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Week Ending: June 16th , 2007
Alan Franciscus
Editor-in-Chief
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This Issue:
June 9th, 2007
Liver Op Ex-Junkie Runs for Ireland
http://www.redorbit.com/
By LYNN JOLLY
A FORMER addict who once popped 100 Valium pills a day is taking part in the World Transplant Games.
Dubliner John Edwards is recovering following a liver transplant after 24 years of abusing drugs.
He now runs two drug rehabilitation centres in Scotland with his wife Tricia and will be in the Ireland squad at the Bangkok event in August.
The 52-year-old Clontarf man said: "God is not finished with me yet. It was a close one this time though."
He was diagnosed with hepatitis C in 2005 and has cirrhosis and cancer of the liver.
John now hopes to raise enough cash to build a rehab unit for men in Ireland. He said: "I was taking 100 Valium a day, which is enough to kill an elephant.
"I started using drugs in the 60s. I used to inject very strong sleeping pills. When heroin came on the scene I got involved in that."
He is running the 400m, 800m and 1500m races, taking part in the four by 100m relay, doing a 5km road race and a 5km cycling time trial.
Irish squad manager Colin White said: "There is a squad of 28 and they are all recipients of kidneys, livers, hearts and pancreas."
To donate sponsorship, call 01 6205306 or email colin@ika.ie.
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Reminder, Health Canada: Courts Approve the Pre-1986/post-1990 Hepatitis C Settlement Agreement
http://new.marketwire.com
OTTAWA, ONTARIO--(Marketwire - June 9, 2007) - The Honourable Tony Clement, Minister of Health, welcomes today's court decisions that give approval to the Settlement Agreement for all those infected with hepatitis C from the blood system prior to January 1, 1986, and from July 1, 1990, to September 28, 1998. Canada's New Government has set aside approximately one billion dollars to compensate those infected during the July 1, 1990, to September 28, 1998 time frame.
The compensation fund will be administered by Crawford Class Actions Services, an independent third party at arm's length from the federal government that was selected by the courts. Crawford will provide reports on its activities to the federal government, class counsel and the courts. The Government of Canada does not have control over the timing of the remaining steps.
Class members should contact their class counsel for details of the agreement and the next steps in applying for compensation.
"Canada's New Government is extremely pleased by today's unanimous approval of the settlement agreement by the courts in four jurisdictions, confirming that the settlement agreement is fair and reasonable," Minister Clement said. "While no amount of money can fully compensate these victims for their pain and suffering, Canada's New Government has never wavered in its commitment to compensate all victims of tainted blood, no matter the date of infection."
"We know that people have waited long enough for a resolution to this matter. We trust that the fund administrator will move towards issuing the cheques in the near future," Minister Clement added.
In 1998, federal, territorial and provincial governments provided compensation to those infected with hepatitis C through the blood system between January 1, 1986, and July 1, 1990. Canada's New Government worked to reach a settlement agreement with class counsel that would provide compensation to those Canadians who were excluded from the previous compensation program. In taking these actions, the government was guided by the recommendations of the Krever Inquiry.
Prime Minister Stephen Harper announced July 25, 2006, that the federal government had successfully reached an agreement on the elements of a settlement. Since that announcement, Canada's New Government worked as quickly as possible to complete the detailed final agreement, which was sent to the courts for approval in December 2006.
The Agreement, which is without admission of legal liability on the part of the federal government, was completed with class counsel on December 15, 2006, and was subject to court approval in British Columbia, Alberta, Ontario and Quebec. The infrastructure required to receive and evaluate applications must now be set up.
The terms of the agreement govern the provision of compensation to those infected through Canada's blood supply prior to January 1, 1986, and from July 1, 1990 to September 28, 1998. It expands on the details already provided by Prime Minister Stephen Harper on July 25, 2006, and includes the benefit schedules that will be used to determine amounts that each individual will receive.
Egalement disponible en francais
Health Canada news releases are available on the Internet at www.healthcanada.gc.ca/media
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June 11th, 2007
Two-thirds of HIV-positive gay men with acute HCV achieve a good response to HCV therapy
www.adismap.com
Michael Carter
Treatment for acute hepatitis C virus infection achieved a sustained virological response in almost two-thirds of HIV-positive gay men, according to data presented to the Third International Workshop on HIV and Hepatitis Coinfection in Paris on June 7th.
Dr Sanjay Bhagani of London’s Royal Free Hospital, told delegates that 60% of patients with the ‘hard-to-treat’ hepatitis C genotype 1 achieved a sustained virological response. Patients whose baseline hepatitis C viralload was below 800,000 copies/ml and who had a rapid response (an undetectable hepatitis C viral load after four weeks of treatment) to therapy were most likely to experience successful treatment.
Outbreaks of hepatitis C have been reported amongst HIV-positive gay men in several European countries. It is thought that most of these men acquired the infection sexually. Because of increasing incidence of the infection in HIV-positive patients, and due to ongoing uncertainties about the best time to start hepatitis C therapy, and the duration of therapy, investigators in the UK, France and Germany formed a collaborative study in early 2007 to determine the risk factors, natural history and optimal treatment strategies for hepatitis C infection in HIV-positive individuals.
Preliminary retrospective data, collected from four treatment centres between 1999 and early 2006 were presented to the Paris workshop.
A total of 161 cases of acute hepatitis C were diagnosed in HIV-positive gay men at these centres. The average age was 38 years and sexual transmission was suspected in 88%, with 15% having a recent infection with syphilis. Most of the patients (93%) had their infection diagnosed due to abnormal liver function tests, but 17% were tested for hepatitis C infection because of the presence of symptoms.
Anti-hepatitis C therapy was initiated by 144 individuals and 131 completed this treatment. Data on these individuals were presented.
The majority of patients (70%) had the hard-to-treat genotype 1, with a further 10% having the equally difficult-to-treat genotype 4.
Potent anti-HIV therapy was being taken by 70% of patients, and immune function was well preserved in the study population, median CD4 cell count being 444 cells/mm3 and 80% of individuals had a viral load below 400 copies/ml. The initiation of anti-hepatitis C therapy caused a change of HIV therapy in 38% of patients.
Only 14% of patients took what is now considered to be the standard of care for coinfected patients (pegylated-interferon plus ribavirin). Treatment was started within twelve weeks of hepatitis C being diagnosed in 57% of patients.
A total of 16% of individuals stopped therapy within 20 weeks, mostly because of intolerable side-effects. Most individuals (51%) took between 20 – 28 weeks of anti-hepatitis C treatment with 33% taking over 28 weeks therapy. Most of the patients who received longer duration of treatment received their care at the Royal Free Hospital in London.
A sustained virological response was achieved by 64% of patients overall, and by 60% of patients with genotype 1, a result which Dr Bhagani found highly encouraging.
Unsurprisingly, infection with genotypes 2/3 was associated with a higher odds ratio of a sustained virological response, as was treatment with a combination of pegylated-interferon and ribavirin. An undetectable hepatitis C viral load at weeks four and twelve predicted a sustained treatment response. Patients whose baseline hepatitis C viral load was below 800,000 copies/ml were also more likely to have a successful response to treatment. Receiving less than 20 weeks of therapy predicted poorer treatment response.
A blood disorder related to hepatitis C therapy was observed in 10% of patients and 13% experienced depression, a recognised side-effect of pegylated-interferon.
