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News Review

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HCV ADVOCATE WEEKLY NEWS REVIEW:
A Review of HCV, HBV and HIV/HCV Coinfection Related News and Highlights

Week Ending: January 29th, 2005

Alan Franciscus
Editor-in-Chief

To download pdf version click here


This Issue:


Blood Donor Infects 7 with Hepatitis B (Japan)

NHS Knew Blood for Transfusions Was Contaminated with Hepatitis (Scotland)

Magic Bullet for Hepatitis C

Metabasis Therapeutics, Inc. (MBRX) Announces an Extension and Expansion of Its Existing Collaboration With Merck & Co., Inc. (MRK) to Develop New Treatments for Hepatitis

Bristol Entecavir Hepatitis Therapy Slated for Antiviral Cmte. Review

Neumega® May Have Role in Treatment of Chronic Hepatitis C

Needlestick Injuries in Healthcare Workers Still Occurring, UK

Health Ministry Prepares Strategy on Hepatitis (Pakistan)

Alcohol, Tobacco & Obesity: Synergistic Risks for Liver Cancer

A New Website Resource, www.Heplinks.Com Was Recently Launched on the First Annual International Hepatitis C Awareness Day (Philippines)

Hepatitis C Could Become 'AIDS of the 21st Century,' New York Lawmaker Warns

Research and Markets: Hepatitis B & C - Winning Battles but Not the War

Scientists ID Molecular 'Switch' in Liver that Triggers Harmful Effects of Saturated and Trans Fats

Thalidomide of Little Value for Advanced Liver Cancer

All-Clear for 98 Women in Health Scare (UK)

Cosmetic Injections Are Linked to Spread of Variant CJD and Hepatitis


January 23rd, 2005


Blood Donor Infects 7 with Hepatitis B
SourceURL:http://www.yomiuri.co.jp
Yomiuri Shimbun

At least seven people were infected with hepatitis B by a blood donor who was found Friday to have passed the Japanese Red Cross Society's screening test and donated blood on 78 occasions since 1994, according to the Red Cross.

The Red Cross reported the cases to the Health, Labor and Welfare Ministry's Pharmaceutical Affairs and Food Sanitation Council on Friday, fearing that more people may have been infected with HBV through infusions with the tainted blood.

According to the Red Cross, all blood given by the donor was processed into blood products, but it does not know how many patients received infusions of the products. It was discovered recently that the blood of quite a few people who are infected with HBV contains extremely low concentrations of the virus. However, the virus remains contagious in low concentrations. It is difficult for the Red Cross to detect HBV even using high-precision screening techniques. The donor's blood is believed to be contain a low concentration of the virus.

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NHS Knew Blood for Transfusions Was Contaminated with Hepatitis
SourceURL:http://www.sundayherald.com
By Liam McDougall, Home Affairs Editor

Government refuses public inquiry into unsafe practice

BLOOD from Scottish prisoners continued to be used in NHS transfusions during the 1980s despite serious concerns that the practice was unsafe.

Confidential minutes from meetings held by directors of the Scottish National Blood Transfusion Service (SNBTS) also show the agency was taking increasing quantities of blood from American troops and that doctors knew in 1981 the blood they were buying in from the US was contaminated with at least two forms of the hepatitis virus.

The documents, released under the Freedom of Information Act, are now to be used by lawyers to build up a case for the government to order a judicial inquiry into how thousands of patients in the UK -- including hundreds of Scots --contracted HIV and hepatitis from contaminated blood in the 1970s and 1980s.

More than 1000 people are now dead as a result of receiving infected blood and many have gone on to develop Aids and liver cancer because of their infection. Haemophiliac families, who were given NHS products to make their blood clot, have been wiped out by the faulty treatments.

But unlike other countries where so-called "tainted blood" scandals have led to inquests and criminal convictions, the UK government has refused a public inquiry into what has become known as "the biggest medical treatment disaster in the history of the NHS".

The government has said that an inquiry is not justified "as it does not believe any new light would be shed on this issue as a result".

But details of the secret SNBTS meetings were hailed by campaigners last night as "dynamite" and a "breakthrough" in their fight to find out how they became infected.

It comes as Glasgow-based lawyer Frank Maguire, who represents around 140 patients who contracted hepatitis C through infected blood products, is preparing to take a case against the Lord Advocate, Scotland's most senior law officer, to force an inquiry.

Maguire, of the law firm Thompsons, said: "No-one has ever been given a proper explanation of how this happened and who was responsible."

The dossier reveals that in 1983, a time when the US had stopped taking blood from its prisoners amid growing concerns about the spread of HIV and hepatitis, Scotland continued with its policy of taking blood from inmates. Documents from the government in Canada, which also continued with the controversial practice, showed there was a "high probability" of prison blood being contaminated with both HIV and hepatitis C.

Effective heat treating of blood --which killed hepatitis and HIV-- was not introduced in Scotland until 1987.

In the minutes of a SNBTS meeting held on March 29, 1983, the directors warn that the Medicines Inspector had "commented adversely on the practice of collecting blood in prisons and borstal institutions" and admit that blood collecting sessions were held "in penal institutions in all regions".

However, minutes of a meeting held six months later reveal nothing was done and, despite concerns from some SNBTS doctors, the practice continued. The minutes state: "On the matter of collection in prisons and borstals it was noted that the Medicines Inspector had expressed concern at the practice. Owing to different circumstances in the transfusion regions the directors had been unable to reach a consensus."

The minutes conclude: "Some directors felt that a blanket decision to cease visiting prisons would be a mistake."

But at a meeting of the UK's Regional Transfusion Directors in 1988, there was proof the agency knew how dangerous the practice was. The minutes of that meeting note that "many" donors who were subsequently found to have become seriously ill with hepatitis "had come from blood donor sessions in Her Majesty's Prisons".

