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Week Ending: August 11th , 2007
Alan Franciscus
Editor-in-Chief
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This Issue:
August 4th, 2007
Charity's ploy 'horrifying'
http://www.thestar.com
David Bruser
Staff Reporter
Organ Donation's pitch is emotional but only 10% goes to transplant research
Give $150 to save the life of a Canadian needing an organ transplant.
That's the message being aggressively telemarketed to millions of homes nationwide by a Toronto-based charity called the Organ Donation and Transplant Association of Canada.
Tens of thousands of Canadians moved by the emotional pitch have pledged their hard-earned money. "It's about saving a life," the telemarketer says, promising donations will "go towards providing a much needed organ to someone who desperately needs it."
The problem is, the donations do not save lives. Of the roughly $4 million the charity has told the federal Charities Directorate it raised in the last three years, the majority was spent on telemarketing, office expenses and other unknown items. Only $410,000 (about 10 per cent) has gone to transplant research. There are no doctors, organ donors or transplant recipients on the charity's board of directors.
Much of the money raised is paid to Xentel, an international Calgary-based company that has been criticized by provincial and state regulators for misleading donors when telemarketing for other charities.
'There's so much that has to be done with such few resources that you can't do everything perfectly' --GABRIEL ETELE, Organ Donation and Transplant Association
The suggestion that donating money will fund surgery – when, in fact, transplants are paid for by Canada's public health care system – is misleading and amounts to emotional blackmail, says Debbie Bielech, who eight years ago donated part of her liver to her son Matt.
"They tried to sell me on the fact that they have saved thousands of children's lives across Canada. I know that's not a fact," she said. "Financially, it's got nothing to do with them. Everything is covered by the government."
Bielech says she has received three telemarketing calls at her Richmond, B.C., home in the past two years. One in particular, still rankles.
"(The caller) went on to tell me: `Did you know children can only receive children's organs?' Which was really a wrong comment to say to me. I'm a donor to my son, so I'm pretty knowledgeable."
Organ Donation is run by Gabriel Etele, a professional fundraiser. His past includes a personal bankruptcy in 1998. From an apartment in Toronto, Etele – who refers to himself as "Dr." because he earned a PhD in communications from an online school called Honolulu University – launched Organ Donation in 2004.
When presented with the Star's findings, Etele said he will continue fundraising, but make the telemarketing script more accurate. "It's not an excuse, but there's so much that has to be done with such few resources that you can't do everything perfectly," Etele said.
Etele also said his goal is to save lives, and the money donors have given to research helps. But he says his young charity needs to spend money to raise money so he can do good, charitable works.
Neither Etele nor Xentel would say exactly how much is spent on fundraising.
Etele received charitable status from the federal government based on claims he would create a "national volunteer health charity" dedicated "solely to organ and tissue donation and transplant."
Instead, Etele hired paid fundraisers, effectively outsourcing the normally painstaking work of building a charitable support base to a for-profit, publicly traded telemarketing firm, Xentel DM.
Xentel carries a reputation in North America for aggressive pitches. In Alberta, the provincial government ordered the company in December to stop misleading and dishonest telemarketing done in the name of social services and slain RCMP officers. (Xentel has pledged to remind its employees of the company's "honest representations" policies.)
South of the border, state agencies have several times taken issue with Xentel's American operation for misleading telemarketing. For example, Xentel Inc. was fined $100,000 last year and is banned from calling any South Carolinians on behalf of both a police and a firefighter charity after state regulators alleged misrepresentation of how donations would be spent. Xentel spokesperson Len Wolstenholme said his company prefers to avoid costly U.S. legal battles and when necessary settles the case, admits no guilt and pays a fine.
Wolstenholme added that for nearly 30 years his company has "assisted a great many organizations and a great many Canadians link up with one another" and that all calls are recorded so that complaints can be investigated.
Etele had help starting Organ Donation from Craig Copland, now a director of Xentel. Copland says there is no conflict because he resigned from the charity before joining the company. Meanwhile, Copland's daughter, Charis, sits on the charity's board. Copland said he has helped many charities. He earns an annual royalty (he won't say how much) from Xentel for helping add Organ Donation to the company's huge client roster.
The application Copland and Etele made to the federal Charities Directorate reveals a long list of lofty but unrealized goals:
A network of volunteer chapters across Canada. Office space. Strong relationships with other, more established agencies operating in this field, such as The Kidney Foundation. A medical review committee to disburse grant money.
The Star found that apart from the paid telemarketers and a website that gives little insight into the charity's purported good works, the organization has no public face. It does not even have an office.
The website, www.organdonations.ca, also piggybacks on the legacy of Olympic gold medalist swimmer Victor Davis to give the appearance the charity is at the forefront of organ donation awareness. In 1989, Davis died when struck by a car that fled the scene. As he wished, his organs were donated so others could live.
The charity never asked for, nor was given, permission from the Davis family, said Victor's father, Mel.
"This is crap," says Mel, 70, from his home in Guelph. "I'm certainly ticked off. There's no doubt they should have got permission from me. I've never heard of them."
Etele says he got permission from CBC to promote an upcoming movie on the famous swimmer but he says he will contact Mel Davis to get his approval.
Several outraged medical experts and organ donors say the charity has tried to solicit money from them by making untrue claims.
Upon learning what the Star found, the head of the Canadian Society of Transplantation, Dr. James Shapiro, feels what Organ Donation is doing is "sick" and "horrifying" and he believes it may be pushing Canadians away from becoming organ donors.
Complaints from the public have surfaced across Canada.
One kidney transplant doctor, Lee Ann Tibbles of Calgary, says she receives calls from the charity about every three months and has personally heard more than eight untrue or groundless claims.
Tibbles says she was told the money donated to Organ Donation saves thousands of lives, pays for medicine that is not covered by provincial health care plans, led to the development of a national transplant list for all organs, and paid for research that led to "organ budding" that she says is "pure science fiction." Tibbles has complained to the Charities Directorate but received no replies.
Etele's charity says it wants to encourage Canadians to donate their organs and get them to sign donor cards to be kept in a wallet or purse. But an Ontario panel of experts recently found that donor cards are largely useless in Ontario and several other provinces because doctors turn to the families of a potential organ donor, not a wallet card. Etele says his charity encourages potential organ donors to inform their families about their decision.