Reference
Bhagani S et al. Treatment for acute hepatitis C (HCV) in HIV-positive men: a European Collaborative Study. Third International Workshop on HIV and Hepatitis Coinfection, abstract 27, Paris, 2007.
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I didn't make a penny from my Hollywood blockbuster
http://www.thisislondon.co.uk/
By Alison Roberts
Lisa Bryer, co-producer of the Bafta Award-winning The Last King of Scotland, is sitting in her office in her big house in Notting Hill drinking a large glass of very green cucumber and celery juice.
She has just returned from a health farm in Brazil called Body and Soul ("more of a boot camp really, with hiking and kayaking and eating lots of vegetables") and looks tanned and well in a kaftan and black slacks.
Indeed, at 49, she is feeling better than she has for some years. Not only has she finally recovered from the shattering exhaustion of filming Last King, in Uganda, she has also just finished a gruelling six-month treatment for Hepatitis C - a disease with which she was infected 25 years ago as a heroin addict.
Bryer's is an extraordinary journey - from eight years of heroin addiction to red carpet receptions and glittering premieres. The elder sister of TV presenter Tania Bryer, in the wake of Last King's worldwide success Lisa became one of the biggest names in British film; yet she has now decided to sell up her independent production company, Cowboy Films, give up work and concentrate instead on her family, City banker husband Eddie Villiers and her nine-year-old twin boys Jamie and Freddie.
She is also increasing the amount of time she devotes to the drugs charity Action on Addiction, of which she is trustee. "I'm incredibly lucky. I have the financial infrastructure to do this. I've worked all my life, I've travelled, and finally I've had this great success with Last King. In a way I'd be a complete schmuck not to give up."
Remarkably, Bryer has not yet made a single penny out of Last King - indeed, she has probably lost money - despite making the movie for less than £5 million and watching its box-office receipts top $40 million.
The story of how the film came to be made is complex. Cowboy Films optioned Giles Foden's book, and spent years developing it. The movie was co-financed by FilmFour and Lottery money was brought in by DNA, the production company owned by Andrew Macdonald, brother of the film's director, Kevin. DNA brought on board Fox Searchlight, with whom it has a deal, to distribute and market the film. But the deal Bryer signed with Fox Searchlight cut neither her nor co-producer Andrea Calderwood into a share of the profits.
Despite the movie's quality and success, her brush with Hollywood has left her deeply disillusioned; the "big machine" that is an American studio lacks "compassion" and can even be "exploitative". At times, flying back and forth from London to Uganda, where filming took place under extremely basic conditions and to a very tight schedule dictated by Fox, she wondered whether she could even go on.
"It did get to a very low point. I remember very vividly arriving in Entebbe on one occasion. I hate flying, absolutely hate it, and now of course I can't get drunk or take any pills. I got off a very bumpy overnight flight at about 5am and drove down this very dangerous road - the road that Idi Amin used to escape the country - to the film set.
"There was a nightshoot - we were filming day and night - and the director Kevin [Macdonald] was tearing his hair out because we could give him no more time or money, but at the same time he was behaving like a perfect gentleman and cutting scenes in his head.
"I was literally there for 24 hours on that occasion. I had to fly back on the 9am flight, and I remember thinking, I actually don't think I can continue with this. On one hand I'm trying to remain sane for my family and my boys, and I'm also trying to run a company with a multi-million-pound turnover. I can't give Kevin what he wants, which is more time, and I can't be a mum properly and what am I doing? I was stuffing my face full of chocolate and feeling physically awful and being even more grumpy and irritable than I normally am.
"It was very tough on the crew. They were filming 16-hour days and Kevin was pushing them to the absolute max. There were threats of mutiny, not because they didn't love Kevin or believe in the film, but because they were just so exhausted. There was malaria and dysentery. Our poor accountant is still suffering the affects of having full-blown malaria. They were hanging in rags."
Unbeknown to her, Bryer was also exhausted because of Hepatitis C. "I was starting to feel shattered, but I was leading a crazy, crazy life." She first discovered the presence of the disease 12 years ago, but was told by doctors that her liver was "OK" and that "the treatment was horrendous and not very successful anyway". Her health was closely monitored, and last year doctors finally advised that she take a six-month course of the powerful drug Interferon. The worst thing about it? "You inject yourself with it every week," she replies, grimacing at the irony.
Bryer is an undeniably successful woman, the kind of person who enters a room and turns heads by sheer force of personality. Yet you sense a trace of fragility beneath the warm confidence. She has never spoken publicly about her drug use before, and though she does so openly and frankly, at times the memories threaten to overwhelm her. She apologises as she trips over words, or, biting her lip, pauses to recompose herself.
She was brought up in Chelsea, the daughter, essentially, of refugees. Her father hauled himself out of poverty in South Africa by winning a Rhodes scholarship to Oxford and then becoming a research fellow at Harvard, and it was in Boston that he met her mother, whose family were Russian Jewish migrants.
Back in London they lived to work, and her father began a successful career as an NHS dentist with a thriving private practice, while her mother Joy, a respected figure in the arts world, founded the European Community Youth Orchestra. The Bryers owned a large house, with the family sandwiched between her father's surgery on the ground floor and her mother's offices at the top.
Yet Lisa, unlike her two sisters, was a very vulnerable little girl. "I had a very good schooling, lovely holidays and parents who loved me. But from a very early age, I just felt I wasn't good enough. I was incredibly insecure. I was the kind of child who walked into a room convinced you were going to hate me. I wouldn't even get to my desk and I'd failed the exam. I was petrified.
"Having two parents who were always working, who had very powerful, very active businesses, did not help at all. I grew up feeling that whatever I said was neither important nor good enough. It's DNA. Neither of my two sisters felt like this."
Her father always wanted his little girls to look pretty and feminine - and so Lisa rebelled by wearing black and getting into hardcore punk.
"I went from being this sweet pretty little girl to this monster with dyed-black hair." She did not pass a single exam and instead, on the night of her 18th birthday, moved out of the family home, taking a job at the Great American Disaster burger bar in Chelsea and a flat with a boyfriend.
Bryer swiftly discovered drugs, progressing from cannabis to heroin. "I discovered something that made me not feel. I loved that - finally I found my friend, my companion. It was addictive very quickly.
"I know it sounds completely mad, but I needed it to stay sane. I needed it to survive. I was in a place in my life where I felt I could never achieve and I didn't want to feel this self-hatred any longer, this inability to really enjoy life. What started off as rebellious fun - part of the whole punk scene - turned into something much sadder and darker."
By day she worked as a cashier at the bar, often pocketing confused customers' change, and by night she was injecting heroin and passing out. "I shouldn't really be here. I overdosed a few times and I was lucky enough to have someone with me on each occasion who got my heart started. You didn't call an ambulance in those days because the police came too."
But it was film-making that got her out. Desperate to help his floundering daughter, her father asked one of his patients, the director Tony Palmer, to find her a job on his new movie. As a result, in 1983 Lisa became a runner on the epic film Wagner, starring Richard Burton, Laurence Olivier, Ralph Richardson and John Gielgud. She was still using heroin, but for the first time she had found something that absorbed her totally.
