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Week Ending: June 4th, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• Depression Unrelated to Level of Chronic Pain
• Oregon State Senators Receive Award for Increasing Hepatitis C Awareness
• Red Cross Pleads Guilty, Apologizes for Tainted-Blood Scandal of 1980s
• Clinical Judgment in Liver Transplant Recipient Selection
• 50,000 Patients Infected with Hepatitis C
• Red Cross Fined $5,000 for Blood Sicknesses
• Health Journal: Long-Dormant Threat Surfaces -- Deaths from Hepatitis C Are Expected to Jump
• A New Hope for Hepatitis Therapy
• Idenix Pharmaceuticals Completes Enrollment of Valopicitabine (NM283) Phase IIb Trial in Treatment Refractory Hepatitis C Genotype 1 Patients
• Donor Characteristics Associated with Liver Graft Survival
• Human Genome Sciences Initiates Phase 2b Clinical Trial of Albuferon(TM) in Combination With Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C
• FDA Announces Nationwide Recall of All Able Drugs
• 8M Pinoys Have Hepatitis B
• S.D. Firm Plans to Test Hepatitis Drug in U.S.
• Rodent Virus Spread through Organ Donation
• Hep Team Chicago: Citywide Program to Knock out Hepatitis A and Hepatitis B among Men Who Have Sex with Men
May 30th, 2005
Depression Unrelated to Level of Chronic Pain
SourceURL:http://www.reutershealth.com
By Karla Gale
NEW YORK (Reuters Health) - Individuals with depression often suffer from chronic physical pain and chronic pain sufferers are often depressed. A new study shows that both conditions should be tackled separately and independently from each other.
"There is a sense in clinical practice that if someone has both pain and depression, that maybe depression is causing the pain and if you address depression the pain will get better," Dr. Daniel J. Clauw from the University of Michigan in Ann Arbor told Reuters Health. His group's findings contradict that theory.
Does depression bring about pain? Or does pain lead to depression? Because these two conditions frequently co-exist, there has been much speculation about whether one causes the other or whether a common underlying factor provokes both, Clauw and colleagues note in a report in the medical journal Arthritis and Rheumatism.
To investigate, they studied 53 patients with fibromyalgia, a condition characterized by widespread pain and tenderness to the touch, which is often accompanied by depression. They also studied 42 healthy controls.
Based on results of brain imaging studies and a thumbnail pressure test, the researchers found that fibromyalgia patients needed much less applied pressure to the thumbnail than healthy controls to activate neurons associated with acute pain. This heightened sensitivity to pain applied to fibromyalgia patients, regardless of whether or not they were depressed.
Additionally, according to the researchers, there was only a weak link between sensory regions of the brain associated with pain and emotional regions of the brain associated with depression.
While depression and pain often occur concurrently, that does not mean they're the same underlying problem and can be managed in the same way, Clauw said. Therefore, prescribing an antidepressant will not necessarily relieve the suffering of a depressed patient whose pain is not only real but also intensely physical, he and colleagues note.
SOURCE: Arthritis and Rheumatism May 2005.
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Oregon State Senators Receive Award for Increasing Hepatitis C Awareness
SourceURL:http://www.medfordnews.com
SALEM, Oregon - The Hepatitis C Caring Ambassadors Program is giving its award of appreciation to four State Senators for their dedication to increasing public awareness in the fight against Hepatitis C. The senators receiving the award are Senator Laurie Monnes Anderson (East Multnomah County), Senator Bill Morrisette (Springfield), Senator Floyd Prozanski (South Lane/North Douglas counties), and Senator Vicki Walker (Eugene).
Senators Walker and Prozanski have loved ones who have been afflicted by Hepatitis C. Both have consistently used their position to educate the public about this disease.
"Hepatitis C has no socioeconomic boundaries," said Senator Walker, "it touches the lives of thousands of Oregonians."
"This disease is preventable and I have worked very hard to see that other families don't have to endure the ravages of this disease," said Senator Prozanski.
Senators Monnes Anderson and Morrisette have worked closely with local groups to increase awareness, access to testing and treatment for people with Hepatitis C. As a public health nurse, Senator Monnes Anderson worked intimately with the victims of this disease. "At the current moment, this disease is below the radar," said Senator Monnes Anderson, "The biggest obstacle with fighting Hepatitis C is educating the public and health care workers."
Senator Morrisette has been one of the leading advocates for identifying and treating Oregon's prison population which is disproportionately afflicted with Hepatitis C. "If we test for Hepatitis C in the prisons, we can treat these people while they are incarcerated," said Senator Morrisette. "This will ensure that when prisoners are released they will not require additional services from our social programs, and it will prevent them unknowingly infecting others."
Hepatitis C is the most common chronic, blood-borne viral infection in the United States, and is the leading cause of chronic liver disease among Americans. An estimated 3.9 to 4.5 million Americans have been infected with the Hepatitis C virus, including at least 64,000 Oregonians.
The Hepatitis C Caring Ambassadors Program is a national program designed to increase the public's awareness of the dangers of Hepatitis C and to increase access to testing and treatment facilities. Governor Ted Kulongoski has proclaimed the month of May 2005 as Hepatitis Awareness Month in Oregon.
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Red Cross Pleads Guilty, Apologizes for Tainted-Blood Scandal of 1980s
SourceURL:http://www.canada.com
Colin Perkel, Canadian Press
HAMILTON (CP) - Tens of thousands of Canadians infected with AIDS or hepatitis C got an apology from the Canadian Red Cross on Monday after the charity pleaded guilty to distributing tainted blood in exchange for dropped criminal charges.
"The Canadian Red Cross Society is deeply sorry for the injury and death caused to those who were infected . . . and for the suffering caused to families and loved ones of those who were harmed," Dr. Pierre Duplessis, the organization's secretary general, told the Ontario Superior Court in a video-taped apology as tearful victims looked on.
"We accept responsibility through our plea for having distributed harmful products to those that rely on us for their health."
The charity accepted responsibility for the deadly tainted-blood scandal of the 1980s and early 1990s and said it would pay a $5,000 fine and dedicate $1.5 million to a scholarship fund and research project aimed at reducing medical errors.
In exchange for a guilty plea under the federal Food and Drugs Act, the Crown withdrew charges of criminal negligence causing bodily harm and common nuisance.
At a news conference, Duplessis apologized again to victims, saying "blood they had trusted to give life ended up taking it away."
An emotional Mike McCarthy, spokesman for the Canadian Hemophilia Society and tireless activist for victims, welcomed the admission of wrongdoing but with little satisfaction.
"How can anyone be satisfied? Thousands of people lost their lives. Hundreds and hundreds of people are living with these fatal viruses today," McCarthy said.
"There's no great outcome here for anybody that's gone through the tainted-blood scandal."
John Plater, who contracted HIV and hemophilia from the bad blood, called the conviction a historic occasion.
"This will go down in history as the first day we got finally to the reality that there was breaking of law that led to this," said John Plater, who is also Ontario president of the Canadian Hemophilia Society.
