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Week Ending: April 7th , 2007
Alan Franciscus
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April 1st , 2007
Aussie John's Health Scare
http://www.news.com.au
By Ros Reines
AUSSIE Home Loans founder John Symond yesterday revealed he was among dozens of patients tested for hepatitis C following an outbreak at his doctor's Double Bay clinic.
Dr Danny Hameiri, a weight-loss specialist whose clients include some of the eastern suburbs' wealthiest socialites, was forced to close his practice after the contamination scare was exposed on Friday.
A recorded message at his Cooper St practice yesterday directed patients concerned about the hepatitis C investigation to a NSW hotline, and said the surgery was expected to reopen only at the end of April.
Three of his patients have been diagnosed with acute hepatitis C but Mr Symond, who had recommended the doctor to friends, said he had been given the all-clear.
"Yes, I have had Danny's vitamin C injections but I have been tested and I'm all clear,'' Mr Symond told The Sunday Telegraph.
"I have also recommended him to friends and they seem to be OK, too. I have known about this for a while.''
A spokeswoman for Dr Hameiri said he was co-operating fully with the NSW Health investigation.
"He's obviously concerned for his patients' welfare, that's why he contacted the health department in the first place,'' the spokeswoman said. "It's been a difficult thing for him to deal with.''
She said the doctor had contacted most of his patients dating back to 2004 to inform them of the inquiry.
Mr Symond, who said he has shed 27kg, has been a loyal patient of Dr Hameiri's for nearly a year.
"I think he's a good bloke and I will probably go to him again once he is allowed to open up again,'' Mr Symond said.
Lady Susan Renouf also became a shadow of her former self after becoming one of the doctor's devotees.
NSW Health was yesterday still trying to contact all 127 patients who may have been infected with the potentially deadly disease after receiving vitamin or mineral injections at the Cooper St clinic.
Health experts believe the spread of hepatitis C at the clinic may be due to a "breakdown in infection control''.
A woman in her 50s was diagnosed with hepatitis C in January, while another in her 40s was diagnosed in February.
A third patient infected with hepatitis C in 2004 is also being investigated.
Dr Hameiri preaches a strict but natural approach to weight-loss, based on a diet high in vegetables and vitamin supplements.
Hepatitis C causes liver damage, including cirrhosis and liver cancer, although it can take years to develop.
There is no vaccine and, of those exposed to the virus, three-quarters can develop a chronic or ongoing infection.
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Silent Epidemic Hepatitis C Has U.S. Taking Notice
http://www.mcall.com
By Sam Kennedy Of The Morning Call
OraSure Technologies is developing a diagnostic test to detect the disease earlier.
The reckless excess of the 1970s came back to haunt Jim Weaver in 1999, when he donated blood at his church.
Routine screening found the Lehighton resident had hepatitis C, a potentially deadly liver disease. A family man with a factory job, he traced his infection to an earlier life, when he experimented with intravenous drugs.
''It's like somebody in your family dies when you get diagnosed,'' he said.
Hepatitis C kills as many as 10,000 Americans a year, a figure that is expected to double or triple in the next decade or so, surpassing annual AIDS deaths, according to the Centers for Disease Control and Prevention.
Nonetheless, it is known as a silent epidemic because infections often go undetected for years, even decades. The CDC estimates that 4.1 million people in this country, or nearly 2 percent of the population, have the disease, although fewer than half are aware of it.
However, a new diagnostic test under development by OraSure Technologies of Bethlehem could soon reduce the ranks of people who -- like Weaver, before his accidental discovery -- don't know they are hepatitis C-positive.
OraSure is the company that created the first U.S.-approved rapid HIV test, OraQuick, which can detect the AIDS virus in blood or saliva in less than 20 minutes. Its hepatitis C test is supposed to work the same way.
Such ease of use and speed could have a major impact on the fight against hepatitis C, much as it has with HIV/AIDS, according to health officials and activists. Primarily, they say, it would prompt more people to seek treatment and make lifestyle changes that can head off more drastic measures, such as liver transplants.
''It's an important piece of health information,'' Ian Williams, head of hepatitis epidemiology at the CDC, said of diagnosis. ''Earlier is better.''
Shortly after donating blood at his church, Weaver began to show some of the symptoms of acute infection -- weight loss, fatigue, confusion. His name was put on a liver transplant list.
But he had recently quit drinking alcohol. And with the addition of a new diet heavy on fruits and vegetables, his liver function made a dramatic turnaround. Transplant plans were scrapped.
''I still eat pepperoni pizza -- but only once in a while,'' said Weaver, now 51 and leader of the Hepatitis C Support Group of the Lehigh Valley. ''It's a different way of living, but it beats the alternative.''
Getting the facts
Hepatitis C, discovered in 1989, eight years after the first case of AIDS was diagnosed, is caused by a virus that lives in blood. It has spread primarily through intravenous drug use and blood transfusions, and to a lesser extent through other routes, such as sex and health-care worker needle sticks.
More than half of people infected with hepatitis C eventually become chronically ill; two-thirds of those develop liver cirrhosis, making it the leading reason for liver transplants. While the disease can sometimes be cured through potent chemotherapy, such treatment has only a one-in-three chance of success.
The rate at which hepatitis C is spreading in this country has slowed dramatically. The number of new cases has dropped from an estimated peak of 240,000 a year in the 1980s to 26,000 in 2004, according to the CDC.
But the bulk of hepatitis C carriers are baby boomers. And since the disease tends to go undetected until people are into middle age -- all boomers are now at that stage -- epidemiologists are bracing for a surge of acute cases.
''When you look at death certificate data, it does look like that takeoff is starting to happen,'' the CDC's Williams said.
Pennsylvania began tracking hepatitis C cases in 2002. The number of new cases increased steadily over the next three years, from 6,800 in 2002 to 10,400 in 2005, a 53 percent increase.
The number of new cases in Allentown jumped fivefold during the same period, to 493 in 2005. Preliminary data for 2006 shows a decrease in new cases, suggesting high-risk populations have been thoroughly canvassed.
Giving a face to the problem
Robert Csandl, executive director of Keenan House, a drug treatment facility in Allentown, estimated that more than half of his clients are hepatitis C-positive.
One such person is Joseph Bailey, 47, who was recently paroled to Keenan House after a 31/2-year prison sentence. He believes he contracted the disease from a prison tattoo, although there's really no way to know for sure; he also acknowledged trying intravenous drugs in the mid-1980s.
When he confides to others that he has hepatitis C, he said he usually gets the same nonchalant response:
'''Yeah, me too.'''
Beyond the prisons and drug treatment facilities where hepatitis C is so common, the reaction can be quite different. At a recent gathering of Weaver's Hepatitis C Support Group, which meets monthly at Sacred Heart Hospital in Allentown, several participants described the stigma associated with their illness.
''People assume you got it through drug use–Everyone thinks, 'It serves him right for sticking that needle in his arm,''' said Marjorie Wharton, 50, of Bethlehem.
In Wharton's case, transmission occurred during a blood transfusion when she was treated for cancer as a teenager. A transfusion, after a car accident in 1971, was also the likely culprit for James Bradley, 70, of East Allentown, who had a liver transplant nearly a decade ago.
Barbara Christman, 56, of Macungie, believes she contracted hepatitis C cleaning surgical instruments for her father, a doctor. She was diagnosed several years ago. ''I lost a lot of friends as soon as they knew,'' she said.
And that wasn't all. Her marriage of 20 years soon ended, as well.
''The most underreported aspect of hepatitis C is the damage it does to relationships,'' Weaver said. ''It breaks up families.''
The OraQuick HIV test upon which the hepatitis C test is being modeled is about as easy and quick as a home pregnancy test: One uses a swab to capture saliva from the mouth; the swab is then inserted into a plastic receptacle that indicates after 20 minutes whether the test is positive or negative.
By comparison, the current method of testing for hepatitis C requires a blood sample to be analyzed by a laboratory, which means people typically have to wait at least a week for the results.
