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Week Ending: August 15, 2009
Alan Franciscus
Editor-in-Chief
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This Issue:
August 11, 2009
Eiger BioPharmaceuticals Announces Initiation Of CLEAN-1 HCV Phase 1b Trial
www.prnewswire.com
- Proof of Concept Study Investigating NS4B-RNA Binding Inhibitor
Eiger BioPharmaceuticals, Inc., a biotechnology company developing antiviral therapies, announced that the first patients have been dosed in an innovative clinical trial in patients chronically infected with the hepatitis C virus (HCV). The trial, run in centers in Australia and New Zealand, will investigate the antiviral effect of clemizole monotherapy in the absence of interferon.
CLEAN-1 will evaluate the safety and antiviral activity of clemizole, a first generation antihistamine, in 28 days of oral therapy in treatment-naive patients infected with HCV genotypes 1 and 2. This direct antiviral study represents an important first step in evaluating the therapeutic potential of inhibiting a new target in HCV -- small molecule inhibition of the interaction between NS4B and HCV-RNA that is required for HCV replication.
"This proof of concept study is an important first step in our comprehensive development strategy for clemizole and newly discovered NS4B-RNA binding inhibitors for the treatment of HCV," said David Cory, President and CEO of Eiger. "Inhibiting the NS4B-RNA interaction represents an exciting new approach toward developing interferon-free, virus-specific agents to treat HCV."
Eiger BioPharmaceuticals recently announced the acquisition of the exclusive license to this novel HCV technology, discovered in the labs of Stanford scientist and Eiger Founder, Dr. Jeffrey Glenn, M.D., Ph.D. and colleagues. Clemizole targets a non-structural protein found in the HCV genome, NS4B, which binds to HCV-RNA and is required for virus replication. Disrupting the function of this protein represents a new approach to treat HCV infection and may be associated with less drug resistance than polymerase and protease inhibitors in development.
About NS4B and Clemizole
Binding of the non-structural protein NS4B to the 3' terminus of the HCV negative RNA strand is a recently identified target for drug intervention. The requirement of this target for viral replication has been genetically validated. The two component nature of this target, involving interaction between NS4B and HCV-RNA, creates mutational constraints that should decrease resistance to pharmacologic inhibitors, compared to agents designed against a single component target such as the NS3 protease. Clemizole hydrochloride was identified as a specific inhibitor of NS4B-RNA binding. Clemizole, a first generation antihistamine, was widely used in Europe and in the U.S. beginning in the late 1950's, marketed under various brand names, for the management of allergic disorders and various dermatological conditions. Clemizole is no longer marketed as a single agent antihistamine anywhere in the world.
"In the process of studying clemizole's newly discovered anti-HCV activity, we have found that it not only has several unique and remarkable features of its own that can make it ideal for hepatitis C, but clemizole also appears to be able to significantly increase the efficacy of other agents in clinical development," said Jeffrey Glenn, Founder of Eiger. "Together this suggests that clemizole has the potential to be an ideal component of all future anti-HCV cocktails."
About Eiger BioPharmaceuticals, Inc
Eiger is focused on the discovery and development of new antiviral agents against novel targets for the treatment of hepatitis virus infections. Eiger's pipeline includes repurposed clinical stage therapeutic agents as well as preclinical NCEs from discovery that exhibit antiviral activity against Hepatitis C, Hepatitis D, and other viruses.
Source: Eiger BioPharmaceuticals, Inc.
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Metabolic Bone Disease In Cirrhosis Patients
http://www.medicalnewstoday.com
Long-standing liver disease has long been recognized to result in fragile bones with increased risk of fractures. In various international studies, the overall incidence has varied from 11% to 48%, with a fracture rate of 3%-44%. However, the reason for this is poorly understood. With liver transplantation becoming a viable option in liver disease and offering complete cure and long-term survival, bone disease is becoming the major determinant of survival and quality of life in these patients.
A research article published in the World Journal of Gastroenterology addresses this problem. The research team was led by Tushar R Bandgar from KEM Hospital, India.
They found that low bone formation and increased resorption led to fragile bones in these patients. Contributing factors identified were inadequate sunlight exposure, reduced physical activity, low body weight, vitamin D deficiency and low level of testosterone. They also demonstrated that the severity of bone loss was accelerated in patients with low IGF-1 level. IGF-1 is normally synthesized in the liver and its synthesis is affected early in cirrhosis. The present study also found that the increased estrogen level seen in cirrhosis was protective against osteopenia.
These results shed new light on bone disorders seen in patients with cirrhosis. As most of the factors identified are correctable or treatable, it should provide additional help in treatment of these patients, such that they have better quality of life and survival.
Reference:
George J, Ganesh HK, Acharya S, Bandgar TR, Shivane V, Karvat A, Bhatia SJ, Shah S, Menon PS, Shah N. Bone mineral density and disorders of mineral metabolism in chronic liver disease. World J Gastroenterol 2009; 15(28): 3516-3522
http://www.wjgnet.com/1007-9327/15/3516.asp
Source: Lai-Fu Li, World Journal of Gastroenterology
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ANA773 Demonstrates Significant Antiviral Response In Early Clinical Trial In Hepatitis C Patients
http://www.medicalnewstoday.com
Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) pannounced viral load data for the final cohort of hepatitis C patients in a Phase I clinical trial of ANA773, the Company's oral inducer of endogenous interferons that acts via the toll-like receptor 7 (TLR7) pathway. In patients who received 2000 mg ANA773 every other day over 10 days, the mean (+/-SEM) maximal decline in viral load was 1.3 (+/-0.4) log10, compared to a mean maximal decline of 0.3 (+/-0.1) log10 in patients who received placebo (p=0.037). Five of the eight patients who received 2000 mg ANA773 experienced a maximal decline of greater than 1 log, while none of the eight patients who received placebo experienced a decline of greater than 1 log (p<0.001 for the proportion of patients with maximal response greater than 1 log compared to placebo). The mean end-of-treatment decline was 0.6 log10 in patients who received 2000 mg ANA773 compared to 0.1 log10 in patients who received placebo. ANA773 was well-tolerated in patients throughout the course of the study and there were no serious adverse events reported.
