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  • Major successes on Capitol Hill

    Aug. 26, 2021 – A key aspect of the Hepatitis B Foundation’s efforts to eradicating hepatitis B is advocacy, particularly trying to educate and influence members of the U.S. Congress and their staffs. Our work this year with the House Appropriations Committee resulted in major wins in terms of policy and funding priorities at several federal agencies. That includes Foundation initiative to obtain Congressional funding to create a Center of Public Health Excellence targeted at finding better treatments and ultimately the elimination if hepatitis B. Funding for the Center depends on final approval of the FY 2022 spending bills later this year. If it’s funded, the Center would be a huge win in the fight against hepatitis B. It would centralize hepatitis B elimination efforts and provide expert resources, advice, training, capacity building and technical assistance for state and local health departments, social service organizations and community health providers on how to best prevent, treat and control hepatitis B to increase the rate of adult vaccination for hepatitis B. While we wait for final word to celebrate the Center’s creation, please note the following successes that are already final and making an immediate difference.  Language included in the House Appropriations Bill that was recommended by the Foundation includes: NIH will issue new targeted calls for research to cure hepatitis B. The National Cancer Institute will support research needed to develop a liver cancer screening test using the blood and saliva samples from widespread COVID testing. The National Center for Advancing Translational Science (NCATS) will explore ways to increase success through collaboration with business incubators, using the example of the Pennsylvania Biotech Center. CDC will have an increased $5 million in funding for its Division of Viral Hepatitis at the CDC, was encouraged to continue investing in hepatitis B grants for community-based organizations and has been asked to develop a plan to increase the rate of adult hepatitis B vaccination. The HHS Office of the Secretary was urged to make sure they are not discriminating against employees with hepatitis B and encouraged to implement strategies aimed at reversing the rates of viral hepatitis.  To learn more about this amazing progress, please click here to read the entire Report from Washington. Together we can eliminate hepatitis B.

    https://www.hepb.org/news-and-events/news-2/major-successes-on-capitol-hill/
  • Hepatitis B Foundation releases report on first-ever Externally Led Patient-Focused Drug Development meeting for hepatitis B

    Doylestown, Pa., Oct. 27, 2020 – In cooperation with the U.S. Food and Drug Administration (FDA), the Hepatitis B Foundation hosted an Externally Led Patient-Focused Drug Development (PFDD) meeting focused on hepatitis B in June. Today, the Foundation released its comprehensive report on the information-gathering event. The Foundation has posted the 55-page report, along with a complete transcript of the meeting, the more than 300 email comments that were submitted and a link to the official video recording on its website. The FDA has reviewed and posted the report on its External Resources and Information Related to Patients’ Experience page. The Foundation was given approval by the FDA to organize and conduct this meeting, which was an online-only event due to COVID-19, making it the first PFDD to be conducted exclusively as a webcast since the agency began holding PFDD meetings in 2012. Held on June 9, the four-hour meeting allowed health care providers, FDA officials and drug developers to hear directly from patients and family members, specifically regarding their experiences living with chronic hepatitis B, to better inform these and other key stakeholders about the patient perspective. By incorporating personal anecdotes and firsthand experiences, the FDA can enhance its decision-making in terms of drug development and clinical trial design with relation to hepatitis B. The PFDD meeting focused on two formal topics: 1) living with chronic hepatitis B: symptoms and disease impacts, and 2) perspectives on current and future approaches to treatment. A panel of four individuals for each topic shared their opinions and experiences to begin the dialogue. An FDA facilitator led each discussion. Audience members who were viewing the webcast also were able to participate in the discussion by sending in comments on the Foundation website or by calling in. Additionally, participants online who are living with hepatitis B, or family members of someone living with HBV, were encouraged to participate in live polling with a series of questions and to submit comments and their own questions. More than 650 people joined the online PFDD meeting from around the globe. Chari Cohen, DrPH, MPH, who is the foundation’s senior vice president, organized the meeting. “Overall, the discussion documented the significant physical and emotional impact for people living with hepatitis B, which leads to reduced quality of life and affects family and social relationships, as well as education and careers for many people,” Dr. Cohen said. “We heard directly from the people who joined us about their experiences with fatigue, shame and isolation, stigma and discrimination, and their fear of dying prematurely from liver cancer.” Participants discussed major challenges with current treatment including finding a knowledgeable clinician to manage their hepatitis B, cost of medication, and the burden of taking a daily pill for many years.  PFDD participants stressed a strong desire for future treatments that will result in loss of hepatitis B surface antigen (HBsAg, the blood marker of infection) and reduced risk of liver cancer over a finite treatment period. There was strong interest in participating in future clinical trials that might lead to a functional cure, as long as trials would not be too disruptive of daily lives and participants would receive adequate safety information on experimental treatments. In addition to conducting the PFDD meeting, the Foundation collected patient experiences through an online survey and in-depth phone interviews. More than 2,100 people from 102 countries responded to the survey, and 24 people participated in the phone interviews. Results coincide what the Foundation team learned from the PFDD meeting and also highlighted the different experiences and challenges faced by people living in other countries. For example, outside the U.S., more people documented experiencing stigma and discrimination, and had difficulty finding affordable care and treatment for their hepatitis B. Along with prominently posting the complete report from the June 9 PFDD on www.hepb.org, the Hepatitis B Foundation will be announcing its availability through its newsletters and social media plus professional publications and meetings. All of the experiences collected from the PFDD meeting, the survey and the interviews will be used by the Foundation to help advocate for the needs of people living with hepatitis B, and ensure that drug and clinical trial development take the needs and concerns of patients into account. # # #