OraSure expects to begin formal hepatitis C test trials this summer and to seek Food and Drug Administration approval by the end of the year, said company Chief Executive Officer Douglas Michels. It hopes to begin selling the test by the second half of next year.
Timothy Friel, an infectious disease specialist at Lehigh Valley Hospital, said the public's understanding of hepatitis C is at least a decade behind that of HIV/AIDS. OraSure's new test could help to close that gap, he said.
''It allows you to take that testing technology out onto the street,'' he said. ''It's definitely going to get people talking.''
sam.kennedy@mcall.com
610-820-6517
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Make Hepatitis Screening a Must
http://www.nst.com.my
By : ANNIE FREEDA CRUEZ
E-mail : news@nst.com.my
Some 2.5 million Malaysians have hepatitis, or inflammation of the liver, with the majority suffering from hepatitis B. What is worrying, Tan Sri Dr Ismail Merican tells ANNIE FREEDA CRUEZ, is that six per cent of Malaysians are carriers of the disease and most of them are unaware of it
MANY Malaysians apparently are confused over hepatitis A, B and C.
This is why the Ministry of Health and the Liver Foundation are saying it over and over again: Malaysians must undergo hepatitis screening.
"If you are vaccinated against one type of hepatitis, it does not mean that you are protected against the others," said Tan Sri Dr Ismail Merican, consultant hepatologist, Liver Foundation president, and director-general of Health.
Hepatitis A is an infectious, food and water-borne disease and it is one of the world’s most common infectious diseases, 10 to 100 times more common than typhoid and 1,000 times more common than cholera.
About 50 per cent of Malaysians below the age of 30 do not have antibodies for hepatitis A and they are therefore susceptible to the disease, which could lead to acute liver failure, especially in older patients.
"Hepatitis A does not lead to chronic liver disease, but those who get it may suffer from serious morbidity for weeks and months which will affect their productivity."
Those without immunity against hepatitis A should get vaccinated as it would protect them against the disease for up to 10 years. There is a vaccine that offers protection against both hepatitis A and B.
But there is no vaccine to prevent hepatitis C which affects three per cent of the world’s population.
Hepatitis C is especially common among intravenous drug users and those who undergo dialysis or transplants. Up to 80 per cent of those with hepatitis C will suffer from chronic hepatitis, which can lead to liver cancer.
Dr Ismail advised those who received blood transfusions before 1995 to get themselves tested. Treatment is largely palliative, with curative intervention being possible in less than 25 per cent of patients diagnosed with liver cancer.
"There are new modalities of treatment, especially for those suffering from hepatitis B and C."
This is why the liver foundation always emphasises on the five strategies — talking to the public to create awareness on hepatitis; talking to doctors on treatment available and changes in treatment; screening for hepatitis A, B, and C; importance of vaccination; and counselling for those with hepatitis.
"With treatment, their risk of contracting chronic liver disease or liver cancer could be substantially lowered," said Dr Ismail
Sadly, though, almost 80 per cent of liver cancer patients discover this too late and there is very little that can be done for them at that stage.
It is especially tragic as the cancer could have been prevented had the patients been protected against hepatitis B.
"As such, those without immunity against hepatitis B should get themselves vaccinated."
Dr Ismail said the government had been immunising infants against hepatitis B since 1989.
"This is why it is important that those born before 1989 go for screening as they are at a higher risk of getting liver cancer as a result of hepatitis B."
"Epidemiological studies have shown that liver cancer development is closely associated with chronic hepatitis B virus infection."
Hepatitis B, which is a severe form of viral hepatitis, is 100 times more infectious than HIV, and is largely transmitted through exposure to bodily fluids containing the virus.
This includes through unprotected sexual contact, blood transfusion, re-use of contaminated needles and syringes, and from mother to child during childbirth.
"If you are a hepatitis B carrier, you are 200 to 300 times more at risk of getting liver cancer," said Dr Ismail.
"Go for hepatitis screening. Sufferers of the disease can be examined, counselled and treated," he said.
Dr Ismail said hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver occurring predominantly in patients with underlying chronic hepatitis B and C and cirrhosis.
HCC is one of the top five cancers among Malaysian men, and the age-standardised annual incidence of HCC is 2.8 cases per 100,000 population.
"It accounts for 5.6 per cent of all cancers and 8.1 per cent of all cancer-related deaths in the country," said Dr Ismail,
HCC, also called hepatoma, is a primary malignancy (cancer) of the liver. Most cases of HCC are secondary to either hepatitis infection (usually hepatitis B or C) or cirrhosis (alcoholism being the most common cause of hepatic cirrhosis).
Treatment options of HCC and prognosis are dependent on many factors but especially on tumour size and staging.
Dr Ismail said chronic hepatitis B infection is the most common underlying cause of liver cancer in East and Southeast Asia while Hepatitis C is the main cause in Japan and other developed countries.
Dr Ismail said the incidence of liver cancer in chronically hepatitis B virus infected individuals is about 100 times higher than in the uninfected population, and the lifetime liver cancer risk of males infected at birth approaches 50 per cent.
As far as hepatitis C virus associated liver cancer is concerned, it typically develops after 20 to 30 years of infection and is generally preceded by cirrhosis of the liver.
"There is a difference between hepatitis B and C. While both can cause liver cancer. In hepatitis C, it tends to cause cancer later," said Dr Ismail.
In Malaysia, he said, chronic hepatitis B is the most common cause for the development of liver cancer.
He added data from a local tertiary liver unit revealed 65 per cent of liver cancer patients were hepatitis B carriers, 10 per cent had evidence of chronic hepatitis C while five per cent had evidence of hepatitis B- and C-related liver diseases.
"Twenty per cent of liver cancer patients had no evidence of hepatitis B or hepatitis C-related liver diseases."
Surgical resection (removing part of the organ) is considered for patients with single tumour, non-cirrhotic or have cirrhosis but still have well preserved liver function.
"Liver transplantation has been shown to provide good long term disease free survival in selected cases."
Dr Ismail said retrospective three-year survival rates with liver transplantation vary between 18 per cent and 69 per cent (depending on the stage of the disease) while with resection the range is 31 to 51 per cent.
Its applicability, he said, was limited by high costs, shortage of donor organs and the long waiting time, during which period the progression of malignancy can occur, and the limited healthcare resources.
"The best strategy is prevention of primary liver cancer with hepatitis B vaccination."
What is hepatitis?
- Hepatitis is an inflammation of the liver, and can be caused by a viral or bacterial infection, liver injury caused by a toxin (poison), and even an attack on the liver by the body’s own immune system.
- Hepatitis A: The virus is transmitted through the faeces of infected persons. People usually get hepatitis A by eating food or drinking water that’s contaminated with faeces.
- Hepatitis B: This is a more serious infection and it may lead to a condition called cirrhosis (permanent scarring of the liver) or liver cancer, both of
- which cause severe illness and even death.
- Hepatitis B is transmitted from person to person through blood or other body fluids.
- Hepatitis C: Like hepatitis B, this infection can lead to cirrhosis or liver cancer. Hepatitis C is transmitted from person to person through blood or other
- body fluids.
THE Malaysian Liver Foundation will conduct its Liver Update at the Sunway Lagoon Resort Hotel in Subang on July 12-15. Liver experts from around the world will be invited to talk on the latest developments in the field of liver and new treatment modalities.
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April 2nd, 2007
FDA Approves Accelerated Dosing Schedule for GlaxoSmithKline's Twinrix
http://www.pharmalive.com
- New Vaccine Schedule Offers Protection Against Hepatitis A and Hepatitis B -
PHILADELPHIA, April 02, 2007 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved Twinrix(R) [Hepatitis A Vaccine (Inactivated) and Hepatitis B (Recombinant) Vaccine], for an accelerated dosing schedule that consists of three doses given within three weeks followed by a booster dose at 12 months. The approval means Twinrix, the only hepatitis A and hepatitis B combination vaccine available in the United States, is now available on a dosing schedule at 0, 7, 21-30 days, followed by a booster dose at 12 months. The vaccine was first approved for adults over age 18 years by the FDA in May 2001 on a 0, 1, 6-month dosing schedule.
