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  • Hepatitis B Foundation: Now Part of the NORD Rare Disease Community!

    We’re pleased to announce that the Hepatitis B Foundation (HBF) is now a member of NORD, the National Organization for Rare Disorders, representing our program, Hepatitis Delta Connect. NORD is a patient advocacy organization dedicated to individuals with rare diseases and the organizations that serve them. We will join 280 other patient organization members, all committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and patient services. Although globally, hepatitis delta is estimated to affect 15-20 million people, in the U.S. it is classified as a rare disease, as it is estimated to affect less than 200,000 people. The complicated nature of the virus and limited prioritization contribute to the gap in awareness, resources, testing practices and adequate treatments for hepatitis B and delta coinfection. Joining NORD will help amplify our voice, raise awareness about hepatitis delta in people living with chronic hepatitis B, provider and pharmaceutical communities and contribute to health policy efforts. Hepatitis Delta Connect has previously been active with NORD through participating in rare disease Twitter chats and presenting a poster at the NORD Rare Action Summit in October 2018. We’re very excited to be a part of the coalition, and to be spreading awareness about hepatitis delta! For more information about Hepatitis Delta Connect, visit www.hepdconnect.org or email connect@hepdconnect.org.

    http://www.hepb.org/blog/hepatitis-b-foundation-now-part-nord-rare-disease-community/
  • What is silymarin (milk thistle), and is it helpful for managing my hepatitis B and D?

      Silymarin, an herb and extract of milk thistle seeds, is a supplement commonly taken by hepatitis patients across the world, yet its proven benefits remain controversial. It is not a treatment for hepatitis B or D, nor has it been shown to have any effect against fighting the viruses. This herb is believed to have possible benefits on liver health due to its antioxidant and free radical fighting properties, although no studies have found a consistent positive effect on viral load or fibrosis scores 1 . Silymarin is often taken by patients or suggested by their health care provider during or after interferon treatment ends, presumably with the hope of a protective or anti-inflammatory effect on the liver. But a 2013 study on hepatitis C patients unsuccessfully treated with interferon (the standard treatment for hepatitis B and D coinfection) found no significant difference in silymarin’s ability to lower ALT scores over placebo, a pill with no active drug ingredients 2 . Another 2013 metanalysis reviewed 8 studies which tested silymarin against a placebo and looked for measurable levels of improvement in ALT scores, of which the results were mixed and inconsistent1. Interestingly, several studies have found improvements in patients’ self-reported patient quality of life after taking silymarin 1 - perhaps due to decreased stress or self-perceived control over their health. However, a 2012 study which randomly assigned patients either silymarin or placebo to measure possible declines in ALT or virus levels, in addition to self-reported quality of life, found little to no improvement in any of these outcomes3 regardless of whether they took milk thistle or a placebo. As mentioned in our previous blog post, the U.S. National Institutes for Health (NIH) has published a directory of what scientific research has discovered about common herbal supplements. Probably the most popular herbal supplement pitched as a liver remedy is milk thistle, and its extract

    http://www.hepb.org/blog/silymarin-milk-thistle-helpful-managing-hepatitis-b-d/
  • What's the Difference: Hepatitis B vs Hepatitis C?

    With five different types of viral hepatitis, it can be difficult to understand the differences between them. Some forms of hepatitis get more attention than others, but it is still important to know how they are transmitted, what they do, and the steps that you can take to protect yourself and your liver! This is part one in a three-part series. What is Hepatitis? Hepatitis means “inflammation of the liver”. A liver can become inflamed for many reasons, such as too much alcohol, physical injury, autoimmune response, or a reaction to bacteria or a virus. The five most common hepatitis viruses are A, B, C, D, and E. Some hepatitis viruses can lead to fibrosis, cirrhosis, liver failure, or even liver cancer. Damage to the liver reduces its ability to function and makes it harder for your body to filter out toxins. Both hepatitis B and C are blood-borne pathogens, which means that their primary mode of transmission is through direct blood-to-blood contact with an infected person. Also, both hepatitis B and C can cause chronic, lifelong infections that can lead to serious liver disease. Hepatitis B is most commonly spread from mother-to-child during birth while hepatitis C is more commonly spread through the use of unclean needles used to inject drugs.   Hepatitis B vs. Hepatitis C Despite having an effective vaccine, hepatitis B is the world’s most common liver infection; over 292 million people around the world are estimated to be living with chronic hepatitis B. While hepatitis C tends to get more attention and research funding, hepatitis B is considerably more common and causes more liver-related cancer and death worldwide than hepatitis C. Combined, chronic hepatitis B and C account for approximately 80% of the world’s liver cancer cases. However, studies show that those with chronic hepatitis B are more likely to die from liver-related complications than those who are infected with hepatitis C. With hepatitis C, most people develop cirrhosis, or

    http://www.hepb.org/blog/whats-the-difference-hepatitis-b-vs-hepatitis-c/
  • Karen and Dave’s Story

