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December 19th, 2004


Use of Syringes May Increase HIV/AIDS, Hepatitis Threats
SourceURL:http://www.dailytimes.com.pk
By Shahzad Raza

Relevant legislation yet not presented in parliament

ISLAMABAD: The National AIDS Control Programme (NACP) has expressed concerns over the use of syringes, even for minor illnesses, and feared this trend may increase HIV/AIDS and Hepatitis cases in the country.

NACP officials said that no awareness campaign had been launched to contain the use of syringes by doctors. Referring to the World Health Organisation’s (WHO) estimate, they said Pakistan had the highest per capita use of syringes in the world.

The WHO reports says an individual should not get more than four injections per year. In Pakistan, an individual on average gets over 10 injections every year. WHO figures show that over 1.4 billion syringes are sold in Pakistan every year. NACP officials said a large number of discarded syringes were being used resulting in the spread of Hepatitis and HIV/AIDS.

They said the multi-billion rupees business of syringes was increasing in every part of the world. The officials observed that both doctors and patients wanted quick recovery from illness.
They said a powerful countrywide marketing campaign by syringe manufacturers had also encouraged the use of syringes by doctors. NAPC officials estimated that 60 percent of both doctors and patients chose injections as a preferable way of administering medicines. They claimed that 70 percent of injections piercing the human bodies were dangerous.

During its media campaign, NACP highlighted the matter on a small scale, asking patients to avoid injections as best as possible. However, the NACP awareness campaign in print and electronic media had been suspended for the last seven months.

Four month ago, Nasir Khan, health minister, announced that a bill called “Disposable Medical Devices Act, 2004,” would be presented in parliament to protect people from risky use of syringes.

A health ministry official said the proposed law would urge doctors to recommend injections for their patients only in unavoidable situations. Patients would also be encouraged to take medicines orally, he added.

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December 20th, 2004

Hepatitis B Often Undetected, Study Says
SourceURL:http://www.theglobeandmail.com
Canadian Press

WINNIPEG -- Hepatitis B may be lurking in the general population at rates higher than anyone suspected, Winnipeg researchers have suggested.

The liver disease is believed to infect less than 1 per cent of the Canadian population, but University of Manitoba professor Gerald Minuk has reported that standard tests miss most infections.

For every person in his study who tested positive on the standard test, four or five more were found to be infected when a more expensive DNA-based test was used.

However, Prof. Minuk noted that people whose infections show up only on the more sophisticated test may be less likely to get sick.

The hepatitis B virus spreads through dirty needles and sex, and from mother to baby at birth.

It causes yellow skin, fatigue, loss of appetite and joint pain. If the infection becomes chronic, the virus can cause liver cancer, liver failure and sometimes death.

Prof. Minuk's team started by studying 241 dialysis patients in Winnipeg. Two tested positive for hepatitis B with the standard test, just above the rate expected in the general population, but nine more tested positive on the DNA test. The research was published in the November issue of Hepatology, the journal of the American Association for the Study of Liver Diseases.

People getting dialysis may not be representative of the general population, so Prof. Minuk has completed another study of about 600 people living in a northern community.

He won't discuss the results until they are published in a coming issue of another journal.

He said most people in his dialysis study who were found through the DNA test to have hidden infections had low levels of the virus in their blood.

It's possible "there's so little virus there that it's not causing any harm and it's not likely to cause any harm," Prof. Minuk said.

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PEGASYS® Plus Ribavirin Combination Therapy Receives Positive Opinion in Europe for Treatment of Hepatitis C and HIV Co-infection
Source: Roche Pharmaceuticals

Pegasys therapy will become the only hepatitis C treatment for HIV-HCV co-infected patients

Basel, Switzerland – December 20, 2004 – Roche announced today that the European Medicines Agency (EMEA) has granted a positive opinion for PEGASYS® (peginterferon alfa-2a (40KD)) in combination with ribavirin for the treatment of chronic hepatitis C (HCV) in clinically stable patients co-infected with HIV. This decision will result in the first hepatitis C treatment ever to be indicated for HIV-HCV co-infected patients. Co-infection has emerged as a major public health concern with data suggesting that globally 30% of patients with HIV infection also have HCV.

“It is clearly important that we treat these patients as we now know that the leading cause of death in HIV-HCV co-infected patients is liver disease as a result of hepatitis C,” said Dr. Francesca Torriani, Associate Professor of Medicine, Antiviral Research Centre, University of California and the lead author of the APRICOT (AIDS PEGASYS Ribavirin International CO-infection Trial) study. “With the great strides made with potent antiretroviral therapy allowing HIV-infected patients to live longer, we don’t want to see those benefits disappear by the emergence of fatal liver disease.”

The study on which the positive opinion has been granted
The extension of the current label is based on the results of APRICOT (AIDS PEGASYS Ribavirin International CO-infection Trial). APRICOT is the first and only international multicentre prospective study evaluating the efficacy and safety of pegylated interferon combination therapy in HIV-HCV co-infected patients. Results from the trial were recently published in the peer-reviewed New England Journal of Medicine. (Torriani FJ et al. Peginterferon Alfa-2a plus Ribavirin for Chronic Hepatitis c Virus Infection in HIV-Infected Patients. N Engl. J Med. 2204;351(5): 438-450.)