"Hepatitis A and hepatitis B are serious liver diseases which can be prevented through vaccination," stated travel medicine specialist Bradley A. Connor, M.D., Past President, International Society of Travel Medicine and a principal study investigator. "Twinrix's new accelerated dosing schedule offers an option that could benefit individuals such as those preparing to travel internationally to high-risk areas. It may also benefit emergency first care responders, especially those deploying to disaster areas overseas, as well as others at risk for hepatitis, such as people with sexually transmitted diseases and those who are HIV positive."
Many regions throughout the world are endemic for hepatitis A and hepatitis B, such as Africa, Asia, South America and parts of the Caribbean. Worldwide, approximately 1.5 million cases of hepatitis A are reported annually. In addition, hepatitis B has infected 2 billion people - one-third of the world's population. Millions of Americans travel each year to countries where hepatitis A and hepatitis B are endemic. An overwhelming majority of these international travelers are not vaccinated before the trip. Therefore, international travelers may be at risk for contracting both hepatitis A and hepatitis B. They should consult their health care provider prior to traveling abroad.
The FDA approved the new dosing schedule after reviewing the safety and immune response of Twinrix given to 250 healthy adults (aged 18 years or older) at 0-, 7-, and 21- to 30-day schedule, followed by a booster dose at 12 months, compared to separate vaccinations with monovalent hepatitis A vaccine (HAVRIX at 0 and 12 months) and hepatitis B vaccine (ENGERIX-B at 0, 1, 2, and 12 months) given to 246 healthy adults as a control group. The study demonstrated that the individuals who completed the series of Twinrix on the accelerated dosing schedule had an immune response comparable to those individuals who received complete vaccination with separately administered hepatitis A and hepatitis B vaccines.
About Vaccine-Preventable Hepatitis (VPH)
Vaccine-Preventable Hepatitis includes hepatitis A and hepatitis B. Hepatitis C is not vaccine preventable. Hepatitis A is a serious liver disease caused by the hepatitis A virus. This virus is found in the stool of persons with hepatitis A and is spread by close personal contact and by eating food or drinking water contaminated with the hepatitis A virus. Hepatitis A can be easily passed between people within the same household. About one in five people with the disease has to be hospitalized. Hepatitis A can be fatal. Symptoms of the disease can include fever, fatigue, loss of appetite, nausea, abdominal discomfort, jaundice (yellow skin and eyes) and dark urine.
Hepatitis B is a serious liver disease caused by the hepatitis B virus. The virus is passed through infected blood or body fluids. Approximately 50 percent of people with hepatitis B do not notice signs or symptoms. Those who do may experience diarrhea and vomiting, nausea, fatigue, loss of appetite, muscle and joint pain, and jaundice. Hepatitis B can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. An estimated 1.25 million Americans are chronically infected with Hepatitis B. Estimates show that tens of thousands of people (mostly young adults) are infected each year.
About Twinrix(R)
As with all prescription medications, please talk with your healthcare provider to see if Twinrix is right for you.
In clinical trials with Twinrix, the most common side effects included pain and redness at the injection site, headache, and tiredness. These effects were mild and did not last more than 48 hours. (See Adverse Reactions section of the Prescribing Information for Twinrix for other potential side effects.) As with any vaccine, there is a small risk of allergic reactions. If you notice any problems following vaccination, or if you are allergic to any component of the vaccine such as neomycin, yeast, or latex, please inform your healthcare provider.
For more information on Twinrix visit www.gskvaccines.com.
GlaxoSmithKline - A Leader in Vaccines
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.
GlaxoSmithKline Forward-Looking Statements
Cautionary statement regarding forward-looking statements under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995: the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report 2005.
CONTACT: Jennifer Armstrong of GlaxoSmithKline, +1-215-751-5664; JamesRobertson, +1-212-798-9869, for GlaxoSmithKline
Web site: http://www.gsk.com/ http://www.gskvaccines.com/
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Lawyers Examine Hepatitis C Case
http://new.edp24.co.uk
Specialist solicitors have launched an investigation into the death of a 47-year-old businessman who died from liver cancer after being infected with the Hepatitis C virus during a routine blood transfusion.
Stuart Oliver from Wisbech was given infected blood during surgery for injuries he received in a car crash in 1987.
He carried the deadly infection without knowing for almost two decades and by the time he was taken ill in late 2004, it was too late to save him and he died in January 2005.
Sheffield-based law firm Irwin Mitchell is now investigating the circumstances surrounding the provision of contaminated blood to Mr Oliver and his subsequent medical treatment, to establish whether the disease could have been identified at an earlier stage.
Although there are tests available to screen blood donors for Hepatitis C, these were not available prior to 1991. The NHS designed a 'look back' procedure to identify and trace patients who had received unscreened blood.
But Mr Oliver slipped through the net and was never told that the blood he had been given could be potentially fatal.
Gary Walker, a solicitor at Irwin Mitchell Solicitors said: “There are clearly some very important issues which cannot be addressed in a civil claim which affect all patients who received potentially affected blood products.
“Our main concern is over the adequacy of the look back procedure which we believe has failed to identify a number of those who are at risk.
“A more effective screening system may have led to an earlier diagnosis of Mr Oliver's disease and meant that treatment could have been commenced sooner.”
An independent enquiry led by Lord Archer of Sandwell, a Labour peer and former solicitor general, is to be held into the supply of contaminated NHS blood to haemophilia patients. Mr Oliver's family are urging Lord Archer to extend the scope of this enquiry to include all people who have been provided with contaminated blood.
Last night Mr Oliver's daughter Kerry said: “Although there is nothing we can do for my dad we want people to be aware that if they received a blood transfusion before 1991 they could be infected with a deadly disease. We want to make sure that no one else has to go through what we've been through”.
The Health Protection Agency believes that up to 200,000 individuals have contracted Hepatitis C from infected blood. But only one in four are actually aware that they have the disease.
Earlier this year Body Shop founder Dame Anita Roddick revealed that she was diagnosed with Hepatitis C after a routine medical examination. She had unknowingly been living with the disease for over 30 years after receiving a blood transfusion during the birth of her daughter.
Anyone who thinks they might be at risk of infection should contact their doctor.
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Nautilus Biotech Begins Phase I Clinical Trial in the USA for Subcutaneous Belerofon(R), its Long-Lasting, Interferon-Alpha Drug
http://www.medicalnewstoday.com
Nautilus Biotech has announced that it has initiated a Phase I clinical trial for subcutaneous Belerofon(R), its long-lasting human Interferon (IFN) alpha. Belerofon has therapeutic potential for the treatment of a number of conditions, including chronic Hepatitis C.
Following recent approval by the US Food and Drug Administration, the Phase I clinical trial is being held in Austin, Texas in the USA and involves six treatment groups of eight male and female volunteers, aged 18 to 50 years. The trial is an open-label, ascending dose study of four doses of subcutaneous (SC) Belerofon, which will be compared to SC administered IntronA(R) (a Schering-Plough product) and Pegasys(R) (pegylated Interferon alfa-2a (40KD), a Roche product).
The primary objective of the trial is to evaluate SC Belerofon in healthy adult subjects, for safety, tolerability and pharmacokinetics in comparison with IntronA and Pegasys. The second objective is to evaluate the comparative pharmacodynamics of the three products. Nautilus Biotech expects initial results from the trial to be available during Q3 2007.
Belerofon is an engineered variant of IFN-alpha. It has a single point mutation for lower sensitivity to protease-mediated degradation, unchanged molecular weight and specific antiviral activity compared to non-pegylated IFNs. Following subcutaneous administration in animals, SC Belerofon shows a longer half-life and subsequently improved exposure profile compared to native IFN alpha and pegylated derivatives.
"We are confident that Belerofon has the potential to set a new Gold Standard Interferon in the treatment and management of Hepatitis C," said Nautilus Biotech's CEO, Manuel Vega. "The start of a clinical trial for subcutaneous Belerofon is a major milestone in our move to become a leading drug development company."
