatitis Delta 2/18/20: New Insights into Hepatitis B and Hepatitis Delta Virus Entry 2/1/20: The Effect of Twelve Weeks of Treatment with Ezetimibe on HDV RNA Level in Patients with Chronic Hepatitis D 1/2/20: Hepatitis Delta Has Higher Health Care Cost Burden Than Hepatitis B 12/26/19: REP2139 Demonstrates Functional Cure in Both HBV, HDV  11/12/19: Eiger Announces Phase 2 LIFT Study Results During AASLD 2019 11/1/19: MYR Pharmaceuticals to Present on Myrcludex B During AASLD 2019 11/1/19: FDA Guidance to Help with Hepatitis Delta Drug Development 8/20/19: Pegylated Interferon Lambda Receives FDA Breakthrough Therapy Designation 7/29/19: Russia Plans Production of Myrcludex B 4/13/19: MYR Announces Phase 2 Myrcludex B Trial Data at The International Liver Congress 2019 4/11/19: Eiger Announces Phase 2 LIMT Hepatitis Delta Study Progress at The International Liver Congress 2019 3/5/19: MYR Pharma Announces Grant of Promising Innovative Medicine (PIM) Designation by British MHRA for Myrcludex B 12/18/18: Eiger Announces PRIME Designation Granted by European Medicines Agency for Lonafarnib 12/17/18: Eiger Announces Breakthrough Therapy Designation Granted by FDA for Lonafarnib 6/4/18: Digestive Disease Week: Hepatitis Delta: The 'Forgotten Virus' is Still Here 10/23/18: MYR Pharma Announces FDA Breakthrough Therapy Designation for Myrcludex B 9/5/17:  Pegylated Interferon Lambda Receives FDA Orphan Drug Designation 7/27/17: Pegylated Interferon Lambda Receives FDA Fast Track Designation  5/25/17: MYR Pharma Announces Myrcludex B PRIME Designation by the EMA 12/23/14: EB Pharma Announces License Agreement for Tipifarnib from Janssen Pharmaceutica for Development in Hepatitis Delta  12/22/14: Lonafarnib Recieves Orphan Drug Designation by FDA and EMA  

    https://www.hepb.org/research-and-programs/hepdeltaconnect/news-archive/
  • Drug Watch

    Drugs in Development for Hepatitis Delta: Drug Mechanism Company Clinical Trial Phase Designations  Lonafarnib + Ritonavir Prenylation Inhibitor Eiger BioPharma, USA Phase III (Fully enrolled - data expected by mid-late 2023)          FDA Breakthrough Therapy Designation FDA Fast Track Designation FDA Orphan Drug Designation EMA Orphan Drug Designation EMA PRIME  Hepcludex (Formerly Myrcludex B)   Entry Inhibitor Gilead Sciences, Inc. Monotherapy: Conditional approval by EMA & Biologics License Application filed with FDA - ongoing Phase III and Phase I trials EMA PRIME FDA Breakthrough Therapy Designation FDA Orphan Drug Designation Promising Innovative Medicine (PIM) Designation by British MHRA Lambda (Pegylated Interferon) Immune Response  Stimulator Eiger BioPharma, USA Phase III Enrolling FDA/EMA Orphan Drug Designation FDA Fast Track Designation FDA Breakthrough Therapy Designation JNJ 3989 + Nucleos(t)ide Analog RNA Interference Compound Janssen Research & Development, LLC Phase II N/A REP 2139 - Mg (in combination with PEG-IFN and Tenofovir) HBsAg Inhibitor  Replicor, Canada Phase II planning in progress (Europe + USA); Compassionate Access Program Available    N/A Vir 2218 + Vir 3434 SiRNA Immune Response Stimulator/HBsAg Inhibitor/Entry Inhibitor Vir Biotechnology Phase II Enrolling N/A Ropeginterferon Alfa-2b (P1101) Immune Response Stimulator PharmaEssentia Phase I (Enrolling) & Phase II (Not Yet Enrolling) N/A HH-003 Entry Inhibitor Huahui Health Phase II N/A Hepalatide NTCP Target Shanghai HEP Pharmaceuticals Phase II N/A BJT-778 Monoclonal Antibody Bluejay Therapeutics Phase I N/A HH-006 Entry Inhibitor Huahui Health Phase I N/A HBV/HDV Entry Inhibitor & Interferon Alpha Receptor Agonist Entry Inhibitor Assembly BioSciences Pre-clinical N/A GI-18000 Immune Response  Stimulator GlobeImmune, USA Pre-clinical  N/A Chart Updated May 2023Glossary:  Terms: HBV = Hepatitis B Virus, CHB = Chronic Hepatitis B, HDV = Hepatitis Delta Virus, CHD = Chronic Hepatitis Delta, PEG-IFN = Pegylated