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Week Ending: January 22nd, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• State Plan to Combat Viral Hepatitis
• Piercing Shop Owners Getting Ready to Open Tattoo Shops
• Bayer Wins US FDA Approval for Automated Hepatitis C Test UPDATE
• Hepatitis C the Silent Disease
• Discontinuation of Pegylated Interferon plus Ribavirin Therapy
• Patient Concerns Regarding Chronic Hepatitis C Infections
• The Survival Benefit of Liver Transplantation
• C-ing the Light: People Who Know They Have Hepatitis C Fight the Stigma Along with the Disease
• Altor BioScience Corporation Establishes Collaboration with Leading Massachusetts General Hospital Investigator to Develop TCR-based Agents to Detect and Treat HIV and HCV Infection
• S.A. Firm at the Center of New Int'l AIDS Prevention Program
• BML Now Accepting Orders for Invader-based Hepatitis B Virus Genotype Testing
• U.S. Warns of Safety Risks of Boehringer AIDS Drug
• Health Department Revaccinating Children and Adults
• Lives Improving for Hepatitis B Sufferers
• Doctors Stand with Govt against Hepatitis
• Organetix, Inc. Announces Hepatitis C Patients Continue to Progress and Plans to Commence a Double Blind Placebo Controlled Study in Second Quarter of 2005
• Over 200,000 Suffer from Deadly Hepatitis C in Iran
• Pegasys Receives Positive Opinion in the European Union for the Treatment of Chronic Hepatitis B
• Peginterferon Alfa-2a for Hep C after Liver Transplantation
• Antivirals for Cirrhotic Hep C Reduce Hepatocellular Carcinoma
• Coffee and Caffeine Consumption Reduce the Risk of Elevated Serum Alanine Aminotransferase Levels
• Harney Apologises Formally on Hepatitis C Case
January 18th, 2005
State Plan to Combat Viral Hepatitis
SourceURL:http://www.allamericanpatriots.com
January 18, 2005 -- Augusta--Although thousands of Mainers are affected by viral hepatitis, many are unaware that they are infected or at risk. With the potential for outcomes such as cirrhosis, liver cancer, or death, earlier rather than later intervention is essential.
Today, the Maine Department of Health and Human Services, Bureau of Health released a 3-year plan for confronting this emerging health issue. The publication, entitled, "Viral Hepatitis Prevention and Control: An Action Plan for Maine," was created after receiving input from a statewide group of 70 experts and patient advocates. "The most important thing a person can do to prevent viral hepatitis is to become informed. If you think you are at risk, ask your health care provider for information about testing or vaccination," said Dr. Lani Graham, Acting Director of the Bureau of Health.
The Plan includes goals, objectives, and action steps describing how to prevent new hepatitis infections as well as how to help persons who are already infected.
Core components of the Plan include strategies for advocacy and funding, medical and social service provider education, general public education, care and support for persons infected, and prevention of new infections.
Some major activities outlined in the Plan include:
Educating Maine health care providers, social service providers, and allied health workers about viral hepatitis.
Developing a statewide viral hepatitis media campaign for the general public.
Educating persons at highest risk about viral hepatitis.
Creating a grassroots advocacy network for persons affected by and infected with hepatitis C.
Creating a statewide viral hepatitis coalition to increase funding for prevention, testing, and treatment.
Creating Regional Centers of Excellence (RCE) for primary health care providers to obtain clinical guidance on complex viral hepatitis cases.
Developing an Integrated, Coordinated, Comprehensive System (ICCS) of care and support for persons at-risk for and/or infected with hepatitis C.
Viral hepatitis refers to infections caused by several different viruses that affect the liver: hepatitis A, B, and C. All of these viruses cause acute, or short-term viral hepatitis. The hepatitis B and C viruses can also cause chronic or long-term hepatitis. Hepatitis A is found in the feces of a hepatitis A-infected person and is most commonly spread either by person-to-person contact or ingestion of contaminated food or water. Hepatitis B and C are found in blood and certain body fluids. Both viruses are spread when blood or body fluids from an infected person enters the body of a non-infected person. While there are vaccines to prevent hepatitis A and B, there is currently no vaccine to prevent hepatitis C. Each year, approximately 1,300 cases of viral hepatitis are reported to the Maine Department of Health and Human Services, Bureau of Health. Chronic hepatitis C accounts for the majority of the reported cases and greatest burden of disease. With an estimated 20,000 persons in Maine infected, fewer than 30 percent are aware of their hepatitis C infection status. As a result, opportunities for preventive and therapeutic care that could slow or eliminate the progression of the disease are lost.
To obtain a copy of the Plan or to learn about viral hepatitis and/or hepatitis testing and vaccination resources in Maine, check out: www.mainepublichealth.org. Click on "Hepatitis Program."
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Piercing Shop Owners Getting Ready to Open Tattoo Shops
SourceURL:http://www.fox21.com
A Hepatitis outbreak forced health investigators to shut down tattoo parlors back in the 1950's, but that's about to change. George Nelson, owner of "Body Links" says the phone is ringing off the hook at his shop in Spartanburg. It's a shop that specializes in body piercing but he says the calls aren't about the latest belly rings, he says callers want to know about tattoos.
"My telephone rings three to four times a day wanting to know how much tattoos will cost and when we can start doing it," said Nelson.
He opened "Body Links" about seven years ago when he moved from Florida after finding out Tattoos were illegal in South Carolina. Now he's opening a new tattoo shop and Ashley Cox says she can't wait for the doors to open.
"I want a fairy tattoo and that's what I'm going to do on my birthday. My dad is taking me and I've been waiting for one," commented Cox.
You have to be 18 to get a tattoo and in the past customers would have to cross state lines to get one.
"We went to Gastonia when we got my sister's and they made appointment after appointment and sometimes they got canceled and it was a waste of time and gas," commented Cox.
However, before a new shop opens artists must follow regulations handed down by the State Department of Environmental Control like training and how to sterilize instruments properly.
"Sterilization is important to keep everything clean keep from spreading disease and cross contamination," said Nelson.
