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Gilead Initiates Phase III Tenofovir Trials for Chronic HBV

FDA Approves Baraclude (entecavir) for Chronic Hepatitis B

FDA Approves Pegasys for the Treatment of Chronic Hepatitis B

First National Hepatitis B Awareness Week May 9-16, 2005

Aim for the B Campaign Spotlights Hepatitis B

NIH Liver Disease Research Action Plan Released

New HBF and University Oxford Partnership

U.S. Senator Rick Santorum Hosts HBV Congressional Briefing


*Please Note: Links to archived articles may have expired. If you are unable to access the page via the links below, try searching the HBV Research List Archives at http://archive.mail-list.com/hbv_research/

2006

FDA Grants Orphan Drug Designation to Nexavar for the Treatment of Hepatocellular Carcinoma
April 26 - The U.S. Orphan Drugs Act encourages the development of drugs for the diagnosis, prevention, or treatment of a medical condition that affects less than 200,000 Americans. Hepatocellular cancer, or liver cancer, is a highly fatal disease. Read Full Article.

NVHR Strategic Plan to Eliminate Viral Hepatitis Now Released!
April 19 - The first-ever national hepatitis plan has just been released by the National Viral Hepatitis Roundtable. It calls for all Americans to work together to bring an end to the needless suffering caused by viral hepatitis in the United States. Click here to read the full “Eliminating Hepatitis: A Call to Action”.

Online Cancer Resource Helps Asian Americans
April 13 - Asian Americans can now access online cancer information written in a variety of languages via a Web site funded by the National Cancer Institute and launched by the American Cancer Society and the Asian American Network for Cancer Awareness, Research and Training. Read Full Article.

Liver Biopsy Not Foolproof
April 12 - Liver biopsy is considered a gold standard for staging chronic liver disease, but sometimes it’s fool's gold, according to data reported at the American College of Physicians meeting. Read Full Story.

Experts at NIH Meeting Agree Key Issue in Hepatitis B Treatment is to Avoid Drug Resistance
April 10 - The National Institutes of Health (NIH) convened a national meeting to address current controversies in the management and treatment of hepatitis B and to make recommendations on directions for future research. Although there was vigorous debate on every issue, the experts all agreed that resistance to the currently approved drugs is a key concern in the treatment of hepatitis B. Read Full Article.

“The Vaccinators” Hit London Bars to Promote Hepatitis Vaccination
April 7 - Arriving in a “superhero” bus, men dressed as “The Vaccinators” launched a vaccine campaign to stamp out hepatitis A and B in the gay community. Read Full Article.

Oklahoma State House Panel Passes Tattoo Regulation Measure
April 5 - Oklahoma legislators are responding to an increase in hepatitis cases blamed on unsanitary tattooing practices, with an HBV outbreak in 2004 linked to home tattooing. Read Full Article.

Monotherapy vs. Combination Therapy for the Treatment of Chronic HBV?
April 4 - The issue of monotherapy vs. combination therapy for chronic HBV was a topic for debate at the 2006 Shanghai-Hong Kong International Liver Congress held in China. Read Full Article.

Pros and Cons of Serologic Clearance of HBsAg as a Treatment Endpoint for Chronic HBV Infection
April 4 – Whether serologic clearance of HBsAg is the best treatment endpoint for patients with chronic HBV infection was discussed at the 2006 Shanghai-Hong Kong International Liver Congress. Read Full Article.

Characteristics of Drug Resistant HBV in Co-infected HIV/HBV Individuals on Extended Lamivudine Therapy.
April 4 – The issue of greater immunocompromise and drug resistance among HIV co-infected patients makes the timing and selection of HBV therapy critical in this population. Read Full Article.

Telbivudine Provides Greater Response than Lamivudine in Chinese Patients with Chronic HBV
March 27 - New clinical data demonstrates telbivudine provides both superior antiviral and clinical efficacy in Chinese patients after one year of use when compared with lamivudine. Read Full Article.

American Academy of Pediatrics Endorses CDC's HBV Recommendations for Infants, Children, and Adolescents
March 27 - CDC recommends ALL newborns receive the first dose of HBV vaccine before leaving the hospital, and ALL children and teens up to 19 years of age be vaccinated. Read Full Article.

Phase 2 HBV Data Show Strong Efficacy for Pradefovir Mesylate
March 19 – Pradefovir, using Metabasis’ pro-drug technology to achieve higher concentrations of adefovir in the liver, shows significant viral load reduction. Read Full Article.

Man Claims He Got Hepatitis Through Illegally Harvested Tissue
March 23 - A Nebraska man claims he contracted hepatitis B and C through a tissue transplant that was illegally harvested in a massive scam of stolen body parts. Read Full Article.

Impact of HBV on Liver Transplantation in the U.S.
March 20 – HBV is generally considered to be a minor health issue by many gastroenterologists; however, with growing immigration from overseas, it may eventually have a big impact on liver transplants. Read Full Article.

Menatetrenone Improves Hepatocellular Carcinoma Outcome
March 16 – Results of a pilot study suggest menatetrenone for hepatocellular carcinoma (primary liver cancer) reduces recurrences and improves survival. Read Full Article.

HBV DNA Levels Early Predictor of Nonresponse with Interferon alpha
March 17 – HBV DNA testing at baseline and 12 weeks has high predictive value for identifying patients who will not reach sustained response with IFN therapy. Read Full Article.

Phase 2 HBV Data Show Strong Efficacy for Pradefovir Mesylate
March 19 – Pradefovir, using Metabasis’ pro-drug technology to achieve higher concentrations of adefovir in the liver, shows significant viral load reduction. Read Full Article.

Transient Elastography Detects Cirrhosis in Chronic Liver Disease
March 9 - FibroScan, a noninvasive technique that measures liver fibrosis, accurately detects cirrhosis in patients with chronic liver disease. Read Full Article.