The complete dossier --which totals more than 100 pages and includes minutes from confidential meetings of SNBTS directors over two decades from the 1970s -- contains the acknowledgement that haemophiliacs were being given blood that contained "non-A, non-B" hepatitis, which later became known as hepatitis C.

The information in the document appears to contradict evidence that former health minister Malcolm Chisholm gave to the health committee when he said the dangers from hepatitis C were not known until 1990.

Campaigners last night reacted with fury to the revelations. Robert Mackie, a haemophiliac who contracted HIV in March 1984 through contaminated blood products and who now has full-blown Aids, said: "This information is outrageous. It's now my belief that I was infected with blood that was taken from the British prison service. It made me physically sick when I read it."

"I'm so bloody angry about this. I asked year after year if the products were safe and each time they told me categorically that the blood was screened. Obviously this was lies. These papers show they could not care less about any of us."

Mackie, who stays in the Borders, was only told by doctors that he had HIV more than three years after becoming infected. Two uncles and a cousin, also haemophiliacs, died from Aids in the 1990s after receiving contaminated blood products. A nephew has hepatitis C.

"What we need now is a judicial inquiry into how we came to be infected with contaminated blood ," he said.

Philip Dolan, chairman of the Scottish Haemophilia Forum, said: "We have continually requested an independent public inquiry and this information reinforces this. It's a scandal."

Brian Adam, an SNP MSP who has been a vocal supporter of haemophiliacs, said he backed calls for an inquiry "wholeheartedly".

An SNBTS spokeswoman admitted that blood was taken from prisoners until 1984 but said it had done everything it could have to prevent the spread of HIV and hepatitis.

She added: "SNBTS took a proactive approach to hepatitis B, HIV and hepatitis C prevention. In each case, donor exclusion criteria were introduced as evidence became available; specific tests for each of the viruses were introduced promptly and effectively."

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January 24th, 2005


Magic Bullet for Hepatitis C
SourceURL:http://www.forbes.com
Adviser Soapbox
Scott Gottlieb

When I was a resident in medicine, there was a virus that frightened doctors who had to handle needles and scalpels. Doctors were afraid that in the hurried delivery of emergency care, a hand would slip or a scalpel would fall, and a doctor would accidentally stick herself. If a patient had the virus, chances were good that a doctor could soon have it, too.

But I'm not talking about HIV, the virus that causes AIDS. I'm talking about hepatitis C.

There are about 200 million people in the world who are infected with the hepatitis C virus (HCV)--almost five million in the U.S. alone. The virus causes your liver to swell and stops it from working. Eventually, the liver can become incapable of functioning because constant inflammation kills the organ. HCV is spread by contact with the blood of an infected person, and it is extremely contagious, even more contagious than AIDS.

In industrialized countries, hepatitis C causes 40% of all of the advanced liver disease and 60% of liver cancers. When patients reach these advanced stages, there are not many cures. Short of a liver transplant, many patients with advanced liver disease soon die.

Today, the standard treatment for hepatitis C is the combination of an antiviral medicine that targets the virus and an immune system-boosting drug that helps the body fight the infection. This elixir works for about half of all patients, but many patients can't tolerate the regimen or their bodies don't respond to it.

But there is new hope in the development of a class of drugs known as protease inhibitors. This isn't the same kind of protease inhibitor that has been used to successfully treat AIDS. In the case of HCV, the drug is targeted at a unique kind of protease enzyme only used by the hepatitis C virus.

The most advanced and most promising protease inhibitor for hepatitis C belongs to the Cambridge, Mass.-based biotechnology company Vertex Pharmaceuticals (nasdaq: VRTX - news - people ).

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Scientists at Vertex used structure-based drug design to create the drug, known as VX-950. Structure-based design means that scientists use special equipment to make computer models of a three-dimensional structure of the enzyme they are targeting. This enables more rational attempts to design drugs to stick inside the enzyme's active site, by building the ideal drug one atom at a time, like a microscopic Lego set.

The small trial is going to compare the safety and effectiveness of VX-950 to a sugar pill in about 60 healthy volunteers and patients with hepatitis C. The study is expected to finish up this year. It should give Vertex a good look at just how potent the new drug is, as well as a peek at whether it is safe.

If VX-950 works, it will be a big advance for patients with hepatitis C. It could also be a blockbuster medicine--a first-in-class, broad-spectrum antiviral drug that could work for many, if not most, patients infected with hepatitis C. The market for drugs that treat hepatitis C was worth $1.6 billion last year and is expected to grow to $4 billion by 2009.

Doctors have high expectations for this drug class. But there is plenty of caution. At least one other protease inhibitor that was targeted against hepatitis C has failed in development, largely because it had too many side effects.

Keep in mind how protease inhibitors all work. They block an enzyme that belongs exclusively to the hepatitis C virus. There isn't a human protein that is closely related to hepatitis C protease, so the drug should not be interfering with any human cellular processes at all.

That means that the only way these drugs could cause side effects in people is if the liver doesn't break them down very well. This seems to be precisely the problem with older, early formulations of protease inhibitors that were developed by another company, Boehringer Ingelheim. These kinds of problems with metabolism are most often related to the way the drug is designed, not the underlying mechanism of the drug itself.

Schering-Plough (nyse: SGP - news - people ) is also believed to be in early clinical testing with a protease inhibitor of its own that targets hepatitis C. Several other companies have research programs focused on HCV protease inhibitors, including Gilead Sciences (nasdaq: GILD - news - people ), Merck (nyse: MRK - news - people ), Pfizer (nyse: PFE - news - people ), GlaxoSmithKline (nyse: GSK - news - people ) and InterMune (nasdaq: ITMN - news - people ). By all accounts, however, Vertex is farthest along.

