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Week Ending: February 19th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Officials: Make Tattoos Safe
• Tánaiste to Establish Enquiry for Hepatitis C/HIV Patients
• Veterans Back Each Other up in Organ-Transplant Groups
• Link between Meth, HIV and Hepatitis to Be Examined at Summer Conference
• ViroPharma Announces Start of HCV-796 Phase 1 Program
• Former Red Cross Chief Wants Charges Stayed
• How Hepatitis C Short-Circuits the Immune System
• Lawyers Try to Stop Tainted Blood Trial
• Hepatitis B Vaccine in Potatoes Shows Promise
• Bioenvision Evaluates New Agent in Fight against Hepatitis C; Patient Enrollment Begins in Multi-Center, International Phase II Clinical Trial
• Human Genome Sciences Completes Enrollment in a Phase 2 Clinical Trial of Albuferon(TM) in Treatment-Naive Patients with Chronic Hepatitis C
• My Fight to Stop Deadly Jabs
• Trial of Acarbose in Hepatic Encephalopathy
• Pittsboro's Biolex to Test Hepatitis C Therapy
• UK Conservative Party Proposes Requiring Immigrants to Be Tested for TB, HIV, Hepatitis B
• Pegylated Interferon-2b and Lamivudine vs Lamivudine Alone
• Hep C Coinfection Increases Risk of Fulminant Hepatic Failure
• Not All Hepatitis C Patients Need Treatment
• Pin-Stick Victim Has Hepatitis
February 12th, 2005
Officials: Make Tattoos Safe
SourceURL:http://vh10239.moc.gbahn.net
House Bill 1519
The bill would:
• Prohibit tattooing for anyone under the age of 18.
• Require tattoists and tattoo parlors to be licensed by the health department.
• Require semi-annual inspections of tattoo parlors.
• Limit sales of tattoo equip-ment to licensed professionals.
• Allow fines of up to $5,000 for persons convicted of violating the law.
Proponents say ensuring the safety and health of people getting tattoos is the purpose of proposed legislation to legalize and regulate the tattoo industry in Oklahoma, and state health officials and a local businessman say they hope legislators pass the bill this session.
Oklahoma, the only state that outlaws tattooing, should legalize the practice to protect people from diseases transmitted through unsanitary underground tattoos, state health commissioner Dr. Mike Crutcher and other officials said at a news conference Friday.
"We are pleased to support this legislation so we can assure a protected environment for those who seek tattoos in Oklahoma," Crutcher said.
Loyd Samples owns Hellbilly, a local tattoo and piercing establishment. Samples said he agrees wholeheartedly with regulating the industry. He said it is important to ensure cleanliness and prevent disease transmission.
Samples, whose business is inspected by the health department because he is licensed for piercing, said too often people have problems with tattoos given in underground establishments.
"A lot of people come in here asking 'Can you fix this?'" he said. "And I'll say 'Where did you get it done?' and they say they went to a guy's house with a kit."
He said he would like to see laws even more stringent than proposed in the current bill.
A similar bill was killed last year on the Senate floor after narrowly passing a committee. This time the measure may face a tough test in the Republican-controlled House of Representatives. It's scheduled for a committee hearing next week.
"I'm more focused on getting worker's comp and tort reform passed than I am about tattooing," said Rep. Mike Thompson, R-Oklahoma City. "Tattooing was not a big issue for me when I was out campaigning."
The popularity of tattoos boomed in the last decade and has now become commonplace with all segments of society, said Rep. Al Lindley, D-Oklahoma City, who introduced the bill.
"I think a lot of people would be surprised at the number of bankers and lawyers getting tattooed," Lindley said.
With local law enforcement agencies reluctant to use scarce resources to investigate illegal tattooing, Crutcher said some illegal tattoo artists are openly advertising their services in city phone directories.
"This lack of enforcement is not lost on those providing illegal tattooing," Crutcher said.
In 1997, Samples said, he was co-owner of the first Oklahoma shop ever raided, Freaks Mercantile of Tulsa. He said he paid a $100 fine and reopened the next day, and the law as it is written now has loopholes that make it difficult to enforce.
Tigger Liddell, an Oklahoma City native who operates several tattoo parlors in Texas, said the popularity of tattoos is forcing many people in Oklahoma to go to unsafe artists and risk getting a disease through a dirty tattoo needle.
"I know of full-blown underground tattoo studios operating in Oklahoma right now," Liddell said. "Sometimes they're clean and sometimes they're not."
Crutcher said there has been a spike in the number of new hepatitis C infections, a serious disease that can be passed through use of dirty needles. Health officials have documented about 7,000 new cases of hepatitis C cases since 2000, a jump of 78 percent. The exact cause of the increase has not been determined.
Dr. Edward Brandt Jr., a regents professor at the University of Oklahoma Health Sciences Center, said the American Medical Association and the Oklahoma State Medical Association both support regulating the practice of tattooing.
"Any time you break the skin with an unsanitary object, you run the risk of infection," Brandt said. "Our view is that regulation and the regulation of appropriate preventive measures is critical."
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Tánaiste to Establish Enquiry for Hepatitis C/HIV Patients
http://www.politics.ie/
The Government has agreed to a proposal from the Tánaiste and Minister for Health and Children Mary Harney T.D., to establish a scheme to address the insurance difficulties experienced by persons infected with Hepatitis C/HIV through the administration within the State of blood and blood products.
The Tánaiste said "I am pleased to announce the establishment of this Scheme which will provide reasonable access to the insurance market for those for whom the cost is prohibitive or cover is unavailable".
The person requiring insurance will pay the average basic premium, which an uninfected person of the same age/gender would pay, with the State paying the addition risk premium or assuming cover on the life where the assuror deems the person uninsurable.
The Scheme will cover all standard life assurance policies offered by life assurors who are authorised to transact life assurance business in Ireland and who opt to participate in the Scheme. A scheme to cover travel insurance loadings will also be devised.
The main components of the scheme are:
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life assurance to age 75, with a maximum life assurance cover of € 400,000 or 7 times earned income of the Eligible Participant or his/her Partner up to a maximum of €500,000. These sums will be indexed in accordance with the Consumer Price Index.
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mortgage protection cover up to age 75 on purchasing or changing the primary residence, up to a maximum of the Average House Price in Dublin + 25% or €375,000, indexed in accordance with TSB/ESRI (Dublin) House Price Inflation; For an initial period of twelve months (or, if later, three years from the date Hepatitis C/HIV is diagnosed) all persons with Hepatitis C/HIV will be entitled to apply for cover under the Scheme.
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Thereafter, a waiting period to apply, during which full cover would be phased in over two years for the under-50s and three years for over-50s).
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There will be an open period for young people who are not able to avail of insurance/mortgage protection at this time, until the date of their 30th birthday.
The Tánaiste thanked Dr Elizabeth Kenny, Chairman of the Consultative Council on Hepatitis C and the executive members of Positive Action, Transfusion Positive, the Irish Haemophilia Society and the Irish Kidney Association for their co-operation and assistance in devising the scheme.
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Veterans Back Each Other up in Organ-Transplant Groups
SourceURL:http://www.sbsun.com
San Bernardino County Sun
By C.L. LOPEZ, Staff Writer
Saturday, February 12, 2005 - LOMA LINDA - Many people let out a collective sigh of relief when Marine Lance Cpl. Christopher LeBleu got a lifesaving liver transplant.