Diabetes Associated with an Increased Risk for Hepatocellular Carcinoma (HCC)
March 8 – A significant association between HCC and diabetes, independent of alcohol use or viral hepatitis, was found in a review of 10 studies. Read Full Article.

Baraclude Trumps Epivir as HBV Therapy
March 8 - Two international studies showed that Baraclude (entecavir) appears to be superior to Epivir-HBV (lamivudine) at reducing viral loads in patients with HBV. Read Full Article.

The Extrahepatic Consequences of Cirrhosis
March 3 - Cirrhosis can result in serious damage to the liver, as well as other vital organs. Read Full Article.

Ask the Experts about Hepatitis B
March 3 – What is your diagnosis of a 32 year old patient with HBeAg-negative/HBeAb-positive, normal ALT, and high viral DNA? Read Dr. Paul Martin’s Answer.

HBV Infection Predicts Clearance of HCV in Hemophiliacs
Feb 28 - Consistent with what has been seen in other patient groups, chronic HBV infection was associated with a nine-fold increased chance of HCV clearance in hemophiliac patients. Read Full Article.

Gilead Sciences Launches STOP Hep B Campaign
Feb. 28 – Community partnerships and interactive online education provide opportunities for patients and caregivers to “stop hepatitis B” together. Read Full Article.

UK Issues HBV Treatment Guidance
Feb. 21 - The U.K. National Institute for Health and Clinical Excellence recommends the use of two new drugs for treating hepatitis B. Read Full Article.

New Compound May Protect Against Liver Cancer
Feb. 15 - National Cancer Institute researchers found a new compound that protects against the development of liver cancer in lab animals. Read Full Article.

ANA380 Shows Robust HBV Viral Reduction
Feb. 14 - Anadys announced that ANA380 in phase II trials showed significant viral load reduction in patients with lamivudine-resistant HBV. Read Full Article.

AIDS Overtakes HBV in China
Feb. 13 - The Chinese government said that AIDS surpassed hepatitis B as the country's third-deadliest infectious disease in 2005. Read Full Article.

HBV Genotype Linked to Liver Damage in HIV Co-Infections
Jan. 31 - A study found that the degree of liver damage in HIV/HBV co-infected patients is affected by HBV genotype. Read Full Article.

National Hepatitis B Act Reaches Congress!
The first-ever hepatitis B legislation H.R. 4550, the "National Hepatitis B Act" was introduced by U.S. Representatives Mike Honda (D-CA) and Charles Dent (R-PA) to Congress on December 15 in an historic bi-partisan effort. Read Full Article.

2005

Overall Cancer Deaths Still Dropping, But Liver Cancer is Increasing
Oct. 5, 2005- Liver cancer seems to be on the rise researchers reported in the Journal of the National Cancer Institute, a blip of bad news in the nation's otherwise optimistic annual report on cancer that shows survival continuing to improve. One factor may be hepatitis infections. Read Full Article.

Stalking a Cancer That's Silent and Deadly
Oct. 11, 2005- The New York Times reports that although you don't hear much about liver cancer, its incidence is increasing faster than any other cancer in the United States – an increase that is expected to continue for two more decades. The striking increase in liver cancers here and in other developed countries is a result of chronic and usually silent infections by the hepatitis B and C viruses. Read Full Article in the New York Times.

Hepatitis B Vaccine Considered For All Adults
Sept. 26, 2005- Many in the health community believe the time is right to broaden the assault against hepatitis B, and they hope to persuade the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices to recommend its vaccine for all adults. The committee is scheduled to discuss the vaccine during its Oct. 26-27 meeting. Read Full Article.

New Web Site to Track Clinical Drug Trials
Sept. 22, 2005- The International Federation of Pharmaceutical Manufacturers and Associates, a trade group for the global drug industry, has launched a new website at www.ifpma.org/clinicaltrials. It is designed to help users navigate 250,000 links to find clinical trials information and results on other sites run by federation members and government and nonprofit groups. Read Full Article.

Europe Suspends Sales of Pediatric Vaccine
Sept. 20, 2005 - The European Medicines Agency has suspended sales of Sanofi Pasteur Merk's childhood vaccine Hexavac because of concerns about the long-term protection against hepatitis B. Experts at the London-based agency have identified a problem with the hepatitis B element of the shot, resulting in decreased ability of the vaccine to stimulate an immune response. Hexavac is a vaccine for infants and children against diphtheria, tetanus, whooping cough (pertussis), hepatitis B virus, polio virus and Haemophilus influenzae type b.

Thinking Outside the Black Box: Toward Optimal Treatment of Chronic Hepatitis B in HIV Patient
Sept. 14, 2005 – Treatment and management of HIV-HBV coinfection represents a growing concern both in the US and worldwide, where health authorities estimate more than 300 million persons are living with chronic hepatitis B, 40 million with HIV-1 infection, and an unknown number living with both these viral infections. HIV contributes to HBV disease progression and HBV hastens progression of HIV disease. Read Full Article.

Relationship of Genotypes of HBV to Mutations, Disease Progression and Antiviral Therapy
Sept. 13, 2005 –Genotypes may account not only for differences in the prevalence of HBV mutants in various geographic regions, but also for differences in clinical outcome and response to therapy, according to a report in the J. of Viral Hepatology 12(5) 2005. Read Full Article.

Why Treat Hepatitis B Now? The Clinical View
Sept, 12, 2005 – This Treatment Update, by Dr. Emmet Keeffe at Stanford U. School of Medicine, includes CME-certified Educational Modules as well as Interactive Case Challenges and is now available to you on the Clinical Care Options Web site. Read Full Article.

HBF and IHVR Scientists Report On GP73, a Resident Golgi Glycoprotein, is a Novel Serum Marker for Hepatocellular Carcinoma
Sept. 6, 2005 - HBF and IHVR scientists reported in the J. of Hepatology (Aug. 30, 2005) that GP73 was better than AFP for the diagnosis of early HCC. Further validation studies are needed to confirm the role of GP73 in the early detection of HCC. Read Full Article.