There are also some other promising drugs in development for hepatitis C. But the protease inhibitors alone hold out some of the best near-term promise to fulfill the holy grail of hepatitis C therapy--a single potent pill that can destroy the virus all on its own, or in a small cocktail where the drug is used in combination with older medicines.

Vertex thinks it might have found the magic bullet. A clinical trial expected to finish this year could provide doctors, patients and investors with the first sure sign of whether Vertex is right.

Dr. Gottlieb is a practicing physician and a fellow at the American Enterprise Institute. He recently left the FDA, where he was Director of Medical Policy Development and a senior adviser for medical technology to the FDA Commissioner.

Send comments and questions to newsletters@forbes.com.

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January 25th, 2005


Metabasis Therapeutics, Inc. (MBRX) Announces an Extension and Expansion of Its Existing Collaboration With Merck & Co., Inc. (MRK) to Develop New Treatments for Hepatitis C
SourceURL:http://www.biospace.com/

SAN DIEGO, Jan. 25 /PRNewswire-FirstCall/ -- Metabasis Therapeutics, Inc. announced today that it has extended and expanded a hepatitis C collaboration that was established with Merck in December 2003. The companies will continue their joint efforts to identify novel small molecule therapeutics for the treatment of hepatitis C virus infections (HCV) for an additional twelve months, through December 2005.

Under the extension, which was permitted under the terms of the existing agreement, Merck will continue to contribute drug candidates to the collaboration and fund Metabasis' efforts to apply its technologies to those candidates with the goal of producing a candidate suitable for clinical development. The agreement was expanded to provide for use of certain other technologies in addition to Metabasis' proprietary HepDirect(TM) technology.

Metabasis has developed expertise and technology for improving drugs that act primarily in the liver. One example is the Company's proprietary HepDirect technology, a prodrug technology that specifically targets production of the biologically active form of certain drugs to the liver. Preclinical studies have shown that use of the HepDirect technology may result in higher active drug concentrations in the liver and decreased exposure to non-liver tissue. Accordingly, HepDirect prodrugs may have the potential to improve efficacy, reduce toxicity and thus improve the treatment of liver and liver-related diseases. Metabasis' HepDirect product candidate for the treatment of Hepatitis B is currently in Phase II clinical development.

"We view Merck's decision to extend the collaboration as a further validation of our technologies, our team and the exciting progress made to date in this program," said Dr. Mark Erion, Metabasis' Executive Vice President of Research and Development. "We look forward to building on that progress during the second year of the collaboration and are optimistic that together we may successfully discover potential new treatments for HCV."

It is estimated that up to 3% of the world population has been infected with HCV, according to NHANES III (Third National Health and Nutrition Examination Survey), which means there are more than 170 million chronic carriers at risk of developing liver cirrhosis and/or liver cancer. Nearly 4 million Americans are infected with HCV and about 2.7 million Americans (70%) of those are chronically infected with HCV. In 2002 the NIH issued a report that conservatively estimated that HCV is responsible for 10,000 to 12,000 annual deaths in the United States, where the number of people diagnosed with chronic HCV is expected to increase fourfold from 1990 to 2015.

About Metabasis (http://www.mbasis.com/)
Metabasis Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs principally to treat metabolic diseases linked to pathways in the liver and to treat liver diseases. The company has established a broad product pipeline targeting large markets with significant unmet medical needs. Metabasis has three internally discovered, novel product candidates in clinical development: CS-917, pradefovir mesylate (previously known as remofovir) and MB07133, indicated for the treatment of type 2 diabetes, hepatitis B and primary liver cancer, respectively. All three products are being studied in patients and preliminary evidence of efficacy has been demonstrated with CS-917 and pradefovir mesylate. Metabasis has developed several proprietary technologies for use in discovering and optimizing drugs, including the NuMimetic(TM) technology and the HepDirect(TM) technology. The NuMimetic technology was used to discover CS-917, a first-in-class gluconeogenesis inhibitor, and was also used to identify MB07803, a 2nd generation gluconeogenesis inhibitor that is expected to enter the clinic in 2005 for the treatment of type 2 diabetes. The HepDirect technology, a liver-targeting prodrug technology, was used to develop pradefovir mesylate and MB07133 and is also being used in a partnership with Merck to discover new treatments for hepatitis C. Metabasis is continuing to identify and develop new product candidates using its proprietary technologies and know-how.

Forward-Looking Statements:
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the progress, goals and success of Metabasis' collaboration with Merck to develop new treatments for hepatitis C, Metabasis' progress on its other strategic goals and pursuit of its corporate objectives, the completion of clinical trials for Metabasis' product candidates, the expansion of Metabasis' product pipeline, and the designation of additional product candidates from Metabasis' advanced research programs, and the strength of Metabasis' proprietary position as well as other statements about Metabasis' proprietary technologies, product candidates, research programs and collaborations. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Metabasis' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress and timing of clinical trials for Metabasis' product candidates; the fact that positive results from pre-clinical studies and early clinical trials does not necessarily mean later clinical trials will succeed; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing Metabasis' product candidates; adverse side effects or inadequate efficacy of Metabasis' product candidates or proprietary technologies; Metabasis' dependence on Merck and its other licensees and collaborators for the clinical development and registration of its product candidates including any product candidates yielded in Metabasis' collaboration with Merck, among other things; the scope and validity of intellectual property protection for Metabasis' product candidates, proprietary technologies and their uses; competition from other pharmaceutical or biotechnology companies; Metabasis' ability to obtain additional financing to support its operations; and other factors discussed in the "Risk Factors" section of Metabasis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2004. All forward-looking statements are qualified in their entirety by this cautionary statement. Metabasis is providing this information as of this date of this release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Metabasis Therapeutics, Inc.