“We’re proud to be leading the way in finding innovative solutions for patients with unmet medical needs,” said Ciro Caravaggio, Head of the Hepatitis Franchise at Roche. “Roche has a strong heritage of developing virology medications and the positive opinion for PEGASYS and ribavirin in HIV-HCV co-infection reinforces our overall commitment to helping patients who are infected with either one virus or both.”

APRICOT Results

Investigators randomized 868 patients from 19 countries into APRICOT. Patients co-infected with HIV-HCV were randomized to receive either PEGASYS 180 μg once weekly plus ribavirin 800 mg daily; PEGASYS 180 μg monotherapy once weekly (plus placebo), or conventional interferon alfa-2a (Roferon® A) 3MIU three times a week in combination with ribavirin 800 mg daily, all for 48 weeks.

The key results of APRICOT were:
• 40% of patients treated with PEGASYS plus ribavirin achieved a sustained virological response (SVR which is indicative of a cure) compared with 20% of patients treated with PEGASYS monotherapy and 12% of patients treated with conventional interferon/ribavirin.
• Genotype 1 patients, those with the most difficult to treat type of the virus, treated with PEGASYS plus ribavirin achieved a four-fold increase in SVR compared with conventional interferon/ribavirin (29% vs 7%).
• 62% of genotype 2/3 patients treated with PEGASYS plus ribavirin combination therapy achieved an SVR compared to 20% with conventional interferon/ribavirin.
• PEGASYS plus ribavirin therapy effectively treated hepatitis C in patients with HIV-HCV co-infection being compatible with antiviral treatment and had a positive effect on the virological control of HIV infection.
• In APRICOT, treatment with PEGASYS plus ribavirin is associated with the greatest overall histological improvement, even in patients who do not achieve an SVR.

Multiple Indications for PEGASYS
Today’s indication closely follows the European Commission Decision in November, 2004 to approve PEGASYS for the treatment of patients with persistently ‘normal’ alanine aminotransferase (ALT) levels. ALT is an enzyme found in the blood and it was thought that only if levels were high that liver damage was present, and therefore, that treatment should be initiated. The Roche study on which the approval was granted demonstrated that patients with ‘normal’ ALT also have liver damage present and benefit from treatment.

About PEGASYS
PEGASYS, the market leader worldwide in hepatitis C therapy, provides significant benefit over conventional interferon combination therapy in HCV patients of all genotypes. The benefits of PEGASYS are derived from its large 40 kilodalton (KD) branched-chain polyethylene glycol (PEG) construction, which allows for sustained drug levels over the course of a full week. PEGASYS also distributes more readily to the liver (the primary site of infection) than conventional interferon. PEGASYS is the only pegylated interferon available as a ready-to-administer solution. Each weekly subcutaneous injection contains 180 mcg of pegylated interferon alfa-2a (40KD), which is the approved dose for all patients, regardless of body weight.

Roche in Virology
Roche is committed to the field of virology, having introduced effective treatments for hepatitis C as well as having a range of medications for HIV. Roche introduced Roferon-A, followed by PEGASYS in hepatitis C and now PEGASYS is demonstrating similar superior efficacy over conventional interferon in hepatitis B. Roche also has its own brand of ribavirin, COPEGUS, to be used in conjunction with Roferon- A or PEGASYS for HCV. Since 1986, Roche has been at the forefront of groundbreaking research and development of new drugs and technologies for care of patients with HIV. Medications developed by Roche for HIV include Fortovase and Invirase (two formulations of saquinavir), administered in combination with ritonavir, and Viracept (nelfinavir). Viracept, introduced in 1997, has proven efficacy and safety in the treatment of HIV infection, is widely used in early treatment and has a unique cross-resistance profile. Most recently, Roche introduced Fuzeon (enfuvirtide), the world’s first HIV fusion inhibitor and the first innovation in HIV treatment since 1996. Roche manufactures HIV, HBV and HCV diagnostic systems under the tradename AMPLICOR to detect the presence of, and quantity of HIV RNA, HCV RNA, or HBV DNA in a person’s blood.

Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in Diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

All trademarks used or mentioned in this release are legally protected.

Further information about Hepatitis C:
http://www.health-kiosk.ch/start_hepa

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Don't Be a Part of the Hidden Time Bomb
SourceURL:http://news.scotsman.com
JULIA HORTON

A KISS between a grandmother and her grandchildren is a simple show of affection which is cherished by families all over the world.

But for years Sheila Davies feared that if she demonstrated her love for her grandchildren physically it could prove the kiss of death for them.

For Davies is one of hundreds of Scots who contracted the deadly virus hepatitis C after being given a contaminated blood transfusion.

She learned that she had the virus by chance within months of being infected during an operation at the old Edinburgh Royal Infirmary in the late 1980s-its presence was picked up when she went to donate blood.

As a result she was given treatment before the virus could develop and cause potentially fatal diseases such as liver cancer. Davies has now been clear for the past two years.

But symptoms often develop over a period of 20 to 30 years, meaning many people carry the deadly virus for decades without knowing that they have it.

There are thought to be 35,000 people in Scotland today who have no idea that they have contracted hepatitis-putting themselves and their loved ones at risk of dying needlessly as the virus goes unchecked and untreated.

Today Davies, 68, is backing a proposed new Scotland-wide campaign aimed at encouraging people to get tested to find out if they are part of the hidden time bomb.

The Lothian grandmother of five, who lives in Old Town, Broxburn, says: “I think it is essential to have an awareness campaign because apart from anything else these people are infecting other people without even knowing it.