Impact of Chronic Viral Hepatitis on Health-Related Quality of Life in HIV
Sept. 6, 2005 - Little is known about the health burden of chronic viral hepatitis in HIV-infected patients. A study compared health-related quality of life of patients with HIV and hepatitis C virus (HCV) or HIV and hepatitis B virus (HBV) coinfection to those with HIV monoinfection. Findings were reported in Am J Gastroenterology (Sept. 2005). Read Full Article.

Thalassemic Children at Higher Risk of Acquiring Hepatitis
Sept. 4, 2005 - In India, every year about 10,000 children are born with thalassemia, which represents 10% of the total number of thalassemic children born worldwide. Since thalassemic patients have to undergo blood transfusion regularly, they are at a higher risk of acquiring hepatitis B and C. Read Full Article.

24 HBV Therapies and Vaccines are FDA-approved or In Development
Aug. 29, 2005 - With FDA approval in 2005 of peginterferon alfa-2a (Pegasys) and Entecavir (Baraclude), there is now an impressive 40% percent increase in the number of approved drug treatment options for HBV infection. Read Full Article.

HIV and Hepatitis B Virus Coinfection: Question and Answers
Aug. 25, 2005 - Learn about the current treatment of hepatitis B in the setting of HIV infection, emerging therapeutic strategies, and therapeutic guidelines. Read Full Article.

Eating Soy May Ease Liver Cancer Risk, Claim Scientists
Aug. 25, 2005 - Adding soy to your diet may be the key to keeping liver cancer at bay, says an international team of scientists who studied the effect of this soybean-derived substance in a group of Japanese people at risk for the disease. Read Full Article.

Research Proves Black Tea as Powerful as Green, Yet Consumers Don't Recognize Health Benefits
Aug. 23, 2005 - A recent survey reveals that Americans overwhelmingly associate health benefits with green tea and overlook the health benefits of regular, black tea. Seventy-one percent identify hot green tea as a good source of antioxidants, while only 34 percent of respondents view regular hot tea as a good source of antioxidants. In fact, regular (black) and green tea have virtually the same amount of antioxidants. Read Full Article.

Online Registration Now Available for HepDART 2005 Conference
Aug. 18, 2005 – The bi-annualHepDART conference will be held in Hawaii Dec 11-15, 2005. The goal is to bring clinicians, researchers, and basic scientists together to advance the knowledge of drug development in the treatment of hepatitis B and C. Visit www.informedhorizons.com/hepdart2005/

A One Year Trial of Telbivudine, Lamivudine, and the Combination in Patients With Hepatitis B e Antigen-Positive Chronic Hepatitis B
Aug. 18, 2005 - The results of a study comparing telbivudine, telbivudine and lamivudine vs. lamivudine alone in the treatment of hepatitis B e-antigen positive adults with compensated chronic hepatitis B was reported in Gastroenterology 2005 (Aug;129). Read Full Article .

Viral Link to Liver Cancer Found
Aug. 17, 2005 - Doctors at the MD Anderson Cancer Center in Texas report that they've found how HBV can help mediate the development of liver cancer in people with the viral infection. This finding paves the way for a possible treatment, either to prevent liver cancer or for people who already have the disease, the researchers point out. Read Full Article.

Open Wide: Dental Health and Viral Hepatitis May Be More Important Than You Think
Hepatitis Magazine (July-Sept 2005) - There are three important issues for patients to consider – the special dental concerns of hepatitis patients, the risk of transmission to the dentist (which is greatly decreased due to a safe vaccine), and the strict dental requirements for the patient who needs a transplant. In many instances, poor dental health can result in a patient being rejected for transplant. Read Full Article.

HIV/Hepatitis Coinfections: Special Treatment Issues in Patients With Liver Disease
Aug. 9, 2005 - Diseases such as end-stage liver disease are replacing opportunistic infections as leading causes of mortality in patients with HIV disease. In some patient populations, almost all individuals will carry both HIV and hepatitis C virus (HCV), many will have hepatitis B virus (HBV) coinfection, and some will be infected with all 3 viruses. An expert interview with Paula Greiger, MD, discusses the additional challenges posed by these hepatitis coinfections. Read Full Article.

Telbivudine Achieves Primary Endpoint in Phase III GLOBE Trial, Largest Ever Registration Trial in Hepatitis B
July 28, 2005 -The largest hepatitis B registration trial to date, GLOBE trials, sponsored by Idenix and Novartis, enrolled more than 1,350 patients in over 130 medical centers worldwide. The ongoing trial is evaluating the safety and efficacy of telbivudine compared to lamivudine in patients with HBeAg-positive and HBeAg-negative compensated chronic hepatitis B for two years of treatment. Read Full Article.

Lamivudine Prophylaxis in HBV Carriers Receiving Chemotherapy for Malignancies
July 25, 2005 - Reactivation of hepatitis B virus (HBV) is a well-recognized complication of chemo/immunosuppressive therapy in individuals who are HBV surface antigen-positive inactive carriers and in individuals with chronic HBV infection. Read Full Article.

Gilead Initiates Phase III Clinical Trials for Tenofovir for Chronic Hepatitis B
July 19, 2005 - Gilead Sciences has begun enrolling patients in its Phase III clinical program evaluating the oral antiviral drug tenofovir disoproxil fumarate (tenofovir DF) for the treatment of chronic hepatitis B. Two Phase III clinical trials (Studies 102 and 103) will evaluate tenofovir DF among patients with either hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B or HBeAg-negative/anti-hepatitis B "e" positive (anti-HBe positive) chronic hepatitis B. Read Full Article.

