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Week Ending: May 19th , 2007
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May 12th , 2007
Panel would relax limits on needle-exchange programs
http://morningsentinel.mainetoday.com
By ANN S. KIM
Staff Writer
AUGUSTA -- A state panel is backing legislation that would relax limits on needle-exchange programs for drug users as a way to reduce the transmission of blood-borne infections such as human immunodeficiency virus and viral hepatitis.
A bill before the Legislature would allow participants to exchange an unlimited number of used syringes for sterile ones, eliminating the current limit of 10 per visit. The measure also would protect participants from criminal charges that could stem from the possession of residual amounts of drugs in the used syringes.
Proponents of the measure hope drug users who don't live near a program site will find it more worthwhile to make the trip if they can exchange more needles.
Injection drug use can carry a high transmission risk for HIV and hepatitis B and C. The use of sterile syringes is an important strategy in fighting transmission of disease.
"Clearly, if you're in a rural area, this bill will help you because you can drive fewer times and exchange more needles," said the bill sponsor, Rep. Lisa Miller, D-Somerville.
Miller introduced the bill at the request of the state HIV Advisory Committee. The proposal goes before the Health and Human Services Committee today for a public hearing.
Miller introduced the bill at the request of the state HIV Advisory Committee. The proposal goes before the Health and Human Services Committee today for a public hearing.
A total of 555 people are enrolled in four state-certified needle-exchange programs in Maine. The programs are in Portland, Augusta, Bangor and Ellsworth.
On average, 10 syringes is the equivalent of a three-day supply, said Martin Sabol, the advisory committee chairman and manager of Portland's infectious disease program.
It's legal to buy up to 10 syringes without a prescription, but injection drug users may avoid pharmacies because they don't want to be seen making the purchases or because they want to avoid requirements such as providing an ID or signing a log.
It's also possible to sterilize syringes, but there's room for error, said Kate Perkins, an advisory committee member who is also director of health programs at Medical Care Development.
Maine would not be alone in having no cap on exchange programs. Oregon, Hawaii, San Francisco, Baltimore and Vancouver already allow an unlimited number, she said.
Proponents acknowledged that some uneasiness remains around needle-exchange programs because of a sense that they condone drug use. Maine passed a law allowing them 10 years ago.
"It makes people feel uncomfortable. I will not deny it's a difficult issue," Miller said.
Even one of her co-sponsors has some reservations about the proposal. Rep. Robert Walker, R-Lincolnville, said he likes the public heath benefit of such programs. But he is not sold on the idea of lifting the cap altogether.
The pool of HIV-positive people using dirty needles is small, thanks to active outreach programs, but the likelihood of sharing a needle with someone infected with hepatitis C is much greater, Perkins said.
An estimated 20,000 people in Maine are infected with hepatitis C, with up to a half unaware of their infection, according to the Maine Center for Disease Control. Hepatitis C is the most common blood-borne infection in the United States and the leading cause for liver transplantation. There is no vaccine, and treatment is expensive.
Proponents of the bill cite concerns about hepatitis C as one reason for the proposal. According to Maine Center for Disease Control data, between 1,025 and 1,381 cases have been reported each year from 2000 to 2005. The data does not indicate when the cases were contracted.
Nationally, the number of new infections has decreased from an average of 240,000 in the 1980s to roughly 26,000 in 2004. But The Boston Globe reported this week that suspected and confirmed cases of hepatitis C among 15- to 25-year-old Massachusetts residents rose sharply from 254 in 2001 to at least 784 in 2005.
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Hepatitis C Is Silent Epidemic In Maryland
http://www.emaxhealth.com
Hepatitis C
An estimated 100,000 Marylanders are infected with hepatitis C virus (HCV) and nearly two-thirds of them don't know it.
"Complications of HCV infection are a serious health burden in our State," said Michelle Gourdine, M.D., DHMH Deputy Health Secretary for Public Health Services. "That's why DHMH is working to help all Marylanders be more aware of this important public health problem."
Nine out of 10 people with HCV infection have no symptoms in the early stages of the disease. In fact, serious symptoms may appear 20 - 30 years after infection and by then, the liver may have been badly damaged. Testing for HCV infection involves only a blood test and usually can detect the infection within months after it starts, long before serious liver injury occurs.
"There is no vaccination to protect against HCV", said Dr. Gourdine. "But there are ways to protect your liver and avoid transmitting HCV. If you're at risk, a simple blood test is a good way to know your status."
HCV infection is four times more prevalent than HIV infection and the most common blood borne infection in the United States. It's the leading cause of liver disease and the number one indication for liver transplants.
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Vermonters urged to get tested for hepatitis C
http://www.timesargus.com/
By Mel Huff Times Argus Staff
BURLINGTON – The Vermont Department of Health is urging people most likely to have been exposed to hepatitis C to get tested for the disease.
"Hepatitis C is a silent infection," said Patsy Tassler, a Department of Health epidemiologist. People can be unaware that they harbor the hepatitis C virus until it starts causing liver disease and other problems.
In Vermont, 61 percent of cases of hepatitis C are found in men and 57 percent are seen in people over 40. People can be infected for decades before having symptoms.
"Lots of people who don't consider themselves at high risk are infected," Tassler said. "If you have any risk factors, even decades in the past, you should ask for a test and know your status. There are preventive actions to protect your liver and prevent spreading the infection."
Hepatitis C, a potentially fatal liver disease, is among the most common blood-borne illnesses. In Vermont, it is the second most commonly reported communicable disease: In 2006, there were nearly 900 newly identified cases. Based on national statistics, as many as 12,000 Vermonters have hepatitis C, the health department stated.
In a recent article in the Journal of the American Medical Association, researchers reported that hepatitis C infection was associated with a 20 percent to 30 percent greater risk of non-Hodgkin lymphoma, a lymph tissue cancer. They also found that the hepatitis C virus was more than three times as common in U.S. veterans who used the Veterans Affairs health care system as in the general population: 5 percent of those veterans were infected with the virus.
The study, which involved hundreds of thousands of veterans cared for at VA facilities between 1997 and 2004, was carried out by Dr. Thomas P. Giordano and colleagues at Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center in Houston. Risk factors for hepatitis C include:
Using needles, syringes and other "works" that have been used by other people and may have infected blood on them. (Even injecting drugs one time decades in the past can result in infection, Tassler said.)
Having received a blood transfusion, a blood product like plasma or a solid organ transplant before July 1992 from a donor whose blood was infected with hepatitis C. (Since July 1992, the blood supply has been screened, Tassler noted.)
Receiving long-term kidney dialysis. (The number of times you go through dialysis increases the possibility that you've come in contact with something that is contaminated, Tassler explained.)
For health care workers, frequently contacting blood on the job, especially through accidental needle sticks.
In March, the health department started a new program that offers free and anonymous hepatitis C testing at the syringe-exchange programs in Burlington, St. Johnsbury and White River Junction.
People can also ask their health care provider for a test, Tassler said. Medicaid and VHAP cover hepatitis C antibody and viral testing. Medicare does not pre-approve testing but reviews requests for payment and covers it if it is "medically necessary."
If providers request the test because they believe a patient is at risk for the hepatitis C infection, the test would be considered medically necessary, according to the health department.
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May 13th, 2007
Virus Sponge' Could Improve Flu Treatments, Diabetes Care, Vaccine Development
http://www.sciencedaily.com
Science Daily — Influenza virus H5N1, which caused the recent outbreak of avian flu, may have a new enemy.
Researchers at the University of Maryland's A. James Clark School of Engineering have created a "virus sponge" that could filter a patient's blood in a process similar to kidney dialysis, removing the virus from the patient's body. The concept could also be used to make vaccine production more efficient and in a pill to reduce glucose levels in diabetics, among other applications.
The virus sponge is based on a technology called molecular imprinting. In molecular imprinting, researchers stamp a molecule's shape into a substance (in this case, a hydrogel—a sponge-like material). When the specific molecule filters through the hydrogel, it fits in the imprint hole and is trapped.
The research group of Peter Kofinas, a professor in the Clark School's Fischell Department of Bioengineering, is the first to apply molecular imprinting to the capture of viruses, and to show that this approach is possible using an inexpensive hydrogel.
Kofinas' team has so far used this technique on plant viruses and Human Parvovirus B19, which causes "fifth disease" in babies, and has now begun work on the H5N1 influenza virus.