"The commencement of a Phase I clinical trial for SC Belerofon represents an important development in our pipeline of novel engineered protein drugs," said Paul Martin, Nautilus Biotech's Vice President Strategy. "It demonstrates Nautilus Biotech's ability to move novel engineered proteins from design to the clinic quickly and efficiently."
In addition to the injectable Belerofon evaluated in this clinical study, Nautilus Biotech has formulated lyophilized Belerofon together with inactive ingredients to produce enteric-coated tablets for oral administration and filed an IND for oral Belerofon in February 2007. All currently marketed Interferon alpha drugs are administered by injection.
About Hepatitis C
Hepatitis C (HCV) is the most prevalent liver disease in the world. HCV infection causes chronic inflammation in the liver that can lead to cirrhosis, liver failure, liver cancer or death. HCV infection represents a significant medical challenge worldwide. Currently, there is no vaccine that can prevent hepatitis C.
According to the World Health Organization, more than 170 million people worldwide suffer from chronic HVC. With only half of all HCV patients benefiting from current therapy, there is considerable market potential for new medical solutions. The HCV market is expected to grow from $2.2 billion in 2005 to $4.4 billion in 2010 and $8.8 billion in 2015 due to improved market penetration and better diagnosis rates (source: Datamonitor).
About Nautilus Biotech
Nautilus Biotech is a drug discovery and development company with a pipeline of next-generation therapeutic proteins with superior pharmacological profiles that address unmet clinical needs. The company's protein engineering technology can significantly improve the pharmacological characteristics of important blockbuster protein drugs, offering improvements in drug stability and administration. The company is also creating proprietary 'third generation' therapeutic proteins which are, per se, suitable for oral administration.
The therapeutic proteins market is currently valued at over $35bn, and growing at a rate of 10-15% per annum. Nautilus Biotech has created a portfolio of next-generation therapeutic proteins with improved profiles, including long-lasting Interferon alpha (Belerofon), hGH (Vitatropin(R)), Interferon beta, Erythropoietin, Interferon gamma, Clotting Factor IX (in collaboration with Wyeth Pharmaceuticals) and HMGB1 (in collaboration with Creabilis Therapeutics). Nautilus Biotech has established a strong intellectual property position covering enhanced versions of these multibillion dollars molecules and is rapidly moving these products into clinical development.
Nautilus Biotech
Nautilus Biotech is a private company with headquarters in Genopole(R) biopark, (Evry, France). For more information about Nautilus Biotech visit http://www.nautilusbiotech.com/
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Phynova - Significant Progress in Product Pipeline
http://www.oxfordshirebioscience.com
Phynova Group plc (AIM: PYN), the developer of prescription pharmaceuticals derived from Chinese botanical medicines, announces significant progress with its portfolio of products in development.
Pipeline highlights:
- PYN17 for treating the symptoms of chronic hepatitis C on track for start of Phase II clinical trial in April 2007
- PYN18, an antiviral for treating hepatitis C, shows activity against dengue virus, a new indication
- PYN22, a candidate treatment for obesity and fatty liver, successfully reduces body fat in preclinical studies
Phynova will present further supplementary data at the "BioTrinity" company showcase and partnering conference in Oxford on 28 March 2007.
Robert Miller, Chief Executive of Phynova, commented: "Traditional Chinese medicine contains a wealth of candidate compounds with demonstrated efficacy and safety. We select specific plant-derived drug candidates in China and prove their value in rigorous Western preclinical and clinical models. I am delighted that our lead product, PYN17 for chronic hepatitis C, is progressing on schedule for a Phase II trial to start next month. Encouraging progress elsewhere in Phynova´s pipeline validates our business strategy and makes us confident that our approach will generate a strong product portfolio.
"We are also encouraged by the fact that Phynova´s growing market presence, including the relationship with Botanic Century in Beijing, is resulting in an increased inflow of commercially attractive new drug development opportunities."
Chronic Hepatitis C treatment on track to start Phase II clinical trial in April 2007
Phynova´s PYN17 is a treatment for the symptoms of chronic Hepatitis C, a viral liver disease. Hepatitis C is endemic in many parts of Asia and is now becoming a serious threat in the Western word, with over 4 million cases in the USA. In January 2007, the FDA approved Phynova´s PYN17 Investigational New Drug (IND) application and Phynova has recently held a successful Investigator Meeting in the US with participating physicians, heralding the start of the Phase II clinical trial. This trial will begin in April 2007 in five centres in the US. An interim analysis is expected around the end of the year.
Hepatitis C antiviral also active against dengue virus
Phynova´s PYN18 is an antiviral in development for the treatment of Hepatitis C virus (HCV). Current treatments for HCV are only partially effective and have significant associated toxicity. PYN18 is a novel antiviral medicine that Phynova expects to have a better benefit to risk ratio than existing treatments. In addition, as strategies for treating HCV treatments increasingly involve combinations of drugs, Phynova believes that PYN18 will be used alongside existing treatments to enhance their effectiveness.
Phynova has recently demonstrated that PYN18 is also active against dengue virus, the causative agent of Dengue Haemorrhagic Fever ("DHF"), a common and serious tropical disease that is endemic in much of Asia. Preclinical studies were carried out with Phynova´s collaborators at the Sirriraj Hospital in Bangkok, Thailand. The results indicate that PYN18 has a broader spectrum of antiviral activity than previously believed. This provides a clear commercial opportunity for PYN18 in the potential treatment of DHF. Phynova will pursue the DHF indication along with its work on HCV and other potential RNA virus targets.
Lipid lowering compound successfully reduces body fat in preclinical models
Phynova´s PYN22 is a lipid lowering compound in-licensed from China. Preliminary in vitro and in vivo experiments indicate that PYN22 reduces both blood lipids and percentage body fat. Data generated by Phynova´s Chinese collaborators have been confirmed and extended by a group in the UK. They have shown that PYN22 reduces both insulin resistance and blood glucose levels in a similar manner to that seen with the oral antidiabetic rosiglitazone (GlaxoSmithKline´s Avandia), one of the current standard treatments for Type II diabetes, often associated with fatty liver disease. Data on blood lipids and liver fat in a specific in vivo model are pending. Phynova expects to commence clinical testing of PYN22 during 2007.
Obesity is associated with a number of metabolic disorders, including type II diabetes and fatty liver disease. Obesity is a huge and rapidly growing problem worldwide, with the fastest increase in Asia as populations already predisposed to Type II diabetes adopt a Western diet and life style. There are few effective treatments for obesity or for fatty liver disease.
For more information: http://www.phynova.com/Press_Centre.asp
For further information, please contact:
Phynova Group PLC 07775 920 963
Robert Miller, Chief Executive Officer
Abchurch Communications 020 7398 7700
Peter Laing/Martin Sutton/Stephanie Cuthbert
Nominated Adviser:
Nabarro Wells & Co. Limited 020 7710 7400
Marc Cramsie/John Wilkes
Broker:
J M Finn & Co. Limited
Sam Smith 020 7628 9688
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April 3rd, 2007
Rare Case of Dental Patient-to-Patient Hepatitis B Virus Transmission Recorded
http://www.sciencedaily.com/
Science Daily — Researchers have documented a case of hepatitis B virus (HBV) transmission between two patients at a dentist's office in the United States. While this kind of infection is exceedingly rare, universal vaccination against the virus would likely have prevented both cases, according to the authors of the case report and an accompanying commentary. Both appear in the May 1 issue of The Journal of Infectious Diseases.
The case report, by John T. Redd, MD, MPH, and colleagues from the Centers for Disease Control and Prevention (CDC) and the New Mexico Department of Health, describes the index patient as a sexually inactive 60-year-old woman with no history of intravenous drug use or other potential exposures to HBV who had undergone multiple tooth extractions on a single office visit. A cross-match of the state's Hepatitis B Registry identified the source patient: a 36-year-old woman who had had teeth extracted hours earlier on the same day in the same office by the same surgeon and assistants, and receiving the same medications as the index patient. No evidence of HBV infection was found in any member of the office staff.