    https://www.hepb.org/news-and-events/news-2/hepatitis-b-foundation-releases-report-on-first-ever-externally-led-patient-focused-drug-development-meeting-for-hepatitis-b/
  • HBV Journal Review - January 2014

    HBF is pleased to connect our blog readers to Christine Kukka’s monthly HBV Journal Review that she writes for the HBV Advocate. The journal presents the
 latest in hepatitis B research, treatment, and prevention from recent academic and medical journals. This month, the following topics are explored: Amniocentesis Increases Risk of Hepatitis B Infection in Infants Tenofovir Alone Effective in Treating Adefovir-Resistant Hepatitis B Another Study Confirms Increased Pancreatic Cancer Risk in People with Hepatitis B Studies Uncover the Strengths and Weaknesses of the Antiviral Entecavir Antiviral Telbivudine Appears to Protect Kidney Health Experimental Treatment Would Help Immune System Attack HBV Infection Study Shows Antiviral Treatment Helps Liver Function Is There a New Normal for Healthy ALT Levels? Obesity May Decrease Hepatitis B Vaccine Effectiveness, But Old Age Does Not High Rates of Coinfections Underscore Need for Coordinated Care More Evidence: Lamivudine Should Not Be Used in Pregnant Women  HBV Journal Review January 1, 2014 Vol 11, no 1 by Christine M. Kukka Amniocentesis Increases Risk of Hepatitis B Infection in Infants 
Chinese researchers compared the rates of hepatitis B virus (HBV) infection in infants born to HBV-infected women who underwent amniocentesis to women who did not and found that the procedure increased HBV infection in infants. Amniocentesis is the sampling of amniotic fluid using a hollow needle inserted into the uterus. The fluid is used to screen for developmental abnormalities in a fetus. According to the report published in the November 2013 Journal of Hepatology, researchers found that women with high viral loads who underwent the procedure had higher rates of infecting their infants (6.35%) than those who did not (2.53%). The scientists compared infection rates in 63 infants whose mothers had amniocentesis against 198 infants whose mothers did not. However, when the mothers' viral loads were moderate,

    http://www.hepb.org/blog/hbv-journal-review-january-2014/
  • Entecavir + Tenofovir Works Well for Hepatitis B Patients with Prior Treatment Failure