"This new technology could be integrated into hospitals and healthcare centers at minimal cost," according to Kofinas. Modifying existing dialysis machines to include the virus sponge technology would be relatively simple, he said.
"This virus removal device can be used the same way as a kidney dialysis machine," Kofinas continued. "If you have a viral infection, you can go to the hospital and have your blood cleaned of that virus."
While a new vaccine must be developed each year for the strain of influenza that is expected to be the most potent, a hydrogel can be imprinted as a universal filter for all flu strains. However, to achieve better performance, a hydrogel filter can also be produced to catch a particular strain of the virus.
The molecular imprinting process has many applications beyond trapping viruses.
"Applying the technology to a drug or food additive could contribute to the dietary freedom of those who suffer from type II diabetes," Kofinas said.
A pill containing the hydrogels could be developed to remove excess sugars when taken with food, thus helping diabetics regulate their diet, Kofinas explained. The hydrogels would work within the small intestine to remove glucose prior to absorption into the blood stream.
Drug manufacturers could use the hydrogel filters in vaccine production. Pharmaceutical companies use viruses to create the vaccines that fight them. Hydrogels could be used to strip the virus out of the finished medication—a process that is currently very time-consuming and expensive.
Another potential application is to use the material as a filter in masks for those needing protection in case of biological warfare or other harmful biological agent exposure.
Kofinas has filed a patent on this technology. Currently, he is collaborating with researchers at the National Institutes of Health on how to use the hydrogels to clean human viruses out of blood. Advances in this area could help ensure a safer blood supply by allowing for the low-cost removal of viruses like hepatitis and HIV from donor blood.
Kofinas is also associate chair and director of graduate studies in the Fischell Department of Bioengineering. His graduate students, Linden Bolisay, Brendan Casey, Angela Fu and Daniel Janiak, continue to contribute to this research.
Note: This story has been adapted from a news release issued by University Of Maryland, College Park.
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NEW JERSEY: "Five Towns Applied for Needle Exchange Programs"
Gregory J. Volpe
Asbury Park Press
Five municipalities hoping to operate needle exchange programs have applied to New Jersey's Department of Health and Senior Services. After years of debate, a state law enacted in December allows up to six cities to pilot NEPs to determine whether they protect intravenous drug users (IDUs) from blood-borne diseases.
Critics maintain that NEPs will spread crime and encourage drug use, claims NEP advocates deny. To muster legislative support for the NEP bill, lawmakers included $10 million to help treat drug dependence.
Twelve cities qualify to pilot an NEP. To be eligible, the law states municipalities must have more than 350 residents with HIV/AIDS and an IDU-related HIV/AIDS prevalence rate of over 300 cases per 100,000 residents. The five jurisdictions that applied are Newark, Paterson, Trenton, Camden, and Atlantic City. They could gain state approval by summer's end.
Atlantic City's Health Department plans to use vans as well as fixed sites for its NEP. "It's been a battle, so we're glad to see it," said Ron Cash, department director.
"It's going to be crucial to saving lives of injection drug users," said Jose Quann, program coordinator of the Camden Area Health Education Center. "[IDUs] will have access to sterile syringes that they might not get infected or infect their loved ones."
In five years, the state Health Commissioner is to deliver a report to the Legislature about the status of the pilot NEPs and whether the effort should be continued and expanded.
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May 14th, 2007
Looming dread of HIV-Hep C co-infection in State
http://www.e-pao.net
Source: The Sangai Express
India
Imphal, May 13: With lack of treatment facilities on one hand and no scientific study being conducted on the issue, HIV-Hepatitis co-infection is becoming a serious health issue posing threat to HIV positive people living in Manipur. Talking to The Sangai Express on the sidelines of the convention for People living with HIV/AIDS at State Guest House here today, a participating HIV positive patient who has been co-infected with Hepatitis C pointed out that HIV-Hepatitis Co-infection is becom- ing a serious health related issue many HIV infected/affected people in Manipur today. He pointed out that there has been no policy to conduct study and find out the extent of the HIV-Hepatitis co-infection in Manipur.
However, as per his knowledge, out of every 10 HIV infected/affected persons, 8 of them are also infected with Hepatitis C in Manipur. During 2000-2001, ICMR conducted a study in Churachandpur and Imphal, and come out with the findings that the rate of HIV-Hepatitis co-infection is 98 percent in Churachandpur and 92 percent in Imphal, the patient informed, adding that treatment for Hepatitis C on people who have already been infected/affected with HIV is very difficulty. According to the recommendation of the World Health Organisation, a patient with HIV-Hepatitis co-infection has to be given medicine course for one complete year.
However, for getting such treatment in private, a patient has to shell out at least Rs 5 to 7 lakhs in a year, which is not affordable to many, he lamented. The patient further informed that of all the types of Hepatitis C from 1 to Vto five, the type III is common among the HIV-Hepatitis co-infection cases in Manipur.
This type is easier to treat, he added. However, one dilemma being faced by the patients, he said is that the HIV positive people whose CD4 cell count is below 200 are given ART drugs, and Hepatitis C affects the liver and so are the ART drugs.
Therefore, how the treatment for Hepatitis C is to be carried out for patients who are already under ART therapy is rather perplexing.
‘We like to live for long in the society.
But we cannot decide whether we should get the ART treatment for strengthening our immune system or save our lungs from deterioration’, he said. It is a really unfortunate that there has been no facility for treatment or intervention programme or prevention programme for HIV-Hepatitis co-infection in Manipur so far, said the patient, who has been trying to get the treatment since 2002 but not able do so due to poor financial condition of his family, while drawing the attention of the authorities concerned for taking up necessary measures in this regard.
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Nautilus OK'd to test hep C drug
http://www.upi.com
PARIS, May. 14 (UPI) -- Nautilus said Monday the U.S. Food and Drug Administration cleared its potential hepatitis C treatment, oral Belerofon, for a phase 1 trial.
Belerofon is a formulation of interferon-alpha that is intended to last longer in serum and reach blood levels comparable to those obtained by injected products.
"The development of an orally administered Interferon-alpha highlights the potential of Nautilus Biotech's technology platform," said Paul Martin, the firm's vice president of strategy. "It represents the promise of a third generation of therapeutic protein drugs that can be taken more easily and have great commercial potential to replace established injectable products."
The phase 1 trial of Belerofon is scheduled to begin later this year. Nautilus said it will be an open-label, ascending dose study of four doses of the investigational compound.
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Drugs Users Are Increasingly More Cautious With Needles
http://www.sciencedaily.com
Science Daily — Even though HIV can be well treated these days, drug users are still more cautious about using needles than they used to be. That is the conclusion of Colette Smit following her study into 25 years of HIV in the Netherlands.
Earlier research had shown that since the introduction of the effective HAART therapy, in 1996, homosexual men have more unsafe sex. Smit established that drug users did not exhibit more risky behaviour once the perspective of HIV-infected drug users improved. Due to improved hygiene drug users acquired less HIV and less hepatitis C.
Hepatitis
Smit also examined coinfections. Due to the increased life expectancy relatively more HIV patients have died from other causes in recent years. Infections as a consequence of a reduced immunity (AIDS) remained the number one cause, but the study also revealed an increase in hepatitis and liver-related death. The cause of this was mostly hepatitis C.
Drugs users with both HIV and hepatitis C have a seven times higher chance of dying from liver-related diseases than drug users with just hepatitis C. The side effects of the therapy might also be the cause of the increased chance of liver-related mortality. Patients need to be followed up for longer for definite statements to be made about this.
Smit used data from various studies for her research, some of which were funded by NWO. These studies had mainly been performed in Amsterdam over the past 25 years.
HAART
HAART is the acronym for Highly Active Antiretroviral therapy. This is a combination of various antiviral drugs that suppress the HIV virus. The introduction of HAART in 1996 led to a considerable fall in AIDS mortality.
The HAART therapy is not able to cure HIV. However there is a considerable increase in the life expectancy of HIV-infected persons. Nevertheless this remains considerably lower than that of the general population.
Note: This story has been adapted from a news release issued by Netherlands Organization for Scientific Research
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Asians losing race with hepatitis
http://www.whittierdailynews.com
By Patricia Jiayi Ho Staff Writer
Liver diseases occur at much greater rate
As an Asian-American politician, Chi Mui was part of an elite new group of leaders. He became San Gabriel's first Asian mayor in March 2006.
As an Asian, Mui belonged to a larger, more disturbing health care demographic. He died of liver cancer after about a month in the position, at 53.