Blood tests indicated that the source patient had had chronic HBV infection with a high viral load at the time of oral surgery. Genetic analysis showed that virus of the same genotype and subtype was isolated from both patients, and that the isolates had identical DNA sequences in a sampled region. Medical records and blood tests of 25 patients operated on after the source patient showed that 16 (64 percent) were vaccinated and immune to HBV. "I was pleasantly surprised by the high prevalence of immunity," commented Dr. Redd. "It may have helped to limit spread of the virus."
How was the infection transmitted from source to index patient? When investigators visited the office and monitored its operation they found all staff members followed standard infection control practices. The investigators could only speculate that there might have been a lapse in clean-up procedures after the source patient, leaving an area contaminated with her blood.
HBV infection has long been a concern in dental infection control. The blood-borne pathogen is hardy, persisting in dried blood on surfaces for a week or more. It can be present even in the absence of visible blood.
With routine vaccination against the virus in U.S. dental health care personnel over the last two decades, the incidence of HBV infection in this high-risk group has dramatically fallen, and no cases of dentist-to-patient HBV transmission have been reported in the United States since 1987. This is the only known case of patient-to-patient transmission in a dental setting.
The authors concluded that the case underscored the need for meticulous maintenance of blood-borne pathogen infection control for all patients in dental settings. They also said that it reinforced the value of universal childhood HBV vaccination, which has been recommended in the United States since 1991.
In an accompanying editorial, Ban Mishu Allos, MD, and William Schaffner, MD, of Vanderbilt University School of Medicine, noted that adults account for most new cases of HBV infection in the United States, and that current recommendations based on such risk factors as sexual activity and intravenous drug use have resulted in meager vaccination rates. "Fewer than 10 percent of young adults with high-risk behaviors have received HBV vaccine," they said. In contrast, the incidence of HBV infection in children has been dramatically reduced by universal vaccination policies, and surgeon- and dentist-to-patient transmissions of the infection were essentially eliminated with routine vaccination of health care workers.
Accordingly, since those who engage in high-risk behaviors are generally younger, the editorialists recommended universal HBV vaccination of all adults up to age 40. "Universal age-based recommendations," they argued, "might have prevented both the source patient's infection and subsequent transmission to the index patient in the oral surgeon's office."
Fast Facts
- This is the only known documented case of hepatitis B virus transmission between two dental patients in the United States.
- HBV infection results mainly from sexual activity or intravenous drug use. It can be prevented with a vaccine.
- HBV is a hardy virus that can persist in dried blood on surfaces for a week or more; it can be present even in the absence of visible blood.
- No cases of dentist-to-patient HBV transmission have been reported in the United States since 1987.
Note: This story has been adapted from a news release issued by Infectious Diseases Society of America.
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Pharmasset Announces Clevudine and Hepatitis C Presentations at EASL
http://www.prnewswire.com
The 42nd Annual Meeting of the European Association for the Study of the Liver
PRINCETON, N.J., April 3 /PRNewswire/ -- Pharmasset announced today that presentations of preclinical studies of Clevudine for the treatment of hepatitis B (HBV) and PSI-6130, the parent molecule of R7128, for the treatment of hepatitis C (HCV) will be made during the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL) being held in Barcelona, Spain from April 11-15, 2007. The PSI-6130 studies were conducted through Pharmasset's HCV collaboration with Roche. Dr. Phillip Furman, Pharmasset's Vice President of Biological Sciences, will be presenting Pharmasset's posters beginning on Thursday, April 12, 2007 at 7:00pm (CEST). The complete abstracts can be viewed at
http://www.easl.ch/liver-meeting.
- Clevudine is Efficiently Phosphorylated to the Active Triphosphate form in Human Hepatocytes
C. Niu 1, E. Murakami 1, M.J. Otto 1, P.A. Furman 1 (1 Pharmasset, Inc., Princeton, NJ, USA)
- Study subject: initial half-life of the clevudine triphosphate. Inhibition of HCV Replication by PSI-6130: Characterization of Activity in the HCV Replicon System W.R. Jiang 1, S. Ali 1, S. Le Pogam 1, C. Daniel 1, S. Chiu 1, T. Kretz 1, I. Najera 1, P. Furman 2, N. Cammack 1, J. Symons 1 (1 Roche Palo Alto LLC, Palo Alto, CA, USA; 2 Pharmasset Inc.,Princeton, NJ, USA)
- Study subject: inhibition of HCV replication using combinations of PSI-6130 with other HCV inhibitors. Inhibition of HCV Replication by PSI-6130: Mechanism of Biochemical Activation and Inhibition P.A. Furman 1, E. Murakami 1, H. Bao 1, J. Symons 2, M.J. Otto 1 (1 Pharmasset, Inc., Princeton, NJ, USA; 2 Roche Palo Alto LLC, Palo Alto, CA, USA)
- Study subject: investigation of the enzymes involved in the phosphorylation of PSI-6130 and inhibition of HCV NS5B.
About Clevudine
Clevudine is an oral, once-daily pyrimidine nucleoside analog that we are developing for the treatment of HBV. We licensed clevudine from Bukwang Pharm. Co., Ltd., a Korean pharmaceutical company. Bukwang has recently initiated the commercial launch of clevudine in the Korean market under the brand name Levovir. We plan to initiate two Phase 3 clinical trials of clevudine for registration in the United States and Europe in the second calendar quarter of 2007.
About R7128, a Prodrug of PSI-6130
R7128 is a polymerase inhibitor being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase. The current R7128 Phase I clinical trial is a multiple center, observer-blinded, randomized and placebo- controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1.
About Hepatitis B Virus (HBV)
Hepatitis B viruses can cause liver disease leading to significant morbidity and death. HBV can cause either acute or chronic (lifelong) infection. The World Health Organization (WHO) has reported that approximately 350 million people worldwide have chronic HBV infection. According to the Centers for Disease Control and Prevention (CDC), approximately 1.25 million people in the United States are chronically infected with HBV, and the Hepatitis B Foundation reports that 100,000 people will become infected with HBV this year.
About Hepatitis C Virus (HCV)
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Contact:
Alan Roemer
Vice President, Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125
Statements in this company press release may constitute forward-looking Statements and are subject to numerous risks and uncertainties, including The failure of clevudine and R128 to perform as expected, the company's Ability to attract and retain qualified personnel to conduct the required Clinical trials of clevudine and R128 , the status of the company's HCVllaboration with roche, the company's future capital needs to fund the Clevudine and R128 development programs, the company's ability to obtain Additional financing, the company's ability to obtain required regulatory Approvals for clevudine and R128, the development of competitive hbv and Hcv products by others, the existence of third-party patent rights, and Other risks inherent in discovery and development stage programs at a Biotechnology company. The actual results for clevudine and R128 may Differ materially from those anticipated in this company press release. The Company disclaims any obligation to update the statements contained in this Company press release.
SOURCE Pharmasset, Inc.
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April 4th 2007
Hepatitis C Virus Blocks 'Superinfection'
http://newswire.rockefeller.edu
There’s infection and then there’s superinfection – when a cell already infected by a virus gets a second viral infection. But some viruses don’t like to share their cells. New research from Rockefeller University shows that the hepatitis C virus, which infects cells in the liver and can cause chronic liver disease, can block other hepatitis C variants from infecting the same cell.
Research from Charles Rice’s laboratory at Rockefeller last year created the first hepatitis C virus that could be grown in cell culture. Using this virus, called HCVcc, the scientists, lead by graduate student Donna Tscherne, tried to infect cells previously infected with hepatitis C virus. But it didn’t work; the cells couldn’t be infected. The same was true when they tried to infect cells that contained hepatitis C virus of other genotypes than that of HCVcc. Only when they gave the cells a drug that could inhibit virus replication could they superinfect them with HCVcc. The first virus was stopping HCVcc from infecting the cells, a phenomenon called superinfection exclusion.
“A virus can interfere with a secondary infection in a variety of ways,” says Rice, head of the Laboratory of Virology and Infectious Disease and the Maurice R. and Corinne P. Greenberg Professor. “It can interfere with how a virus attaches to the cell, its penetration, or its access to the cell’s resources.” If both viruses are competing for the same resources in the cell, then the first virus can confiscate them so none are available for the second virus.