Experimental HBV Drug Pradefovir Shows Promising Phase 2 Results
July 19, 2005 - Valeant Pharmaceuticals reports promising 24-week interim data from a Phase 2 study of its oral antiviral compound pradefovir. The company is evaluating the safety and efficacy of pradefovir for the treatment of compensated chronic hepatitis B. Read Full Article.

Is Routine Screening for HCC Recommended for the Hepatitis B Patient in the Inactive Carrier State?
July 19, 2005 - Dr. Emmet Keeffe, Professor of Medicine, Chief of Hepatology, Medical Director, Liver Transplant Program, Stanford University Medical Center, Stanford, California, responds to this question in a comprehensive manner. Read Full Article.

CDC Releases Guidelines for Improving HBV Vaccination Rates Among High-Risk Adults
July 15, 2005 – The Centers for Disease Control and Prevention (CDC) has issued guidelines to improve influenza, pneumococcal polysaccharide, and hepatitis B vaccination coverage among high-risk adults younger than 65 years. Although vaccines are effective and widely available, vaccination rates remain low. Read Full Report.

New England Journal of Medicine Article Supports PEGASYS as a First-Line Therapy in Chronic Hepatitis B
June 29, 2005 - According to a major study published in the June 30 edition of the New England Journal of Medicine, patients with the most common form of hepatitis B in the United States who are treated with PEGASYS(R) (peginterferon alfa-2a) are more likely to achieve a sustained response than those treated with lamivudine, the current standard of care. "Good therapeutic options are what people affected by hepatitis B need. This appears to be another important step forward," said Timothy M. Block, Ph.D., president of the Hepatitis B Foundation. Read Full Article.

Panel Backs Tougher Hepatitis B Guidelines
June 29, 2005 - Vaccine experts voted Wednesday to strengthen a national recommendation that all healthy newborn babies get a hepatitis B shot before leaving the hospital, saying "exceptions should be rare" and should require documentation and follow-up. Read Full Article.

Science Making Headway Against Hepatitis B
June 29, 2005 - Two new studies suggest researchers are moving closer to finding the best treatments for chronic hepatitis B for specific patients. Dr. Anna S.F. Lok, a renowned hepatologist, wrote an editorial that accompanies the studies in the June 30 issue of the New England Journal of Medicine. Read Full Article.

NIH Requests Applications for Clinical Studies of Milk Thistle in Chronic Liver Disease
June 29, 2005 - The National Institutes of Health have a keen interest in studying the potential benefits of silymarin (milk thistle) on the liver. Dr. Jay Hoofnagle, of the Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), writes about the NIH-initiated effort to conduct the first scientifically rigorous study of silymarin in Hepatology July 2005. Milk thistle has been used for centuries to treat acute and chronic liver diseases. A letter of intent is requested by August 15, 2005 and final applications by September 12, 2005. Applicants are limited to the United States. For details, visit the NIH grant page. Read Full Article.

Milk Thistle: Effects on Liver Disease and Cirrhosis and Clinical Adverse Effects
Learn more about milk thistle from the Agency for Healthcare Research and Quality, Rockville, MD. Read Full Article.

Dynavax Starting Phase III Trial of Vaccine for Hepatitis B Virus
June 24, 2005 - Aiming to file a biologics license application in 2007, Dynavax Technologies began a pivotal Phase III trial to test its HBV vaccine against Engerix-B (GlaxoSmithKline, or GSK), in older adults. Dynavax reported positive data from a Phase II/III trial with the vaccine, which showed statistically significant superiority in protective antibody response and robustness of protective effect after three vaccinations vs. GSK's product in older adults. Read Full Article.

Soy Intake Linked With Reduced Hepatocellular Carcinoma Risk
June 21, 2005 - Consuming miso soup and other soy foods may reduce the risk of hepatocellular carcinoma (HCC), according to the results of a study published in the June 10th issue of the International Journal of Cancer. The team adjusted for hepatitis B and C viral infection, which are major HCC risk factors in this population. Read Full Article.

Pharmasset to Develop Clevudine for the Treatment of Chronic Hepatitis B
June 27, 2005- Pharmasset and Bukwang Pharm. Co. announced that they have entered into an exclusive license agreement under which Pharmasset will develop and commercialize Clevudine, also known as L-FMAU, for the treatment of chronic hepatitis B virus (HBV) infections in the Americas, Europe, and other select territories. Clevudine is a potent oral, once-daily HBV antiviral drug currently in Phase 3 clinical trials in Korea and has been the subject of earlier stage clinical trials under an Investigational New Drug application filed with the US FDA. Read Full Article.

Double Dose of Hepatitis B Vaccine More Effective for HIV Patients
June 21, 2005- A study reported in Vaccine shows that a double dose of a commonly used hepatitis B vaccine is [more] effective in preventing the disease in HIV-positive adults. Read Full Article.

Combination of Nucleoside Analogues in the Treatment of Chronic Hepatitis B
June 16, 2005- Owing to the persistence of hepatitis B virus and the selection of drug-resistant mutants, antiviral therapy for chronic hepatitis B relies on the combination of nucleoside analogues. Read Full Article.

NIH Grant for Stem Cell Research for Hepatitis and Cirrhosis
June 14, 2005- Vesta Therapeutics will research use of adult stem cells as a possible treatment for liver disease with funding from the National Institutes of Health. Read Full Article. Read Rudy's Story with Stem Cell Transplant for HBV.

Fibromyalgia Frequency in Hepatitis B Carriers
June 8, 2005- Fibromyalgia (FM) is characterized by diffuse musculoskeletal pain, fatigue, morning stiffness, and sleep disturbance. A study reported in the Journal of Clinical Rheumatology (June 2005) study suggests that chronic hepatitis B appears to increase the risk of FM and many of the typically associated symptoms…physicians should be aware of this apparent association. Read Full Article.