“Before I was told that the treatment had been as effective as it has been I was wary of kissing my grandchildren in case they had a cut around the mouth and the virus was passed on to them.

“It was not a pleasant feeling. One of my grandsons was extremely badly effected. He was only about nine or ten at the time and he was not sleeping.

“When I asked him what was wrong he said: ‘Are you going to die, grandma?’ That did effect me quite a lot.

“I am a keen gardener but after I was told I had the virus I was terrified that if I pricked myself on a rose or something, someone else pricking themselves too could be at risk [of contracting hepatitis C].

“That sort of thing worried me terribly.”

She continues: “I was given a blood transfusion in about 1987 [after undergoing various gynaecological operations, which were followed by a hysterectomy] and I only found out that I had the virus when I went to give blood several months later.

“Until then I had never even heard of hepatitis C. The treatment was not pleasant, I was having injections three times a week and I had to take capsules as well.

“The symptoms were not too bad, I was mostly very tired. But I had a lot of other health problems, too, and my husband was very worried about me.”

Hepatitis C is usually spread by direct blood-to-blood contact with an infected person.

Drug addicts become infected with the virus through intravenous drug use.

Baywatch star Pamela Anderson helped focus attention on hepatitis C after going public when she contracted the virus, through, she believes, sharing a tattoo needle with former husband Tommy Lee of Motley Crue fame.

The virus can also be transmitted through unprotected sex.

Other victims, such as Davies, became infected through contaminated blood transfusions before the introduction of screening for the virus in 1991.

Campaigners have long accused health chiefs of knowing about the problem and failing to act.

Recently they won a battle for compensation from the Government, with ministers agreeing to make ex gratia payments of £20,000 to £45,000.

Davies, who received her compensation a few months ago, says: “When I heard that they had known about the virus and how to get rid of it but financial reasons stopped them doing anything about it that made me very angry.”

Carriers can develop cirrhosis of the liver, leading eventually to liver failure, or liver cancer.

However, Davies has a good prognosis thanks to the chance early diagnosis.

“For the last two years when I have been tested they have not been able to detect the virus, and I am hoping that if I am OK when they test me again in January I might be able to put myself forward for organ donation. That is the thing that has upset me most, not being able to be an organ donor.”

The new campaign in Scotland to help detect more undiagnosed cases of the blood-borne virus is being planned following a similar £2 million drive south of the Border launched by chief medical officer Sir Liam Donaldson earlier this month.

Charles Gore, chief executive of the Hepatitis C Trust, which is in negotiations with the Scottish Executive over the new campaign, says: "It is very difficult to identify people who are past drug users and are now barristers, for example. They may have experimented with drugs once at Edinburgh University in 1975 before anyone knew about hepatitis C, or HIV, etc.

“It’s not going to be on their radar that they should be tested.

“Someone who had a motorbike crash in 1975 and received a lot of blood [through a blood transfusion] is also at risk-they did not screen blood until 1991.

“It is very difficult to get to these people without doing a national campaign.”

Charles hopes that Scotland will go further than Westminster and inject “proper” resources to fund a “proper” campaign.

“There is quite a low spend on this in England,” he says. "It is also being launched now, just before Christmas, and it feels like this isn’t a huge priority for the Department of Health.

“In Scotland I’m hoping that they will not follow the English lead and that instead they will not shy away from devoting proper resources to a proper action plan and awareness campaign.

“There was a preliminary meeting [earlier this month] with various groups including ourselves, the Scottish Executive and the Hepatitis Resource Centre, to discuss an action plan, including an awareness campaign to try and identify all these people who have hepatitis C but don’t know they have it.

“These people are at risk of developing serious liver disease themselves, and of infecting other people.”

Jeff Frew, of Edinburgh support group Cap C, also hopes Scottish politicians will do more than their colleagues south of the Border to tackle the virus. He says: “There’s 35,000 undiagnosed people walking the streets of Scotland who do not know they have got it.

“That’s a bloody big time bomb. With a publicity campaign we could identify them to stop them developing serious liver damage, and just as importantly, to stop them unwittingly transmitting the virus to other people.

“There is a lot of scope and opportunity for the Scottish Parliament to do something positive."

THE campaign which Gore and Frew would like to see would include TV advertisements and large billboards pointing out the dangers and urging people to get tested.

Other victims, however, are cynical about the campaign.

Like many haemophiliacs Andrew Gunn, formerly based in Leith, contracted the virus as a teenager through contaminated blood he received as treatment for his condition.

Last month he was fined £100 after admitting throwing paint at the Scottish Parliament with a fellow protester in frustration at the Government’s refusal to hold a public inquiry into the use of infected blood supplies. The 29-year-old musician, who now lives in Inverness, says: “Of course people should be made aware of the risks but it is too little too late.

“The whole thing has been a huge, murderous cover-up. To say now that they want to raise awareness is just a total joke.”

An Executive spokesman says: “Estimates indicate that 40-50,000 people in Scotland are chronically infected with hepatitis C-yet only 18,116 people have been reported.

“The Executive is therefore developing an action plan which will be supported by an appropriate public awareness-raising campaign."

The Executive currently provides some £8.119m to NHS Boards across Scotland “to assist with their work to prevent the spread of all blood-borne viruses, including HIV and Hep C.”

It also gives around £500,000 each year to voluntary organisations working to raise awareness to prevent the spread of hepatitis C and other blood-borne viruses.