Copies of the telemarketing "pitches" obtained by the Star show no education is provided to donors, though there is a brief mention of donor cards. The pitches start out with a request for $150. If the person does not say yes, they lower the amount several times, finally ending with $15, saying that's what seniors and students donate.
At one point, the telemarketer says that if everyone gave $50, it would "help end the pain for those waiting for a transplant and their families as well."
Xentel's Wolstenholme says pitches are the responsibility of the charity.
With the help of Xentel, the charity boasts it has contacted more than five million Canadian households, sent out more than 300,000 donor cards, and collected donations from 80,000-plus people.
Shapiro, of Edmonton, says the numbers are "astounding," and wishes the organization of medical professionals that he leads had that kind of reach. "A donation to their organization would have no impact whatsoever on organ donation activities, as far as I can see," he said.
Organ Donation, in its annual returns to the federal Charities Directorate, is calling some of its fundraising expenses "charitable" works. It's a practice the Star exposed while investigating another charity, Mothers Against Drunk Driving, and that the Canada Revenue Agency says is not allowed. However, Etele said his method of accounting falls in line with federal charity rules.
That Organ Donation uses this kind of accounting puzzles even John Totten, an acquaintance of Etele and a transplant recipient who helped the charity by telling his story on its website.
"It sounds to me like a strange practice, there's no doubt about that," said Totten. "How does the federal government allow that to happen?"
Meanwhile, Copland and Etele helped set up a similar charity, Organ Donation and Transplant Association of America, in Florida. The charity, which also uses Xentel, is run out of a condo in North Palm Beach that belongs to an American associate who also runs the Children's Leukemia Research Association. That charity also uses Xentel and reports that it took in $1.65 million in donations in 2005, but $1.29 million stayed with Xentel.
(Etele and Copland say they are no longer involved with the American organ donation charity.)
Jim Mitchell, who volunteers in Durham Region to raise awareness about organ donation, doesn't understand how a charity can direct so little back into the community it pumps for money.
"You take something out of the community, hey, you put something back," says Mitchell, who speaks to church groups, mans booths in malls and attend picnics to spread his message. "Volunteers don't work for money."
Good works?
In its reports to Canada's charity regulator, the Organ Donation and Transplant Association has bolstered its good works by taking credit for $5.4 million of non-transplant-related medical supplies shipped overseas. The actual cost to the charity was only $50,000 and another charity assembled the goods.
Organ Donation's Gabriel Etele said the supplies helped people in Jamaica, Malawi, Ecuador and other countries, and it helped satisfy a Canadian requirement that charities spend most of their resources on good works.
Meeting the requirement is difficult for charities that have high fundraising and administration costs. Adding the big foreign expenditure helps, Etele said.
"The board felt it was a very good thing to do," Etele said. "For every dollar, you're getting 100 times the value in terms of helping people as a humanitarian act."
One document lists intravenous poles, hospital mattresses, and hospital pyjamas, among other medical items. In 2005, the goods were assembled by Universal Aide Society, a charity based out of Gabriola, B.C. Etele said Organ Donation paid the $25,000 shipping costs because Universal Aide could not afford to. He then recorded $2.3 million worth of charitable expenditures. Other foreign transactions brought the total value of foreign charitable expenditures since Organ Donation started in 2004 to $5.4 million and a total shipping cost of only $50,000.
The charity makes no mention of these good works in its telemarketing script or on its website.
David Bruser can be reached at 416-869-4282, or dbruser@thestar.ca.
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Hepatitis C rampant in region’s jails
http://thechronicleherald.ca
By JOHN GILLIS Health Reporter
Nearly one-third of federal prison inmates in Atlantic Canada have hepatitis C, prompting officials to hire a hepatologist to manage their care.
Documents from Correctional Service Canada say about 29 per cent of inmates in this region are known to be infected with the hepatitis C virus, which can lead to chronic liver infection, cirrhosis and even liver failure.
That rate compares to 0.31 per cent of the Nova Scotia population who were infected with hepatitis C between 1997 and 2006, according to the provincial Health Promotion and Protection Department.
Dr. Kevork Peltekian, who works in the gastroenterology division at the Queen Elizabeth II Health Sciences Centre in Halifax, is listed as the proposed hepatologist who may manage the care of federal prison inmates.
He would provide care to inmates at Atlantic Institution in Renous, N.B., Westmoreland Institution, Dorchester Penitentiary and Shepody Healing Centre in Dorchester, N.B., and Springhill Institution in Springhill.
The contract calls for him to provide up to 15 in-person, video or telephone consultations per month of at least six hours each, working with offenders and assisting and training prison staff.
The contract is worth $427,500 for one year, plus four option years.
Neither Dr. Peltekian nor officials from Correctional Service Canada could be reached on Friday.
People concerned with the spread of infectious diseases in prisons say the move is a good one but not enough is being done to address the problem.
"It’s a welcome initiative," said Richard Pearshouse, senior policy analyst with the Canadian HIV/AIDS Legal Network in Toronto. "I think as well as the concern for treatment and medical care of people who are already infected, we should also be encouraging (Correctional Service Canada) to look to the prevention of hepatitis C and HIV as well."
Earlier this week, studies published in the Canadian Medical Association Journal found the prevalence of HIV and hepatitis C infection among inmates in Ontario remand facilities and Quebec provincial prisons was many times that of the general population.
Correctional Service Canada has said the sharing of needles for drug use and unsafe tattooing practices are the primary means of transmission inside prisons.
A commentary accompanying the journal articles condemns correctional and government officials for failing to take measures that would reduce the chance of transmitting the viruses.
Last year, Public Safety Minister Stockwell Day axed a year-old program that offered prisoners tattoos with sterile equipment for a nominal fee.
The federal government has also failed to implement any kind of needle-exchange program for imprisoned drug users, despite being advised by an expert committee in 1994 that such measures would inevitably be needed to control the spread of viruses in prisons. The commentary by Richard Elliott, deputy director of the Canadian HIV/AIDS Legal Network, calls this a "deadly disregard" for prisoners’ health, noting Correctional Service Canada itself found the cost of the tattoo program was low related to the costs of caring for prisoners with HIV or hepatitis C.