CONTACT: Paul Laikind, Ph.D. of Metabasis Therapeutics, Inc.,+1-858-622-5550, or Susan Neath of Atkins + Associates, +1-858-527-3486, for Metabasis Therapeutics, Inc.

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Bristol Entecavir Hepatitis Therapy Slated for Antiviral Cmte. Review
SourceURL:http://www.fdaadvisorycommittee.com

FDA's Antiviral Drugs Advisory Committee will discuss Bristol-Myers Squibb's oral hepatitis agent entecavir March 11.

The committee is slated to review the firm's NDAs for tablets and an oral solution of the nucleoside analogue for treatment of chronic hepatitis B infection.

Bristol announced its submission of entecavir Oct. 4, 2004. The application is receiving a six-month priority review. A European submission is also pending.

Results from Bristol's Phase III trials comparing entecavir to lamivudine (GlaxoSmithKline's Epivir-HBV) showed significantly greater improvements in liver histology and reductions of HBV DNA levels for entecavir.

Roche filed a Pegasys (interferon alfa-2a) sBLA for chronic HBV in July 2004 based on similarly designed studies.

To arrange for live videoconferencing, or to order videotapes & DVDs, email webcasthelp@fdcreports.com or call 800-627-8171.

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Neumega® May Have Role in Treatment of Chronic Hepatitis C
SourceURL:http://professional.cancerconsultants.com

Researchers from the Brooke Army Medical Center in San Antonio have reported that Neumega® (interleukin-11) may reduce hepatic inflammation in patients with chronic hepatitis C who have failed anti-viral therapy. The details of this report appeared in the December 2004 issue of the American Journal of Gastroenterology .[1]

Hepatitis C affects approximately 170 million individuals worldwide. Following acute infection, the virus persists in many patients and a minority of patients develops chronic disease. Chronic hepatitis can progress slowly over many decades to chronic active hepatitis and cirrhosis, ultimately leading to end-stage liver disease or hepatocellular carcinoma. Approximately 20% of patients who develop cirrhosis will get cancer. It takes approximately 20 years to develop cirrhosis and 25-30 years to develop cancer. It is rare to develop hepatocellular carcinoma without cirrhosis. The U.S. is witnessing an increase in hepatitis C infection similar to the increase observed in Japan 50 years ago. Hepatitis C-associated hepatocellular cancer is increasing in incidence, while cancers related to alcohol and hepatitis B are remaining constant. There will be an expected 3-fold increase in hepatitis C-associated liver cancer over the next 20 years. Current treatment for hepatitis C consists of interferon alfa plus ribavirin; however, the response rate to interferon and ribavirin is only 50%.

Currently, a large trial is being carried out in patients with cirrhosis to determine if 8 years of therapy with interferon alfa plus ribavirin prevents liver cancer. Vaccine development is still a futuristic program and other treatment modalities are needed to control hepatitis C and to prevent future cases of hepatocellular carcinoma. Anti-inflammatory cytokines, which have an effect on liver inflammation have not been evaluated in patients with chronic hepatitis C infection. Furthermore, growth factors such as Neupogen®, erythropoetins and Neumega® have rarely been used as supportive care for patients having low blood cell counts from interferon and ribavirin.

Neumega® is a multifunctional cytokine that can reduce inflammation through down-regulation of multiple pro-inflammatory mediators from activated macrophages. An early study indicated that Neumega® ameliorates T-cell mediated hepatic injury in a murine model.[2] Neumega® has also been found to decrease acetaminophen-induced hepatotoxicity when given prior to drug exposure in a murine model.[3]

In the current study, Neumega® was given daily for 12 weeks to 20 patients with choronic hepatitis C who had failed antiviral therapy. The investigators observed an improvement in histology and a decrease in serum enzyme levels. These authors suggest that further long-term studies be undertaken with Neumega® to confirm these findings.

Comment: This is a novel and potentially important observation that may have implications for the prevention of hepatocellular cancer, especially in patients who do not clear virus with antiviral therapy. It is also possible that by combining anti-inflammatory cytokines with antiviral therapy, a better therapeutic effect could be achieved.

References:
[1] Lawitz EJ, Hepburn MJ, Casey TJ, et al. A pilot study of interleukin-11 in subjects with chronic hepatitis C and advanced liver disease unresponsive to anti-viral therapy. American Journal of Gastroenterology. 2004;99:1-6.

[2] Bozza M, Bliss JL, Maylor R, et al. Interleukin-11 reduces T-cell-dependent experimental liver injury in mice. Hepatology . 1999;30:1441-1447.

[3] Trepicchio WL, Bozza M, Bouchard P, et al. Protective effect of rhIL-11 in a murine model of acetaminophen-induced hepatotoxicity. Toxico Pathol. 2001;29:242-249.

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January 26th, 2005


Needlestick Injuries in Healthcare Workers Still Occurring, UK
SourceURL:http://www.medicalnewstoday.com

The latest Health Protection Agency report on the occupational exposure of healthcare workers (HCWs) to bloodborne viruses (BBVs) shows that nine healthcare workers were infected with hepatitis C through needlestick injuries over the last six years, with seven reported between July 2003 and June 2004.

Between 1996 and 2004, 2140 incidents of significant occupational exposure to BBVs were reported to the Agency; 47% (997/2140) of these HCWs were exposed to hepatitis C and 26% (551/2140) to HIV. These figures, gathered through the Agency's monitoring programme, which looks at exposures to BBVs in healthcare settings, indicate that there are still too many exposures occurring. Although over half of the injuries looked at occurred during the procedure, over a third were after the procedure and during disposal of clinical waste, including exposures sustained while recapping needles or clearing clinical waste left by another worker.