It's what Nelson says he does everything before piercing and what he plans to do in his new shop. Before owners are able to open a shop, they must first get a permit from the Department of Environmental Control and become certified. Lawmakers are expected to pass a final bill in late March.
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Bayer Wins US FDA Approval for Automated Hepatitis C Test UPDATE
SourceURL:http://uk.biz.yahoo.com
LEVERKUSEN, Germany (AFX) - Bayer AG (Xetra: 575200.DE - news) 's HealthCare Diagnostics division said its automated hepatitis C test has been approved by the US Food and DrugAdministration.
The test is developed, manufactured and sold by Bayer Diagnostics for Ortho-Clinical Diagnostics, Inc, a subsidiary of Johnson & Johnson (NYSE: JNJ - news) .
A Bayer spokeswoman explained that the test has been developed for Bayer's ADVIA Centaur Immunoassay System, a fully automated invitro diagnostic testing-lab which can perform more than 100 blood tests per minute.
John Nosenzo, senior vice president in North America for Bayer HealthCare Diagnostics said the test will make the testing of at-risk individuals a more routine and reliable (procedure), reducing errors often garnered through manual test methods. The ADVIA Centaur System can test other conditions, such as cancer,cardiovascular diseases, fertility and allergy.
The automated hepatitis C test was approved in Europe, Latin America and Asia Pacific in April 2003.
The spokeswoman would not offer details as to what the test's peak sales potential in the US is, or the test's current annual sales.
In 2003 the Bayer group posted sales of 28.5 bln eur, with the HealthCare contributing 8.8 bln eur.
The ADVIA Centaur System had sales of 387 mln eur in 2003.
Hepatitis C is a viral infection of the liver that affects an estimated 200 mln people worldwide, or around 3 pct of the world's population.
ragnhild.kjetland@afxnews.com
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Hepatitis C the Silent Disease
SourceURL:http://www.herald-review.com
By BETHANY CARSON H&R Staff Writer
DECATUR - Bob Moody is one of many middle-aged adults realizing the effect of an illness he most likely contracted 30 years ago, but he doesn't know exactly when or how he got it.
He called it a silent illness. Communities often don't know what it is. People infected might not know they have it. Even those who know they have it might seal their lips because of a stigma associated with the disease.
It's Hepatitis C, an inflammation of the liver caused by certain viruses. It can lead to chronic liver disease or cancer, but it's difficult to detect and diagnose, according to one Decatur specialist.
"The majority of people have no signs or symptoms," said Dr. Venkat Minnaganti, infectious disease specialist. "At some point in the illness, they might feel some abdominal pains. Fatigue is one of the most common."
A liver functioning test can also reveal the infection. Others discover their infection when trying to donate blood because blood banks screen for Hepatitis C and HIV.
When the infection started, however, is another common unknown.
Those who received a blood transfusion or an organ transplant prior to 1992 should be tested, according to the Illinois Department of Public Health.
And about 80 percent of the people who share needles to inject drugs are infected with Hepatitis C.
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Discontinuation of Pegylated Interferon plus Ribavirin Therapy
SourceURL:http://www.gastrohep.com
Early discontinuation of 'ineffective' anti-viral therapy is unpopular with patients, reports the most recent issue of Alimentary Pharmacology and Therapeutics and further education regarding the cost-effectiveness will be needed if early discontinuation is to be accepted.
Current therapy for chronic hepatitis C infection involves a course of pegylated interferon and ribavirin.
Patients who do not show a virological response after 12 weeks of therapy have a low probability of sustained virological response and it is therefore recommended that such patients stop treatment.
Dr D'Souza and colleagues from London undertook a study in order to assess patients' views of early treatment cessation.
The researchers conducted a open-labelled study in 3 UK centres, using patients with biopsy-proven chronic hepatitis C requiring therapy.
The research team offered the participants the choice of a full course of therapy with 40 kDa pegylated interferon- 2a plus ribavirin (24 or 48 weeks depending on viral genotype) or early cessation if therapy had failed after 12 weeks.
4% of patients did not achieve an early virological response with the 40-kDa pegylated interferon- 2a plus ribavirin—Alimentary Pharmacology and Therapeutics
The researchers enrolled 95 participants in total and the majority (69%) did not wish to discontinue therapy even if it had low probability of success.
In this unselected UK population, the researchers found that very few patients (4%) did not achieve an early virological response with the 40-kDa pegylated interferon- 2a plus ribavirin.
In addition, the research team noted that 2 of the 4 early virological non-responders decided to continue therapy.
Dr R. D'Souza concluded, "Early discontinuation of 'ineffective' anti-viral therapy may prove less popular with patients than with health care providers."
"Further patient-directed education regarding the cost-effectiveness of therapy will be needed if early discontinuation of unsuccessful therapy is to be accepted by patients."
Alimentary Pharmacology & Therapeutics; 2005: 21: (1): 43
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January 19th, 2005
Patient Concerns Regarding Chronic Hepatitis C Infections
SourceURL:http://www.gastrohep.com
A survey in January's Journal of Viral Hepatitis indicates that health care providers who focus counseling efforts exclusively on viral transmission are unlikely to address other important concerns of patients with chronic hepatitis C.
Counseling of patients with chronic hepatitis C infections is often limited to discussions regarding how the virus is transmitted and what can be done to decrease the risk of transmission to others.
Dr Minuk and colleagues from Canada designed a study in order to document the principal concerns of newly diagnosed and follow-up patients with chronic hepatitis C, and thereby enhance counseling strategies and content.
The researchers involved 70 newly diagnosed and 115 follow-up patients with chronic hepatitis C virus (HCV) infection in the study.
The participants were asked to identify those concerns that were of utmost importance to them.
The researchers asked participants, firstly in an open-ended manner (volunteered) and then they asked them to prioritize concerns from a prepared list of 7 potential ones (prioritized concerns).
The most common volunteered concerns of newly diagnosed patients was disease progression (27%)——Journal of Viral Hepatitis
The researchers found that the most common volunteered concerns of newly diagnosed patients were: disease progression (27%) and premature death (19%).