Two weeks after that transplant, LeBleu, a 22-year-old Iraq War veteran, is progressing but still in critical condition at Loma Linda University Medical Center, officials said Saturday.
But the wait goes on for a group at the nearby Jerry L. Pettis Memorial Veterans Medical Center.
In 1993, Richard Menzel, 53, received a transplant that saved his life. Hepatitis C had destroyed the Vietnam War veteran's liver. After his transplant, Menzel wrote a letter to the family of his liver donor to thank them, but they never wrote back.
"I pray for the family all the time, and I thank God they made the decision to be a donor. That's a hard decision to make at that point in time,' Menzel said. "You want to let them know you are going to live the best you can with the time they gave you. The support groups are my way of giving back.'
Since then, he has spent his days advocating organ donations and supporting other veterans who are awaiting transplants.
Loma Linda is a second home for the Riverside resident, who visits Pettis Memorial several times a week to see if any of the members of the hospital's organ transplant support groups are there.
Menzel has been the group's president for eight years.
"I try to visit them and encourage them,' he said.
Menzel also belongs to the Loma Linda University Medical Center's pretransplant support group, the United Organ Transplant Association based in Chino, and is an ambassador for OneLegacy transplant donor network. The mission is to educate the public about organ donation and those in need of transplants.
"It's giving them something I didn't have when I went through it,' he said.
During the hourlong monthly meetings, there are highs and lows. Laughter mixes with tears. There is camaraderie in the room.
They already share a bond because they are veterans and it's made even tighter by what we have been through with the transplants, said Roy Martin.
The battles they speak of are not of their tours of duty but the daily battles for their lives. And the battle scars they have are not from combat but surgeons' scalpels.
One by one, the veterans introduce themselves. Some already have received their transplants and are there to encourage those who are waiting for a second chance at life.
Reality sinks in amid their laughter as they talk about their health problems.
"Here's our hero,' said Menzel when it was Martin's turn to speak.
Martin smiled broadly as the group applauded and cheered.
Martin wore a shirt commemorating the Summer Olympics, but he has set his own records. Between 2001 and 2004, Martin had one kidney and three liver transplants.
"It's been frightening each time. When they tell you your organs fail, you may not get another one. The hardest thing is the waiting,' Martin said. "Most people pass away waiting; you get familiar with your mortality.'
When a member of the support group dies, he said, it's like losing a family member because they are all going through the same thing.
"That could be any one of us,' said Menzel. "You have someone going through the same thing you went through, we are all looking for that rainbow of getting a new organ and new life.'
It is easy for the veterans to become depressed.
"You get desperate and you get at times a little depressed because of the waiting your life has changed a lot,' said Jaime Cambrelen. "The waiting is the worst.'
The Army veteran from Monrovia has visited Pettis Memorial several times a week for the past year but only recently began attending the support group meetings. His wife, Elsa, attends with him.
The past year has been difficult for the couple since Jaime became ill. The treatment that he received killed the hepatitis C but damaged his liver even further.
He's preparing to go to Portland, Ore., where he will be again evaluated to see when he will be placed on the list for a transplant.
Menzel, upon whose shoulder many transplant patients lean, lost his greatest support system when his wife died of breast cancer two years ago.
She had cancer during his first transplant and was at his side before the surgery, he said.
Now Menzel looks to his son for support.
In January 2004, Menzel had a biopsy. Doctors found hepatitis C in his transplanted liver. He will make the trip to Portland on April 10 to determine if he will be placed on the list for a transplant now or must wait until he becomes sicker.
"It's scary,' he said. "The first time I had my wife with me. Now I don't have her with me.'
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February 14th, 2005
Link between Meth, HIV and Hepatitis to Be Examined at Summer Conference
SourceURL:http://www.sltrib.com
By Rhina Guidos
The Salt Lake Tribune
Growing problem: A state health official says myths about meth "lead to danger, including death"
It's a problem that's leaving few communities untouched. It has exploded in rural America, in minority communities, among women and the poor.
The use of methamphetamine as a stimulant drug keeps police officers, doctors and social workers busy trying to deal with its impact.
This summer, Salt Lake City will play host to those seeking to combat the problem at the Science and Response in 2005 Conference. The event, scheduled for Aug. 19 and 20, bills itself as the first national conference on methamphetamine, HIV and hepatitis.
Conference organizers will bring in scientists from Yale and Harvard medical schools, the Johns Hopkins Bloomberg School of Public Health and law enforcement and social workers from around the country.
"It's time we took a serious look at how our communities are responding to this issue," said Luciano Colonna of Salt Lake's Harm Reduction Project, one of the conference sponsors.
Some suspect meth use may be leading to higher rates of HIV and hepatitis because one way of introducing it to the body is through injection. It is also a drug that is used to bring about heightened sexual activities, said Robert Heimer, associate professor of epidemiology and public health and pharmacology at  the Yale School of Medicine.
"The epidemic is changing its face," said Heimer, also one of the organizers.
Just Friday, New York City health officials announced they had discovered a man infected with a rare strain of HIV that is resistant to nearly all anti-retroviral drugs used to treat the infection, and made stunningly swift progression from infection to full-fledged AIDS. Investigators believe the patient may have contracted the virus in October when he engaged in unprotected anal sex with multiple partners while using crystal methamphetamine.
Largely used in rural American communities, meth has found its way to cities and to new users, particularly among minorities and women.
"This is a rainbow drug and it doesn't matter what color you are, it doesn't matter what your ethnicity is," Colonna said.
Organizers will talk about prevention of the drug's use, but also activities to minimize the harm to those who use it.
Heimer said no one really knows the prevalence of meth, but its use is on the rise.
"It's becoming more dispersed in many communities . . . making inroads as a party drug, a widespread drug in gay, Native American, white rural communities throughout the West and Midwest. We really don't know all  those emerging drug trends."
Edwin Espinel, ethnic health coordinator with the Utah Department of Health, said the conference will be an opportunity to address the problems arising in the state.
"We're going to have the latest information available," he said. "We need to know how to confront this problem because there is much more misinformation, myths. Those myths lead to danger, including death."
Colonna said law enforcement will be included in the conference but the problems methamphetamine is causing, along with its connection to HIV and hepatitis, need to be solved in a variety of ways.
"We can't arrest our way of this problem," he said. "It's not something criminal justice can solve."
For more information, contact the Harm Reduction Project at 355-0234.
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ViroPharma Announces Start of HCV-796 Phase 1 Program
SourceURL:http://uk.biz.yahoo.com
EXTON, Pa., Feb. 14, 2005 (PRIMEZONE) -- ViroPharma Incorporated (NASDAQ: VPHM - news) (Nasdaq (NASDAQ: news) today announced that dosing has begun in the Phase 1 clinical trial for HCV-796, a novel polymerase inhibitor being developed as a potential new product to treat hepatitis C. ViroPharma is conducting this Phase 1 clinical trial with its partner in the development of antiviral compounds targeting hepatitis C (HCV), Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - news) (NYSE:WYE). Preclinical studies have shown that HCV-796 may be more potent than other anti-HCV compounds developed to date between the two companies.
"HCV-796 represents an exciting opportunity for us, as this non-nucleoside, based on preclinical tests, is the most potent of all of the molecules targeting HCV that we have brought into clinical trials," commented Dr. Colin Broom, ViroPharma's chief scientific officer. "For the first time in the history of this collaboration, we with our partners at Wyeth Pharmaceuticals have two promising anti-hepatitis C compounds in humans. With the first compound, HCV-086, we remain on track to have proof of concept antiviral data available from the ongoing Phase 1b trial later this quarter. We hope to initiate a similarly designed Phase 1b proof of concept studies with HCV-796 in HCV-positive adults during the second quarter of 2005, with data available from that trial in the fourth quarter of 2005."