Dr Fortune Ncube from the Health Protection Agency said, “The fact that preventable exposures are still occurring highlights the continued need to ensure that correct procedures are followed in the handling of sharps and in the disposal of clinical waste. Although the last case of a HCW occupationally contracting HIV was in 1999, it is vital that healthcare workers are aware of the importance of immediately reporting incidences following injury. Appropriate referral, testing and prompt treatment are also very important and can prevent the onset of infection and the need for specialist aftercare. It is also vital that healthcare workers infected through an occupational exposure are aware of the treatment options now available to them. Employers should support frontline staff and ensure that safety information and appropriate facilities for a safe working environment are available.”

“This report also recommends improvements in surveillance techniques, to ensure that the guidelines to reduce exposure incidents are as effective as possible. Our current methods of surveillance have worked well in identifying and dealing with incidents of exposure, but we need to identify further ways of gathering information. As well as encouraging better data collection of incidents, we have recommended that the Agency, alongside partners such as the Department of Health, looks at establishing a sentinel surveillance system to support existing work. This would allow for more detailed examination of the risks facing healthcare workers, and would lead to a greater understanding of the factors involved in occupational exposures to bloodborne viruses, helping us develop more targeted and appropriate prevention measures.”

“At present, information on follow-up testing of healthcare workers exposed to bloodborne viruses is also incomplete. It is essential that HCWs are properly tested and followed up to ensure that they have not been infected with a BBV through their occupational exposure.”

Notes to Editors
1 For further information: Please contact the Health Protection Agency Press Office on 020 8327 7098/7097/6055/6647.

2 This report includes significant occupational exposures incidents reported to the Health Protection Agency between 1st July 1996 and 30th June 2004 from reporting centres, currently 150, geographically scattered throughout England with four actively reporting centres in Wales and one actively reporting centre in Belfast , Northern Ireland.

3 Hepatitis means swelling or inflammation of the liver. The most common causes of hepatitis are viral infections. Hepatitis C infection (also known as Hep C or HCV) is one such virus that can cause long-lasting infection and can lead to liver disease including liver cancer. In the absence of treatment it is estimated that around 15-20% of infected people clear their infections naturally within the first 6 months of infection. For the remainder, hepatitis C is a chronic infection that can span several decades and can be life-long.

4 The surveillance of significant occupational exposures to bloodborne viruses (BBVs) in health care workers looks at the type of exposures reported to the scheme and the situation surrounding the event. The scheme collects data on the number of health care workers exposed to hepatitis B (HBV), hepatitis C (HCV) and HIV, and information on the use and management of treatment following exposure to these viruses.

5 The first documented case in the UK of a health care worker acquiring HIV following an occupational exposure was in 1984. Following this, a passive surveillance system was established, involving health care workers in England , Wales and Northern Ireland for exposures to HIV. This was changed to a more active surveillance system in July 1997, and was expanded to include hepatitis B and hepatitis C.

6 The full report can be accessed here: hpa.org.uk/infections/topics_az/bbv/s_report.htm

This is a press release from the Health Protection Agency

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Health Ministry Prepares Strategy on Hepatitis
SourceURL:http://www.dailytimes.com.pk
Staff Report

* Prime minister to receive report this week
* Media retreat on health held

ISLAMABAD: The Health Ministry will present a detailed report to Prime Minister Shaukat Aziz by the end of January on ways to control the spread and hazards of hepatitis in the country.

Syed Anwar Mehmood, federal health secretary, said this while talking to journalists on Tuesday after presiding over the opening session of the National Media Retreat on Health. The retreat was arranged to educate journalists about government’s activities in the health sector.

Mr Mehmood said the ministry had prepared a comprehensive strategy to control hepatitis and pledged to provide a hepatitis-free atmosphere to the people.

Dr Rehan Hafiz, national programme manager of the Extended Programme on Immunisation (EPI), told Daily Times that the prime minister had set up a task force to review the hepatitis situation in the country and prepare its report.

He said the task force had almost finalised a national project against hepatitis. He added that the project would cover all aspects of the disease throughout the country.

Dr Hafiz said hepatitis B was spreading in the country with a prevalence rate from six to seven percent and added that there were about 10 million hepatitis B patients in the country. Hepatitis B and C are global health problems. About 350 million carriers of the hepatitis B virus in the world. Hepatitis-B is a deadly liver disease having same mode of transmission as AIDS.

A NIH senior official said the Global Alliance for Vaccines and Immunisation (GAVI), which is financially supported by the Bill and Melinda Gates Foundation, would provide financial support to Pakistan for the hepatitis-B campaign till 2007. He added that the government would have to purchase the anti-hepatitis vaccines after 2007. About the NIH performance, the federal health secretary said the institute must improve its vaccines production capacity.

In his presentation, Dr Hafiz admitted that EPI was facing problems for lack of field staff facilities and motivation. He said misperception about EPI was high among illiterate people. Dr Zahid Larik, national programme manager for Family Planning & Primary Health Care, gave a presentation on the role of lady health workers.

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Alcohol, Tobacco & Obesity: Synergistic Risks for Liver Cancer
SourceURL:http://www.gastrohep.com

Alcohol, tobacco and obesity are independent risk factors for hepatocellular carcinoma in our patient population, and they interact synergistically to increase the risk of hepatocellular carcinoma, reports the most recent issue of Journal of Hepatology.

Alcohol has been shown to be an important risk factor for hepatocellular carcinoma (HCC).

The role of tobacco as a risk factor for hepatocellular carcinoma is controversial.

Recently, obesity has been reported to be a risk factor for hepatocellular carcinoma.