"We (had) thought a terrible mistake had caused the worst public health disaster in this country's history and what we've heard today is: No, in fact, people broke the law."
In an agreed statement of facts, prosecutor John Ayre told the court the organization had been too slow in implementing screening for HIV and hepatitis C in blood in the 1980s.
Ayre said convicting the non-profit organization of a criminal offence and levying a large fine would cripple its ability to carry on the humanitarian relief work for which it is renowned.
"The Red Cross has now said it is sorry and responsible for its actions," Ayre told the court.
"The apology . . . is as complete as one could contemplate."
Justice James Kent accepted the plea but asked to hear from victims before issuing a sentence on June 30.
Victims will have that opportunity through a website. (www.attorneygeneral.jus.gov.on.ca/vw/blood)
The blood scandal is considered one of the worst public health disasters in Canadian history.
More than 1,000 Canadians became infected with blood-borne HIV and up to 20,000 others contracted hepatitis C after receiving tainted-blood products.
About 3,000 people had died by 1997 and the death toll has grown, although it's not clear by how many.
As part of the settlement, the Red Cross will dedicate $750,000 to a post-secondary education fund for victims and their families.
It will also give the University of Ottawa another $750,000 to set up a national research initiative aimed at preventing errors in the health-care sector.
Duplessis said none of the money will come from charitable donations.
Instead, the organization, which has already paid victims $70 million, will use its own internal funds from the sale of its blood-related assets.
The organization ended its involvement in blood distribution in 1998 following a damning public inquiry and transferred those services to the Canadian Blood Services and Hema Quebec.
The agency then used proceeds from the transfer to provide $70 million in compensation to those infected, restructured under bankruptcy protection and brought in new leadership.
Michael Edelson, lawyer for the Red Cross, said it would be unfair for anyone to focus on the proposed $5,000 fine.
"People may have a perception that it's a slap on the wrist but don't forget there's a $1.5-million initiative here which will last for many years to come (and a) previous payment of $70 million," said Edelson.
The charges were laid in November 2002 after a complex five-year investigation by the RCMP.
Several individuals, including Dr. Roger Perrault, a former director at the Red Cross, still face criminal charges.
Perrault's lawyer denied any criminal activity by his client but has asked the courts to stay the charges because Perrault is in poor health.
Plater said he could live with the Red Cross plea bargain, but added that victims would be less forgiving if deals are struck in cases yet to come before the courts.
"We'll be outraged if we see the same sort of plea-bargaining going on there," Plater said.
Victims also say they are still fighting for proper compensation.
Ottawa and the provinces announced a $1.2-billion package in 1998, but it offered benefits only to victims infected from 1986 to 1990.
Allan Rock, then health minister, said pre-1986 victims were excluded because nothing could have been done before then to prevent spread of the disease.
Several provinces including Ontario and Quebec have since extended compensation to those victims.
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May 31st, 2005
Clinical Judgment in Liver Transplant Recipient Selection
SourceURL:http://www.gastrohep.com
An allocation process based on the Model for End-Stage Liver Disease rather than clinical judgment would significantly alter organ allocation, and may reduce waiting list mortality, finds the latest issue of Liver Transplantation.
Minimization of death while waiting for liver transplantation involves accurate prioritization according to clinical status and appropriate allocation of donor livers.
Dr Michael Fink and colleagues from Australia compared clinical judgment in the Liver Transplant Unit Victoria with Model for End-Stage Liver Disease.
Patients who died waiting were 3 times as likely to be prioritized by Model for End-Stage Liver Disease - Liver Transplantation
The research team conducted a retrospective analysis of the Liver Transplant Unit database over a 2-year period from 2002 to 2004.
The team reported that a total of 1118 prioritization decisions and 263 allocation decisions occurred.
The researchers noted that prioritization decisions were concordant in 68%, comparing priorities assigned by clinical judgment with those assigned by Model for End-Stage Liver Disease.
Allocation decisions were concordant in 72% of the cases, comparing donor liver allocation with prioritization by Model for End-Stage Liver Disease.
The investigative team also compared donor liver allocation with prioritization by clinical judgment and noted that allocation decisions were concordant in 77% of the cases.
The team found that of the 52 patients allocated a liver, only 23 would have been allocated on the basis of Model for End-Stage Liver Disease.
The researchers also found that 29 patients were prioritized on the waiting list in the week prior to transplantation according to the Model for End-Stage Liver Disease.
The research team reported that a total of 10 patients died on the waiting list in the 2-year period.
In addition, the researchers observed that patients who subsequently died waiting were 3 times as likely to be prioritized by Model for End-Stage Liver Disease as clinical judgment.
One half of the patients who could have received a donor liver, but who died waiting, would have been allocated the organ on the basis of Model for End-Stage Liver Disease.
Dr Fink's team concludes, “An allocation process based on Model for End-Stage Liver Disease rather than clinical judgment would significantly alter organ allocation in Australia and may reduce waiting list mortality.”
Liver Transpl 2005: 11(6): 621 -26
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50,000 Patients Infected with Hepatitis C
SourceURL:http://www.expatica.com/
AMSTERDAM--Up to 50,000 people were infected in the Netherlands with Hepatitis C via blood transfusions during the 1980s and 1990s, the Dutch Hepatitis Association (HVN) said on Tuesday.
However, the HVN said the patients are not aware they were infected with the virus, because the illness only starts showing symptoms 10 years after infection.
Despite repeated requests, the Dutch government has repeatedly refused to track down the patients, news service 'NOS' reported on Tuesday.
The revelations came on the same day the Canadian Red Cross (CRC) pleaded guilty in court to the distribution of contaminated blood.
Tens of thousands of Canadians were infected with the HIV virus and hepatitis B. Three thousand have since died, 'Radio Netherlands' reported.
In exchange for a guilty plea, the Canadian public prosecutor agreed to drop charges of criminal negligence causing death and nuisance against the CRC.
The CRC will also donate USD 1.2 million to research and to fund scholarships for family members of those afflicted. It also made a public apology to victims and families.
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Red Cross Fined $5,000 for Blood Sicknesses
SourceURL:http://www.herald.ns.ca
By JOHN GILLIS Health Reporter and The Canadian Press
Hep C victim 'can't see any victory' in society's guilty plea, apology
The Canadian Red Cross faces a fine of $5,000 for distributing tainted blood that infected tens of thousands of people with HIV and hepatitis C.
The charity pleaded guilty Monday in Hamilton to violating the Food and Drug Act by distributing bad blood products in the 1980s and early 1990s.
Charges of criminal negligence causing bodily harm and common nuisance were withdrawn in exchange for the guilty plea.
A joint submission by defence and Crown lawyers also includes a $1.5-million payment to be divided between a medical research project and post-secondary scholarships for family members of those affected.
"I can't see any victory of any kind in this at all," said Bruce DeVenne of Lower Sackville, who got hepatitis C in 1986 from clotting products used to treat a bleeding disorder.
He said the Red Cross's assets should be seized and divided among the victims.
Mr. DeVenne, who said scholarships are of no use to him and other victims whose children are long past university, said the deal flies in the face of the Red Cross slogan, We're There When Disaster Strikes.