For help and advice about hepatitis C call the Hepatitis C Trust national helpline on 0870 200 1200.

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December 21st, 2004


Flamel Moves Hepatitis Product into Phase I/II
SourceURL:http://uk.biz.yahoo.com/

French biopharmaceutical firm Flamel Technologies (NASDAQ: FLML - news) has enrolled the first patient in a phase I/II study of its Medusa formulation of long-acting interferon-alpha for the treatment of hepatitis and hepatitis C.

French biopharmaceutical firm Flamel Technologies has enrolled the first patient in a phase I/II study of its Medusa formulation of long-acting interferon-alpha for the treatment of hepatitis and hepatitis C.

The hepatitis and hepatitis C product has been developed using Flamel's Medusa technology, which is designed to deliver controlled-release formulations of therapeutic proteins.

The phase I/II study is designed to demonstrate the safety profile of the product and to define the maximum tolerable dose. The second objective of the study is to evaluate the pharmacokinetic profile of the long-acting interferon, compared with Schering-Plough's immediate release product Viraferon.

Dr Gerard Soula, founder, president and CEO of Flamel Technologies, said: "We are excited by the results of our existing pre-clinical studies of our long-acting interferon alpha formulation in monkeys and are eager to confirm these results in humans. We believe this formulation could challenge the PEG version of interferon, by making it a safer product."



Spike in Hepatitis Cases Spurs Awareness Effort
SourceURL:http://www.dailymail.com
Associated Press

Mercer health nurse says number of cases is 50 percent higher than 2003

A large increase in hepatitis B cases in Mercer County has prompted a public awareness campaign to inform residents about the disease's symptoms and risk factors.

As of Friday, the Mercer County Health Department had reported 15 cases of hepatitis B and four to five cases of hepatitis C to the state Department of Health and Human Resources, DHHR spokesman Joe Thornton said.

Mercer County public health nurse Melody Rickman said the number of hepatitis B cases is about 50 percent higher than the total for 2003.

"Our concern is, we just want to educate the public and make them aware," Rickman said Monday.

"People need to know how hepatitis B is spread," he said.

The spike in hepatitis B cases has attracted the attention of the federal Centers for Disease Control, Rickman said. The state also is tracking the number of cases, Thornton said.

The increase could be partially attributed to the county becoming more aggressive in tracking and reporting the disease, Rickman said.

Health care providers are being educated about how to report hepatitis and health departments are being trained to follow up on reports.

Both hepatitis B and hepatitis C attack the liver and can be fatal, according to the CDC's Web site. Symptoms include jaundice, fatigue, abdominal pain, loss of appetite, nausea, vomiting and joint pain.

The hepatitis B and C viruses are transmitted through blood or other body fluids and can be spread by sharing drugs or needles, having sex with an infected person without using a condom or exposure to needles or other sharp objects on the job.

"We're looking to see why . . . what is the risk factor? It has to be in the community," Rickman said.

"We want to see if we've had an increase in sharing needles, people that don't know their sex partners or are practicing unsafe sex . . . where would be the best place to focus our education efforts."

Several residents have called the county health department since the campaign began earlier this month.

"People weren't outraged, they were just concerned and asking questions," Rickman said.

In addition to education, health officials want to let residents know that a vaccine is available for hepatitis B, she said.

There is no vaccine for hepatitis C, according to the CDC's Web site.

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December 22nd, 2004


PEGASYS Approved for Chronic Hepatitis B in Switzerland
SourceURL:http://www.newratings.com/
PRNewswire

BASEL, Switzerland, December 22 /PRNewswire/ -- Roche today announced that PEGASYS(R) (peginterferon alfa-2a (40KD)) has been granted marketing authorisation by the Swiss regulatory authorities, Swissmedic, for the treatment of chronic hepatitis B. The approval has been granted for both the HBe antigen-positive and HBe antigen-negative forms of the disease and was based on one of the largest clinical development programmes in hepatitis B ever, which included three global studies in more than 1,500 patients.

The studies showed that PEGASYS was superior to two therapies currently recommended first-line; interferon alfa and lamivudine. In contrast to lamivudine, the most commonly prescribed medication today, PEGASYS works by a two-pronged approach. It stimulates the immune system as well as inhibits virus replication. This offers physicians a new option with the advantages of a finite treatment duration and lasting remission from the disease.

"This is a major milestone, not only for Switzerland, but for the more than 90 other countries worldwide that rely on Swiss regulatory review for their own approval process," said William M. Burns, Head of Roche's Pharmaceutical Division. "Based on the results of our clinical programme, we would anticipate that PEGASYS will become a first-line treatment for chronic hepatitis B," he said, adding that PEGASYS is the worldwide market leader for the treatment of hepatitis C.

About Chronic Hepatitis B
Chronic hepatitis B is a major global healthcare problem affecting more than 350 million people and it is one of the principal causes of liver failure, cirrhosis, and liver cancer. Between one-quarter and one-third of people with chronic hepatitis B will go on to develop progressive liver disease; and approximately one million die annually, making it the 10th leading cause of death worldwide.

