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• Alnylam Discloses HBV Program, Shows 2 Log HBSAG Knockdown with Research-Grade SNALP Tech

  Harnessing the Power of RNAi Gene Silencing in Quest of a Cure for Chronic Hepatitis B, and the HBV KnockDown blog written by Dirk Haussecker, who believes it's about time everyone got serious about a functional cure for hepatitis B.  Following cryptic remarks during a conference call earlier this year, Alnylam today officially announced its entry into the cure-HBV race.  In impressive data presented at the ongoing TIDES meeting, the company showed that up to 0.5mg/kg SNALP-siRNA was able to knock down HBsAg by ~2 log (99% knockdown) in infected chimpanzees.  The data had been generated by Merck from which Alnylam acquired the RNAi assets in January.  The goal is now to apply some of the learnings generated with Merck’s research-grade SNALP LNP technology and come up with a new candidate based on Alnylam’s GalNAc delivery platform (IND to be filed end of 2015). In addition to the impressive HBsAg knockdowns, 3-4log knockdowns of viral DNA in serum were seen in the 4 chimpanzees.  In the most viremic chimp, the 4log lowering of viral load was able to normalize liver enzyme (ALT) levels that had been elevated by ~5x ULN.  Intriguingly, in 2 chimps with normal ALTs at the time of treatment, liver enzymes started to increase after dosing had finished (ruling out SNALP LNP as the culprit) and in 1 case also well after viral DNA had started to recover following cessation of RNAi dosing. Intriguingly, while viral DNA recovered in this short study involving the administration of 3 doses (for every chimp 0.125mg/kg, then 0.25mg/kg, then 0.5mg/kg) over a span of 40 days, there were indications of a desired immunological response similar to that seen withARC520 in the chimp study, most notably an elevation of interferon gamma accompanied by ~2x increases in ALT in 2 of the chimps. The competition   With Tekmira, ISIS/GSK and now Alnylam (and possibly more to come) following on the heels of Arrowhead Research and ARC520, the competitive landscape is

  http://www.hepb.org/blog/alnylam-discloses-hbv-program-shows-2-log-hbsag-knockdown-with-research-grade-snalp-tech/
• HBV Journal Review – May 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: Adding Interferon to Ongoing Antiviral Treatment Is Highly Successful Vitamin E Helps HBV-Infected Children Lose HBeAg, Reducing Liver Damage Common Chinese Toad May Hold the Key to Preventing and Treating Liver Cancer Even at Top Hospitals, Doctors Fail to Treat Hepatitis B Patients Properly Study Finds Doctors More Likely to Treat Hepatitis B in Men Than Women Study Confirms Doctors Frequently Fail to Screen and Vaccinate Those at Risk Antiviral Treatment Dramatically Improves Liver Cancer Test Accuracy $50 Cash Incentive Increases HBV Immunization 12-Fold Hepatitis B and C Cause Ten-Times More Deaths Than HIV in Europe HBV Journal Review May 1, 2014 Volume 11, Issue 5 by Christine M. Kukka Adding Interferon to Ongoing Antiviral Treatment Is Highly Successful  Adding pegylated interferon to ongoing antiviral treatment produced remarkable rates of hepatitis B "e" antigen (HBeAg) loss and even hepatitis B surface antigen (HBsAg) loss, according to a study presented at the International Liver Congress held in London in April. Eighty-three HBeAg-positive patients in China, who had been on antivirals for more than two years, had 48 weeks of interferon treatment added to their treatment regimen. A control group continued on only antivirals: 60% of the group treated with add-on interferon lost HBeAg and their viral loads dropped below 2,000 IU/mL. In contrast, only 13.8% of patients treated with only antivirals achieved those benchmarks. 27.7% of patients in the combination treatment group lost HBsAg. No one in the antiviral group lost HBsAg. All patients who had low HBsAg levels (less than 1,000 IU/mL) at the start of interferon treatment achieved HBeAg loss and