"I was 25, and I loved every minute of that film, travelling all over Europe and finally realising that my life could be good. But I couldn't stay off the drugs. I guess I got to the point where I just thought once a junkie, always a junkie, and I'm going to die a junkie.
"Then I reached out to a friend of mine, someone I'd done a lot of using with. I bumped into him at a nightclub, and he looked incredibly well. He told me he'd been going to something called Narcotics Anonymous, and that he would take me to a meeting. I went along and just burst into tears. I thought: I'm in the right place. This is a room full of people like me - and they're getting better."
But she needed more than NA alone, and eventually discovered the UK's first residential rehab centre, a private facility called Broadway Lodge in Somerset. Bryer asked her father for the money, and to his credit, after understandable fury at her terrible confession, he gave it to her. She hasn't taken drugs, nor drunk alcohol, since.
Bryer still goes to NA, partly for her own sake and partly to help others beginning to tackle their addiction. She also works with addicts in Holloway Prison, whose desperate circumstances sadden her enormously.
"I always had this infrastructure of family and friends. But you go into Holloway and these girls - and they're very young - all come from abuse or foster care. They've all had babies kicked out of them, or been involved in prostitution - and they don't want to be like that. They don't have any hope, any infrastructure, any support."
Life improved day-by-day, she says. She was 35 when she met her husband, on a skiing holiday. Both huge football fans, she was wearing a Chelsea bobble hat and he the Arsenal version.
"I'd been told to take him and his friends out on the slopes because the people they were with weren't very good at skiing. I said fine, but if you're not there at 9am, I'm going without you, and we only stop for half an hour for lunch. So this poor man thought, who is this horrible grumpy woman I've got to ski with? But by lunchtime I was in love, for the first time ever in my life. Despite the Arsenal hat."
Today, she says, her life revolves around her twin boys, conceived by IVF and born when she was 40. Since selling her business - which, before Last King, primarily made adverts - Bryer has given up the nannies, the PA, the staff. "Motherhood is the greatest challenge I've ever had. I'm still very busy - I'm involved with several children's charities in Africa, too - but I'm here during the day for them. And I love it.
"The thing is, now that I'm a parent, I've also forgiven my parents a million times. Because now I realise how hard it is to do. The older I get, the younger and happier I feel. And that's because I know myself better. In the end, as much as I feel let down by the studio, I also feel that life's too short.
"It's important to say that they did give us the money to make the film, they did take a risk and when we delivered a great film, they did get behind it, and spent millions getting bums on seats. It was my decision to involve them and I knew that by doing that I wasn't making a good financial deal - but that they would make sure the world saw it. And the world has seen it. I think it's a really important film about a really important historical subject. And that, for me, is worth a lot more at the end of the day than just about anything else."
Is it a permanent retirement? She narrows her eyes and smiles. "I'm doing some advisory work. I'm keeping my hand in. Maybe one day." When she's mothered those boys to pieces, I wouldn't bet on Lisa Bryer not making another successful comeback.
• www.actiononaddiction.org.uk
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Low CD4 cell count, high HIV viral load are associated with occult HBV in HIV-positive patients
www.aidsmap.com
Michael Carter
Occult hepatitis B infection in HIV-positive individuals is associated with a low CD4 cell count and a high HIV viral load, according to Dutch data presented to the 3rd International Workshop on HIV and Hepatitis Coinfection in Paris on June 8th. The investigators in Utrecht also established that a prevalence of occult hepatitis B infection of 5% in HIV/hepatitis B coinfected individuals.
Occult, or hidden hepatitis B infection, is defined as the presence of hepatitis B’s DNA and core antibodies in plasma, but without hepatitis B surface antigen. Earlier studies have suggested that it is presented in between 0% and 89% of HIV/hepatitis B infected individuals, the large difference due to different testing techniques and study populations.
To try and establish a more reliable indication of the prevalence and risk factors of occult hepatitis B infection in HIV coinfected patients, investigators at the university of Utrecht conducted a retrospective study involving patients who received care between 1999 and 2006.
A total of 197 HIV/hepatitis B coinfected individuals were included, 32 of whom were also infected with hepatitis C virus. Median CD4 cell count was 317 cells/mm3 and median HIV viral load was 85,000 copies/ml.
Occult hepatitis B infection was diagnosed in nine individuals (5%). It has been suggested that infection with hepatitis C virus is associated with an increased risk of occult hepatitis B, but only one patient who had hepatitis C virus had occult hepatitis B.
Patients with occult hepatitis B infection had significantly lower CD4 cell counts (median 105 cells versus 323 cells/mm3, p = 0.01), and significantly higher HIV viral loads (median 5.5 log10 versus 4.9 log10, p = 0.019). The investigators suggest that these clinical characteristics suggest that occult hepatitis B could be considered an ‘opportunistic infection’ as it occurred in patients with immune deficiency.
None of the patients with occult infection were taking antiretroviral therapy at baseline. The initiation of anti-HIV therapy lead to a median increase of CD4 cell count to 300 cells/mm3 over three years and all the patients hepatitis B infection became well controlled, either because the patients were taking an antiretroviral drug with activity against hepatitis B (3TC, FTC, or tenofovir), or because of improving immune function.
Reference
Velemena M et al. Occult HBV in HIV infected individuals is related to low CD4 count and high plasma HIV load. Third International Workshop of HIV and Hepatitis Coinfection, Paris, abstract 32, 2007.
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Only 25% of HIV-positive patients with acute HCV accepting HCV therapy
www.aidsmap.com
Michael Carter
Only a quarter of HIV-positive individuals diagnosed with acute hepatitis C infection are accepting anti-hepatitis C therapy, according to data from one of the UK’s leading sexual health clinics presented to the Third International Workshop on HIV and Hepatitis Coinfection in Paris on June 7th. The investigators, from the Mortimer Market Centre at University College Hospital, London, also reported that they have detected cases of sexual transmission of hepatitis C infection in HIV-negative gay men. Doctors in Brighton reported seeing cases of the infection in HIV-negative gay men at a conference earlier this year.
Between 1999 and April 2006, a total of 108 acute hepatitis C infections had been diagnosed in HIV-positive gay men attending the Mortimer Market Clinic. Most of these infections (60%) were diagnosed due to abnormal liver function, but 28% were detected due to screening or contact tracing, and 12% because of the presence of symptoms.
Most men are thought to have acquired hepatitis C sexually. Only 8% reported a lifetime history of injecting drug use. 18% reported having a sexual partner who was infected with hepatitis C virus and 36% had been diagnosed with a sexually transmitted infection in the previous year. This compared to between 18 - 20% of HIV-positive men without hepatitis C seen at the clinic.
The men had a median age of 38 years, and had been diagnosed with HIV a median of four years previously. Hepatitis C was, however, diagnosed in 17% of men within a year of their HIV diagnosis and in 40% of men within five years after their HIV was first diagnosed.
The hardest of all hepatitis C genotypes – genotype 1 – was present in 69% of the men, with 19% having genotype 4 infection, which is also difficult to treat.
Hepatitis C infection cleared spontaneously in 10% of the men. However, rebound or reinfection occurred in six men.
Only 25 men, (24%) accepted anti-hepatitis C therapy and 60% of these achieved a sustained virological response. The investigators reported that many patients were declining treatment because they hoped better, more tolerable therapy would become available in the future. The best results were seen when, as per the guidelines of the British HIV Association, treatment with pegylated-interferon and ribavirin was used. Only 33% of patients who received pegylated-interferon alone achieved a sustained virological response.