    One Couple’s Journey through Hepatitis B, Hepatitis D and Liver Cancer “Dave knew he had hepatitis B for decades, but honestly, no one ever seemed concerned. His liver enzymes were slightly elevated, so the doctor told him to just watch what he ate and drank. He didn’t even insist on bi-yearly blood tests! In 2016, Dave was scheduled for a routine colonoscopy. Because he’d been looking pale and sickly around that time, I suggested they do a blood test first at his family doctor. His numbers were off the chart. They sent us back for the colonoscopy and added an endoscopy too. They found four varices (enlarged veins in the esophagus that can indicate serious liver disease). How did this happen? This was when I started to get angry. The gastroenterologist called us in to discuss the results. He asked if Dave knew he had hepatitis B. Dave said yes, knowing his drug use in his teens and early twenties was likely the source. Dave never felt shame about it at all, and just accepted it as a path he took, and thankfully came out of. After that conversation, the doctor slammed his chart shut and pushed it across the desk. He said that Dave’s liver was so badly damaged that there was nothing he could do and to ‘come back in a year’. When we asked about his options for treatment for the varices and his hepatitis B, he actually told me that no one would treat the varices unless they were bleeding! He also told us that hepatitis B antivirals would “make things worse”. That didn’t make sense. We asked about a transplant. He said there was ‘no way’ anyone would give him a new liver. He didn’t even let us know that there were actual liver clinics for this very purpose. He sent Dave away to die, really. Many months later, with much perseverance, we made it to Stanford, where he was immediately put on entecavir to treat his hepatitis B and to hopefully relieve some of his liver damage. That doctor alerted us that he should also be tested for hepatitis D, a

    http://www.hepb.org/blog/karen-daves-story/
  • What New Treatments Are on the Horizon for Hepatitis B/D Coinfected Patients?

    Although there are highly effective treatments available to manage hepatitis B, there are few available treatments for hepatitis D, and none are U.S. Food and Drug Administration (FDA) approved. Hepatitis D is the most severe form of viral hepatitis, and coinfection can accelerate liver damage and cause cirrhosis or liver cancer in as little as 5 years for some patients. Currently there is no approved drug for acute or chronic hepatitis B/D coinfection, but in trials pegylated interferon alpha has shown to be somewhat effective. By stimulating the body's immune system, around 25-30% of patients are able to suppress their hepatitis D viral load with weekly injections over 48 weeks. Emerging research is showing higher rates of effectiveness with prolonged interferon treatment beyond one year, but it can be difficult for patients to continue due to the physical and mental toll of interferon on the body. Antiviral medications that are proven effective against hepatitis B are sometimes prescribed along with interferon therapy for patients with a high hepatitis B viral load, but these have no effect on hepatitis D. It is urgent that more treatment options be developed for the millions of hepatitis B/D patients that are eagerly awaiting them. The good news is that with renewed scientific interest, research and funding, eight new drugs are currently in development that offer hope for more treatment options in the coming years. Two drugs have even been granted special designations by the FDA and one by European Medicines Agency (EMA), paving the way for increased resources and funding for development. Due to recent advancements, the future looks hopeful, and within a few years it is likely there will be more treatment options available. Below is a chart that provides more information on these new drugs and their current clinical trial status. Pegylated Interferon Lambda Pegylated-interferon-lambda (PEG-IFN-λ) is a well-characterized, late-stage, first in class, type III

    http://www.hepb.org/blog/new-treatments-horizon-hepatitis-bd-coinfected-patients/
  • In the news: Coverage of our programs and people