Dr Marrero and colleagues from Michigan, America investigated whether these factors increase the risk of hepatocellular carcinoma in American patients.

The research team enrolled consecutive patients with hepatocellular carcinoma, cirrhosis without hepatocellular carcinoma and, control patients without liver disease in order to assess their exposure to risk factors.

Risk of HCC increased 6-fold for alcohol and 5-fold for tobacco – Journal of Hepatology

When the researchers compared HCC cases to cirrhotic controls, they found that the risk of HCC increased 6-fold for alcohol, 5-fold for tobacco and 4-fold with obesity.

The research team used spline regression, in order to reveal a dose-dependent relationship between alcohol and tobacco exposure with risk of HCC.

There was significant interaction between alcohol, tobacco and obesity, with synergistic indices greater than 1.

Dr Marrero concluded, "Alcohol, tobacco and obesity are independent risk factors for HCC in our patient population, and they interact synergistically to increase the risk of HCC."

"Data from this study may allow us to stratify cirrhotics into low- and high-risk groups for the development of HCC surveillance strategies."

Journal of Hepatology; 2005: 42 (2): 218-24

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A New Website Resource, www.Heplinks.Com Was Recently Launched on the First Annual International Hepatitis C Awareness Day
SourceURL:http://www.mb.com.ph

The web portal is a result of a cooperative initiative among hepatitis C and liver disease patient associations in Europe and the Middle East. It is supported by Roche.

Information found on www.Heplinks.com includes: Facts about hepatitis C, frequently asked questions and answers, links to patient associations and liver organizations, information about relevant scientific or medical congresses and meetings, links to relevant journals and publications.

Every year the number of people newly affected with the hepatitis C virus (HCV) increases by three to four million worldwide, adding to the 170 million people already infected.

“You have company” was the theme of the first International Hepatitis C Awareness Day. Every year, October 1 will be recognized as Hepatitis C Awareness Day. This day aims to draw attention to a virus that is a major global healthcare problem, infecting approximately three percent of the world’s population. Hepatitis C is one of the main causes of liver disease, cirrhosis, liver cancer and also the leading cause of liver transplantation worldwide.

Hepatitis C is a blood-born viral infection of the liver that was first identified only in 1989. Few people realize that they are infected as the symptoms are non-specific (such as fatigue) and people tend to become aware when the disease is quite advanced.

Transmission by blood products has been reduced to almost zero due to screening for the virus, so today the most common route of transmission is the use of unsterilized needles (such as those used in tattooing and by intravenous drug users) and syringes.

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Hepatitis C Could Become 'AIDS of the 21st Century,' New York Lawmaker Warns
SourceURL:http://www.newstarget.com

A State Sentator from Long Island, New York says he is afraid that Hepatitis C could turn into the "AIDS of the 21st Century." He has started pushing for the state to begin more initiatives to keep the virus in check. The lawmaker pointed to some alarming statistics: Nassau County recorded about 7,000 cases of Hepatitis C last year, and Suffolk County saw 4,365 cases.

Overview:
Warning that hepatitis C could become "the AIDS of the 21st century," Sen. Chuck Schumer came to Long Island yesterday to push for more resources to fight the virus.

Suffolk County has recorded about 7,000 cases of hepatitis C, while 4,365 cases have been reported in Nassau, health officials said.

"We really don't know the rate of new infections that occur on Long Island, but we do know that the burden of hepatitis C will continue to grow," Ackman said.

Hepatitis C is one of a group of infectious viruses that attack the liver, and if left untreated it can cause permanent liver damage.

Experts still don't fully understand how hepatitis C is transmitted.

But the Centers for Disease Control estimates that 60% of new cases are caused by needles shared by intravenous drug users.

Ackman said needle exchange programs could be one step in reducing the infection rate on the Island.

The virus also is spread by unclean body piercing tools and tattoo needles.

"It has been transmitted through tattoos in prison settings, where obviously you don't have licensed tattoo products," Ackman said.

People who had blood transfusions more than 12 years ago - before there was proper screening against the virus - also are at risk.

And drug users who snort drugs such as cocaine or crystal meth are putting themselves at risk for infection.

That's because users often share straws, and the tiny blood drops sometimes left on those straws can be infectious, Ackman said.

Also, using drugs leads to high-risk behavior such as unprotected sex, Schumer said.

It's unclear to what extent unprotected sex plays a role in the virus' transmission, but Ackman estimated that it accounts for 10% to 15% of the new cases.

Source: http://www.nydailynews.com/boroughs
/story/272575p-233397c.html


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January 27th, 2005


Research and Markets: Hepatitis B & C - Winning Battles but Not the War
SourceURL:http://biz.yahoo.com

DUBLIN, Ireland--(BUSINESS WIRE)--Jan. 27, 2005--Research and Markets (http://www.researchandmarkets.com/reports
/c12272
) has announced the addition of Stakeholder Insight: Hepatitis B & C - Winning Battles But Not The War to their offering

According to the WHO, 350400 million are chronically infected with HBV and 170200 million with HCV. Although HBV vaccination and routine screening of donated blood has decreased incidence, the death toll resulting from chronic disease, cirrhosis and HCC is as high as one million per year (WHO, 2002). For HCV related conditions, this number will increase further over the next 1020 years.

Despite substantial prevalence for both HBV and HCV, the incidence of new infections within the seven major markets has reduced over the last decade due to HBV vaccination, increased blood and pre-natal screening along with awareness campaigns regarding routes of transmission. Our recent physician survey indicates that while diagnosis rates of HBV have remained flat since 2002, HCV diagnosis rates have increased 2-4 fold, with highest growth in Japan

Increased uptake and aggressive life-cycle management of peginterferons (plus ribavirin) have driven the current standard of care to 73% of first-line choice for HCV. Our physician research (180 respondents) reveals higher use of branded peginterferon plus ribavirin packages, where consistency was cited as key selection criterion. Again, the treated patient pool will be increased by higher diagnosis, redefinition of 'normal' ALT and maintenance therapy. However, the needs of non-responders, genotype 1 and intolerant patients will not be satisfied in the short term.