Reference
Turner J et al. Acute hepatitis C: presentation and outcome of early treatment. Third International Workshop of HIV and Hepatitis Coinfection, Paris, abstract 26, 2007.
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Roche’s Hepatitis C drug patent challenged
http://www.business-standard.com/
P B Jayakumar / Mumbai
Swiss pharmaceutical major Hoffmann-La Roche’s patents rights over Hepatitis C drug Pegasys has been challenged by public interest groups at the Indian Patent Office.
This is the second post-grant opposition filed against Pegasys, after Wockhardt, a domestic drug firm, approached the patent office with a similar plea two months ago.
Pegasys was the first drug to receive patent production and subsequent market monopoly according to the changed patent law of 2005. Its patent is valid in India until May 16, 2017.
The public interest groups have said that patent protection and the resultant high price of the drug is making it unaffordable for an estimated 12.5 million Hepatitis C infected people in India. The groups also argued that the product was not an innovation and hence not eligible for patent protection.
Sankalp, a Mumbai-based non-governmental organisation that provides treatment and rehabilitation support to injecting drug users, backed by a group of NGOs led by Lawyers Collective, filed the opposition with the Patent Office on May 18, citing that Roche sells the drug at a price of Rs 2.25 lakh for a 6-month treatment course.
Absence of patent protection could help Indian pharmaceutical companies develop cheap reverse-engineered versions of Pegasys, it said.
Roche India said its parent company Roche was assessing the post-grant opposition filed by Sankalp and would reply to the Indian Patent Office within the stipulated time.
India amended the Patent Act in 2005 to bring in a new product patent regime, instead of the earlier process patents which legalised copying of drugs. By the new rules, generics drugs cannot be manufactured by changing the process and the product patent holder gets exclusive right to sell the product in the country.
Under the amended Indian Patent Act 2005, an application for a patent can be challenged within 12 months of publicising the application (pre-grant opposition) and after grant of the patent (post-grant opposition). The company has to respond to the challenge within a month.
Girish T Telang, managing director of Roche India, told Business Standard that the introduction of Pegasys has seen treatment costs for Hepatitis C patients drop to about one-third and the rate of cure has gone up to 80-95 per cent from 30-35 per cent earlier with normal interferons (a naturally occurring protein with antiviral effects).
“We also give Ribavirine (an anti-viral drug) free to patients as part of the total package. Pegasys is a technological advancement from Roche. The drug was launched in Switzerland in 2001, in US and Europe in 2002 and in the very next year, we made it available to Indian patients,” he said.
It is not fair to demand it should not be given patent protection in India,” Telang said.
Earlier, in a much-publicised similar case, multinational pharma major Novartis is fighting a case with the Indian Government for denying it exclusive rights to market its cancer drug Gleevec in the country.
A few months ago, Indian drug maker Cipla had filed a pre-grant opposition against granting of patent for Gilead Life Science’s Viread, an HIV/AIDS drug. The NGOs also had filed opposition to the Virea patent.
Sankalp alleges that Pegasys, a new-generation Hepatitis drug that helps to reduce the normal three injections per week to one injection per week, involves combining interferon with a structure called polyethelyene glycol (PEG) which helps the interferon to remain in the bloodstream.
The technology of combining interferon and other biologically active proteins with PEG had been known for years prior to this patent, the NGO says.
NGO sources said patent protection is only granted to inventions that are new and involve an inventive step. Under some legal provisions that are unique to Indian patent law, they said, “Roche’s ‘invention’ is at most a ‘mere admixture’ of known substances and thus unpatentable under section 3(e) of the Patents Act, and it is just a ‘new form of a known substance’ and not patentable under section 3(d) of the Act. The patent is an attempt to obtain a monopoly over technology that existed in the public domain,” they said.
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June 12th, 2007
Therapy slows hepatitis C in transplant recipients
http://www.reutershealth.com
NEW YORK (Reuters Health) - For liver transplant recipients who experience a recurrence of hepatitis C infection, antiviral therapy can slow the progression of liver fibrosis, according to the results of a study published in the medical journal Gastroenterology.
Hepatitis C virus infection is the most common cause of cirrhosis and liver cancer in the Western world and Japan, and hepatitis C-related liver disease is the most common reason for liver transplants, Dr. Xavier Forns, of the Hospital Clinic, in Barcelona, and colleagues explain. Unfortunately, the new livers also become infected "and chronic hepatitis and cirrhosis develop in a significant proportion of patients."
In their study, the researchers assessed the effect of antiviral therapy on disease progression in 81 hepatitis C-infected liver transplant recipients.
Liver fibrosis the scaring of the organ tissue, leading to the excessive accumulation of protein, including collagen, in response to liver disease, resulting in impaired liver function. Progression of fibrosis leads to cirrhosis, liver cancer and ultimately liver failure.
The 54 patients with a mild hepatitis C recurrence (fibrosis stage F0 to F2) were randomly assigned to 48 weeks of pegylated interferon alfa-2b and ribavirin, the standard treatment for hepatitis C infection, or to 48 weeks with no treatment.
All 27 patients with a severe hepatitis C recurrence (F3 to F4, cholestatic hepatitis) received standard treatment.
Liver biopsy was performed at the beginning and the end of the trial in all 81 patients.
Among the patients with a mild recurrence, a sustained response to treatment was achieved by 13 (48 percent) of the treated patients and in 5 (18.5 percent) of the untreated patients.
Liver fibrosis progressed by at least 1 stage in 19 untreated patients (70 percent) with mild disease, 7 treated patients (26 percent) with mild disease, and in 14 treated patients (54 percent) with severe disease.
Further analysis, accounting for other possible contributing factors, showed that treatment was the only variable that was independently associated with improvement or stabilization of fibrosis.
Adverse events were common during antiviral therapy, and severe adverse events occurred significantly more often in those with severe recurrences.
"These results suggest that treatment at early stages of hepatitis C recurrence is the best strategy to achieve a sustained virological response," Forns and colleagues conclude. "However, due to the high incidence of adverse events in this population, assessing the effect of treatment (and viral clearance) on disease progression is crucial."
SOURCE: Gastroenterology, May 2007.
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Valopicitabine Combined With Standard of Care Cleared Hepatitis C Virus in 72% of Patients Who Completed 12 Weeks of Treatment in a Phase II Trial
http://www.redorbit.com
CAMBRIDGE, Mass., June 12 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. today announced results from a phase II study designed to evaluate triple combination therapy, consisting of valopicitabine (NM283), Idenix's lead drug candidate for the treatment of hepatitis C, pegylated interferon and ribavirin compared to pegylated interferon and ribavirin, the current standard of care, in patients infected with the genotype-1 strain of the hepatitis C virus (HCV). This study demonstrated no pharmacokinetic or pharmacodynamic drug-drug interaction between valopicitabine and ribavirin. The triple combination showed consistently higher rates of HCV PCR-negativity, defined as serum HCV RNA levels below 20 copies/mL, compared to the standard of care at every point analyzed in this study. Additionally, the tolerability of the triple combination was satisfactory, with only three discontinuations from the study.