    The most obscure and bizzare local mascots: From a dancing liver to a walking cheesesteak, get to know our lesser-known mascots. - Philadelphia Inquirer - Feb. 22, 2023 O’Liver B. Hepatitis, a 6-foot-5 human liver with arms, legs, and a toothy grin, may be the mascot of Hannibal Lecter’s dreams, but he works for the Hepatitis B Foundation of Doylestown, raising awareness of the vaccine-preventable virus that causes liver cancer. Born in Philly, O’Liver spent his early years noshing on cheesesteaks and hanging with his other mascot homies before attending mascot school, where he earned the nickname “Big Filter.” Hepatitis B Foundation president responds to Janssen decision on company’s hepatitis B drug development program - Bucks County Herald -Feb. 16, 2023 Hepatitis B Foundation President Chari A. Cohen expressed frustration that Janssen has decided to shut down its program to develop a drug to treat hepatitis B, which is incurable and infects millions in the U.S. and globally. Industry publications have reported that J&J plans to walk away from its hepatitis B and D portfolio and pull out of the hepatitis B space, according to a news release posted on the foundation’s website. Barnabas MD chosen for Hepatitis B Foundation’s 2023 Community Commitment Award - ROI-NJ - Jan. 19, 2023 The Hepatitis B Foundation, a global nonprofit organization based in Doylestown, Pennsylvania, said it recently chose Dr. Su Wang, the medical director of Viral Hepatitis Programs and the Center for Asian Health at Cooperman Barnabas Medical Center in Livingston, to receive the Foundation’s 2023 Community Commitment Award. Wang is a practicing internist who also lives with hepatitis B. She was diagnosed when she donated blood in college.Hepatitis B Foundation’s Dr. Yasmin Ibrahim appointed to national Patient Engagement Collaborative - U.S. Food and Drug Administration - Jan. 13, 2023 The U.S. Food and Drug Administration and the Clinical Trials Transformation Initiative have announced eight newly selected representatives for the Patient Engagement Collaborative, including Yasmin Ibrahim, MD, PhD, MBA, of the Hepatitis B Foundation. According to the CTTI, “The group of 16 patients, caregivers, and patient group representatives will meet with the FDA several times a year to discuss topics such as communication, transparency, and the best ways for patients to engage the FDA about medical product regulation.” Hepatitis B Foundation names Baruch S. Blumberg Prize winner - Healio.com - Nov. 19, 2022 The Hepatitis B Foundation has awarded Stephen Urban, PhD, the 2023 Baruch S. Blumberg Prize for his development of bulevirtide, the first drug approved for the treatment of hepatitis D. “The entire hepatitis B/D community owes a tremendous debt to Dr. Urban for his conception, design and creation of new therapeutics for hepatitis B and D, as well as for his pioneering work on basic science advances toward understanding HBV and HDV virology,” Chari Cohen, DrPH, MPH, president of the Hepatitis B Foundation, said. Hepatitis B Foundation Awarded Community Project Funding Grant - Doylestown Patch - Oct. 22, 2022 Bucks County Congressman Brian Fitzpatrick (PA-01) presented the Hepatitis B Foundation with a $475,000 Community Project Funding grant for its Center of Public Health Excellence. The funding will allow the Foundation to provide expert resources, training, and technical assistance on how to prevent, treat, and control Hepatitis B to state and local health departments, social service organizations, and community health providers. Philadelphia joins fight against hepatitis - HepMag.com - Sept. 26, 2022 Catherine Freeland, associate director of public health research at the Pennsylvania-based Hepatitis B Foundation, thinks universal testing for hepatitis would be a “huge win” in the fight against hepatitis but admits that it’s unclear how such a policy might be implemented. The city of Philadelphia, meanwhile, is hoping for more funding to help it do its part in eliminating viral hepatitis. In Philly’s push to eliminate hepatitis, a ‘silent infection,’ how many have it remains a big unknown - Philadelphia Inquirer - Sept. 25, 2022 A national push to eliminate two types of hepatitis is hindered by too little information about who's infected. Universal testing would avoid the complications of both obstacles and would be “a huge win,” said Catherine Freeland, associate director of public health research at the Hepatitis B Foundation, a Pennsylvania-based nonprofit promoting testing and treatment of the virus. Still, she said, it’s unclear how soon the recommendation could take effect.  Language barriers, bias, and cultural differences hinder access to health care for Asian Philadelphians – Philadelphia Inquirer - Sept. 21, 2022 A lack of health care services for Asian Americans in Philadelphia contributes to poor screening for serious illnesses like Hepatitis B. The virus is not well-known to most primary care physicians, said Catherine Freeland, associate director of public health research at the Hepatitis B Foundation. “Providers frequently misinterpret test results,” she said. “If you talk to someone in medical school, they don’t spend a lot of time on hep B.” The "love story" behind a local institution (p.35) - Central Bucks Business & Arts Journal - Spring 2021 During the late Eighties, Joan was a nurse at a Philadelphia hospital and Tim was a professor at Jefferson University, researching the herpes simplex virus. Then, unexpectedly, a routine health exam determined that Joan was positive for hepatitis B. “When I was diagnosed with chronic hepatitis B, instead of panicking, he changed his whole focus of research to search for a cure for hepatitis B,” Joan recalls. Allow People With HIV and Hepatitis B to Enlist in the Military, Urge Lawmakers - HepMag.com - Sept. 12, 2022Congress members write to Biden, pushing for the Department of Defense to allow people with HIV and hepatitis B to enlist in the military.  Buckingham man's liver cancer inspires new research lab - Bucks County Courier Times - Aug. 21, 2022On Aug. 8, 2022, the Steven W. Miller Laboratory dedication ceremony was held at the institute at the Pennsylvania Biotechnology Center in Buckingham. Friends, colleagues and family came to see the unveiling of the plaque outside of the lab to honor Steve.  Generic subscription services like Mark Cuban’s promise cheaper drugs — but will it work? - PharmaVoice - Aug. 4, 2022The rising price of drugs and the complexity of the healthcare system have brought about the advent of online subscription generic drug services offering to cut out the middlemen. Now it’s time to see whether that’s economically viable. World Hepatitis Day 2022 - CDC Global Immunization - July 27, 2022CDC, in collaboration with the Nigerian Primary Health Care Development Agency, the African Field Epidemiology Network, and the Hepatitis B Foundation, is working with 40 healthcare facilities in Nigeria to train healthcare workers and community volunteers, with the goal of improving coverage of the hepatitis B birth dose (HepB-BD) and the additional 3-dose series (HepB3). Destigmatizing hepatitis B - Nature - April 1, 2022"...people with hepatitis B are barred from deployment in the US military. This puts their careers at risk, says Catherine Freeland, director of the public-health programme at the Hepatitis B Foundation, a patient-advocacy charity based in Doylestown, Pennsylvania. “That’s a significant consequence that’s unnecessary, and it’s not based on current updated medical guidelines,” Freeland adds. Some $6.6M is coming to Bucks from Washington. Bucks County Courier Times - March 21, 2022Hepatitis B Foundation’s Center of Public Health Excellence... will allow the Hepatitis B Foundation to provide expert resources, training, and technical assistance on how to prevent, treat, and control hepatitis B to state and local health departments, social service organizations, and community health providers, according to Fitzpatrick's office. Fred Beans awards $250K in EITC funds to orgs in Bucks Co. and beyond - The Reporter - March 2, 2022A repeat beneficiary, the Hepatitis B Foundation, directs the funding from Beans to its High School Science Enrichment Program, which provides unique hands-on learning opportunities for Bucks County high school students in the Foundation’s labs at the Pennsylvania Biotechnology Center. And Then There Were 4: VBI Scores FDA Approval with Hepatitis B Vaccine – Genetic Engineering & Biotechnology News - Dec. 6, 2021Approval of PreHevbrio came nearly a month after the U.S. Centers for Disease Control (CDC)’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended universal HBV vaccination for all U.S. adults aged 18-59 and for adults age 60+ with risk factors for infection. “As we work to implement the ACIP’s new universal hepatitis B vaccine recommendation for all adults ages 19 to 59, as voted on in November, we benefit from having more tools, including this newly approved three-antigen hepatitis B vaccine,” said Chari Cohen, DrPH, MPH, the senior vice president of the Hepatitis B Foundation.

