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Week Ending: September 26, 2009
Alan Franciscus
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This Issue:
September 20, 2009
Depressing trends in liver transplants look set to continue
http://www.guardian.co.uk
Denis Campbell, health correspondent
The length of time a patient in liver failure has to spend on the transplant waiting list is rising, and their chances of being among the chosen are diminishing. Almost one in five of those waiting for a liver never get one and die, just as 103 people did last year. Mortality from liver disease among men in the UK has gone up seven-fold since the 1970s. At the moment, 380 Britons, of whom 21 are under 18, are on the list.
Those lucky enough to be offered a new liver face an operation that can last up to eight hours. Last year, 701 patients had the procedure at liver transplantation centres around the UK, such as King's College Hospital in London and the Edinburgh Royal Infirmary (ERI), where Frank Deasy was treated. Each of those operations is a life-saver. While a patient with kidney failure can survive on dialysis for years, no such alternative is available for liver patients.
"It's a big operation – huge. When I describe it to patients beforehand I tell them that the surgeon is going to remove the biggest solid organ in their body, which usually weighs between one and one and a half kilos, put in a new one and make all the important connections between the veins and arteries," explains Dr Ken Simpson, a liver specialist at the ERI.
Three surgeons usually participate, reflecting the complexity of the task. However, complications are unusual. "It's very uncommon not to have someone survive the surgery," Simpson adds. Plus the risk of the body rejecting the new organ, a danger in most transplantation, is low.
The ERI's liver transplantation unit tells a national story. "At the beginning of 2000 there were five or six people on our waiting list at any one time, but a year ago it was 35," says Simpson. "Today it's 17 and usually it's between 20 and 30, so that's a five-fold increase in nine years." Why such a jump? More alcohol-related problems, more cases of fatty liver disease due to rising obesity and a growing number of cases of viral hepatitis, such as hepatitis B and C. The ERI's surgeons carry out about 60 liver transplants a year, but another 15 patients die because they do not receive an organ.
There are exciting developments in this area of medicine. In the past few years advances in surgery have meant that donated adult livers can be split between two patients. Typically, about 30-40% of one will go to a child and the rest to an adult. Both parts of such a liver grow to full-size within a month. But only livers that are large and healthy can save two lives in this way.
"There's a significant shortage of all organs," says Simpson. "The government has put a lot of resources into tackling the problem, but we still have a low rate of donation. As a consequence, the need is rising faster than the availability of organs. These depressing trends look set to continue for the foreseeable future."
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Health care Rx for N.Y. prisons
http://www.timesunion.com
New York's prisons provide, among other things, medical care to nearly 60,000 people. Yet the prisons operate the only health care system in New York that's not monitored by the state Health Department.
The result is medical care that, while improving, is still deficient in many ways, as a report by the Correctional Association of New York detailed earlier this year.
That could be readily fixed, of course. The Health Department could, and should, be given authority to exert more influence in prisons and jails, just as it does over all other hospitals and clinics in New York. All it would take is passage of a bill under consideration in the Legislature.
An important first step across what Assemblyman Richard Gottfried, D-Manhattan, calls the barrier between public health and the prison system came last week as Governor Paterson wisely signed a law that will require Health Department oversight of treatment of prison inmates with HIV and hepatitis C.
New York has the largest number of HIV-positive prison inmates, an estimated 4,000, of any prison system in the country. That's 20 percent of infected inmates nationwide. New York also has an estimated 8,400 inmates infected with hepatitis C. That, at least, is the toll that we know about.
The Correctional Association report noted that fewer than half of the HIV-positive inmates and only about 70 percent of those with hepatitis C have been identified. The number of inmates being treated for these diseases varies among the state's 70 correctional facilities, even though the inmate population is much the same, demographically, from one to another. Such an inconsistency in treatment, we expect, will change under the Health Department's oversight.
Even more could change, in fact, if the Legislature and the governor were to extend regulation of medical care in New York's prisons beyond their two most serious health problems.
There's little to the arguments against such legislation. Mr. Gottfried and Sen. Thomas Duane, D-Manhattan, say the fiscal impact of their bills would be minimal. Conversely, there's a fiscal benefit to be reaped from improving medical care in prisons before inmates' health deteriorates further or they re-enter society -- as almost all eventually will.
New York already stands apart, boldly and proudly, from other states for addressing the problems posed by HIV and hepatitis C in its prisons. A state government with its share, and then some, of embarrassments could distinguish itself by requiring that health care in prisons and jails meet professional standards, as required by its constitution.
The issue:
Gov. Paterson signs a law that requires more oversight of prison health care.
The Stakes:
Treating inmates like everyone else is a chance for New York to set an example for other states.
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John Hollis: Test can bring ‘silent killer' into the light
http://www.appeal-democrat.com
The people who know hepatitis C call it "the silent killer."
They call it that because it can live in its victim for five, 10, 20 years doing its damage to the liver, before any symptoms appear.
The term "silent" could also be used for the way the medical establishment seemingly has ignored the disease.
The attitude reminds me of when AIDS first raised its ugly head. In the early days of that disease, few people or organizations were willing to put in the effort and money to attack it because it was only something that affected "those people." In the case of AIDS, gays were "those people"; in the case of hep C, "those people" are druggies and the homeless.
But it's not just gays who are stricken with AIDS, and it's not just druggies or the homeless who have hep C.
Advocates, who have been working for years to raise awareness of the disease and convince the government to provide more funds, have not been able to mount a public—awareness campaign as the gays have for AIDS. They haven't caught the public's attention as the anti—breast cancer advocates have. Why? Most people can't get too excited about throwing their hard—earned tax dollars at a disease that they perceive — if they even think about it — as largely self—inflicted.
If only that were the case.
Before 1992, there was no way to test blood or tissues for the hep C virus. This often meant that persons, unknowingly carrying the virus, could donate (or sell) blood and pass on the disease. Two of the people I interviewed for the story in today's Lifestyles section are fairly sure they did just that. They can only guess at the number of people they infected, through no fault or intention of their own.
Veterans are also at a high risk of having the disease.
I'll use myself as an example.
I was an Army medic in Vietnam who treated the sick and injured. It wasn't uncommon for me to have other soldiers' blood or other bodily fluids on my skin almost every day.
By the luck of the draw, the disease passed me by, but I easily could easily have been infected. Back in the day, field medics didn't use rubber gloves or masks for a number of reasons: We were ignorant of the danger; we saw ourselves as young and invulnerable; and we had more important things to do — like saving lives.
The military had another chance to infect myself and many others in the mid-'70s when another swine flu threatened the country. Back then, they had this really efficient way of injecting drugs. They used an air gun that shot the serum into arm after arm, allowing the medics to quickly inoculate a large number of people without having to take the time to change syringes or always taking time to clean the gun between uses. So if person A had a disease, the gun could easily transfer the germs to person B, quickly and efficiently.
No one knows how many veterans received more than just the flu shot.
Other groups who could be infected are medical professionals; first—responders such as firefighters or police officers; and upstanding folks who, in their younger days, did a single stupid thing and became infected.
The statistic hep C advocates use is that more than 80 percent of the people who have the disease don't know it. While I'm not sure how they can substantiate that figure, I am convinced that a large number of people are walking around with the disease untreated. Walking around, leading their daily lives, while the virus silently eats away at their bodies.
The facts:
• There were 3,725 deaths from chronic liver disease in California in 2002.
• Chronic viral hepatitis C is a leading cause of cirrhosis, end-stage liver disease and liver cancer.
What to do? If you think you're at risk from past activities, tell your doctor to order the test. Give a little blood. The test will either clear your mind or it will open the door to treatment. And like all diseases, the earlier the treatment, the greater the chance of recovery.
John Hollis is an Appeal—Democrat copy editor and features writer.
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New Guidelines Help Primary Care Doctors Treat Liver Transplant Recipients
www.medscape.com
Karla Gale, MS
September 11, 2009 — A recent survey found that most transplant centers expect primary care doctors to manage the overall care of liver transplant recipients after 6 months of transplantation.
With this in mind, Dr. Brendan M. McGuire, from the University of Alabama at Birmingham, and associates drafted comprehensive guidelines, published in the American Journal of Transplantation for September, to assist the primary care physician in the long-term care of liver transplant recipients.
"In addition to routine health care needs, unrelated to the transplant, primary care physicians are faced with complex management of chronic illness and cancer screening that have unique implications due to chronic immunosuppression," the authors note. "However, most PCPs have no formal training in transplantation."
The guidelines address drug interactions and side effects of immunosuppressive agents and allograft dysfunction. In addition, they cover renal dysfunction, metabolic disorders, and preventive medicine, and malignancies. Other issues include disability and productivity in the workforce, issues specific to pregnancy and sexual function, and pediatric patient concerns.
The tie between transplant centers and primary care providers is not being severed, however. In many instances, physicians are advised to confer with the transplant center.
Such situations include prescription of any new medication or any time liver function tests rise 1.5-times or more above normal; in the event of renal dysfunction or metabolic disease; the development of malignancies that require reductions in immunosuppression, and when medications need to be adjusted in the event of pregnancy.
Dr. McGuire's team includes tables summarizing some of the drugs and substances that may alter levels of cyclosporine, tacrolimus and sirolimus, as well as lists of vaccines that are and are not safe to give to recipients or their household contacts. They also recommend looking for possible drug interactions on www.epocrates.com and www.pdr.net.
In many instances, standard treatment for medical conditions is appropriate, the authors say. For example, in the case of renal dysfunction, they remind physicians to optimize treatment of such conditions as diabetes and hypertension to minimize further renal injury and to evaluate with urine analysis with possible referral to a nephrologist.
According to Dr. McGuire and his associates, many metabolic disorders occur at higher rates in transplant recipients that require special attention. These include diabetes, hypertension, dyslipidemia, obesity, gout, and metabolic bone disease. Standard therapy is called for, except in cases where drug interactions may be problematic.