New Antiviral Therapies for Hepatitis B
June 6, 2005- Dr. Anna Lok provides an excellent overview of current antiviral therapies for chronic hepatitis B. After a brief discussion of treatment goals and the efficacy of currently
approved medications, new therapeutic agents and combination therapies that are now in clinical trials are reviewed. Read Full Article.

Bayer Receives FDA Approval for Hepatitis B Tests
June 6, 2005 - Bayer HealthCare received approval from the U.S. Food and Drug Administration (FDA) for its automated HBsAg (hepatitis B surface antigen) Diagnostics and HBsAg Confirmatory assays. The fully automated tests, which are used to aid in the diagnosis and confirmation of acute or chronic hepatitis B infections, brings to eight the total number of hepatitis assays available – the most comprehensive, automated hepatitis (A, B and C) testing portfolio available in the U.S. Read Full Article .

Hepatitis B Virus May Be a Risk Factor for Other Cancers Besides Hepatocellular Carcinoma
June 1, 2005 - It is well known that chronic infection with the hepatitis B virus (HBV) is a major risk factor for hepatocellular carcinoma. However, HBV might also favor the development of other types of cancer, according to data presented at the DDW 2005 conference in Chicago (May 14-18, 2005). Read Full Article

Doctors Fight Liver Disease With Body's Own Stem Cells
May 28, 2005 - British doctors have made a "significant" breakthrough using patients' own stem cells to regrow their livers, raising the possibility of it replacing organ transplants in future. Read Full Article

Adefovir Dipivoxil Demonstrates Sustained Efficacy in HBeAg-negative Chronic Hepatitis B Patients
May 23, 2005 - Adefovir Dipivoxil (Hepsera) demonstrated efficacy and safety in 184 HBeAg-negative chronic hepatitis B (CHB) patients enrolled in a 96-week randomized, placebo -controlled trial. Patients on Adefovir in the second 48 weeks were offered up to 3 additional years of the drug. Read Full Article

Treatment With Adefovir Results in Sustained Reductions of HBV DNA Levels
May 20, 2005 - Treatment with 10 mg of adefovir dipivoxil for 192 weeks resulted in significant and sustained reductions in hepatitis B virus (HBV) DNA virus levels, with the majority of patients achieving prolonged HBV DNA suppression and sustained ALT normalization, according to findings presented at Digestive Disease Week 2005.The study indicates that adefovir dipivoxil provides durable HBV DNA suppression and a low incidence of resistance. Read Full Article

Entecavir Could Dominate First-Line Hepatitis-B Monotherapy
May 19, 2005 - Bristol-Myers Squibb's recently-launched anti-hepatitis B (HBV) drug, entecavir (Baraclude), could dominate the hepatitis-B therapeutic market, according to information reported in Pharmaprojects, the leading pharmaceutical pipeline-tracking database. Results presented at the recent 18th International Conference on Antiviral Research held in Barcelona, Spain, last month appeared to support entecavir's superiority over the widely-used anti-hepatitis-B drug, lamivudine (Epivir). Read Full Article

Advances in the Management of Hepatitis B
May 18, 2005 - The current treatment guidelines for HBV infection, which were revised in 2004, are already outdated. The field is evolving at a rapid pace, and what is accepted as the current standard of therapy will likely change in the next year. This report focuses on current therapies as well as new concepts that are evolving in the management of hepatitis B, as based on key data presented during this year's meeting of the European Association for the Study of the Liver (EASL). Read Full Article 

Positive Two-Year Data for Telbivudine for the Treatment of Chronic Hepatitis B
May 16, 2005 - According to a presentation given at the 2005 Digestive Disease Week (DDW) meeting, Telbivudine treatment nearly doubles proportion of patients achieving clinical efficacy measures compared to lamivudine. Data analysis indicates rapid and profound viral suppression early in the course of therapy is linked with better clinical outcomes out to two years. Read Full Article

FDA Approves Pegasys for the Treatment of Chronic Hepatitis B
13 May 2005 - Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Pegasys(R) (peginterferon alfa-2a), the most prescribed hepatitis C medication in the United States, for the treatment of chronic hepatitis B (CHB). Pegasys is the first and only pegylated interferon approved for the treatment of chronic hepatitis B, including both variations of the virus - HBeAg-positive and HBeAg-negative chronic hepatitis B. Read Full Article.

FDA Approves Baraclude (entecavir) for Chronic Hepatitis B
29 March 2005 - Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved the oral antiviral drug BARACLUDE (entecavir) for the treatment of chronic hepatitis B infection in adults. The drug will be available in the United States as early as April 8, 2005. Read Full Article.

HBV 2005 International Meeting Open for Registration
This year marks the 20th anniversary of the International Meeting on the Molecular Biology of Hepatitis B Viruses, which will be held September 18-21 at the Kirchhoff Institute in Heidelberg, Germany, and organized by Drs. Timothy Block and Stephan Urban. It remains the definitive international meeting that covers all aspects of the biology, virology, immunology and pathogenesis of hepatitis B and hepatitis D, as well as the latest developments in antiviral therapies against these two viruses. Abstract submission deadline is July 18, 2005 and a limited number of travel grants for graduate students and post docs are available. For more information or to register, visit www.hbvmeeting.org.

New Clinical Trial Opens Comparing Entecavir vs. Adefovir
Bristol Myers Squibb is conducting a Phase IIIb comparative study of entecavir vs. adefovir in patients who have chronic hepatitis B. The treatment period is for up to 96 weeks. The study began January 2005 and trial sites are located throughout the US and Canada. Contact: Bristol-Myers Squibb toll-free at 1-866-892-1267 ext. 150.

PKIDS Launches Listservs For Kids With Hepatitis B and C
Jan. 10, 2005- Thanks to PKIDs, children and teens living with hepatitis C or B now have their own Internet listservs, giving them a chance to "talk" with other infected youth from around the United States and the world.  The two listservs, one for children ages 8 to 12 and one for teens ages 13 to 19, are designed to allow youth the freedom to speak from their hearts. To help ensure a safe environment, the lists are moderated and there are no identifiers for those posting to the lists.