    https://www.hepb.org/news-and-events/in-the-news-coverage-of-our-programs-and-people/
  • Journal articles recommended by our Emerging Scholars Scientific and Medical Advisors

    Each month, one of our emerging scholars in the field of hepatitis B basic and clinical research recommends one or two current scholarly article(s) in the field. PICK OF THE MONTH - June 2023 For June, our presenting emerging scholar is Tung-Hung Su, MD, PHD. A multicenter randomized-controlled trial of nucleos(t)ide analogue cessation in HBeAg-negative chronic hepatitis B Bömmel  F, Stein  K, Heyne  R, Petersen  J, Buggisch P, Berg C, Zeuzem S, Stallmach A, Sprinzl M, Schott E, Pathil-Warth A, Arnim U, Keitel V, Lohmeyer J, Simon KG, Trautwein C, Trein A, Hüppe D, Cornberg M, Lammert F, Ingiliz P, Zachoval R, Hinrichsen H, Zipprich A, Klinker H, Schulze Zur Wiesch J, Schmiedeknecht A, Brosteanu O, Berg T. DOI: 10.1016/j.jhep.2022.12.018. PMID: 37062574 [website link] The article discusses the STOP-NUC that aimed to assess the possibility of achieving a functional cure for chronic hepatitis B by discontinuing long-term nucleos(t)ide analogues (NUCs) treatment. NUCs are the standard treatment for chronic hepatitis B, but they rarely result in a functional cure, defined as the loss of hepatitis B surface antigen (HBsAg). The trial involved 166 HBeAg-negative patients without advanced fibrosis who had been on continuous NUC treatment for at least four years at baseline. The patients were randomized into two groups: stopped NUC treatment (Arm A) while the other continued treatment (Arm B) for a 96-week observation period. The results showed that the group that discontinued NUC treatment (Arm A) had a significantly higher rate of HBsAg loss (10.1%) compared to the group that continued treatment (0% in Arm B). Patients with baseline HBsAg levels below 1,000 IU/ml had a greater chance of HBsAg loss. No serious adverse events related to treatment cessation were reported. The results of the STOP-NUC trial provide evidence supporting the concept of stopping NUC treatment as a potential therapeutic option to induce functional cure in certain patients with chronic hepatitis B. However, adopting the stopping NUC strategy should have a close monitoring schedule and protocol for retreatment in case of a severe flare. Further investigation into other ethnicities should be conducted. PICK OF THE MONTH - April 2023 For April, our presenting emerging scholar is Julie Lucifora, PhD, HDR. She has selected two articles.  A 3-Year Course Of Bulevirtide Monotherapy May Cure Hdv Infection In Cirrhotics  Anolli MP, Degasperi E, Allweiss L, Sangiovanni A, Maggioni M, Scholtes C, Oberhardt V, Neumann-Haefelin C, Dandri M, Zoulim F, Lampertico P. J Hepatol. A 3-Year Course Of Bulevirtide Monotherapy May Cure Hdv Infection In Cirrhotics. 2023 Jan 3:S0168-8278(22)03475-4. doi: 10.1016/j.jhep.2022.12.023. Online ahead of print. PMID: 36931396 [website link] Chronic Hepatitis Delta (CHD) leads to the most severe form of viral hepatitis and until recently patients had very limited therapeutic options. Bulevertide is the first specific drug against hepatitis delta virus (HDV) that was conditionally approved for the treatment of CHD in 2020 in Europe. It was designed to block HDV entry and thereby propagation within the liver of infected patients. In this case report, the authors described the first case of CHD cure in a patient with severe clinical conditions, including compensated cirrhosis and portal hypertension, receiving Bulevertide monotherapy. HDV viral load declined rapidly and became negative 28 weeks after beginning of the treatment. After 3 years, the treatment was stopped and HDV viral load remained undetectable for at least 72 weeks. All markers of liver function were normalized during or after treatment. This article raises hopes for patients with CHD. Improved hepatitis delta virus genome characterization by single molecule full-length genome sequencing combined with VIRiONT pipeline Charre C, Regue H, Dény P, Josset L, Chemin I, Zoulim F, Scholtes C. Improved hepatitis delta virus genome characterization by single molecule full-length genome sequencing combined with VIRiONT pipeline. J Med Virol. 2023 Mar;95(3):e28634. doi: 10.1002/jmv.28634. PMID: 36879535 [website link] Hepatitis Delta Virus (HDV) is a small virus with a high genetic variability. Differences in HDV genome sequences may lead to differences in replication, propagation, pathogenesis and response to treatment. It is therefore very important to be able to properly assess HDV genome sequences variations in patients. So far, this was not routinely performed because sequencing approaches available were challenged by the features of the HDV genome. In this article, the authors developed a workflow to amplify, sequence, and analyze the whole HDV genome in a single fragment from patient’s sera. They made available online for free the bioinformatic tools necessary to analyze data. This new approach, that can be implemented in medical centers, will help to better characterize circulating HDV genomes among the population and allow correlation with disease outcome and response to treatments. PICK OF THE MONTH - March 2023 For March, our presenting emerging scholar is Angel Yen-Chun Liu, MD.   Wen-Juei Jeng, George V Papatheodoridis, Anna S F Lok. Hepatitis B. Lancet 2023 Feb 9; S0140-6736(22)01468-4. doi: 10.1016/S0140-6736(22)01468-4. https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(22)01468-4.pdf Impact: The article generally and intact summarize the epidemiology, virology, pathophysiology, prevention, diagnosis, natural history, management as well as new therapies in development of hepatitis B. It can provide the effective information to understand the hepatitis B infection, especially from informative and exquisite figures. PICKS OF THE MONTH - January 2023 For January our presenting emerging scholars are Julie Dang, PhD, MPH and Mohsin Khan, MSc, PhD. Julie Dang, PhD, MPH Pham TN, Le DH, Dao DV, Phan LT, Pham TT, Nguyen TB, Mize GW, Gish RG, Lee WM, Trang A, Le AN. Establishing baseline framework for hepatitis B virus micro-elimination in Ho Chi Minh City, Vietnam–A community-based seroprevalence study. The Lancet Regional Health-Western Pacific. 2023 Jan 1;30:100620. https://www.thelancet.com/journals/lanwpc/article/PIIS2666-6065(22)00235-8/fulltext Impact: This is the first population-based community HBV study to estimate the prevalence of HBV statuses in Vietnam. Use of three sero-marker screening for HBV enabled researchers to distinguish among those who were: HBV susceptible population (negative all three seromarkers), chronic carriers (HBsAg(+)), HBV exposure with immune control (anti-HBc total (+), with or without anti-HBs), and HBV vaccination (anti-HBs(+) without HBsAg). Researchers also found wide variations in HBsAg (+) and HBV vaccination rates between districts, risk factors, and socio-economic statuses. This study demonstrated the feasibility of conducting a large-scale comprehensive HBV screening and access to care program in an HBV endemic country that involved collaboration among diverse stakeholders including government, health care institutions, community organizations, and private sector.   