The report notes that a number of malignancies occur more commonly in liver transplant recipients than in the general population, including various virally mediated cancers, cutaneous cancers, and colon and upper aerodigestive cancers. In some cases, the transplant center should be consulted about lowering the dose of immunosuppressants, since long-term immunosuppression is the basis for the higher incidence.
The rate of spontaneous abortion is high after liver transplantation, and women are advised to wait at least a year after transplantation before becoming pregnant.
In general, quality of life improves after a successful transplant. However, health-related quality of life may be lower than in the general population. Permanent disability is rare, the report indicates, and patients can often return to work after the incision heals and the patient can perform activities of daily living.
Am J Transplant. 2009;9:1988-2003. Abstract
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Liver failure brings dilemma in possible death penalty case
http://www.lasvegassun.com/
By Richard A. Serrano
Dilemma in case against Aryan Warrior isn’t new, but has big significance here
Ronald L. (Joey) Sellers, who awaits trial on murder and racketeering charges, is sick from liver failure and without a transplant could die within a few years. His lawyers say they plan to make this central to their argument.
Federal prosecutors here and in Washington are weighing whether to seek the death penalty for the reputed leader of a violent white supremacy prison gang awaiting trial on murder and racketeering charges. If they prevail, Ronald L. (Joey) Sellers would be the first in decades in Nevada to die at the hands of the United States government.
But his death could be swifter. Indicted in federal court for allegedly helping run the vicious Aryan Warriors gang in state prisons, he is ill with liver failure and without a transplant could die within three years.
Indeed, he is so desperate for a transplant that his lawyers say they plan to make it a central part of their argument to spare his life when the Justice Department’s special Capital Case Review committee convenes to determine whether he should be tried for capital murder.
Hanging over that hearing room in Washington will be a searing dilemma.
Prosecutors do not object to a transplant, but point out that he has not yet been deemed a transplant candidate. They want his criminal case to proceed, noting in court papers that in the meantime his “medical treatment is being monitored at the highest levels.”
Defense lawyers argue that health issues should take priority over the criminal case. Why spend untold taxpayer dollars and government manpower to convict, imprison and execute a man who will die a lot faster and a lot cheaper if his liver simply shuts down? “Irony and tragedy is often lost on bureaucrats,” his lawyer, Richard Kammen, said in an interview.
It is the sort of predicament that has confronted other death row cases, and other prosecutors, defense lawyers, judges and prison wardens. Physical ailments often strain the judicial system and make what many see as an imperfect death penalty process all the more medieval.
Time was ticking down for Jerry Joe Bird when he suffered a stroke in his Texas death row cell in June 1991. The prison rushed him to a hospital, where he was treated for a week. Then he was returned to the death house and strapped into the gurney. He was put to death for killing an antique-gun collector in the Rio Grande Valley. “Go ahead,” he told his executioners. “Start things rolling.”
Two years later in Virginia, Charles Sylvester Stamper was carried to the electric chair by prison guards, his lifeless feet dragging along the floor. He was partially paralyzed five years earlier in a prison brawl, and that put him in a wheelchair. He had killed three co-workers at a Shoney’s restaurant, and in the end asked to make his last steps to the chamber with his leg braces and walker. The prison turned him down.
In December 1999, David Martin Long began hoarding prescription anti-depressants in his cell in Huntsville, Texas. Two days before his execution for killing three women in the Dallas area, he swallowed the pills, hoping to commit suicide and cheat the executioner. He was taken to a hospital and placed on life support. He soon was revived and then returned to Huntsville to be executed by lethal injection. As the needle brought him death, a dark liquid drained from his nose and mouth. Officials said it was the solution used to treat his drug overdose.
In Arizona, 94-year-old Viva Leroy Nash, the oldest man on death row in America, still awaits his trip to the chamber for shooting a young coin shop clerk in Phoenix in 1982. On death row Nash has suffered strokes, high blood pressure and heart ailments. But his fragile heart keeps beating and his legal appeals drag on. It is anyone’s guess how he will die.
Just last Tuesday the execution of Romell Broom in Ohio was called off when authorities could not find a suitable artery for injection. He was set to die for raping and killing a 14-year-old Cleveland girl. But years of heroin use had left his veins weakened and unpliable, and after two hours officials gave up. Gov. Ted Strickland issued a one-week reprieve.
Therein lies the quandary, especially for convicts like Nash and Broom, and Joey Sellers in Nevada.
“You can’t punish people twice,” said Richard C. Dieter, executive director of the Death Penalty Information Center in Washington. His nonprofit group monitors capital punishment and seeks to ensure that condemned men are treated fairly — both legally and humanely.
“You can’t give them the death penalty and then shortchange them on proper medical treatment. Constitutionally, you can’t do that,” Dieter said.
Traci Billingsley, a spokeswoman in Washington for the U.S. Bureau of Prisons, said that all federal inmates, including the 55 with death sentences, are given good medical care, including lifesaving operations when appropriate.
“All of our inmates are eligible to be considered for a transplant,” she said when asked about the Sellers case. She said several inmates have been given kidney and bone marrow transplants, but only one received a new liver. Nevertheless, she said, “we do whatever is medically necessary.”
In Nevada, 82 offenders sit on death row in the state prison system. The state has executed 12 people in the past 20 years. The last was Daryl Mack, put to death in April 2006 for strangling a woman in Reno.
On the federal level, sources could not name any executions in Nevada in at least the past 50 years, and could not remember any federal death penalty trials in Nevada since capital punishment was reinstated in 1976 by the U.S. Supreme Court.
That makes the Sellers case all the more significant.
His attorney, Kammen, said “there’s no question” he needs a transplant. His liver was damaged after contracting hepatitis C from alleged unsanitary conditions at the state prison in Ely, where he was incarcerated for life for a string of offenses in Reno, including first-degree murder. “To look at him and to speak to him, he’s obviously quite ill,” Kammen said.
His medical records warn that he has “end stage liver disease due to chronic hepatitis C.” Sellers has lost more than 40 pounds this year and yet is severely bloated. A hernia the size of an adult fist protrudes from his intestines and groin. Last year doctors told him he might not last another three or five years, Kammen said.
His brother and son have offered to donate half their livers to save him. But his future remains unsettled as the prosecution maintains his condition is not so critical. Sellers is now at the Federal Correctional Institute at Terminal Island, Calif.
As Billingsley said, if a transplant is deemed medically necessary, he likely would be taken to a hospital in the community where he is housed. If he is on death row, that would be in Terre Haute, Ind.
Sun researcher Rebecca Clifford-Cruz contributed to this story.
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Hepatoma: Deadly
http://globalnation.inquirer.net
By Dr. Philip S. Chua
Cebu Daily News
HEPATOMA is a common and deadly cancer among Asians. I lost a close friend, a Fil-Am physician, a couple of years ago, and a few others before that, all to hepatoma. They all lived for only about 6 months from the time of diagnosis.
What is hepatoma?
Also known as hepatocellular carcinoma, hepatoma is the most common (70 percent to 85 percent) primary cancer of the liver. The rarer ones are cholangiocarninoma, hepatoblastoma and angiosarcoma. The word primary means the cancer originated in the liver, in contrast to secondary or metastatic liver cancer , which originated from another organ, like cancer of the lung, breast, pancreas, colon, or stomach spreading to the liver. Most cancer found in the liver are metastatic from other organs.
What is the incidence ?
In the United States, the incidence is between 1 to 5 cases per 100,000 population per year. About 70 percent of cases of hepatoma worldwide are due to chronic hepatitis B infection, compared to only 20 percent in the United States, where 60 percent to 80 percent are alcoholic cirrhosis-related. Among those not caused by hepatitis B virus, 50 percent to 70 percent were due to chronic hepatitis C infection. Mean age of hepatoma patients is 55-62 years, and with a male to female sex ratio of 3-4 :1
What causes hepatoma?
Those with chronic hepatitis B or C infection are prone to develop liver cancer. Other causal agents include alcoholism and chronic liver cirrhosis.
Will hepatitis lead to hepatoma?
While those who have hepatitis B or C have increased risk of developing hepatoma, not all persons with a history of hepatitis B or C infection will automatically develop hepatocellular carcinoma. For these persons, a healthy lifestyle could help boost the immune system and conceivably lessen the risk.
What are the other risk factors ?
Chronic use of oral contraceptives, unsterile intravenous drug abuse, primary biliary cirrhosis, hemochromatosis, some metabolic disorders (Niemann-Pick), chlonorchiasis, gallstones, and choledochal cyst, chronic exposure to vinyl chloride polymers.
What are the symptoms ?
Some cases have no symptoms at all till the hepatoma has progressed, and different individuals may experience symptoms in variable ways. Some of the most common symptoms and signs are abdominal pain, weight loss, fever, nausea, vomiting, swollen abdomen, fatigue, jaundice (yellow discoloration of the skin and eyes), large mass in the right upper quadrant of the abdomen.
How is hepatoma diagnosed?
A complete medical history and physical examination by a physician is essential. Some tests are liver function test, abdominal ultrasound, computed tomography or CT scan, magnetic resonance imaging or MRI, hepatic arteriography, liver biopsy with a needle for specific microscopic pathological diagnosis, laparoscopy, and, if needed, exploratory laparotomy.
What is the prognosis?
Unless the diagnosis is made very early, which is not the usual case, life expectancy after the diagnosis of hepatoma is established generally ranges between 6-8 months.
How can one prevent hepatoma?
Vaccination against hepatitis B virus to prevent getting hepatitis B infection is an effective way to significantly reduce the risk of developing hepatoma. Hepatitis B is transmitted sexually, and through blood transfusion, like hepatitis C. So preventive mesures in this regard is fundamental. On top of this, abstinence from, or moderation in intake of, alcoholic beverages will help.
Any sign that vaccination helps ?
Yes, since universal immunization against hepatitis B was implemented among children, statitsics show that the incidence of hepatoma has been reduced to 1/4 to 1/3, compared to the period before the use of the vaccine. Global immunization against hepatitis B among all infants will surely help in minimizing, if not eradicating hep-b caused hepatoma.