interferon, NTCP = Sodium/Taurocholate Cotransporting Polypeptide, HBsAg = Hepatitis B Surface Antigen, RNA = Ribonucleic Acid, ASPIN = Active Site Polymerase Inhibitor Nucleotide, SiRNA = Small Interfering RNA (a strand of synthetic RNA designed to specifically target a particular messenger RNA for destrutcion), FDA = U.S. Food and Drug Administration, EMA = European Medicines Agency, NIH = National Institutes of Health, British MHRA = Great Britain Medicines and Healthcare products Regulatory Agency Interferon Alpha (IFN-α) Pegylated interferon alpha has been used as an off-label treatment for CHD since 1980. Viral response rates typically range between 25 and 30% with this treatment. International guidelines recommend a treatment duration of 48 weeks. A high relapse rate and severe side effects with IFN-α make the study of alternative treatments timely and critical. Lonafarnib + Ritonavir Lonafarnib is a "prenylation inhibitor" and works by targeting the protein assembly process, which prevents new viruses from being created. Lonafarnib combined with Ritonavir has shown promise in reducing hepatitis delta virus levels. Eiger Biopharmaceuticals has completed their Phase III D-LIVR clinical trial and data is expected later in 2023. Lonafarnib has been granted Fast Track Designation and Breakthrough Therapy Designation by the FDA, PRIME Eligibility Designation by the EMA, and Orphan Drug Designation by the FDA and EMA.  Hepcludex (formerly Myrcludex B) Hepcludex (generic name bulevirtide) is an “entry inhibitor” that works by stopping the hepatitis delta virus from entering and infecting hepatocytes (liver cells), and breaking the cycle of reinfection. It has shown activity against the hepatitis B virus, and in July 2020 was approved by the European Commission for prescription in Europe, including Russia and the former Soviet Union, as the first effective hepatitis D drug in the world. In September 2020, it was launched in Germany, France, and Austria. In November 2021, Gilead Sciences filed a Biologics License Application with the FDA for approval of the drug in the United States. In November of 2022, this application was not approved, but this was related to concerns about the manufacture and delivery of the drug, rather than its clinical efficacy or safety, so hopes are high that the application will be re-submitted quickly and approved in 2023. In April of 2023, the drug was approved for prescription in the wider European Union and the UK. Studies have also shown promise for Hepcludex when combined with PEG-IFN in reducing hepatitis delta viral levels. Gilead Sciences, Inc. is still conducting Phase III clinical trials, which are no longer recruiting participants, to investigate the long-term effects of Hepcludex. These studies have shown the achievement of significant response for HDV at 48 weeks. This drug has been granted PRIME Eligibility by the EMA, Breakthrough Therapy and Orphan Drug Designation by the FDA, and Promising Innovative Medicine Designation by the British MHRA.  Pegylated-Interferon-Lambda (PEG-IFN-λ) Pegylated-Interferon-Lambda is a type III interferon that works by activating the body's own immune system to fight the virus. Research has shown the ability of combination therapy with Ritonavir and Lonafarnib to reduce hepatitis delta virus levels and Eiger BioPharmaceuticals is currently enrolling participants in its Phase III LIMT-2 Study. PEG-IFN-λ has been granted Breakthrough Therapy and Fast Track Designation by the FDA, and Orphan Drug Designation by the FDA and EMA. JNJ-3989 + Nucleos(t)ide Analog JNJ 3989 is an RNA interference compound that works by targeting transcription of viral RNA, specifically those deriving from HBV cccDNA (this stands for closed covalent circular DNA, a unique DNA structure that forms in response to infection of a cell), which could also impact HDV infection. So far, only HBV monoinfected participants have been included in clinical trials. The results of these trials, in which JNJ-3989 was combined with a treatment like Entecavir or Tenofovir, were very promising and indicated a rapid decline in HBsAg levels. A new phase II study has completed enrollment and evaluating the safety and efficacy of JNJ-3989 in people who are co-infected with HDV.  