"ANA773 has demonstrated a significant short-term antiviral response in HCV patients, comparable to many historical reports of interferon as a single agent," commented Steve Worland, Ph.D., Anadys' President and CEO. "Given its oral delivery and favorable tolerability profile to date, we believe that ANA773 holds promise as a potential replacement for injectable interferon products in HCV therapy. We intend to seek partnership opportunities to continue advancing the development of ANA773, with the objective of creating well-tolerated, all oral combination regimens to treat hepatitis C."
James L. Freddo, M.D., Anadys' Senior Vice President, Drug Development and Chief Medical Officer added, "We are very encouraged by this data and the potential to further improve response by combining ANA773 with other agents, including ribavirin, an agent that improves response to interferon. Additionally, alternative dosing schedules may further improve pharmacological response to TLR7 activation, as was seen in preclinical studies of ANA773."
In an earlier cohort in which six patients received 1600 mg ANA773 every other day over 28 days, the mean (+/-SEM) maximal decline was 1.0 (+/-0.3) log10 (p>0.1 compared to placebo), with two patients experiencing a maximal decline of greater than 1 log during treatment. The mean end-of-treatment decline was 0.5 log10 at 1600 mg. Patients who received lower doses than 1600 mg showed correspondingly less antiviral response. The Company intends to present complete results from this study at the upcoming Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Oct. 30 - Nov. 3 in Boston.
ANA773 Phase I Clinical Trial in HCV
The Phase I clinical trial of ANA773 in HCV was conducted in the Netherlands under a two-part protocol. Part A of the study included both single and multiple doses of ANA773 in healthy volunteers. Successive cohorts of volunteers received ascending dose levels of ANA773. The primary objectives of Part A of the study were to assess safety and tolerability. Full results from Part A of the study were presented at the EASL Conference in April of this year. In Part B of the study, HCV patients received ANA773 every other day for either 28 or 10 days. The primary objectives of Part B were to assess safety, tolerability and viral load decline. Doses initially explored in Part B of the study were 800 mg, 1200 mg, and 1600 mg dosed every other day for a period of 28 days. Based on the viral load data from the 1600 mg cohort, in April of this year Anadys amended the protocol to include a fourth cohort of HCV patients who received 2000 mg of ANA773 dosed every other day over a period of 10 days.
About ANA773 and TLR Pharmacology
ANA773 is the Company's oral inducer of endogenous interferons that acts via the toll like receptor 7 (TLR7) pathway. Results from preclinical pharmacology studies have shown that ANA773 can elicit desired immune responses and that the profile of response can be modulated by both dose and schedule of administration. Results of completed 13-week GLP toxicology studies have shown that with every-other-day dosing of ANA773, immune stimulation of a magnitude believed to confer therapeutic potential can be achieved without adverse toxicology findings. The immune stimulation observed with every-other-day dosing of ANA773 in preclinical studies included induction of interferon-alpha and interferon dependent responses at levels that are sustained over 13 weeks of dosing. Furthermore, dose-dependent stimulation of innate immune response in healthy volunteers was observed in Part A of the Phase I clinical trial with ANA773 (presented at EASL, 2009).
About Anadys
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C. The Company believes hepatitis C represents a large unmet medical need in which meaningful improvements in treatment outcomes may be attainable with the introduction of new medicines. The Company is developing ANA598, a non-nucleoside polymerase inhibitor for the treatment of hepatitis C. The Company has also investigated the potential of ANA773, an oral, small-molecule inducer of endogenous interferons that acts via the Toll-like receptor 7, or TLR7, pathway in hepatitis C.
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PTC Therapeutics Announces Achievement of Major Milestone in Schering-Plough Hepatitis C Collaboration
http://www.bio-medicine.org
SOUTH PLAINFIELD, N.J., Aug. 10 /PRNewswire/ -- PTC Therapeutics, Inc. (PTC) today announced that it has reached a major research milestone in its collaboration with Schering-Plough Corporation (NYSE: SGP) receiving a $2 million payment in connection with the designation of a development candidate for the treatment of hepatitis C virus (HCV) infection.
The collaboration began in March of 2006 based on PTC's HCV efforts that were initiated using the GEMS(TM) technology (Gene Expression Modulation through Small Molecules). Under the terms of the collaboration, PTC and Schering-Plough are conducting a joint research program and Schering-Plough will be responsible for development and commercialization efforts worldwide. Schering-Plough made an upfront payment of $12 million in 2006 and PTC may earn additional milestone payments if specific development, regulatory and commercial goals are achieved. Total payments to PTC could exceed $200 million. Schering-Plough will receive exclusive worldwide commercialization rights for any approved products and pay PTC royalties on worldwide net sales.
"This important milestone represents the third development candidate arising from our novel technologies and research efforts and demonstrates PTC's ability to identify potential treatments across multiple therapeutic areas. We are very gratified to reach this milestone with Schering-Plough, a recognized leader in antiviral research and a wonderful partner to PTC," said Stuart Peltz, Ph.D., president and CEO of PTC Therapeutics. "Hepatitis C is an area of great unmet medica l need and we are pleased to be on the road to provide additional treatment options for patients."
About GEMS(TM)
Gene Expression Modulation by Small-molecules (GEMS(TM)) is PTC's novel and proprietary technology platform for the identification of small-molecules that modulate post-transcriptional control mechanisms. Compounds identified through the GEMS technology target processes that act through the untranslated regions (UTRs) of messenger RNA (mRNA) molecules. PTC has successfully employed the GEMS technology in drug discovery programs in oncology, infectious diseases, cardiovascular diseases, and neuromuscular disorders with corporate partners such as Celgene, Gilead, Pfizer, and Schering-Plough.
SOURCE PTC Therapeutics, Inc.