What are the treatments available ?
The attending physician, who has all the data available including the stage of the liver cancer, will determine and recommend the appropriate treatment strategy and options. The patient, as always, especially in cases of hepatoma, has the final say.
The management could include surgery to remove the entire liver (and liver transplant for specific candidates that qualify) or partial resection of the liver with cancer, depending on the extent of involvement, external beam radiation therapy to kill the cancer cells, or, in advanced cases, to shrink the size of the tumor for pain relief, chemotherapy intravenously, or intra-arterial chemo given directly thru a catheter in the liver artery, chemo-embolization to clog the artery and cut the blood supply to the liver and anti-cancer drugs delivered to the liver directly. Radio-frequency ablation, using a special probe to kill the cancer cells with heat. Laser and microwave therapy also use heat to kill the cancer cells. A a few patients who qualify, liver transplantation may be an option, provided the cancer has not spread to other organs.
The team of physicians and surgeon, led by the oncologist, will formulate a treatment plan for each individual patient.
We all look to the day when deadly diseases like hepatoma and all other cancers could be prevented with the use of vaccines, or effectively treated with oral medications, like in the case of tuberculosis, which used to spread and ravage all the organs of the body like cancer, until French scientists Calmette and Guerin discovered the BCG vaccine against TB in 1906, and later, streptomycin was isolated on October 19, 1943 by Albert Schatz, a graduate student, and first randomized trial of the drug used against TB in 1947.
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September 21, 2009
Data Safety Monitoring Board Recommends Continuation of Celsion's Phase III ThermoDox(R) Study for Primary Liver Cancer
www.medicalnewstoday.com
Celsion Corporation (NASDAQ:CLSN) announced the Data Safety Monitoring Board ("DSMB") has reviewed the safety data from the first group of patients enrolled in its pivotal ThermoDox® Phase III clinical trial for primary liver cancer ("HEAT study") and has recommended that Celsion continue to enroll patients in the trial.
The DSMB for the ThermoDox HEAT study is comprised of an independent group of medical and scientific experts who are responsible for reviewing and evaluating patient safety and efficacy data. The DSMB reviews safety data at regular intervals and its charter is to ensure patient safety and monitor the quality and overall conduct of the study. The study design and statistical plan for the Phase III ThermoDox trial also incorporates a pre-planned interim efficacy analysis by the DSMB after patient enrollment is complete with the intent to stop the study if there is overwhelming evidence of treatment benefit or an extremely low probability of treatment success.
Michael H. Tardugno, President and Chief Executive Officer of Celsion stated, "We are pleased that the DSMB has recommended continuing the study based on its review of the safety data. We expect patient enrollment to continue to accelerate, as the trial was recently expanded to Japan in coordination with our exclusive Japanese license partner Yakult. We note that under our partnership, Yakult will bear all costs associated with the Japanese cohort. Additionally, Celsion anticipates that regulatory approval for new clinical sites in China is imminent. Together with the expected activation of sites in Malaysia, the Philippines, and Thailand, the Company projects 60 sites by year end. We expect to complete enrollment in the spring of 2010."
Celsion's global Phase III ThermoDox study for primary liver cancer is enrolling 600 patients and is being conducted under a FDA Special Protocol Assessment (SPA). The study is designed to evaluate the efficacy of ThermoDox in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival. Additional information on the ThermoDox Phase III clinical study may be found at http://www.clinicaltrials.gov .
About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States and is rapidly growing worldwide at approximately 1,000,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries. Among the standard treatment options for liver cancer is surgical resection of the tumor; however 80% to 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors.
About ThermoDox®
ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. ThermoDox® is administered intravenously and in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. Localized mild hyperthermia (39.5-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
ThermoDox has already demonstrated remarkable evidence of clinical activity in Phase I studies for primary liver cancer and recurrent chest wall breast cancer. For the primary liver cancer indication, Celsion has been granted FDA Orphan Drug designation. For recurrent chest wall breast cancer, ThermoDox(R) is being evaluated in a pivotal Phase I/II open-label, dose-escalating trial that is designed to measure durable local complete response at the tumor site. Celsion expects to enroll approximately 100 patients in the U.S. within calendar year 2010
ThermoDox(R) is a registered trademark of Celsion Corporation
Source: Celsion
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Risky Behaviors among Truckers Lead to Higher Rates of STIs Including Hepatitis C
www.medicalnewstoday.com
Long-distance truck drivers participate in higher risk behaviors, a New Mexico study reports. Researchers examined sexually transmitted infection, HIV and hepatitis C virus prevalence and risk behaviors among 652 truck drivers between 2004 and 2006. Mobile clinic vans were used to conduct this study at a large trucking terminal in Albuquerque, N.M., and at 10 truck stops throughout the state. Fifty-four drivers - 8.5 percent - tested positive for hepatitis C. Furthermore, alcohol consumption is a strong independent risk factor for the progression of hepatitis C Virus-associated liver disease that potentially can be modified through patient education and behavior change, researchers imply.
Results suggest a need for hepatitis C screening and STI risk-reduction interventions in this population.
The study's authors conclude, "Our results suggest that drivers may benefit from HIV, STI and hepatitis prevention interventions embedded within comprehensive wellness programs that are convenient and easily integrated into the mobile environment of the trucking industry."
Source: American Journal of Public Health
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September 22, 2009
Mediterranean diet trims the wallet
www.reuters.com
NEW YORK (Reuters Health) - Sticking to a Mediterranean diet rich in fish, olive oil, legumes, fruit and vegetables is heart healthy, but expensive, maybe even prohibitively so, new research from Spain hints.
Consequently, "upstream" measures -- such as taxes on unhealthy foods and/or subsidies on healthy foods -- may be needed to "increase the probability of adopting a healthy dietary pattern leading to better health and disease prevention among the population," Dr. Maira Bes-Rastrollo told Reuters Health.
The researcher, from the Department of Preventive Medicine and Public Health, School of Medicine, University of Navarra, and colleagues studied the costs of Mediterranean and Western dietary patterns in more than 11,000 Spanish university graduates with a similar level of income. All of them were participating in a long term study launched in 1999 to assess ties between diet and obesity and long term health problems.
Their analysis revealed that the more closely these young adults adhered to the healthy Mediterranean diet, the more money they spent each day on food.
In contrast, the more closely they followed a "Western" diet - high in saturated fat, sugar, and red meat - the less money they shelled out each day on food.
This Spanish study, Bes-Rastrollo noted, shows that "a healthy Mediterranean dietary pattern is more expensive to follow than a Western dietary pattern and I am sure that the same study conducted in the United States would find the same results or even higher differences in costs between dietary patterns."
This "economic barrier" should be considered when counseling populations about following a healthy diet "because cost may be a prohibitive factor," she added.
The researchers also report that 31 percent of study subjects gained weight during the study - just over half a kilo, or 1.1 pounds, every year - and, after adjusting for factors likely to influence the results, people who spent the most on food were 20 percent more likely to gain weight, regardless of which dietary pattern they favored.
Those who had higher food bills tended to be older, were more likely to have quit smoking, tended to drink more calorie-laden fruit juice, soft drinks and alcohol and generally weighed more to begin with - suggesting that they were more prone to weight gain due to lifestyle or genetic factors, the researchers note.
SOURCE: Journal of Epidemiology and Community Health, September 2009.
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Hepatitis B Vaccine Fails in Half of all Celiac Patients: Is it Time to Re-evaluate Current Immunization Strategies?
http://www.celiac.com/
Celiac.com 09/21/2009 - Failure of the hepatitis B vaccine in people with celiac disease is common. In fact, vaccine failure occurs in about 50% of all attempts to vaccinate people with celiac disease against hepatitis B. Research shows that age at celiac diagnosis and other factors can influence response rates.
The August 12 issue of the medical journal Vaccine features a timely article on failure of the hepatitis B vaccine in people with celiac disease, which asks the very sensible question of whether it is time to reevaluate our current vaccine procedures.
One of the most important signs of non-responsiveness to the hepatitis B vaccine is a genetic marker called human leukocyte antigen (HLA) phenotype DQ2. It's interesting that people with celiac disease often carry these same genetic markers, and that fact is at the center of one hypothesis about why celiac patients are less able to respond to the hepatitis B vaccine.
A team of researchers recently set out to assess responsiveness rates to the hepatitis B vaccine among patients with celiac disease. The team was made up of S. Leonardi, M. Spina, L. Spicuzza, N. Rotolo, and M. La Rosa of the Broncho-Pneumology & Cystic Fibrosis Unit of the Department of Pediatrics at the University of Catania, in Catania, Italy.
The team describes the results of a retrospective study on celiac patients vaccinated with three intramuscular injections of recombinant hepatitis B vaccine (Engerix B) in doses of 10mug at 3, 5 and 11 months of age.
Their results showed that half of the celiac disease patients (50%) failed to respond to the vaccine course, and that those who did best were less than 18 months of age at the time of diagnosis for celiac disease; that group showed a significantly higher response rate to the vaccine.
The study confirms that celiac patients have a far higher failure rate for hepatitis B vaccination than healthy control subjects. These results strengthen the call to re-evaluate current hepatitis B vaccine strategies for patients with celiac disease and to assess whether to recommend a course of re-vaccination.
Source: Vaccine - August 12, 2009
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Prisons can't contain rising medical costs
http://www.hutchnews.com
By Ken Stephens - The Hutchinson News
Health care costs have spiked with a population growing older and sicker
The health clinic at the Hutchinson Correctional Facility sees more than 1,000 prisoners a month for everything from minor illnesses to end-of-life care, from regular blood pressure and glucose monitoring to dental work, eye exams and psychiatric treatment.
The clinic, with 75 employees, is open 24 hours a day, seven days a week and can handle just about anything short of surgery and advanced life support.