PEGASYS Superior to Standard Therapies
PEGASYS has been proven twice as effective as conventional interferon for the treatment of the most common form of chronic hepatitis B, hepatitis B e antigen (HBeAg)-positive chronic hepatitis B, in a multinational phase II trial. These findings were published in the July 2003 Journal of Viral Hepatitis.(i)

Two large-scale multinational phase III trials, in patients with both the HBeAg-positive and HBeAg-negative forms of chronic hepatitis B, demonstrated that after 48 weeks of therapy, more patients achieved a sustained response with PEGASYS than with lamivudine. Furthermore, these studies demonstrated that the addition of lamivudine to PEGASYS did not improve response rates over PEGASYS alone.

The phase III study results in HBeAg-negative chronic hepatitis B, the most difficult-to-treat form of the disease, were published in September in the New England Journal of Medicine,(ii)and the results of the phase III study in patients with HBeAg-positive chronic hepatitis B were presented at the 2004 Annual Meeting of the American Association for the Study of Liver Diseases in November.(iii) Both lead investigators have stated that the results of these trials warrant PEGASYS becoming the first-line treatment for HBeAg-positive or HBeAg-negative chronic hepatitis B.

"Until now, conventional interferon or lamivudine have been the first-line treatments for patients with chronic hepatitis B, but these clinical trials have proven that PEGASYS outperforms both," said Dr George Lau, gastroenterologist at the Queen Mary Hospital, Hong Kong; and Assistant Dean in the Department of Medicine at the University of Hong Kong. "This approval means that we have a significant new option whereby patients can achieve a lasting remission and we only need to provide treatment for a limited 48-week period."

PEGASYS was filed for the treatment of chronic hepatitis B simultaneously in Switzerland, the United States and the European Union in the summer of 2004, and approvals in the US and the EU are anticipated early in 2005. It is the first pegylated interferon indicated for the treatment of chronic hepatitis B anywhere in the world and has already been approved for this indication in Thailand and Taiwan.

About PEGASYS
PEGASYS, a new generation hepatitis therapy that is different by design, has already become the worldwide market leader in hepatitis C. PEGASYS has a dual immunomodulatory and antiviral mode of action. The improved pharmacokinetic profile ensures drug plasma concentrations are maintained at constant levels throughout the one week dosing interval. PEGASYS therapy in chronic hepatitis B is given once weekly as a 180 microgram subcutaneous injection for a 48-week period.

Roche in Hepatitis

Roche is committed to the viral hepatitis disease area, having introduced Roferon-A(R) for hepatitis B and C, followed by PEGASYS in hepatitis C and a full development program in hepatitis B. Roche has its own brand of ribavirin, COPEGUS(R), which is used in conjunction with Roferon A or PEGASYS for HCV. In addition, Roche manufactures HBV and HCV diagnostic and monitoring systems: The COBAS AMPLICOR(TM) Test, and the AMPLICOR(TM) MONITOR Test, two testing systems used to detect the presence of, and quantity of, HBV DNA or HCV RNA in a person's blood. Roche has just received a positive opinion from the EMEA in the European Union for a new indication for PEGASYS and COPEGUS as a treatment for patients co-infected with HIV and HCV. More than 40,000 patients worldwide continue to participate in trials with PEGASYS and COPEGUS as Roche examines the unmet medical needs of hepatitis C patients. Roche's commitment to viral hepatitis also extends to its pursuit of strategic alliances and partnerships to develop new compounds for the future.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

All trademarks used or mentioned in this release are legally protected.

Further information:
WHO Hepatitis B fact sheet:
www.who.int/mediacentre/factsheets/fs204/en
(English)

References
(i) Cooksley WG, Piratvisuth T, Lee SD, et al. Peginterferon alpha-2a (40kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat 2003; 10:298-305.
(ii) Marcellin P, Lau GK, Bonino F, et al. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2004; 351:1206-17.
(iii) Lau GK, et al. Peginterferon alfa-2a (40KD) (PEGASYS®) monotherapy and in combination with lamivudine is more effective than lamivudine monotherapy in HBeAg-positive chronic hepatitis B: results from a large, multinational study. Hepatology, 2004; Vol. 40 (4); Suppl. 1:171A

Contact: Sheila Gies, Roche, +1-973-687-0188; Joanne Galea, Axon Communications, +44-(0)20-8822-6779

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December 23rd, 2004


Risk Factors for Liver Cancer Identified in Asymptomatic HCV
SourceURL:http://www.cancerpage.com

NEW YORK DEC 23, 2004 (Reuters Health) - High alanine aminotransferase (ALT) levels, male sex, advancing age and lower serum cholesterol all increase the risk that patients with asymptomatic hepatitis C virus (HCV) infection will develop hepatocellular carcinoma (HCC), Japanese researchers report.

While HCV infection is a known risk factor for HCC, Dr. Hideo Tanaka of the Osaka Medical Center for Cancer and Cardiovascular Diseases and colleagues note, it is unclear what percentage of people with asymptomatic infection will go on to develop cancer.

To investigate, the researchers looked at a group of individuals 40 years or older who donated blood between 1991 and 1993, some of whom were found to have HCV infection. Study participants included 1927 individuals with HCV but without hepatitis B virus (HBV) infection; 2519 HBV-infected individuals who were HCV negative; 25 people infected with both HBV and HCV; and 150,379 seronegative controls. The subjects were followed until December 31, 2000 or a diagnosis of HCC, for a mean follow-up of 99 months.

Among men with HCV, the cumulative risk of developing HCC was 21.6%, while the risk for women was 8.7%. HCC risk increased in tandem with rising ALT levels, and also increased as baseline serum cholesterol levels dropped. Cancer risk increased with age among both men and women.