"Where are they?" he asked.
"They've slithered through every loophole they could and hidden behind every lawyer they could to avoid liability."
Dr. Pierre Duplessis, the secretary general of the Red Cross, apologized to victims Monday in a videotaped statement played in Ontario Superior Court.
"Canadian Red Cross Society is deeply sorry for the injury and death . . . for the suffering caused to families and loved ones of those who were harmed," he said. "We accept responsibility through our plea for having distributed harmful products for those that rely on us for their health."
Because he was infected in 1986, Mr. DeVenne falls within the window of a 1999 compensation agreement. But he hoped the court would award victims more.
"I took the apology and I went over to Superstore. . . . I couldn't even get a can of soup with it," he said. "People need money. They have to pay their mortgages, they have to support their families, they have to pay for their drugs."
The judge accepted the lawyers' submissions but won't formally deliver his sentence until June 30, after he consults the victims and their families. The $5,000 fine is the maximum allowed under the Food and Drug Act.
The guilty plea doesn't acknowledge those who were secondarily infected by others who received tainted blood, said Janet Conners of Hatchet Lake.
Her late husband, Randy, who had hemophilia, contracted HIV from bad blood and unknowingly passed the virus to her.
"I felt more represented or included with the original charge of public nuisance," she said.
Ms. Conners, who has since remarried, said she feels the guilty plea will strengthen the present and future accountability of the current blood system by demonstrating that consequences will follow bad decisions.
But she said the agency's charitable status probably earned it a lighter penalty.
"If a corporation distributed cyanide, I don't think people would settle for an apology and a donation to a university and a guilty plea," she said. "Approximately 2,000 people were infected with HIV. Those who haven't died will."
Prosecutor John Ayre said the proposed sentence was reasonable given that the Red Cross no longer collects or distributes blood and is a humanitarian organization.
None of the funds involved will come from donations but from the agency's own internal resources, Mr. Ayre said.
"The apology is as complete as one could contemplate," he said. "The Red Cross has now said it is sorry and responsible for its actions."
That was some comfort to William Goucher of Round Hill, Annapolis County, who was infected with hepatitis C during open heart surgery in 1985.
"At least they've admitted they were guilty, which they wouldn't before," he said.
Mr. Goucher didn't know he was infected until the Red Cross warned him seven years ago to get tested. The disease has been dormant for 20 years, but blood tests last month showed his liver enzymes were beginning to rise.
"It's like living with a time bomb," he said.
Mr. Goucher has never received any compensation.
More than 1,000 Canadians became infected with blood-borne HIV, and up to 20,000 others contracted hepatitis C after receiving tainted blood products in the 1980s and early 1990s.
About 3,000 people had died by 1997, and the death toll has grown, but recent estimates were not available.
John Playter, a spokesman for the Canadian Hemophilia Society, called the admission historic because it was the first time anyone had acknowledged that laws were broken and that the tainted blood disaster wasn't just a terrible accident.
Hemophiliac James Kreppner, 43, of Toronto was hit with a terrible double whammy.
"I needed blood transfusions in the 1980s, and those transfusions infected me with both hepatitis C and HIV," he said.
"Many of my friends were also infected, and two-thirds of them are deceased."
But Mr. Kreppner said he felt satisfied that at least something was done to rectify the mistakes of the past.
"I'm pleased, and in particular, that there's an apology to the victims because in the past, the Red Cross treated this as though it were some natural disaster that it had no hand in and wasn't responsible for," he said.
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Health Journal: Long-Dormant Threat Surfaces -- Deaths from Hepatitis C Are Expected to Jump
SourceURL:http://www.post-gazette.com
By Paul Davies, The Wall Street Journal
In the coming decade, thousands of baby boomers will get sick from a virus they unknowingly contracted years ago.
Some 8,000 to 10,000 people die each year from complications related to hepatitis C, the leading cause of chronic liver disease and liver transplants. The virus is spread through contact with contaminated blood, usually from dirty needles or, less often, unprotected sex. The symptoms can include jaundice, abdominal pain and nausea.
In recent decades the number of new hepatitis C infections in the U.S. has plummeted -- falling 90 percent since 1989, the result of improved screening of the blood supply and less sharing of needles by drug users.
But the number of deaths related to hepatitis C is expected to triple in the next 10 years, according to the Centers for Disease Control and Prevention. That's because symptoms lie fallow for decades after infection. Many of the people getting sick today contracted the virus from the mid-1960s through the 1980s, when infection rates skyrocketed. Infectious-disease experts say their patients are mainly baby boomers who probably caught the virus from risky behavior in their youth.
"The majority of my patients experimented with drugs during the '60s and '70s and now work on Wall Street," says Robert S. Brown Jr., medical director for the Center for Liver Disease and Transplantation at New York Presbyterian Hospital. In fact, two-thirds of people with hepatitis C are white, male baby boomers who live above the poverty line, according to the CDC.
As many as four million people in the U.S. have been infected with hepatitis C, and world-wide 130 million people have the virus. About 20 percent clear the virus without the help of drugs. But most people carry the virus for years without knowing it -- delaying treatment and possibly risking infecting others.
The Centers for Disease Control estimates 60 percent of hepatitis C patients acquired the virus by sharing dirty needles and syringes while doing drugs. Another 15 percent got the virus through unprotected sex, and 10 percent have been infected through blood transfusions that occurred before 1992 when a test for the virus was developed. Although rare, especially in the U.S., hepatitis C can be transmitted through contaminated devices used for tattoos, body piercing and manicures. There have also been outbreaks in hospitals when infection-control procedures failed.
Current drug treatments have made major strides in the past decade, but still work on only about 50 percent of those suffering from chronic hepatitis C. The treatment goal is to reduce the amount of virus in the blood in order to prevent cirrhosis and end-stage liver disease.
Roche Holding AG of Basel, Switzerland, is the market leader in treating hepatitis C, followed by Schering-Plough Corp. of Kenilworth, N.J. Both companies market a combination therapy using the antiviral drug ribavirin and pegylated interferons, which are proteins that boost the immune system. The treatment is no fun: Patients endure weekly injections and daily pills for 48 weeks with flu-like side effects.
Promising new treatments that may benefit more patients and have fewer side effects are on the horizon. Two small biotech companies, Vertex Pharmaceuticals Inc. and Idenix Pharmaceuticals Inc., both of Cambridge, Mass., have drug trials under way, though treatments probably won't be available to patients for several years. Earlier this month, Idenix announced that in a small clinical trial, its drug -- either alone or combined with currently available treatments -- slashed the level of hepatitis C virus in the blood in most patients. Vertex announced results earlier this month from a preliminary trial involving 34 patients: Five of the participants tested negative for the hepatitis C virus within two weeks of beginning treatment.
Hepatitis C is just one among a several hepatitis viruses, including hepatitis A, B, D and E. Hepatitis A is very contagious and is spread via contaminated water and food. But it can be prevented with a vaccine and isn't life threatening. Hepatitis B can also be prevented with a vaccine. It is similar to C, though it is more contagious and more likely to be transmitted sexually. Hepatitis D and E are very rare in the U.S.