Inmate health care there and at similar clinics at Kansas' other prisons will cost the Kansas Department of Corrections $46.5 million in the 2009-10 fiscal year. That's up 116 percent from the $21.4 million KDOC paid in 2000.
By another measure, the cost of medical care has grown from 10.3 percent of the department's total operating costs in 2000 to 17 percent today.
And there are plenty of reasons to worry that the cost of inmate medical care will continue to rise, including a predicted increase in the number of inmates and a prison population that is growing older and consequently sicker.
"The primary factor," Secretary of Corrections Roger Werholtz said, "is what everybody is experiencing - health care costs are just going up. Part of the reason is that what were a lot of new and experimental pharmaceuticals and procedures are no longer experimental but community standards of care now. HIV and hepatitis C were really considered terminal illnesses with very poor prognosis. Now people are being managed with those illnesses for very extended periods of time. And we are obligated to extend that care when medically indicated."
That obligation stems from a 1976 U.S. Supreme Court ruling in a Texas prison case. The court said states are required to provide "adequate medical care" and cannot be "deliberately indifferent" to those needs. Subsequent court decisions have refined and defined those terms. But basically, if prison officials know of a medical need, they cannot disregard it.
At the main Hutchinson Correctional Facility, there are a couple of examination rooms, an X-ray facility, four infirmary beds for 24-hour care, three reverse air-flow isolation beds for patients with communicable diseases such as tuberculosis, two rooms used by full-time dentists, another room for eye exams and other areas for mental health services.
Kansas prisons have about 75 infirmary beds system wide, and all those are usually occupied, said Viola Riggin, KDOC's director of health care services. A new 45-bed clinic under construction at Lansing will open in July 2010, resulting in a net gain of about 29 beds.
But when their conditions can't be cared for within the walls, inmates go to hospitals in the nearby community, where medium- and maximum-security inmates are accompanied by guards who maintain a 24-hour-a-day watch. Riggin said KDOC averages about 48 patient days a month in community hospitals.
KDOC also has designated centers of excellence at various correction facilities where inmates with particular ailments are consolidated for more cost-effective care by specialists. At any one time, there are about 25 inmates getting chemotherapy or other cancer treatment at the El Dorado Correctional Facility, Riggin said. El Dorado also is the center for physical and occupational therapy. Lansing is the center for dialysis and cardiac care.
Because of a growing number of inmates with hepatitis, last year KDOC spent $23,500 to buy insurance to cover the cost of kidney transplants. However, Riggin said KDOC hasn't had an inmate requiring a transplant in her seven years with the department.
Kansas inmates are charged $2 for an initial sick call at the prison clinics, but they do not have to pay if they don't have funds. If their medical complaint requires follow-up visits, they are not charged for those.
Inmates do not have to pay for medications. But KDOC and Correct Care have wielded their bulk buying power to obtain those medications for 39 percent of the retail price, Riggin said. That program was recognized for an Innovation Award in 2006 by the Council of State Governments for allowing other state and local government agencies to piggy back on KDOC's pharmaceutical contract, saving small counties up to $6,000 a month and large urban counties more than $200,000 a month.
Inmate medical care also includes what Riggin called "clinical discharge planning" to ensure that inmates are ready for release back into the community and to monitor them for 90 days after their release.
KDOC, she said, doesn't want inmates failing to meet conditions of parole or committing new offenses because they've gone off medication or can't see a psychiatrist on the outside.
Of the $25 million increase in the cost of inmate medical care over the past 10 years, a major portion came in 2006, when the cost jumped from $27.1 million the previous fiscal year to $40.8 million.
Riggin said that was because the state had an artificially cheap contract with Prison Health Services, the company that held the contract for providing inmate medical care early in the decade. Prison Health Services, she said, was hemorrhaging money under the contract and sought without success to get the state to renegotiate. When that failed, Riggin said, the company paid $6 million to Correct Care Solutions to take over the contract in October 2003. Correct Care also lost money on the contract until it expired and a new deal was negotiated in 2006.
Of the $63.3 million increase in KDOC's annual operating budget since 2000, nearly 40 percent can be attributed to the rising cost of inmate medical care.
When state revenue shortfalls forced every state agency to cut its budget this year, Werholtz decided to close four small facilities and two conservation camps, but he was able to cut only $675,000 from the inmate health care budget, proportionately less than other elements of his operating budget.
"Obviously, we found a way to trim (the health care budget)," Werholtz said. "Basically we're doing that by holding positions open. It's something we don't like to do because we don't want to get into a position where we're withholding health care."
One thing the rising cost of health care can't be blamed on is the size of the prison population, which is down about 7 percent since 2004. As of Aug. 31, there were 8,626 prisoners in the system.
Because the cost of medical care has risen at the same time the prison population has declined, the cost per prisoner has gone from $2,772 a year in 2001 to an estimated $5,407 in 2009-10.
Riggin points out that prison inmates typically have more medical problems than the average person on the outside. That's because many inmates come from backgrounds of poverty, where they couldn't afford to see doctors routinely or to take daily maintenance drugs. Many also were involved in illegal drugs that took a toll on their bodies.
"We get inmates coming to us very worn down and ill," Riggin said.
More than 4,000 inmates in the system have chronic illnesses, she said.
Those include conditions such as asthma, cardiac problems, hypertension, congestive heart failure, seizures, diabetes, renal failure, hepatitis and HIV, she said.
Those types of problems may well grow in coming years because the prison population is getting older for a couple of reasons.
First, sentencing laws requiring inmates to serve 20, 25 or 50 years before becoming eligible for parole for crimes such as felony murder, treason, first-degree murder and first-degree murder with aggravating circumstances have led to a growing number of aged prisoners.
In 1998, there were only 575 prisoners age 50 or older. At the end of the 2009 fiscal year, there were 1,232 prisoners age 50 or older, an increase of 114 percent.
The number of prisoners serving "life" sentences has grown from 782 in 2002 to 857 in 2008.
Second, the percentage of new inmates who are 40 or older when they arrive to begin serving their sentences also is on the rise. In the early '90s, only about 11 percent of the new inmates were 40 or older. That figure has been at least 21 percent every year since 2000. In 2009, 25.8 percent of the new inmates were 40 or older.
Both those factors could push the cost of medical care higher. So could an expected increase in the number of inmates.
Unrelated programs cut because of state budget problems will force KDOC to hold on to prisoners longer, which Werholtz said will cause the inmate population, which had declined about 7 percent since 2004? , to start growing again, and faster than earlier projections.
"I wouldn't say I'm alarmed (about health care's growing share of the budget)," Werholtz said. "But we are always concerned about things that are harder to control. It's no different than utility costs. ... You have to have electricity, you have to have water, you have to have heat, and there's very little you can do to control the costs other than some conservation. It's the same with health care. ... We just have to make sure health care is provided as effectively as possible. But we can't control the costs of a heart catheterization or dialysis or an HIV drug regimen."
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September 23, 2009
Lawyers: More cases of hepatitis discovered
http://www.lasvegassun.com
By Jeff German
Endoscopy clinic infected at least three more patients, plaintiffs’ attorneys say
Lawyers suing the Endoscopy Center of Southern Nevada say they have discovered a new cluster of hepatitis C cases that originated at the clinic and predict the discovery will have a big impact on the massive litigation over the outbreak.
“This is just the tip of the iceberg,” attorney Will Kemp said Tuesday. “I think we’re going to find more and more clusters as we go forward.”
The Southern Nevada Health District has identified July 25, 2007, and Sept. 21, 2007, as the dates when the potentially deadly virus was known to have been transmitted at the Endoscopy Center, run by Dr. Dipak Desai. Tests revealed that one person was infected there on the July 25 date, and six picked up the virus on the Sept. 21 date, officials said.
But in court papers filed Tuesday, the plaintiffs’ lawyers said they have uncovered evidence independent of the health district that “strongly suggests” the virus was also transmitted to at least three patients who underwent colonoscopies at the Endoscopy Center on March 15, 2007.
The three patients, whose identities the lawyers are withholding for privacy reasons, are represented separately by three of the lead law firms suing Desai and the Endoscopy Center for malpractice.
The three firms — Kemp, Harrison & Jones; Mainor Eglet Cottle; and Gillock, Markley & Killebrew — made the discovery after months of comparing medical records of all of their clients in the case.
According to the lawyers and their court papers, the same physicians, nurses and nursing assistants participated in the colonoscopies of the three patients all within 90 minutes on March 15, 2007. “Patient A” underwent a colonoscopy at about 9:05 a.m., “Patient B” had one at 9:35 a.m. and “Patient C” went through the procedure at 10:35 a.m.
The lawyers said medical records show all three cases involve the same genotype, or strain, of the hepatitis C virus, as well as the same anesthetic, Propofol. The lawyers contend that the sloppy handling of vials and syringes containing Propofol led to the infections.
The discovery is expected to give the plaintiffs’ lawyers ammunition to attack the defense’s claim that there was no widespread abuse of procedures at the clinic.
“This is pretty compelling proof,” attorney Nia Killebrew said. “It goes toward establishing that it wasn’t just an isolated incident or two. This was indeed a pervasive practice at this clinic.”
Attorney Robert Eglet said he and his colleagues aren’t finished sharing records and plan to extend their cooperation to other law firms suing the Endoscopy Center, as they work to learn how their clients were infected.
“I’m confident that we’re going to find additional clusters out there,” Eglet said.
Brian Labus, the health district’s senior epidemiologist, said this was the first he’d heard of a new grouping of infections linked to the clinic, but that he was not surprised.
“We know that there were other days when there was potential for transmission,” he said.
He added, however, that he expects the discovery to have a greater impact on the litigation than the health district’s investigation into the hepatitis C scare.
“In the end, it doesn’t change the findings that we discovered in our investigation,” he explained. “We weren’t trying to find every case. We were looking at the big picture of what happened there.”
He said the health district expects to make public a final report of its 18-month investigation soon, but has not set a date for its release.