Mui had hepatitis B, a disease that can be prevented and that is dubbed a "silent killer" that affects a disproportionate number of Asians. The virus puts them at greater risk of developing liver cancer and cirrhosis.
The HBV-related death rate among Asian Americans is seven times greater than the rate among American whites, according to the Centers for Disease Control and Prevention.
Race-specific attention to the virus consists so far of patchwork efforts by nonprofits, some of which piece together funding sources for workshops, screening fairs and vaccinations.
Health care workers say a more comprehensive approach is needed.
"Hepatitis B and liver cancer is the greatest health care disparity," said the center's director, Dr. Sammy So. "Almost every Asian knows of someone who died from liver cancer."
Chronic hepatitis B infection affects 0.3 percent of the U.S. population, but Asians make up more than half, or roughly 700,000, of the known hepatitis B carriers, according to the Asian Liver Center at Stanford University. Most contract the virus overseas, and many are unaware they have it.
Of the HBV-positive women who gave birth in Los Angeles County in 2005, 81 percent were Asian, according to the Los Angeles County Department of Public Health. Nearly 50 percent were from the San Gabriel Valley.
While the virus can be spread through unprotected sex and shared needles, experts say most Asians become infected through their mothers during birth or in childhood.
A vaccine can actually knock down the disease after it is contracted if administered at young enough an age.
The Herald Cancer Association in San Gabriel relies on funding from foundations, medical centers and drug companies to sponsor outreach programs, which are held in Mandarin and English.
"Without the help of the government, we're just a nonprofit at the mercy of pharmaceuticals, whether they will give us the grant or not," said the Rev. David Lee, director of the Christian-based association.
At a screening event in October, more than one out of 10 participants tested positive for the virus.
Follow-up is crucial for carriers, said Lee, who was diagnosed as a carrier in his late teens.
To compare Chi Mui and Lee, the difference early detection makes is life or death.
Like Mui, Lee, 47, said he realized he was infected when he first tried to donate blood as a young man. Based on the science back then, he was told not to worry about it. But Lee had half his liver removed at 34, after doctors discovered a tumor.
Mui was less fortunate. He was caught up with campaigning for City Council, said Mui's widow, Betty Mui. After two years without tests, doctors found an 8cm liver tumor. The cancer later spread to his pelvic bone.
"It developed so fast," said Betty Mui, who is now a key volunteer at Herald Cancer Association. She also contracted the virus at a young age and gets regular blood tests and ultrasound screenings. "People have to be very careful about it."
Hepatitis B can go undiagnosed. Carriers usually have no symptoms and appear healthy. It may not show up on tests for liver function, and doctors don't always think to order specific blood work to test for it, Lee said.
By the time patients notice the yellow eyes and swollen bellies associated with cirrhosis, or the vague upper abdominal pain that may indicate liver cancer, their problems are at an advanced stage. Treatment of liver disease is complicated and risky; transplants are hard to come by.
"We feel that in the Chinese community, knowledge is spreading," said Lucy Young, Herald's cancer projects director. "We receive quite a few phone calls about when we will do blood tests again, vaccinate again."
The programs are on hiatus while funding is sought. Three shots costing as much as $60 each are required for vaccination. The association also works with community groups in San Diego and Orange counties.
"We still have a lot of work to do, not only in San Gabriel Valley," Young said. "Those carriers, most of them are in the underserved population. Either they don't have insurance coverage or they don't know where to go for follow-up."
The hepatitis B vaccine was introduced in the early 1980s. Since the early '90s, it has been administered to most infants born in the United States. In California, vaccination is required for entry to kindergarten and the seventh grade, said Laurene Mascola, who heads Los Angeles County's Acute Communicable Disease Control Program.
The county's hepatitis B efforts center on vaccinating infants and tracking pregnant women who have HBV, and high-risk behavior groups such as jail populations and gay men.
Nonetheless, some health care professionals are eagerly awaiting the outcome of a bill currently making its way through the state Assembly.
"This is something near and dear to my heart," said the bill's author, Assemblywoman Fiona Ma, D-San Francisco. She contracted the virus from her mother.
Without screening and management, one in four with the virus will die from liver cancer or cirrhosis, according to the Asian Liver Center.
San Francisco launched a campaign in April to test and vaccinate all its Asian residents for hepatitis B, a combined effort by the city government, private healthcare and community organizations.
AB 158 was passed in the Assembly Health Committee in April, the first of several hurdles it must clear before it can land on the governor's desk in the fall.
"It is a public health concern; it deserves funds from legislative avenues," said Jeff Goad, an associate professor of clinical pharmacy at USC and a member of a hepatitis B taskforce. "There is not a lot of action to fund treatment and management. The government ... allows the private system to handle treatment, but that doesn't always happen."
One of the organizations that stands to benefit from the bill is St. Vincent Medical Center in Los Angeles. The hospital is opening a center in July that will deal specifically with hepatitis in Asians and could receive some of the $4 million the bill proposes.
"I don't think there is a recognition even among physicians of the magnitude of the problem among Asians," said Tse-Ling Fong, a liver specialist who will direct the Asian Pacific Liver Center.
Fong said the center will target Asians 18 and older, particularly those born overseas. In keeping with the hospital's charitable care policy, the center will accept both insured and uninsured patients.
"My hope is that three or four generations from now, hepatitis B will be something like smallpox that we no longer talk about," Fong said.
patricia.ho@sgvn.com
(626) 578-6300, Ext. 4586
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Hall would stop VA executive bonuses until backlog is reduced
http://www.thejournalnews.com
By BRIAN TUMULTY
WASHINGTON BUREAU
WASHINGTON - Catherine Bonanno of Cortlandt is frustrated that her husband has been fighting the Department of Veterans Affairs since 2005 on a ruling that denied him higher coverage for advanced hepatitis C he contracted in Vietnam in the early 1970s.
The fact that Philip Bonanno, 59, works in the housekeeping department at the VA hospital in Montrose hasn't helped. Nor has it helped that the VA provides him benefits for the skin lymphoma he contracted from loading Agent Orange onto planes during his Vietnam service in 1971-72.
Top officials of the agency ought to be required to wait in line at a VA office, Catherine Bonanno said, adding, "I really think they should be made to go through the system with no one recognizing them."
Rep. John Hall is proposing legislation that wouldn't go that far but would deny pay bonuses to top officials at the VA until the agency slashes its current backlog of disability claims to 100,000 from four times that many.
According to the VA, the backlog of cases awaiting a disability rating stood at 405,248 as of May 5. That's 9.2 percent more than the 371,038 pending cases a year earlier.
Hall, a freshman Democrat from New York, said he's been promised a House vote on his proposal before Memorial Day, and the bill could reach the floor as early as next week.
"There's plenty of ink, radio and TV time devoted to the discussion about the war policy, but relatively little to those who carry out the policy," Hall said. "Whether or not we as Americans agree on the war, I think there's across-the-board agreement that we need to take care of these servicemen and -women and their families."
Iraq war veterans with disability claims are joining aging Vietnam and Korean War veterans who have filed claims for ailments that may have worsened recently or recurred.
Ted Wolf, a 62-year-old Vietnam veteran from Pomona, said that the VA cut his disability benefit for prostate cancer when it went into remission but that he faced long delays with his claim when the cancer re-emerged in August in five different places in the skeleton and four in the skull.
"I said I don't know if I'll be around in six to nine months," said Wolf, who noted there's no dispute about his cancer being service-related.
Wolf said the difference between partial and full benefits is $626 monthly versus $2,400.
The Associated Press recently reported that the VA awarded $3.8 million in performance bonuses to top officials. A list of the awards obtained by Hall shows that 226 officials received bonuses ranging from $8,000 to $33,000.
At a House Veterans Affairs Committee hearing Wednesday, Hall and other lawmakers on the panel asked VA Secretary Jim Nicholson how the bonuses could have been given at the time when the average disability claim is taking 177 days to be acted upon.
"That is too long in my opinion," Nicholson said. He said that four years ago, the wait averaged 220 days. The VA's proposed 2008 budget requests money to hire 450 additional claims evaluators who could bring that figure down by at least 18 percent. That would reduce the wait to an average of 145 days, which Nicholson said is his goal.
As for the bonuses awarded to top officials, Nicholson said none of them went to political appointees.
"They are all given to career SEF, senior executive service, professional government employees, and there is a very detailed prescribed set of criteria we get from the Office of Personnel Management of the federal government to use in determining who should be considered," he said.
