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Week Ending: April 19, 2008
Alan Franciscus
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April 12th, 2007
PUBLIC HEALTH CRISIS: Insurer broadens hepatitis caution
By Annette Wells and Brian Haynes
Review-Journal
Anthem alert addresses procedures done before March 2004
Although Southern Nevada Health District officials maintain there is no evidence that the unsafe injection practices they believe led to six people contracting hepatitis C at a Las Vegas endoscopy clinic took place before March 2004, at least one health insurance provider isn't taking any chances.
Anthem Blue Cross Blue Shield plans to alert all members treated at the Endoscopy Center of Southern Nevada at 700 Shadow Lane to speak with their physicians about having tests for blood-borne diseases regardless of procedure date.
Anthem spokeswoman Sally Vogler said Friday that the notification will appear in the form of an advertisement in the Review-Journal on Sunday and on April 20.
She said the advertisement stems in large part from the possibility of patients who were treated at the clinic before March 2004 testing positive for hepatitis C or another blood-borne disease.
Vogler and Anthem's senior counsel Molly McCoy said the insurance provider's advertisement isn't alleging that unsafe injection practices occurred at the Shadow Lane facility before the date set by the health district, or that the health agency is not being thorough in its investigation.
"This is really about covering all the bases," Vogler said.
In late February, the health district sent letters to 40,000 patients who underwent procedures at the Shadow Lane facility between March 2004 and Feb. 11 urging them to be tested for hepatitis strains C and B and HIV, the virus that leads to AIDS.
The notification, now considered the largest in U.S. history with respect to blood-borne diseases, was the result of a cluster of people identified with hepatitis C in January.
All six had been treated at the endoscopy clinic, one on July 25 and five on Sept. 21, health officials said. Each of those patients had undergone procedures with the sedative Propofol, health officials said.
Health district officials believe patients were exposed when nurse anesthetists reused syringes on infected patients and contaminated single-use vials of medicine. The infection spread when the vials were shared among multiple patients.
Lawyer Robert Eglet, whose firm, Eglet Mainor Cottle, represents more than 4,000 clinic patients, said Anthem's ad came as little surprise.
"It's not something that anybody hasn't been saying since Day One," he said.
Of his 210 clients who have tested positive for an infectious blood-borne disease, several had procedures well before the March 2004 date set by the health district, he said.
"March 2004 has always been an arbitrary date," he said, noting that it was chosen because the only records kept in the Shadow Lane clinic went back to that time. Earlier patient records probably are stored elsewhere, he said.
Brian Labus, the health district's senior epidemiologist, said the decision was based on the identification of the unsafe injection practices and the determination that these practices had been the standard practices of the clinic since a remodeling in March 2004.
"We are limited to those dates," Labus said, but he added he didn't think it unreasonable for people to speak to their doctors about being tested even if their procedures occurred outside that time frame. "We just don't have evidence to urge patients prior to March 2004 to get tested."
Eglet said he believes it's only a matter of time until the health district sends notification letters to patients of the Desert Shadow Endoscopy Center, at 4275 Burnham Ave., at which health officials have said a seventh patient probably contracted hepatitis C. Eglet represents the patient, a male, who underwent a procedure in 2006 and tested positive for hepatitis several weeks later within the incubation period for developing illness. The case never was reported to the health district.
Labus said the health district is trying to determine whether any Desert Shadow patients should be notified. Disorganization of medical records being held at the Metropolitan Police Department is slowing that investigation.
Labus said police have received several bids from companies experienced with sifting through medical records, but he said the process is going to take some time to accomplish.
In the meantime, he said, the health district continues to receive positive test results and is interviewing patients with positive tests to determine any link to the endoscopy clinic.
Anthem officials said they haven't received any test claims that show positive results since the health district's announcement. The insurance provider has had a contract with the Gastroenterology Center of Nevada, the umbrella of the Shadow Lane and Burnham Avenue facilities, since the late 1990s.
Anthem also plans to send letters to more than 15,000 of its members who were treated at the Shadow Lane facility between the health district's dates to reinforce testing.
"Because of the time span, we felt it necessary to be absolutely accurate with addresses,'' Vogler said.
Eglet characterized the Blue Cross Blue Shield ad as a good preventive step to help identify infected patients so they can begin treatment sooner rather than later.
Contact reporter Annette Wells at awells@reviewjournal.com or 702-383-0283. Contact reporter Brian Haynes at bhaynes@reviewjournal.com or 702-383-0281.
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Program nets Vassar Brothers Medical Center state honor
http://www.poughkeepsiejournal.com
By Sarah Bradshaw
State Department of Health Commissioner Richard Daines presented Vassar Brothers Medical Center with an award Friday, recognizing the hospital for its Perinatal Hepatitis B Immunization Program.
The program provides screening and immunization for newborns of mothers who have tested positive for Hepatitis B.
Vassar Brothers was the only hospital in the state to achieve 100 percent compliance with the immunization program, according to Vassar Brothers spokeswoman Theresa Mulkins.
"As a pediatrician, I am extremely proud of Vassar Brothers Medical Center's commitment to providing the highest quality services to women and children," said Daniel Aronzon, Vassar Brothers CEO, in a press release.