In their court papers, the plaintiffs’ lawyers listed the three patients as new witnesses in the case and said they would turn over copies of “relevant medical records” of the patients to the defendants as part of their obligation under the court’s rules.
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Discovery could improve hepatitis C treatment
http://www.eurekalert.org
Walter and Eliza Hall Institute researchers are part of an international team that has discovered a genetic variation that could identify those people infected with hepatitis C who are most likely to benefit from current treatments.
Dr Melanie Bahlo and Dr Max Moldovan from the institute's Bioinformatics division worked with researchers from the University of Sydney and elsewhere to analyse the genomes of more than 800 people, including more than 300 Australians, who were receiving treatment for chronic hepatitis C infection.
Their genome-wide association study of people receiving hepatitis C treatment revealed that genetic variants near the interferon gene IL28B were associated with people's response to treatment.
Three per cent of the world's people are infected with hepatitis C and few are able to clear the virus without treatment.
The standard treatment is a combination of pegylated interferon-alpha and ribavirin (PEG-IFN-alpha/RBV). However this treatment is expensive ($20,000 per person in Australia), can have serious adverse effects and is unsuccessful in 50-60 per cent of cases.
At present it is not possible to identify the 40-50 per cent of people who will respond well to treatment.
To address this problem, Dr Moldovan and Dr Bahlo are building and evaluating statistical models that incorporate genetic variants, in combination with clinical and baseline factors, to best predict treatment outcome.
Through this approach the research team found that people having a specific genetic profile at a genetic variant called rs8099917 showed the strongest virological response when undergoing treatment.
The research results were published online last week in the international journal Nature Genetics. Two other research papers validating the same finding have been published in the past month.
Dr Bahlo said with the knowledge of the gene variants it would be possible to develop a diagnostic test, based on a person's genetic profile, to identify those who are likely to respond to treatment with PEG-IFN-alpha/RBV.
Further, the location of the newly-discovered genetic variant opens the way for development of a more effective hepatitis C treatment, which is likely to result in fewer adverse effects than PEG-IFN-alpha/RBV.
Finding effective treatments is essential as many people infected with hepatitis C become chronic carriers of the disease and may develop liver cirrhosis or liver cancer.
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For further information contact Penny Fannin, Strategic Communications Manager, on +61 3 9345 2345, 0417 125 700 or fannin@wehi.edu.au
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Hope for Hepatitis C patients: two new drugs on horizon
http://www.ksdk.com
By: Kay Quinn
KSDK -- Hope for some of the 40 thousand people in St. Louis living with Hepatitis C.
Local researchers are on the brink of proving that two new drugs will cure almost 80 percent of all cases.
Some of those infected with this liver disease say living with it is like waiting for a bomb to go off.
That's because most people don't even know they have Hepatitis C, and once it's diagnosed, the liver can already be permanently damaged, leading to cirrhosis, cancer and death.
But thanks to two promising new drugs, that's all about to change.
"I was really surprised," recalled Peter of his hepatitis C diagnosis, "and I was scared and my first thought was liver cancer because that's the worst thing that can happen."
Peter is a husband and father of two who asked that we only use his first name. He says for decades, he lived with the fear of knowing he had hepatitis C.
"No one wants to go through life with a disease that they don't know when all of a sudden its going to jump up and get you," says Peter.
In the past ten years, two drugs: peg interferon and Ribavirin have been found to cure up to 50 percent of cases. But Dr. Bruce Bacon, a St. Louis University researcher, is just wrapping up clinical trials of two new drugs that will dramatically boost that cure rate. The drugs are Telaprevir and Boceprevir.
"We expect with these new protease inhibitors to be in the 70 to 80 percent range," says Dr. Bruce Bacon, a St. Louis University School of Medicine researcher and director of the division of gastroenterology and hepatology.
Hepatitis C is spread through blood-to-blood contact, and the drugs work by interfering with virus's ability to replicate.
They won't replace interferon and Ribavirin. They'll be added to them.
Still getting people to be screened and treated for Hepatitis C is a challenge. And so is getting patients to treatment.
"I didn't want to do it because I heard the side effects are terrible," says Peter.
But after much encouragement from his doctors, Peter spent the past year helping to test the drugs.
Nausea was his worst side effect. But today, he's amazed at how much better he feels, physically and emotionally.
"This past year, I kid you not, was probably the best year of my life even though I was on this drug," says Peter. "But the support I got from Dr. Bacon's people, and from my job, and my family, I mean I felt so good about myself."
There is still a great deal of stigma surrounding hepatitis C, but it's hoped these new treatments that will be widely available in 2011 will help tear down some of that.
A group called "Friends of the St. Louis University Liver Center" will host the 7th annual Denim and Diamonds fundraiser on September 26th to raise money for liver disease research.
Country singing star Naomi Judd, who was cured of her hepatitis C by Dr. Bacon, will return for the fundraiser this year.
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Shasta County supervisors extend needle exchange program
http://www.redding.com
By Amanda Winters
The Shasta County Board of Supervisors voted Tuesday to extend the public health department's syringe-exchange project through September 2012.
The project, started in September 2006, allows intravenous drug users to trade one used "dirty" needle for one new "clean" needle, Shasta County Public Health Director Donnell Ewert said.
Ewert said the project, which costs about $19,000 a year, helps prevent the spread of blood-borne diseases, such as hepatitis C and HIV, by allowing users to get clean needles instead of sharing and using dirty syringes.
Shasta County Health Officer Andrew Deckert said the syringes pose a danger not only to intravenous drug users but also to law enforcement agents who risk getting stuck by needles when patting down suspects. Waste facility workers also are at risk when sorting through garbage, he said.
Since the program began, 126 unique clients have come to the two exchange stations, Deckert said.
Nearly 85 percent of clients were tested for sexually transmitted infections, and 84 percent got HIV tests, he said. The exchange stations also supply health education materials, condoms and referrals to testing and drug treatment programs. He said 83 percent were referred to formal drug treatment, and at least three people have come forward saying they've quit drugs because of the help they received.
Some 4,310 pounds of dirty needles had been deposited in the project's safe kiosks posted around the county through July, Deckert said. Rates of Hepatitis C, HIV and Hepatitis B have declined since the program started, he added.
But the numbers weren't enough to convince all the supervisors that the program was worth it.
Supervisor Les Baugh told Deckert he wanted to see more done to get drug users to treatment.
"I'm not willing to settle for three people," he said. "Their lives are too important."
Supervisor Glenn Hawes said he knew of a woman who lost her children because of her drug use, but through the program she was able to get treatment, get clean and ultimately get her family back.
"That one person is worth a year of this," he said.
Supervisor Linda Hartman said she didn't support the project in 2006 and doesn't support it now.
"I still do not believe the needle exchange is the way to go," she said, adding that the data was not convincing enough.
Ewert contended that the contact the exchange center has with drug users is important and without it fewer of them would get the help they need.
Supervisor and former Redding Police Chief Leonard Moty said he found it hard to support the program but saw the value in protecting innocent bystanders, such as police officers, who could get stuck by a dirty needle.
"I think they (drug users) are going to get the needles anyway (without the project)," he said. "They'll get them elsewhere and they'll probably be dirty."
Hartman said even the clean needles handed out at the exchange center won't be clean for long.
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Unanimous support for free crack pipes plan
http://www.canada.com
By Philip Round,
ComoxValley Echo
A crack cocaine pipe education and harm reduction program has won the unanimous support of Courtenay councillors.
The program includes stepping up the distribution of free equipment to people smoking crack illegally to try to cut down the spread of diseases.
The idea is being promoted by AIDS Vancouver Island, which last night sent a delegation to the city council to urge written support for the program.
Getting local government backing for what some see as a controversial idea is a requirement of Vancouver Island Health Authority before the local program can tap into further funds.
To emphasize the authority's own support for the idea, VIHA's north island medical health officer, Dr. Charmaine Enns, spoke as part of the delegation.
The others were Heidi Exner, manager of health promotion and community development with AIDS Vancouver Island; and Sara Sullivan, a positive wellness counselor and harm reduction worker with the same organization.
The three-pronged plan aims to:
- Decrease harms associated with crack use, including chronic cuts, wounds, blisters, burns and open sores on lips, hepatitis C and other diseases, including tuberculosis.
- Increase the level of awareness of risks associated with crack cocaine use and help users reduce the risks associated with their behaviour.
- Get more users connected to services that could help them, such as AIDS Vancouver Island's own positive wellness program, and referrals to other health and social services agencies.
The delegation stated that smoking crack was a relatively neglected public health issue in Canada. But it was already very prevalent in the Comox Valley, said Sullivan.
In a written submission, the three jointly commented: "People who smoke crack are extremely vulnerable to the transmission of hepatitis C and B and tuberculosis and are known to participate in other risky behaviours, such as unsafe sex."
As a harm reduction measure, they noted that free "safer crack use kits" are already issued in several Canadian cities. The aim is not only to encourage safer behaviour among people who smoke crack, but also to forge direct contacts between users and social and health care workers.
The kits provide the basic equipment users need to smoke, such as stems or pipes, filters and rubber mouthpieces.
Like needle exchanges, the issue of such kits is frequently controversial because the taxpayer pays for the equipment.
That issue was raised by Coun. Jon Ambler, who described it as "an extremely thorny and complex issue" that definitely caused public concern.
People questioned whether public money should be spent on something that allowed illegal drug-taking activity to take place. There was also the issue of why such materials were given out free when veterans, for example, had to pay for their medical supplies.
But if it could be shown that the program actually cut wider healthcare costs and helped reduce the risk to healthcare workers and others, he would endorse it.
Enns said the initiatives paid for themselves many times over by reducing the spread of diseases like Hepatitis C, which otherwise had to be tackled from public funds.
The program decreased health costs, lowered risk to the health of the wider community, prevented additional illnesses and helped save lives. Further, it helped bring marginalized people back in to society and into the health care system.