Hall said his legislation, which is still being drafted, would cover senior-level professionals and political appointees, but not hospital managers, doctors or nurses.
"My concern is with the people at the very top," he said.
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May 15th, 2007
ZioPharm Treats First Patient in Phase II ZIO-101 Liver Cancer Trial
http://www.therapeuticsdaily.com
NEW YORK--(BUSINESS WIRE)--May 10, 2007 - ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP), announced today dosing of the first patient in a phase II trial of ZIO-101 (organic arsenical) for the treatment of patients with primary liver cancer. Primary liver cancer is one of the most commonly occurring cancers in the world. The study will take place at five major U.S. liver cancer treatment centers including sites in New York, Boston, Miami, Seattle, and Atlanta.
"Liver cancer is one of the most difficult cancers to manage," commented Brian Schwartz, M.D., Chief Medical Officer at ZIOPHARM. "However there are a number of strong scientific and historical reasons to suggest that ZIO-101 could have a positive impact on patients suffering from this disease. We look forward to seeing if this novel form of organic arsenical will give clinicians an additional treatment option."
For more details on the trial please see www.clinicaltrials.gov. In addition to the phase II liver cancer trial, the Company is conducting phase II studies with ZIO-101 in advanced multiple myeloma and diverse hematological cancers, including acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS) and acute promyelocytic leukemia (APL).
About ZIO-101
ZIO-101 is a proprietary small molecule organic arsenical licensed from The University of Texas M. D. Anderson Cancer Center and Texas A&M University. ZIO-101 induces cell cycle arrest and cell death by targeting several cellular pathways essential for cell survival. Exposure to ZIO-101 has a direct as well as indirect effect on mitochondrial functions, resulting in depletion of energy supply to the cell and induction of apoptosis (programmed cell death). Increase in intra-cellular Reactive Oxygen Species enhances this effect on mitochondrial functions and consequently the activation of the signal transduction pathway leading to apoptosis. In addition, ZIO-101 interrupts the cell cycle at the G2/M phase of tumor cells inducing cell death through this pathway as well.
About ZIOPHARM Oncology, Inc.
ZIOPHARM Oncology, Inc. is a biopharmaceutical company engaged in the development and commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer drugs to address unmet medical needs. The Company applies new insights from molecular and cancer biology to understand the efficacy and safety limitations of approved and developmental cancer therapies and identifies proprietary and related molecules for better patient treatment. For more information, visit www.ziopharm.com .
Forward-Looking SafeHarbor Statement:
This press release contains forward-looking statements for ZIOPHARM Oncology, Inc. that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurance that any of the Company's development efforts relating to its product candidates will be successful, or such product candidates will be successfully commercialized. Other risks that affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of the Company's product candidates, the risk that the results of clinical trials may not support the Company's claims, and risks related to the Company's ability to protect its intellectual property and its reliance on third parties to develop its product candidates. The Company assumes no obligation to update these forward-looking statements, except as required by law.
ZIOP-G
Contact
ZIOPHARM Oncology, Inc.
Investors:
Suzanne McKenna, 646-214-0703
smckenna@ziopharm.com
or
Media:
Tina Posterli, 917-322-2565
tposterli@rxir.com
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Australian scientists directly target cancer cells
http://www.therapeuticsdaily.com
Reuters Health
SYDNEY (Reuters) - An Australian biotechnology firm said on Thursday it had developed a means of delivering anti-cancer drugs directly to cancer cells, which aims to avoid the debilitating toxicity associated with chemotherapy.
The method uses nanotechnology, which involves molecules far smaller than a human cell.
Direct targeting of chemotherapy drugs would allow dosages thousands of times lower than that in conventional chemotherapy and be more easily tolerated by patients, said the firm.
Writing in the May issue of U.S.-based Cancer Cell journal, the biotech firm EnGeneIC said it had developed nano-cells containing chemotherapy drugs.
Via antibodies on their surface, these nano-cells target and latch on to cancer cells. Once attached, the nano-cell is engulfed and the drug is released directly inside the cancer cell.
The firm said the bacterially derived nano-cell, called EnGeneIC delivery vehicles, had proven safe in primate trials and resulted in significant cancer regression.
It hoped to carry out human trials later in 2007 if it gained approval from Australian, U.S., European and Japanese regulatory authorities.
"For the first time there is a real possibility that this technology could lead to the use of multi-drug combinations and eventual custom-made therapies in cancer patients," research scientist Jennifer MacDiarmid said in a statement.
"In terms of tumor therapy, most late-stage cancer patients carry tumor cells that exhibit various forms of drug resistance. Our technology may provide the first in-vivo (inside an organism) solution to this serious hurdle."
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Medicare Issues Proposed Coverage Decision on Erythropoesis Stimulating Agents
http://pharmalive.com
IN RESPONSE TO FDA'S RECENT BLACK BOX WARNING AND PUBLIC HEALTH ADVISORIES
WASHINGTON, May 15, 2007-The Centers for Medicare & Medicaid Services (CMS) announced today its proposed decision to limit coverage of erythropoiesis stimulating agent (ESA) treatment for beneficiaries with certain cancers and related neoplastic conditions, either because of a deleterious effect of the ESA on the beneficiaries’ underlying disease or because the underlying disease increases their risk of adverse effects related to ESA use.
The proposed national coverage decision (NCD) was made in response to a Food and Drug Administration (FDA) black box warning regarding the use of ESAs. FDA recently announced concerns about the use of ESAs by adding Black Box warnings to all ESA labels.
This led CMS to open a National Coverage Analysis (NCA), on March 14, 2007, on the use of ESAs for conditions other than end-stage renal disease (ESRD), which was the first step toward issuing this proposed NCD.
FDA also conducted an Oncologic Drug Advisory Committee meeting on May 10, 2007 that raised concerns about the use of ESAs in oncology patients.
“We pay close attention to FDA black box warnings because the safety of our Medicare beneficiaries is paramount,” said CMS Acting Administrator Leslie V. Norwalk, Esq. “We have carefully examined the evidence surrounding these labeling changes and have issued this proposed decision to protect our beneficiaries.”
CMS proposes that ESA treatment is only reasonable and necessary under specified conditions for the treatment of anemia in certain cancers.
CMS is seeking public comments on this proposed decision. The public comments period is open until June 13. Medicare local contractors have the discretion to make reasonable and necessary determinations for all uses of ESA therapy for beneficiaries with cancer whose condition is not addressed in the proposed decision memorandum.
“Because there is a preponderance of emerging data for ESA use in the oncology setting, we have narrowed the focus of the national coverage analysis to ESA use in cancer and related neoplastic conditions,” said Barry M. Straube M.D., Chief Medical Officer for CMS and Director of the Agency’s Office of Clinical Standards and Quality.
ESAs are anti-anemia biologics, distributed as Epogen and Aranesp and as Procrit. They are manmade versions of erythropoietin, a hormone that is produced in the kidney, and stimulate the bone marrow to make more red blood cells.
ESAs are FDA-approved to treat anemia in patients with ESRD and reduce the need for blood transfusions in patients with ESRD and chronic kidney failure, as well as in cancer patients whose anemia is caused by chemotherapy. Epogen and Procrit are also approved for some patients scheduled for major surgery to reduce potential blood transfusions, and for the treatment of anemia due to zidovudine therapy in patients with human immunodeficiency virus (HIV).
This proposed decision is the latest step in CMS’ efforts to closely review the use of ESAs in the Medicare population. In addition to this proposed NCD, CMS continues to review its monitoring policy for the use of ESAs in the ESRD setting.
“Medicare beneficiaries with cancer and renal disease are among our most vulnerable patients, and we are dedicated to ensuring that they are receiving appropriate care,” said Dr. Straube.
For national coverage decisions, the Medicare Modernization Act of 2003 requires CMS provide a 30-day period for public comment on the proposed decision and make a final decision no later than 60 days after the conclusion of the public comment period.
Details of Medicare coverage policy are available at the CMS coverage Web site at www.cms.hhs.gov/center/coverage.asp .
Contact: CMS Office of Public Affairs
202-690-6145
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Timing of Cardiac Interventions May Impact Outcome for Liver Transplant Patients: Presented at ATC
http://www.docguide.com
By Arushi Sinha
SAN FRANCISCO, CA -- May 14, 2007 -- Researchers have found that patients previously treated for cardiac interventions prior to a liver transplant fared worse than patients who underwent similar procedures after their liver transplant, according to a study presented at the 7th meeting of the American Transplant Congress (ATC).