Scope of Report
•Comprehensive overview of HBV and HCV epidemiology with comment on latest dynamics
•Analysis of drug treatment choice per line therapy per region for both HBV and HCV
•Discussion with key opinion leaders with regard to clinical and non-clinical attributes of therapy
•Future outlook for new HBV and HCV therapies along with unmet needs assessment

Highlights
While diagnosis rates of HBV have remained flat since 2002, HCV diagnosis rates have increased 2-4 fold with highest growth in Japan.

Based on current estimates of prevalence, diagnosis and treatment current patient pools of between 1.8-2.0 million per disease.

To increase the treatment pool, manufacturers of hepatitis treatments can either tap into a substantial amount of unidentified cases or meet the needs of non-responder or difficult to treat patients.

For more information visit http://www.researchandmarkets.com/reports/c12272

Contact:
Research and Markets
Laura Wood
Senior Manager
Fax: +353 1 4100 980
press@researchandmarkets.com

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Scientists ID Molecular 'Switch' in Liver that Triggers Harmful Effects of Saturated and Trans Fats
SourceURL:http://www.eurekalert.org

BOSTON--Dana-Farber Cancer Institute researchers have identified a molecular mechanism in the liver that explains, for the first time, how consuming foods rich in saturated fats and trans-fatty acids causes elevated blood levels of cholesterol and triglycerides and increases one's risk of heart disease and certain cancers.

In the Jan. 28 issue of Cell, scientists led by Bruce Spiegelman, PhD, report that the harmful effects of saturated and trans fats are set in motion by a biochemical switch, or co-activator, in liver cells called PGC-1beta.

Until now, scientists lacked a detailed explanation of how saturated and trans fats caused an increase in blood cholesterol and triglycerides, while diets high in unsaturated and polyunsaturated fats did not. Evidence pointed to the liver, which is responsible for the body's synthesis of triglycerides and cholesterol, but the molecular chain of events from eating fats to the buildup of cholesterol and triglycerides in the blood were unknown.

"What we have found is a missing link, a mechanism by which saturated fats and trans fats can do their dirty work," said Spiegelman, who carries out basic research on fat cells and metabolic pathways in diabetes and cancer at Dana-Farber. "It offers the opportunity to try to understand what makes these fatty acids so deleterious, and what we need to avoid."

Moreover, it is possible that in the future, drug therapy might be used to "turn down" the mechanism, decreasing cholesterol levels and heart disease risk, explained Spiegelman, who is also a professor of cell biology at Harvard Medical School.

Saturated fats are found in fatty cuts of meat, whole-milk dairy products, butter, and palm and coconut oils; they are associated with higher risk of coronary disease. The healthier polyunsaturated fats are those that remain liquid at room temperature, such as various types of vegetable oils.

Trans-unsaturated fatty acids, or trans fats, are artificially produced solid fats used in shortening and margarine, baked goods, and the oils used to cook french fries and other fast food. Studies have shown that trans fats not only raise LDL levels in the bloodstream but lower high-density lipoproteins (HDL, or "good" cholesterol) and may have even stronger adverse effects than do saturated fats.

The researchers report that when activated by harmful fats, PGC-1beta alters liver metabolism through a cascade of biochemical signals. The result is an upsurge in the liver's production of very low-density lipoprotein (VLDL) cholesterol, the precursor of low-density lipoprotein (LDL) cholesterol (known as the "bad" form of cholesterol) and triglycerides — another fatty substance —that are secreted into the bloodstream.

PGC-1beta belongs to a specific family of co-activators, proteins that interact with other proteins to turn genes on and off and adjust their activity, like a dimmer switch that varies the brightness of a light. Co-activators join with other regulatory proteins called transcription factors in controlling the expression of genes. Spiegelman and Jiandie Lin, PhD, the paper's lead author and a researcher at Dana-Farber, have previously discovered the PGC-1 co-activator family and several of its biochemical activities.

The Dana-Farber researchers made the discovery in searching for the function of PGC-1beta co-activator that was isolated in 2002. Experiments including the measurement of gene activity by microarrays showed that saturated and trans fats caused greater activity of the gene that makes PGC-1beta co-activator than did unsaturated fats.

The research also showed that when the fats triggered PGC-1beta, the co-activator interacted physically and turned up the function of sterol responsive element binding proteins. These important parts of the mechanism activate many key genes of lipid biosynthesis involving the pathways of cholesterol and triglycerides; these genes directed the liver to manufacture more cholesterol, which it does in the form of very low-density lipoproteins. The investigators noted that in mice fed high-fat diets, the PCG-1beta mechanism actually decreased cholesterol in the liver while increasing it in the bloodstream.

"Before this report, it wasn't clear what the differences were between saturated fats and unsaturated fats in their ability to raise cholesterol blood levels," commented Jeffrey Flier, MD, an obesity specialist at Beth Israel Deaconess Medical Center. "These are important findings in a long-established area of medicine."

Grants from the National Institutes of Health supported the research.

The paper's other authors are based at Dana-Farber, Duke University Medical Center, and the University of California, Los Angeles.

Dana-Farber Cancer Institute (www.danafarber.org) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.

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Thalidomide of Little Value for Advanced Liver Cancer
SourceURL:http://www.cancerpage.com

NEW YORK JAN 27, 2005 (Reuters Health) - Though well tolerated by most patients, thalidomide treatment of advanced hepatocellular carcinoma (HCC) results in only modest responses, according to a report in the January 1st issue of Cancer.