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August 12, 2009
Protesters seek cheaper drugs at HIV/AIDS meeting
www.reuters.com
By Tan Ee Lyn
BALI, Indonesia, Aug 12 (Reuters) - A small band of protesters holding aloft a banner disrupted a large HIV/AIDS conference in Indonesia on Wednesday to demand access to drugs to treat HIV patients dying from Hepatitis C.
The World Health Organisation says 4-5 million people living with HIV/AIDS around the world are also infected with hepatitis C, a disease that can cause liver failure.
"Hepatitis C + silence = death," read the banner carried by protesters accusing pharmaceutical giant Roche AG (ROG.VX) of setting the price of a drug to fight Hepatitis C virus (HCV) too high for dying patients to afford.
Protesters said pegylated interferon, a drug marketed by Roche and intended to flush out the virus, costs $1,500 a month.
"Shame on you Roche, shame on you!" they chanted.
Roche was not immediately available for comment.
Most people infected with both HIV and Hepatitis C are injecting drug users. Both diseases are blood borne and transmission is through the sharing of used needles and other equipment, even cotton swabs.
Although international health agencies and governments have sought to make HIV drugs available to sufferers, high costs limit access to treatment for hepatitis C in most countries.
According to the WHO, injecting drug users are excluded from treatment in many countries due to fears of the interaction between drugs and the likelihood of reinfection.
But Nanao Haobam, who is infected with both viruses, said such an approach was untenable as patients were dying.
"In my community back home, I have seen more than 50 (HIV positive) people die because of HCV. There must be many more than that," he said.
Haobam, 38, is a former injecting drug user and now an HIV/AIDS activist in Bangkok. He told Reuters he learned he was HIV positive in 2000 and was diagnosed with HCV two years later.
"I was on treatment, but that didn't get rid of all the HCV. I recently saw a doctor and he advised me to start treatment for hepatitis as I am now in the initial stage of cirrhosis," he said.
"But I just can't afford it, I have to leave this matter in the mercy of God."
Failure to treat cirrhosis, the hardening of the liver, will lead to a patient requiring a transplant or dying.
The prevalence of chronic HCV infection among patients with HIV in western Europe and the United States is estimated at 25 to 30 percent. In Asia, 80 to 90 percent of injecting drug users who are HIV positive are co-infected with HCV.
Co-infection rates average over 40 percent in eastern Europe and extend to 70 to 95 percent in Estonia, Russia and Ukraine.
"If governments can't make the drug available, the least they can do is to get rid of the patent, so that generic versions can be made," Haobam said.
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Pioneer in fight against hepatitis and HIV: Ron Lucas, 1932-2009
http://www.brisbanetimes.com.au
Ian Gust
PROFESSOR Ron Lucas played a critical role in the development of the hepatitis A vaccine as a physician at Melbourne's Fairfield Hospital.
He was later a key medical figure in HIV-affected communities when AIDS began to appear in the 1980s.
Lucas was also a leader in a dispute at Fairfield Hospital in the 1970s that forced the Victorian government to intervene and replace the new medical superintendent and the board. The superintendent had sought to radically alter the hospital.
Not long after, the new hospital board established a research centre, which later became the Macfarlane Burnet Centre for Medical Research, now the Burnet Institute. Lucas was appointed to the inaugural board of the centre and was a key person in its success.
Charles Ronald Lucas, who has died aged 76, was born in Ballarat and attended Ballarat Grammar School when it was led by the well-known educator and playwright G.F. ''Jack'' Dart. After completing school, Lucas became a resident at Trinity College while he studied medicine. His great passion was cricket, he was an accomplished left-handed batsman who represented Melbourne University with distinction. Former colleague and Test spin bowler Doug Ring always said had Lucas not lost five years of his cricketing career to medicine, he would have probably played for Victoria and possibly Australia.
After graduating, Lucas spent a brief period at Horsham Base Hospital before being recruited in 1964 by John Forbes to Fairfield Hospital for Communicable Diseases, where he remained until he retired in the early 1990s.
An outstanding physician, he worked closely with the laboratory team: initially pathologist Joan Schiavone and biochemist Jacov Kaldor and then for 20 years with myself, a virologist. The 1970s and '80s were an exciting period for developments in virology at Fairfield, and Lucas, while primarily a clinician, used his role to challenge existing paradigms, create hypotheses and help others, with different skills, to sort out the answers.
With the advent of diagnostic tests for hepatitis B and later hepatitis A, he worked closely with the virology team, laying the building blocks for the current knowledge of the natural history of those diseases, as he did later with hepatitis C.
During the 1970s Lucas pioneered a number of techniques to combat fulminant hepatitis B in Australia and was thrilled when a vaccine was developed and the disease largely disappeared. He also had a critical role in the development of the hepatitis A vaccine, caring for a large family with hepatitis A infection at Fairfield Hospital, from whom HM175, the strain that became the basis of the world's first licensed vaccine, was isolated.
For several years, workload permitting, Lucas and a couple of colleagues played midweek cricket with the Seagulls, an eclectic bunch of ageing footballers, cricketers and couldabeens.
During the dispute with the hospital's new superintendent, the huge respect with which Lucas was held by his peers was a significant factor in the resignation of most of the medical staff and the threatened resignation of the scientific team that forced the Victorian government's intervention.
With the arrival of AIDS in the 1980s, Fairfield became the hospital at which most patients with the disease in Victoria were managed. There was a great deal of anxiety among the public and many health professionals, but Lucas's calm, pragmatic and non-judgmental approach endeared him to the HIV-affected communities.
He paved the way for the establishment of dedicated clinics to provide care for HIV-infected individuals and acted as a guide and role model for an entire generation of infectious-diseases physicians and physician scientists.
In 1977 he was one of the founding members of the Australian Society for Infectious Diseases and organised the first five or six national ASID meetings. He was also a clinical teacher of medical students from both Monash University and Melbourne University for about 30 years. For his contributions to teaching and his academic achievements, earlier this year Lucas was honoured with a professorial appointment from Monash University.
After he retired in 1992, he spent time in New Zealand to establish the first hepatitis B immunisation program there before settling back at his property at Eltham, indulging his other passions of woodwork and gardening. His finely turned furniture made from jarrah fenceposts recovered from Fairfield Hospital's grounds were highly sought after, as was his company.