Also important concerns were infecting family members (13%), side-effects of treatment (11%) and miscellaneous others.
The research team recorded patients' prioritized concerns in descending order.
They included: infecting family members, development of liver cancer, infecting others, development of cirrhosis, social stigma of having liver disease, need for liver transplant and loss of employment.
The principal volunteered and prioritized concerns of follow-up patients were similar to those of newly diagnosed patients.
The researchers found that the volunteered and prioritized concerns were relatively consistent across the different genders, age groups, ethnic backgrounds, education level, marital status, employment, modes of viral acquisition and duration of follow-up.
Dr Minuk concluded, "These results indicate that health care providers who focus counseling efforts exclusively on viral transmission are unlikely to address other important concerns of newly diagnosed and follow-up patients with chronic hepatitis C infection."
Journal of Viral Hepatitis; 2005: 12 (1): 51
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The Survival Benefit of Liver Transplantation
SourceURL:http://www.gastrohep.com
With 1 year post-transplant follow-up, patients at lower risk of pre-transplant death do not have a demonstrable survival benefit from liver transplant, reports February's issue of the American Journal of Transplantation.
Demand for liver transplantation continues to exceed donor organ supply.
Comparing recipient survival to that of comparable candidates without a transplant can improve understanding of transplant survival benefit.
Dr Meriona and colleagues from Michigan, America undertook a study of waiting list and post-transplant mortality among a cohort of 12, 996 adult patients who had been placed on the waiting list between 2001 and 2003.
The investigators used time-dependent Cox regression models to determine relative mortality rates for candidates and recipients.
The researchers found that overall, deceased donor transplant recipients had a 79% lower mortality risk than candidates.
Survival benefit increased with increasing MELD score—American Journal of Transplantation
In addition, the research team found that at Model for End-stage Liver Disease (MELD) 1820, mortality risk was 38% lower among recipients compared to candidates.
Survival benefit increased with increasing MELD score; at the maximum score of 40, recipient mortality risk was 96% lower than that for candidates.
In contrast, the researchers found that at lower MELD scores, recipient mortality risk during the first post-transplant year was much higher than for candidates.
Dr Meriona concluded, "Liver transplant survival benefit at 1 year is concentrated among patients at higher risk of pre-transplant death."
"Futile transplants among severely ill patients are not identified under current practice."
"With 1 year post-transplant follow-up, patients at lower risk of pre-transplant death do not have a demonstrable survival benefit from liver transplant."
American Journal of Transplantation; 2005: 5 (2): 307
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C-ing the Light: People Who Know They Have Hepatitis C Fight the Stigma Along with the Disease
SourceURL:http://www.herald-review.com
By BETHANY CARSON - H&R Staff Writer
DECATUR - Bob Moody is one of many middle-aged adults realizing the effect of an illness he most likely contracted 30 years ago, but he doesn't know exactly when or how he got it.
He called it a silent illness. Communities often don't know what it is. People infected might not know they have it. Even those who know they have it might seal their lips because of a stigma associated with the disease.
It's hepatitis C, an inflammation of the liver caused by certain viruses. It can lead to chronic liver disease or cancer, but it's difficult to detect and diagnose, according to one Decatur specialist.
"The majority of people have no signs or symptoms," said Dr. Venkat Minnaganti, infectious disease specialist. "At some point in the illness, they might feel some abdominal pains. Fatigue is one of the most common."
A liver functioning test also can reveal the infection. Others discover their infection when trying to donate blood because blood banks screen for hepatitis C and HIV.
When the infection started, however, is another common unknown.
Those who received a blood transfusion or an organ transplant before 1992 should be tested, according to the Illinois Department of Public Health.
And about 80 percent of the people who share needles to inject drugs are infected with hepatitis C.
Otoniel "Tony" Delgado of Decatur hates drugs, alcohol and cigarettes for that reason.
"I hate that stuff with a passion," he said. "I hate what it does to people. I hate what it did to me. I hate what it does to the young kids running around. They don't know."
He abused injection drugs as a 20-year-old in Chicago. Now, the 55-year-old has a completely new life and, recently, a new liver.
He has also joined a group of infected adults to spread knowledge, not fear.
Detecting the disease
Delgado was diagnosed at a time when even the medical community did not have a high level of awareness about hepatitis C, in the early 1990s.
"I was having some medical problems, and my doctor didn't know exactly what it was," he said. "You don't feel anything. There was no pain involved."
A biopsy and blood tests revealed he had Type 1, the most difficult to treat.
Minnaganti said the level of awareness has increased since hepatitis C became a reportable disease in 2001.
Since then, 375 people have reported being hepatitis-C-positive in Macon County, said Dianna Heyer, nursing services coordinator for the Macon County Health Department.
She said most them are in their 40s and early 50s, but they've probably had it for years.
"I have some people who have had blood transfusions," she said. "Many of them report a history of injection drug use when they were teenagers.
"This is something they did a long time ago, and they only might have done it one time," she said. "(But) you don't have to be an injection drug user to have hepatitis C."
The disease is only transmitted from blood contact, not casual contact.
"It's not airborne," Heyer said. "It's not hugging. It's not kissing."
Sexual intercourse poses a 4 percent to 5 percent risk, as does breastfeeding.
Blood from a toothbrush, needle or even nail clippers, on the other hand, can pose a greater risk.
"Anything that can transmit blood can transmit hepatitis C," Heyer said.
The most important thing now, however, is not how each patient got it but how to give them support and understanding, she said.
Fighting the stigma
Bob Moody of Decatur was diagnosed almost three years ago.
"I didn't know what it was," he said.
He immediately told his plant manager and co-workers at Archer Daniels Midland Co. in Decatur that if he cut himself, they should not touch his blood.
That was after his physician told him he didn't have to disclose his diagnosis.
"I thought the adult thing to do was to tell them about something that could affect them," he said. "The most unfortunate thing with the disease is people are afraid to be known that they have it because of the stigma."
He compared the stigma to that of pregnant teenagers in the 1960s, as "something dirty" or the result of doing "something wrong."