Mayor Greg Phelps said his views on the issue had changed after he read details of two studies carried out in Vancouver and Victoria.
The cost issues had opened his eyes to another perspective and forced him to reexamine his own beliefs.
"I was somewhat skeptical," he said. "But now I count myself amongst the converted."
Enns added that while people could have strong views about drug use, it was not the role of health professionals to be judgmental.
Their objective was to treat illness and to reduce the risk of further illness without picking and choosing which patients deserved help.
They did not, for example, refuse to treat tobacco users because they choose to smoke, even though the dangers were clear; nor would they decline treatment to those who were injured in car crashes because they were not wearing a seat belt.
Sterile and safe crack pipe kits did not encourage substance abuse, but helped reduce the level of harm.
Councillor Ronna-Rae Leonard insisted the issue was very significant in the local community and support must be given to the health professionals.
"We are not supporting illegal drug use but we are supporting better health and we need to see it that way," she said.
While voting in favour of the proposal, Coun. Larry Jangula was not convinced it would do a lot of good. "It's a Band Aid on a severed arm," he commented. "I'd rather the money went in to treatment."
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Everyone Should Be Tested for ‘Hidden Disease’ of Hepatitis C
http://www.brooklyneagle.com
By Betty Vega
There are an estimated 200 million people worldwide infected with HCV — ”making it one of the greatest public health threats faced in this century, and perhaps one of the greatest threats to be faced in the next century. Approximately five million people across the country are infected with Hepatitis C. It is five times more prevalent than AIDS and approximately 10,000 people die annually as a result of HCV. 65% of those infected with Hepatitis C are between 30 and 49 years old.
Hepatitis C is often called a “hidden disease” or “silent epidemic” because those infected with HCV are often unaware for 10-30 years after exposure. The symptoms of HCV are easy to misdiagnose and often resemble the flu or a variety of other conditions. When symptoms are present they can include extreme fatigue, nausea, liver pain, and depression.
Hepatitis C is a blood-borne virus that predominantly infects the cells of the liver. This causes inflammation of and sometimes significant damage to the liver, thus affecting its ability to perform essential functions. There are several ways one can contract the virus. Having had a blood transfusion prior to 1992, being born to a mother with hepatitis C or needing a C-section; having sex with an infected person (if blood is present); being tattooed or pierced with unspecialized tools that were used on an infected person; getting stuck accidentally with a needle used on an infected person; sharing an infected person’s razor, hairbrush, comb or toothbrush; sharing drug needles with an infected person and manicures or pedicures.
This is where the need for education and awareness arises. Through standard blood workup procedures, hepatitis C will not show up. Unfortunately even with elevated liver enzymes, doctors don’t equate that with hepatitis C. For the most part, physicians don’t know nearly enough about the virus. People should see a gastroenterologist or better yet, a hepatologist, who will have more knowledge about diagnosis for hepatitis C. The only way to determine if you have this virus is by having a hepatitis C test, exclusively.
Without treatment, approximately 20% of those untreated will develop cirrhosis, (fibrosis occurs when extensive scar tissue develops), liver cancer, or will need liver transplantation (when liver no longer can function) or face death.
I went through years of annual blood workups displaying elevated liver enzymes and was told it meant nothing. Could be from taking other meds or being overweight; never going forward with any other testing. I met a new primary care physician in 2002 who, after seeing my blood results, told me to get this other test I had never heard about. So I went to the lab, got tested for hepatitis C and got the phone call at work. I was positive.
My reactions were mixed; mostly shock. I did, however, follow her directions and saw a hepatologist who treated me for a year and a half. The news was wonderful. I had cleared this virus. It was four years September 13th. I’m one of the lucky ones. This year I lost a couple of friends who were never treated for the virus. They became quite ill and eventually their livers gave out. It doesn’t have to be that way. I’ll never know how I got it or exactly how long ago. At this point it doesn’t matter. Getting tested is the only thing that matters. It’s life or death.
Betty Vega, a hepatitis C survivor, is support group facilitator for the disease at Long Island College Hospital. She can be reached at BettyV444@aol.com for more information.
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The 60th Annual Meeting of the American Association for the Study of Liver Diseases
Boston, MA – Hynes Convention Center
October 31 – November 3, 2009
The Liver Meeting® is the premier meeting in the science and practice of hepatology, including the latest findings on new drugs, novel treatments, and the results from pilot and multicenter studies.
Approximately 10 percent of Americans have some form of liver disease, and the diseases strike disproportionately among certain populations but mostly regardless of lifestyle choices. There are now numerous treatments for both hepatitis B and C, and screening, treatment, and prevention of hepatitis remain important issues. Liver cancer is one of the few cancers growing in incidence, and the obesity epidemic has dire consequences for the nation’s liver health and wellness.
The almost 2000 abstracts addressing these issues that will be presented are available to members of the press at our website (www.aasld.org), including 240 abstracts that will be presented in oral sessions.
- Where:
Boston, MA – October 31 - November 3, 2009
- Poster Presentations:
October 31 – November 3
- Oral Presentations:
November 1 – 3
An AASLD President’s press conference highlighting key abstracts and issues presented at the Liver Meeting® is scheduled for Saturday, October 31 at 4:00 pm.
Founded in 1950, AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD has grown into an international society responsible for all aspects of hepatology, and our annual meeting attracts 7,500 physicians, surgeons, researchers, and allied health professionals from around the world.
Please contact AASLD at 703-299-9766 for information about the above presentations, or to receive any additional information about The Liver Meeting® – or visit our website at www.aasld.org.
Please contact Ann Tracy to register as press for the meeting: 703-299-9766 or atracy@aasld.org.
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September 24, 2009
HCV: Wait for Something New or Treat Now?
http://www.aidsmeds.com
by David Evans
Some people coinfected with both HIV and hepatitis C virus (HCV) are holding out for new treatments that will improve their chances of permanently clearing HCV. David Evans talks with HCV/HIV coinfection activist Tracy Swan to find out whether the current crop of experimental agents will be worth the wait.
Some people coinfected with both HIV and hepatitis C virus (HCV) have told AIDSmeds.com during the past year that they are waiting on the arrival of new HCV protease and polymerase drugs before staring HCV treatment. Their rationale is that the new treatments might be much less toxic and more effective than today’s pegylated interferon-ribavirin combination therapy.
Waiting for better treatments is not an unreasonable desire. The side effects of interferon and ribavirin are sometimes quite serious and debilitating, and frequently unpleasant. To make matters worse, the side effects aren’t matched with high rates of treatment success. HCV treatment is effective for only 15 to 30 percent of coinfected people in the United States because most of them are infected with the most insidious strain of HCV: genotype 1.
The risks of waiting to start hep C treatment are not inconsequential, however. Liver damage from HCV develops and progresses more rapidly in people coinfected with HIV and HCV. People with serious liver scarring from hepatitis C—called cirrhosis—are at risk for liver failure and liver cancer.
To get the scoop on the progress of experimental treatments for HCV and their possible influence on treatment for people who are coinfected, AIDSmeds checks in with Tracy Swan, hepatitis/HIV project director of the Treatment Action Group in New York City.
People are hoping that the new treatments might allow people to forgo using pegylated interferon and/or ribavirin. What are the prospects for that?
The ultimate goal is to get rid of peg-interferon and ribavirin, but it’s clear from trials that ribavirin is here to stay for a while, at least for use in combination with newer agents, since it boosts response rates and lowers the risk of relapse after HCV treatment.
As far as interferon, nobody knows whether a combination of antiviral drugs will be enough to get rid of HCV for good, or just keep it suppressed during treatment. Interferon and ribavirin work to stimulate the immune system and fight viruses, so it is not clear whether fighting the virus without kick-starting the immune system will do the job.
In terms of what that means for when those newer drugs might become available for people who are coinfected, are we talking about a couple of years after the trials first start?
Well, the development plan [for people infected with only HCV] is further along, and if everything goes well they should be on the market by 2011.
In that case, even though the coinfection studies may not be completed, or have fully reported their results, it might still be possible for people who are coinfected to have access to the new drugs?
Yes, doctors can prescribe them, and one reason why activists have been fighting so hard for coinfection trials is that we need to see if the drugs are safe and effective in people who are coinfected. We also need to know if there are any drug interactions that would make them difficult to use with HIV drugs. The first coinfection trials are slated to open later this year with hepatitis C protease inhibitors, Schering-Plough’s boceprevir and Vertex’s telaprevir.
Each of the drugs has a different profile. Both of them seem to be boosting response rates in Phase II studies, but they’re not going to make the current standard of care less toxic—and they add side effects, because you’re adding another drug.
When we’re looking at a response rate in people who are coinfected of about 15 to 30 percent, what might be considered a sufficient improvement to warrant the additional side effects?
There’s so much room for improvement. I think the things that would be most appealing would be a shorter course of treatment and higher response rates.
Might there be success with shorter duration of treatment in people who are coinfected?
I suspect no, only because people who are coinfected have higher hepatitis C viral loads than people who are infected with HCV alone and current therapy is less effective in coinfected people. You could look at people infected with just HCV, who haven’t responded to a first round of HCV treatment and are getting retreated, and that might be the closest comparison group. This is where I think that Jules Levin [from the National AIDS Treatment Advocacy Project] has a good idea.
And what’s that good idea?
Because of the higher viral loads and because current therapy doesn’t work as well in people who are coinfected, it’s probably going to be best to wait until there are drugs from different classes that can be combined with each other and with pegylated interferon and ribavirin to lower the risk of HCV drug resistance.
This is because the new drugs are similar to many HIV drugs, in that it is easy to develop drug resistance?
Exactly. In fact it may be easier with the hepatitis C drugs.
If a person becomes resistant to one of the new drugs, is he or she likely to have cross-resistance with other similar drugs in the pipeline?
Yes, unfortunately. In HIV, with protease inhibitors, they’re not all cross-resistant; you still have other options within that family of drugs. So far it’s looking like that’s not the case with hepatitis C drugs.