Mohsin Khan, MSc, PhD Chu JYK, Chuang YC, Tsai KN, et al. Autophagic membranes participate in hepatitis B virus nucleocapsid assembly, precore and core protein trafficking, and viral release. Proc Natl Acad Sci U S A. 2022;119(30):e2201927119. https://www.pnas.org/doi/10.1073/pnas.2201927119 It is widely known that Hepatitis B virus (HBV) replication is regulated by autophagy. This investigation, led by Prof. Jing-hsiung James Ou at UCLA, has precisely examined and characterized how autophagic membranes participate in the HBV life cycle. Autophagy is a process in which the cells eliminate their organelles and macromolecules. Under normal circumstances, autophagy ensures homeostasis and proper recycling of cellular biomaterials. However, the signaling events of autophagy are often altered during stress, inflammation, and infection. Interestingly many pathogens, especially viruses, have evolved with successful strategies to hijack this cellular process to support their replication. HBV is one among those viruses that are successful invaders and play with autophagic machinery efficiently. Autophagy, at the cellular level, starts with the formation of isolation membranes that are called phagophores (PP). PP are crescent structures that subsequently expand to form complete double-membrane vesicles called autophagosomes (APS). The APS can fuse with either lysosome or MVBs (multivesicular bodies) to form autolysosomes or amphisomes respectively. In this investigation, it was observed that the PP and APS, purified from the cells that contained replicating HBV, are highly enriched with core particles. These PP- and APS-associated core particles contain hypo-phosphorylated core protein. The PP-associated core particles have mostly double-stranded HBV DNA, while APS-associated core particles are rich in both, single- and double-stranded DNA. With some additional experiments, it was further confirmed that APS-associated core particles are nucleocapsids that contain viral pgRNA (progenome RNA) and/or DNA. It was also observed that the association of HBV core with PP and APS is independent of pre-core protein. Interestingly, the ectopically expressed core protein did not localize to APS. These observations suggest that the cellular trafficking of individually expressed core protein does not entirely mimic the trafficking of core protein originating from active HBV replication. Possibly, the packaging of pgRNA is a cooperative event that is required for the association of core to APS. Additionally, it was noted that HBV could induce the formation of amphisome, and disruption of this event suppresses HBV release from the cells. It signifies that although HBV induces autophagy via PP and APS formation, it does not promote autolysosome formation. In other words, HBV induces only early events of autophagy and utilizes PP and APS for packaging and replication purposes. However, it directs a major pool of APS towards amphisome formation and does not promote the degradative stage of autophagy to ensure the successful release of mature HBV. In summary, this report provided detailed information about the intracellular trafficking of HBV proteins and the relation between autophagy and HBV replication. This will be very helpful for the development of novel anti-HBV drugs that target the autophagic pathway. PICK OF THE MONTH - December 2022 For December, our presenting emerging scholar is Peter Block, MD, MSc.  Yuen M-F, Lim S-G, Plesniak R, et al. Efficacy and safety of bepirovirsen in chronic hepatitis B infection. N Engl J Med 2022; 387:1957-68. https://pubmed.ncbi.nlm.nih.gov/36346079/ The search for an HBV cure has been an area of active investigation for decades. While the backbone of our current treatment – nucleotide/nucleoside analogues (NAs) – can suppress the virus, they rarely eradicate it. The scientific community has therefore sought to develop novel therapeutics with curative effects. The article highlighted here describes the clinical efficacy of bepirovirsen, a new antiviral agent that may bring us closer to this goal. Bepirovirsen is an antisense RNA-based drug delivered that impairs HBV replication by targeting viral messenger RNA in the infected hepatocyte.  This study evaluated its antiviral activity through a phase 2b clinical trial in patients with CHB either receiving (or not receiving) NA therapy. Study participants were randomized into different treatment arms, where they received varying durations of therapy with bepirovirsen and then were followed for 24 weeks after completion of treatment. The major takeaway is that a significant minority of study participants treated with bepirovirsen achieved a functional cure from CHB, defined by the sustained clearance of both HBV DNA and HBV surface antigen (HBsAg). While this primary endpoint was achieved in only 6% of the total study population, rates of response were higher in certain subgroups. Specifically, upwards of 16-25% of patients with low pre-treatment levels of HBsAg attained clearance of both HBV and HBsAg after receiving bepirovirsen. These rates of functional cure are much higher than what is typically seen in those receiving conventional monotherapy with NAs. Overall, the study reports promising clinical data on an emerging treatment option for chronic hepatitis B. Future studies on bepirovirsen will be monitored closely by the HBV community, as such studies should clarify the durability of bepirovirsen’s antiviral activity, safety profile, and long-term outcomes. PICKS OF THE MONTH - November 2022 For November, our presenting emerging scholar is Lena Allweiss, PhD.  She has selected two articles.  Smc5/6 silences episomal transcription by a three-step function. Abdul F, Diman A, Baechler B, Ramakrishnan D, Kornyeyev D, Beran RK, Fletcher SP, Strubin M. Nat Struct Mol Biol. 2022 Sep;29(9):922-931. doi: 10.1038/s41594-022-00829-0 https://pubmed.ncbi.nlm.nih.gov/36097294/ The chromosomal maintenance complex SMC5/6 is a restriction factor against HBV because it blocks transcription from its episomal viral genome. For an active infection to be established, HBV relies on its regulatory protein HBx to specifically degrade this complex and relieve its transcriptional suppression. This publication describes the mechanism by which SMC5/6 silences viral transcription from the HBV genome - a mechanism that might hold true for the restriction of other DNA virus such as HIV and HPV. Elucidating this process will not only generate basic knowledge about the interaction of viruses with their hosts but might also assist with the design of antiviral drugs targeting HBx. Conversion of hepatitis B virus relaxed circular to covalently closed circular DNA is supported in murine cells. Wei L, Cafiero TR, Tseng A, Gertje HP, Berneshawi A, Crossland NA, Ploss A. JHEP Rep. 2022 Jul 9;4(9):100534. doi: 10.1016/j.jhepr.2022.100534. https://pubmed.ncbi.nlm.nih.gov/36035363/ Mice are often used to study viral infections and test novel antiviral treatments. In the case of HBV, however, mice cannot simply be used for these purposes since HBV does not naturally infect mice. Scientists are currently trying to develop a genetically modified mouse model that is engineered to express missing factors or eliminate inhibitory factors necessary to establish an HBV infection in these mice. In this publication, the authors show that a crucial step in HBV infection, the conversion of incoming viral relaxed circular DNA to covalently closed circular DNA, does take place in mouse hepatocytes, thus ruling out this step as a potential block for infection establishment. This knowledge is important because it will help create such a mouse model for HBV research, a model in which this step does not need to be modified.  