Moody said that attitude needs to change.
"There is no shame in having the disease and fighting it," he said. "The only shame is that people may die of this disease because they're afraid to seek treatment because of the stigma and how they would be viewed by their peers."
He faced his diagnosis with an "I'm here, come and get me" attitude, but it was still difficult to accept.
"When you're faced with a terminal disease, and you don't know if there's any way out of it, and you don't know when it'll kill you, but it can, it (forces you to make) some real important decisions," he said.
For him, the important decision was he wanted to live rather than die.
Treating the disease
Deciding whether to undergo drug therapy is another of those important decisions.
"The treatment for hepatitis C is very complex," said Minnaganti. "It's still evolving."
Although he said the treatment is better than what it was a few years ago, the response to the drug therapy greatly varies. It's effective in less than half of the patients, according to the state health department.
The side effects are another consideration.
Moody was diagnosed with a more treatable genotype, Type 2B. His was told he could die of old age before he died of complications from hepatitis C.
But at 48 years old, he thought he "better go for the gusto."
He took the treatment, knowing there's no cure.
"At best, you can knock it back to the point it's not going to change your lifestyle," he said.
He called his treatment "ugly," initially feeling as though he had the flu.
Then, his eyes felt more sensitive to light. He sat in a dark room reading every "Harry Potter" book with his son's pit bull in his lap.
He sometimes felt sorry for himself.
"Here I am. I'm stuck. Where do I go from here?"
He experienced mood swings, felt things became insurmountable and was short-tempered with his wife of 30 years, Kathy.
"God love her because I was an ass," he said.
The side effects also included feeling suicidal, homicidal and depressed. Physically, his red and white blood cell count dropped.
"It's so uncertain," he said. "You have to keep your eyes on the prize."
Offering support
Eighteen months after his treatment ended, Moody said the Macon County Hepatitis C support group played an important role in his treatment.
"If you keep it inside, it'll drive you insane," he said, wiping his eyes with his white handkerchief.
The monthly support group started two years ago this month.
"We have people in our support group from all walks of life," Heyer said, "some who have had success with treatment, and some who have not."
Delgado is one whose body rejected multiple rounds of therapy, and he has had three near-death experiences since 2001.
Living through four years of repeated hospitalizations and liver cancer, Delgado found support in his wife of 36 years, Karen, their six children and 11 grandchildren, his church and his co-workers at the Decatur Public Library. He now offers his insight to others at the support group.
"The worst thing you can do is give up," he said. "The best thing you could do is educate yourself so you know what's going on with your body. It's not as scary."
Prevention
Growing stronger after his liver transplant at St. Louis University Liver Center, Delgado still wants to share his experience to make others more cautious.
"They start evaluating how they're living," he said.
Currently, the Macon County Health Department can screen people who have a history of injection drug use.
Lora Suter, a public health nurse instrumental in establishing the hepatitis C support group, said it's hard to catch new people.
"Because it's not spread person to person very easily, there's not a lot of motivation for the health care world and the government world to provide a lot of money to help eradicate this virus and to do research," she said.
The health department has received $20,000 a year since 2002 to start a screening program, according to Illinois Department of Public Health spokeswoman Tammy Leonard.
"They actually had a great program," she said.
The grant ran out in 2004, meaning the county will not receive any money for hepatitis C screenings this year.
By next year, the Illinois Department of Public Health hopes to submit a strategic plan to policymakers regarding hepatitis C programming and funding, Leonard said.
Bethany Carson can be reached at bcarson@herald-review.com or 421-6968.
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Altor BioScience Corporation Establishes Collaboration with Leading Massachusetts General Hospital Investigator to Develop TCR-based Agents to Detect and Treat HIV and HCV Infection
SourceURL:http://www.biospace.com/
MIRAMAR, Fla., Jan. 19 /PRNewswire/ -- Altor BioScience Corporation today announced that it has established a collaboration with Massachusetts General Hospital (MGH) and Howard Hughes Medical Institute to use viral specific T-cell receptors (TCR) for research, diagnosis and treatment of HIV and hepatitis C (HCV) infections. The collaboration brings together the leading HIV/HCV research program of Professor Bruce Walker, M.D., a Howard Hughes Medical Institute investigator at the Partners AIDS Research Center at MGH, characterizing immune responses in virally infected patients, and STAR(TM) technologies developed at Altor for soluble TCR-based targeting reagents.
Hing Wong, Ph.D., CEO of Altor, stated, "We are very excited about having the opportunity to work with Dr. Walker and his colleagues at MGH. Dr. Walker is one of the foremost authorities on viral antigen expression and the resulting T-cell immune responses in HIV and HCV infected patients. His laboratory has generated a number of different T-cells that react against these viruses. We have found that T-cells reactive against tumor associated antigens could be used to generate soluble TCR-based reagents, capable of quantitatively detecting antigens on cancer cells and inhibiting growth of primary tumors in animal models. This collaboration will allow us to extend our strategies to viral diseases."
Normally, TCRs on the surface of T-cells recognize disease targets on tumor or virus-infected cells. Altor has developed STAR(TM) technology to capture the disease recognition properties of the TCR in a soluble reagent. Altor's lead STAR molecule against cancer is currently in the late stages of pre-clinical development and is financially supported by a phase II SBIR grant from the National Cancer Institute.
Using STAR(TM) technology, Altor will work with Dr. Walker's laboratory to generate and test TCR-based diagnostic reagents. The goal of the collaboration is to better understand and monitor changes occurring during viral infection. If successful, Altor believes these studies could lead to immunotherapeutics that target HIV- or HCV-infected cells more effectively than currently available treatments.
About Altor BioScience:
Altor (http://www.altorbioscience.com/) is a privately held biotechnology company developing targeted immunotherapies for treating cancer, viral infections, and autoimmune diseases. Altor's patented technologies facilitate the production of soluble TCR and major histocompatibility complex molecules. Altor is employing these technologies to improve the safety and efficacy of existing therapeutics.