It costs $29,000 a year to treat a prisoner with HIV and $26,000 to treat a prisoner with hepatitis C.
Mr. Pearshouse said the failure to support ways to prevent disease transmission seems to reflect a sense of denial about drug use in prisons by administrators and politicians.
"We are labouring under the misconception that it’s possible to prevent drugs from entering prisons, where we know from studies within Canada and also international studies that drug use is very prevalent inside correctional facilities," he said.
"Because of a misguided zero-tolerance approach to drug use inside prisons, we’re not looking out for the health of those prisoners."
He said people who are incarcerated do not give up their right to good health.
Mr. Elliott’s commentary suggests the lack of preventative programs could form the basis for legal action.
"If the political will cannot be mustered to implement evidence-based measures to protect the health of those in the state’s custody, it may be time to put the evidence of this ongoing denial of human rights before the courts."
(jgillis@herald.ca )
“We are labouring under the misconception that it’s possible to prevent drugs from entering prisons, where we know from studies . . . that drug use is very prevalent inside correctional facilities.” – richard pearshouseHIV/AIDS Legal Network
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August 5th, 2007
Beating a stigma and staying alive
http://www.theherald.co.uk
GINNY CLARK
Helen Croly is battling to change the way other people view hepatitis C.
I was thinking about coming off drugs when they told me that I had hepatitis C. So I thought, what's the point? If the drugs don't kill me, this will."
Six years ago Helen Croly, then an injecting drug user, was lying in a hospital bed awaiting treatment for an abscess on her leg when she was told the result of a routine blood test. As many people still believe, she thought it was a death sentence. She was wrong.
Around 22,000 people in Scotland have been diagnosed with hepatitis C, and 55,000 more are estimated to have the virus but have never been tested and simply don't know. Now, with the Scottish Executive's initial two-year action plan on hepatitis C underway, the twin focus is on improving local community-based treatment, care and support services for those who have been diagnosed, and on trying to raise awareness and encourage more people to come forward for testing.
One of the problems is that there are so many myths surrounding hepatitis C, including a certain stigma, with many people believing, incorrectly, that it is a drug-users' problem only.
"There is still so much misunderstanding about how it can be caught and how it affects people," says Louise Chisholm, manager of C-Level, the Glasgow-based charity working with people at risk of, infected by or affected by hepatitis C, in addition to the professionals operating with these groups. "Hepatitis C can be very serious and may lead to liver failure, yet most people with it can still lead long and healthy lives."
One-fifth of the people who catch the virus will also become clear of it without any treatment, while at least half the others can be cured with the combined approach of weekly injections of interferon and twice-daily doses of Ribavirin tablets. This happens over varying periods from three months to a year, depending on which type of hepatitis C has been diagnosed. Overall, however, eating properly, avoiding alcohol and staying active are vital to keeping healthy.
Helen's problems began with the premature death of her partner in 1996. The loss of the father to her two young children, aged four and seven months at the time, understandably hit her hard.
"I felt I couldn't cope," she says. "I felt I was left on my own." She fell into drug use, her children were taken into foster care, and by the time she was given the hepatitis C diagnosis, she was at rock bottom. With support and advice, however, she not only came off drugs but began the process of changing her lifestyle to improve her general wellbeing.
"I had to stay positive for my children - and I got there eventually, as I've been clean for five years," she says. "The virus had started to affect my spleen and my gall bladder, and I had no energy and constantly felt run-down. But once I started getting my appetite back and eating properly, things began to improve.
"Although I have type one of the virus, I'm not undergoing the treatment. I attend hospital regularly for liver function tests and right now everything is fine."
The great news for Helen - now 20 weeks pregnant and, together with her two other children, excitedly looking forward to this addition to the family - is that everything is progressing well. "I have to take iron, as mine is a bit low, and I inject heparin daily to prevent blood clots, but I've had the detailed scan and everything is great," she explains. "There is a five per cent risk of transferring the virus during the birthing process, but otherwise it's all about looking after myself properly. "I used to be so ignorant about the virus, but now that I know more about it, I can look forward to the future."
Helen's experience has proved valuable in helping others to come to terms with the diagnosis, and she works with C-Level as a volunteer peer educator at residential and community rehabilitation units, at GP methadone clinics and with community addiction teams.
Alex McGuire, another former addict, is now a board member on C-Level. However, since beating drugs five years ago, he's gone on to achieve a degree in arts and social sciences. He graduated last year, two years after his hepatitis C diagnosis.
"I got it through years of drug and alcohol abuse," he says. "I started on alcohol very early and turned to intravenous drug use in 1982, when I was 23. At that time there were no needle exchanges. We used the same needles, cleaned to our best ability, but passed about. I'm very fortunate that hepatitis C is all I got."
After 20 years, and going into rehabilitation, Alex was eventually clean. "Drugs had beaten me into the ground and I'd had every door shut in my face," he says. "But rehab gave structure to my life. Getting off drugs is relatively easy. Staying off them is the challenge.
"While I was at university I was doing some community work and a mate found out that he had the virus, so I thought I'd get tested too. I'd had a test about four years before, but I never got the results. It was just denial - thinking no news is good news. So when I found out after this test that I had hepatitis C, I was completely shattered.
"I was advised to go to C-level and I found out what a fantastic service they provide, including talking to people before they undergo the test, helping to explain away some of their fears. Previously, the only information I had was from other people at Narcotics Anonymous, but C-level blew away all the myths."
With type three, Alex was put on a six-month course of treatment. "The treatment can affect people in different ways, and it hit me hard after about three months," he says. "It was affecting my behaviour and I was snapping at people. After some discussion, I stopped taking it. When my blood was tested again, the virus was non-detectable.
"I don't really feel like I've got it. As long as I'm living well, that's fine. If I was taking drugs or alcohol or not eating properly, it would kick in and inflame my liver."
Now Alex is continuing to help C-Level, doing voluntary work, learning sign language - and helping to bust those myths.
"It's put down as a drug addict's disease, but anybody can catch it. I heard of a woman who got it from wearing her daughter's earrings."
For one 50-year-old mother and grandmother, who prefers to remain anonymous, it was a series of transfusions given to her after childbirth, from 1977 to 1981, that gave her hepatitis C. It was in 1992, when she herself was donating blood, that the virus was diagnosed.