Two thirds of individuals with HCV infection had low ALT levels at baseline, and their risk of HCC was low, while the one third with high ALT had an incidence of HCC similar to that seen among people diagnosed with chronic hepatitis.

Among individuals with both HCV and HBV infection, HCC incidence over 9 years was 12%, compared to 3% for those with HCV only and 2% for those with HBV only.

The findings underscore the importance of developing effective HCV screening programs in countries where the infection is prevalent, the researchers conclude.

SOURCE: International Journal of Cancer 2204;112:1075-1080.

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Women Catch Hepatitis C at Beauty Shop and Hairdresser's
SourceURL:http://english.pravda.ru

Hepatitis C virus stays in human body for years and even for a lifetime

Doctor from Moscow's clinical hospital #15 Alhares Heirbek talks about hepatitis and prevention of the disease

- Is the risk to catch hepatitis C higher than risks to catch other diseases?

The virus of hepatitis C is more frequent than that of hepatitis B. Some experts say there are about 500 million people infected with hepatitis C today; 200 million of them are not mere carriers of the virus but are infected.

- What are the ways to catch hepatitis C?

The virus usually transmits through blood; many drug addicted persons are infected with hepatitis C. People dealing with donors and blood transfusion often catch the disease too. The virus can be transmitted with spittle, sweat, tears and genital secretion through wounded skin or mucous membranes. Young women form a risk group as they may get infected with hepatitis C when visiting hairdresser's and beauty shops if they use non-sterile tools. From this point, women should be careful when they go to beauty shops to have manicure, hair style, epilation or tattoo.

-Is hepatitis C particularly dangerous?

In 80 percent of cases the disease proceeds secretly and reveals no symptoms. With 70-80 percent of patients infected with hepatitis C acute hepatitis develops into chronic one, which in its turn often develops into cirrhosis and liver cancer. What is more, doctors do not have yet important knowledge and safe protection from the disease. Today, medicine already has reliable methods to diagnose the disease and effective medicine to cure it.

- Why does hepatitis C almost always develop into chronic one?

This happens because of the virus's peculiarities. When getting to the organism, it behaves the same way as other similar viruses do and attacks liver. At that, the hepatitis A virus gets out of the organism as soon as it achieves the goal, but the hepatitis C virus will stay in the organism within several years or even for the whole life. The virus became invulnerable because it may easily change its form and continue to destroy liver.

- Do people feel anything at that?

It often happens so that doctors reveal hepatitis C during other checkups. It may also proceed together with jaundice and resemble the classical hepatitis. Jaundice is a serious disease as well but at least it is easier to reveal it; it seldom develops into a chronic form. Unfortunately, it is often difficult to say how hepatitis C may become apparent: people may feel weakness, get tired easily, have poor appetites and muscular pains. As a rule, people do not take such symptoms seriously; if they visit doctors the disease is diagnosed as respiratory infection or something else.

- What are the symptoms of chronic hepatitis C?

People infected with hepatitis C feel weakness and lethargy within several years; it is just in 10-15 years that the disease comes out. In addition to weakness patients have pain in the right subcostal area and lose too much flesh. Medical examination reveals that liver is enlarged; blood tests prove that something is wrong with liver. Then, patients will reveal all signs typical of cirrhosis: water accumulation in the stomach, bleeding and intoxication.

- What methods does modern medicine use to diagnose the disease?

There are no general checkups to reveal patients diseased with hepatitis C in this country. Only people belonging to the risk group or those who are suspected of the disease undergo special blood tests. Blood tests demonstrate if there are antibodies to the virus in blood. At that, all medical methods cannot help to say if the disease is progressing too far. Biochemical blood tests determine to what extent liver cells are damaged with a patient.

- Can the serious disease be cured?

Doctors say that 60 per cent of patients successfully recover if medical treatment was started before hepatitis C developed into a chronic form. Successful treatment of chronic hepatitis C is registered just in 20-30 per cent cases. At that, women, especially young ones, undergo medical treatment more successfully than men. Many medicines have been developed recently to fight the virus. But antiviral medicines depress brain activity. That is why treatment must be done together with blood tests. Acute hepatitis C requires 3-month medical treatment while the chronic form v 12 month-treatment. Together with the medicines, doctors will prescribe to follow a diet.

- How can people prevent the dangerous disease or protect themselves in case they communicate with people infected with hepatitis C?

Be careful and do not risk for nothing. Attend only reliable beauty shops and licensed medical institutions. Personal hygiene must be in the focus in families with diseased people. Unfortunately, doctors offer no vaccine against hepatitis C now, but they hope the problem will be solved in the nearest future.

Svetlana Vinogradova
Zhenskoye Zdorovye

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New Remicade Warning: Arthritis, Crohn's Disease Drug Linked to Rare but Deadly Liver Failure
SourceURL:http://my.webmd.com/

By Daniel DeNoon

Dec. 23, 2004 -- Remicade is linked to rare but sometimes deadly liver reactions, drug maker Centocor and the FDA announced Wednesday.

Remicade is approved to treat rheumatoid arthritis and Crohn's disease.

In a "Dear Healthcare Professional" letter, Centocor is warning doctors that patients treated with Remicade have developed acute liver failure and other liver problems, including jaundice.

Some patients died or required liver transplants to save their lives. The liver reactions occurred two weeks to more than a year after Remicade treatment. Lab tests for abnormal liver enzymes -- a standard test for liver trouble -- did not always predict these liver reactions.