    https://www.hepb.org/news-and-events/reports/journal-articles-recommended-by-emerging-scholars/
  • Advocacy Efforts for People with Hepatitis B

    Our Advocacy Efforts Imagine not being able to pursue a lifelong dream of becoming a healthcare professional because of a chronic hepatitis B infection. For most people, hepatitis B related discrimination is seen as a problem outside the U.S. The HBF, however, spent years helping individuals either denied admission to medical/dental/nursing schools, or threatened with dismissal from their training programs because of a chronic hepatitis B diagnosis. This personal story describes the experience of one of the people that we helped. In 2011 HBF mobilized support from national leaders and the Centers for Disease Control and Prevention (CDC) to address the growing problem. The CDC responded and published updated Recommendations for Hepatitis B Infected Healthcare Providers and Students (July 2012), which clearly state that hepatitis B is not a reason to deny or dismiss a person from studying or practicing a healthcare profession. These new CDC recommendations became the cornerstone of the landmark hepatitis B settlement by the U.S. Department of Justice in 2013, which successfully made hepatitis B a protected condition under the Americans with Disabilities Act (ADA). Following this ruling, a federal letter prohibiting hepatitis B discrimination was sent to ALL health related schools in the U.S. regarding the illegality of hepatitis B discrimination.  In recognition of the HBF’s key role in addressing hepatitis B-related discrimination, HBF executive director and co-founder Ms. Joan Block was honored by the White House for her advocacy success and the resulting protection now provided by the ADA for individuals living with chronic hepatitis B infection in the United States. You can join our current grassroots advocacy here with Hep B United.      National Advocacy Highlights HBF helped organize the first joint Hepatitis on the Hill visits to members of Congress in March 2015, which was held again in March 2016. This event brings together more than100 hepatitis advocates to Washington, DC, where patients and family members can share their stories to put a human face on the devastating impact of hepatitis B and C. The primary goal of these Hill visits is to urge our elected officials to increase federal funding to provide better services for those affected and to find a cure for hepatitis B. The WHO designated July 28 as World Hepatitis Day, which is the birth date of Dr. Baruch S. Blumberg. Dr. Blumberg is a Co-Founder of the HBF and Nobel Prize winner for his discovery of the hepatitis B virus. In 2015, a White House Briefing was held to commemorate this day where national leaders, including HBF executive director and co-founder Joan Block, were honored for advancing the goals of the U.S. National Viral Hepatitis Action Plan. HBF leaders - Dr. Robert Gish, HBF medical director, and Dr. Chari Cohen, HBF director of Public Health –  provided expert testimony for A National Strategy for the Elimination of Hepatitis B and C in the United States, being prepared by the National Academies of Sciences, Engineering and Medicine (formerly known as the ‘Institute of Medicine’). This is a two-part report scheduled for release in 2016 and 2017.   

    https://www.hepb.org/research-and-programs/advocacy/
  • HBF Reports and Publications

    The Hepatitis B Foundation and Blumberg Institute have produced the following reports and manuscripts toward the elimination of hepatitis B and related scientific advances. The Foundation's annual reports are posted here. Journal articles recommended by our Emerging Scholars Scientific and Medical Advisory Board, which is a new service, are posted here. Below are published manuscripts aimed at supporting the elimination of hepatitis B. Health-related quality of life for adults living with hepatitis B in the U.S.: a qualitative study, Journal of Patient-Reported Outcomes (2021) Research led by the Hepatitis B Foundation adds important information about the quality of life impact of living with chronic hepatitis B. The team conducted in-depth interviews with a sample of 19 individuals living with chronic hepatitis B. The study found that the psychological impact of chronic hepatitis B on study participants’ quality of life was considerable and contributed to depression, anxiety, homelessness, drug use and incarceration. The study results support the hypothesis that chronic hepatitis B impacts quality of life and often negatively affects emotional health. Findings suggest it would be beneficial to include quality of life assessment in the medical management of hepatitis B, to improve quality of life for those living with hepatitis B. Cure Everyone and Vaccinate the Rest: The Patient Perspective on Future Hepatitis B Treatment, Journal of Viral Hepatitis (2021) While many journal articles have been written about hepatitis B, it's uncommon for one to be so focused on the people living with hepatitis B. Through qualitative interviews, this team of Hepatitis B Foundation researchers explored treatment preferences for those living with chronic hepatitis B. Many expressed a desire for drug therapies to not cause side effects that make them sick, for instance. Overall patients preferred treatment options that were user-friendly and didn’t require visiting infusion centers. Cost and access to treatment was also a huge concern. Many individuals reported that they would try any potential functional cure that didn’t make them sick and was affordable and accessible. The patient interviews provide valuable data about the quality of life of patients and how a functional cure will be transformative for them. The importance of understanding treatment preferences of people living with hepatitis B is stressed as new therapies are being developed.  