Lucas, married first, Elaine Hall in 1956 and that marriage ended after 13 years; they had three children. He was then partner and husband to Jo Cornish for 40 years, and they had one child. He is survived by Jo, his children David, Eric, Kate and Michael, three grandchildren, and his older brother, Ken.
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Snohomish County health district laying off 25 more employees
http://seattletimes.nwsource.com
By Charles E. Brown
Seattle Times staff reporter
Snohomish County's health district is making more cuts to local programs and staff, for the third time this year.
Effective Oct. 1, budget shortfalls will result in layoffs for 25 health district employees, and cuts for the district's Sexually Transmitted Disease Clinic, its home-visiting and disease-investigation programs and its tuberculosis- and hepatitis-prevention programs.
The health board also cut $150,000 in funds for emergency preparedness.
The cuts were announced today at the county Health Board meeting.
The health district said it is still $200,000 short of a balanced budget this year, with a projected $1.2 million shortfall for next year, despite previous cuts, a short-term loan from Snohomish County and a yearlong hiring freeze.
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FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs
www.hcvadvocate.org
On August 12, 2009 the U.S. Food and Drug Administration (FDA) released final rules governing expanded access to investigation drugs for people with serious illnesses. Later today the FDA will launch a new Web site geared toward patients and medical providers to explain the final rules. The FDA hopes that the new rules will expand the use of investigational drugs across different disease states for people with potentially serous illness.
HCSP/HCV Advocate will closely follow the implemention of the expanded access program and advocate for people living with HCV who face serious illness. Please circulate this information to others including people living with hepatitis C, HCV service and medical providers. We need to raise the level of education and awareness about expanded access to potentially life-saving drugs.
---------------------------------
FDA NEWS RELEASE
For Immediate Release: Aug. 12, 2009
Media Inquiries: Karen Riley, 301-796-4674,
karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs
The U.S. Food and Drug Administration published two rules today that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options.
To support the effort to help these patients, the agency also is launching a new Web site where patients and their health care professionals can learn about options for investigational drugs. In general, these options include being treated with a drug that has been approved by FDA, being given an investigational drug as part of a clinical trial, or obtaining access to an investigational drug outside of a clinical trial.
The new rule, “Expanded Access to Investigational Drugs for Treatment Use,” makes investigational drugs more widely available to patients by clarifying procedures and standards. The other rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” clarifies the specific circumstances and the types of costs for which a manufacturer can charge patients for an investigational drug when used as part of a clinical trial or when used outside the scope of a clinical trial.
“With these initiatives, patients will have the information they need to help them decide whether to seek investigational products,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand.”
Clinical trials are studies of drugs and biologics that are still in development and have not yet been approved by the FDA. Many patients enroll in clinical trials to gain access to investigational therapies and contribute to finding out how well an investigational therapy works, and how safe it is for patients. Obtaining a drug or biologic under an expanded access program may be an option for some patients who are not able to enroll in clinical trials.
The FDA has allowed expanded access to experimental drugs and biologics since the 1970s. That access has allowed tens of thousands of patients with HIV/AIDS, cancer, and other conditions to receive promising therapies when no approved alternative is available.
“The final rules balance access to promising new therapies against the need to protect patient safety and seek to ensure that expanded access does not discourage participation in clinical trials or otherwise interfere with the drug development process,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Clinical trials are the most important part of the drug development process in determining whether new drugs are safe and effective, and how to best use them.”
Additional Information
Web site that explains the options for investigational drugs
Final Rules for Expanded Access to Investigational
Drugs for Treatment Use and Charging
for Investigational Drugs
August 13, 2009
Open Letter about Hepatitis B in China
http://hbversinchina.blogspot.com/
Wen Yu
Dear Mr. Franciscus,
I am a Chinese Hepatitis B virus carrier. I on behalf of 130 million Chinese Hepatitis B virus carriers turn to you for help.
Hepatitis B discrimination in China is very serious. The Chinese government is planning to enact a policy to permit kids who carry Hepatitis B virus to enter kindergartens. This policy is in the hearing process (the deadline is Aug. 15). There are many opposed voices in the Chinese society. *Please help us to convince the government to pass this policy and other related policies!*
From 1990s to present, kids who are carrier are disenfranchised the right of entering kindergartens. They have no friends to play with, they cannot receive preschool education and they are labeled as “infection patients”. You can image that almost every kid in this situation has more or less psychological health problem. Please help these disadvantaged children and their heart-broken mothers.
According to professional theories, people may be infected Hepatitis B by three methods: blood-borne transmission, sexually transmission, and maternal-neonatal transmission. The healthy virus carriers have no hazards to the public. However, because of misunderstandings and some policies, the Hepatitis B carriers are discriminated and nearly abandoned by the whole society.
Fortunately, Chinese government already realized this issue and began to modify some related policies and laws step by step. However, the most critical policies and laws are still in the pending status. Please share your professional thoughts of how to treat people with disease equally. Please help us to get more support from international experts of infectious disease or gastroenterology. We do need your professional knowledge to help us convince the Chinese society.
Hepatitis B discrimination in China is so critical that following population groups need your help.
Pregnant women and newborns: Most carrier pregnant women are forced to deliver babies in infection hospitals which means the babies’ birth certificates are marked “born in infection hospital”. These cute babies have to carry this burden for the whole life no matter he/she is Hepatitis B carrier or not, just because their mothers are virus carriers. They are labeled since born. We admit that some pregnant women need to deliver babies in infection hospitals because their health condition, but for healthy carriers, please do not force them!
Preschool children: About 90-95% babies of carrier mothers are lucky to avoid infected Hepatitis B by shooting vaccines. However, there is still 5-10% babies become Hepatitis B carriers. As mentioned above, no kindergarten accepts them. Discrimination, aloneness, depression and other negative influences accompany with them since about 2 years old and last for their whole lives. Please give them a chance to play and learn in kindergartners like other kids!