PKIDs (Parents of Kids with Infectious Diseases) is a national nonprofit organization serving families of children infected with chronic viral hepatitis and HIV/AIDS.

To access the listservs, go to: www.pkids.org/listserv.htm and click on the appropriate link.

NIH Action Plan Charts Future Challenges For Liver Disease Research
Jan. 3, 2005 - The National Institutes of Health (NIH) released the trans-NIH "Action Plan for Liver Disease Research", a comprehensive plan that addresses the burden of liver diseases in the United States and maps out challenges for future research over the next decade.  The Action Plan is available at http://liverplan.niddk.nih.gov

Standard Tests Miss Most Hepatitis B Infections
Jan. 5, 2005 - Researchers in Canada report that hepatitis B may affect people in the general population at rates higher than previously suspected. In a study with 241 dialysis patients, every person who tested positive on the standard test, four or five more patients were found to be infected when on the more sensitive DNA test. CDC HIV/STD/TB Prevention News Update (1/5/05). Read Full Article. 

2004

Clinical Relevance of HBV Genotype in Children and Hepatocellular Carcinoma
Dec. 6, 2004 – The aim of this Taiwanese study was to investigate the influence of HBV genotypes on the clinical outcome of chronic childhood HBV infection and hepatocellular carcinoma (HCC). A total of 460 HBV carrier children were followed-up for 15 years and 26 children with HBV-related HCC were recruited. Gastroenterology, Dec. 2004 (127:6).  Read Full Article.

Oral Hepatitis B Vaccine Clears Early Hurdle As Potential New Treatment
Dec. 3, 2004 – MicroScience a UK company, has completed a Phase I study of a new therapeutic vaccine for patients with chronic hepatitis B. It is given orally and provides a new approach to clearing the hepatitis B virus. The oral vaccine appears to stimulate the appropriate type of immune response required to promote clearance of the hepatitis B virus in chronic carriers. Read Full Article.

Entecavir Better Than Lamivudine In Chronically Infected Hepatitis B Patients
October 31, 2004-  According to data to be presented at the 55th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), the Bristol-Myers Squibb Company investigational chronic hepatitis B compound entecavir demonstrated significantly greater improvements in both liver histology and reductions of hepatitis B virus (HBV) DNA levels compared to lamivudine in two studies investigating both nucleoside-naïve, e-antigen-negative (HBeAg-) chronic hepatitis B patients (Study AI463-027) and e-antigen-positive (HBeAg+) chronic hepatitis B patients who had developed resistance to lamivudine (Study AI463-026) -- both multinational, double-blind, Phase III clinical trials.  Read Full Article.

GlaxoSmithKline vaccine, Fendrix®, to prevent infection from hepatitis B for specific high-risk patients to be approved soon in Europe 
October 27, 2004 - GlaxoSmithKline has received a positive opinion from the Committee for Medical Products for Human Use (CHMP) of Europe dated Oct. 215, 2004, for its new adjuvanted hepatitis B vaccine Fendrix® for high-risk patients. Official approval is anticipated in three 3 months.  Read Full Article.

Widespread Dissemination of Single HBV Variant in England
Oct 14, 2004 - Over a 10-year period in England, an "unexpectedly high proportion" of cases of acute hepatitis B infections were caused by a single variant, UK epidemiologists have discovered.
Reuters Health Information 2004. Read Full Article.

Rituxan May Be Associated With HBV Reactivation and Fulminant Hepatitis
Oct. 9, 2004 - The FDA has received reports of fulminant hepatitis, hepatic failure, and death among some patients with hematologic malignancies, such as non-Hodgkin's lymphoma, taking rituximab (Rituxan) therapy. The FDA recommends that patients at high risk of HBV infection be screened before initiation of rituximab therapy. Hepatitis B carriers should be closely monitored during therapy. Medscape 2004. Read Full Article.

Caffeine Breath Test Measures Liver Function
Oct. 11, 2004 (Reuter) - Forget the liver biopsy. Now it's possible to detect advanced fibrosis -- a complication of many liver diseases including hepatitis B, hepatitis C, fatty liver disease and hemochromatosis -- by means of a simple breath test. Read Full Article.

Bristol-Myers Squibb Submits Applications In U.S. And Europe To Market Entecavir
October 4, 2004- Bristol-Myers Squibb Company (NYSE: BMY) today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for entecavir, an investigational antiviral agent under development for the treatment of chronic Hepatitis B. Read Full Article.

Sustained Response After a 2-Year Course of Lamivudine Treatment of Hepatitis B e Antigen-Negative Chronic Hepatitis B
September 24, 2004- Hepatitis B e antigen-negative chronic hepatitis B is characterized by the absence of hepatitis B e antigen, detectable serum hepatitis B virus DNA by non-PCR-based assays, and liver necroinflammation. J Viral Hepat 11(5) 2004. Read Full Article.

Hepatitis B Virus Genotype C Linked to Increased Hepatocellular Carcinoma RiskSeptember 23, 2004- Patients infected with hepatitis B virus (HBV) genotype C, face an increased risk of hepatocellular carcinoma compared with patients infected with HBV genotype B, according to a report in the October issue of Gut. Read Full Article. 

Tenofovir and Lamivudine Combination Therapy for 96-weeks in HIV and HBV Co-infected Patients Effective
September 22, 2004- Researchers in France describe results of a pilot study of 6 individuals coinfected with HIV and HBV, in whom complete and sustained suppression of HBV was attained during 96 weeks of combination therapy with lamivudine (Epivir-HBV) and tenofovir (Viread). Read Full Article.   

Ask the Experts- Chronic Hepatitis B-  Role of Liver Biopsy
September 20, 2004- Is a liver biopsy necessary in a patient who is HBsAg-positive, HBeAg-negative, has normal liver enzymes, and has detectable HBV DNA on PCR? Emmet B. Keeffe, MD, explores the issues. Medscape Gastroenterology 6(2)2004.  Read Full Article.