Animal studies have shown thalidomide to be effective in models of angiogenesis, the authors explain, and clinical studies have shown it to be potentially effective against a variety of cancers.

Dr. Albert Y. Lin from Santa Clara Valley Medical Center, San Jose, California and colleagues investigated whether thalidomide could improve outcomes in 27 patients with unresectable HCC, 31% of whom had metastatic disease at the time of study entry.

With a median daily dose of thalidomide of 300 mg, the authors report, the median time to disease progression was 42 days, and the median survival was 123 days.

Only one patient (3.9%) experienced a partial response, the report indicates, with his alpha-fetoprotein level falling from 34,630 ng/mL to 18 ng/mL after 10 weeks of treatment and with radiographic imaging showing more than 80% decrease in tumor bulk.

"These dramatic results suggest that although they are infrequent, responses of HCC to thalidomide can occur and may be clinically significant," the investigators write.

Patients commonly experienced fatigue, somnolence, and constipation during therapy, the researchers note, but there were few severe adverse events related to thalidomide treatment.

"The results of the current phase II study indicate that thalidomide treatment in patients with unresectable HCC is relatively well tolerated," the authors conclude. "However, the associated response rate is modest."

"In the future," the researchers add, "combining thalidomide or the more potent analogue CC5013 with other targeted agents, such as epidermal growth factor receptor inhibitor, may produce better treatment outcomes."

"The study confirms the original findings of [others] who showed that thalidomide lacks clinical activity in HCC and has relatively increased toxic effects," writes Dr. Scott Wadler from Weill Medical College, Cornell University School of Medicine, New York in a related editorial.

"At many institutions, thalidomide is routinely offered to patients with HCC in lieu of enrollment into clinical trials," Dr. Wadler adds. "The article by Lin and colleagues serves as an important course correction for the academic oncologist."

SOURCE: Cancer 2005;103:1-3,119-125.

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January 28th, 2005


All-Clear for 98 Women in Health Scare
SourceURL:http://edinburghnews.scotsman.com

ALMOST 100 Lothian women at the centre of a smear test health scare have been given the all-clear.

The women were put at risk of contracting diseases such as HIV and hepatitis after being given tests with non-sterilised equipment.

However, Lothian Health has now told the 98 patients that none of them had picked up an infection after the blunder at the Newland medical practice in Bathgate.

The scare happened in November 2003 after boxes containing treated and untreated equipment were mixed up. Letters were sent out to all the women who had had tests at the time of the incident and they were screened for various diseases.

Rachel Hardie, consultant in public health medicine for Lothian Health, confirmed none of the women involved had been infected. "

"While we accept the distress and concern that this incident caused the patients affected we hope this helps reassure them," she said.

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January 29th, 2005


Cosmetic Injections Are Linked to Spread of Variant CJD and Hepatitis
SourceURL:http://news.independent.co.uk/
By Jeremy Laurance, Health Editor

Injection of "fillers" to plump up lips and smooth out wrinkles could spread infections such as variant CJD and hepatitis, the Government's chief medical officer warned yesterday.

"Aesthetic fillers" injected under the skin, popular with celebrities to counter sagging features, use material from animals, birds and human corpses, Sir Liam Donaldson said.

In a crackdown on rogue cosmetic surgery clinics, Sir Liam said: "We do have to look into the use of aesthetic fillers to establish if there is any risk of variant CJD, hepatitis and other blood-borne viruses. There is no evidence of outbreaks in relation to the use of products but this is something we need to look into."

One of the most heavily used materials is collagen, which may contain bovine material carrying a potential risk of infection with BSE. The singer Kylie Minogue was reported this week to have had injections of a filler to enhance her lips.

Many fillers fall outside any system of regulation because they use human tissue. There are an estimated 20,000 high street clinics offering cosmetic treatments from Botox injections, which paralyse muscles rather than fill out wrinkles and do not contain animal or human tissue, to facelifts with widely varying standards and varying skill of surgeons.

They are to be regulated by the Healthcare Commission, the independent watchdog, and subject to regular inspections from April next year.

Cosmetic treatments are the most rapidly growing area of private health care. The Healthcare Commission said there were more than 34,000 surgical procedures performed in 2003-04 but these do not include chemical peels, laser treatments and Botox injections.

Private clinics estimate demand for Botox injections doubled last year to almost 100,000 treatments. Sir Liam said Botox was a prescription drug which it was illegal to advertise and should be administered only by a doctor or nurse.

Sir Liam warned that organisers of Botox parties, where women are entertained with drinks in hotel rooms or people's homes, could face prosecution. He was responding to two reports from the Healthcare Commission and the Expert Group on the Regulation of Cosmetic Surgery which called for tougher controls. Simon Gillespie, head of operations at the Healthcare Commission, said registered cosmetic surgery clinics mostly met the necessary standards, especially the larger ones, but they numbered only a few hundred.

"We have concerns about the number of organisations that did not fall under the scope of regulations, such as those providing Botox, chemical peels and injectable fillers," he said.

Harry Cayton, the Government's national director for patients and the public, said a search of the internet would throw up more than 300,000 websites promoting cosmetic treatments or exposing what happens when it goes wrong.

The expert group made 20 recommendations for action in cosmetic surgery, covering operations such as breast enlargement, liposuction and nose jobs, as well as treatments including Botox and fillers. Professional bodies are to be asked to develop specialist training programmes for cosmetic surgeons "as a matter of urgency".

The British Association of Aesthetic Plastic Surgeons said some doctors were "misleading patients" about qualifications. Its president, Adam Searle, added: "Often, patients do not have enough information to make educated choices which leaves them vulnerable."


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