The goal of the study was to examine the role of cardiovascular risk factors in patients with cardiac interventions before or after liver transplant.
"This research is important because as patients get older, they are more prone to having prior treatment for heart disease," explains Michael Herman, fellow, liver transplant/hepatology fellowship, department of transplantation, Mayo Clinic, Jacksonville, Florida, United States.
The study examined two groups of patients who had received liver transplants. The first group of 12 patients underwent the liver transplantation after having had coronary artery bypass grafting (CABG). One of these patients also had coronary artery stenting (CAS). A second group of 14 patients had the liver transplants before they had cardiac interventions -- two of these patients had undergone CABG and 12 of whom with a CAS.
In both sets of patients, the main cause of liver disease was attributed to hepatitis C virus (HCV). Mean age of patients was 61.4 years in the first group and 54.9 years in the second group. All patients were male in the first group, while in the second group there were 11 men and 3 women.
Cardiac disease was due to a variety of factors in both cohorts, including hyperlipidemia and tobacco use. For patients who had cardiac intervention prior to liver transplantation, the survival rate at one year was 67%, and at three years it was 58%. In comparison, patients who had cardiac intervention after to liver transplantation, the 1-year survival rate was 100%, and the 3-year survival rate was 93%.
The researchers reported that no deaths were directly attributable to HCV.
Based on these findings, Dr. Herman and his colleagues concluded that patients with prior bypass or stent intervention for cardiac disease may be at higher risk for serious adverse events compared with those who have cardiac intervention subsequent to liver transplant.
Their results seem to suggest that the timing of cardiac intervention may be a key consideration in outcomes for liver transplant patients.
"Our study suggests that patients who had cardiac intervention after transplant did better," said Dr. Herman.
[Presentation title: Outcome in Patients Undergoing Cardiac Interventions Before and After Liver Transplantation. Abstract 1581]
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Spanish anaesthetist sentenced in Hepatitis C case
http://www.typicallyspanish.com
By m.p
He was found guilty of infecting 275 patients with the virus
The Spanish anaesthetist, Juan Maeso, has been found guilty of infecting 275 patients with the Hepatits C virus and has been sentenced to 1,933 years in prison.
The ruling from the Valencia Provincial Court, released on Tuesday, finds him guilty of infecting patients in four hospitals in the Valencia Region, over a period covering 1988 until 1997: he will serve a maximum term of 20 years and must pay compensation of close to one million euros.
Total compensation reaches more than 20 million, and includes direct civil responsibility for one of the hospitals – the Hospital Casa de Salud where more than 220 patients were infected – and subsidiary civil responsibility for the health department of the Generalitat de Valencia, the regional government.
Himself a morphine addict, Juan Maeso was charged with injecting patients with the same needle he used on himself.
The court resolution comes almost 20 years after the hepatitis C infections were first detected, and more than a year and a half after the first hearing took place.
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Hep C sufferer jailed for syringe attack
http://news.ninemsn.com.au
A hepatitis C sufferer who injected a sunbaking backpacker with a blood-filled syringe has been jailed for five-and-a-half years.
Louis James Champion, 36, pleaded guilty in Brisbane District Court to one count of sexual assault and one of wounding with intent to transmit a disease over the attack at Hervey Bay in May last year.
The court heard the 26-year-old female backpacker had fallen asleep on the beach at Pialba on May 28, and woke up to find Champion on top of her.
Prosecutor Jacob Robson told the court when the woman awoke Champion stabbed her in the thumb with the blood-filled syringe.
He said Champion suffered from hepatitis C and the woman had to endure a six month wait for blood tests to clear her of the disease.
The court heard Champion had been addicted to drugs and alcohol since his early 20s.
Judge Helen O'Sullivan sentenced Champion to five-and-a-half years jail and listed him as a serious violent offender, meaning he must serve at least 80 per cent of his sentence.
"Your actions were that of a sick man which most of the community would find abhorrent," Judge O'Sullivan said.
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Chimp test signals hepatitis vaccine progress
http://www.scidev.net
Wagdy Sawahel
Scientists have created a vaccine for hepatitis C that can induce an immune response in chimpanzees.
The hepatitis C virus is spread through contaminated blood. Infection can lead to permanent scarring of the liver, chronic liver infection and liver failure.
There is currently no vaccine available, and treatment ― costing US$1600–2300 a month for 6 to 12 months ― is beyond the means of most people in the developing world.
Researchers at the US-based National Institutes of Health have shown that a candidate vaccine made up of molecules that resemble parts of the hepatitis C virus can induce an immune response to the virus in animals.
These are attractive as a candidate vaccine because they can induce an immune response, but are not infectious.
Previous attempts to create a hepatitis C vaccine using virus-like particles have resulted in only partial protection from infection.
Immunisation of four chimpanzees with the candidate vaccine resulted in a detectable and sustained immune response for at least six months. When they were inoculated with the hepatitis C virus, they quickly controlled the infection.
In contrast, three out of the four unvaccinated animals became chronically infected with the virus when inoculated.
The researchers also found that the viral levels in the vaccinated animals were five to tenfold lower than those of the control chimpanzees, demonstrating the vaccine's efficacy.
Yet the immune response in the vaccinated animals was still weak. The next stage, according to lead researcher T. Jake Liang, will be to improve the efficacy of the candidate vaccine through genetic modification to induce a stronger immune response against the virus.
Daniel Okenu, a Nigerian scientist at the US-based Morehouse School of Medicine, welcomed the new development and told SciDev.Net that a vaccine would benefit developing countries, as they have limited resources to pay for costly treatment regimes.
He remains sceptical, however, about whether patent regulations will allow this technology to be available to low-income countries.
According to the World Health Organization, most of the estimated 170 million people with hepatitis C worldwide are in developing countries.
Okenu highlighted the need to encourage local production of such vaccines at affordable prices.
The study was published in Proceedings of the National Academy of Sciences last week (7 May).
Link to abstract in PNAS
Ref: Proceeding of the NationalAcademy of Sciences doi 10.1073/pnas.0702162104 (2007)
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Hepatitis is taking its toll on America
http://www.clarionledger.com
By Shanderia K. Posey
sposey@jackson.gannett.com
If you were told there is a disease running rampant in America that in 20 years is estimated to cause more deaths per year than AIDS, you'd want to know what it is, right?
Furthermore, you'd want to know how to avoid getting it as well.
The disease is hepatitis C, and it could be closer to you than you think. More than 4 million Americans are infected with hepatitis C and 1.4 million more have chronic hepatitis B, according to The American Liver Foundation.
There are five forms of hepatitis - A, B, C, D and E. The viruses cause inflammation of the liver. Chronic hepatitis C is the main reason for adult liver transplants in the United States.
SILENT KILLER
Experts refer to hepatitis as the "silent killer" because the disease can lay dormant for up to 20 years without exhibiting any symptoms. Common symptoms of hepatitis B and C are fatigue, fever, nausea, vomiting, pain near the liver and jaundice which causes yellowing of the skin and whites of the eyes.
Understanding how the disease is spread is key to protecting yourself.
Hepatitis A is usually transmitted through drinking water or eating food that has been contaminated with fecal matter containing the virus.
Hepatitis B is spread by contact with bodily fluids such as blood, semen, vaginal secretions and saliva of an infected person.
Hepatitis C can spread by bodily fluids as well and also by sharing combs, toothbrushes or other personal grooming articles that may have blood on them.
Blood screenings for hepatitis C began in 1992. Some people stricken with the disease contracted it via blood transfusions before testing began.
GET TESTED
Chronic forms of hepatitis can be fatal. Hepatitis B and C eventually can lead to cirrhosis or scarring of the liver, liver cancer or liver failure.
There is hope, though. A vaccine can prevent hepatitis B, and new treatments for hepatitis C are proving effective.
A simple blood test can determine whether a person has the disease. May is Hepatitis Awareness Month, and there's no better time to call your doctor and get tested.
Awareness of this disease should reverse the increase of infection, stop liver damage in its tracks and lessen the toll on families everywhere.
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May 16th, 2007
HBV Not Directly Tied to Increased Stroke Risk
http://www.medscape.com
NEW YORK (Reuters Health) May 04 - The increased risk of stroke or myocardial infarction associated with hepatitis B appears to be secondary to liver dysfunction rather than a direct consequence of HBV seropositivity, Korean and UK researchers report in the May issue of Stroke.