CONTACT: Peter Rhode, Ph.D. of Altor BioScience Corporation,+1-954-443-8601, or peterrhode@altorbioscience.com
Web site: http://www.altorbioscience.com/
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S.A. Firm at the Center of New Int'l AIDS Prevention Program
SourceURL:http://www.bizjournals.com
A new international initiative has been started in San Antonio aimed at protecting African health care workers from HIV and Hepatitis C infections during childbirth.
Dr. Richard Watson is leading this effort. He is the inventor of the Joey Umbilical Safety System, an innovative device that allows doctors to safely clamp and cut the umbilical cord and placenta of newborns. It is designed to protect health workers from the spray of blood from cutting the cord.
In the United States, there are devices and procedures that protect health care workers from becoming infected by blood and any blood-borne pathogens such as Hepatitis C and HIV.
However, the most common instruments used in Africa are a razorblade and string -- which places workers at a high risk for contracting a disease. In Malawi, Africa alone, 92 health care workers are expected to contract HIV/AIDS in the next 12 months because of being sprayed by blood by the cutting of the cord.
San Antonio-based Vital Needs International developed the Joey Clamp & Cutter and it has won three design awards since being approved by the Food and Drug Administration.
Watson has launched Joeyaid -- a collaborative program with Population Services International to distribute the device in Africa. PSI delivers products to more than 70 undeveloped countries.
"The focus of Joeyaid is to provide a safe childbirth delivery standard to skilled health care attendants in Africa and beyond," Watson says. "What he have found, tragically, are that midwives and other health care providers are positioned as disposable medical goods. Our team is now compelled to get Joeys and other needed medical products to Africa."
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BML Now Accepting Orders for Invader-based Hepatitis B Virus Genotype Testing
SourceURL:http://www.investors.com/
Tokyo, Japan, Jan 19, 2005 (JCNN via COMTEX) -- BML began accepting orders for HBV genotype, a testing service designed for laboratory use to determine genotypes of hepatitis B virus, from January 15.
Co-developed with Hiromitsu Kumada of the Toranomon Hospital, the HBV genotype, which is based on Invader assay, a gene analytic method developed by US company Third Wave Technologies, can determine subtypes of hepatitis B virus.
The new service is expected to clarify the correlation between virus genotypes and effective treatments. With a view to launching diagnostic products, the company plans to promote the service at clinical sites.
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U.S. Warns of Safety Risks of Boehringer AIDS Drug
SourceURL:http://www.reuters.com/
By Lisa Richwine
WASHINGTON (Reuters) - An important AIDS drug can cause sometimes deadly liver damage but remains a key option for many patients, U.S. health officials warned on Wednesday.
The Food and Drug Administration said doctors should weigh benefits and risks before prescribing the drug, Boehringer Ingelheim's Viramune, also known by the generic name nevirapine.
No serious liver toxicity or deaths have been reported when a single dose was given to prevent mother-to-child transmission of the deadly HIV virus that causes AIDS, the FDA said.
Nevirapine is distributed for that use in African countries as part of President Bush's effort to fight the spread of AIDS. The drug is also used in the United States.
Controversy has swirled recently in Africa, with South Africa's ruling African National Congress accusing U.S. officials of conspiring with Boehringer Ingelheim, a private company based in Germany, to hide nevirapine's side effects. U.S. health officials dispute the charge.
The FDA, in a statement, said cases of liver damage that produce a rash, fever or other symptoms were more common with nevirapine than with other HIV-fighting drugs. Some instances have been fatal, including some in pregnant women.
Females and patients with higher counts of infection-fighting cells called CD4 cells have greater risks of developing liver damage, the FDA said.
The FDA said side-effect warnings had recently been revised on the drug's prescribing information.
Nevirapine is one of the medicines used in drug cocktails that can suppress the HIV virus and keep patients healthy. HIV patients have limited options for suppressing the fatal virus, and alternative drugs also have serious side effects, the agency said.
"In spite of the potential for serious and life-threatening liver toxicity and skin rashes with nevirapine, there are multiple reasons why nevirapine remains an important part of an HIV treatment regimen (for many people)," the FDA said in a statement.
A Boehringer spokeswoman could not immediately be reached for comment on Wednesday.
The AIDS virus killed 2.3 million people in Africa in 2004.
Nevirapine came under question recently when a scientist from the National Institutes of Health, who was fired but is contesting the dismissal, charged a study of the drug in Uganda was sloppily run.
A committee of experts at the Institute of Medicine is reviewing the research to see if it was so flawed the data are useless.
The NIH has said the allegations are false and endanger the lives of babies because people will be afraid to use a valuable drug.
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January 20th, 2005
Health Department Revaccinating Children and Adults
SourceURL:http://www.fayettecountyreview.com/
Somerville, TN -- Parents of children who received vaccinations at the Fayette County Health Department between January 1, 2001 and October 31, 2004 are being asked to bring their children to the health department to be revaccinated, as well as adults who got hepatitis B or tetanus vaccinations during that period.
Health department officials say that vaccines were improperly stored at freezing temperatures, which made them ineffective in preventing disease.
"Anyone who got shots at the health department during this time is not fully protected against infectious diseases, but the ineffective vaccine is not harmful in any way," said Dr. Shavetta Conner, Regional Health Officer. "Any shots that were given during that time period will need to be repeated - except for measles, mumps, and rubella and chicken pox vaccinations which were not affected by the low storage temperature. It is particularly important to revaccinate children to make sure that they are not at risk for preventable illnesses."
Letters have been mailed to both adults and parents of children who were immunized at the Fayette County Health Department during that period to give them information about the revaccination effort and asking them to contact the health department for an appointment. All shots will be free of charge, and additional clinic times will be set up to make it more convenient. The number and timing of the repeated shots will be timed to make sure that there is no additional risk from getting repeat doses.
Dr. Conner said that the storage problem has been corrected, and the health department has taken steps to insure that vaccine is properly stored in the future. "Improper storage of the vaccine occurred because of an employee's error in monitoring the temperature. We regret that the mistake occurred and apologize for any inconvenience or anxiety this may cause health department clients. Our goal is to make sure that all children in Tennessee are fully protected from preventable diseases," said Dr. Conner.