An Updated Assessment of Chronic Hepatitis B Prevalence Among Foreign-Born Persons Living in the United States, Hepatology (2021) Previous research has shown that there are about 0.42 million U.S. born individuals that have chronic hepatitis B. Unfortunately, though, there has not been a comprehensive analysis of the prevalence of chronic hepatitis B in foreign born individuals. The researchers in this study gathered articles published ranging from 2009-2019 that reported the prevalence of chronic hepatitis B in emigrants and in-country populations of 117 countries.  Hepatitis B Virus Elimination in the U.S.: Time to Dismantle Barriers and Implement Solutions, Current Hepatology Reports (2021) The World Health Organization has challenged the health care and public health professionals to work toward eliminating hepatitis B virus (HBV) infection as a threat by 2030, but the U.S. currently has fallen behind. This is due to various barriers, including the bureaucratic isolation of health care and public health services. The U.S. is failing to improve HBV screening and expand adult vaccination, so acute cases are increasing. Simple policy and guideline changes are recommended to allow the nation to decentralize and scale-up screening, vaccination and patient care. Needs of Individuals Living With Hepatitis Delta Virus and Their Caregivers (2016-2019) Hepatitis delta virus (HDV) is a serious coinfection of the hepatitis B virus (HBV) that is estimated to affect between 48 to 72 million people worldwide. Data are limited on the informational needs of people living with HDV. Health Insurance Costs Impacting Shoppers Living with Hepatitis B (2020) This report is a resource to help people living with hepatitis B make informed decisions when choosing a health insurance plan. It can also be shared with policymakers to inform them of potentially discriminatory benefit plan designs in various states. The Role of the Pharmacist in Preventing Hepatitis B in the Context of the Opioid Crisis, Preventing Chronic Diseases (2020) The purpose of this document is to inform individuals that Hepatitis B is transmitted through infected blood and body fluids, and common routes of transmission include unprotected sexual contact, perinatal transmission, and injection drug use for example the Opioid Crisis.  Profiling the circulating mRNA transcriptome in human liver disease, Oncotarget (2020) This report profiles the human circulating mRNA transcriptome in people with liver cirrhosis (LC) and hepatocellular carcinoma (HCC) to determine whether mRNA analytes can be used as biomarkers of liver disease. Protein phosphatase 1 catalyzes HBV core protein dephosphorylation and is co-packaged with viral pregenomic RNA into nucleocapsids, PLOS Pathogens (2020)The purpose of this document is to identify RNA packaging into nucleocapsids sheds new light on the molecular mechanism of HBV replication and development of therapeutics to cure chronic HBV infection Protecting the Rights of Health Care Students Living With Hepatitis B Under the Americans With Disabilities Act, Public Health Reports (2020)The purpose of this document is to identify the issues of Living with HBV infection can mean living with stigma and discrimination. Opportunities for Federal-Community Collaboration to Reduce Disparities in Hepatitis B: 2014-2016, Hep B United (2020) The purpose of this document is to identify areas where Hep B United and other community-based coalitions can work with federal agencies and within their local coalition to further the priority areas identified in the U.S. Department of Health and Human Services. The Impact of Nail Salon Industry Policies and Regulations on Hepatitis B Awareness and Prevention, Hepatitis B Foundation (2019)This report reviews results of an analysis of the nail salon occupational environment and culture, and identifies opportunities for state-level policy or regulatory interventions and community-based strategies to increase education, screening, prevention, and treatment for hepatitis B. Roadmap for a Cure, Hepatitis B Foundation (2017) This report provides an overview of our research agenda, with information on priority research areas and potential funding. Research Priorities for the Discovery of a Cure for Chronic Hepatitis B: Report of a Workshop, Science Direct (2017)This publication summarizes the opinions of 30 experts in the fields of hepatitis B and liver cancer research convened by the Hepatitis B Foundation to identify projects they deemed important to the goal of finding a cure for chronic hepatitis B and D and the diseases with which these viral infections are associated. Hepatitis B Foundation and FDA Meeting Report, Hepatitis B Foundation (2017)Representatives from the Hepatitis B Foundation and HBV Forum met with representatives from the US FDA in March 2017 to discuss clinical development of hepatitis B therapeutics.     