    … Nearly 10% had primary non-response (1 log but still detectable at week 24 or 48) and 33% experienced viral breakthrough while on treatment (>1 log increase over the lowest level). At baseline 52% had evidence of lamivudine resistance, 25% had entecavir resistance, and 7% had adefovir resistance; about one-quarter had no resistance mutations and 16% had viral load too low for sequencing. All participants in this ongoing, open-label, single-arm study were re-treated with 1 mg entecavir plus 300 mg tenofovir, both once-daily, for up to 96 weeks. After 96 weeks patients and investigators could elect to pursue further treatment using commercially available hepatitis B drugs. Read more

    http://www.hepb.org/blog/entecavir-tenofovir-works-well-for-hepatitis-b-patients-with-prior-treatment-failure/
  • HBV Journal Review – November 2013

    HBF is pleased to connect our blog readers to Christine Kukka’s monthly HBV Journal Review that she writes for the HBV Advocate. The journal presents the
latest in hepatitis B research, treatment, and prevention from recent academic and medical journals. This month, the following topics are explored: Patients Who Clear Hepatitis B During Antiviral Treatment Do Well Long-Term However, the Prognosis is Poor for Most Who Stop Antiviral Treatment How Effective Are Antivirals in Reducing Cirrhosis and Preventing Liver Cancer? New Antiviral Besifovir Hampered by Carnitine Deficiency in Early Clinical Trial Liver Cancer Remains Major Health Threat, with Few Treatment Options Scientists Develop a Better Mouse for Hepatitis B and C Research HBV-Infected People Have a Higher Risk of Rheumatoid Arthritis Ear Wax May Transmit Hepatitis B Children with Frequent Ear Infections Do Not Respond as Well to Vaccines Clean-Shave Haircuts Leave Traces of Virus on the Scalp  HBV Journal Review November 1, 2013 Vol 10, no 11 by Christine M. Kukka Patients Who Clear Hepatitis B During Antiviral Treatment Do Well Long-Term
Patients who respond well to antiviral treatment and clear the hepatitis B surface antigen (HBsAg) during treatment generally do well in the years after treatment stops, according to a report published in the October 2013 issue of the journal Gut. Korean researchers monitored patients who cleared HBsAg during antiviral treatment with either lamivudine (Epivir-HBV) or entecavir (Baraclude) for nearly six years after treatment stopped. Antiviral drugs work by interfering with HBV's biochemistry to stop them from replicating. In this study, a very small percentage--about 0.33% of the 5,409 patients--cleared HBsAg each year. Patients who were most likely to lose HBsAg had highly-elevated alanine aminotransferase (ALT) levels when they started treatment--indicating their immune systems were already attacking the HBV-infected liver cells. ALT levels rise when liver

    http://www.hepb.org/blog/hbv-journal-review-november-2013/
  • Hepatitis B Foundation Says “Thank You!” to its 100-plus Volunteers

    Doylestown, April 22, 2020 – During National Volunteer Week in the United States, the Hepatitis B Foundation is publicly thanking its more than 100 volunteers worldwide. Those dedicated individuals work with the Foundation to help serve people living with hepatitis B, their families and health care providers, sharing information about the resources available to them, particularly about the treatment and prevention of the infectious disease. “We are extremely grateful for the many, many hours and the very creative input provided by our volunteers around the world, particularly here in the United States,” said Dr. Timothy M. Block, President of the Foundation. “Our organization was founded by volunteers and we continue to rely on volunteers for leadership, outreach, public awareness and fundraising. In fact, our annual fundraising event, which coincidentally is this Friday, depends on volunteers for auction donations and much more. So, on behalf of the Foundation, I’ll say ‘Thank you very, very much’ to all of our volunteers.” Volunteers make up the Foundation’s Board of Directors and serve as Scientific and Medical Advisors. More than 40 volunteers work as “storytellers” for the Foundation’s highly regarded #justB campaign. Some of our volunteer #justB storytellers (Photo by Alex Le).   Dr. Block and his wife, Joan, created the Foundation in 1991, with two other volunteers, Janine and Paul Janine Witte, who were deeply moved by the plight of a young family affected by hepatitis B. With the personal support of Dr. Baruch Blumberg, who won the Nobel Prize for his discovery of the hepatitis B virus, and the help of the local community, the Wittes and Blocks responded to this unmet need by working tirelessly to establish the Hepatitis B Foundation, which has since grown from a grassroots effort into a professional organization with a global reach and substantial scientific research. 