For more information, parents may contact the Fayette County Health Department at 465-5243.
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Lives Improving for Hepatitis B Sufferers
SourceURL:http://english.peopledaily.com.cn
More than half of hepatitis B patients have lost out on an ideal job or educational opportunity because of their disease, a sample survey shows.
However, China has made some progress in protecting the working rights of hepatitis B virus (HBV) carriers, said Weng Xinhua, an expert from the Chinese Medical Association.
The Ministry of Personnel and the Ministry of Health revised national standards covering health qualifications for public servants saying that HBV carriers who do not show symptoms can still apply for jobs in the public service.
And Zhang Xianzhu, a young man in the city of Wuhu in East China's Anhui Province, won the country's first job discrimination case involving the rights of non-infectious HBV carriers in early 2004.
Zhang sued the Wuhu municipal government's personnel bureau in December of 2003 after he was rejected for employment because he has HBV.
And Central China's Hunan Province also cancelled the regulation forbidding HBV carriers to be public servants last year.
Meanwhile, the amended Chinese Prevention and Treatment of Infectious Diseases, which became effective last December 1, also says that companies and persons cannot discriminate against HBV carriers.
China has 120-million HBV carriers, nearly one 10th of its population, and 30 million of them have become active patients, said Weng at a meeting yesterday.
But Weng added: "The hepatitis B virus (HBV) brings out a lot of bad effects on people's health, work, and family and social activities."
Among these bad effects, discrimination is still a quite severe problem, said Weng yesterday in Beijing, as he reported the results of the survey to the media.
About 52 per cent of the 425 hepatitis B patients surveyed said they once lost a job or educational chance due to their disease.
And 47 per cent worry their employers might lay them off if they discover they are HBV sufferers. The survey is actually done by Synovate Healthcare, a company headquartered in London.
The patients come from six cities, including Shanghai, Beijing, Guangzhou, Chengdu, Wuhan and Shenyang. They took the survey from October to November of 2004.
Source: China Daily
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Doctors Stand with Govt against Hepatitis
SourceURL:http://www.dailytimes.com.pk/
LAHORE: The Pakistan Society of Gastroenterology on Wednesday announced that it would help the government control hepatitis, said Dr Muhammad Saeed Khokhar, the project director of the Services Institute of Medical Sciences.
“Hepatitis B and C are affecting almost 10 percent of the total population of the country and hospitals are flooded with patients suffering from this disease,” Dr Khokhar said on Wednesday.
He said that the spreading of the disease could be controlled with adopting preventive measures and that the gastroenterology society has decided to cooperate with the federal and provincial governments in this regard.
Dr Khokhar stressed the need to utilise print and electronic media as well as non-government organisations to raise awareness about the preventive measures. He suggested that hepatitis B vaccination in the Expanded Programme of Immunisation be included for infants. APP
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Organetix, Inc. Announces Hepatitis C Patients Continue to Progress and Plans to Commence a Double Blind Placebo Controlled Study in Second Quarter of 2005
SourceURL:http://biz.yahoo.com
NEW YORK, NY--(MARKET WIRE)--Jan 20, 2005 -- Organetix Inc. http://www.organetixinc.com (OTC BB:OGTX.OB - News) announced today that the Hepatitis C patients from the June 2004 study are continuing to use the Company's A4+L formula and continue to enjoy a significant improvement in their quality of life. Organetix intends to conduct a follow-up study by the end of March 2005.
Organetix, Inc. also plans to commence a new double-blind study involving a larger sample size with a placebo control during the second Quarter of 2005. Current laboratory results are continuing to support the safety and efficacy of the A4+L liver formula. These results will also support and strengthen all future patent applications.
About Organetix, Inc.
Organetix, Inc. (www.organetixinc.com) is a biotechnology company that is in the process of treating patients with a unique nutraceutical that appears to relieve symptoms of Hepatitis C. Organetix has the exclusive worldwide rights for this nutraceutical product. Hepatitis C is a life-threatening, blood-borne, liver disease that is caused by a virus. It is estimated that millions of individuals worldwide are infected with Hepatitis C making it one of the greatest public health threats faced in recent years.
Statements contained in this press release, which are not historical facts, are forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based largely on the Company's expectations and are subject to a number of risks and uncertainties beyond the Company's control, including but not limited to economic, competitive and other factors affecting the Company's operations, management team effectiveness, expansion strategies, available financing, market prices and recovery costs, government regulations involving the Company, facts and events not known at the time of this release, and other factors discussed in the Company's filings with the Securities and Exchange Commission.
These statements are not guarantees of future performance and readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update publicly any forward-looking statements.
Contact:
Corporate Communications Group, Inc.
David Pomerantz
516-791-0000 ext. 102
david@ccgnewyork.com
Source: Organetix, Inc.
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Over 200,000 Suffer from Deadly Hepatitis C in Iran
SourceURL:http://www.iranfocus.com
Tehran, Jan. 20 --There are currently "200,000 sufferers of the Hepatitis C virus in Iran", according to the head of the Iranian Medical Association.
Speaking to a state-run news agency, Dr. Iraj Khosronia warned, "One of the most dangerous viruses affecting human society is Hepatitis C--but people's awareness about this disease is very limited".
Khosronia accused government-controlled media of deliberately avoiding the issue and said "if the media do not educate people in the necessary way then this disease will bring more harm than AIDS to our society. People have no information about the Hepatitis vaccines".
Hepatitis C is easily transmitted via blood is drug addicts who use syringes are most in danger of being infected, Khosronia said.
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January 21st, 2005
Pegasys Receives Positive Opinion in the European Union for the Treatment of Chronic Hepatitis B
Source: http://www.roche.com
First pegylated interferon to be indicated for treating chronic hepatitis B
Roche announced today that the Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for Pegasys (peginterferon alfa-2a (40KD)) for the treatment of chronic hepatitis B. The decision is granted for both types of the disease - HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB). The recommendation will now go to the EU Commission for final approval. Hepatitis B is a major public health concern with data suggesting that globally, more than 350 million people are infected with the virus and approximately one million die each year from the disease.