"I didn't feel unwell; I felt perfectly normal," she says. "It was a terrible shock. In the middle of 1993 I had the first lot of treatment, and the interferon injections were at the test stage at that time. It didn't work. My liver is tested every six months and it was a case of waiting for new treatments. Just now I'm halfway through a year's treatment of interferon and ribavirin. I've had some mild depression and fatigue but it's actually OK. Even if it doesn't work completely, it will hold the virus back - give my body a rest.
"Considering the length of time I've had it, I don't feel ill. I'm slowing down a bit, and maybe a bit more forgetful, but that could just be getting older.
"I did feel angry when I was diagnosed, and I also felt guilty and worried about my children. But they all know about it and they haven't been affected.
"I did receive a compensation payment of £20,000. I was lucky in that I had written proof of my transfusions. Some people who were infected that way don't have the paperwork as not all records were kept.
"But I do feel the strain of keeping it all inside. The stigma isn't so bad now, but a lot of people still don't understand."
The biggest worry for her, however, concerns the background to her diagnosis. "I had been giving blood twice a year for six months before they found out. Who might I have given it to?"
The Facts About Hepatitis C
- Hepatitis C is a blood-borne virus, passed by blood-to-bloodstream contact. Sharing needles or other paraphernalia for drug use currently represents the highest risk.
- However, this doesn't mean only injecting drug users get hepatitis C. Anyone can catch the virus from another infected person by sharing toothbrushes or razors, through unsterilised tattooing or piercing equipment, unsterile medical equipment (perhaps in an underdeveloped country) or from blood transfusions in the UK before 1991.
- Sexual transmission can happen - but, again, only via blood-to-blood contact. This risk is increased by having any other sexually transmitted disease (STD), anal sex or multiple partners. Transmission between monogamous hetero-sexual partners is rare.
- There are six different types of hepatitis C - genotypes. Genotypes one, two and three are most common in the UK. Any genotype can cause liver disease, but although genotype one takes longer to treat than two and three (one year as opposed to six months) and also has a lower success rate for treatment, it will not make the patient more ill than the other types.
- For every 100 people who catch hepatitis C, 20 will clear the virus within six months of being exposed, 60 will remain chronically infected but may not develop any serious symptoms, and 20 will begin to develop serious liver disease within 20 years.
August 6th, 2007
IAS: Atazanavir safe and effective in HCV-coinfected patients with cirrhosis
http://www.aidsmap.com
Michael Carter, Monday
The protease inhibitor, atazanavir (Reyataz) is safe and effective in HIV-positive patients with liver cirrhosis, according to a retrospective Spanish study presented as a poster to the recent International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Sydney.
The investigators, from the Hospital Ramon y Cajal in Madrid, found that patients with cirrhosis who received atazanavir had both an immunological and virological response to the drug, but did not experience any clinically significant liver-related side-effects.
Large numbers of HIV-positive patients are coinfected with either hepatitis B virus and/or hepatitis C virus, and liver-related causes of death, often caused by hepatitis coinfections, are an increasingly important cause of mortality amongst HIV-infected individuals.
There are, however, limited data about the safety and effectiveness of antiretroviral drugs in patients with advanced liver disease. This is because studies into the safety and efficacy of drugs normally exclude patients with cirrhosis.
Although patients coinfected with hepatitis C virus who received atazanavir in clinical trials showed no evidence of significant liver-related toxicity, there are no data about the safety of the drug in patients with advanced liver disease. Atazanavir therapy is associated with a yellowing of the skin in some patients as the drug can increase levels of bilirubin. Although this is not medically dangerous, some patients find it distressing and stigmatising.
Accordingly, investigators in Madrid undertook a single-site study to assess the immunological and virological efficacy of atazanavir with or without ritonavir boosting in patients with compensated or decompensated cirrhosis. They all examined ALT and bilirubin levels to see if the drug in its boosted or unboosted forms was associated with any significant liver-related side-effects.
The study involved patients who received treatment between June 2003 and April 2007. Follow-up data for one year were analysed. A total of 34 individuals were included in the study. All were coinfected with hepatitis C virus, seven had decompensated cirrhosis and 27 had compensated cirrhosis.
The majority of patients were male, injecting drug users, and had extensive prior experience of antiretroviral therapy. Mean CD4 cell count before the initiation of atazanavir therapy was 214 cells/mm3 amongst patients with decompensated cirrhosis and 325 cells/mm3 with compensated cirrhosis. Approximately 40% of patients had an undetectable viral load.
Ritonavir-boosted atazanavir was taken by 71% of patients with decompensated cirrhosis and by 78% of those with compensated cirrhosis. Anti-hepatitis C treatment was taken at the same time as atazanavir-containing HIV therapy by 14% of those with decompensated cirrhosis and 59% of those with compensated cirrhosis.
At baseline, 71% of those with decompensated cirrhosis had significantly elevated ALTs (above 40 IU/ml), as did 90% of those with compensated cirrhosis. Total bilirubin above 1.2mg/dl was present at baseline in 57% of those with decompensated cirrhosis and 59% of those with compensated cirrhosis.
After a year of treatment with boosted or unboosted atazanavir the number of patients with decompensated cirrhosis with a viral load below 50 copies/ml increased to 80%, and all patients with compensated cirrhosis achieving this outcome (p = 0.006). Median CD4 cell count increased to a median of 450 cells/mm3 amongst patients with decompensated cirrhosis and to a median of 220 cells/mm3 amongst those with compensated cirrhosis. These increases were statistically significant (p = 0.04).
There were no significant changes in either ALT levels or bilirubin amongst patients with decompensated cirrhosis. Amongst patients with compensated cirrhosis, ALT levels did not change significantly, but mean bilirubin increased from a baseline of 1.7mg/dl to a mean of 2.4mg/ml, a statistically significant change (p = 0.035).
“In this retrospective cohort of patients with either compensated or decompensated liver cirrhosis, atazanavir boosted or unboosted has been safe and well tolerated”, comment the investigators, who add, “the efficacy of atazanavir in cirrhotic patients is high, even in this highly pre-treated group of patients.”
Reference
Hermida JM et al. Efficacy and safety of atazanavir in HIV-infected patients with liver cirrhosis. Fourth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, abstract MOPEB060, Sydney, 2007.