    https://www.hepb.org/news-and-events/news-2/hepatitis-b-foundation-says-thank-you-to-its-more-than-100-volunteers/
  • Message from Dr. Timothy Block, Hepatitis B Foundation President

    April 6, 2020 To the hepatitis B community around the world, Let me begin by paraphrasing something I heard, which I found inspirational: “Let’s think about a time in the near future when we are past all of this, looking back. How much we will celebrate, and how much we will have learned.”  But that time has not yet come. So, this letter is to let each of you know how the Hepatitis B Foundation and its research arm, the Baruch S. Blumberg Institute, are meeting our mission right now. And, indeed, we diligently continue to work towards our mission to find a cure and improve the quality of life for those affected by hepatitis B worldwide. Certainly, things are not as usual, but our work does continue. The COVID 19 crisis is understandably the current world priority. But it is still important that, to the extent possible, the momentum we have generated toward hepatitis B patient services and cure research continue.  Right now, our strategy focuses on endurance, service and resilience. The Hepatitis B Foundation team is primarily working from home, though our information and education services continue unchanged, and our Helpline is still running for all those who need it. Our April 24th gala will now be “virtual” with some very creative twists. Our June 9th Patient-Focused Drug Development Meeting will become a “virtual” meeting on the same date, and registration will be open to all! We are still updating our website and social media on a daily basis and, just last month, added a Clinical Trial Finder to help people with hepatitis B around the world find clinical trials near you. We also added a new resource section on COVID-19 to share information for people with hepatitis B and liver disease. The Blumberg scientists continue their research and the labs remain open to carry out our hepatitis B and liver cancer research, with additional safety measures in place and limits on the number of scientists who are in at one time. Our scientists are spending much-needed time researching, writing and attending “virtual” meetings and journal clubs. The hepatitis B and liver community should know that we have not stopped working for hepatitis B and liver cancer (HCC) patients. At a time when the world, understandably, is distracted with another, very important crisis, the work of the Hepatitis B Foundation and Blumberg is all the more critical. And we will be there.  Sincerely, Tim Block President and Co-Founder

    https://www.hepb.org/news-and-events/news-2/message-from-dr-timothy-block-hepatitis-b-foundation-president/
  • HBV Journal Review – August 2013

    … antigen factories shut down and HBV reproduction de- clines dramatically. Early RNAi research found that RNA silencing worked extremely well in the liver, but the challenge has been to create a formula and delivery system to target hepatitis B antigens in liver cells without affecting other important cells. Arrowhead Research Corp. found that when the small RNA interrupters are linked to cholesterol, they target liver cells extremely well, and the addition of special polymers helps the gene silencing process. Arrowhead designed an intravenous formula, called ARC-520, that is utilized in its Phase 1 trial. The hope is that when the viral load is dramatically reduced, the body's immune system can gain the upper hand and eradicate the infection on its own. In addition to its mouse trial, a similar trial involving an HBV infected chimp with an extremely high viral load also led to rapid reduction in HBV DNA and a 90% reduction in another hepatitis B antigen—the hepatitis B "e" antigen (HBeAg). The clinical trial of ARC-520 (which uses a Dynamic Polyconju- gate delivery platform and includes two distinct RNA silencing agents that should shut down hepatitis B anti- gen reproduction) in humans is taking place in Melbourne, Australia. It is a randomized, double-blind, placebo- controlled trial. Each group of six healthy volunteers will receive either a placebo intra- venous injection or a single dose of ARC- 520... Continue reading about this and additional studies…  

    http://www.hepb.org/blog/hbv-journal-review-august-2013/
  • Hepatitis B and Social Security Disability Benefits