There is no vaccine to prevent hepatitis C. The virus was discovered only in 1989, and it wasn't until 1992 that a blood test was developed to detect it. The CDC says that 80 percent of those infected never have symptoms. In later stages of the disease, the virus can lead to cirrhosis, a buildup of scar tissue that blocks blood flow through the organ. At this stage, many patients need a liver transplant to survive.
In March 2001, Larkin Fowler was working in mergers and acquisitions for J.P. Morgan when he learned through a blood test required to join a gym at work and a subsequent doctor's visit that he had hepatitis C.
Mr. Fowler, now 35, believes he was infected either in 1989 or 1998. In 1989, he and some fellow college fraternity members went on a road trip to a football game. "A few too many cocktails and the next thing you know we all had frat tattoos," says Mr. Fowler. In 1998, he broke his leg while traveling in Bora Bora and received several shots in a hospital there. Mr. Fowler thinks it is more likely he was infected by a dirty needle while receiving medical care in Bora Bora.
Mr. Fowler completed his treatment in May 2002. He would take his weekly injections on Friday mornings and by the evening often be in bed with a high fever and chills. But the treatment worked and he has since been free of the virus.
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A New Hope for Hepatitis Therapy
SourceURL:http://www.newsday.com
BY BRYN NELSON
STAFF WRITER
After years of disappointing news, the outlook for hepatitis C drug therapy may be brightening under a deceptively simple premise: Attacking the virus head-on is the best way to improve both the low response rate and high side-effect burden of existing therapies.
Although relief may yet be years away, the pipeline is quickly filling with drugs designed to block key proteins involved in viral reproduction and subversion of a patient's immune response. The story behind one of these drugs, developed by Cambridge, Mass.-based Vertex Pharmaceuticals, says much about the emerging optimism in a field plagued by frequent failure.
"From where we sit, we're not on the doorstep of new treatments that are going to be in the marketplace this year," says Joshua Boger, chairman and chief executive of Vertex. "But we are on the doorstep of mid-stage clinical trials that are going to usher in a paradigm shift for clinical treatment."
By the end of the decade, he predicts, research and clinical tests could well lead to a treatment that has at its core a drug that directly hits a viral target. Boger is betting the target will be hepatitis C protease, and that a drug now called VX-950 will be the one to block it.
Existing therapies - alpha-interferon in particular - have unquestionably helped hundreds of thousands of patients, and reformulations are making the most of their anti-viral properties. In February, for example, the Food and Drug Administration approved a combination of ribavirin and pegylated alpha-interferon (marketed by Roche as Pegasys) for treating chronic hepatitis C infections in patients whose treatment has been complicated by HIV co-infection.
Even so, hepatitis C experts concede that for many patients, available treatment options are of no benefit. A big reason is that the most common variety of the virus in the United States - known as genotype 1 - also is the most difficult to treat, with a documented response rate ranging from 40 to 56 percent. Last year, researchers at Duke University Medical Center found that response rates among infected African-American patients are even lower.
Relapse is common
A significant portion of patients may relapse after the course of treatment ends, and for up to 15 percent of hepatitis C patients, the side effects of injected interferon therapy force a premature end to treatment, regardless of the response.
The relatively broad immune-boosting activity of interferon is often accompanied by flu-like symptoms, while more problematic side effects may range from hair loss, rashes and fatigue to severe depression and aggravated liver disease. In addition, ribavirin can cause severe anemia, or a low red blood cell count.
Understandably, the biomedical industry and patient advocates have a vested interest in pursuing alternative therapies. A "whole flock of companies" are doing just that, says Dr. Douglas Dieterich, a hepatitis C expert at Mount Sinai School of Medicine in Manhattan. In large part, their drugs are designed to hit the virus where it counts: undermining its ability to replicate or to outmaneuver the body's defenses.
In a study published this month in the journal Nature, researchers at Rockefeller University in Manhattan worked out the structure of a pivotal protein domain within the viral RNA replication machinery, offering a potential target for a drug that blocks the ability of the virus to copy its own RNA.
But another class of drugs known as protease inhibitors, including VX-950, are generating much of the current buzz. As in HIV, researchers say the protease enzyme of hepatitis C is absolutely essential for viral replication to occur. It's also relatively specific.
"There isn't any protease similar in the human body," Boger says.
But to be effective, a drug blocking the enzyme's activity must bind to its business end, and nowhere else - a tough assignment as researchers found.
"The so-called active site of that protein wasn't a nice deep groove or tunnel, just a shallow cleft, an indentation," Boger notes. "This was a little bit akin to climbing a rock face with your bare hands. There wasn't much to hang on to."
Less than two years ago, however, drug company Boehringer Ingelheim provided a critical proof-of-principle experiment, when a molecule under development dramatically lowered the hepatitis C viral load in infected volunteers within two days. The drug, named BILN 2061, proved remarkably specific, but fell by the wayside due to animal toxicity concerns.
The partial promise left unanswered another another vital question: "A puzzle with any persistent viral infection is why it persists," Boger says. "Why doesn't the host's immune system just wipe it out?"
In this case, research suggests, the hepatitis C protease not only helps the virus copy itself but also blocks the liver's ability to naturally produce interferon, and hence, its ability to eradicate the virus. Earlier this year, scientists in Texas and Maryland discovered how the protease halts the cell's emergency response. The situation, Boger says, is akin to a burglar cutting a home's telephone wires to block the police from coming to the rescue.
A drug that blocks the protease, then, could halt the viral one-two punch with one of its own, and Vertex and its competitors are scrambling to deliver the first blow. In an early Phase Ib double-blind trial with VX-950, 34 European volunteers with pre-existing genotype-1 hepatitis C infections received either a placebo or one of three doses of the experimental drug over a two-week period, during and after which doctors examined their viral loads.
Patients who received 750 milligrams of the drug every eight hours achieved a 10,000-fold decrease in viral levels, on average, after two weeks, with a reduction to undetectable levels observed in two of eight patients.
New drug well tolerated
Boger says the drug has been well tolerated so far and has not been associated with any serious adverse events in the limited clinical trials.
"Right now, there's no single-agent drug that shows much more than a log drop in the virus and for a virus that's five to six logs, that's only a small piece of the puzzle," he said before the VX-950 results were announced earlier this month.
"Anything more than a log drop would have the potential to be a paradigm shift."
Even if a shift occurs, however, no one expects an outright replacement of alpha-interferon, at least right away.
"If they're trying to escape interferon, they are not going to be able escape interferon for eight to 10 years," Dieterich insists, a sentiment shared by Long Island-based hepatitis C specialist Dr. Melissa Palmer.
But the approach, if all goes as planned, may eventually tip the balance toward a therapy that successfully treats many more hepatitis C patients than those it leaves behind.