These events appear to be quite rare. They've been reported in three patients before Remicade approval, and in 35 patients worldwide since the drug has been approved. In that time, some 576,000 patients have been treated with Remicade.

Remicade works by suppressing the immune system. That's helpful to patients whose overactive immune reactions underlie their rheumatoid arthritis, Crohn's disease, or ankylosing spondylitis. But it can also be a problem. Remicade treatment has been previously linked to serious infections including tuberculosis. Some of these infections have been fatal.

The Centocor letter also notes that a warning about risk of pneumonia has been added to the Remicade label.

Liver Failure Symptoms
Patients taking Remicade should be aware of symptoms of liver damage or failure, which include:
 •Nausea
 •Loss of appetite
 •Fatigue
 •Diarrhea
 •Jaundice

SOURCES: FDA. WebMD Medical Reference in collaboration with The Cleveland Clinic: Liver Failure.

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December 24th, 2004

Identifying Early Death after Transplantation
SourceURL:http://www.gastrohep.com

Researchers in January's Liver Transplantation find that donor and recipient factors, including donor body mass and recipient ethnicity, identify patients who have a high chance of early death after transplantation.

Seronegative hepatitis is a common cause of acute liver failure (ALF) requiring liver transplantation.

Dr Wigg and colleagues from South Australia undertook a study in order to examine outcomes following transplantation in this group and to identify factors associated with early (<2 months) mortality.

The researchers studied 110 consecutive cases of seronegative ALF transplanted at the Queen Elizabeth Hospital, Birmingham, between January 1992 and January 2004.

The research team preformed univariate analysis of 44 pretransplantation recipient, donor, and operative variables in order to identify factors associated with early posttransplantation mortality.

Survival following transplantation for seronegative hepatitis was 83%, 81%, and 73% at 2, 12, and 60 months, respectively—Liver Transplantation

The researchers used multiple logistic regression analysis in order to identify variables as significant or approaching significance.

The research team found that survival following transplantation for seronegative hepatitis was 83%, 81%, and 73% at 2, 12, and 60 months, respectively.

In addition, the researchers noted that the majority (71%) of deaths occurred within the 1st 2 months and sepsis / multiorgan dysfunction was the most common cause of early death.

Univariate analysis revealed 9 variables predicting early death.

On subsequent multivariate analysis, the investigators identified high donor body mass index (BMI; a possible surrogate marker for hepatic steatosis) as the most important predictor of early death.

The researchers noted that recipient age >50 and non-Caucasian recipient ethnicity were other variables associated with early death.

This study specifically examined factors that determine the early outcome of transplanted seronegative ALF patients.

Dr Wigg concluded, "We found that donor and recipient factors identify patients who have a high chance of early death after transplantation."

Liver Transpl; 2005: 11 (1): 27-34

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Risk Factors for De Novo Neoplasia after Liver Transplant
SourceURL:http://www.gastrohep.com

Liver transplant recipients have a higher risk of cancer-related mortality than the general population, and a further increased risk of de novo noncutaneous neoplasia occurs with old age, alcoholism, and smoking.

Immunosuppression increases the risk of posttransplant malignancy and it may increase posttransplant mortality.

The finding of factors related to the development of posttransplant malignancy may serve as a guide to avoid those risk factors and to develop strategies of posttransplant surveillance.

Dr Herrero and colleagues from Pamplona, Spain undertook a survey of the incidence and risk factors of malignancy in 187 consecutive liver transplant recipients surviving more than 3 months.

None of the 12 patients surviving less than 3 months had de novo neoplasia.

The researchers studied the impact of malignancy on survival in this case-controlled study.

After a median follow-up of 65 months, the research team found that 49 patients developed 63 malignancies: 25 patients had 35 cutaneous neoplasias and 27 patients had 28 noncutaneous malignancies.

The researchers noted that the 5- and 10-year actuarial rates of cutaneous neoplasia were 14 and 24% and the rates of noncutaneous neoplasia were 11 and 22%, respectively.

Cutaneous neoplasia had no effect on survival, whereas patients with noncutaneous malignancy had a significant reduction of survival—Liver Transplantation

The research team found that risk factors for the development of cutaneous malignancy were older age and Child-Turcotte-Pugh A status.

Risk factors for the development of noncutaneous malignancy were older age, alcoholism, and smoking.

The investigators noted that cutaneous neoplasia had no effect on survival, whereas patients with noncutaneous malignancy had a significant reduction of survival.

The researchers calculated that the overall relative risk of cutaneous and noncutaneous neoplasia, as compared with the general population were 16.91 and 3.23, respectively.

The relative risk of cancer-related mortality (after excluding recurrent malignancy) was 2.93.

On performing multivariate analysis the researchers showed that noncutaneous malignancy was an independent risk factor for posttransplant mortality.

Dr Herrero concluded, "Liver transplant recipients have a higher risk of cancer-related mortality than the general population."

"This increased risk is due to the development of noncutaneous neoplasia."

"Older age, alcoholism, and smoking increase the risk of de novo noncutaneous neoplasia."

Liver Transpl; 2005: 11 (1) : 89-97

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Giving the Greatest Gift
SourceURL:http://www.zanesvilletimesrecorder.com
By TONYA SHIPLEY
Staff Writer

'Hero' organ donor allowed man to live to see his grandson

Had Jeff Lloyd not gotten a liver transplant nearly 5 years ago, it is unlikely he would have lived to meet his now 4-year-old grandson, Jacob Young.