Rice and Tscherne believe this phenomenon may explain the mechanism of HCV superinfection exclusion. The scientists found that HCVcc is blocked at some point after it has entered the cell; most likely at a step, or steps, involved in replication. Future studies are being designed to try to identify what proteins are important for this step.
“Understanding superinfection exclusion has potentially important implications for understanding the biology of hepatitis C,” says Rice. The mechanism could, for instance, help the hepatitis C virus generate a large pool of variants that would be able to withstand attack from the immune system or from antiviral drugs. If the process of superinfection exclusion could be recreated therapeutically, it could also open up new treatment avenues.
Journal of Virology 81(8): 3693-3703 (April 2007)
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XTL Hepatitis C Drug Passes Phase I Trial
http://www.globes.co.il
Gali Weinreb
Development of XTL-6865 will probably be suspended, unless a partner can be found to finance further development.
XTL Biopharmaceuticals Ltd. (Nasdaq:XTLB); LSE: XTL; TASE:XTL) has announced that its XTL-6865 molecule has passed Phase I clinical trials for evaluating the safety and pharmacokinetic properties of the drug in patients with chronic hepatitis C. Although the trial failed to demonstrate that the drug was effective, the company said the study was too small and not designed for this purpose.
The announcement implied that, although XTL-6865 was shown to be safe, the main goal of the study, development would be probably suspended for now, unless a partner could be found to finance further development.
XTL CEO Ron Bentsur said, "We intend to focus our resources on commencing our clinical program for Bicifadine, for the treatment of diabetic neuropathic pain, and on completing our Phase I study for XTL-2125, our small-molecule compound for the treatment of chronic hepatitis C."
XTL-2125 is due to begin Phase II clinical trials shortly.
The share rose 3.1% to $3.95 on Nasdaq in response to the announcement, even though Brean Murray Carrett analyst Jonathan Aschoff disagrees with the trend. He reiterated his recommendation for the share, but cut the target price to $9 from $10.
There are a number of reasons for this, despite the success of the trial for XTL-6865. XTL has limited resources, amounting to only $15 million in cash, after buying the rights to Bicifadine. The company must use this money carefully and achieve important milestones if it is to survive. Otherwise, it will have to try to raise more capital at a time when the biggest events since its last offering were the failure of its joint hepatitis B treatment with Cubist Pharmaceuticals Inc. (Nasdaq:CBST) and the plunge in its share.
Published by Globes [online], Israel business news - www.globes.co.il - on April 4, 2007
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April 5th 2007
Vertex Pharmaceuticals Shares Continue Rising as Hepatitis C Drug Data Nears
http://www.canadianbusiness.com
NEW YORK (AP) - Shares of Vertex Pharmaceuticals Inc. have been on the rise since Tuesday as the release of clinical trial data for the biotech drug developer's hepatitis C drug Telaprevir nears.
The stock climbed 88 cents, or 3 percent, to $30.73 in afternoon trading on the Nasdaq. Shares, which have traded between $26.98 and $45.38, are up 10 percent since Tuesday.
Since mid-March shares have climbed from year-low levels as expectations on data from a major Telaprevir trial normalize. Shares began plummeting from a year-high in December, when Vertex stopped treatment in 9 percent of the patients in the clinical trial because of adverse events, prompting analysts to rethink expectations of the study.
The Phase II clinical trial tests a 12-week regimen of Telaprevir and Roche's Pegasys interferon product along with the antiviral drug ribavirin to see how many patients have a sustained virological response 12 weeks after discontinuing therapy. The 12-week regimen is the shortest of its kind.
Piper Jaffray analyst Rachel McMinn, who rates Vertex an "Outperform," said the "home-run" scenario of a 75 percent sustained virological response is possible, but a long shot. A rate of 40 percent to 50 percent is more likely, the analyst said.
Data on the trial will be presented mid-month at the annual meeting of the European Association for the Study of the Liver.
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Health Watch: Avoiding a Painful Piercing
http://media.www.hartfordinformer.com
Lisa M. Wilowski, APRN
Body piercing has become more popular today with adults and adolescents alike. Traditional earlobe piercing is being replaced by displays of needles, rings and steel posts as adornments on noses, navels, brows, nipples and numerous other body structures. When considering a body piercing, one should be aware of some important facts. Because the piercing industry is not regulated, the ability of the person performing the piercing and sterility of the procedure cannot be assured. Becoming an educated consumer prior to pursuing a piercing may help one decrease his/her chance of experiencing complications.
Methods of Piercing
Two types of piercing are generally used: spring-loaded guns and needles. Spring-loaded guns can be used with or without a disposable setup or autoclavable part. Because these guns are not easily cleaned and disposable parts may not be used, it is recommended that they only be used for ear piercing. Needle piercings are more popular and involve bringing the jewelry through the hole after piercing. Different gauge sizes of needles are used depending on the area of the body to be pierced.
Piercing Sites
Earlobe piercing has been the more traditionally chosen site, but other sites have become more popular. Common oral and facial piercing sites include the cartilage of the ear, nostrils, nasal septum, eyebrows and lips. Torso piercings include navel and nipple areas, and genital areas of the male are meatus, glans and scrotum. Of the female are clitoral hood and inner and outer labia.
Complications
All piercing sites break the integrity of the skin and decrease the natural barrier to infection. Some common side effects of piercing are pain, redness and swelling occurring at the site, bleeding, infection, drainage, scars, cyst formations and trauma. There have been other more serious complications reported such as allergic reactions, hematoma formations, damages to veins and nerves, sexually transmitted diseases and neuroma.
Infections can range from mild to severe. Most infections occur as the result of improper piercing technique, poor hygiene or improper post-procedure site and skin care. Mild infections are site specific, while severe infections can progress to sepsis and toxic shock syndrome. Most bacterial infections heal with treatment if medical attention is sought in a timely manner.
Two cases of tetanus, spore-forming bacteria, have been reported. Viral hepatitis has also been reported with piercings. Shared and unsterile jewelry and piercing equipment increases the likelihood of transmitting hepatitis B and is a risk factor of hepatitis C. While there is no immunization for hepatitis C, people considering piercing should be up-to-date on their tetanus and hepatitis B vaccinations. HIV transmission is a potential risk but not as great as hepatitis, because HIV dies at room temperature. Sexually transmitted diseases are more easily transmitted with genital piercing. The sterilization of instruments with an autoclave greatly reduces these risks.
The choice of jewelry can cause complications. If the jewelry is too thin, it can cut through tissue and migrate out of position. If jewelry is not inserted deeply enough, it may lead to rejection by the body. Jewelry must be of sufficient diameter and appropriate for the chosen site to heal properly without expulsion of the jewelry from the pierced site. Jewelry with a nickel-base can cause allergic reactions in 10 percent of women and two percent of men. Surgical-grade stainless steel, solid 14 or 18 karat gold or niobium, titanium and platinum are recommended jewelry metals.
Some complications are site specific. Multiple piercings on the rim of the ear cartilage take longer to heal and are more susceptible to infection due to the reduced blood supply of cartilage. Nose piercings have increased infection due to the natural presence of bacteria in this area. Embedded jewelry is a common complication at this site.
The tongue has more piercing complications than any other site. Reported complications include: aspiration or choking with airway obstruction, edema, cracked teeth, cellulitis of the mouth tissues, speech impediments, interference with chewing and swallowing, nerve damage resulting in permanent loss of taste and numbness, prolonged bleeding, increased salivary flow and increased risk of infection due to the natural presence of bacteria at this site.
It is recommended that persons who need prophylactic antibiotics for dental procedures should also use this same antibiotic treatment prior to tongue piercing. Nipple piercings experience trauma from clothing, possible scar tissue at the areola, infection, rejection and migration due to improper positioning of pierced jewelry.
Genital piercings can cause more serious health threats, which include mucosal trauma with sexual activity, condom tears risking STD transmission and pregnancy and an increase risk of infection with intercourse while the wound is healing.