“Today marks another milestone in Pegasys’ history as an effective antiviral agent,” said Ciro Caravaggio, Head of the Hepatitis Franchise at Roche. “We set out to explore the potential of Pegasys in treating chronic hepatitis B and demonstrated its effectiveness against both forms of the virus and against the two leading medications used to treat it today, lamivudine and conventional interferon,” he said. “It’s also an achievement for Pegasys in that it becomes the only pegylated interferon indicated for the treatment of chronic hepatitis B.”
In contrast to lamivudine, Pegasys works with a dual mode of action: it stimulates the immune system as well as inhibits virus replication. This offers physicians a new option with the advantages of a finite treatment duration and lasting remission from the disease, avoiding the burden of putting their patients on a life-long therapy.
“Studies have shown that Pegasys offers the best chance for a sustained response, in a defined treatment period, for chronic hepatitis B patients,” said Professor Patrick Marcellin, Hepatologist at Hôpital Beaujon, Clichy, France and one of the lead investigators of the Phase III global studies. “Pegasys is an effective pegylated interferon, and the only one that has been studied directly against lamivudine. Its response against this agent, as well as interferon, support its use as first line therapy for chronic hepatitis B.”
The studies on which the positive opinion has been granted
The CHMP positive opinion was based on one of the largest clinical development programmes in chronic hepatitis B, which included three global studies in more than 1,500 patients from 19 countries.
Pegasys has been proven twice as effective as conventional interferon for the treatment of the most common form of chronic hepatitis B, hepatitis B e antigen (HBeAg) -positive chronic hepatitis B, in a multinational phase II trial. These findings were published in the July 2003 Journal of Viral Hepatitis.
Two large-scale multinational phase III trials, in patients with both the HBeAg-positive and HBeAg-negative forms of chronic hepatitis B, demonstrated that after 48 weeks of therapy, more patients achieved a sustained response with Pegasys than with lamivudine. Furthermore, these studies demonstrated that the addition of lamivudine to Pegasys did not improve response rates over Pegasys alone.
The phase III study results in HBeAg-negative chronic hepatitis B, which is particularly prevalent in the Mediterranean areas and is the most difficult-to-treat form of the disease, were published in September 2004 in the New England Journal of Medicine. The results of the phase III study in patients with HBeAg-positive chronic hepatitis B were presented at the 2004 Annual Meeting of the American Association for the Study of Liver Diseases. Both lead investigators have stated that the results of these trials warrant Pegasys becoming the first-line treatment for HBeAg-positive or HBeAg-negative chronic hepatitis B.
About Pegasys
Pegasys, a new generation hepatitis therapy that is different by design, has already become the worldwide market leader in hepatitis C. Pegasys has a dual immunomodulatory and antiviral mode of action. The improved pharmacokinetic profile ensures drug plasma concentrations are maintained at constant levels throughout the one week dosing interval. Pegasys therapy in chronic hepatitis B is given once weekly as a 180 g subcutaneous injection for a 48-week period.
Pegasys has recently been approved for the treatment of chronic hepatitis B in Switzerland, Taiwan and Thailand. Approval in the US is expected this year.
Roche in Hepatitis
Roche is committed to the viral hepatitis disease area, having introduced Roferon-A for hepatitis B and C, followed by Pegasys in hepatitis C and a full development program in hepatitis B. Roche has its own brand of ribavirin, Copegus, which is used in conjunction with Roferon A or Pegasys for HCV. In addition, Roche manufactures HBV and HCV diagnostic and monitoring systems: The COBAS AMPLICOR Test, and the AMPLICOR MONITOR Test, two testing systems used to detect the presence of, and quantity of, HBV DNA or HCV RNA in a person’s blood. Roche has received a positive opinion in the EU for a new indication for Pegasys and COPEGUS as a treatment for patients co-infected with HIV and HCV and it has also been filed in the United States. More than 40,000 patients worldwide continue to participate in trials with Pegasys and COPEGUS as Roche examines the unmet medical needs of hepatitis C patients. Roche’s commitment to viral hepatitis also extends to its pursuit of strategic alliances and partnerships to develop new compounds for the future.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2003 the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
All trademarks used or mentioned in this release are legally protected.
Media Office contacts
Phone: +41 61 688 8888
e-mail: basel.mediaoffice@roche.com
- Baschi Dürr
- Alexander Klauser
- Daniel Piller (Head of Group Media Office)
- Katja Prowald (Head of Science Communications)
- Martina Rupp
References
Cooksley WG, Piratvisuth T, Lee SD, et al. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat 2003; 10:298-305.
Marcellin P, Lau GK, Bonino F, et al. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2004; 351:1206-17.
Lau GK, et al. Peginterferon alfa-2a (40KD) ( Pegasys®) monotherapy and in combination with lamivudine is more effective than lamivudine monotherapy in HBeAg-positive chronic hepatitis B: results from a large, multinational study. Hepatology, 2004; Vol. 40 (4); Suppl. 1:171A
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Peginterferon Alfa-2a for Hep C after Liver Transplantation
SourceURL:http://www.gastrohep.com
Peginterferon alfa-2a treatment for 48 weeks is safe and tolerable and offers some efficacy in the post-OLT setting, reports the February's issue of Hepatology.
There is currently no effective treatment for recurrent hepatitis C after orthotopic liver transplantation (OLT).
Dr Chalasani and colleagues performed 2 randomized, controlled trials - a prophylaxis trial and a treatment trial - in order to evaluate the safety and efficacy of peginterferon alfa-2a in patients who had undergone orthotopic liver transplantation.
The prophylaxis trial enrolled 54 patients within 3 weeks after OLT, and the treatment trial enrolled 67 patients 6 to 60 months after OLT.
In each trial, patients were randomized to treatment with once weekly injections of 180 g peginterferon alfa-2a or no antiviral treatment for 48 weeks and were followed up for 24 weeks thereafter.
Peginterferon alfa-2a treated patients had significantly lower hepatitis C virus RNA levels and more favorable changes in hepatic histological features compared with untreated controls.