Students in elementary schools, junior/senior high schools: Most schools accept carrier students, but there are still some schools refuse to accept carrier students or force carriers to drop off schools!
Students in higher education areas: Carrier students have fewer boundaries to apply undergraduate programs than to apply graduate programs. There are quite a lot of graduate schools refuse to admit carriers no matter how outstanding the students are. Please help them to realize their dreams!
Young people in job markets: Experiencing all challenges above, these carriers eventually graduate and begin to look for jobs. They can pass several competitive interviews, but there are shoot down by blood test. No offers, no future, no hope. Please give them work opportunities. They need to live!
You may wonder that health history should be personal privacy. Technically, you are right. Medical history should not be disclosed to anyone unless the person him/herself agree. But, Hepatitis B carriers in China have not any privacy. We are labeled, we are discriminated, and we need your help!!!
Below are some links relevant to Hepatitis B discrimination. These articles are only a tiny part of an iceberg. Most of articles talk about suicide caused by discrimination. I did not select articles related to depression, anxiety and other negative experience because there are too many. I am sorry that all articles are in Chinese. If you need, I could translate some of them.
Again, appreciate for your great help in advance! We cordially turn to your for help. Please use your expertise, no matter in which field, to help us.
Best Regards
A carrier
******************************************
Hepatitis B Discrimination Report
http://www.hbver.com/Article/ygqs/ygqs
/200908/6649.html
Some carrier mothers’ experience: no kindergarten accepts their kids:
All mothers are suffering blame from family members, discrimination from society and guilty when they face their kids. A mother even killed her son and then committed suicide in 2008.
http://www.chinaedunet.com/yejy/jjnews/
2009/5/content_169989.shtml (May, 2009)
Zhou Yichao’s story:
Zhou was an outstanding and sunshine young man. After graduated from a famous university, he passed all interviews in local government recruitment. However, because he was a carrier, he was rejected. He killed two HR persons and then waited for arrest. Zhou was executed for voluntary manslaughter. He was the only child of a widow and was only 22 years old at that time. http://www.people.com.cn/GB/shehui
/1063/2692956.html (Jan. 2003)
Lei Chuang;s story:
Lei was rejected by a graduate school of Chinese Academy of Science (CAS) because he is a carrier. He wrote letters to 500 academicians and asked them for help. Finally, although the CAS didn’t admit him, he was admitted by another graduate school.
http://www.china.com.cn/city/txt/2008-10
/22/content_16647727.htm (Sep. 2008)
A 18 years old young man committed suicide because of Hepatitis B discrimination
http://bbs.66wz.com/viewthread.php?
tid=189862 (Jul. 2006)
A young female carrier committed suicide because she was fired by a company and cannot found other jobs
http://www.people.com.cn/GB/shehui/47
/20020411/707346.html (Mar. 2000)
A 16 years old student was forced to drop of school because he is a carrier http://news.dayoo.com/society/57401/200904
/15/57401_5694601.htm (Apr. 2009)
A Ph. D student committed suicide because he was a carrier
http://news.qq.com/a/20050213/000031.htm (Feb. 2005)
A 32 years old young man committed suicide by burning himself because of Hepatitis B discrimination
http://www.qingdaonews.com/content/2007-02/16/content_7728065.htm (Feb. 2007)
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Just call man at center of hepatitis cases Dr. Delay
http://www.lasvegassun.com
By Jeff German
Desai’s lawyers slow civil, bankruptcy cases to crawl
Attorneys for Dr. Dipak Desai, who is squarely at the heart of litigation over last year’s hepatitis C outbreak, are mounting the best possible defense on his behalf: stall, stall and stall.
They know the courts aren’t nearly as speedy as one of Desai’s endoscopy clinics.
So, in the face of overwhelming evidence against the owner of the endoscopy center that was ground zero for the outbreak, Desai’s lawyers know that stalling is easily accomplished.
One significant and simple way to stall the civil lawsuits is to protect Desai behind the bankruptcy filing of his clinics. Check.
And then, delay the bankruptcy proceedings. Check.
“It’s a classic legal strategy,” says Will Kemp, one of the lead plaintiffs’ lawyers in the massive litigation over the hepatitis scare. “When you don’t have any defense, you delay.”
Three of Desai’s clinics, including the Endoscopy Center of Southern Nevada, filed for bankruptcy protection last month, just as key depositions were about to take place.
That action alone temporarily put the patients’ litigation on hold, potentially delaying the first trials scheduled for October. Some 5,000 former patients, including more than 200 who allege sloppy medical procedures caused them to be infected with the hepatitis C virus, are suing Desai and his clinics.
U.S. Bankruptcy Judge Mike Nakagawa has scheduled a hearing for Aug. 26 on whether to allow those lawsuits to proceed in District Court.
But the bankruptcy proceedings exposed Desai to another set of risks — revealing a potential gold mine of financial information relevant to the patients’ litigation and a parallel criminal investigation.
That’s when the doctor’s lawyers implemented another stalling move.
On Tuesday, the day Desai was to sit down with bankruptcy court investigators and face tough questions under oath about his business affairs, Nakagawa postponed the grilling.
The subpoena ordering Desai to appear for questioning requires him to bring two years worth of bank statements from his clinics beginning in July 2007. The subpoena also asks for the 2007 and 2008 tax returns of Desai and the clinics.
Desai is likely to have to give up those documents at some point, but when investigators will get a chance to question Desai about them is uncertain.
One of Desai’s criminal attorneys, Margaret Stanish, struck an agreement with the bankruptcy trustee to delay the examination for at least a month to allow Stanish time to present evidence in court that Desai is too sick to answer financial questions. In July 2008, Desai’s lawyers reported that he had suffered a stroke.
There is a chance Desai may never be questioned in Bankruptcy Court. According to the agreement, Stanish intends to seek a court order from Nakagawa preventing the examination from taking place.
Ed Bernstein, another lead plaintiffs’ lawyer in the endoscopy litigation, says this is a typical legal move on the part of Desai, who has a long track record of being “missing in action” in the case.