"I am very encouraged to observe this degree of viral clearance coupled with a very low rate of discontinuations in patients treated with the triple combination of valopicitabine, pegylated-interferon and ribavirin in this study," said Dr. Fred Poordad, Chief of Hepatology and Liver Transplantation, Cedars Sinai Medical Center, and an investigator in this study. "These data represent an important achievement in the development of novel HCV combination therapy."
Study Design and Results
The three-arm, partially blinded, randomized study enrolled 117 treatment- naive, HCV genotype-1 infected patients at approximately 20 centers in the United States. Patients in arm A (n=39) received 200 mg/day of valopicitabine and pegylated interferon alpha 2a; patients in arm B (n=39) received 200 mg/day of valopicitabine, weight-based dosing of ribavirin, and pegylated interferon alpha 2a; and patients in arm C (n=39) received placebo, weight- based dosing of ribavirin and pegylated interferon alpha 2a. For all patients in this study there was a seven day lead-in period, where patients received either valopicitabine or placebo alone; the additional components of each arm's therapeutic regimen were administered beginning on day eight.
The primary endpoint of the study was to assess pharmacokinetic and pharmacodynamic drug-drug interaction between valopicitabine and ribavirin after 36 days of treatment. Drug levels for both NM107 (the active form of valopicitabine) and ribavirin when administered alone or together were within the range of 80 to 125 percent, indicating the lack of an interaction. At day 36, 23 percent of patients treated with triple combination therapy (arm B) were HCV PCR-negative per protocol, compared to 11 percent of patients treated with the standard of care (arm C) and 14 percent of patients treated with valopicitabine and pegylated interferon (arm A). These findings demonstrated no pharmacokinetic or pharmacodynamic drug-drug interaction between valopicitabine and ribavirin.
The key secondary endpoints for the study were antiviral activity, safety and tolerability at 12 weeks. Of patients that completed 12 weeks of therapy, 72.2 percent of patients treated with triple combination therapy (arm B) achieved HCV PCR-negativity, compared to 61.5 percent of patients treated with the standard of care (arm C). There were three discontinuations from the study, all due to adverse events (AEs), one of which was attributed by the clinical investigator to valopicitabine-related gastrointestinal toxicity. The two other AEs, including a serious adverse event (SAE), were attributed by the clinical investigators to pegylated interferon or pegylated interferon/ribavirin. All of the discontinuations occurred in the triple combination arm (arm B).
At the end of 12 weeks, patients were permitted to roll over to pegylated interferon plus ribavirin for up to 48 weeks of total treatment; all eligible patients elected to do so.
"These results support our hypothesis that valopicitabine can be administered in combination with pegylated interferon and ribavirin," said Douglas Mayers, M.D., executive vice president and chief medical officer of Idenix Pharmaceuticals. "We are very pleased with the viral kinetics and HCV RNA clearance rates observed in patients treated with triple combination therapy in this study and look forward to further development of this combination."
About Valopicitabine
Valopicitabine is an investigational nucleoside polymerase inhibitor being evaluated in ongoing clinical trials for the treatment of hepatitis C. The most common adverse events reported in valopicitabine clinical trials to date include nausea, vomiting, fatigue, diarrhea, headache, flu-like symptoms and depression. Idenix is developing valopicitabine in collaboration with Novartis Pharma AG.
About Hepatitis C
HCV infection is the most common chronic blood-borne infection in the United States.(1) The Centers for Disease Control and Prevention estimates that 4 million Americans have been infected with HCV, and 2.7 million of these carry chronic HCV infections.(2) Hepatitis C-related liver failure is the most common indication for liver transplantation in the United States.(2) As the prevalence of severe liver disease attributable to hepatitis C rises, deaths due to complications from hepatitis C infection, currently 8,000 to 10,000 per year in the United States, are increasing and are expected to triple by 2010.(3)
Conference Call Information
Idenix will hold a conference call today at 8:30 a.m. EDT. To access the call please dial (800) 774-5358 U.S./Canada or (706) 758-9475 International and enter passcode 3143678 or to listen to a live webcast of the call, go to "Calendar of Events" in the Idenix Investor Center at http://www.idenix.com/. Please log in approximately 10 minutes before the call to ensure a timely connection. A replay of the conference call and webcast will be available until June 26, 2007. To access the replay, please dial (800) 642-1687 U.S./Canada or (706) 645-9291 International and enter the passcode 3143678.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and HIV. For further information about Idenix, please refer to http://www.idenix.com/ .
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward- looking statements can be identified by the use of forward-looking terminology such as "will," "can be," "expect," "anticipates," "advance," "significant achievement," "pending," "encouraging," "believe," or similar expressions and implied statements with respect to the regulatory success of valopicitabine or the Idenix clinical development program in hepatitis C, or any potential pipeline candidates and expectations with respect to the size of the market for Hepatitis C. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management's expectations could be affected by unexpected regulatory actions or delays; results of clinical trials, including additional data relating to the ongoing or future clinical trials evaluating its product candidates; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the company's dependence on its collaboration with Novartis Pharma AG; the ability of the company to attract and retain qualified personnel; competition in general; the company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries and the Company's ability to accurately assess the market. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" in the company's annual report on Form 10-K for the year ended December 31, 2006 and filed with the Securities and Exchange Commission, the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2007 and other filings that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company's expectations only as of the date of this release and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
(1) Center For Disease Control National Prevention Strategy.
(2) Center for Disease Control. Hepatitis C Fact Sheet accessed online at http://www.cdc.gov/ncidod/
diseases
/hepatitis/c/fact.htm.
(3) Davis, G. et al., Projecting Future Complications of Chronic Hepatitis C in the United States. Liver Transplantation, April 2003.
Idenix Pharmaceuticals' Contacts: Media: Teri Dahlman (617) 995-9905 Investors: Amy Sullivan (617) 995-9838
Idenix Pharmaceuticals, Inc.
CONTACT: Media, Teri Dahlman +1-617-995-9905, or Investors, AmySullivan, +1-617-995-9838, both of Idenix Pharmaceuticals, Inc.
Web site: http://www.idenix.com/
http://www.cdc.gov/ncidod/diseases/
hepatitis/c/fact.htm
Source: PRNewswire-FirstCall
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Prolonging hepatitis C therapy by an additional 20 weeks has few benefits
www.aidsmap.com
Michael Carter
Prolonging the duration of hepatitis C therapy in HIV-positive patients chronically coinfected with hepatitis C virus only has a long-term benefit for individuals infected with the easier-to-treat genotypes of hepatitis C, according to data presented to the Third International Workshop on HIV and Hepatitis Coinfection held in Paris last week.
HIV-positive individuals chronically coinfected with hepatitis C virus typically have a poor response to anti-hepatitis C therapy. Of the third or so of patients who do achieve a sustained virological response (an undetectable hepatitis C viral load six months after hepatitis C therapy has been completed) many experience a subsequent relapse of their hepatitis C infection. Some doctors have suggested that prolonging anti-hepatitis C therapy by up to six months may increase the chances of coinfected patients achieving a sustained response to their therapy.
Italian investigators therefore designed the ROMANCE study involving coinfected patients. All achieved an end of treatment response to hepatitis C therapy consisting of pegylated-interferon and doses of ribavirin adjusted by weight. The standard duration of treatment was initially provided: patients infected with the easier-to-treat hepatitis C genotypes 2 and 3 received 24 weeks of hepatitis C therapy, and those with genotypes 1 and 4, which are harder-to-treat, received 48 weeks treatment.