Some people are trying to weigh the risks of starting HCV treatment versus waiting. Given what we know about the more rapid progression of liver damage in people who are coinfected, what should people consider to help them make that decision?
It’s kind of complicated. About 30 percent of coinfected people appear to be rapid progressors with their hepatitis C. People who are heavy drinkers and people with fewer than 200 CD4 cells are at greater risk for serious liver disease from hepatitis C, but there’s a whole lot we don’t know about who might be a rapid progressor. People can do a few things, like reduce the amount of alcohol they drink, or not to drink at all. If they’re not on antiretroviral therapy, getting the CD4 count up may help prevent the liver damage, but those aren’t really substitutes for getting a biopsy and finding out what’s going on inside the liver.
Basically, the more liver damage a person has, the less likely that HCV treatment is going to work. So you don’t want someone to wait too long, because we don’t really have a salvage therapy. If someone is stable, they’re not a rapid progressor and they’ve been successful at making some of the very difficult lifestyle changes, they might decide that they’re comfortable with just monitoring their liver progression and waiting for a little while.
Do we know when we might see these new experimental drugs tested in combination with each other?
Actually, Roche is doing a study right now combining a hepatitis C protease inhibitor (R7227) with a hepatitis C polymerase inhibitor (R626), and the results from that short Phase I study will be presented at the [American Association for the Study of Liver Diseases] in November.
So we might have a first glimpse quite soon?
Yeah, I’d say it’s a glimmer or a proof of concept, and I think it’s very exciting and could be the way forward—but one limitation is that the current hepatitis C therapy works both by stimulating the immune system and fighting the virus directly, and we just don’t know what’s going to happen without interferon, that immune component. So we’ll have to see, or we’re going to be stuck in the same treatment paradigm.
Do any studies look at how or when it might be possible to treat HCV without interferon?
No, this is the first pioneering study, because they had to see if the drugs could be used together in the first place, and how much will they drop the virus, and will it stay suppressed after you take the drugs away?
Anything else you think people should consider about deciding when to treat HCV?
It’s a really tough decision, and a lot depends on how comfortable someone feels with risk in either direction: the risk of trying a treatment that has a lot of side effects and might not work, versus the risk of waiting and getting more liver damage. So it’s a really tough thing. I think that talking to other people who’ve been through treatment, and maybe getting a second medical opinion might really help people get to the point where they’re comfortable with whatever they decide.
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Rockefeller virologists and MIT tissue engineers receive $5.8 million NIH grant to study hepatitis
http://newswire.rockefeller.edu
Scientists studying hepatitis at Rockefeller University and the Massachusetts Institute of Technology will receive a $5.8 million grant to study hepatitis infection under the National Institutes of Health’s inaugural Transformative R01 grant program, a groundbreaking initiative designed to encourage high-risk research. The grant, which will run for five years beginning in 2009, will fund efforts to elucidate the notoriously complex mechanisms underlying disease progression in hepatitis B and C virus infection.
Chronic infections with hepatitis B and C viruses, which take root in the liver, affect an estimated 500 million people worldwide, leading to diseases including hepatitis, cirrhosis, liver failure and cancer, and causing more than 1.5 million deaths each year. Though a vaccine and several drugs that target the hepatitis B virus exist, there are no vaccines for hepatitis C, and numerous obstacles stand in the way of developing treatments. Both viruses, for example, employ robust replication systems that are difficult to permanently disrupt. The hepatitis C virus, furthermore, has already exhibited resistance to antiviral drugs currently available to help fight it. Coinfection with both viral strains is relatively common, compounding their individual impacts. And scientists do not currently have in vitro or in vivo models that accurately imitate human liver biology and pathogenesis, which would help facilitate research.
In collaboration with Sangeeta N. Bhatia, professor in the Harvard-MIT Division of Health Sciences and Technology, researchers in Rockefeller’s Laboratory of Virology and Infectious Disease, headed by Charles M. Rice, Maurice R. and Corinne P. Greenberg Professor, first aim to address this last issue by refining cell culture techniques recently developed by Bhatia and Salman Khetani, a former postdoctoral associate in Bhatia’s laboratory who is now director of research at Hepregen. Recent investigations with such cultures by Alexander Ploss, a research associate in the Rice lab, have already revealed important insights about the disease progression of the two viruses. The team is also developing three-dimensional human liver organoids for use in mice reconstituted with a human immune system. With these tools, Rice, Bhatia, Ploss and their colleagues propose to characterize hepatitis B and C infections, to clarify how they influence each other on both the cellular and systemic levels and, ultimately, to inform the development of novel preventive and therapeutic remedies.
The Transformative R01 (TR01) program was launched this year under the NIH Roadmap for Medical Research, an umbrella program established in 2004 to identify and address traditional roadblocks to innovative research. TR01 grants support exceptionally innovative, high-risk, original and/or unconventional research projects that have the potential to create or overturn fundamental paradigms. These projects tend to be inherently risky, but if successful can profoundly impact a broad area of biomedical research.
Before joining Rockefeller University in 2000, Rice completed his Ph.D. in biochemistry and postdoctoral studies at the California Institute of Technology and served on the faculty of the Washington University School of Medicine for 14 years. Rice is the executive and scientific director of the Center for the Study of Hepatitis C, an interdisciplinary center established jointly by Rockefeller, NewYork-Presbyterian Hospital and Weill Cornell Medical College. Rice is a member of the National Academy of Sciences.
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Woman wins 'lonely battle' with infectious disease
http://www.stltoday.com
By Harry Jackson Jr.
St. Louis Post-Dispatch
Marlene Barron learned a lesson from her life-and-death battle with hepatitis C: that accepting a helping hand is as valuable as giving one.
Before the illness, she prided herself in her self-sufficient, heartland spirit of not asking for help.
"I was private and prideful," she said. "I found that wasn't very healthy."
The lesson began shortly after Barron was infected in June 2003 with hepatitis C through a medical accident.
Six months after exposure, symptoms broke out.
"It was the flu times 100," she said. The drugs were just as debilitating. Worse, they didn't work.
She hid her illness because hepatitis C is sometimes stereotyped as a disease of misbehavior, especially drug abuse.
But infections can stem from anything that exposes someone to someone else's blood.
According to the National Institutes of Health, the hepatitis C infection rate is four times higher than HIV disease.
Many people don't know they're infected. Untreated, the disease can cause liver cancer.
Fear and Aversion
Barron took a year off from work and spent most of her time in bed. "My husband was virtually a single parent to our twin daughters," she said. "He did everything."
Still, she continued to hide, expecting ridicule.
"It was a lonely battle, because I was fearful of rejection by my friends."
She shared her plight with fewer than 10 people.
Then, a friend said, "Do you think the people you associate with would treat you that way?"
She began discussing her plight, and friends rushed to her rescue. Church members, neighbors and friends pitched in with house cleaning, child care, shopping, meals.
"I didn't understand how wonderful people were until I found my neighbor coming by and washing our clothes for us," said Barron's husband, Cory Barron.
A friend introduced her to a website called "CaringBridge.org," best described as a Facebook for people with devastating illnesses.
Barron joined, explained her illness and wrote a weekly, sometimes daily, diary.
That brought help from people she'd never met.
"A woman wrote she wanted to know about me so she could pray for me," she said. Another stranger helped her win coverage from her health insurance company.
Rather than feel ashamed, she said, she felt better.
Miracle Doctor
The Rev. Robert Hartmann, a pastoral care counselor at St. Louis University Hospital, while not connected with Barron, said her story isn't uncommon.
"Many people come from (life-threatening) challenges changed," Hartmann said. "Accepting help can be as redemptive as giving help."
Barron's health began to improve after she discussed her illness with Dr. Damon Clines, a gastroenterologist and hepatologist whose son attended Promise Christian Academy in Chesterfield, where Barron is an occupational therapist.
Clines said her zeal impressed him. "She had a lot to live for and she wasn't ready to throw in the towel, so we gave it another shot," he said.
In April, 14 months after beginning treatment, there's no sign of the virus and no symptoms, Clines said. Barron is back to full speed and recently hosted a party for about 200 people who helped during her ordeal.
"I fought because I don't want anyone else married to my husband," she said. "I wanted (my daughters) to know that I fought hard to be their mom."
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September 25, 2009
Override Lynch's med marijuana veto
http://nhbr.com
By Burt Cohen
Unless you hid under a rock all summer, you know most Americans don't want government interference in their health care.
Democrats and Republicans may have their differences, but there is universal agreement that decisions regarding medical treatments must be exclusively between the doctor and patient. If a doctor and patient agree on a particular course of treatment, then the patient should be permitted to access that treatment, and neither the government nor insurance companies should have any business blocking this process. All agree?
Well, then, it's easy to understand why the vast majority of Granite Staters disagree with Governor Lynch's veto of the medical marijuana bill. The House and Senate agreed that government should not stand between doctors and seriously ill patients who could benefit from medical marijuana, and both chambers voted to pass House Bill 648 with solid margins of support, but that may not be enough to get these patients the protection and access they deserve.
A final vote to override the veto comes up Oct. 28, and with two-thirds majorities required in both chambers, it is expected to be very close.
It should be a slam dunk.
A 2008 Mason-Dixon poll showed that 71 percent of New Hampshire voters support allowing seriously and terminally ill patients to access medical marijuana for personal use if their doctors recommend it. Only 21 percent were opposed. Legislators have no need to look for political cover.
Fortunately, the committee members who actually heard the testimony from those afflicted with serious illnesses have become strong supporters of the bill. They actually listened to patients, gave the issue fair study, and worked hard to pass a tightly-crafted, exceptionally responsible bill.
By contrast, Governor Lynch chose not to meet with any of the seriously ill patients who had been so instrumental in convincing the House and Senate.
In light of this, his veto was unfortunate, but not a great surprise. The only good news for patients is that this veto can and should be overridden.