Dr. Yun-Mi Song of Sungkyunkwan University School of Medicine, Seoul and colleagues note that there have been conflicting findings on the possible association between hepatitis B virus surface antigen (HBsAg) seropositivity and cardiovascular disease.
To investigate, the researchers followed more than 521,000 men aged 30 to 64 years from 1990 to 1991.
After adjustment, HBsAg seropositivity was associated with a decreased risk of ischemic stroke and MI (odds ratios, 0.79 and 0.74) and an increased risk of hemorrhagic stroke (odds ratio 1.33).
Risks for stroke and MI were similar between HBsAg-seronegative and HBsAg-seropositive men in the absence of liver dysfunction.
Conversely, men with both HBsAg seropositivity and liver dysfunction had a higher risk of hemorrhagic stroke and lower risks of ischemic stroke and MI than HBsAg-seronegative men.
The findings, the researchers point out, do not support the hypothesis that HBV infection itself plays an important role in the etiology of MI or ischemic stroke through a proinflammatory effect.
"Rather," they conclude, "decreased coagulation status in HBV-associated chronic liver dysfunction appeared to increase the risk of hemorrhagic stroke while reducing the risk of ischemic stroke and MI."
Stroke 2007;38:1436-1441.
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'Over 12 million people have Hepatitis C in India'
http://timesofindia.indiatimes.com
NEW DELHI: About 12.5 million people in the country have Hepatitis C, Lok Sabha was informed Wednesday.
In a written reply, Minister of State of Health and Family Welfare P Lakshmi said that according to the Indian Council of Medical Research (ICMR), there are 12.5 million Hepatitis C (HCV) carriers in the country.
"It is generally accepted that chronic Hepatitis occurs in about 55 per cent of HCV infected individuals within 15-20 years of infection," she said.
The minister said a team led by Prof. Sunil Shaunak and other researchers from Hammersmith Hospital at Imperial College with the help of London School of Pharmacy have claimed that a new drug "Pegylated interferon" is effective for curing Hepatitis C.
Lakshmi said the researchers have not requested them for clinical trials of the drug, which is said to be cheap.
Guideline for Angioplasty: she informed the House that the Society for Cardiovascular Angiography and Interventions – an international professional organisation of interventional cardiologists – has released a set of guidelines for health centres for doing angioplasty.
They have advised patients going in for angioplasty to now check into centres that provide standardised care, enhanced patient safety and a reliable back-up infrastructure, she added.
But, she said according to AIIMS, the most widely followed angioplasty guidelines is the one periodically provided by the American Heart Association.
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Byng man has liver transplant, is progressing well
http://www.adaeveningnews.com
Dorothy Milligan Byng correspondent
Last year I wrote several times about Joe Tingle’s condition as he waited for a liver transplant. The community did several things to help. This year, however, I had lost contact, and I’d wondered about the Tingles. The following news release found its way to my mailbox this week, and I’m happy to share the good news with all of you.
Thomas Joe Tingle, Byng resident, underwent a successful liver transplant operation on March 3 at Baylor All Saints Medical Center in Fort Worth, Texas.
Surgery began at 9 a.m. and lasted four hours. Joe was held in ICU for 24 hours and released from the hospital in a remarkable five days. According to information provided by Baylor All Saints, the typical length of stay for this operation is approximately 10 days. According to his wife, Susie, Joe is doing very well. His personal physician, Dr. Ruiz, has also been pleasantly surprised by the current rate of progress.
Joe was diagnosed with liver failure, caused by the hepatitis C virus, in April 2002. It is estimated that as many as 200 million people worldwide are infected by heapatitis C, and this disease is the leading cause of liver transplantation in the U.S. Joe’s hepatitis was contracted from a tattoo he got years ago, before the importance of proper sterilization techniques were commonly known.
According to Baylor All Saints, liver transplantation is the most complex of all organ transplant surgeries, but prognosis is generally good due to improved surgical techniques, intensive care management, and the development of effective immunosuppressive drugs. According to the United Network of Organ Sharing’s database as of March 2007, 16,932 patients are currently awaiting liver transplants in the United States. In the year 2000 a total of 4,934 liver transplants were performed in the U.S., and an estimated 1,000 people died while waiting for a liver. The median wait for an adult transplant at Baylor is 200 days. The donor of Joe’s liver was a 67 year old male.
Despite Joe’s impressive rate of recovery so far, he and his wife must continue to live in the Fort Worth area for the next three months in order to be near his doctor. Joe and Susie are currently living in Saginaw, Texas.
Both Joe and Susie are very thankful for all the support they have received from family, friends, and neighbors who organized several events to raise money to help offset some of the family’s medical costs. Events included bake sales, yard sales, a blood drive, an auction and a turkey shoot. Joe’s fellow employees at Reagent Chemical contributed over $10,000 toward his COBRA insurance coverage. The family is extremely grateful for these acts of kindness. Joe is the father of six and the grandfather of eight.
Those wishing to learn more about organ donation are encouraged to call 866-ASK-HRSA or visit the national organ donor website at www.organdonor.gov.
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May 17th, 2007
BHIVA 2007: Is chronic HCV co-infection sometimes being misdiagnosed as acute HCV in HIV-positive gay men?
www.aidsmap.com
Edwin J. Bernard,
Increasing numbers of HIV-positive gay men are being diagnosed with hepatitis C (HCV) co-infection, according to several papers presented last month in Edinburgh at the 13th Annual Conference of the British HIV Association (BHIVA) with the British Infection Society. However, an observational study from Imperial College and St Mary’s Hospital in London suggests that recent HCV antibody seroconversion does not necessarily mean acute HCV infection; they recommend using HCV viral load measurements (PCR) as the preferred screening method for high-risk individuals.
Increasing incidence of new HCV diagnoses
Since 2002 a steadily increasing number of HIV-positive gay men in London and Brighton are being diagnosed with HCV co-infection: the vast majority of these infections appear to have been sexually transmitted.
This year’s BHIVA conference saw several presentations on acute and recently diagnosed HCV infection and its treatment in HIV-positive gay men. The Health Protection Agency’s Dr Murad Ruf reported that 389 cases of acute HCV co-infection had been seen in HIV-positive gay men in London and Brighton up to June 2006. Incidence rose from 7 per 1000 person years in 2002 to 12 per 1000 person years in 2006, resulting in an estimated annual incidence of 1.33% per year (95% CI, 0.99-1.78). Put another way, one out of every 83 HIV-positive gay men in London and Brighton is being newly diagnosed with HCV co-infection each year.
Treating acute HCV
However, as with HIV infection, there is a difference between being newly diagnosed and recently infected. Unlike HIV, knowing the difference between acute (usually defined as HCV infection acquired in the previous six months) and chronic (usually defined as HCV infection for longer than six months) HCV infection has important treatment implications: HCV is much more likely to be eradicated during the acute stage.
A recent small German study found a 61% sustained virological response (SVR) rate in HIV-positive men who began treatment during acute HCV infection following 24 or 48 weeks treatment with pegylated interferon (and weight-based ribavirin for patients with HCV genotypes 1 or 4).
In contrast, two major international studies have found that 48 weeks’ treatment with pegylated interferon and ribavirin during chronic HCV infection achieves a much lower SVR (up to 40%) of coinfected individuals, although this is much lower for individuals coinfected with HCV genotypes 1 and 4 (the most frequently-seen HCV genotypes amongst recently-diagnosed gay men).
The two London centres with the most experience of treating HCV co-infection reported data on the management and treatment of acute HCV at the conference. Chelsea and Westminster Hospital reported a 66% SVR rate using pegylated interferon and weight based ribavirin for 24 weeks: treatment success was significantly associated with a higher median CD4 percentage at the start of therapy (29% versus 24%; p<0.007), but, surprisingly, not HCV genotype (p=0.908). The Royal Free Hospital reported an SVR of 77% following 48 weeks of peglyated interferon and weight based ribavirin. However, only 75% of those who began anti-HCV therapy could tolerate 48 weeks’ treatment.
Diagnosing acute HCV
Since both centres concluded that timely diagnosis of acute HCV in co-infected individuals is extremely important, given the much higher SVR rates achieved, it is also critical that acute HCV is diagnosed correctly. There is no standard way of diagnosing acute HCV but three factors are usually considered:
- abnormal liver function tests (alanine-aminotrasferase; ALT)
- positive HCV viral load (HCV PCR)
- documented seroconversion for HCV antibodies
Dr Emma Thomson from Imperial College presented data from St Mary’s Hospital on 32 HIV-positive gay men who appeared to present with acute HCV infection. The object was to assess the sensitivity of HCV antibody versus HCV PCR at three-monthly intervals and also to estimate the median time from HCV PCR positivity to HCV antibody seroconversion.