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August 7th, 2007
Peregrine Pharma Says Its Bavituximab HCV Phase Ib Study Results Selected For Oral Presentation - Quick Facts
http://www.tradingmarkets.com
(RTTNews) - Peregrine Pharmaceuticals Inc. on Tuesday revealed the selection of final data from its Phase Ib study of bavituximab in patients with chronic hepatitis C viral or HCV infection for an oral presentation at The Liver Meeting 2007.
The company said it believes that bavituximab represents a unique approach with significant clinical promise for treating chronic hepatitis C virus infections.
Bavituximab is the first investigational agent in a new class of anti-phosphotidylserine monoclonal antibodies that targets and binds to cellular components that are normally not present on the outside of cells, but that become exposed on certain virally infected cells and on the surface of enveloped viruses.
Bavituximab was well tolerated and showed encouraging signs of antiviral activity in Phase la and Phase lb trials in patients with chronic hepatitis C viral infection, the company said.
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Houston Doctor Sentenced to Prison for Fraud
http://www.myfoxhouston.com
HOUSTON -- The U.S. Department of Justice announced Aug. 6 that a Houston doctor who specialized in treating Hepatitis C patients has been sentenced to prison on numerous counts of fraud.
A federal jury found Dr. Ira Klein guilty of 18 counts of mail fraud and 26 counts of health care fraud in Nov. 2006. The counts were related to a scheme that would defraud various insurance companies of more than $10 million.
U.S. Distrct Judge David Hittner sentenced the 61-year-old Klein to a 135 month prison term followed by a three-year term of supervised release. Klein must also pay back more than $11 million dollars of restitution.
At an Aug. 6 hearing, the federal court found that Klein obstructed justice by allegedly conspiring with three other jailhouse inmates to arrange the murder of the Assistant United States Attorney prosecuting the case, a Federal Bureau of Investigation Special Agent investigating the case and his own wife.
According to the U.S. Department of Justice, Klein met with someone to discuss payment for arranging the killing of his wife and the FBI agent then sent $250,000 to the individual by wire transfer.
The arrangement and wire transfer was actually conducted with an undercover federal agent.
Judge Hittner also said at the hearing that Klein faces an indictment of arson in a murder attempt against his wife in Florida along with possible federal charges for trying to arrange the murders of the federal agent and the Assistant U.S. Attorney.
Klein was indicted on fraud in Feb. 2006 for billing insurance companies for services he did not provide to his Hepatitis C patients. The scheme Klein was indicted on involved ordering large quantities of medications used to treat Hepatitis C and providing medications to patients to administer to themselves at home while billing insurance companies as if the injections had been administered by him or his staff in his office.
Most of the claims Klein had filed for services provided were based on dates when patients were not treated at his office. Several former patients testified that Klein refused treatment when insurance companies stopped paying the exorbitant fees he would charge.
Representatives from the Texas State Board of Medical Examiners and the Texas Board of Pharmacy testified Klein violated board rules and state law by acting as a pharmacy and ordering large quantities of prescription drugs that were available by prescription from a pharmacy.
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Calderdale liver disease warning
http://www.halifaxcourier.co.uk
Sarah Kelly
A FATAL liver disease is attacking hundreds of Calderdale people – but many do not even realise they have it.
That's the warning from Calder Valley MP Chris McCafferty who says up to 600 residents are suspected to be carrying Hepatitis C, but only one in 10 know about their condition.
"It is vital that these people are diagnosed so they can undergo treatment before it is too late," she said.
"There is a scandalous lack of public awareness about the disease, even amongst some doctors and nurses.
"Treatments are more effective if they are started during early stages of the infection so it is vital that people who have been at risk get tested."
Hepatitis C is a blood-borne virus which attacks the liver. It can lead to fatal liver disease and liver cancer.
Mrs McCafferty is joining the Hepatitis C Trust in calling new health minister Alan Johnson to take action to tackle the condition.
She wants a mass campaign to raise awareness of the disease and encourage people at risk of infection to get tested.
"I am already actively involved in backing calls for extra help for people with hepatitis C, and I am a patron of the Peacock Project – a local help group for people with hepatitis B and C.
"Now I have joined up with the Hepatitis C Trust to demand that the Government takes action now to increase public awareness of the disease to ensure that more people in Calder Valley get tested and treated."
Earlier this year the Courier reported health experts' warning that hepatitis C was a "hidden health timebomb" that could explode in Calderdale.
It highlighted the work of the Peacock Project – a support group for hepatitis sufferers in Calderdale and Kirklees – which is looking to expand its service and raise more awareness of the condition.
For more information about joining or supporting the Peacock Project, call its support and development worker Amanda Kent on 01422 348777.
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Investigational Antitumor Agent Nolatrexed Fails in Phase III Study of Liver Cancer
http://www.medscape.com
NEW YORK (Reuters Health) Aug 01 - Nolatrexed (Eximias Pharmaceutical Corp.) showed "minimal activity" for the treatment of unresectable hepatocellular carcinoma (HCC) in an international phase III trial, researchers report in the July 20th issue of the Journal of Clinical Oncology.
Dr. Robert G. Gish of the California Pacific Medical Center in San Francisco and colleagues compared nolatrexed, a novel thymidylate synthase inhibitor, with doxorubicin in 445 patients with unresectable HCC. In the absence of an approved treatment, doxorubicin is frequently used as first-line therapy.
Nolatrexed is unlike other thymidylate synthase inhibitors, such as fluorouracil, because it does not require active uptake into cells, the researchers note.
Patients had Karnofsky scores of 60% or greater, Cancer of the Liver Italian Program scores of 3 or less and adequate organ function.
After nearly 5 years, 377 patients had died. Median overall survival was 22.3 weeks for nolatrexed and 32.3 weeks with doxorubicin, with a hazard ratio of 0.753 in favor of doxorubicin.
The objective response rate, which consisted of partial responders plus complete responders, was 1.4% for nolatrexed and 4.0% for doxorubicin.
Median progression-free survival was 12 weeks for nolatrexed and 10 weeks for doxorubicin. Median time to treatment failure was 8.4 weeks for nolatrexed and 9.1 weeks for doxorubicin.