    https://www.hepb.org/news-and-events/reports/
  • CDC National Progress Report on Hepatitis Elimination Reveals Rise in Acute HBV Infections and Low Birth Dose Vaccination Rates in the U.S.

    DOYLESTOWN, PA (October 27, 2017): Today, the Centers for Disease Control and Prevention (CDC) released their national progress report on viral hepatitis elimination in the United States, which measures progress towards achieving 2020 goals. The report reveals ongoing challenges, underscoring the importance of increasing focus on federal hepatitis B virus (HBV) research and funding, according to leaders at the Hepatitis B Foundation, the nation’s leading nonprofit research and disease advocacy organization. The CDC report reveals continuing challenges in addressing the public health threat of hepatitis B, with new increases in rates of acute hepatitis B infection among adults, particularly those between the ages of 30 and 59 years. The recent spike in acute HBV infections is attributed to increases in injection drug use related to the ongoing opioid crisis. Additionally, the report shows little progress made in the percentage of newborns who receive the hepatitis B vaccine within 3 days of birth at 74.5%, well below the 2020 goal of 85 percent. The low rates of HBV birth dose rates across the country means babies are particularly vulnerable to chronic HBV infection, slowing the nation’s progress towards elimination of perinatal hepatitis B transmission. In the U.S., it is estimated that about 1,200 infants become infected with hepatitis B at birth. “Hepatitis B clearly remains a serious public health problem in the U.S. We must improve our efforts and strategies to increase HBV vaccination coverage among both adults and infants,” said Chari Cohen, DrPH, MPH, vice president for public health and programs at the Hepatitis B Foundation and Hep B United coalition co-chair. “More importantly, in order to make real progress towards achieving our goals to eliminate hepatitis B, we must collect data and measure the rates of chronic HBV infection, which affects the majority of individuals in the U.S. Without national surveillance of chronic HBV infection, we are not measuring our progress in screening, linkage to care, and treatment.” The report also showed a decrease in HBV-related deaths in 2015 at 0.45 per 100,000, revealing large disparities among men and Asian Americans and Pacific Islanders who experience more than 3 times higher the rate of HBV-related deaths. The full report can be found at: https://www.cdc.gov/hepatitis/DVH2017NationalProgressReport.htm. About the Hepatitis B Foundation: The Hepatitis B Foundation is the nation’s leading nonprofit organization solely dedicated to finding a cure for hepatitis B and improving the quality of life for those affected worldwide through research, education and patient advocacy. To learn more, go to www.hepb.org, read our blog at hepb.org/blog, follow us on Twitter @HepBFoundation, find us on Facebook at facebook.com/hepbfoundation or call 215-489-4900. # # #  

    https://www.hepb.org/news-and-events/news-2/cdc-national-progress-report-on-hepatitis-elimination-reveals-rise-in-acute-hbv-infections-and-low-birth-dose-vaccination-rates-in-the-u-s/