Pegasys Study Published in New England Journal of Medicine
This study compares Pegasys, (peginterferon alpha-2a), to lamivudine in
patients with hepatitis B antigen (HBeAg) negative chronic hepatitis B and
finds it is more effective. Read Full Article.

NIH Proposes Free Access for Public to Research Data
September 8, 2004- The National Institutes of Health (NIH) has proposed a major policy change that would require all scientists who receive funding from the agency to make the results of their research available to the public for free. The proposal, posted on the agency's Web site late Friday and subject to a 60-day public comment period, would mark a significant departure from current practice, in which the scientific journals that publish those results retain control over that information. Read Full Article.

Four Years of Treatment With Lamivudine: Clinical and Virological Evaluations in HBe Antigen-Negative Chronic Hepatitis B
August 16, 2004-  Most information on the efficacy of lamivudine (Lam) in the treatment of chronic hepatitis B (CHB) has been derived from studies on patients with disease sustained by wild-type hepatitis B virus (HBV).[1,2] In this setting therapeutic remissions are marked by durable seroconversion from HBe antigen (HBeAg) to antibodies to HBeAg (anti-HBe) and by the normalization of liver enzymes and clearance of serum HBV DNA. Read Full Article.

Preventing Vertical Transmission of Hepatitis B
Approximately 350 million people worldwide are chronically infected with hepatitis B virus (HBV), and over 1 million die each year. Given the worldwide importance of chronic HBV, it is imperative that vertical transmission, a major route of infection, be halted. Perinatal transmission of HBV results from exposure of fetal mucous membranes to infectious maternal blood or serum-derived body fluids. Read Full Article.  

Current Issues in Hepatitis B
Hepatitis B virus (HBV) infection remains a global health concern. It is estimated that 2 billion individuals worldwide have been infected with this virus; 350 million are chronically infected, and 50 million new cases are diagnosed annually. Implementation of HBV vaccination programs has led to significant reductions in the HBV infection rate among children and healthcare workers. Read Full Article.

CDC Reports on Transmission of Hepatitis B Virus in Georgia Correctional Facilities
August 13, 2004- Incarcerated persons have a disproportionate burden of infectious diseases, including hepatitis B virus (HBV) infection. Among U.S. adult prison inmates, the overall prevalence of current or previous HBV infection ranges from 13% to 47%. The prevalence of chronic HBV infection among inmates is approximately 1.0%-3.7%, two to six times the prevalence among adults in the general U.S. population. Read Full Article.

CDC's Division of Viral Hepatitis Redesigns MSM Web Section
August 13, 2004- CDC's Division of Viral Hepatitis recently launched a web section that provides information about preventing hepatitis A and hepatitis B among men who have sex with men (MSM).  Even more recently, the page was redesigned to better meet the needs of gay and bisexual men themselves, rather than just health care professionals.  Click here to access fact sheets, articles, recommendations, and other specialized publications such as the National Minority AIDS Council's full-color booklet "Protect Yourself from Hepatitis." Health care providers can also use the site to download posters and brochures for their MSM clients.

Adefovir Dipivoxil and Tenofovir Are Highly Efficacious Therapies in HBV Patients with Lamivudine Resistance
August 13, 2004-  Emergence of lamivudine (Epivir-HBV)-resistant hepatitis B virus (HBV) is a major concern in HIV and HBV coinfected patients. Treatment of patients with new nucleotide analogues such as adefovir dipivoxil/ ADV (Hepsera) or tenofovir disoproxil fumarate/ TDF (Viread) has shown good efficacy in controlling wild-type or lamivudine-resistant HBV replication. Read Full Article. 

High HBV Transmission Rates in Prisons Are Preventable
August 5, 2004- Rates of hepatitis B virus (HBV) transmission are high in state correctional facilities. However, most inmates appear to be willing to undergo vaccination, which would prevent HBV transmission during incarceration and reduce transmission in the community after their release. Reuters Health Information, 2004. Read Full Article. 

In Dose Escalation Study, Clevudine Shows Potent Anti-HBV Effects 24 Weeks After Cessation of Once Daily Dosing
August 2, 2004- Current approved therapies for the treatment of chronic hepatitis B virus (HBV) infection are limited in their ability to produce a cure or to durably suppress the virus. Several promising new anti-HBV drug candidates are now in Phase II or Phase III clinical trial, including entecavir (Phase III), emtricitabine (Phase III; NDA filed), peginterferon alfa-2a (Pegasys) (Phase III), telbivudine (Phase III), valtorcitabine (Phase II), amdoxovir (Phase II), and clevudine (Phase II in US; Phase III in South Korea). Clevudine is a pyrimidine analog that has demonstrated potent anti-HBV activity in vitro and in animal models. Read Full Article.

Management of the Coinfected Patient: HIV/Hepatitis B and HIV/Hepatitis C
July 27, 2004- Deaths from liver disease have increased in persons infected with human immunodeficiency virus (HIV) because of coinfection with chronic hepatitis B and C; consequently, all HIV-infected patients should be screened for hepatitis B and C, and all those susceptible should be vaccinated for hepatitis B. Read Full Article.

Roche Files for Application with FDA to Market Leading Hepatitis C Medication Pegasys(R) for Chronic Hepatitis B Treatment
July 26, 2004- Roche announced today the submission of a supplemental new biologics license application (sBLA) with the U.S. Food and Drug Administration to market Pegasys® (peginterferon alfa-2a) for the treatment of chronic hepatitis B (CHB). Simultaneously, Roche has also filed with the European Medicines Agency to market Pegasys for this indication in the European Union. Pegasys received FDA approval for the treatment of chronic hepatitis C in October 2002 and today is the most prescribed chronic hepatitis C medication in the U.S. "Hepatitis B is a serious public health threat worldwide and can be deadly if left untreated," said Salvatore Badalamente, M.D., Medical Director, Roche. "We are committed to offering Pegasys as a new option to the millions of people throughout the world who are chronically infected with hepatitis B." Read Full Article.