“He was competent enough to meet with his lawyers to make a decision to file bankruptcy,” Bernstein explains. “But now he’s trying to say he’s not competent enough to answer questions.”
Desai this year resorted to a different delay tactic in the endoscopy litigation. He asserted his Fifth Amendment right against self-incrimination and refused to answer key questions about the operation of his clinics. He supposedly was too sick to show up to a sworn deposition himself, so he sent Stanish in his place to take the Fifth for him.
But is Desai really that sick?
Two weeks ago a clinical neuropsychologist hired by the Nevada State Medical Examiners Board concluded that Desai is well enough to stand up to the rigors of disciplinary proceedings before the board. As a result, the board’s executive director stated the board would move forward with a hearing on whether to take away Desai’s medical license.
The board isn’t alone in not buying Desai’s latest ill-health claims. The plaintiffs’ lawyers are skeptical, too. And who can blame them?
“It seems like another way to try to avoid responsibility for his actions,” attorney Marni Rubin says. “What it comes down to is that they’re playing dirty, and they’re playing sneaky.”
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16 Patients Test Positive for Hepatitis at Siouxland Urology
http://www.ksfy.com
By Chuck Harmer
Attorneys for former patients at Dakota Dunes based Siouxland Urology say some patients have tested positive for blood borne illnesses. In April, we learned the clinic had used "one time" medical supplies, multiple times on multiple patients, possible exposing patients to blood borne illnesses. Soon after, five patients filed a class action lawsuit. Attorneys for those patients say some Siouxland Urology clients have tested positive for blood borne illnesses.
At the home of Mark Crabtree, a stay at home dad, he was a Siouxland Urology patient and returned for a blood test this Spring. He tested negative for Hepatitis but Mark tells KSFY he's still concerned because there's still more testing to be done. "I went in for the original test. I got the paperwork back it said it was negative but that I should re-test in six months because the HIV portion of it could take as much as 6 months to show," stated Mark.
Mark says that uncertainty has been tough to deal with as a dad, "My kids get hurt you know do I treat them? What do I do? It's, you know, it's scary."
In response to the new class action lawsuit filing, Siouxland Urology center is trying to assure patients they have nothing to be scared of. So far, it says there are no positive HIV tests and in response to the hepatits cases, it released a statement saying, "The Center conducted extensive reviews of the medical records and blood test results of cystoscopy patients treated before and after patients who tested positive. The review revealed no evidence of patient-to-patient transmission of hepatitis as a result of the cystoscopy procedure."
Despite the response, Mark is considering his own lawsuit at least until he undergoes his second test, "I still think about it daily. i mean i have to get another test and like i said, with my kids and my wife it's really scary."
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Number of Hepatitis A cases now at 30
http://www.qctimes.com
Deirdre Cox Baker
The 30th case of hepatitis A from a summer outbreak of the disease in the Quad-City region this summer was reported today. The Illinois Department of Public Health and the Rock Island County Health Department reported the total number of cases, saying they are all related to people who visited a McDonald's restaurant at 400 W. 1st St., Milan, Ill., this summer.
Rock Island County has its 16th reported case, an individual who visited the Milan McDonald's during both June and July, officials said. "This individual is not in a sensitive occupation and does not pose a risk to the public," said Theresa Foes, a spokeswoman for the Rock Island County Health Department.
The hepatitis A vaccine or a drug called immune globulin will be provided to the patient's contacts, she said.
Confirmed cases of hepatitis A from the Quad-City outbreak stretch from Woodford County, near Peoria, Ill., to Scott County, Iowa. Rock Island County has the most with 16, while four victims are from out-of-state, Illinois authorities said. Other Illinois counties with residents who have been diagnosed are Mercer, Henry and Warren.
The Rock Island County Health Department inoculated more than 5,324 area residents against the disease. All of them visited the Milan McDonald's in early or mid-July.
The Rock Island County Sheriff's Department completed an investigation this week into the reporting of the disease. An investigator concluded that Trinity Regional Health System and Metropolitan Medical Laboratory, both of which were involved during the initial phases of the outbreak, failed to promptly report confirmed cases to the health department. A delay in acting on the belated reports then occurred because a health department employee was on vacation.
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CEUS: To Diagnose Postoperative Vascular Complications after Liver Transplantation
www.medicalnewstoday.com
A research article published on August 7, 2009 in the World Journal of Gastroenterology addresses this problem. Contrast-enhanced ultrasound (CEUS) has been applied gradually in recent years because of its fine vascular tracing and perfusion visualization. A research team led by Professor Yan Luo from West China Hospital found that CEUS improved the flow visualization of the hepatic artery, portal and hepatic veins and bridging vein, as well as evaluation of liver graft parenchyma perfusion. CEUS has high sensitivity and specificity for finding hepatic artery thrombosis, hepatic artery stenosis, portal vein thrombosis and liver infarction. CEUS can be performed at the bedside, and has no iodine allergy or X-ray exposure. Therefore, this new technique should be used more frequently after liver transplantation.
Although this study included a limited number of patients, the research is interesting and the results are useful for diagnosis of vascular complications early after liver transplantation.
Reference:
Luo Y, Fan YT, Lu Q, Li B, Wen TF, Zhang ZW. CEUS: A new imaging approach for postoperative vascular complications after right-lobe LDLT. World J Gastroenterol 2009; 15(29): 3670-3675 http://www.wjgnet.com/1007-9327/15/3670.asp
Source: Lin Tian, World Journal of Gastroenterology
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Evaluation of Spot Urine Test to Monitor Dietary Sodium Compliance in Liver Disease Patients
www.medicalnewstoday.com
A research article published in the World Journal of Gastroenterology addresses this question. The study designed by Dr. El-Bokl and performed by Dr. Senousy and colleagues evaluated using spot urine Na/K ratio as an alternative. Forty patients with liver cirrhosis and ascites were admitted to Ain Shams University Hospital in Cairo, Egypt. The spot urine tests were compared to the standard 24-h urine collection test.