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Idenix Pharmaceuticals Completes Enrollment of Valopicitabine (NM283) Phase IIb Trial in Treatment Refractory Hepatitis C Genotype 1 Patients
SourceURL:http://biz.yahoo.com
- First Hepatitis C Antiviral Drug to Reach This Stage of Development -
CAMBRIDGE, Mass., May 31 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases, today announced that it has completed enrollment of its phase IIb clinical trial of valopicitabine (NM283) with more than 170 treatment refractory hepatitis C genotype 1 patients. The company believes that this is the first time a direct antiviral drug has reached this stage of clinical testing for this patient population.
"Today, there are very limited treatment options for treatment refractory hepatitis C patients, or patients that have failed prior treatment with existing hepatitis C therapies. Among this patient population, approximately 10 percent respond to retreatment with the current standard of care, pegylated interferon plus ribavirin," said Jean-Pierre Sommadossi, Ph.D., Idenix's chairman and chief executive officer. "Since standard treatment is only effective in about half of genotype 1 patients, it is estimated that 30,000 - 40,000 patients in the U.S. will fail treatment each year. Our development program for valopicitabine is seeking first to address this major, growing, unmet need."
Phase IIb Trial Design
Valopicitabine is being evaluated in a phase IIb clinical trial in patients who have previously failed treatment with pegylated interferon plus ribavirin. This six-month head-to-head trial, comparing the combination of valopicitabine plus Pegasys® to ribavirin plus Pegasys®, is evaluating more than 170 hepatitis C genotype 1 patients who have previously failed at least 3 months of treatment with pegylated interferon plus ribavirin, the current standard therapy. Idenix expects to report initial clinical data from this phase IIb trial in the fall of 2005. Currently, the company anticipates initiating a phase III clinical trial in this patient population in the first half of 2006.
About Valopicitabine (NM283)
Valopicitabine (NM283) is an oral, novel nucleoside analog that was co- discovered by Idenix and the University of Cagliari through a cooperative laboratory agreement under the direction of Dr. Paolo LaColla, Director of the Department of Biomedical Sciences and Technologies of the University. Valopicitabine (NM283) is currently being developed in combination with pegylated interferon for use in both treatment refractory and treatment naive patient populations.
About Hepatitis C
There are approximately 170 million people worldwide with chronic hepatitis C virus (HCV) infection, of which approximately 2.7 million are in the United States. Chronic HCV infection accounts for 40 percent of end-stage cirrhosis, 60 percent of liver cancer and 30 to 40 percent of liver transplants in the United States and other industrialized countries. Responses to current treatment options are frequently inadequate due to the inability of some patients to tolerate these treatments and by their limited effectiveness, particularly in patients infected with HCV genotype 1. The genotype 1 strain of HCV is the most treatment-resistant HCV genotype and is estimated to cause more than 70 percent of the reported cases of hepatitis C in the U.S. and Japan, and more than 65% of the reported cases of hepatitis C in Western Europe.
About Idenix
Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News) 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 human immunodeficiency virus (HIV). Idenix's headquarters are located in Cambridge, Massachusetts. The company also has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. 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. Statements in this press release other than those that are historical in nature are "forward-looking statements." Forward-looking statements, which include statements with respect to the potential therapeutic benefits and successful development of the company's product candidates and the company's drug discovery and research, regulatory approval processes and commercialization activities, are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. These risks and uncertainties relate to the results of clinical trials and other studies with respect to the product candidates that the company has under development; the timing and success of submission, acceptance and approval of regulatory filings; the company's dependence on its collaboration with Novartis Pharma AG; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the ability of the company to attract and retain qualified personnel and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. These and other risks are described in greater detail under the caption "Factors That May Affect Future Results" in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2005 and filed with the Securities and Exchange Commission 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.
Pegasys® is a registered trademark of Hoffmann-La Roche.
Contact:
Idenix Pharmaceuticals, Inc.
Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838
Source: Idenix Pharmaceuticals, Inc.
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June 1st, 2005
Donor Characteristics Associated with Liver Graft Survival
SourceURL:http://www.gastrohep.com
Research in this month's Transplantation shows a negative effect on graft survival with elderly donors, presenting with hypertension and metabolic acidosis, or a prolonged intensive care unit donor stay, whilst norepinephrine shows a protective effect.
Organ availability is affecting the development of liver transplantation in its entirety, leading to transplant teams expanding the criteria for accepting organ donors.
In these circumstances, analysis of the impact of the donor's characteristics on graft survival becomes mandatory.
Dr Cuende and colleagues from Spain used univariate analysis to analyze 52 donor variables from 5150 liver transplants performed between 1994 to 2001.
The investigative team entered those with statistically significant impact on graft survival in a Cox regression model.
Norepinephrine administration has a relative risk less than 1 – Transplantation
In the analysis, the team linked the recipients' characteristics and other factors to the graft technique.
The investigators found that several donor factors negatively affect graft survival, including donor age, cause of death, and body mass index.
The team also found that vasoactive drug administration, prolonged intensive care unit stay, and increased alkaline phosphatase negatively affected graft survival.
Additional factors that negatively affected graft survival included liver enzyme levels, low bicarbonate level, and antecedents of hypertension.
However, the research team identified only 4 risk factors graft loss when donor variables are controlled with recipient or technique variables in a Cox regression model.
The 4 risk factors that the team identified included donor age, antecedents of hypertension, prolonged intensive care unit stay, and low bicarbonate levels.
In the same analysis, the investigators observed that norepinephrine administration has a relative risk less than 1.
Dr Cuende's team concluded, "We conducted a multivariate analysis of the impact of 52 donor characteristics on liver graft survival."
"This analysis showed the negative effect of an elderly donor, with hypertension combined with the presence of metabolic acidosis, or a prolonged intensive care unit donor stay."
"The administration of norepinephrine alone during donor management showed a protective effect."
Transplant 2005: 79(10):1445-52
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Human Genome Sciences Initiates Phase 2b Clinical Trial of Albuferon(TM) in Combination With Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C
Source: http://biz.yahoo.com
ROCKVILLE, Md., June 1 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI - News) announced today that it has begun dosing patients in a Phase 2b clinical trial of Albuferon(TM) (albumin-interferon alpha) in combination with ribavirin to evaluate the efficacy and safety of Albuferon in patients with chronic hepatitis C virus (HCV) genotype 1 who are naive to interferon alpha-based treatment regimens. Genotype 1 accounts for nearly 70% of all HCV infections in North America and is generally regarded as the most difficult HCV genotype to treat.(1)
The trial is a randomized, open-label, multi-center, active-controlled, dose-ranging study conducted in Australia, Canada, Czech Republic, France, Germany, Israel, Poland and Romania. A minimum of 440 patients will be enrolled in the Phase 2b study and randomized into four treatment groups, three of which will receive subcutaneously administered Albuferon (900 mcg at 14-day intervals, 1200 mcg at 14-day intervals, and 1200 mcg at 28-day intervals(1)). The fourth treatment group will serve as the active control group and will receive weekly 180-mcg doses of subcutaneously administered Pegasys (peginterferon alfa-2a). All patients will receive weight-based oral daily ribavirin at 1000 or 1200 mg in two divided doses. The primary objectives of the Phase 2b study are to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon alpha-naive patients with chronic hepatitis C genotype 1. The primary efficacy endpoint will be sustained virologic response, defined as undetectable virus at 24 weeks after completion of 48 weeks of treatment.