    Please welcome guest blogger, Ram Meyyappan, senior editor of Social Security Disability Help as he provides advice on applying for Social Security Disability Insurance or Supplemental Security  Income should your HBV prevent you from working. Hepatitis B (HBV)  is often referred to as a "silent infection" because those chronically infected may have few or no symptoms, or may not be unaware of their infection for decades. However, over time, the risk of serious liver disease is certainly possible and symptoms can range from mild to severe.  Severe symptoms rarely occur with an acute HBV infection, but can have very serious outcomes.  If your condition is severe to the point that you can no longer continue to work, you may qualify for SSDI (Social Security Disability Insurance) or Supplemental Security Income (SSI) benefits from the Social Security Administration (SSA). You can learn more about SSDI and SSI here Hepatitis B and Qualifying for Benefits When you submit an application for Social Security Disability benefits an adjudicator will review your file and compare your condition with a listing of conditions known as the SSA Blue Book (http://www.ssa.gov/disability/professionals/bluebook/). This Blue Book contains a listing of conditions and qualifying criteria that may qualify an individual for Social Security Disability benefits. Unfortunately Hepatitis B does not have its own listing in the Blue Book. You may still be able to qualify for disability benefits, however, if you are able to prove that you suffer from an associated condition (such as depression) that is included in the Blue Book. Some of the conditions that may qualify an individual for Social Security Disability benefits that are listed in the Blue Book and that may be associated with Hepatitis B include: 5.05 Chronic liver disease 5.08 Unexplained weight loss 5.09 Liver transplant 12.04 Affective disorders If you are applying for disability benefits based on an associated condition that is

    http://www.hepb.org/blog/hepatitis-b-and-social-security-disability/
  • Timothy M. Block, PhD, President of Hepatitis B Foundation and its Baruch S. Blumberg Institute, named a 2017 National Academy of Inventors Fellow