Results showed adequate accuracy for the spot urine test. Also, it had adequate sensitivity and specificity in identifying patients that were not compliant to the diet. Previous studies have been published as abstracts and showed similar results, however, the study performed by Dr. Senousy is considered to be the first full publication that explains the method of the study and research details.
Dietary sodium restriction is an important aspect in the treatment of ascites. Noncompliance can be misinterpreted as diuretic resistance, which can lead to unnecessary higher diuretic doses, or even using other forms of treatment like aspiration of ascitic fluid. The authors state that the new test is more practical compared to urine collection and it allows identification of patients that are noncompliant, for whom the next step should be diet education rather than increasing diuretic dose.
Reference:
El-Bokl MA, Senousy BE, El-Karmouty KZ, Mohammed IEK, Mohammed SM, Shabana SS, Shalaby H. Spot urinary sodium for assessing dietary sodium restriction in cirrhotic ascites. World J Gastroenterol 2009; 15(29): 3631-3635 http://www.wjgnet.com/1007-9327/15/3631.asp
Source: Lin Tian, World Journal of Gastroenterology
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Can Sequential TACE and Cryosurgery Improve Survival Times for Patients with HCC?
www.medicalnewstoday.com
Hepatocellular carcinoma (HCC)--a liver cancer--is recognized as one of the most common cancers in the world that disproportionately affects Southeast Asians and Africans. While there are therapies that possibly provide a cure, surgical removal and liver transplantation are invasive and radical options. However, even these approaches only benefit a small proportion of the total number HCC patients. Cryosurgery is a minimally invasive technique of using extreme low temperatures to freeze and kill tumors, improve patient' survival times, and reduce surgical complications. Cryosurgery can be potentially applied to any surgery for solid organ cancers where conventional surgery would otherwise be used to remove undesirable tissue. It is anticipated that in the near future, cryosurgery will increasingly replace the use of traditional techniques of ablation.
A research article discussed was published on August 7, 2009 in the World Journal of Gastroenterology. This article will address the best method to treat HCC which can not be removed by operation. The findings of this study are significant to the procedures that are performed daily at Fuda Cancer Hospital Guangzhou, and will hopefully change the practices at other cancer centers as well.
TACE is based on the fact that normal liver gets its blood supply from two sources: the portal vein (about 70%) and the hepatic artery (30%). HCC gets its blood exclusively from the hepatic artery. TACE works by sending a catheter up the hepatic artery and its branch, and then injecting embolic material. Embolization blocks the tumor-feeding vessels and leads to cancer cell death and tumor shrinkage. Without this procedure, the hepatic artery and branches would continue to feed the liver tumor and allowing it to continue growing.
TACE performed prior to cryoablation may be expected to increase the efficacy of the cryoablation for HCC, to decrease local recurrence at the ablation area, improve survival times, and reduce bleeding complications. Cryosurgery combined with TACE, allows a broader group patients with HCC to be treated. Previously, only a small portion of HCC patients could be treated with conventional methods; even then, only those with small tumors. If TACE is performed prior to cryosurgery, more patients can be treated, even those with larger tumors.
Reference:
Xu KC, Niu LZ, Zhou Q, Hu YZ, Guo DH, Liu ZP, Lan B, Mu F, Li YF, Zuo JS. Sequential use of transarterial chemoembolization and percutaneous cryosurgery for hepatocellular carcinoma. World J Gastroenterol 2009; 15(29): 3664-3669 http://www.wjgnet.com/1007-9327/15/3664.asp
Source: Lin Tian, World Journal of Gastroenterology
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August 14, 2009
Results of Enhanced Hepatitis Surveillance Program Assessed
http://www.modernmedicine.com
Program may improve care for HCV infection but places heavy burden on local health departments
THURSDAY, Aug. 13 (HealthDay News) -- Enhanced surveillance programs for hepatitis C virus (HCV) infection can expedite care to infected individuals, but it places a heavy burden on local health departments and there is currently no evidence that it will reduce infection or death rates, according to a study by the Centers for Disease Control and Prevention (CDC) published in the September issue of Emerging Infectious Diseases.
R. Monina Klevens, D.D.S., of the CDC in Atlanta, and colleagues assessed the data on new cases of HCV infection discovered following enhanced surveillance programs in Colorado, Connecticut, Minnesota, New York, Oregon, and Pinellas County, Florida. The CDC assessments included the number of laboratory reports associated with each new case and the accuracy of epidemiologic information collected, including demographics and clinical test results.
The authors report that the enhanced surveillance identified a total of 20,285 new cases of confirmed HCV infection for an annual rate of 69 new cases per 100,000 population. Eight-nine percent of cases were identified by clinical laboratories, most frequently as the result of a positive test for HCV RNA (53 percent). For every four laboratory reports, approximately one new case of HCV infection was identified.
"Local health departments need chronic HCV infection surveillance to document effects of disease, identify persons in need of linkage to care, and prevent complications among persons infected," Klevens and colleagues conclude. "However, accurately collecting the necessary information is challenging for health departments, and we currently lack evidence that obtaining these data will result in a lower incidence of illness and death."
Full Text
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Hepatitis C Virus Coinfection Ups Risk of HIV-Related Infections
www.medscape.com
Anthony J. Brown, MD
August 14, 2009 — HIV-infected patients coinfected with hepatitis C virus (HCV) are over three times more likely to develop an HIV-related bacterial or mycotic infection compared with their HCV-negative counterparts, new research shows.
By contrast, HCV coinfection does not increase the risk of non-Hodgkin lymphoma, according to the report in the August 15th issue of Clinical Infectious Diseases.
"At present, with the exception of lymphoma, there are few data concerning the risk of specific opportunistic diseases in HCV-infected and -uninfected patients," Dr. Antonella d'Arminio Monforte, from San Paolo University Hospital Milan, Italy, and colleagues note.
In the present study, the researchers assessed the impact of chronic HCV infection and HCV-related cirrhosis on the development of AIDS-defining illnesses in a large cohort of HIV-infected patients from Italy. The study featured 5397 patients who were categorized into three groups: no HCV, HCV with cirrhosis, and HCV without cirrhosis.