John McHutchison, M.D., Coordinating Center Principal Investigator for the Phase 2b study, and Professor of Medicine and Director, GI/Hepatology Research, Duke Clinical Research Institute and Duke University Medical Center, Durham, NC, said, "The current standard of care for the treatment of chronic hepatitis C is a combination of pegylated interferon alpha and ribavirin. This combination produces cures in approximately 42-46 percent of all genotype 1 HCV patients completing therapy, leaving more than 50 percent who relapse or do not respond. Clearly, chronic hepatitis C represents a significant unmet medical need. The preclinical and clinical evidence to date supports the continued evaluation of the potential of Albuferon to help meet this need. The next logical step is the current study of Albuferon in combination with ribavirin in a larger population of treatment-naïve genotype 1 patients with chronic hepatitis C."(2-11)
David C. Stump, M.D., Executive Vice President, Drug Development, said, "Based on the preclinical and clinical results that have emerged thus far, we believe that Albuferon has the potential to become an important therapeutic option for the treatment of chronic hepatitis C. The Phase 2b study announced today is the largest Albuferon trial to date. We recently reported the positive results of a Phase 2 study of Albuferon monotherapy in interferon alpha-naïve patients with genotype 1 hepatitis C.(12-13) The data that emerged demonstrate that Albuferon is well tolerated, has a prolonged half- life and shows robust antiviral activity, with durable dose-dependent reductions in HCV viral load. The data also enabled our identification of the range of active doses that will be evaluated in the larger Phase 2b trial announced today. In February 2005, we disclosed preliminary data from a separate ongoing Phase 2 clinical trial of Albuferon in combination with ribavirin, which show that Albuferon can be administered safely and repetitively at 2-week or 4-week intervals in combination with ribavirin in patients who have failed to respond to previous interferon alpha-based treatment regimens.(14) The results of clinical and preclinical studies to date afford confidence in the ability to administer Albuferon safely in combination with ribavirin to treatment-naïve patients.(15-21) We are hopeful that Albuferon will one day provide an important therapeutic option for the treatment of chronic hepatitis C."
The results of a Phase 2 clinical trial of Albuferon monotherapy in interferon alpha-naive patients with genotype 1 chronic hepatitis C were presented at the 40th Annual Meeting of the European Association for the Study of the Liver (EASL).(12-13) Data presented on 56 patients demonstrate that Albuferon exhibited robust antiviral activity in genotype 1 HCV. A mean reduction in HCV viral load of 3.2 log at Day 28 was observed in the combined 900 mcg and 1200 mcg dose cohorts, with 69% of patients (18/26) in these cohorts showing a >2-log reduction in HCV viral load at Day 28. Undetectable viral load was observed at Day 42 (28 days after the second injection) in 23% of patients (6/26) in the combined 900 mcg and 1200 mcg dose cohorts. Robust dose-dependent viral kinetics were observed, with the majority of patients in the 900 mcg and 1200 mcg cohorts exhibiting a second-phase decline in viral load of >0.3 log per week, which has previously been shown to be predictive of sustained virologic response (SVR) in treatment with the pegylated interferons.(22) Reductions in viral load of equal to or greater than 2 log are reported in approximately 42% of genotype 1 HCV patients treated with pegylated interferon alpha products in combination with ribavirin.(23) The results presented at EASL demonstrate that Albuferon remained in the blood substantially longer than is reported for recombinant interferon alpha and pegylated interferon alpha. Albuferon exhibited a median half-life of 148 hours, supporting dosing at intervals of 2-4 weeks. This compares with a reported mean (range) elimination half-life of 80 hours (50-140 hours) for Pegasys and 40 hours (22-60 hours) for PEG-Intron.(23-25) Albuferon was well tolerated with adverse events that were transient and mostly mild to moderate in severity. There were no discontinuations due to reductions in hematologic cell counts. No subjects developed newly emergent antibodies to alpha interferon.
Albuferon is a novel, long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. Human Genome Sciences modified interferon alpha to improve its pharmacological properties by using the company's proprietary albumin fusion technology.
Hepatitis C infection is an inflammation of the liver caused by the hepatitis C virus. It is the most common chronic blood-borne infection in the developed world. It is estimated that as many as 170 million people worldwide are infected with hepatitis C virus. This includes nearly four million people in the United States. The hepatitis C virus is transmitted primarily through significant or repeated exposures to infected blood. Intravenous drug use and sexual contact with infected persons account for the majority of new hepatitis C infections. When detectable levels of the hepatitis C virus in the blood persist for at least six months, a person is diagnosed as having chronic hepatitis C.
For more information about Albuferon, see http://www.hgsi.com/products/albuferon.html. Health professionals interested in more information about trials involving Human Genome Sciences products are encouraged to inquire via the Contact Us section of the company's web site, http://www.hgsi.com/products/request.html, or by calling (301) 610-5790, extension 3550.
Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based protein and antibody drugs to patients.
HGS, Human Genome Sciences and Albuferon are trademarks of Human Genome Sciences, Inc.
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Footnotes:
1. It is important to note that the method of measurement for dose determination in the Phase 2b study of Albuferon in combination with ribavirin in treatment-naïve patients (as well as in other Phase 2 studies of the compound) is different from the method of measurement in the Phase 1/2 study of Albuferon. Accordingly, the 900-mcg dose in the current study is equivalent to a 680-mcg dose in the Phase ½ study, and the 1200-mcg dose is equivalent to 900 mcg in the Phase ½ study.
2. Manns MP, McHutchison JG, Gordon S, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa 2b plus ribavirin for initial treatment of chronic hepatitis C: a randomized trial. The Lancet 2001; 358:958-65.
3. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. New England Journal of Medicine 2002; 347:975-982.
4. Carithers RL, Zeuzem S, Manns MP, et al. Multicenter, randomized controlled trial comparing high dose daily induction interferon plus ribavirin versus standard interferon alfa-2b plus ribavirin. Hepatology 2000; 32:3317A (abstr).
5. Zeuzem S. Heterogeneous virologic response rates to interferon-based therapy in patients with chronic hepatitis C: who responds less well? Ann Intern Med 2004; 140:370-381.
6. Alter MJ. Epidemiology of hepatitis C in the West. Semin. Liver Disease. 1995;15:5-14.
7. Strader DB, Wright T, Thomas DL, and Seeff, LB. AASLD Practice Guideline: Diagnosis, Management, and Treatment of Hepatitis C. Hepatology 2004 April; 39 (4): 1147-1171.
8. Hadziyannis SJ, Sette H, Morgan TR, et al. Peginterferon alfa 2a and ribavirin combination therapy in chronic hepatitis C. Ann Intern Med 2004; 140:346-355.
9. Shiffman ML, Di Bisceglie AM, Lindsay KL, et al. Peginterferon alfa 2a and ribavirin in patients with chronic hepatitis C who have failed prior treatment. Gastroenterology 2004; 126:1015-1023.