Grade 3 and 4 stomatitis, vomiting, diarrhea and thrombocytopenia were more common in nolatrexed-treated patients. Alopecia was more common with doxorubicin. Treatment discontinuation rates were higher with nolatrexed than doxorubicin.
"The extended survival in the doxorubicin arm was unexpected, based on the information available at the time of the origination of the phase III trial," Dr. Gish and colleagues write. "To our knowledge, this is the largest randomized controlled trial utilizing doxorubicin as a control arm ... for the treatment of unresectable HCC with chemotherapy."
The team concludes, "Nolatrexed should not be tested again in this disease at this dose and schedule. However, nolatrexed does have high bioavailability, has the potential to be effective in other tumors, and may have potential in pancreatic or head and neck cancer based on phase II data."
On the other hand, "The survival rates demonstrated in the doxorubicin-treated patients are of interest and could support further licensing trials that may lead to the approval by regulatory authorities as a primary treatment of HCC," the investigators propose.
J Clin Oncol 2007;25:3069-3075.
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August 8th, 2007
'We must do more to reduce death toll from disease'
http://www.newhamrecorder.co.uk
THOUSANDS of deaths among ethnic communities from hepatitis B could be prevented with better education and removing the stigma attached to the disease, according to experts.
At particular risk is the ethnic population in places like Newham. Many may have been born outside the UK in areas where prevalence of the disease is especially high. They are also more likely to visit friends and relatives living in these high-prevalence regions.
Ways of limiting the spread of the disease, as well as treatment for those affected, was discussed at a meeting involving representatives from London's ethnic communities, medical experts and the media.
The event was organised by the B Aware Campaign to explore ways of containing the spread of the virus among high-risk populations.
Hepatitis B is a very infectious disease and a serious public health problem. The virus can be transmitted from mother to child during, or soon after, birth or through direct contact with the blood or body fluids of someone who is infected.
The disease is 50 to 100 times more infectious than HIV. The earlier in life a person becomes infected with the hepatitis B virus the greater the likelihood of long-term chronic infection and its complications.
Penny Webb, co-ordinator of the Hepatitis B Foundation UK, said: "Here in London we have thousands of people born abroad who don't realise they have the ticking time bomb of liver cancer inside them because they haven't been tested for hepatitis B."
Of London's 7.1 million population, 40 per cent were from ethnic communities, according to figures from the 2001 census. This figure is thought to have increased substantially in the last few years with immigration from Eastern Europe.
Among the 40 per cent, the rate of chronic hepatitis B infection is two per cent.
In Newham the number of confirmed new cases were three in 2005, eight in 2006 and four from January to July this year.
Newham Primary Care Trust has systems in place for testing the population in general and checking high-risk groups.
All pregnant women who book for antenatal care in the borough are tested for the disease. If they are found to be positive they will be treated and, once their babies are born, the infants will be vaccinated against the disease. The partners of the women will also be followed up and treated and/or offered vaccination.
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New Test Improves Detection Of Liver Cancer
http://www.sciencedaily.com
Science Daily — Cancer of the liver is very difficult to detect, and it is a major cause of death in Asia and Africa, with rising incidence in Western countries as well.
Now, VIB researchers connected to Ghent University, in collaboration with research centers in Beijing and Shanghai in China, have developed a test to detect liver cancer in an early stage. A small blood sample is the only requirement for the test. The new test enables accurate detection of liver cancer in over 50% of the cases for which previous diagnostic tests have not been able to provide a definitive answer.
Liver cancer
Hepatocellular carcinoma (HCC) is the most prevalent primary liver cancer. The disease most often appears following a chronic inflammation of the liver as a consequence of a hepatitis B or C virus infection or cirrhosis of the liver. Cirrhosis of the liver comprises a group of liver diseases in which the normal liver cells become damaged and are replaced by scar tissue.
This reduces the amount of healthy liver tissue, and the accumulation of scar tissue disrupts the development and functioning of this complex organ. Cirrhosis of the liver has various causes, including: excessive use of alcohol, chronic viral hepatitis B, C and D infections, diseases of the bile ducts, and parasitic infections.
Half a million patients die every year in China because of cirrhosis of the liver or liver cancer. 60% to 80% of the patients with liver cancer have a previous history of cirrhosis of the liver. In Belgium as well, 350 new cases of liver cancer occur each year. Transplantation often offers the only possible remedy. Detection methods that would detect HCC in an early stage would save many lives.
Current detection methods
Methods of detecting malignant growths are often based on the concentration of particular substances -- called 'markers' -- present in the blood. For the detection of HCC, only one marker (AFP) is generally used. However, this marker has a low specificity and is frequently inadequate because of false-positive results.
New blood test
A new test for detecting HCC was developed by Xue-en Liu, Liesbeth Desmyter and colleagues under the supervision of Cuiying Chen (Chitty) in collaboration with scientists in China. This test is based on previous work of Prof. em. Roland Contreras and Nico Callewaert.
By examining blood concentrations in Chinese patients with cirrhosis of the liver due to a hepatitis B virus infection, they found that the quantities of two particular sugar groups that appear on the blood proteins varied according to the stage of the disease. Furthermore, these values correlated with the size of the tumor. The ratio of these values forms the basis of the new blood test. The researchers were able to make the correct diagnosis in 70% of the cases a success rate that equals that of the AFP tumor marker currently being used in the clinic.
Promising results
When the AFP test is used in combination with the new test, the accuracy of HCC diagnosis rises dramatically. The new test succeeds in detecting liver cancer in more than half of the patients with cirrhosis of the liver for which the AFP test provides no answer. This test would allow frequent and non-invasive analyses to be carried out on cirrhosis patients, which would enable scientists to detect liver cancer in an earlier stage and to closely monitor the development of the disease.
At the moment, the researchers are working on implementing this test for the diagnosis of liver disease in compliance with clinical practice. The new results concerning HCC diagnosis provide an extra incentive for pursuing this development as intensively as possible.
Funding
This research has been funded by BOF, FWO, UGent and VIB.
Note: This story has been adapted from a news release issued by VIB, Flanders Interuniversity Institute of Biotechnology.
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August 9th, 2007
AVI drops hepatitis C trial to focus on Neugene
http://www.pharmaceutical-business-review.com
By Sarah Routledge
AVI BioPharma is discontinuing its planned dose-escalating hepatitis C trial and focusing on advancing its Neugene candidates targeting cardiovascular and genetic diseases in a strategic shake-up of the company's pipeline.