The current Phase 1a study is an ascending single dose, placebo-controlled trial designed to assess the safety and tolerability of HCV-796 in healthy adult volunteers, as well as to gather pharmacokinetic data. The study is being conducted at a leading clinical research facility in the United States. Should those data support further advancement of the product, the companies plan to initiate a Phase 1b multiple dose study in patients with chronic HCV infection to assess the antiviral activity, safety, tolerability and pharmacokinetic profile of HCV-796 during the second quarter of 2005.
About Hepatitis C
Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.
About ViroPharma Incorporated
ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(r) Pulvules(r), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/pulvules_pi.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at www.viropharma.com.
Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties, including those relating to the company's anticipated schedule relating to its HCV clinical development program as well as its ability to find an effective small molecule antiviral treatment for HCV disease. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. Conducting clinical trials for investigational pharmaceutical products is subject to risks and uncertainties. There can be no assurance that ViroPharma's studies as part of the HCV program can be conducted within the timeframe that the company expects, that such studies will yield positive results, or that ViroPharma will be successful in gaining regulatory approval of any of its HCV product candidates. These factors, and other factors, including, but not limited to those described in ViroPharma's quarterly report on Form 10-Q for the quarter ended September 30, 2004 filed with the Securities and Exchange Commission, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
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Former Red Cross Chief Wants Charges Stayed
SourceURL:http://www.ctv.ca/
The man who was in charge of the Canadian Red Cross blood program when thousands were infected with HIV and hepatitis C says he is too sick to stand trial, and wants charges against him stayed.
Dr. Roger Perrault is facing three counts of criminal negligence causing bodily harm and seven counts of common nuisance by endangering the public.
Lawyers for Perrault told a Toronto court on Monday that their client is too ill to face charges. They say he has an undisclosed, long-standing heart condition.
Victims of the tainted blood scandal are frustrated with the progress of the case.
"The patience is wearing thing, not just because, you know, it's a complicated case. It's because people are dying waiting for the truth," said hepatitis C victim Mike McCarthy.
Perrault began working for the Canadian Red Cross in 1972. For two years, he ran Ottawa's blood centre, and in 1974 was promoted to director of blood transfusion services.
He held that post from 1974 to 1986. During that time, about 1,200 Canadians were infected with blood-borne HIV and 10,000 to 20,000 were contaminated with hepatitis C.
James Kreppner, who contracted HIV and hepatitis C from tainted blood, says he has watched many of his friends die, including at least one friend who was infected as a child.
"I think people have to take responsibility and own up to that responsibility," Krepner said.
"And I do think, you know, the court can make Mr. Perrault comfortable in terms of these proceedings. But I think he has to answer for some actions."
In 2002, The RCMP laid charges in the tainted blood scandal against Perrault, three other doctors, the Canadian Red Cross and a U.S. drug company.
The RCMP Blood Task Force was formed following a report from the inquiry of Canada's blood system, led by Justice Horace Krever.
Krever's report, released on Nov. 26, 1997, blasted Ottawa, the provinces and the Canadian Red Cross. He also named individuals who were central to the tragedy.
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February 15th, 2005
How Hepatitis C Short-Circuits the Immune System
Source: University of Texas Medical Branch at Galveston
http://www.newswise.com/
Newswise — To find an effective treatment for hepatitis C, which chronically infects nearly 200 million people worldwide, researchers need to understand how the virus is able to avoid destruction by the immune system. Hepatitis C persists in the body for decades after an initial infection, often causing so much liver damage that liver transplantation may be a patient’s only chance for survival.
Now, scientists at the University of Texas Medical Branch at Galveston (UTMB) and the University of Texas Southwestern Medical Center in Dallas have figured out two key parts of hepatitis C’s strategy for evading the human immune response. In papers to be published online today in the Proceedings of the National Academy of Sciences (PNAS), UTMB and UT-Southwestern researchers define two critical elements of the immune response shut down by a hepatitis C virus protein called NS3/4A. These virus-caused “short circuits” prevent the production of signaling molecules that mobilize cells’ antiviral defenses.
In an additional paper, appearing in the current Journal of Virology and available now online, the UT Southwestern and UTMB researchers demonstrate the critical role played by one of the “circuits,” known as the RIG-I pathway, in cellular defense against hepatitis C virus.
The discoveries are particularly important in light of recent promising results from early clinical trials of new investigational drugs that target NS3/4A and both block the reproduction of hepatitis C and nullify its ability to dodge immune defenses, according to Stanley M. Lemon, a senior author on the papers and director of UTMB’s NIH-funded hepatitis C research center. “At least one protease inhibitor has had extraordinary activity against hepatitis C in human clinical trials, but we’re going to need to improve on it in a number of ways, including reducing the potential for the virus to become resistant to it,” Lemon said. “A better understanding of how NS3/4A does its work in blocking the immune response will help make that possible.”
Lemon’s group, including lead author and assistant professor of microbiology and immunology Kui Li, postdoctoral fellows Josephine C. Ferreon, Mitsuyasu Nakamura, Allan C.M. Ferreon and Masanori Ikeda, collaborated with Michael Gale and Eileen Foy of UT Southwestern on one PNAS paper, “Immune evasion by hepatitis C virus NS3/4A protease-mediated cleavage of the Toll-like receptor 3 adaptor protein TRIF.” Lemon and Li also collaborated with the UT-Southwestern team led by Gale on the second PNAS paper (“Control of antiviral defenses through hepatitis C virus disruption of retinoic acid-inducible gene-I signaling”), on which Foy is the lead author, and Rhea Sumpter, Jr., Yueh-Ming Loo, Cynthia L. Johnson, Chunfu Wang, and Penny Mar-Fish are co-authors.
The PNAS articles can be found on the journal’s Early Edition web page, located at http://www.pnas.org/papbyrecent.shtml. The Journal of Virology paper is at http://jvi.asm.org/cgi/content/full/79/5/2689.
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Lawyers Try to Stop Tainted Blood Trial
SourceURL:http://www.thestar.com
TARA BRAUTIGAM
CANADIAN PRESS
A doctor at the centre of the tainted-blood tragedy that infected thousands of Canadians wants criminal charges against him halted because he's too sick to face them, his lawyers said yesterday.
Lawyers for Dr. Roger Perrault, the former head of the Canadian Red Cross, told a Toronto court that a lengthy trial could jeopardize his life and are asking his charges be stayed.
"He's in a position under a great deal of stress," Perrault's lawyer Eddie Greenspan, said in an interview.
"If the stress is significant it could cause a further heart attack."
Greenspan said the 68-year-old Perrault has had two heart attacks and open heart surgery after suffering from coronary artery disease for 23 years.
Perrault was charged in 2002 with criminal negligence and common nuisance endangering the public after an RCMP investigation into the blood scandal.
"A lot of us that are survivors are not in the best of health, so I think we're all suffering from ill health here," victim James Kreppner said in an interview.
Kreppner, 42, was infected with HIV and hepatitis C after a blood transfusion about 20 years ago.
He was one of thousands who became infected after receiving tainted blood products in the mid-1980s. It has been called the worst public health disaster to strike Canada in the past century.