Preventive Care
Proper skin is essential beginning immediately after the piercing. Do not handle or touch the pierced site unnecessarily. This can increase the chance of infection. For the first six months, the site should be cleaned twice a day with a mild antibacterial soap. After cleansing, a small amount of antiseptic should be applied (not rubbing alcohol because it's too drying). Tongue piercings should be cleansed with antiseptic mouthwash several times a day until healed.
Jewelry should not be removed until the site has completely healed. Healing times vary according to placement; those with exposure generally heal faster than those covered with clothing. Healing times range from one to two months for ear lobes, four to six months for ear cartilage, two to three months for nose and three to four months for labia. Healing can take as long as 12 months and proper site skin care should continue for the whole time to prevent an increased chance of infection.
If the site becomes infected, don't immediately remove the jewelry (unless nickel-based). It is probably not associated with the infection and removing it before the infection is cleared up can lead to an abscess. Increased cleansing three to four times a day with antibacterial soap and application of an antiseptic should be promptly instituted. Seek medical attention with any signs of infection: redness and swelling, drainage, increased pain, swollen glands or fever. If an antibiotic is prescribed, remember to finish the entire dose, usually 10 days.
How to increase you chances of a "safer" piercing
There are no 100 percent safe piercing procedures, but knowing what to look for in a piercer and piercing studio can increase your chance of a better outcome.
- Does the studio look clean?
- Does the reputable or licensed piercer provide thorough instructions about the procedure, risks, consent and aftercare?
- A safe and professional piercer is active in selecting the proper jewelry for the site, and is sensitive to the person's needs.
- A single use setup should be used for the piercing and the piercer should wear gloves.
- Single use needles should be used. Look for brown stripes on the packaging indicating the product has been sterilized.
- An autoclave is used to sterilize the piercing items.
- The skin area to be pierced should be cleansed with topical antiseptic.
If these conditions are not satisfactory, seek another facility and professional piercer. The American Professional Piercers' Web site www.safepiercing.com lists safe studios.
Knowing more about body piercing prior to seeking the procedure can help eliminate some of the more common problems associated with body piercing during the procedure, and it increases the chances for a more successful outcome after the procedure.
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Liver Diseases, Hepatitis C Assuming Alarming Proportions in Pakistan: Warns Health Experts
http://www.onlinenews.com.pk
Karachi -- Health experts and speaker at a seminar on “Innovations in management of Hepatitis C” warned that Hepatitis C and other liver related disease were assuming alarming proportion in Pakistan with each passing day.
The seminar was organised by Sarwar Zubari Liver Centre at Arag Auditorium of Dow University of Health and Sciences (DUHS) on Thursday.
Vice Chancellor DUHS Prof. Masood Hameed Khan expressed concern over the fast increase in Hepatitis C and other liver-related diseases in Pakistan.
He laid stress on the need to create awareness about liver diseases so that the fast growing of liver disease could be contained and the number of liver patients could be minimized.
He urged that seminars and workshops should be arranged so that awareness could be created about the disease.
Prof. Masood said that liver transplant was the last option in case of liver failure but being so expensive and lack of human resources this facility was not available in all hospitals of the country.
Dr. Adeel Butt, Director International Scholars Programme University of Pittsburgh and Director of VAPHS Infectious Diseases Clinics USA said that joindus and liver cancer might happen to the patients of Hepatitis C due to which liver might fail functioning.
He rejected the notion that impure water and unhealthy food was the main cause of the disease instead use of unsafe syringes is responsible for spreading the fatal disease.
“50 to 60 per cent patients of hepatitis c are curable but they can not be treated completely due to other diseases in the patient. Conventional therapy is used across the world to treat this illness and must be introduced in all hospitals of Pakistan, he observed.
Director Sarwar Zubair liver Centre, Dr. Rana Masood Khan said that these types of seminars for bringing awareness to the people would be organized in future.
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PEGINTRON(TM) Approved in China for Treating Chronic Hepatitis B
http://www.prnewswire.com
Individualized Treatment Provides an Effective, New Option to Chinese Patients
KENILWORTH, N.J., April 5 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that PEGINTRON(TM) (peginterferon alfa-2b) has been approved by the Chinese State Food and Drug Administration (SFDA) for the treatment of patients with chronic hepatitis B, the most prevalent infectious disease in China and one of the country's leading causes of death. There are 120 million chronic carriers of the hepatitis B virus in China and each year more than 330,000 people die in China due to hepatitis B-related complications, including cirrhosis and liver cancer.
PEGINTRON is administered once weekly at an individualized dose according to a patient's weight and is the only pegylated interferon indicated in China for a 24 week treatment duration in the hepatitis B patient population. The SFDA approval is based in part on a multicenter clinical trial in e-antigen positive chronic hepatitis B patients in China showing that PEGINTRON achieved a sustained response with 24 weeks of therapy when used as a first-line treatment.(1) PEGINTRON has been available in China since 2004 for the treatment of chronic hepatitis C.
"Schering-Plough is pleased to offer this effective new treatment option for Chinese patients with chronic hepatitis B, a major public health problem in China," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "We applaud the SFDA and Chinese healthcare professionals for their ongoing efforts in fighting hepatitis B, and we are committed to continuing our work with them and to educating patients on the importance of effective antiviral treatment."
Schering-Plough has been working together with Chinese healthcare professionals and patients for nearly 15 years on hepatitis B education for INTRON(R) A, which was approved in China for hepatitis B and C in 1993. In addition, the company offers ongoing educational programs in China to help support patients on PEGINTRON and INTRON A therapy.
PEGINTRON
PEGINTRON is not approved in the United States for treatment of chronic hepatitis B. In the United States, PEGINTRON is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age.
Important Safety Information Regarding U.S. Labeling for PEGINTRON and REBETOL
WARNING
Alpha interferons, including PEGINTRON, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEGINTRON therapy.
Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.
REBETOL and combination REBETOL/PEGINTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEGINTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6-month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.
PEGINTRON
There are no new adverse events specific to PEGINTRON as compared to INTRON A (Interferon alfa-2b, recombinant) for Injection; however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEGINTRON were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEGINTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEGINTRON.
Psychiatric adverse events, which include insomnia, were common (57%) with PEGINTRON, but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEGINTRON.
PEGINTRON/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
The following serious or clinically significant adverse events have been reported at a frequency less than or equal to 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.
In the PEGINTRON/REBETOL combination trial the incidence of serious adverse events was 17% in the PEGINTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEGINTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEGINTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34% of those receiving INTRON A/REBETOL.
REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com .
SCHERING-PLOUGH DISCLOSURE NOTICE:
The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for PEGINTRON. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part I, Item 1A, "Risk Factors" in the company's 2006 10-K.
Reference
(1) Zhao H, Si CW, Wei L, Wan MB, Ying YK, Hou JL, Niu JQ. A multicenter, randomized, open-label study of the safety and effectiveness of pegylated interferon alfa-2b and interferon alfa-2b in treating HbeAg positive chronic hepatitis B patients. Zhonghua Gan Zang Bing Za Zhi. 2006 May;14(5):323-6.
Schering-Plough press releases are also available on PRNewswire's Web site at http://www.prnewswire.com
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April 6th 2007
Central Iowa Networking 4/6
http://desmoinesregister.com/
You should get to know...
Shahid Habib
Director, Center for Liver Disease at Iowa Health Des Moines
Background: I was born in a middle-class Muslim family in Lahore, Pakistan. My father was a businessman, and my mother was a housewife. Both of them are retired now and living happily. I have five siblings: three sisters and two brothers. All are married. My brothers are in the same business as my father was. One of my sisters is a banker; my other two sisters are housewives. I completed my elementary, high school, medical school and post-doc fellowship in Pakistan. I married my wife in 1993 and we have three kids: Sana, Namrah, Mohammad. My wife, Huma, has always been behind me in everything I do, and she is the motivation of my life.
Why I do what I do: I work as a physician specializing in liver medicine, or hepatology. I felt that patients with liver disease are ignored throughout the world, though liver diseases are not uncommon. Viral hepatitis (hepatitis C and B) is so common in Pakistan and Far East Asia, and it became my motivation.