AVI BioPharma also said that it would be optimizing compounds targeting infectious diseases, and testing new technologies that leverage the Neugene antisense platform, such as exon-skipping pre-RNA interference technology (ESPRIT).
Advertisement"As announced in May, we have evaluated the many potential treatment applications made possible by the versatility of Neugene antisense and will focus our internal resources on those that offer what we believe to be the most viable near-term market opportunities," said K Michael Forrest, interim CEO of AVI.
"We continue to be impressed with the progress of our partner, Global Therapeutics (a Cook Medical company), in developing Neugene compounds targeting restenosis. We also expect to advance our own clinical programs in the months ahead, including the ongoing Neugene trial in coronary artery bypass graft surgery and a new trial using our Esprit technology in Duchenne muscular dystrophy."
As part of the pipeline refocusing, AVI is discontinuing its planned dose-escalating hepatitis C (HCV) trial using AVI-4065. Instead, AVI researchers will apply recent innovations to HCV compounds with the goal of improving the delivery to targeted cells, increasing potency and lowering overall dosage requirements, potentially resulting in a more commercially viable product.
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August 10th, 2007
Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
http://pharmalive.com
- Early Antiviral Activity with HCV-796 Supports Follow-up with Standard of Care Including Evaluation of Sustained Virologic Response (SVR) -
EXTON, Pa., Aug. 10 /PRNewswire-FirstCall/ -- ViroPharma Incorporated announced today the decision made with Wyeth Pharmaceuticals, a division of Wyeth , to discontinue dosing with HCV-796 in combination with pegylated interferon and ribavirin in its current Phase 2 study. All subjects, following consultation with the principal investigators at each site, will have the option of continuing on the combination therapy of pegylated interferon and ribavirin, the standard of care. This decision follows yesterday's review by the joint safety review board of safety data accumulated to date, which show elevated liver enzyme levels in some patients after 8 weeks or more of therapy with HCV-796 with pegylated interferon and ribavirin.
The companies conducted a thorough safety review of liver enzyme levels in all patients. Clinically significant elevations of liver enzymes were observed in approximately eight percent of patients receiving HCV-796, including two patients who experienced serious adverse events leading to withdrawal from active therapy with HCV-796, pegylated interferon and ribavirin. In contrast, elevated liver enzymes were seen in only one percent of patients on standard of care. Elevations of liver enzymes appear to be transient in some patients. The U.S. Food and Drug Administration has been notified that all patients on triple therapy will now be maintained on only pegylated interferon and ribavirin for the remainder of the clinical study.
"While substantial efforts are ongoing to continue analysis of these data, we consider it to be in the best interests of patients to discontinue dosing with HCV-796 at this time," commented Dr. Colin Broom, ViroPharma's chief scientific officer. "We and Wyeth are focused on patient safety. We are acting quickly and with the best interests of patients in mind. "
"This is a clear disappointment in light of the exciting antiviral activity observed to date in this study. Although this represents a potential setback for hepatitis C patients, we are committed to the health and safety of patients, and this decision was absolutely the right thing to do," commented Michel de Rosen, ViroPharma's president and chief executive officer. "We are committed to understanding the observations that led to this decision in the hope of advancing this potential therapeutic agent in the future."
Clinical trial investigators are being notified of the current data and the change in clinical plans. ViroPharma and Wyeth will continue to analyze the efficacy and safety data from this ongoing study in order to make a benefit risk assessment for the future development of HCV-796.
Phase 2 Preliminary Antiviral Data
All patients currently in the study have received at least 8 weeks of dosing. We have not completed a full analysis of all data, including discontinuations and withdrawals. Preliminary analysis of antiviral data has been performed on patients who have completed 4 weeks and a portion of patients who have completed 12 weeks of therapy. Not all patients who have completed 12 weeks of therapy have data available at this time.
The above data are based on 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 was also assessed in a group of HCV genotype 1 patients who had previously failed treatment (null-responders). The number of subjects enrolled and dosed in each of the three treatment groups ranged from 78 to 84.
Individual subjects in all dose cohorts will continue to be eligible for treatment for up to 48 weeks with standard of care, provided that, sufficient antiviral responses are observed at interim time points (12 and 24 weeks of treatment). Subjects will continue to be followed for an additional 24-week period to assess sustained virological response (SVR).
Conference Call and Webcast
ViroPharma is hosting a live teleconference and webcast with senior management to discuss these matters on August 10, 2007, 2007 at 10:00 a.m. Eastern Time. To participate in the conference call, please dial (877) 366-0713 (domestic) and (302) 607-2000 (international). After placing the call, please tell the operator you wish to join the ViroPharma investor conference call.
Alternatively, the live webcast of the conference call can be accessed via ViroPharma's website at http://www.viropharma.com. Windows Media or RealPlayer will be needed to access the webcast. An audio archive will be available at the same address until August 24, 2007.
About Hepatitis C
Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.
Currently, there is no specific antiviral agent directed against HCV that is commercially available, and no vaccine for prevention of HCV infection. Several interferon (IFN) 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 IFN 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 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 future of the Company's HCV clinical development program and the Company's hope of advancing HCV-796 as a potential therapeutic agent in the future. 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 antiviral data that is described in this press release is preliminary and additional safety and antiviral data will become available in the future. Full analysis of the existing and future data may not support any or all of the statements in this press release. There can be no assurance that ViroPharma will conduct additional HCV studies in the future. The FDA or other regulatory authorities may either prohibit any future studies with HCV-796 or alternatively may require additional or unanticipated studies or clinical trial outcomes before granting regulatory approval. The can be no guarantee 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 June 30, 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.
CONTACT:
Vincent J. Milano, Vice President, Chief Operating Officer, Chief Financial Officer and Treasurer, +1-610-321-6225, William C. Roberts,Senior Director, Corporate Communications, +1-610-321-6288, both ofViroPharma Incorporated
Web site: http://www.viropharma.com/
Ticker Symbol: (NASDAQ-NMS:VPHM),(NYSE:WYE)
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August 11th, 2007
Compass Healthcare Communications Announces Relaunch of Infergen Web Site
www.pharmalive.com
PRINCETON, N.J., Aug. 10, 2007 – Valeant Pharmaceuticals North America and Compass Healthcare Communications today announced the launch of a new Website for Infergen® (interferon alfacon-1) – www.Infergen.com.