Patients were then randomised to either stop therapy (Arm A) or to receive an additional 20 weeks of anti-hepatitis C treatment (Arm B). The investigators then compared the proportion of patients who achieved a sustained virological response.
The study enrolled 123 patients between 2002 and 2004. Most of the patients (77%) were men, and 41% had advanced fibrosis.
Over a third (21 patients, 38%) of patients who received prolonged duration of therapy stopped treatment early, either because of side-effects or because they dropped out of the study.
Intent-to-treat analysis showed that continuing treatment conferred no additional benefit. There was no difference in the proportion of patients between Arm A and Arm B (60% versus 60%) who achieved a sustained virological response. As expected, significantly more patients with
genotypes 2 and 3 achieved a sustained treatment response than those with genotypes 1 and 4 (80% versus 64%).
The investigators then performed an on-treatment analysis which was restricted to the patients who completed treatment. This showed that 90% of patients with genotypes 2 and 3 achieved a sustained virological response compared to 60% of those with genotypes 1 and 4, a statistically significant difference (p = 0.04).
Factors significantly associated with an improved odds of a sustained virological response for patients with genotypes 2 and 3 were a higher hepatitis C viral load at baseline (above 600, 000 copies/ml, adjusted odds ratio, 0.15), and a rapid response to anti-hepatitis C therapy (undetectable viral load after four weeks, adjusted odds ratio, 1.08).
The investigators concluded that providing an additional 20 weeks of anti-hepatitis C therapy did not increase the chances of HIV-positive patients coinfected with hepatitis C virus genotypes 1 and 4 achieving a sustained virological response. Continuing treatment for an additional 20 weeks was beneficial for patients with genotypes 2 and 3, provided that they had a higher hepatitis C viral load at baseline, and an undetectable hepatitis C viral load after four weeks of treatment.
Reference
Puoti M et al. Results of randomised controlled trial on the impact of prolonged combination anti HCV treatment on relapse rate in HIV/HCV coinfected patients with HCV RNA negativization at the end of 24 - 48 weeks course of treatment: The ROMANCE study. Third International Workshop on HIV and Hepatitis Coinfection, abstract 1, Paris, 2007.
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June 13th, 2007
FDA warns DuPont about RelyOn claims
http://www.delawareonline.com
By LULADEY B. TADESSE, The News Journal
The U.S. Food and Drug Administration sent a warning letter to DuPont Co. for violating new drug provisions and "misbranding" its RelyOn antiseptic spray and hand wipes.
The FDA said the Wilmington-based chemical giant has insufficient evidence to support claims that its products prevent diseases including hepatitis A, B, and C, and HIV type 1.
"We are not aware of evidence that these products are safe and effective in preventing individuals from becoming infected with Hepatitis A, B, and C, HIV-1," said the FDA letter, dated May 7 and addressed to Charles O. Holliday, chairman and chief executive of DuPont.
The federal agency has ordered DuPont to investigate and determine the cause of the violations and prevent their recurrence, or face legal action.
The "FDA has taken the position that viral and fungal claims, however accurate, should not be on the label for over-the-counter antiseptic products," Stephanie Jacobson, spokeswoman for DuPont, said in a statement. "Given our interest in resolving this issue quickly, DuPont is working closely with the FDA to bring the subject labels in line with their expectations."
DuPont markets the RelyOn spray and hand wipes primarily to hospitals and other health care environments. The company sells other products under the same brand, including RelyOn disinfectant cleaner, to others, including the Newark Police Department.
According to DuPont's Web site, the department uses it to clean areas in holding cells, such as benches, toilets and sinks, in order to kill "germs of highest concern to officers including HIV, Hepatitis A, Hepatitis B, Hepatitis C."
Jacobson said the RelyOn surface disinfectants were not cited in the FDA's warning letter.
An FDA spokeswoman was unavailable for comment.
DuPont manufactures RelyOn products out of state, but distributes them from a center in the Wilmington area. RelyOn products are part of the company's safety and protection business, which last year generated sales of $5.49 billion.
"While we anticipate this to be a growth product for DuPont, the sales of the products affected by this action are significantly immaterial to our chemical business at this time," Jacobson said.
Contact Luladey B. Tadesse at 324-2789 or ltadesse@delawareonline.com.
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ViroPharma Announces Completion Of Enrollment In 500mg BID Arms Of HCV-796 Phase 2 Study
http://www.medicalnewstoday.com
ViroPharma Incorporated (Nasdaq: VPHM) today announced that patient enrollment has been completed in the 500mg BID arms of the ongoing Phase 2 study in hepatitis C patients with HCV-796, a unique orally dosed non nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV). The Phase 2 study is being conducted with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), ViroPharma's partner in development of HCV-796.
The companies expect to release four week treatment data from these arms in the third quarter of 2007, and 12 week treatment data in the fourth quarter of 2007. The companies are performing certain Phase 3 preparatory work at risk to allow initiation of the Phase 3 program as soon as possible.
"We are extremely pleased with our HCV-796 Phase 1b data, as well as the progress and interest in the program overall; our goal remains to be the 'first in class' among non nucleoside polymerase inhibitors, a class of compounds which we believe will play a significant role in future antiviral combination therapies for patients with hepatitis C," commented Stephen Villano, ViroPharma's vice president of clinical research and development. "Our Phase 1b data have helped elucidate the tolerability profile of HCV-796 and the strong antiviral activity of the drug in combination with pegylated interferon. We believe that, thus far, HCV-796 continues to be well- positioned for inclusion in future combination trials to assess improvement in the lives of those afflicted with hepatitis C and increased cure rates in these patients."
The objectives of this Phase 2 trial are to assess the safety, tolerability, pharmacokinetic profile, and antiviral activity of HCV-796, when used in combination with pegylated interferon alfa-2b (PEG-Intron(R)) plus ribavirin (REBETOL(R)) compared to the current standard of care in treatment- naive subjects with HCV genotype 1 infection and in patients with HCV genotype 1 infection who were null-responders (who have failed to achieve a 2 log reduction in viral titer) following prior interferon based HCV therapy. The companies intend to add additional treatment cohorts to the trial to further elaborate antiviral activity.
Phase 2 Design
The Phase 2 study is a randomized, open-label study of the safety, tolerability, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with pegylated interferon plus ribavirin versus pegylated interferon plus ribavirin (standard of care) in HCV genotype 1-infected subjects who are naive to treatment. The combination of HCV-796, pegylated interferon and ribavirin is also being assessed in a group of HCV genotype 1 patients who have previously failed treatment (null-responders). All dose cohorts will be treated for up to 48 weeks with combination therapy, and will be followed for a further 24-week period.
Patients have been enrolled into 3 dosing groups of at least 74 patients per group: (1) treatment naive patients receiving PEG-Intron and ribavirin (control therapy); (2) treatment naive patients receiving PEG-Intron, ribavirin, and 500 mg of HCV-796 every 12 hours; and (3) null-responders receiving PEG-Intron, ribavirin, and 500 mg of HCV-796 every 12 hours.