Two men who had not yet seroconverted were initially diagnosed with acute HCV. However, they were excluded from the study when past blood samples tested positive for HCV viral load: they actually had chronic hepatitis C without HCV antibody seroconversion.
The remaining 30 men had a positive PCR test at baseline, but 77% were HCV antibody negative (sensitivity = 23%) and 19% had normal ALT (sensitivity 81%).
After three months, liver function tests were all above the upper limit of normal although 35% still had a negative HCV antibody test (sensitivity = 65%).
HCV antibody sensitivity reached 93% at nine and twelve months. The median time from positive PCR test to antibody seroconversion was 108 days (range 0-433 days). However, three of the men did not develop antibodies at all during the follow-up period (147, 233 and 240 days post positive PCR test, respectively).
Assay |
PCR |
ALT |
Ab |
Baseline |
100% |
81% |
23% |
3 months |
100% |
100% |
65% |
6 months |
100% |
100% |
78% |
9 months |
100% |
100% |
93% |
12 months |
100% |
100% |
93% |
HIV-negative individuals tend to produce an antibody response to HCV within six weeks of infection. Here, the median time to development of HCV antibody in HIV-positive gay men with recent HCV infection was more than 15 weeks (108 days) and look longer than six months in almost one-in-four (22%).
This small study suggests, then, that different diagnostic tests for acute HCV infection can vary greatly in sensitivity. In particular, some individuals may never develop an HCV antibody response. Relying on a documented negative to positive HCV antibody test as one of the definitions of acute HCV may result in the possible misdiagnosis of chronic HCV infection as acute HCV infection.
The investigators suggest that this misdiagnosis of chronic HCV infection as acute HCV infection might be one of factors responsible for the lower SVR seen during apparently acute infection in co-infected individuals. They add, however, that “it is likely that disturbance of the cell-mediated immune response is the major determinant of outcome [in treating acute HCV in co-infected individuals].”
They conclude by recommending, “where there is high clinical suspicion of recent hepatitis C infection (e.g. raised ALT levels), HIV-infected patients should be screened for the presence of HCV RNA by RT-PCR. HIV-infected patients diagnosed with acute hepatitis C should have a preceding HCV-RNA test to establish the timing of infection.”
References
- Ruf M et al. Evidence of increase in recently acquired hepatitis C in HIV-positive men who have sex with men across London 2002-2006. HIV Medicine 8 (Suppl. 1), O7, 2007.
- Low E et al. The management and treatment of acute hepatitis C in HIV-infected individuals. HIV Medicine 8 (Suppl. 1), O8, 2007.
- Rodger A et al. Treatment of acute HCV with 48 weeks of ribavirin and pegylated interferon (pIFN) in a cohort of HIV co-infected patients. HIV Medicine 8 (Suppl. 1), O9, 2007.
- Thomson EC et al. Delayed antibody seroconversion in HIV-positive men superinfected with hepatitis C virus. HIV Medicine 8 (Suppl. 1), P102, 2007.
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Peregrine Tests Drug for HIV/HCV Patients
http://www.redorbit.com U.S. firm Peregrine Pharmaceuticals said Thursday it has launched a trial of bavituximab in patients co-infected with HIV and hepatitis C.
The dose-escalation study will involve about 24 patients and will take place initially at Newark, N.J.-based Saint Michael's Medical Center, under the direction of study investigator Stephen Smith.
Chronic co-infection with the hepatitis C virus affects a significant proportion of our HIV patients, yet current HCV therapies are often ineffective or poorly tolerated, said Smith. These patients are particularly vulnerable since co-infection is associated with more aggressive progression of HCV-associated liver disease.
Smith said bavituximab has a distinct immunotherapeutic mechanism that might show benefits in this patient population.
Source: United Press International
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May 18th, 2007
MIGENIX to Present Celgosivir Phase II Hepatitis C Results at Digestive Disease Week 2007
http://biz.yahoo.com
VANCOUVER and SAN DIEGO, May 18 /CNW/ - MIGENIX Inc. (TSX: MGI - News; OTC: MGIFF - News), a clinical-stage developer of drugs for infectious diseases will make a presentation of results from a recent hepatitis C Phase II combination therapy study (see April 11, 2007 press release) in a non-responder patient population at Digestive Disease Week (DDW) 2007 being held in Washington, DC May 19-24, 2007. Dr. Kelly Kaita, the Director of the Viral Hepatitis Investigative Unit (VHIU) at the Health Sciences Centre, University of Manitoba and a lead investigator in the MIGENIX Phase II study will make the presentation.
The presentation entitled: "Phase II Study of Celgosivir in Combination with Peginterferon alfa-2b and Ribavirin in Chronic Hepatitis C Genotype-1 Non-responder Patients" (Abstract No. 324227) will be made on Monday, May 21, at 2:45 p.m. (EDT) in Room 206 of the Washington Convention Center. Additionally on May 20, 2007 Dr. Kaita and AnnKatrin Petersen, M.D., Vice President, Clinical Development of MIGENIX will participate in a DDW news conference highlighting progress in new and evolving areas of chronic hepatitis C therapy including celgosivir. A copy of the presentation and the related Abstract will be available at www.migenix.com following the presentation.
Research being presented at Digestive Disease Week 2007 analyzes advancements in the diagnosis of hepatitis C and therapies available to patients who suffer from the disease. DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Digestive Disease Week is considered the largest and most prestigious meeting in the world for the gastrointestinal professional. Every year DDW attracts more than 16,000 physicians, researchers and academics from around the world.
About Celgosivir (MX-3253)
Celgosivir is an oral alpha-glucosidase I inhibitor and is currently the only anti-HCV drug in clinical development that acts on host-directed glycosylation. In preclinical studies, celgosivir has shown excellent in vitro synergy with various interferons in the clinic or in development including Pegasys, PEG-Intron, Infergen, Alferon and IFN-omega (with or without ribavirin) and other drugs in development for the treatment of HCV (e.g. polymerase inhibitors) and therefore has the potential to be included as part of multiple combination approaches to improve efficacy in anti-HCV therapy.
About MIGENIX
MIGENIX is committed to advancing therapy, improving health, and enriching life by developing and commercializing drugs primarily in the area of infectious diseases. The Company's clinical programs include drug candidates for the treatment of chronic hepatitis C infections (Phase II and preclinical), the prevention of catheter-related infections (Phase III) and the treatment of dermatological diseases (Phase II). MIGENIX is headquartered in Vancouver, British Columbia, Canada with US operations in San Diego, California. Additional information can be found at www.migenix.com .
"Art Ayres"
Arthur J. Ayres, CA.
Sr VP Finance & CFO
The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.
For further information
Art Ayres, MIGENIX Inc., Tel: (604) 221-9666 Ext. 233, aayres@migenix.com
Dian Griesel, Ph.D., Investor Relations Group, Tel: (212) 825-3210, Theproteam@aol.com
Source: MIGENIX Inc.
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Schering-Plough Announces Hepatitis C Data Presentations at Digestive Disease Week (DDW) 2007 Annual Meeting
http://biz.yahoo.com
KENILWORTH, N.J., May 18 /PRNewswire-FirstCall/ -- A total of 20 oral and poster presentations on clinical studies with Schering-Plough's hepatitis products, including PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL® (ribavirin, USP) combination therapy for chronic hepatitis C virus (HCV) infection, as well as boceprevir (SCH 503034), the company's investigational oral HCV protease inhibitor currently in Phase II clinical development, will be presented by leading researchers at the 38th annual Digestive Disease Week (DDW) meeting to be held at the Washington Convention Center in Washington, D.C., May 20-23.
Hepatitis C is the most common blood-borne infection in America and the most common form of liver disease, affecting nearly 5 million people in the United States and 200 million people worldwide. It is the leading cause of cirrhosis and liver cancer, and the number one reason for liver transplants in the United States.
PEGINTRON
Clinical investigators will present findings at DDW from numerous PEGINTRON studies evaluating patient response to therapy at certain treatment milestones, an approach that is aimed at individualizing treatment for patients. Schering-Plough also is exploring novel therapeutic approaches with PEGINTRON in combination with investigational antiviral agents to optimize treatment for patients with more difficult-to-treat forms of the disease, such as patients who were nonresponders to previous therapy.