What I do to get away from work: I spend most of time with my family when I am not working. I love traveling, sports and a good workout at the gym to relax.
How I give back to the community: I always try to pay back the community. Currently, I am leading a program supported by the Association of Physicians of Pakistani-descent of North America and a local trust to establish a specialized center for liver diseases in Pakistan, especially focusing on services for hepatitis C and B infection. The focus of this program is to eradicate these infections. In addition, I teach doctor of osteopathy students at Des Moines University.
Words to live by: I am a strong believer in the pillars of character - honesty, responsibility, care, respect and humbleness.
My mentor: My mentor is Dr. Obaid Shakil, director of the hepatology division at the University of Pittsburgh. I am also impressed with the work of Dr. Thomas E. Starzle, who is a pioneer of liver transplantation. He is a man of dedication.
My leadership philosophy: I believe a true leader is rare to find. In my opinion, a true leader is one who cares for humanity regardless of race, religion and ethnicity, is always truthful and trustworthy, practices what he preaches and is a man of symbolic character.
Notable achievements: I feel lucky in that I have achieved what I wanted. I was able to establish a new Center for Liver Disease program in central Iowa with the help of my colleagues. I feel proud of achieving trust from my patients.
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HIV and Hepatitis Co-Infections Challenging
http://www.medpagetoday.com
By Michael Smith, Senior Staff Writer, MedPage Today
Reviewed by Zalman S. Agus, MD;
Emeritus Professor at the University of Pennsylvania School of Medicine.
BOSTON, April 6 -- Co-infection with HIV and either hepatitis B or C remains a clinical challenge, but new therapies appear to have increased the opportunities for effective treatment.
Action Points
- Explain to interested patients that HIV and hepatitis co-infection are becoming increasingly more common around the world.
The risk of death from hepatitis is inversely related to the degree of immune system compromise as measured by the CD4 cell count, said Margaret James Koziel, M.D., of Harvard and Marion Peters, M.D., of the University of California San Francisco, in a review in the April 5 issue of the New England Journal of Medicine.
Liver disease among co-infected patients is "becoming a leading cause of death" worldwide, they pointed out.
The prevalence of HCV and HBV infection among HIV-positive people varies depending on risk factors for transmission, the researchers noted. HCV spreads most easily through exposure to contaminated blood or blood products, so that it is linked to patients with hemophilia or a history of intravenous drug use. Among these patients, rates of co-infection approach 70% to 95%, compared with 1% to 12% among men who have sex with men.
On the other hand, HBV is typically acquired during sexual activity in adolescence or young adulthood. Chronic infection develops in 20% of adults with HIV infection after exposure to HBV. The overall prevalence of chronic HBV infection among HIV-positive persons in the U.S. and western Europe is less than 10%, and it is highest among men who have sex with men and among intravenous drug users.
The main effect of HIV on HCV infection is to accelerate the natural history of the disease, Drs. Koziel and Peters said, although immune restoration with antiretroviral therapy lowers the death rate from liver disease.
The effect of HCV infection on the progress of HIV is less clear. Some reports indicate that HCV slows immune reconstitution, but the effect is modest. At the same time, hepatotoxic effects of HIV therapy are more likely to develop in patients with HCV and HBV.
There is no non-invasive test to predict the degree of injury in HCV-HIV co-infected patients, so many specialists recommend a liver biopsy, to aid in the choice of treatment options.
The goal in HCV therapy is to reach an undetectable level of serum HCV RNA six months after the end of therapy, and the standard of care is pegylated interferon alfa (Pegasys) plus ribivarin (Copegus, Rebetol).
In mono-infected patients sustained responses are seen in up to 55% of patients with HCV genotypes 1 or 4 and up to 80% in those with genotypes 2 and 3.
In co-infected patients, clinical trials have shown response rates that are slightly lower -- between 14% and 44% for genotypes 1 and 4 and between 44% and 73% for the other genotypes.
A key factor is early virological response, defined as no detectable serum HCV RNA or at least a reduction by a factor of 100 after 12 weeks of therapy, Drs. Koziel and Peters said.
"If a patient has not had an early virologic response, the likelihood of a sustained virologic response is negligible," they said.
It's also important to note that ribivarin can interact with some antiretroviral medications, so that modifying HIV therapy may be necessary before starting HCV treatment, they said.
Future directions include:
- The long-term administration of interferon, in the hope of preventing the progression of fibrosis, even without a cure.
- New agents targeting the serine protease and RNA-dependent RNA polymerase proteins.
- The possible benefits of liver transplants in co-infected patients.
The risks in cases of HBV-HIV co-infection are similar -- cirrhosis, end-stage liver disease, and death -- and treatment goals are the suppression of viral replication and improvement in liver disease, Drs. Koziel and Peters said.
"Patients with HIV infection, if nonimmune, should be vaccinated against both hepatitis A virus (HAV) and HBV because of the increased severity of hepatitis in patients with preexisting liver disease. Failure to induce immunity to HAV and HBV is a function of both missed opportunities for vaccination and the immunocompromised state," they wrote.
"In HIV-infected persons, antibody titers after vaccination are lower and less durable than they are in those who do not have HIV infection, and fewer HIV-infected persons have protective levels of antibodies against hepatitis B surface antigen (HbsAg). The rates of response to HAV or HBV vaccines decrease with lower CD4 cell counts and higher levels of HIV RNA."
Long-term therapy of HBV infection is the rule, with nucleoside and nucleotide reverse transcriptase inhibitors, such as lamivudine (3TC) and telbivudine (Tyzeka). Pegylated interferon alfa is effective in mono-infection, but hasn't been tested in patients with both HBV and HIV.
Lamivudine shouldn't be used alone, because of high levels of resistance, approaching 20% to 25% in a year and 90% after four years of therapy, the researchers said.
In patients who need treatment for HBV but not HIV, it's important to choose medications without activity against HIV in order to avoid generating drug-resistant HIV strains.
(Researchers reported at this year's Conference on Retroviruses and Opportunistic Infections that entecavir (Baraclude) may cause HIV resistance when used in patients not being treated for HIV. CROI: HIV Resistance Linked to Hepatitis Drug)
One important area for future research is the long-term efficacy of combination regimens, the authors said, both in patients with HIV alone and HIV and HBV together.
This report was supported by the National Institutes of Health and the AIDS Clinical Trials Group. Dr. Koziel reports receiving consulting or lecture fees from Bristol-Myers Squibb, GlaxoSmithKline, and Valeant and grants from Bristol-Myers Squibb and Valeant. Dr. Peters reports receiving consulting or lecture fees from Gilead, Idenix, and F. Hoffmann-La Roche and grants from Achillion Pharmaceuticals. She has also served on an independent data monitoring committee for GlaxoSmithKline.
Primary source: New England Journal of Medicine
Source reference:
Koziel MJ and Peters MG. "Current Concepts: Viral Hepatitis in HIV Infection." N Engl J Med 2007;356:1445-54.
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Biologic Drug Approved to Prevent Hepatitis B in Liver Recipients
http://news.yahoo.com
FRIDAY, April 6 (HealthDay News) -- HepaGam B, a first-of-its-kind immune globulin product, has been approved by the U.S. Food and Drug Administration to prevent hepatitis B reinfection among people who have received liver transplants, the agency said Friday.
Immune-compromised liver transplant recipients who have already been exposed to hepatitis B are at increased risk of re-infection from the virus, which attacks the liver and can cause liver failure or liver cancer. HepaGam B, produced from human plasma, stimulates an immune response to the virus, the FDA said.
The product reduced the infection recurrence rate to about 13 percent from 86 percent among liver transplant recipients who participated in clinical trials, the agency said. Common adverse reactions included headache and high blood pressure.
HepaGam B was first FDA-approved in January 2006 to prevent hepatitis B infection acquired by sexual or contact exposure, and in unborn infants whose mothers had been exposed to the virus. The product is manufactured by Cangene Corp. of Winnipeg, Canada.
More information
This FDA page has more about the approval.
http://www.fda.gov/bbs/topics/NEWS
/2007/NEW01602.html
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