In 2002, police laid charges against the Canadian Red Cross, an American drug company, Perrault and three other doctors — Dr. John Furesz, Dr. Wark Boucher, and Dr. Michael Rodell.
Kreppner says he's fed up with the legal delays and fears more victims will die before the cases are completed.
Perrault's lawyers will return to court tomorrow to set a date for hearing the motion to stay the charges.
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Hepatitis B Vaccine in Potatoes Shows Promise
SourceURL:http://www.foxnews.com/
By Miranda Hitti
Could potatoes with a built-in hepatitis B vaccine help save the lives of millions of people worldwide?
It might work, judging by a preliminary study from Yasmin Thanavala, PhD, and colleagues. Thanavala works in the immunology department at Roswell Park Cancer Institute in Buffalo, N.Y.
Every year, hepatitis B kills about a million people worldwide, scientists report in the early edition of Proceedings of the National Academy of Sciences. In 1996, it was estimated that 115 million people around the world were infected with the virus that causes hepatitis B, which can lead to liver cancer.
That’s despite the existence of a hepatitis B vaccine. Even in the U.S., hepatitis B vaccination rates fall short of goals. The rates are worse in poorer countries that can’t afford the vaccine or lack cold storage sites, which the vaccine requires.
In the U.S., the hepatitis B vaccine is recommended for all children, which includes a series of three shots given between birth and 18 months of age.
Crafting an Edible Hepatitis B Vaccine
Seeking a more affordable solution, researchers genetically modified ordinary potatoes to carry the gene for the hepatitis B surface antigen. The potatoes were then cloned and cultivated.
Forty-two people who had already been vaccinated against hepatitis B volunteered to try the edible vaccine. Some participants were served ordinary potatoes that did not contain the vaccine. Some got the vaccine potatoes just once, eating plain potatoes in the other two sessions. The remaining volunteers ate the vaccine potatoes in three sessions two weeks apart. All the potatoes were eaten raw.
Promising Results
Ten of 16 volunteers who ate three doses of the vaccine-containing potatoes showed a marked increase in their immune response against hepatitis B.
Nine of 17 volunteers who ate the vaccine potatoes only once also had increased immune responses to hepatitis B.
About 40 percent of the participants who got the vaccine-carrying potatoes didn’t show any immune response to hepatitis B. More studies are needed to find out why that happened. Further research must also test the vaccine on people who hadn’t been previously vaccinated against hepatitis B, say the researchers.
“We are greatly encouraged,” they write. “This prototype study ... gave us a strong and sustained systemic antibody response in 60 percent of the volunteers who ate the [vaccine-carrying] potatoes.”
By curbing hepatitis B, the vaccine could also help combat liver cancer, the fifth most frequent form of cancer worldwide, say the researchers. It’s sensible and ethical, they say, to direct scarce resources for the greatest good.
“Give new vaccination strategies for hepatitis B virus a higher priority, especially those that could be implemented very cost-effectively throughout the developing world,” they write.
By Miranda Hitti, reviewed by Michael W. Smith, MD
SOURCES: Thanavala, Y. Proceedings of the National Academy of Sciences, early edition. News release, Proceedings of the National Academy of Sciences. CDC.
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February 16th, 2005
Bioenvision Evaluates New Agent in Fight against Hepatitis C; Patient Enrollment Begins in Multi-Center, International Phase II Clinical Trial
SourceURL:http://home.businesswire.com
NEW YORK--(BUSINESS WIRE)--Feb. 16, 2005--Bioenvision, Inc. (Nasdaq:BIVN) today announced that the first patients has been enrolled in a multi-center, international Phase II clinical trial to evaluate the clinical efficacy of Virostat for the treatment of chronic hepatitis C.
The investigator sponsored trial is being conducted at specialist centers in Europe and Egypt and will assess the ability of Virostat to reduce viral load and improve quality of life in patients with chronic hepatitis C.
"This begins a new phase of development for Bioenvision, and we look forward to the opportunity to build value in our non-cancer related franchises," said Dr. Chris Wood, Chairman and CEO of Bioenvision. He added, "Current therapies for hepatitis C are costly and not always effective. We hope to offer an alternative in the fight against this epidemic."
About Hepatitis C
Hepatitis C is a viral infection of the liver. The virus, HCV, is a major cause of acute hepatitis and chronic liver disease, including cirrhosis and liver cancer. HCV is spread primarily by direct contact with human blood. The major causes of HCV infection worldwide are use of unscreened blood transfusions, and re-use of needles and syringes that have not been adequately sterilized. The World Health Organization has declared hepatitis C a global health problem, with approximately 3% of the world's population infected with HCV and it varies considerably by region. The prevalence in the US is estimated at 1.3% or approximately 3.5 million people. Egypt has a population of approximately 62 million and contains the highest prevalence of hepatitis C in the world, estimated at over 20% of the nation's approximately 62 million people.
About Virostat
Virostat has shown potent viricidal activity in vitro,. Virostat is an effective against viruses such as HIV and West Nile Virus in laboratory tests. Bioenvision obtained global license rights from Oklahoma Medical Research Foundation (OMRF) for the right to develop and market Virostat for anti-viral indications.
About Bioenvision
Bioenvision's (Nasdaq:BIVN - News) primary focus is the acquisition, development and distribution of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: clofarabine (in co-development with Genzyme Corporation), Modrenal(R) (for which Bioenvision has obtained regulatory approval for marketing in the United Kingdom for the treatment of post-menopausal breast cancer following relapse to initial hormone therapy), and other products in clinical trials. Bioenvision is also developing anti-infective technologies, including the Oligon technology; an advanced biomaterial that has been incorporated into various FDA approved medical devices. For more information on Bioenvision please visit our Web site at www.bioenvision.com.
Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in Bioenvision's compounds under development in particular; the potential failure of Bioenvision's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Bioenvision's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Bioenvision's business, structure or projections; the development of competing products; uncertainties related to Bioenvision's dependence on third parties and partners; and those risks described in Bioenvision's filings with the SEC. Bioenvision disclaims any obligation to update these forward-looking statements.
Contacts
Bioenvision, Inc.
Investors: David P. Luci, Esq., 212-750-6700 davidluci@bioenvision.com
or
Bioenvision Limited
Media: Hugh S. Griffith, 011-44-131-248-3555 hughgriffith@bioenvision.com
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Human Genome Sciences Completes Enrollment in a Phase 2 Clinical Trial of Albuferon(TM) in Treatment-Naive Patients with Chronic Hepatitis C
SourceURL:http://www.prnewswire.com
Preliminary Data Demonstrate Sufficient Antiviral Activity to Support Larger Phase 2b Study in Combination with Ribavirin in Treatment-Naive Patients
ROCKVILLE, Md., Feb. 16 /PRNewswire-FirstCall/ -- Human Genome Sciences,
Inc. (Nasdaq: HGSI) announced today that it has completed enrollment, randomization and dosing in a Phase 2 clinical trial of Albuferon(TM) (albumin-interferon alpha) in patients with chronic hepatitis C who are naïve to interferon-alpha treatments.