Boceprevir (SCH 503034)
Schering-Plough is undertaking a large, fully integrated clinical development program for its oral HCV protease inhibitor boceprevir, with the goal of developing new strategies for improving treatment outcomes for patients with hepatitis C.
At DDW, Schering-Plough will present results of in vitro studies conducted in collaboration with Wyeth/ViroPharma of boceprevir in combination with their investigational non-nucleoside HCV polymerase inhibitor HCV-796.
In Addition, Schering-Plough has initiated the HCV SPRINT-1 study (HCV Serine Protease Inhibitor Therapy-1), a large Phase II study with boceprevir ongoing at sites across the U.S., Canada and Europe. The primary objective of the study is to evaluate the safety and efficacy of boceprevir (800 mg TID) in combination with PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily) in the HCV genotype 1 treatment-naive patient population. The first part of the study (screening cohort 1) has completed enrollment and involves more than 500 patients in five treatment arms. A second part to the study (screening cohort 2) recently opened for patient enrollment and adds two additional treatment arms. This second cohort will evaluate the safety and efficacy of boceprevir in combination with PEGINTRON and a lower dose of REBETOL (400-1000 mg daily). In total, approximately 550-600 patients will be enrolled in the HCV SPRINT-1 study.
Schering-Plough also is conducting a large Phase II study evaluating the safety and efficacy of boceprevir in combination with PEGINTRON and REBETOL in patients chronically infected with HCV genotype 1 who were null responders to previous peginterferon and ribavirin combination therapy (i.e., patients who did not achieve undetectable HCV-RNA or a 2 log decline in viral load with a minimum of 12 weeks of peginterferon and ribavirin combination therapy). This represents a very difficult-to-treat patient population for which there is a great unmet medical need. The study involves approximately 350 patients and is ongoing at centers in the United States and Europe. All study participants have completed treatment with boceprevir in combination with PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily) and are in the follow-up phase of the study. Data from this study will be available later in 2007, and will help guide future clinical development of boceprevir.
Key Oral Presentations at DDW
- Favorable Cross-Resistance Profile of HCV-796 and Boceprevir (SCH-503034) and Enhanced Anti-Replicon Activity Mediated By Combination Treatment; R. Ralston, Monday, May 21, 11:15 a.m., Room 206
- Pharmacodynamic Analysis of the Antiviral Activity of the Non-Nucleoside Polymerase Inhibitor, HCV-796, in Combination With Peginterferon Alfa-2b in Treatment-Naive Patients With Chronic HCV; E.S. Maller, Monday, May 21, 2:15 p.m., Room 206
- Phase II Study of celgosivir in combination with Peginterferon alfa-2b and ribavirin in chronic hepatitis C genotype 1 nonresponder patients; K.D. Kaita, Monday, May 21, 2:45 p.m., Room 206
Schering-Plough Sponsored CME Symposium
"HCV Treatment Decisions: Challenging Issues" Monday, May 21, 6:30-8:30 pm, Grand Hyatt Washington, Independence Ballroom A, 1000 H Street, NW, Washington, D.C.
This case-based symposium is designed to outline effective management strategies for patients with hepatitis C virus infection. Optimizing HCV patient outcome requires a thorough understanding of the underlying patient and disease factors that influence treatment. Clinical scenarios will be presented, and through the use of case studies, the distinguished faculty will review and discuss current data to illustrate their respective treatment decisions.
About PEGINTRON and REBETOL Combination Therapy
PEGINTRON is approved in the United States for use alone or with ribavirin (800 mg/day) for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age.
WARNING
Alpha interferons, including PEGINTRON, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEGINTRON therapy.
Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.
REBETOL and combination REBETOL/PEGINTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEGINTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6- month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.
PEGINTRON
There are no new adverse events specific to PEGINTRON as compared to INTRON® A (Interferon alfa-2b, recombinant) for Injection; however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEGINTRON were "flu- like" symptoms, occurring in approximately 50 percent of patients, which may decrease in severity as treatment continues. Application site disorders were common (47 percent), but all were mild (44 percent) or moderate (4 percent) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2 percent of patients receiving PEGINTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEGINTRON.
Psychiatric adverse events, which include insomnia, were common (57 percent) with PEGINTRON but similar to INTRON A (58 percent). Depression was most common at 29 percent. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1 percent of patients during or shortly after completing treatment with PEGINTRON.
PEGINTRON/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
The following serious or clinically significant adverse events have been reported at a frequency less than 1 percent with PEGINTRON or interferon alpha: severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.
In the PEGINTRON/REBETOL combination trial the incidence of serious adverse events was 17 percent in the PEGINTRON/REBETOL groups compared to 14 percent in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEGINTRON/REBETOL combination therapy trial was 23 percent in the INTRON A/REBETOL group and 31-34 percent in the PEGINTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42 percent of patients receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34 percent of those receiving INTRON A/REBETOL.
REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's strategy regarding and the potential of PEGINTRON, REBETOL and boceprevir (SCH 503034). Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward- looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part I, Item 1A, "Risk Factors" in the company's first quarter 2007 10-Q.
Source: Schering-Plough
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Hepatitis C Infection Hampers Liver Transplant Success
www.forbes.com
FRIDAY, May 18 (HealthDay News) -- While survival rates have improved for liver transplant patients without hepatitis C (HCV), that's not the case for liver recipients infected with the virus, new research shows.
HCV-induced liver disease is the most common reason for liver transplantation in the United States.
The Johns Hopkins School of Medicine-led study looked at more than 5,700 HCV-infected patients and more than 16,100 non-HCV-infected patients who had undergone a liver transplant in the United States between January 1991 and October 2001.
During that time, there was a dramatic spike in the percentage of liver transplant patients with HCV -- from 16.4 percent in 1991 to 54.7 percent in 2001. But the study also found that liver recipients with HCV had a lower 3-year survival rate (78.5 percent) than non-HCV recipients (81.7 percent).
During the study period, survival rates for non-HCV patients improved, but there was no improvement among HCV patients.
"In summary, the survival of patients transplanted with HCV is significantly lower than those without HCV," the study authors wrote. "There has been a statistically significant improvement in patient and graft survival for non-HCV recipients between 1991 and 2001, but for HCV recipients, the survival rate has remained unchanged without any obvious explanations."
The findings are published in the May issue of the journal Liver Transplantation.
More information
The American Liver Foundation has more about liver transplant.
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Leal promises to help Hep C victim
http://www.thepeterboroughexaminer.com
By BILL GLISKY/Examiner city editor
Bill Catt is tired of waiting. Jeff Leal says he will do his best to end that wait.
Catt, who contracted hepatitis C during surgery in 1976, met with Peterborough MPP Leal yesterday seeking help to get the federal government to start doling out money to compensate people like Catt.
Stephen Harper's Conservative government announced nearly a year ago it would compensate the "forgotten victims" of the tainted blood scandal such as Catt.
Previously, only people infected with hepatitis C between 1986 and 1990 were eligible for compensation.
The previous government insisted it couldn't have prevented infections outside that period, but that claim was later disputed when it became known that effective blood screening tests were available before 1986.
According to the new program, people who contracted the disease through tainted blood before 1986 and after 1990 will each collect anywhere from $1,000 to $300,000 once the money starts to flow under the new program.
“The money is available, but we aren’t seeing any of it,” Catt said. “All of us are tired of waiting for promises that are not being kept.”
Catt said he contracted the disease while having surgery to treat Crohn's disease. He had worked as a truck driver, but the hepatitis C coupled with Crohn's has left him unable to work.
He has had some compensation over the years, receiving $25,000 in 1999, $6,000 in 2004 and $3,000 in 2005.
Leal said he would continue to have discussions with provincial Minister of Health and Long Term Care George Smitherman, as well as working with Peterborough MP Dean Del Mastro to get answers to where the federal money is.
“I told (Catt) I would pursue this on his behalf with (federal) Health Minister Tony Clement,” Leal said. “There are a number of issues I hope the federal minister can clarify for me.
“Once that is done I will work with my federal colleague Mr. Del Mastro to try to make some things happen.”
Catt said he appreciated Leal working on his behalf and hoped the MPP had better luck getting the ball rolling on compensation than he had had.
“I didn’t ask for this disease, but it’s not going to go away,” he said. “I am stuck with this for the rest of my natural life.”
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