Outcomes assessed in the treatment groups will include:
- Antiviral activity and percentage of subjects with undetectable plasma HCV RNA levels at weeks 4, 12, 24, and 48;
- Percentage of subjects with sustained virologic response (SVR), defined as undetectable (less than 10 IU/mL, as measured by the Roche COBAS TaqMan(R) assay) plasma HCV RNA levels at 24 weeks after the end of treatment.
About Hepatitis C
Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.
Currently, there is no specific antiviral agent directed against HCV that is commercially available, and no vaccine for prevention of HCV infection. Several interferon products are available worldwide, but there are substantial limitations to the use of these products when given as monotherapy or in conjunction with ribavirin in the treatment of chronic HCV infection. In addition to the relatively poor treatment response in patients infected with genotype 1 HCV, the most common strain in the U.S., Western Europe and Japan, the considerable side effects frequently associated with the use of interferon can lead to discontinuation of therapy in approximately 20 percent of patients.
About ViroPharma Incorporated
ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic- associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs
/Vancocin_pi_2007.htm ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at http://www.viropharma.com.
Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties including those relating to the company's progress of its HCV clinical development program as well as its proposed timelines for release of clinical trial data, initiation of a Phase 3 program, and the Company's belief that HCV-796 continues to be well-positioned for inclusion in future combination trials to assess improvement in the lives of those inflicted with hepatitis C and increased cure rates in these patients. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. Conducting clinical trials for investigational pharmaceutical products is subject to risks and uncertainties. The data that is described in this press release is preliminary and full analysis of the data, or further testing such as the ongoing Phase 2 clinical studies of HCV-796 with pegylated interferon, may not support any or all of the statements in this press release. There can be no assurance that ViroPharma's additional HCV studies will yield positive results, that the FDA or other regulatory authorities will require additional or unanticipated studies or clinical trial outcomes before granting regulatory approval, or that ViroPharma will be successful in gaining regulatory approval of any of its HCV product candidates. These factors, and other factors, including, but not limited to those described in ViroPharma's quarterly report on Form 10-Q for the quarter ended March 31, 2007 filed with the Securities and Exchange Commission, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
PEG-Intron and REBETOL are registered trademarks of Schering-Plough Corporation.
ViroPharma Incorporated
http://www.viropharma.com
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Blood shortages increase danger for women in childbirth: WHO
http://news.yahoo.com
GENEVA (AFP) - More than a quarter of the 500,000 women in the world who die during childbirth suffer fatal bleeding, the UN health agency said Wednesday, urging countries to take steps to secure blood supplies.
Pregnant mothers in poor countries suffer the most from severe bleeding during or after childbirth, which accounts for 34 percent of maternal mortality in Africa, 31 percent in Asia and 21 percent in Latin America and the Caribbean, the World Health Organisation said.
Postpartum bleeding is unpredictable and can kill even a healthy woman within two hours, the WHO warned.
When they do receive blood, pregnant women in developing nations risk being exposed to contaminated or infected supplies, and risk contracting HIV/AIDS and Hepatitis B and C.
Twenty-eight of the 40 countries in sub-Saharan Africa still have inadequate national systems of checks on blood quality, according to the agency.
Poor nations are struggling to find blood donors. Only 45 percent of the global blood supply is collected in developing countries, which are home to more than 80 percent of the worlds population, according to new WHO data.
"Adequate stocks of safe blood can only be assured by regular donation by voluntary unpaid blood donors," the WHO said in a statement to mark World Blood Donor Day on Thursday.
However, developing nations have a relatively low proportion of voluntary unpaid donors, 67 percent compared with 92 percent in wealthy nations, despite major strides in some countries in recent years.
The WHO underlined that blood borne infections are the lowest among voluntary donors, while higher rates are found among family members who donate in an emergency.
But the worst rates of infection and potentially the most risky donors are those who do so for money, it added.
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June 14th, 2007
Lord 'horrified' by blood disaster
http://www.channel4.com
Source: PA News
A former Conservative Social Services Secretary said he was "horrified" to discover after leaving his department how widespread the blood disaster which saw thousands exposed to HIV and Hepatitis C was.
The Rt Hon Lord Jenkin of Roding, who was Secretary of State for Social Services between 1979 and 1981, also said it had later been made clear to him that files relating to contaminated blood products had been destroyed as a "conscious decision".
The independent inquiry into how people were exposed to HIV and Hepatitis C during NHS treatment in the 1980s continues in central London.
More than 2,000 haemophiliacs died as a result of exposure to the viruses in what fertility expert Lord Winston dubbed "the worst treatment disaster in the history of the NHS".
Long after leaving Government, he said he was "quite horrified" to find out how widespread the contamination was, particularly the emergence of Hepatitis C as a "serious scourge".
He said he felt a duty to try to get hold of official papers to help sufferers. But his attempts to retrieve them he said were "chequered". He told the hearing that it was made clear to him that files relating to contaminated blood products had been destroyed as it was thought they would be of no further use. "They had settled the HIV cases and it had not been thought necessary to keep the files," he said. But it was subsequently said that the destruction was an "error", he said, adding that he could not reconcile this with what he had initially been told.
Haemophilia is usually an inherited disorder in which the blood does not clot properly. In the 1970s a new method for producing clotting factors was discovered which used plasma donations from thousands of donors. If one had a blood-borne virus, the whole batch would be contaminated.
America also supplied blood to the UK at this time and it is claimed suppliers paid what became known as "skid row" donors - people thought to have been more likely to have HIV and Hepatitis C.
Lord Jenkin was aware that the service was not self-sufficient and products had been brought in from other sources, which he assumed were reliable. He said he did not know if others in the department knew what the sources were.
Claims have been made that the Department of Health has obstructed the inquiry by refusing to release key documents containing information on how patients were infected. But documents thought to have been missing have subsequently been identified.
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Maxygen Up on Praise for Drug Candidates
http://biz.yahoo.com
Cowen Analyst Starts Maxygen at 'Outperform' Based on Protein Therapy Candidates
NEW YORK (AP) -- Maxygen Inc. shares rose Thursday after a Cowen & Co. analyst praised the company's drug candidates and initiated coverage with an "Outperform" rating.
Analyst Eric Schmidt said Maygen's stock price will rise as those candidates approach late-stage clinical trials. He singled out three of the company's protein therapeutics, Maxy-G34, Maxy-alpha and Maxy-VII, which he said could all reach large markets.
MaxyG-34 treats neutropenia, a blood disorder in which the body does not make enough bacteria-fighting white blood cells. Schmidt said the drug is low risk, and offers major rewards. The company expects to start mid-stage trials soon.
Maxy-alpha is a treatment for hepatitis B and C currently in early-stage testing. Maxy-VII is designed to promote blood clotting, and the company says it is evaluating how to develop the drug after Roche Group ended an agreement to help develop and sell it.
The stock gained 32 cents, or 3.7 percent, to $8.89 in afternoon trading
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Out of the Gate: Genelabs Surges
http://biz.yahoo.com
Analyst Sees Genelabs Technologies Shares Tripling on Strength of Hepatitis C Candidates
NEW YORK (AP) -- Shares of Genelabs Technologies Inc. jumped in Thursday morning trading after an analyst began covering the biopharmaceutical company with a "Buy" rating, predicting the stock price will triple over the next 12 months.
The company has two oral hepatitis C treatments in preclinical testing, and Kevin DeGeeter of Oppenheimer & Co. was optimistic about both candidates. He believes both drugs will begin early stage testing within a year.