Legislators who are still on the fence, those not on the committees who heard from afflicted citizens, now owe it to their constituents to make an effort to listen to patients. If they hear the perspective of their constituents in need of this now-denied medicine, it will change their minds, I guarantee.
There is no question that medical marijuana is effective at alleviating the pain associated with various debilitating conditions. These include cancer, HIV/AIDS, multiple sclerosis, chronic pain, muscle spasms, Hepatitis C and others.
There is no question marijuana clearly does have therapeutic value. The American Public Health Association, the American Nurses Association, the American Academy of HIV Medicine, the Lymphoma Society, as well as several state medical societies, support allowing the medical use of marijuana.
Some readers may not know that very recently I had Hepatitis C. For more than half of patients with Hep C, the biggest problem is keeping them on the interferon and ribavirin. I surely know why — the side effects are truly awful.
Most Hepatitis C patients must endure at least one grueling 48-week course, often two. If I'd had to do another six months of that brutal treatment, I probably would have given up and just taken my chances. There is ample evidence that Hep C patients who use marijuana are more able to stay on their treatment and clear the virus.
As of now, many seriously ill Granite Staters are forced to make a terrible decision: continue to suffer, miss days at work, risk losing their job, or obtain marijuana illegally and risk arrest and prison. That's nuts.
We should stop wasting time and resources on going after sick people and focus on real crime. What do we have to gain by denying those who could benefit from the use of medical marijuana the opportunity to do so?
Regardless of party affiliation, the overwhelming majority of New Hampshire voters agree that doctors, not police officers and bureaucrats, should be the ones deciding what constitutes effective medicine.
State senator from 1990 to 2004, Burt Cohen now hosts a radio talk show. His Web site is www.burtcohen.com.
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Vertex Pharmaceuticals Announces Publication of Telaprevir Abstracts for Presentation at the 60th AASLD Meeting
http://www.drugs.com
Presentations to include SVR results from Study C208 exploring twice-daily telaprevir-based dosing regimen, final PROVE 3 results and additional sub-analysis of PROVE 1 and PROVE 2 in “difficult-to-cure” patients
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep 24, 2009 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that sustained virologic response (SVR) data from Study C208, which evaluated twice-daily dosing of Vertex's investigational hepatitis C virus (HCV) protease inhibitor telaprevir, will be presented in an oral presidential plenary session at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place Oct. 30 – Nov. 3, 2009 in Boston. Additionally, final results from PROVE 3 will be presented in an oral session at the conference. Results from a pooled analysis of PROVE 1 and PROVE 2 in “difficult-to-cure” patients, which include patients with factors potentially having an effect on SVR rates (viral load, race, age, sex, body mass index, genotype subtype and liver fibrosis stage), will be presented in a poster session.
The C208 presentation at AASLD will include SVR data (defined as undetectable HCV RNA at 24 weeks after completion of treatment) and represents the first SVR data for telaprevir-based regimens as part of a response-guided therapy trial design, similar to that being used in the Phase 3 trials of telaprevir. Study C208 is a four-arm, randomized, open label, Phase 2 clinical trial that was conducted by Tibotec in Europe in 161 treatment-naïve patients with genotype 1 HCV infection. Two different dosing regimens of telaprevir (750mg three-times daily or 1125mg twice daily) each were studied in combination with either peg-IFN-alfa-2a (PEGASYS®) or peg-IFN-alfa-2b (PEGINTRON™) and ribavirin (RBV), the standard therapies for chronic HCV infection.
The abstracts were published today and can be accessed on the AASLD website. In accordance with the AASLD embargo policy, the accepted abstract titles are provided below. Vertex is developing telaprevir in collaboration with Tibotec and Mitsubishi Tanabe Pharma.
Telaprevir Presentations
Twice-daily compared to three-times daily telaprevir-based therapy: Study C208
1. “Virological Analysis of Patients Receiving Telaprevir Administered q8h or q12h with Peginterferon-Alfa-2a or -Alfa-2b and Ribavirin in Treatment-Naïve Patients with Genotype 1 Hepatitis C: Study C208” (#194) will be presented in an oral presidential plenary session on Nov. 3, 2009 at 8:15 a.m. EST. The authors of the study are Marcellin, Patrick; Forns, Xavier, Goeser, Tobias; Ferenci, Peter; Nevens, Frederik; Carosi, Giampiero; Drenth, Joost P.; De Backer, Koen; van Heeswijk, Rudolf; Luo Donghan; Picchio, Gaston; Beumont-Mauviel, Maria.
Telaprevir-based therapy in treatment-experienced patients: PROVE 3 Final Analysis
2. “PROVE 3 Final Results and 1-Year Durability of SVR with Telaprevir-Based Regimen in Hepatitis C Genotype 1-Infected Patients with Prior Non-response, Viral Breakthrough or Relapse to Peginterferon-Alfa-2a/b and Ribavirin Therapy” (#66) will be presented in an oral parallel session on Nov. 1, 2009 at 6:00 p.m. EST. The authors of the study are McHutchison, John G.; Manns, Michael P.; Muir, Andrew J.; Terrault, Norah; Jacobson, Ira M.; Afdhal, Nezam H.; Heathcote, E. Jenny; Zuezem, Stefan; Reesink, Hendrik W.; Bsharat, Mohammad; George, Shelley; Adda, Nathalie; Di Bisceglie, Adrian M.
Telaprevir-based therapy in “difficult-to-cure” treatment-naïve patients: PROVE 1 & PROVE 2 Pooled Analysis
3. “Telaprevir, Peginterferon Alfa-2a and Ribavirin Improved Rates of Sustained Virologic Response (SVR) in “Difficult-to-Cure” Patients With Chronic Hepatitis C (CHC): a Pooled Analysis From the PROVE 1 and PROVE 2 Trials” (#1565) will be presented in a poster session on Nov. 3, 2009 at 8:00 a.m. EST. The authors of the study are Everson, Gregory T.; Dusheiko, Geoffrey M.; Ferenci, Peter; Alves, Katia; Bengtsson, Leif; McNair, Lindsay; McHutchison, John G.; Muir, Andrew; Pawlotsky, Jean-Michel; Zeuzem, Stefan.
About Telaprevir
Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is one of the most advanced investigational antiviral agents in development that specifically targets HCV. Telaprevir is being evaluated as part of a global Phase 3 registration program in more than 2,200 treatment-naïve and treatment-failure patients.
Vertex retains commercial rights to telaprevir in North America. Vertex and Tibotec are collaborating to develop and commercialize telaprevir in Europe, South America, Australia, the Middle East and other countries. Vertex is collaborating with Mitsubishi Tanabe Pharma to develop and commercialize telaprevir in Japan and certain Far East countries.
Vertex's press releases are available at www.vrtx.com.
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UW performs rare 2-for-1 'domino' transplant
http://host.madison.com
Devin Rose
Two men are recovering this week at UW Hospital after surgeons there performed the state's first domino transplant, an organ-switching procedure that has only been done 100 times since 1996.
Joe Stoikes, a Madison cabinet maker, needed a new liver because he was suffering from familial amyloid polyneuropathy, or FAP, a potentially fatal rare genetic condition in which amyloid protein builds up in the liver, intestines, nerves and heart.
Meanwhile, Eino Ahlgren, a retired pipefitter from Waukesha, was bordering on liver failure resulting from a decades-old hepatitis C infection.
In a sequence that took more than 12 hours and required three transplant teams, the liver of a deceased donor was put in Stoikes' body before Stoikes' liver was put into Ahlgren's body.
Since Stoikes had only mild symptoms of FAP, the transplant occurred at a good time, said Dr. Anthony D'Alessandro, director of UW's liver transplant program.
Ahlgren, 58, could show symptoms of the disease, D'Alessandro said, but not for at least 20 to 30 years. Even then, they are unlikely to be severe, and might be so mild that no treatment would be needed. Without the liver transplant, Ahlgren might have only lived another one to two years.
Of about 6,000 liver transplants done each year in the country, D'Alessandro said, only a handful are related to FAP.
While the average length of stay in the hospital after a liver transplant is about two weeks, D'Alessandro said Thursday that both patients were doing "extremely well." Stoikes will likely go home today and Ahlgren on Saturday or Sunday.
UW Hospital already had a long list of firsts, D'Alessandro said, and he was sure doctors would continue to be "ready to do some of these innovative procedures when they are presented to us."
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Worker in Hepatitis Case Is Sentenced to 20 Years
http://www.nytimes.com
By Kirk Johnson
DENVER — A former hospital surgical technician who may have infected dozens of surgical patients with hepatitis C by stealing their pain medication and swapping back needles tainted by the virus she carried pleaded guilty on Friday to federal drug charges.
The woman, Kristen D. Parker, 26, who could have faced up to life in prison on the most serious charges, accepted a 20-year prison sentence in a plea agreement with federal prosecutors. Ms. Parker admitted guilt to multiple charges of tampering with a consumer product and obtaining a controlled substance by deceit.
Twenty-seven patients at two hospitals where Ms. Parker worked last year and this year, in Denver and Colorado Springs, have tested positive for a strain of hepatitis C and have been linked to her care, according to state health records. Hepatitis C affects liver function and can have lifelong consequences.
Ms. Parker’s guilty plea does not end the legal saga or the continuing investigation into how exactly the infections were transmitted and who might bear further responsibility.
A lawyer representing nine of the victims treated at Rose Medical Center in Denver said her clients were disappointed with the sentence and unhappy that they were not consulted by federal prosecutors.
“They’re devastated and would have liked to have had some input,” said the lawyer, Hollynd Hoskins, who said she plans to file a civil suit against the hospital.
Ms. Parker, wearing gray-and-white jail stripes and wiping away tears throughout the 40-minute hearing before Judge Robert E. Blackburn, did not make any statements in court beyond responding “yes” or “no” to the judge’s questions about the guilty plea.
But her lawyer, Gregory C. Graf, said outside the courthouse that he thought the lesser sentence was warranted in part by his client’s cooperation with health officials and the police since her arrest this summer.
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