10. Zeng N, Cohen CK, Schwartz P, Rai R. Treatment of HCV infected patients, including non-responders to PEG-IFN alfa-2b/RBV, with PEG IFN alfa-2a/RBV: the Johns Hopkins experience. Digestive Disease Week 2004 Internet Conference Report. Abstract #1233.
11. Management of Hepatitis C: 2002. National Institutes of Health Consensus Development Conference.
12. Bain V, et al. A Phase 2 study to assess antiviral response, safety, and pharmacokinetics of Albuferon in IFN alpha-naive subjects with genotype 1 chronic hepatitis C. 40th Annual Meeting of the European Association for the Study of the Liver (EASL), Paris. April 14, 2005. Oral presentation. (Abstract #18.)
13. (HGSI Press Release) Human Genome Sciences Reports Positive Results of Phase 2 Clinical Trial of Albuferon in Treatment-Naive Patients with Chronic Hepatitis C. April 14, 2005.
14. (HGSI Press Release) Human Genome Sciences Completes Enrollment in a Phase 2 Clinical Trial of Albuferon in Treatment-Naive Patients with Chronic Hepatitis C. February 16, 2005.
15. Balan V, et al. Albuferon(TM) -- A Novel Therapeutic Agent for Hepatitis C: Results of a Phase 1/2 Study in Treatment Experienced Subjects with Chronic Hepatitis C. 55th Annual Meeting of the American Association for the Study of Liver Diseases, Boston. November 2, 2004. Oral presentation (Abstract #265).
16. (HGSI Press Release) Human Genome Sciences Reports Positive Results of Phase 1/2 Clinical Trial of Albuferon(TM) in Chronic Hepatitis C. November 2, 2004.
17. Liu C, Zhu H, Xu Y, Nelson DR, et al. Albuferon(TM) exhibits efficient anti-HCV activity in cell culture. Digestive Disease Week (DDW) 2005, Chicago. Abstract #S920.
18. (HGSI Press Release) Human Genome Sciences Reports Results of Preclinical Study Comparing Anti-Viral Activity of Albuferon and Three Other Forms of Interferon Alpha Used to Treat Hepatitis C. May 17, 2005.
19. Balan V, et al. Molecular profiles of drug response in HCV infected patients during the first four weeks of therapy for chronic hepatitis C virus with pegylated interferon containing regimens or Albuferon. 54th Annual Meeting of the American Association for the Study of Liver Diseases, Boston. October 25, 2003.
20. Moore P, Balan V, et al. Modulation of interferon specific gene expression by Albuferon in subjects with chronic hepatitis C and correlation with anti-viral response. 40th Annual Meeting of the European Association for the Study of the Liver (EASL), Paris. April 14, 2005. (Abstract #447).
21. Osborn B, Olsen H, Nardelli B, et al. Pharmacokinetic and Pharmacodynamic Studies of a Human Serum Albumin-Interferon-a Fusion Protein in Cynomolgus Monkeys. J Pharmacol Exp Ther 2002 Nov; 303: 540-548.
22. Neumann AU et al. The second phase HCV decline slope is the best predictor of sustained viral response during treatment of chronic HCV genotype 1 patients with peg-interferon-a-2b and ribavirin. 53 rd Annual Meeting of the American Association for the Study of Liver Diseases, Boston. November 1-5, 2002. Abstract #778. Hepatology 2002: Vol 36 No 4, Pt 2 of 2.
23. Di Bisceglie AM, Rustgi VK, Thuluvath P, et al. Pharmacokinetics and pharmacodynamics of pegylated interferon alfa-2a or alfa-2b with ribavirin in treatment naive patients with genotype 1 chronic hepatitis C. Hepatology 2004;40,4;734a, abstract LB18.
24. PEGASYS® Physicians Desk Reference. (Last updated December 2003).
25. PEG-INTRON® Physicians Desk Reference. (Last updated September 2003).
Source: Human Genome Sciences, Inc.
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FDA Announces Nationwide Recall of All Able Drugs
Yael Waknine
www.medscape.com
June 1, 2005 — The U.S. Food and Drug Administration (FDA) has notified consumers and healthcare professionals via letter of a nationwide recall of all drugs manufactured by Able Laboratories, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting system.
The action was due to serious concerns in the agency that the drugs were not produced according to quality assurance standards. The company has ceased all current production.
The recall affects mostly generic prescription drugs, including some that contain acetaminophen, that were manufactured under the Able, Ivax, Major, Hawthorn, Cypress, and Breckenridge labels. A complete list of products (with identifying tablet imprint codes or liquid formulation lot numbers) is available at http://www.fda.gov/bbs/topics/NEWS
/2005/NEW01182.html.
Consumers who have been taking these medications are advised to contact their healthcare provider or pharmacist for replacement products. Because the risk associated with sudden discontinuation of needed therapy in many cases outweighs the risk of using the recalled product, consumers are advised to continue taking their medication until they have spoken with their healthcare provider.
The FDA notes that the recall only applies to drugs produced by Able Laboratories and not to similar drugs manufactured by other companies.
The agency is currently evaluating the situation at Able Laboratories to determine product safety and quality and to identify all associated repackers and wholesalers; further updates will be announced as necessary.
Additional information may be obtained by contacting Able Laboratories by telephone at 1-800-982-2253.
Adverse events related to the use of Able drug products should be reported to the FDA's MedWatch program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Reviewed by Gary D. Vogin, MD
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June 3rd, 2005
8M Pinoys Have Hepatitis B
SourceURL:http://www.sunstar.com.ph/
* Solon files bill requiring immunization of all newborn infants v. the disease
EIGHT million Filipinos are afflicted with Hepatitis B, a deadly viral infection that causes inflammation of the liver, according to health department records.
This has prompted Senator Pilar Juliana "Pia" Cayetano to file a proposed measure on the mandatory immunization of all newborn babies against Hepatitis B within 24 hours after birth to control the spread of the disease.
A committee report on the bill was submitted to the plenary Wednesday night and the period of interpellation has started. Cayetano urged her colleagues to support the bill.
"Hepatitis-B is a silent killer, more infectious than Aids (Acquired Immune Deficiency Syndrome). It has no recognizable signs or symptoms until severe damage has occurred," Cayetano said.
She has asked the Department of Health (DOH) to adopt an awareness program to stem the rise in the number of liver cancer victims among Filipinos.
Based on statistics, liver cancer is the fourth most common kind of cancer among Filipinos. It is the second most common among males and seventh among female.
The Philippine Cancer Society has recorded 7,477 Filipinos so far who have liver cancer, second to lung cancer with 15,881 Filipinos suffering from it.
Cayetano warned that the 8 million afflicted with Hepatitis B will continue to infect more people unless the government adopts aggressive measures to address the disease.
"Prevention is the key to fight the high incidence of Hepatitis B and liver cancer. Immunization of babies ensures that they will be protected against the disease," she added.
Cayetano said that the cost of a Hepatitis B vaccine is P49.50 only and this would assure infants of 95 percent protection. (JPM)
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S.D. Firm Plans to Test Hepatitis Drug in U.S.