"Each of these drugs appears to be far more potent than competing products in late-stage clinical development and, in our view, have the potential to be best-in-class drugs," he said. "If Genelabs can successfully move one or two of these novel targets into clinical trials, we believe the company may be a compelling takeover candidate."
The Redwood City, Calif.-based company is developing one of the drugs with Gilead Sciences Inc., and the other with Novartis AG. Genelabs' pipeline also includes a lupus treatment, Prestara, and a hepatitis E vaccine.
DeGeeter said shares will rise to $6 over the next year, tripling Wednesday's closing price of $2.
The stock gained 29 cents, or 14.5 percent, to $2.29.
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Criminal Trial Nears Close In Tainted Blood Case
http://www.allheadlinenews.com
Valerie Chang - AHN News Writer
Toronto, ON (AHN) - The Crown is expected to present closing arguments Thursday in the trial in which doctors and a pharmaceutical company stand accused of criminal negligence causing bodily harm. The case involves a tainted blood scandal that left thousands of persons infected with HIV and hepatitis C in Canada.
The events that gave rise to this case have long been referred to in the media as a "public health disaster."
Armour Pharmaceutical Company, along with Michael Rodell, who was Armour's Vice President of Scientific and Medical Affairs, Donald Boucher and John Furesz, who were with the Bureau of Biologics, and Roger Perrault, who was director of the Canadian Red Cross, have been tried for their respective roles in allowing infected blood products to be used in transfusions in the 1980s and 1990s.
After receiving infected blood products, roughly 1,250 persons contracted HIV and over 20,000 persons contracted hepatitis C.
Among other things, Armour and the individual doctors are alleged to have failed to properly screen blood donors and properly test blood.
In other charges brought as a result of the scandal, the Canadian Red Cross previously entered a guilty plea to a charge of violating the law by distributing an adulterated or contaminated drug and paid a fine of $5,000.
The federal and provincial governments in Canada have paid vast sums of cash to persons who contracted HIV and hepatitis C from the tainted blood products. In 1989, the government appropriated $150 million to compensate persons who contracted HIV, and in 1998, federal and provincial governments appropriated over $1 billion to compensate persons who contracted hepatitis C. The compensation for hepatitis C, however, was limited to persons who contracted the illness between 1986 and 1990. As a result, the Ontario government provided another $200 million for persons who contracted hepatitis C earlier than 1986 and later than 1990.
A verdict is anticipated in the criminal trial late this summer.
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Hep Team SF rolls out vaccine program
http://www.ebar.com
by Raymond J. Aguilera
The San Francisco Department of Public Health and local community health organizations last week rolled out a new program to encourage men who have sex with men to get vaccinated against hepatitis A and B.
Dubbed "Hep Team SF," the program's street-team style advertising and mobile services are expected to help the estimated 50 percent of gay and bisexual men who are not protected against hepatitis A and B get vaccinated.
Hep Team SF is a collaboration between the health department; Magnet, the gay men's center in the Castro; and the Asian Pacific Islander Wellness Center. Funding for outreach workers is being provided by GlaxoSmithKline. A spokesman for the company did not return a call seeking information about the grant, and a health department spokeswoman was unsure of the amount. The actual costs to the health department are for the vaccines themselves.
At a news conference June 5, Health Director Dr. Mitch Katz, said, "We have a lost generation of adults who are susceptible. Those at highest risk for both hepatitis A and hepatitis B are men who have sex with men."
Hepatitis A is transmitted via human feces, and can spread by sexual contact, as well as through contaminated food. Symptoms can last for several months and people can experience serious liver diseases. Hepatitis B can become a chronic, lifelong disease increasing an individual's risk of liver problems, including cancer. Hepatitis B is also 100 times more contagious than HIV, and is transmitted via bodily fluids, including blood, semen, and saliva. Chronic carriers can continue to be infectious to others. Hepatitis C is not vaccine preventable.
Complications of hepatitis A and B can include nausea, abdominal pain, fatigue, and both can potentially lead to liver failure and death. Both hepatitis A and B are preventable with a vaccine series.
There are individual vaccines for both hepatitis A (two shots over a six to 12-month or six to 18-month period) and hepatitis B (three shots over a six-month period), but the simplest is a combination vaccine against both strains administered as a three-shot series over a six-month period. In order to ensure long-term protection, a full series of vaccinations is required, but health officials noted that it's never too late to complete the series once it has begun.
"Getting vaccinated is an easy way for gay and bisexual men to take care of their health and the health of their partners," said Steve Gibson, director of Magnet.
In order to encourage gay and bisexual men to get vaccinated, Hep Team SF will be out in force at street fairs, bars, and clubs throughout the summer and fall educating people about the risks of hepatitis and offering free and low-cost vaccinations.
Health officials said that free vaccines will be offered at Pride, Up Your Alley, Folsom Street Fair and the Castro Street Fair. Low-cost vaccines will be offered at clinics throughout the city this summer. Information and locations for vaccinations are available at the Hep Team SF Web site: www.HepTeamSF.com.
Lance Toma, executive director of the API Wellness Center, called the program "a testament to the vision of health and wellness of all San Franciscans." The program encourages people with insurance and a regular healthcare provider to get the vaccine from their doctors, but Hep Team SF will be at the summer street fairs.
The Hep Team program is being launched in San Francisco after successful test runs in several other large cities. The program started in Chicago in 2005, and in 2006 expanded to Los Angeles, New York, and Atlanta. Last year, more than 2,000 doses of vaccine were administered through Hep Team projects across the country. The programs also created increased awareness of the risk of hepatitis and intent to get vaccinated in those communities.
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June 15th, 2007
Hepatitis C Cases Linked To NYC Doctor
http://www.ny1.com
The Health Department is reaching out to some 4,600 former patients of a local doctor who may have infected at least three of his patients with Hepatitis C between December 2003 and last month.
Health officials are investigating how the disease got transmitted, but what they do know is that the three sick patients were treated by the doctor in August 2006 at any one of the ten clinics where he worked.
"We don't know exactly what went wrong, but we do know it happened during intravenous anesthesia,” said Dr. Marci Layton of the DOH. “That's the reason we made the decision while the investigation is continuing to notify everyone else who may have received anesthesia from this physician."
Health officials are urging the doctor's other patients to get tested for Hepatitis C, a disease which can cause liver damage.
"If you got a letter, there's very detailed information about what needs to be done,” said Dr. Marci Latyon of the Department of Health. “You can discuss it with your physician. We've made one of the Health Department clinics available for testing."
The doctor worked out of 10 outpatient locations in Manhattan.
Officials say people who do not receive a letter are not at risk and stress the spread of HIV through anesthesia is not common.
“I can't emphasize enough that anesthesia almost always is a safe procedure. Most physicians practice very good infection control to prevent this, so if you did not get a letter from the health department you do not need to worry,” says Layton.
But for those who were under the care of the doctor, getting tested is key because there may be no symptoms initially though some infected people may experience flu-like symptoms, including yellowing of the skin and eyes and pale stools and urine.
The health department won't say whether the doctor has Hepatitis C, but he is not working during while the investigation is going on.
The DOH says they will follow up if the letters they send are returned or there is any other problem.
They say they are confident in their list and believe the clinics records are well kept.
The names of the doctor and hospitals involved are not being released.
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