During 25,105 person-years of follow-up, 496 AIDS-defining illnesses occurred. Mycotic infections, principally Pneumocystis jiroveccii pneumonia, and bacterial infections, primarily Mycobacterium tuberculosis infection, were the most common AIDS-defining illnesses, accounting for 154 and 133 of cases, respectively.
Rates were low, the authors note; for example mycotic and bacterial infections had a rate of 5-6 per 1,000 person-years of follow-up.
HCV coinfection increased the odds of developing an AIDS-defining illness by 2.61-fold, the report indicates. More specifically, HCV coinfection was linked to 3.87-, 3.15-, and 2.68-fold increased risks of mycotic disease, bacterial infection, and HIV-related disease (wasting syndrome and AIDS dementia complex), respectively.
Overall, coinfection was associated with a 2-fold increased risk of developing AIDS than were HIV-monoinfected patients. Their data also indicated that the increased risk of AIDS-related illnesses was not affected by use of antiretroviral therapy.
By contrast, HCV coinfection was not associated with elevated risks of non-Hodgkin lymphoma, viral infection, or protozoal infection.
Among HCV-infected patients, those with cirrhosis were at greater risk for mycotic infection, bacterial infection, toxoplasmosis, and HIV-related disease than were those without cirrhosis.
"Clinicians should take these data into account in their clinical management of HCV-coinfected patients, in particular when deciding when to start antiretroviral therapy," the authors advise.
The current study "provides important findings that may affect the clinical management of HCV-HIV coinfection," Dr. Lionel Piroth, from Centre Hospitalier Universitaire de Dijon, France, comments in a related editorial.
"It highlights and strengthens the need for careful follow-up of HCV-HIV-coinfected patients," he added, "including preventive measures (screening, prophylaxis, and vaccination for preventable diseases), effective management of associated comorbidities (particularly addictions), and early and effective therapies against HIV and HCV."
Clin Infect Dis. 2009;49:612-622, 623-625. Abstract
Merck and Schering-Plough Shareholders Approved Pending Merger
www.hivandhepatitis.com
Pharmaceutical companies Merck and Schering-Plough said last week that their respective shareholders have approved plans for a merger announced earlier this year, with more than 99% approval. The deal is expected to close in the fourth quarter of 2009, assuming regulatory approval.
Merck produces the recently approved HIV integrase inhibitor raltegravir (Isentress) and the older protease inhibitor indinavir (Crixivan). Schering-Plough manufactures pegylated interferon alfa-2b (PegIntron), used to treat hepatitis C. The combined company will have a portfolio of 8 drugs in late-stage development, including the CCR5 antagonist vicriviroc and the promising HCV protease inhibitor boceprevir.
Below are excerpts from press releases from the 2 companies announcing the shareholder approval.
Merck Shareholders Approve Merger With Schering-Plough
Whitehouse Station, NJ -- August 7, 2009 -- Merck & Co. (NYSE: MRK) today announced that its shareholders voted overwhelmingly to approve the proposed merger with Schering-Plough (NYSE: SGP). The preliminary tabulation indicates that more than 99% of shares voted were in favor of the transaction. Merck today held its special shareholder meeting in Bridgewater, New Jersey to vote on the proposed merger.
"We are gratified by the shareholder confidence demonstrated through the outcome of today's vote," said Richard T. Clark, Merck's Chairman, President and Chief Executive Officer. "On behalf of Merck's Board and management team, I want to thank our shareholders, customers and dedicated employees for their support throughout this process. We look forward to completing the merger with Schering-Plough and to creating a strong, global leader that can make a substantial difference to patients and global healthcare."
As previously announced on March 9, 2009, under the terms of the agreement, Schering-Plough shareholders will receive 0.5767 of a share of new Merck common stock and $10.50 in cash for each share of Schering-Plough. For Merck shareholders, existing Merck share certificates will automatically represent an equal number of shares in the new Merck after completion of the merger.
The company expects the transaction to close in the fourth quarter of 2009, as originally planned. The transaction remains subject to the satisfaction of customary closing conditions and regulatory approvals, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, as well as clearance by the European Commission under the SEC Merger Regulation and certain other foreign jurisdictions.
All proxy cards and ballots submitted at the special meeting were processed by IVS Associates Inc. for final tabulation and certification. Final voting results will be publicly announced promptly after they have been tabulated and certified.
Schering-Plough Shareholders Approve Merger With Merck
Boston, MA -- August 7, 2009 -- Schering-Plough Corporation (NYSE: SGP) announced the voting results of a special shareholders meeting today regarding the proposed merger with Merck & Co., Inc. More than 99 percent of votes cast voted to approve the merger agreement, with more than 78 percent of common shares voting.
"Today's vote by our shareholders reflects the potential they see to create a strong global health care leader by combining these two companies," said Fred Hassan, Schering-Plough chairman and CEO. "After six years of transformation under our Action Agenda, our Schering-Plough colleagues can be very proud of the strengths and diversity we have created. As we move closer to realizing this merger, we will continue to focus on driving our business and advancing our strong late-stage pipeline until closing."
The merger, which is expected to close in the 2009 fourth quarter, is subject to the satisfaction of customary closing conditions and regulatory approvals, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, as well as clearance by the European Commission under the EC Merger Regulation and certain other foreign jurisdictions.
In the merger, Schering-Plough shareholders will receive 0.5767 of a common share in the combined company (to be called Merck) and $10.50 in cash for each Schering-Plough common share. Each Merck share will become a share of the combined company. Following completion of the merger, it is anticipated that the combined company will continue the dividend policies of Merck, currently a quarterly cash dividend of $0.38 per common share (subject to declaration by the board of directors and a variety of factors including business and financial considerations).
Sources
Merck & Co. Merck Shareholders Approve Merger With Schering-Plough. Press release. August 7, 2009.
Schering-Plough Corp. Schering-Plough Shareholders Approve Merger With Merck. Press release. August 7, 2009.
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