    Timothy M. Block, Ph.D, has been named a Fellow of the US National Academy of Inventors (NAI), the organization announced Tuesday.  Dr. Block is President of the Hepatitis B Foundation, as well as its research arm, the Baruch S. Blumberg Institute, and its Pennsylvania Biotechnology Center. Dr. Block will be inducted into the National Academy Inventors on April 5, 2018, as part of the NAI Conference in Washington, DC.    Election to NAI Fellow status is the highest professional accolade bestowed solely to academic inventors who have demonstrated a prolific spirit of innovation in creating or facilitating outstanding inventions that have made a tangible impact on quality of life, economic development, and welfare of society.    Dr. Block is being recognized for his contributions to therapeutic drug and biomarker of disease screening and discovery. Specifically, for methods of DNA transfer to mammalian cells (1979), methods of discovery of antiviral drugs and biomarkers of liver cancer (1986, 1996, 2000, 2003).  Dr. Block has been involved in viral hepatitis research for more than 30 years as a member of the faculty at Thomas Jefferson University (1984-2005) and Drexel University School of Medicine (2005-2015). He is also Adjunct Professor, Geisinger and University of Pennsylvania. School of Medicine. He has received numerous honors, including an honorary Medical Degree from the Bulgarian National Academy, elected Fellow, American Association for the Advancement of Science and of the Glycobiology Institute of the University of Oxford.  He holds more than 9 patents, co-authored more than 240 scholarly papers, and was named a “Visionary in Hepatitis” by the World Hepatitis Alliance in 2017. Dr. Block is a co-founder of the Hepatitis B Foundation (HBF), which created the Baruch S. Blumberg Institute in 2003 to fulfill its research mission. In 2006, Dr. Block co-founded the Pennsylvania Biotechnology Center, an accelerator for start up companies. The companies are now collectively valued at more than $1.5 billion.  Pennsylvania Biotechnology Center is home to, and managed by, the Blumberg Institute and Hepatitis B Foundation, and is intended to expand their research capabilities.  With the election of the 2017 class there are now 912 NAI Fellows, representing over 250 research universities and governmental and non-profit research institutes. The 2017 Fellows are named inventors on nearly 6,000 issued U.S. patents, bringing the collective patents held by all NAI Fellows to more than 32,000 issued U.S. patents.  Included among all NAI Fellows are more than 100 presidents and senior leaders of research universities and non-profit research institutes; 439 members of the National Academies of Sciences, Engineering, and Medicine; 36 inductees of the National Inventors Hall of Fame; 52 recipients of the U.S. National Medal of Technology and Innovation and U.S. National Medal of Science; 29 Nobel Laureates; 261 AAAS Fellows; 168 IEEE Fellows; and 142 Fellows of the American Academy of Arts & Sciences, among other awards and distinctions.  Baruch S. Blumberg, M.D., Ph.D., inventor of the original hepatitis B vaccine, was inducted in 1993.  On Apr. 5, 2018, the 2017 NAI Fellows will be inducted as part of the Seventh Annual NAI Conference of the National Academy of Inventors at the Mayflower Hotel, Autograph Collection in Washington, D.C. Andrew H. Hirshfeld, U.S. Commissioner for Patents, will provide the keynote address for the induction ceremony.   The 2017 NAI Fellows will be highlighted with a full page announcement in The Chronicle of Higher Education Jan. 19, 2018 issue, and in an upcoming issue of Science and Technology and Innovation, Journal of the National Academy of Inventors.  Those elected to the rank of NAI Fellow are named inventors on U.S. patents and were nominated by their peers for outstanding contributions to innovation in areas such as patents and licensing, innovative discovery and technology, significant impact on society, and support and enhancement of innovation.  The 2017 class of NAI Fellows was evaluated by the 2017 Selection Committee, which included 18 members comprising NAI Fellows, U.S. National Medals recipients, National Inventors Hall of Fame inductees, members of the National Academies of Sciences, Engineering, and Medicine and senior officials from the USPTO, National Institute of Standards and Technology, Association of American Universities, American Association for the Advancement of Science, Association of Public and Land-grant Universities, Association of University Technology Managers, and National Inventors Hall of Fame, among other organizations.  # # #    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 http://hepb.org/blog, follow us on Twitter @HepBFoundation, find us on Facebook at www.facebook.com/hepbfoundation or call 215-489-4900.    About the Baruch S. Blumberg Institute: The Baruch S. Blumberg Institute is an independent, nonprofit research institute established in 2003 by the Hepatitis B Foundation to conduct discovery research and nurture translational biotechnology in an environment conducive to interaction, collaboration and focus. It was renamed in 2013 to honor Baruch S. Blumberg, who won the Nobel Prize for his discovery of the hepatitis B virus and co-founded the Hepatitis B Foundation. To learn more, visit www.blumberginstitute.org.    About the Pennsylvania Biotechnology Center: The Pennsylvania Biotechnology Center offers state-of-the-art laboratory and office space to nonprofit research companies and biotech companies. Managed by the Baruch S. Blumberg Institute and led by a board appointed by the Hepatitis B Foundation, the Center was funded in part by the Commonwealth of Pennsylvania. The facility opened in 2006 in a formerly abandoned warehouse and has since grown to encompass 110,000 square feet on a 10-acre campus. To learn more, visit www.pabiotechbc.org.   * * *  The National Academy of Inventors is a 501(c)(3) non-profit member organization comprising U.S. and international universities, and governmental and non-profit research institutes, with over 4,000 individual inventor members and Fellows spanning more than 250 institutions worldwide. It was founded in 2010 to recognize and encourage inventors with patents issued from the U.S. Patent and Trademark Office, enhance the visibility of academic technology and innovation, encourage the disclosure of intellectual property, educate and mentor innovative students, and translate the inventions of its members to benefit society.     

    https://www.hepb.org/news-and-events/news-2/timothy-m-block-phd-president-of-hepatitis-b-foundation-and-its-baruch-s-blumberg-institute-named-a-2017-national-academy-of-inventors-fellow/