SourceURL:http://www.signonsandiego.com
By Craig D. Rose
UNION-TRIBUNE STAFF WRITER
Giant drugmaker Novartis AG has given a proposed hepatitis treatment from San Diego's Anadys Pharmaceuticals a boost by paying $20 million for a product license and up to $550 million more dependent on the drug's development success.
The proposed treatment, called ANA975, has not been tested on human patients in the United States. But Kleanthis Xanthopoulous, chief executive of Anadys, said the compound has been tested on 36 patients in Europe, and the company plans to file an application to begin patient testing in the United States within months.
If that application is approved by the Food and Drug Administration, Anadys would receive an additional $10 million from Novartis, a Swiss company.
"This is the largest deal we know of at this stage of development," Xanthopoulous said.
ANA975 is a proprietary oral version of isatoribine, which has demonstrated statistical significance in reducing viral levels in the bloodstream of hepatitis patients. Anadys believes the drug targets a key receptor — the so-called toll-like receptor 7 — and thereby rallies the body to fight both the hepatitis C and B viruses.
"Anadys is at the forefront of TLR-based small molecule therapeutics," said Thomas Ebeling, chief executive of Novartis Pharma.
The agreement also gives Anadys an option to retain 35 percent of profits for the hepatitis treatment in the United States, if it pays 35 percent of the commercialization costs. If Anadys declines that option, it would still receive unspecified royalties on domestic sales of the treatment, along with royalties on foreign sales.
The agreement also grants Novartis rights to additional applications of the Anadys drug. Xanthopoulous said those applications might treat other viral diseases, including herpes.
Adam Noah, health care equity analyst for Granite Finanacial Group, said the Novartis deal was a strong boost for Anadys, which raised about $49 million in its initial public offering last year.
"It validates their model and brings them money upfront and on the back end," said Noah, whose firm has a buy rating on Anadys.
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Rodent Virus Spread through Organ Donation
SourceURL:http://www.reutershealth.com
NEW YORK (Reuters Health) - Four transplant recipients in the US became infected with lymphocytic choriomeningitis virus (LCMV), which is normally carried by rodents, after receiving organs from a single donor infected with the virus, according to researchers from the Centers for Disease Control and Prevention.
LCMV seldom causes problems for healthy individuals, but in immune-suppressed patients such as transplant recipients, infection can be serious and even fatal.
The circumstances described in the CDC's publication Morbidity and Mortality Weekly Report began with a woman from Rhode Island who died from stroke complications in early April. There was no evidence of infection at the time of her death and organs from the woman were transplanted into four recipients.
These patients soon showed abnormalities of liver function and blood coagulation, the report indicates, but the cause of the illness was unclear and, ultimately, three of the patients died.
The link with a common donor led investigators to consider an infectious cause of the illnesses. Analysis of tissue from the donor and recipients identified LCMV infection as the cause of disease.
Further testing suggested that the donor had acquired the virus from a pet hamster.
There are no effective pre-transplant tests for screening organ or tissue donors for LCMV infection. Still, the investigators say, the risk of acquiring an unknown LCMV infection through transplantation is very remote and is greatly outweighed by the benefits of organ transplantation.
SOURCE: Morbidity and Mortality Weekly Report, June 3, 2005.
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Hep Team Chicago: Citywide Program to Knock out Hepatitis A and Hepatitis B among Men Who Have Sex with Men
SourceURL:http://biz.yahoo.com
CHICAGO--(BUSINESS WIRE)--June 3, 2005--Tuesday, June 7th, marks the official launch of Hep Team Chicago, a citywide summer program targeting men at risk for hepatitis A and hepatitis B through sex with other men, with a kick-off event at Roscoe's Tavern and Cafe, 3356 North Halsted Street.
Also referred to as Vaccine-Preventable Hepatitis, or VPH, hepatitis A and hepatitis B are serious liver diseases more prevalent among men who have sex with men (MSM) than among the general population. Fortunately there are vaccinations available for hepatitis A and hepatitis B and both the CDC and the Gay and Lesbian Medical Association (GLMA) recommend that all men who have sex with men (MSM) get vaccinated for hepatitis A and hepatitis B.
Hep Team Chicago, in partnership with agencies throughout Chicago including the Chicago Department of Public Health, Howard Brown Health Center and the Center on Halsted will be promoting hepatitis vaccination throughout the summer. The campaign aims to raise awareness that MSM are at increased risk for contracting hepatitis A and hepatitis B; that hepatitis A and hepatitis B are serious (and potentially fatal) infections; and that hepatitis A and hepatitis B are preventable through vaccination.
The Hep Team Chicago outreach program is supported with a website - http://www.hepteamchicago.com - transit and community-wide print and online media ads; citywide distribution of posters, brochures, and palmcards and, the Hep Team will be at major community events this summer, Gay Pride, Windy City Pride and Northhalsted Market Days. Additionally, the Hep Team will be in the Gay Pride Parade wearing distinctive Hep Team Chicago apparel and you will also see then at bars, clubs, beaches and other community venues during the course of the campaign.
According to an online survey conducted in the Chicago area on Gay.com in May among MSM, fewer than half of the survey respondents (48.3%) had received any doses of a vaccine against hepatitis A and hepatitis B and only 47% have discussed vaccination with their healthcare provider. The survey results also show that the 49.1% of the respondents have no plans to be vaccinated in the future. Also troubling is that close to 80% of the respondents received no information about hepatitis or hepatitis vaccinations over the past six months. These preliminary results underscore the need for this information outreach campaign.
Hep Team Chicago recommends that men who have health insurance go to a private provider for vaccination, as vaccination is covered by many insurance plans. For men who do not have health insurance or a regular provider, the Hep Team website - http://www.hepteamchicago.com - lists clinics and providers around the city who stock the hepatitis vaccines. Clinic and provider information is also available at 800-243-2437.
The Chicago Department of Health will be offering free vaccinations on-site at Montrose Beach following the Gay Pride Parade on Sunday, June 26th, during Windy City Pride at the Southside YMCA on Sunday, July 3rd, and at Northhalsted Market Days on Saturday, August 6th and Sunday, August 7th. "For those who don't have insurance coverage or a regular provider, we're offering on-site vaccination at the biggest community events this summer which underscores CDPH's commitment that all MSM should be vaccinated", said Dr. Will Wong, Medical Director, STD/HIV Program, CDPH.
There are multiple options for vaccination against hepatitis A and hepatitis B. There is an individual vaccine against hepatitis A (two shots over a six to twelve month period), an individual vaccine against hepatitis B (three shots over a six month period) and a combination vaccine against both hepatitis A and hepatitis B (three shots over a six month period). A complete series is necessary for long-term protection.
Hep Team Chicago is the largest hepatitis A and hepatitis B public information campaign in the nation aimed at men who have sex with men. Support for this program is provided by the GlaxoSmithKline group of companies.
Contact:
Hep Team Chicago, Chicago
Amy Maggio, 312-840-9291
Source: Hep Team Chicago
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