Infergen, or consensus interferon, is a bio-optimized, selective and highly potent type 1 interferon alpha. It is indicated as a monotherapy for the treatment of adult patients suffering from chronic hepatitis C viral infections with compensated liver disease. Infergen is the only interferon with data in the label regarding use in patients following relapse or non-response to certain previous treatments.
"Compass created the Infergen website to help educate patients and healthcare providers on a new alternative to the current 'watch and wait' approach after initial interferon treatment fails," said Sami Shihabi, Director, Hepatology Marketing, for Valeant. "The site offers treatment information and patient counseling tools for the healthcare professional, customized information for hep-c patients that is segmented by where they are in the treatment continuum, and will facilitate enrollment into our patient support program, Infergen® Aspire™."
"We are excited to work with Infergen to offer hope of a second chance for a cure for patients who have relapsed or for whom initial interferon therapy was unsuccessful, as well as to assist the physicians, nurses and caregivers who support these patients," commented Peter H. Nalen, President and CEO of Compass.
The site can be accessed at www.infergen.com.
About Compass Healthcare Communications Compass is a leading independent, full-service online marketing agency exclusively supporting brands in the healthcare industry. Compass maximizes the marketing power of the Internet by designing, developing and measuring integrated online marketing programs that engage, educate and motivate each audience segment – patients, caregivers and healthcare professionals. More information about Compass is available at www.compasshc.com.
About Valeant Valeant Pharmaceuticals North America is a publicly traded, research-based specialty pharmaceutical company that develops, manufactures and markets pharmaceutical products, primarily in the areas of neurology, infectious disease and dermatology. It is based in Aliso Viejo, California.
INFERGEN® (Interferon alfacon-1) is indicated for the treatment of chronic HCV infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA. Other causes of hepatitis, such as viral hepatitis B or autoimmune hepatitis, should be ruled out prior to initiation of therapy with INFERGEN. The most commonly reported adverse events during initial and subsequent treatment were headache, fatigue, fever, myalgia, rigors, body pain, arthralgia, and nausea.
Important Safety Information:
INFERGEN is contraindicated in patients with known hypersensitivity to alpha interferons or to any component of the product, in patients with decompensated hepatic disease and autoimmune hepatitis. Development of or exacerbation of autoimmune disorders (e.g. autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis) have been reported in patients receiving alpha interferon therapies, including INFERGEN.
Treatment with INFERGEN should be administered under the guidance of a qualified physician, and may lead to moderate-to-severe adverse experiences requiring dose reduction, temporary dose cessation, or discontinuation of further therapy.
Severe psychiatric adverse events may manifest in patients receiving therapy with alpha interferons, including INFERGEN. Depression, suicidal ideation, suicide attempt, and suicide may occur. Other prominent psychiatric adverse events may also occur, including psychosis, aggressive behavior, nervousness, anxiety, emotional lability, abnormal thinking, agitation, apathy and relapse of drug addiction. INFERGEN should be used with extreme caution in patients who report a history of depression. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. In severe cases, therapy should be stopped immediately and psychiatric intervention instituted.
Bone Marrow Toxicity: Alpha interferons suppress bone marrow function and may result in severe cytopenias including very rare events of aplastic anemia. It is advised that complete blood counts be obtained pretreatment and monitored routinely during therapy. Alpha interferon therapy should be discontinued in patients who develop severe decreases in neutrophil (<0.5 x 109/L) or platelet counts (<50 x 109/L).
Hypertension, tachycardia, palpitation, and tachyarrhythmias have been reported in patients treated with INFERGEN. INFERGEN should be administered with caution to patients with preexisting cardiac disease. Supraventricular arrhythmias, chest pain, and myocardial infarction have been associated with alpha interferon therapies.
Pneumonia and interstitial pneumonitis, some resulting in respiratory failure and/or patient deaths, have been induced or aggravated by alpha interferon therapy, including INFERGEN. Patients who develop persistent or unexplained pulmonary infiltrates or pulmonary function impairment should discontinue treatment with INFERGEN.
Chronic hepatitis C patients with cirrhosis may be at risk of hepatic decompensation when treated with alpha interferons, including INFERGEN. During treatment, patients' clinical status and hepatic function should be closely monitored, and INFERGEN treatment should be immediately discontinued if symptoms of hepatic decompensation, such as jaundice, ascites, coagulopathy, or decreased serum albumin, are observed.
Ophthalmologic Disorders: Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots; optic neuritis, and papilledema are induced or aggravated by treatment with INFERGEN or other alpha interferons. All patients should receive an eye examination at baseline. Patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during interferon alpha treatment. INFERGEN therapy should be discontinued in patients who develop new or worsening ophthalmologic disorders.
Ischemic and hemorrhagic cerebrovascular events including hemorrhagic stroke have been observed in patients being treated with INFERGEN. In addition, transient ischemic attack has been reported in young patients being treated with INFERGEN without other reported risk factors.
INFERGEN should be discontinued immediately and appropriate medical treatment instituted if hypersensitivity reactions occur. INFERGEN should be administered with caution to patients with a history of endocrine disorders and should be discontinued immediately in patients who develop signs and symptoms of colitis. In addition, INFERGEN should be suspended in patients with signs and symptoms suggestive of pancreatitis and discontinued in patients diagnosed with pancreatitis.
The most common adverse events reported for INFERGEN during clinical studies were headache (82%), fatigue (69%), fever (61%), myalgia (58%), rigors (57%), body pain (54%), arthralgia (51%), nausea (40%), insomnia (39%), pharyngitis (34%), nervousness (31%), infection upper respiratory (31%), diarrhea (29%), depression (26%), anorexia (24%), injection site erythema (23%), granulocytopenia (23%), dizziness (22%), cough (22%), dyspepsia (21%), thrombocytopenia (19%), anxiety (19%), sinusitis (17%), influenza-like symptoms (15%) and leucopenia (15%).
For U.S. residents only. The products discussed herein may have different product labeling in different countries. Please see Important Safety Information (including Boxed Warning) as well as the Full Prescribing Information and the INFERGEN Medication Guide.
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