The Phase 2 trial, which is being conducted in Canada, is a randomized, open-label, multi-center, parallel-design, dose-ranging study to evaluate the safety, tolerability, pharmacology, and optimal dosing of Albuferon.(1) A total of 56 patients with hepatitis C virus (HCV) genotype 1 have been enrolled in the trial and randomized to five dose groups. Patients are being given two doses of Albuferon administered subcutaneously fourteen days apart. The pharmacodynamic activity of Albuferon is being evaluated based on HCV RNA viral load reductions over a 28-day period of exposure. One of the study objectives is to identify a range of active doses that Human Genome Sciences plans to evaluate in a larger 48-week study of Albuferon in combination with ribavirin in patients with HCV genotype 1 who are naive to interferon treatments.
Preliminary data are available from 38 patients who have completed more than 28 days of the ongoing Phase 2 study, including 30 patients enrolled in the 200 mcg, 450 mcg and 670 mcg dose cohorts, and 8 patients enrolled in the 900 mcg and 1200 mcg dose cohorts.(2) The available data demonstrate that Albuferon is well tolerated with demonstration of antiviral activity in genotype 1 HCV. A reduction in viral load of > or = to 2 log at Day 28 was observed in 57% (16/28) of the patients who received Albuferon at a dose > or = to 450 mcg. A reduction in viral load of > or = to 3.0 log at Day 28 was observed in a majority (5/8) of the 8 patients in the 900 mcg and 1200 mcg dose cohorts. Reductions in viral load of > or = to 2 log are reported in approximately 42% of genotype 1 HCV patients treated with pegylated interferon alpha products in combination with ribavirin.(3) The pharmacokinetic profile of Albuferon supports dosing every 2-4 weeks.
Preliminary eight-week data are available from a separate ongoing Phase 2 clinical trial of Albuferon in patients with chronic hepatitis C who have failed to respond to previous interferon alpha-based treatment regimens.(4) The preliminary data show that Albuferon administered at 2-week or 4-week intervals in combination with ribavirin is safe, well tolerated, and demonstrates antiviral activity in all treatment groups for which data are available.
David C. Stump, M.D., Executive Vice President, Drug Development, said, "The preliminary data from our ongoing Phase 2 clinical trial of Albuferon in interferon alpha-naove patients are encouraging. These preliminary data will be presented in March at the annual meeting of the Canadian Association for Studies of the Liver, and an abstract has been accepted for presentation in April of the final results of the Phase 2 study in treatment-naive patients at the annual meeting of the European Association for Studies of the Liver. The results of the current Phase 2 trial will enable us to identify an optimal range of doses to evaluate in a larger 48-week combination study of Albuferon with ribavirin that we plan to conduct in treatment-naove patients. In addition, the preliminary data emerging from our ongoing Phase 2 combination study in treatment-experienced patients afford confidence in the ability to administer Albuferon safely in combination with ribavirin to treatment-naïve patients."
The results of a Phase 1/2 clinical trial of Albuferon in interferon alpha-experienced adults with chronic hepatitis C were presented at the November 2004 Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).(5-6) Data presented on 119 patients demonstrate that Albuferon is well tolerated, has a prolonged half-life, is biologically active, and able to reduce viral load with dose-dependent magnitude and durability. On average, patients participating in the Phase 1/2 clinical trial had been treated previously for approximately 63 weeks with interferon alpha-containing regimens. Ninety-two percent of the patients (110/119) were infected with hepatitis C virus genotype 1, which accounts for nearly seventy percent of all HCV infections in North America. Patients were treated with one or two doses of Albuferon administered subcutaneously 14 days apart. Doses administered ranged from 7-900 mcg. The Phase 1/2 clinical trial results show that Albuferon is well tolerated, with adverse events that were mostly transient and mild to moderate in severity, and with no discontinuations due to adverse events or reductions in hematologic cell counts. Preliminary immunogenicity data presented at the AASLD meeting show that Albuferon immunogenicity occurs at rates consistent with those reported for other interferon alpha-based therapies, with no apparent correlation between the emergence of Albuferon antibodies and adverse events, antiviral response or pharmacokinetics. The vast majority of Albuferon antibody titers were low (<100 ng/mL). Viral load levels represent the quantity of hepatitis C virus in the blood and are a marker for drug activity. Forty-seven percent of Albuferon-treated patients in the combined single-dose and two-dose cohorts at doses of 120-900 mcg experienced an antiviral response, as demonstrated by reductions in viral load of 1.0 log or greater. The data presented show that both magnitude and duration of early anti-viral response were dose-dependent.
Albuferon is a novel, long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. Human Genome Sciences modified interferon alpha to improve its pharmacological properties by using the company's proprietary albumin fusion technology.
Hepatitis C infection is an inflammation of the liver caused by the hepatitis C virus. It is the most common chronic blood-borne infection in the developed world, and afflicts approximately four million people in the United States. The hepatitis C virus is transmitted primarily through significant or repeated exposures to infected blood. Intravenous drug use and sexual contact with infected persons account for the majority of new hepatitis C infections. When detectable levels of the hepatitis C virus in the blood persist for at least six months, a person is diagnosed as having chronic hepatitis C. The current standard of care for treating chronic hepatitis C is combination therapy consisting of pegylated Interferon and ribavirin, an antiviral drug.(7-14)
Health professionals interested in more information about trials involving Human Genome Sciences products are encouraged to inquire via the Contact Us section of the Human Genome Sciences web site, http://www.hgsi.com/products/request.html, or by calling 301-610-5790, extension 3550.
Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based protein and antibody drugs to patients.
HGS, Human Genome Sciences and Albuferon are trademarks of Human Genome Sciences, Inc.
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Footnotes:
1. (HGSI Press Release) Human Genome Sciences Initiates Phase 2 Clinical Trial of Albuferon(TM) for the Treatment of Chronic Hepatitis C. May 26, 2004.
2. It is important to note that the method of measurement for dose determination in the Phase 2 study of Albuferon in treatment-naive patients is different from the method of measurement in the Phase I/II study of Albuferon. Accordingly, the 200 mcg dose in the current study is equivalent to a 150 mcg dose in the Phase 1/2 study, the 450 mcg dose is equivalent to 340 mcg in the prior study, and the 1200 mcg dose is equivalent to 900 mcg.
3. Di Bisceglie AM, Rustgi VK, Thuluvath P, et al. Pharmacokinetics and pharmacodynamics of pegylated interferon alfa-2a or alfa-2b with ribavirin in treatment naove patients with genotype 1 chronic hepatitis C. Hepatology 2004;40,4;734a, abstract LB18.
4. (HGSI Press Release) Human Genome Sciences Initiates Phase 2 Clinical Trial of Albuferon(TM) in Combination with Ribavirin in Treatment- Experienced Hepatitis C Patients. November 30, 2004.
5. Balan V, et al. Albuferon(TM) -- A Novel Therapeutic Agent for Hepatitis C: Results of a Phase 1/2 Study in Treatment Experienced Subjects with Chronic Hepatitis C. 55th Annual Meeting of the American Association for the Study of Liver Diseases, Boston. November 2, 2004. Oral presentation (Abstract #265).
6. (HGSI Press Release) Human Genome Sciences Reports Positive Results of Phase 1/2 Clinical Trial of Albuferon(TM) in Chronic Hepatitis C. November 2, 2004.
7. Strader DB, Wright T, Thomas DL, and Seeff, LB. AASLD Practice Guideline: Diagnosis, Management, and Treatment of Hepatitis C. Hepatology 2004 April; 39 (4): 1147-1171.
8. Hadziyannis SJ, Sette H, Morgan TR, et al. Peginterferon-alfa-2a and ribavirin combination therapy in chronic hepatitis C. Ann Intern Med 2004; 140:346-355.