ZANESVILLE -- Nearly five years ago someone gave Jeff Lloyd the most amazing gift -- the gift of life. Lloyd was the recipient of a liver because a 26-year-old woman made the decision to become an organ donor. On Dec. 23, 1954, the first successful organ transplant took place in Boston. Now 50 years later, organ donations, while more common, are still facing obstacles.

Facing death
"To me, she is my greatest hero," said Lloyd, about the young woman and mother who was his organ donor.

In 1998, a doctor told him hepatitis was destroying his liver and he would die. Lloyd went to The Ohio State University Medical Center, where he learned a liver transplant could save his life. For 13 months, Lloyd waited for the news that there was a liver out there for him. During that time Lloyd would experience good days, while other days he was so weak he couldn't move.

"I had no doubt in my mind I was going to get one," Lloyd said.

Each organ donor has the potential to save seven lives through the donations of the heart, lungs, liver, kidneys, pancreas and small intestine. Last year, approximately 25,000 Americans received an organ transplant, according to Lifeline of Ohio, an organ procurement agency, which serves 40 Ohio counties including Muskingum.

Through his own ordeal Lloyd said his family was there for him, including his then 10-year-old son who stayed with him in the hospital during the transplant and even asked the doctors questions to make sure his dad would be all right.

Before his own troubles, Lloyd did not know anything about the organ donation process, but now he has become a volunteer for Lifeline of Ohio. He is willing to talk to anyone about how organ donation gave him another chance at life and he wants to help debunk some of the myths around it.

Dispelling the myths
Marilyn Pongonis, Lifeline spokesperson, said the number one myth surrounding organ donation is a belief that hospital and emergency care personnel will not try as hard to save the life of a person who his a donor.

This is absolutely not true, she said.

The experts who handle the organ transplants are not the same people who are treating patients in the hospital. In addition hospital personnel do not have access to the organ waiting lists.

Another myth is that during the organ procurement process, some people believe the body of their loved one will be mutilated making it impossible to have an open casket funeral service. Pongonis said the process by which organs are taken is done in a non-invasive way to treat the donor with dignity and respect.

"We treat the donor as a hero," she said.

Pongonis said it is good for people like Lloyd to share their stories because it puts a face to organ donation and it also helps with another misconception --organ donation doesn't work.

In March, Lloyd will celebrate his fifth year with his new liver.

"I haven't been lucky, I've been blessed. I believe God has been with me throughout. Even when I was getting the transplant, He was here," Lloyd said. "I have a whole new life and you don't realize how much you appreciate life until you look death in the eye."

Lloyd is honest that it hasn't all been sunshine and daisies since his transplant. For the rest of this life he will have to take anti-rejection drugs to keep his body from treating the liver as a foreign object. At one point he was taking 54 pills a day, but now is down to just 17.

He has to have monthly blood work done and has to be careful about infections. He said the anti-rejection drugs weaken the immune system, which makes him more susceptible to infections.

But the trials he is going through now are nothing compared to the fate that awaited him if he did not get the liver.

Working together
This year the numbers of organ donations are expected to increase in Lifeline's coverage area. Last year, the agency oversaw 63 donations.

Kent Holloway, Lifeline chief executive officer, said Lifeline has joined the National Donor Collaborative, a newly founded group which includes organizations like Lifeline and hospitals around the country.

The purpose of the collaborative, which was formed through the Department of Health and Human Services, is to network with each other and develop the best practices. Holloway said they can now see how other agencies are operating and borrow ideas, which can be adapted to this area, whether its for an educational campaign or a way to improve the process for the donor families.

"This week is the 50th anniversary of the first transplant. It's a fairly young science. Our organization is only celebrating its 20th anniversary, so now has been the best time to begin this dialogue from one agency to the next," he said.

The hospitals which are part of the group are ones which are most likely to handle a patient that is an organ donor, like The Ohio State University Medical Center.

The goal of the collaborative is to get a 75 percent donation rate at the hospitals. Holloway thinks this is a reasonable goal based on studies and the donation rates these hospitals have already exhibited.

Muskingum County has been one of the leaders in the state when it comes to the amount of people who are registered donors. According to Lifeline, science July 1, 2002, 51.2 percent of all those who registered for a driver's license or state ID have registered to be a donor. The state average is 48.5 percent.

In November alone, 57 percent of the people who got one of these forms of ID became donors.

Everyday heroes
Lloyd's only wish now is to be able to convey to the family of the 26-year-old woman how grateful he is and thank those who knew the angel who saved his life.

Due to regulations which protect the identities of the donors, Lloyd was only able to write a letter to pass on through Lifeline. He said he knows the woman had children, but does not know her name or where she was from. He has had some correspondence with the family, but is particularly interested in letting her children know what her gift meant.
And to him, it meant getting to meet his grandchildren, continuing his service as a volunteer firefighter, dressing up as a clown to entertain others, returning to his job at Ohio University-Zanesville, talking to others who are on the waiting list and living with a newfound appreciation for life.

"It's like that Tim McGraw song, 'Live Like You Were Dying,'" he said. "Instead of skydiving, I go fight fires, instead of climbing mountains, I get to clown around and instead of 2.7 seconds on a bull, I get to spend every Saturday with my grandson."

tshipley@nncogannett.com

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