  http://www.hepb.org/blog/hbv-journal-review-may-2014/
• Deadliest Cuts of All

  Just 8 cancers (ovary, myeloma, brain, stomach, esophagus, lung, liver, and pancreas) will cause nearly half of all cancer deaths in 2014. Joining a deadly cancers “club” is not on anyone’s wish list. Yet Liver Cancer Connect, a dedicated program of the Hepatitis B Foundation, welcomed the opportunity to become a member of the Deadliest Cancers Coalition. The Coalition was established in 2008 by the Pancreatic Cancer Action Network and other patient advocacy organizations and professional societies. The group addresses policy issues related to the nation’s deadliest (recalcitrant) cancers. These are defined as the cancers that have 5-year relative survival rates below 50%. While various types of cancers fit this definition, it is worth noting that nearly half of the 585,720 cancer deaths expected in 2014 will be caused by eight deadly cancers: ovary, myeloma, brain, stomach, esophagus, lung, liver, and pancreas. Over the past 40 years, the overall 5-year relative survival rate for all cancers has increased from about 50% to 68%. This encouraging progress was mainly thanks to significant federal funding, through the National Institutes of Health (NIH) - the world’s premier supporter of biomedical research - and the National Cancer Institute (NCI). Those federal funds have been matched by investments from pharmaceutical companies, nongovernmental organizations, and states. But some cancers have not even reached the 50% survival benchmark, let alone surpassed it. To improve survival and outcomes for people with these deadliest cancers, Congress passed the landmark 2012 Recalcitrant Cancer Research Act.  The law calls on NCI, which is a part of NIH, to develop scientific frameworks to help improve outcomes for people who have cancers with very low survival rates. Unfortunately, continued budget cuts have led to a 23 percent reduction in NIH’s capacity to fund much-needed medical research, including research that can improve survival rates. And the

  http://www.hepb.org/blog/deadliest-cuts-of-all/
• HBV Journal Review – March 2014

  … levels exceeding 1 million international units per milliliter (IU/mL), tenofovir worked far faster to suppress viral load. • After six months, 18% of tenofovir-treated patients achieved undetectable viral load compared to 11% in the entecavir group. • After 12 months, 51% of tenofovir patients had undetectable HBV DNA compared to 28% of entecavir patients. • And after 18 months, 72% of tenofovir-treated patients were HBV DNA-free, compared to 39% in the entecavir group. “Tenofovir is significantly more effective than entecavir for achieving complete viral suppression in HBeAg-positive, (never before-treated) chronic hepatitis B patients with HBV DNA greater than 1 million IU/mL,” they wrote in the January issue of the journal of Alimentary Pharmacology and Therapeutics. Source: www.ncbi.nlm.nih.gov/pubmed/24467455   Antiviral Treatment After Liver Cancer Surgery Improves Survival Dramatically
 A team of researchers from Thomas Jefferson University Hospital reports that antiviral treatment after removal of a liver cancer tumor increased survival from an average 1.3 years to 6.6 years. The team compared survival in 25 hepatitis B patients who each had  similar-sized liver tumors removed through a process known as tumor ablation–involving the removal of liver tumors using heat, cold or chemicals. Continue reading this review and additional HBV related reviews for March

  http://www.hepb.org/blog/hbv-journal-review-march-2014/
• Re-energized in Our Mission … A Message from Joan Block of HBF

  Historic ruling now officially recognizes HBV infection as a protected disability under the Americans with Disabilities Act. What a difference two years make. In 2011 the Hepatitis B Foundation celebrated its 20th anniversary and we were ready to rest awhile on our laurels after working so hard. But instead, we rallied for new challenges and now we have a lot to celebrate in 2013!   Joan M. Block, Co-Founder and Executive Director In March, the U.S. Department of Justice struck down HBV discrimination in a settlement with two New Jersey medical schools that had denied enrollment to students with hepatitis B. The historic ruling now officially recognizes HBV infection as a protected disability under the Americans with Disabilities Act—a huge advocacy success in which the Hepatitis B Foundation played a key role. To fulfill our mission of decreasing the burden of hepatitis B and liver cancer in the U.S., we partnered with AAPCHO to establish Hep B United as a national program to support local coalitions improve screening, vaccination and linkage to care, particularly among high-risk Asian immigrants. In recognition of Hep B United’s momentum, the CDC recently awarded HBF a major grant to build the coalition and its membership, and to serve as an official partner in their Know Hepatitis B national campaign (see In The News). This year we also created CHIPO, the first national coalition to address the heavy burden of hepatitis B among African immigrants, which is an area of tremendous need. The big news in 2013, however, is the renaming of our research institute in honor of Nobel Laureate Dr. Baruch S. Blumberg, who was a cofounder of the HBF and mentor to many of our scientists and outreach professionals for almost 20 years. Dr. Blumberg believed that a cure was possible in our lifetime, so we are honored to take up the challenge with renewed energy and purpose to fulfill his scientific legacy. Please give generously to our 2013 Annual Fund! Your

  http://www.hepb.org/blog/re-energized-in-our-mission-a-message-from-joan-block-of-hbf/