9. Shiffman ML, Di Bisceglie AM, Lindsay KL, et al. Peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C who have failed prior treatment. Gastroenterology 2004; 126:1015-1023.
10. Zeng N, Cohen CK, Schwartz P, Rai R. Treatment of HCV infected patients, including non-responders to PEG-IFN alfa-2b/RBV, with PEG- IFN alfa-2a/RBV: the Johns Hopkins experience. Digestive Disease Week 2004 Internet Conference Report. Abstract #1233.
11. Zeuzem S. Heterogeneous virologic response rates to interferon-based therapy in patients with chronic hepatitis C: who responds less well? Ann Intern Med 2004; 140:370-381.
12. PEGASYS(R) Physicians Desk Reference. (Last updated December 2003).
13. PEG-INTRON(R) Physicians Desk Reference. (Last updated September 2003).
14. Management of Hepatitis C: 2002. National Institutes of Health Consensus Development Conference.
SOURCE Human Genome Sciences, Inc. Web Site: http://www.hgsi.com
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My Fight to Stop Deadly Jabs
SourceURL:http://newsvote.bbc.co.uk
By Sue Ellis
BBC Radio Current Affairs
Every year, the World Heath Organisation estimates that 1.3 million people die in the developing world from diseases spread by unsafe injections.
"I was reading a newspaper article one day, and there was one line which said that syringes could be a major transmission route for HIV"
That was 20 years ago and it spurred Marc Koska into a crusade against the spread of disease through the reuse of dirty syringes.
At the age of 23, Koska was a self-confessed 'beach bum'. After leaving school, he'd travelled and indulged his passion for sailing and skiing.
He had ended up in the Caribbean making models of murder scenes which were then used in court.
He realised he was good at representing things with his hands.
New design
Then when Marc read about the risks of HIV transmission through unsafe injections, he set about designing a syringe which was impossible to re-use.
There were already designs for auto-disable (AD) syringes around, but Marc felt they were expensive and difficult to manufacture and use.
He decided he had to produce a syringe that could be made on existing equipment, for the same price as a normal disposable syringe and be used in the same way.
He came up with the K1. With this syringe, the plunger locks and breaks if anyone tries to refill it after one injection.
But it was to take Mark another 17 years before his first commercial sale.
He spent years frustrated by the lack of interest given that he saw his syringe as a way of saving thousands of lives.
It's estimated that half of the 16bn annual injections in poorer countries are done with non sterile syringes or needles.
Often they're often just rinsed in tepid water between injections.
Danger
According to Mark Kane, from the Program for Appropriate Technology in Health (PATH), depending on the region, anywhere between 20% and 70% of injections given in developing and transitional countries are potentially dangerous.
Kane has collected data on the problem for the WHO.
In 1999, the first results showed that, every year, about 22m cases of hepatitis B, 2m cases of hepatitis C and 250,000 cases of HIV are being generated by unsafe injections.
"It's a silent epidemic" he said. "An individual who's infected by an unsafe injection may not show symptoms of that infection for 10 or 20 years".
Since 1999, the WHO and UN agencies have made sure that only auto-disable syringes are used in their immunisation campaigns.
But immunisations account for only 5% of the total injections given every year.
All the rest are given for curative reasons (for instance, when someone gets a shot of penicillin from the doctor).
Twenty years on, Marc Koska's syringe is licensed for manufacture in 15 countries across the developing world.
Pakistan production
Marc went to the ground-breaking ceremony for the first AD syringe plant to be built in Pakistan.
“A common view among doctors is, if a needle is not blunt after one use, why not use it twice or thrice?” – Dr Naveed Zafar Janjua
While he was there, he saw some of the problems caused by unsafe injections.
Hepatitis B and C are Pakistan's big killers. On a visit to Rawalpindi's Social Security Hospital, Marc found almost half the patients on the medical wards were suffering from chronic forms of these diseases.
One woman told him she had no idea how she had contracted hepatitis C, but she had been to a private clinic where she had received injection therapy.
Almost 80% of health care in Pakistan is provided by private doctors, many of them unqualified 'quacks', who practice in rural areas.
Treatment by injection is the norm here. Patients believe that it's far quicker and more effective than tablets.
Doctors, too, find they can charge more for an injection than for pills.
Infection source
A recent study carried out by the Aga Khan University in Karachi found that injections in health care settings were a major source of hepatitis B and C infections.
According to Dr Naveed Zafar Janjua, who carried out the study, "a common view among doctors is, if a needle is not blunt after one use, why not use it twice or thrice?"
And once a syringe has been thrown away, the problem isn't over.
There is a market for syringes, which can either be melted down to make plastics, or, more lucratively, be washed and sold to private doctors to be reused.
At a waste dump in Rawalpindi, Marc came across two little boys, Muhammed and Shah Wali.
Their job is to comb the streets for rubbish, often picking up syringes.
Marc watched in horror as they clutched a bundle of dirty syringes, one of them with blood pouring from his hand.
Legislation is in train to regulate the use of medical devices in Pakistan.
But Marc admits: "Making an AD syringe is just one link in the chain.
"Syringes also have to be made widely available, then disposed of effectively.
"90% of the battle is in information and education, but you have to start somewhere."
Eventually, Marc would like to spread his 'one injection - one syringe' message right across the developing world.
In the meantime, his one link is saving thousands of lives.
It's My Story: Mark Koska - Injecting life will be broadcast on BBC Radio 4 at 2000 GMT on 17 February.
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/4270467.stm
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Trial of Acarbose in Hepatic Encephalopathy
SourceURL:http://www.gastrohep.com/
Acarbose is a safe and effective drug in cirrhotic patients with low-grade hepatic encephalopathy and type 2 diabetes mellitus, finds February's issue of Clinical Gastroenterology and Hepatology.
Hepatic encephalopathy in cirrhosis is contributed to by toxic products deriving from the proteolytic bacterial flora-related degradation of dietary nitrogen substances.
Acarbose is a novel hypoglycemic agent acting through the inhibition of glucose absorption in the gut and the promotion of intestinal saccharolytic bacterial flora at the expense of proteolytic flora.
Dr Gentile and colleagues from Naples, Italy undertook a study in order to assess whether acarbose exerts a beneficial effect on hepatic encephalopathy and on postprandial hyperglycemia.
The researchers included cirrhotic patients with low-grade hepatic encephalopathy and type 2 diabetes mellitus in the study.
In total, the research team randomized 107 cirrhotic patients with grade 1 - 2 hepatic encephalopathy and type 2 diabetes mellitus to acarbose 100 mg 3 times daily or placebo for 8 weeks.
The researchers then switched the patients treatments after a 2-week washout period and patients were then followed for 8 more weeks.
Acarbose significantly decreased ammonia blood levels and improved Reitan’s test score – Clinical Gastroenterology and Hepatology
The team determined ammonia blood levels, Reitan’s number connection test, intellectual function, fasting and postprandial glucose levels, glycated hemoglobin values, and C peptide values.
The investigators recorded these values at 2 weeks before and then 4, 8, 11, 14, and 18 weeks after treatment.
The researchers found that acarbose significantly decreased ammonia blood levels and improved Reitan’s test score and intellectual function score compared with placebo.
In addition, the team noted that acarbose caused a 33% decrease in fasting glucose level and an approximately 50% decrease in postprandial glucose level compared with placebo.
Acarbose significantly lowered glycated hemoglobin values and postprandial C peptide compared with baseline values, whereas placebo did not.