REP 2139-Mg REP 2139-Mg is a "nucleic acid-based amphipathic polymer (NAP)" that works by preventing infected liver cells from releasing hepatitis B virus into healthy liver cells. It is being evaluated for use in combination with PEG-IFN and Tenofovir. A study indicated that this combination treatment lowered HBsAg levels, HBV DNA, and HDV RNA in some patients. Planning for Phase II trials for this drug in Europe is currently in progress. A compassionate access program for use of this drug is currently available in Austria, France, Israel, Italy, and Turkey. Vir 2218 + Vir 3434 Vir 2218 is an HBV-targeted SiRNA that has the potential to stimulate an effective immune response and demonstrate direct antivial activity against HBV and HDV. Vir 3434 is a monoclonal antibody that targets HBsAg and is designed to remove HBV and HDV virus from the blood and block the entry of these viruses into liver cells. A phase 2 study of both of these drugs is currently recruiting participants.  Ropeginterferon Alfa-2b (P1101) P1101 is an immune response stimulator that has been shown to be effective in treatment of a rare blood disease called Essential Thrombocythemia. This drug, along with the drug anti-PD1, which falls into a group of drugs that assists the immune system in fighting off some types of cancers, is being evaluated to test its effectiveness in fighting off chronic hepatitis B and D infection. It is hoped that these drugs will help to achieve loss of HBsAg and ALT normalization. A phase 1 study of this drug combination is currently recruiting participants. A phase 2 study is also underway, but is not yet recruiting participants. HH-003 HH-003 is a novel entry inhibitor for HBV & HDV. It has the potential to become a new standard of care that offers functional cure, standalone or in combination of other therapeutics, for patients suffering from chronic HBV infection or HBV/HDV co-infection. A phase 2 study is currently underway, but is not actively recruiting participants, and another is being planned to start recruitment in the future. Hepalatide Hepalatide works by targeting NTCP (Sodium/Taurocholate Cotransporting Polypeptide). A Phase 2 study to evaluate efficacy in people living with chronic hepatitis D will begin recruiting participants in the near future. BJT-778 BJT-778 is a monoclonal antibody against hepatitis B surface antigen (anti-HBsAg mAb). This drug neutralizes and clears hepatitis B and hepatitis D virions and depletes HBsAg-containing subviral particles, which may help to reconstitute an individual’s antiviral immunity and contribute to functional cure for chronic hepatitis B. This drug will enter Phase 1 clinical trials in the near future. HH-006 HH-006 has the same target as HH-003 and is formulated for subcutaneous injection. HH-006 is also suited for a specific subset of the patient population suffering from hepatitis B and D. This drug will enter Phase 1 clinical trials in the near future. HBV/HDV Entry Inhibitor & Interferon Alpha Receptor Agonist These drugs are in the very early stages and have not yet been named - they are both in development by Assembly Biosciences and will work to prevent HDV and HBV from entering healthy liver cells by blocking receptor mechanisms on the healthy cells. GI-18000 GI-18000 is an "immune response stimulator" that works by causing the host's T-cells to target and fight the infected liver cells. For current clinical trials for hepatitis delta click here. Updated May 2023

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