Incidence of acute rejection was similar in the treated and untreated groups in both the prophylaxis and treatment trials—Hepatology
However, only 2 treated patients in the prophylaxis trial (8%) and 3 in the treatment trial (12%) achieved a sustained virological response.
In the prophylaxis trial, 8 patients (31%) in the peginterferon alfa-2a group and 9 (32%) in the untreated group were withdrawn prematurely; whereas in the treatment trial, 10 patients (30%) in the peginterferon alfa-2a group and 6 (19%) in the untreated group were withdrawn prematurely.
The incidence of acute rejection was similar in the treated and untreated groups in both the prophylaxis (12% vs. 21%) and treatment (12% vs. 0%) trials.
Dr Chalasani concluded, "Peginterferon alfa-2a treatment for 48 weeks is safe and tolerable and offers some efficacy in the post-OLT setting."
"Randomized controlled studies are needed to establish the efficacy of pegylated interferon and ribavirin in patients who have undergone OLT."
Hepatology; 2005: 41 (2): 289 – 98
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Antivirals for Cirrhotic Hep C Reduce Hepatocellular Carcinoma
SourceURL:http://www.gastrohep.com
Interferon therapy for cirrhotic patients with chronic hepatitis C, especially those in whom the infection had been cured, inhibited the development of hepatocellular carcinoma and improved survival, finds the most recent Annals of Internal Medicine.
Although cirrhosis is a major risk factor for development of hepatocellular carcinoma, no definitive prospective analyses have assessed the long-term efficacy of antiviral therapy in cirrhotic patients.
Dr Shiratori and colleagues from Japan undertook a study in order to elucidate the role of antiviral therapy in the suppression of liver tumors and survival over a long-term follow-up period.
The researchers designed a prospective cohort study, including a total of 345 patients with chronic hepatitis C and cirrhosis from 25 clinical centers.
The investigators oversaw treatment for 271 patients who received 6 to 9 million U of interferon 3 times weekly for 26 to 88 weeks; 74 participants received no treatment.
The research team carried out regular blood tests and abdominal ultrasonography to detect hepatocellular carcinoma.
The researchers detected hepatocellular carcinoma in 119 patients during a 6.8-year follow-up: 84 (31%) in the interferon-treated group and 35 (47%) in the untreated group.
69 patients died during follow-up: 17% in the treated group and 32% in the untreated group—Annals of Internal Medicine
The research team found that the cumulative incidence of hepatocellular carcinoma among interferon-treated patients was significantly lower than in untreated patients, especially sustained virologic responders.
A total of 69 patients died during follow-up: 17% in the treated group and 32% in the untreated group.
The researchers found that interferon-treated patients had a better chance of survival than the untreated group.
The research team noted that this was especially evident in sustained virologic responders.
Patients enrolled in the control group had declined to receive interferon treatment even though they were eligible for treatment.
Dr Shiratori concluded, "Interferon therapy for cirrhotic patients with chronic hepatitis C, especially those in whom the infection had been cured, inhibited the development of hepatocellular carcinoma and improved survival."
Annals of Internal Medicine; 2005: 142 (2): 105-114
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Coffee and Caffeine Consumption Reduce the Risk of Elevated Serum Alanine Aminotransferase Levels
Source: PubMed
Based on experimental and epidemiologic studies, researchers at the National Institute of Diabetes and Digestive and Kidney Diseases investigated whether coffee and caffeine consumption reduced the risk of elevated alanine aminotransferase (ALT) activity in persons at high risk for liver injury in a national, population-based study.
Participants were 5,944 adults in the Third US National Health and Nutrition Examination Survey, 1988-1994, with excessive alcohol consumption, viral hepatitis, iron overload, overweight, or impaired glucose metabolism.
Liver injury was indicated by abnormal serum ALT activity (>43 U/L).
Results
Elevated ALT activity was found in 8.7% of this high-risk population.
In unadjusted analysis, lower ALT activity was associated with increasing consumption of coffee (P = .001) and caffeine (P = .001). Multivariate logistic regression analyses showed that the risk of elevated ALT activity declined with increasing intake of coffee (P for trend = .034) and caffeine (P< .001).
Comparing persons who drank more than 2 cups per day with non coffee drinkers, the odds ratio was .56 (95% confidence interval, .31-1.0). Comparing persons in the highest caffeine quintile with the lowest, the odds ratio was .31 (95% confidence interval, .16-.61).
These relationships were consistent across subgroups at risk for liver injury and were relatively unchanged when analyses included the entire population or when limited to persons without impaired liver function or right upper quadrant pain.
Fasting insulin concentrations did not mediate the effects.
In conclusion, the authors write, "In this large, national, population-based study, among persons at high risk for liver injury, consumption of coffee and especially caffeine was associated with lower risk of elevated ALT activity."
This study was supported by a contract from the National Institute of Diabetes and Digestive and Kidney Diseases.
Reference
C E Ruhl and J E Everhart. Coffee and caffeine consumption reduce the risk of elevated serum alanine aminotransferase activity in the United States. Gastroenterology 128(1): 24-32. January 2005.
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January 22nd, 2005
Harney Apologises Formally on Hepatitis C Case
SourceURL:http://www.rte.ie/news
The Tanaiste and Minister for Health, Mary Harney, has formally apologised to a 24-year-old man who contracted hepatitis C from his mother at birth.
The apology was issued by lawyers on behalf of Ms Harney after a settlement was reached yesterday evening in a High Court case taken against her and the Blood Transfusion Service Board, now known as the Irish Blood Transfusion Service.
The terms of the settlement are confidential, but they are believed to involve a payment of around 2 million Irish pounds.
The man sued the Minister for Health and the BTSB for the pain and suffering caused by contracting the disease from his mother who had been given an infected blood product in 1977.
He was 13 when he was diagnosed positive.
The man's lawyers said that the disease is likely to limit his life span to less than 70 years of age.
In her apology, Ms Harney said she regretted the pain and suffering caused to the man and to his family by failures in the health services.
The BTSB admitted negligence and agreed it was obliged to compensate the man.
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