The research team found that there was no change in biochemical parameters of liver function after acarbose treatment.
Clinical Gastroenterology and Hepatology; 2005: 3 (2):
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Pittsboro's Biolex to Test Hepatitis C Therapy
SourceURL:http://www.herald-sun.com
PITTSBORO -- Pittsboro-based Biolex Inc. has teamed up with OctoPlus, a Dutch company, to develop a controlled release treatment for hepatitis C, the companies announced Wednesday.
Biolex and OctoPlus expect to have the therapy, called Locteron, in clinical trials in mid-2005, they said. The experimental therapy combines a drug delivery system developed by OctoPlus, based in Leiden, The Netherlands, with a protein produced by Biolex. The protein, recombinant alfa interferon, is used to treat patients with hepatitis B and C and certain cancers.
Locteron would be a good alternative for patients who use alfa interferon products because OctoPlus' biodegradable PolyActive drug delivery technology allows for controlled release of the therapy, the companies said in a release. Thus, hepatitis C patients would need just a single injection of Locteron for a two-week period, compared with the weekly injections required by alfa interferon treatments already on the market.
The form of alpha interferon Biolex wants to use in Locteron, BLX-883, also is currently in a Phase 1 clinical trial as an immediate release therapy. The privately held company, which raised $24 million in venture capital last fall, engineers aquatic plants called lemna to produce the proteins.
OctoPlus said it was drawn to Biolex because of its cost-effective manufacturing process for alfa interferon.
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February 17th, 2005
UK Conservative Party Proposes Requiring Immigrants to Be Tested for TB, HIV, Hepatitis B
SourceURL:http://www.medicalnewstoday.com
The Conservative Party, the main opposition party in the United Kingdom, on Monday proposed immigration guidelines that would require people from non-European Union countries who intend to permanently live in Britain to undergo tests for HIV, tuberculosis and hepatitis B, London's Independent reports (Russell/Morris, Independent, 2/15). Under the proposal, people from outside of E.U. countries who plan to settle permanently in the United Kingdom would have to "demonstrate they have an acceptable standard of health," would not be a threat to public health and would not "impose significant costs or demands" on the country's health agency, the National Health Service, according to BBC News. Under the proposed guidelines, all immigrants would have to undergo a general health check, adult immigrants who are not pregnant would have to have a chest X-ray for TB and immigrants ages 16 and older would have to be tested for HIV and hepatitis B. People from outside the European Union who are from a country with high TB incidence and plan on staying in the country for between six months to 12 months also would have to undergo a chest X-ray (BBC News [1], 2/15). People from non-E.U. countries visiting Britain for less than six months would not have to undergo testing unless they intend to work in health care, child care or teaching, and people under age 16 also would not have to be tested (BBC News [2], 2/15). Any person testing positive for TB would be denied a visa to the United Kingdom, and people who test positive for other conditions, including HIV and hepatitis B, would be dealt with on a "case-by-case" basis, according to BBC News. The Conservatives plan on introducing the proposal if the party wins the general election that is expected for May 5 (BBC News [1], 2/15). The Conservatives said their plan would not deny entry to asylum seekers. However, emigres would be required to undergo health checks to ensure that they receive medical treatment and do not spread infectious diseases, according to BBC News (BBC News [2], 2/15).
Conservative Comments
Michael Howard, leader of the Conservative Party, on Monday said, "We need to control who is coming to Britain to ensure they are not a public health risk and to protect access to the [national health service]." He added, "It's plain common sense, and it's exactly what they do in New Zealand, Canada and Australia" (Independent, 2/15). Official data show that in 2002 there were four TB cases for every 100,000 people born in the United Kindom, compared with 73 cases for every 100,000 people born in other countries, the Scotsman reports. "I don't think anyone would deny the problem we now have with TB is very significantly caused by people who come from abroad," Howard said, adding, "I don't think a responsible government can stand aside and do nothing in the face of this problem" (Lyons, Scotsman, 2/15). The Conservatives say that about 80% of HIV cases associated with heterosexual transmission reported in the United Kingdom in 2003 occurred in Africa, according to London's Guardian (Wintour/Dodd, Guardian, 2/15).
Labour, Other Reaction
Des Browne, immigration minister for the ruling Labour Party, said his party's five-year immigration plan unveiled last week targets screening for TB, AFP/Turkish Press reports (AFP/Turkish Press, 2/15). "We are implementing our existing powers by targeted health screening for TB in high-risk areas at the entry clearance stage," Browne said, adding, "Those who are diagnosed would then need to seek treatment at home before being allowed to enter the U.K." (Reuters, 2/15). Home Secretary Charles Clarke said, "This is a scurrilous attempt by the [Conservatives] to score cheap political points. The [Conservatives] are purposely mixing two separate issues of immigration and asylum" (Independent, 2/15). Labour Member of Parliament Shaun Woodward, who changed parties from the Conservatives, said, "It is incredible. To say someone who [has] HIV, regardless of their economic skills, is to be debarred from entering Britain borders on the obscene." Lisa Power, head of policy and public affairs for the not-for-profit HIV/AIDS advocacy group Terrence Higgins Trust, said the Conservatives' proposal is a "prejudice-based policy," adding, "This is not an effective policy, and there is no proof that similar measures have worked elsewhere" (Guardian, 2/15).
"Reprinted with permission from kaisernetwork.org You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv
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February 18th, 2005
Pegylated Interferon-2b and Lamivudine vs Lamivudine Alone
SourceURL:http://www.gastrohep.com
In patients with HBeAg-positive chronic hepatitis B, combination treatment with pegylated interferon-2b and lamivudine leads to a higher rate of virologic response than lamivudine alone, finds the most recent Annals of Internal Medicine.
Conventional interferon and lamivudine monotherapy are unsatisfactory in treating hepatitis B virus (HBV) infection.
Dr Lik-Yuen Chan and colleagues undertook a study in order to evaluate the efficacy and safety of pegylatedinterferon-2b and lamivudine combination therapy for chronic hepatitis B.
The researchers designed a randomized, controlled, open-label trial to be carried out in an outpatient clinic in a referral center.
The research team enrolled a total of 100 treatment-naive patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B and moderately elevated alanine aminotransferase levels.
The primary end point was sustained virologic response (HBeAg seroconversion and HBV DNA level < 500 000 copies/mL) at 24 weeks after cessation of treatment.
The researchers administered a staggered regimen of combination therapy with pegylated interferon-2b given for 32 weeks plus lamivudine (100 mg daily) given for 52 weeks to the first group.
Rate of sustained virologic response was 36% for the combination treatment group and 14% for the lamivudine monotherapy – Annals of Internal Medicine
The researchers compared the first group to a second group who received lamivudine (100 mg daily) monotherapy for 52 weeks.
The research team found that out of the 100 participants, 96% completed treatment and 80% completed post-treatment follow-up.
In addition, the team noted that the rate of sustained virologic response was 36% for the combination treatment group and 14% for the lamivudine monotherapy group.
End-of-treatment outcomes showed that, compared with monotherapy, patients receiving combination therapy more often had virologic response.
In addition, the researchers found that they had more substantial reductions of HBV DNA and less often had lamivudine-resistant mutants.
The percentages of patients with normalization of alanine aminotransferase levels and histologic improvement did not differ.
The research team observed that adverse effects, such as transient influenza-like symptoms, alopecia, and local erythematous reactions, were more common with combination therapy.