Efficacy of Hepatitis B Vaccination and Interferon Alfa Combination Therapy Versus Interferon Alfa Monotherapy in Children with Chronic Hepatitis B
June 30, 2004- Although interferon (IFN) has been approved in the treatment of chronic hepatitis B in children, it is effective only in 30-40% of this population. In some studies it has been suggested that therapeutic use of anti-hepatitis B virus (HBV) vaccine may be beneficial in patients with chronic hepatitis B. Read Full Article.

HBV and HCV Diagnostic Tests Recalled
July 26, 2004 — The U.S. Food and Drug Administration (FDA) recalled Cobas TaqMan and TaqMan 48 analyzers (made by Roche Molecular Systems, Inc.) on May 24 due to reports of falsely elevated test results, according to an alert sent on Saturday from MedWatch, the FDA's safety information and adverse event reporting program. Read Full Article.

Plant-Derived MAb to HBV Surface Antigen May Provide Treatment Alternative
June 23, 2004- Japanese scientists have successfully used transgenic tobacco cells to produce the human monoclonal antibody (MAb) to hepatitis B virus (HBV) surface antigen (HbsAg). This work demonstrates the "feasibility of producing MAbs to HbsAg in plants as an alternative to anti-HBs human immunoglobulins," Dr. Akira Yano from the National Institute of Public Health in Tokyo and colleagues write in the June issue of the Journal of Medical Virology. Read Full Article. 

Even With Undetectable Levels, Hep B Persists in Liver With Chronic Hep C Infection
June 21, 2004- Hepatitis B virus (HBV) can persist in the liver of patients with chronic hepatitis C without detectable hepatitis B virus DNA in serum, according to a report in the June Journal of Medical Virology. "Our data suggest that the overall prevalence of HBV infection is higher than that known at present, since patients may have HVB-DNA in liver without any other viral marker in serum," lead author Dr. Vicente Carreno from Fundacion para el Estudio de las Hepatitis Virales, Madrid, Spain, told Reuters Health. Read Full Article.

Pegylated Interferon Has Primary Role in Treatment of Chronic Hepatitis B
June 18, 2004- Studies of 4 to 6 months of treatment with conventional interferon alfa for hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection have shown clearance of HBeAg to be higher in treated patients than it is in controls by approximately 25%. These results are considerably better than those from studies of antiviral agents. Read Full Article.

Unusual Cases of HBV Transmission
June 2004- IAC published an education piece titled "Unusual Cases
of Hepatitis B Virus Transmission." This piece replaces the 1994
article "No Risk?? No Way!!" The updated document may be useful to both health professionals and selected members of the public. It was developed to respond to parents who question the necessity of vaccinating infants against HBV [hepatitis B virus] because they believe that only sexually promiscuous persons or drug users could ever become infected with the virus. The piece presents 21 scenarios of HBV transmission via medical procedures, team sports, day care, school, and more. All cases were reported in peer-reviewed journals and citations are provided. "Unusual Cases of Hepatitis B Virus Transmission" is available in ready-to-copy (PDF) format at www.immunize.org/catg.d/p2100nrs.pdf

Telbivudine, a Promising Experimental HBV-specific L-nucleoside
June 2, 2004-  The L-nucleoside telbivudine (LdT) is an investigational new drug for the treatment of chronic hepatitis B. This report highlights the current evidence for the efficacy and safety of this promising antiviral agent. Data from both pre-clinical studies and randomized controlled clinical trials are reviewed. Read Full Article. 

Tolerance of Interferon Alfa Therapy in Children with Chronic Hepatitis
May 26, 2004- The objective of the current study was to assess the side effects of interferon alfa (IFN-a) therapy in children with chronic hepatitis B. This prospective study was performed on 100 children by interviewing the patients and their parents; clinical examinations and laboratory investigations were performed during and after therapy. Read Full Article.

High Viral Load is a Risk Factor for Hepatocellular Carcinoma in Patients With Chronic Hepatitis B Virus Infection
May 24, 2004- How does the serum level of HBV-DNA correlate with progression of the disease? What is the relationship between the level of HBV-DNA and hepatocarcinogenesis in patients with chronic HBV? [J Gastroenterol Hepatol 19(6) 2004]  Read the Full Article

Coffee, Caffeine Consumption Associated With Reduced Liver Disease
May 21, 2004- A U.S. population study of 5,944 adults conducted by researchers at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has found a strong association between coffee drinking and caffeine consumption and a lower risk of liver injury in persons at high risk for liver disease. Read Full Article.

Among Children Who Were Nonresponders to Interferon, One Year Treatment with Lamivudine Provided Benefits
April 30, 2004- Data regarding the effect of extended lamivudine (Epivir-HBV) treatment in children who failed to respond to previous IFN alfa therapy are scarce. Therefore, the effects of lamivudine treatment on ALT activity, HBV DNA and HBeAg seroconversion as well as the occurence of YMDD mutant and adverse effects were determined. Read Full Article.

Readily Obtainable Data Can Predict Inflammation and Fibrosis in Patients with Chronic HBV and May Remove the Need for Liver Biopsies in Some Patients
April 28, 2004- Histologic activity index (HAI) has been shown to correlate with antiviral response in patients with chronic hepatitis B (CHB) and fibrosis determines the urgency of treatment. The objective of the current study was to develop models using readily available objective data to predict inflammation and fibrosis in patients with CHB. Read Full Article

For more information, visit the Hepatitis B Research List. For the latest news from journal articles, abstracts, and more, subscribe to this free electronic list at HBV_Research-on@mail-list.com.

 

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