Dr Lik-Yuen Chan concluded, "In patients with HBeAg-positive chronic hepatitis B, staggered combination treatment with pegylated interferon-2b and lamivudine may lead to a higher rate of virologic response than lamivudine monotherapy."
Annals of Internal Medicine; 2005: 142 (4): 240-250
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Hep C Coinfection Increases Risk of Fulminant Hepatic Failure
SourceURL:http://www.gastrohep.com
HAART and hepatitis C coinfection appear to act synergistically in HIV-infected patients to increase the risk of fulminant hepatic failure, finds March's issue of Journal of Hepatology.
It is uncertain if patients coinfected with hepatitis C and HIV are more likely to suffer fulminant hepatic failure (FHF) when compared to patients with HIV-only.
Dr Kramerab and colleagues from Texas, America undertook a study of a cohort from national administrative databases from the Department of Veterans Affairs in patients hospitalized for the first time with HIV and/or hepatitis C between 10/1991 and 9/2000.
The researchers defined fulminant hepatic failure as occurring after the index hospitalization through 9/2001 in the absence of pre-existing liver disease.
The research team calculated incidence rates, Kaplan Meier cumulative incidence curves, and Cox proportional hazards ratios while adjusting for demographics and other potential confounders.
The researchers identified 11,678 patients with HIV-only and 4761 patients with coinfection.
Cumulative incidence of fulminant hepatic failure in the coinfected group was higher than in the HIV-only group – Journal of Hepatology
The research team noted that there were 92 cases of fulminant hepatic failure yielding an incidence rate of 1.1/1000 person-years and 2.5/1000 person-years in the HIV-only and coinfected groups.
The researchers found that the cumulative incidence of fulminant hepatic failure in the coinfected group was higher than in the HIV-only group.
In addition, the research team noted that the risk of fulminant hepatic failure in patients with coinfection compared to HIV-only during the HAART era was several folds higher than that during the pre-HAART era.
Dr Kramerab concluded, "HAART and hepatitis C coinfection appeared to act synergistically in HIV-infected patients to increase the risk of fulminant hepatic failure, a rare but often fatal disease."
Journal of Hepatology; 2005: 42 (3): 309-314
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Not All Hepatitis C Patients Need Treatment
BY PAUL G. DONOHUE, M.D.
SourceURL:http://sun.yumasun.com
Ask the Doctor
DEAR DR. DONOHUE: I have chronic hepatitis C. My understanding is that anyone with chronic hepatitis C should get treatment. A doctor told me that patients are not treated until they get liver cirrhosis. It seems to me that a patient would have a better chance of recovery if treatment were given early. Will you give your opinion on this? -- I.C.
ANSWER: Nearly 75 percent of people infected with the hepatitis C virus will come down with a chronic liver infection. That means the virus will stay in the liver forever. After 20 years of liver infection, 20 percent to 30 percent of the chronically infected develop liver cirrhosis. Cirrhosis is a scarred, nonfunctioning liver.
Today's medicines have revolutionized hepatitis C treatment. The combination of interferon and ribavirin can bring the number of hepatitis viruses in the body to undetectable levels in more than half of those who get treatment. That doesn't say positively that treatment cures these people, but it is a way of suggesting that they might be cured.
Should everyone with chronic hepatitis C infection be treated? No. Some will not progress to cirrhosis, and treatment can have undesirable side effects. Treatment is given to those who are at an increased risk of progressing to cirrhosis. Indications of potential progression include elevations of blood levels of liver enzymes, demonstration that the hepatitis C virus is circulating in the blood, and biopsy evidence that the liver shows strands of scar tissue or inflammation. Treatment is not delayed until liver cirrhosis has occurred.
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February 19th, 2005
Pin-Stick Victim Has Hepatitis
SourceURL:http://www.nj.com/
By NICK FALSONE
The Express-Times
Transmission risk described as low.
WASHINGTON -- One of the students stuck with a pin at last Friday night's Warren Hills Regional Middle School dance has tested positive for the hepatitis C virus in an initial screening, officials said.
The Warren Hills Regional Board of Education and the Warren County Health Department on Friday announced the results of the screening and encouraged victimized students who have not come forward to contact their physician and the school as soon as possible.
Officials said the announcement is a precautionary measure. More tests have to be conducted on the student, who they declined to identify, before it can be determined that the student definitely has the virus.
Even if the additional tests do show the student definitely has the virus, the risk that it was transmitted to any other students stuck with the pin is "extremely low," county health educator Sheila Risley said.
Twenty students were stuck or poked by what authorities said could have been a pushpin or a safety pin during the dance. Borough police are investigating and there have been no reports of any arrests in the case. The Valentine's dance drew 433 seventh- and eighth-grade students.
The board of education and county Health Department learned of the possible hepatitis C case Thursday from a local physician who contacted the middle school about a student who the physician checked. The student was among the 20 who reported being a victim of the pin-sticking.
An initial screening done by the physician revealed antibodies to the hepatitis C virus, but more tests have to be done to confirm that the student definitely has the virus, according to county epidemiologist Samantha Caudill. She did not know how long the confirmatory tests will take.
Caudill said if the student does in fact have the virus, there is no way it was acquired at the middle school dance. Based on the screening, it would have been acquired prior to the incident, she said.
The concern is that the virus could have been spread to other students through the pin that was used to stick the potentially-infected student, Risley said. The chances of that happening are slim, but officials wanted to get the word out to err on the side of caution, she said.
Risley said it's difficult to quantify how slim of a risk exists because no one knows for certain the size of the pin. The longer the pin, the greater the risk because the virus is carried through blood, she said.
School officials have said the injuries were consistent with a pushpin or a safety pin. It penetrated clothing, but did not penetrate the skin too deeply on the students, they have said.
The county health educator described hepatitis C as a virus that generally exhibits few symptoms, but can damage the liver over time.
The county epidemiologist said treatments are out there, but they're not 100 percent effective. Some people become chronic carriers, but earlier treatment often stops this from happening, she said.
While officials wait for a definite answer on whether the student is infected, they're continuing to seek and compile information regarding the incident, county health officer John Hawk said.
There's a possibility that more students were stuck with the pin and have yet to come forward. If they did get stuck, Hawk is urging them to contact their physician and also contact the middle school's nurse so accurate records can be kept on who was victimized.
"The important thing is to contact a physician," Hawk said. "They can contact the school nurse later."
There was no new information Friday regarding the criminal investigation into the case. Warren Hills Regional Superintendent Peter Merluzzi could not be reached for comment.
However, Warren Hills Regional board member Donna Golda said nothing new was reported to her on Friday. The superintendent has been calling board members at home since the incident happened to give them any updates on developments in the case. He didn't call her Friday, she said.
Efforts to reach other board members Friday night were unsuccessful.
The middle school principal has said no more dances will be held at the school and the district's high school until the incident is resolved. Students who reported getting stuck could not identify the attacker, but have been cooperating with the probe.
Hawk said the health department will continue trying to contact parents of the victimized students over the weekend to explain to them the situation.
Representatives will also remain on call to take inquiries from parents of students who might have been stuck and have yet to come forward.
Those with additional questions can contact the health department at 908-689-6693 weekdays before 4:30 p.m. After 4:30 on weekdays, on weekends or holidays, they can call 908-835-2000 and ask to speak to the on-call health officer.
Reporter Nick Falsone can be reached at 610-867-5000 or by e-mail at nfalsone@express-times.com.
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