Help the littlest patients
"To earn Vassar Brothers recognition as a Top 41 U.S. hospital, you must take particular care of the most vulnerable patients, such as infants and children. Prevention and patient safety is a key component to achieving that designation."
In September, the Leapfrog Group ranked Vassar as one of the top 41 in the nation for quality of service and patient safety.
The commissioner came to the Poughkeepsie campus as part of National Public Health Week and to highlight maternal child health programs.
Daines - along with Dutchess County Department of Health Commissioner Dr. Michael Caldwell, Dyson Foundation President Rob Dyson and representatives from the New York State March of Dimes - toured the hospital's labor and delivery, maternity and neo-natal Intensive Care units.
During a press conference, Daines discussed how health-care providers, New York state and its counties can work together. The partnership could focus on preventive care through screenings, vaccinations and education, he said.
Vassar Brothers is an affiliate of the Health Quest hospital system, which also includes Northern Dutchess Hospital in Rhinebeck and Putnam Hospital Center in Carmel.
Reach Sarah Bradshaw at sbradshaw@poughkeepsiejournal.com or 845-437-4811.
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April 13th, 2007
LIVER DISEASE: Partnership would teach, treat
http://www.lvrj.com
By Paul Harasim And Annette Wells
Review-Journal
Medical centers look into hepatology program
Three prestigious California medical centers are in serious discussions with the University of Nevada School of Medicine to provide sophisticated treatment of liver disease in Las Vegas.
The timing of conversations with Loma Linda University, UCLA and California Pacific Medical Center, which already has a part-time presence in Southern Nevada, isn't coincidental.
Six weeks ago, some 40,000 letters were sent to former patients of the Endoscopy Center of Southern Nevada by health care authorities urging them to get tested for blood- borne diseases including hepatitis C, an incurable, potentially fatal condition that attacks the liver.
Six cases of acute hepatitis C had been traced to the clinic, and now a seventh to a sister clinic. At this point, the need for medical treatment could not be ignored, said Blain Claypool, the Nevada medical school's chief operating officer.
At present, Nevada's medical school does not have a program in hepatology, which is the study of liver disease, nor is there a hepatologist treating patients full time in Las Vegas.
The three medical centers propose to partner with the medical school to set up a program that would both treat patients and teach medical students about liver disease.
"We are having active conversations with multiple parties to make sure those services are available in the community," Claypool said.
One of Nevada's large insurance coalitions asked the school of medicine three weeks ago to contact Loma Linda University Adventist Health Sciences Center about providing services, he said.
That Southern California health center, 240 miles from Las Vegas, includes a medical school, adult and children's hospitals, and research and transplant institutions.
Claypool wouldn't divulge which insurance company had made the request, but said the conversation about contacting Loma Linda University occurred "right in the thick of the hepatitis outbreak.''
Loma Linda University has already submitted a written proposal to the Nevada medical school.
The proposal describes how the university's liver transplant program would assist Nevada's only public medical school in establishing a hepatology program and services. The program would have an educational arm, said Dr. Zeid Kayali, medical director of Loma Linda's liver transplant program.
Representatives of San Francisco's California Pacific Medical Center have spoken to Nevada medical school officials about how they would help set up a program.
On Thursday, a liver surgeon from UCLA toured the medical school and met with staff at the medical school.
Before the outbreak, Las Vegas Mayor Oscar Goodman had been working to bring to Nevada physicians associated with UCLA, the world leader in liver transplants. Since the outbreak, Goodman has stepped up discussions that have largely centered around bringing liver specialists from the Los Angeles university to Las Vegas in a clinic setting.
Goodman said he has hated to see the emotional and physical pain suffered by Southern Nevadans because of the outbreak.
"We need to get first-class health care in Las Vegas," he said. "It is embarrassing to have banners going across CNN and MSNBC talking about our city and a hepatitis outbreak."
Like UCLA, Loma Linda University had been considering liver treatment programs in Las Vegas. But the hepatitis outbreak made them step up their efforts.
Dr. Thomas Sibert, associate vice president of UCLA's David Geffen School of Medicine and head of outreach services, said Wednesday he envisions UCLA physicians -- probably a hepatologist and a liver surgeon -- working twice a month in a clinic for liver problems at University Medical Center, which is affiliated with the Nevada school of medicine.
The medical director of California Pacific's liver transplant program, Dr. Robert Gish, envisions a similar partnership.
For the past two decades, Gish has treated patients on a part-time basis in Nevada.
His practice on behalf of California Pacific has flown specialists to Nevada once a month to consult with and treat patients diagnosed with liver disease. His staff now spends eight to 12 days in Southern Nevada and Northern Nevada each month seeing about 150 patients. Roughly 10 percent of those patients need liver transplants. About 50 percent have hepatitis C, and the rest are patients with other liver problems such as hepatitis B and fatty livers.
"There's a lot of dialogue right now to step up efforts," Gish said, who teaches part time at the Nevada medical school. "Right now, we're providing help to patients, but there's going to be a need for liver specialists to be here full time."
More Patients, More Demand For Treatment
To date, the Southern Nevada Health District has definitively linked seven acute hepatitis C cases to two endoscopy centers owned by Dr. Dipak Desai and others. Health officials believe six of the seven contracted hepatitis C at the Endoscopy Center of Southern Nevada, 700 Shadow Lane, because of unsafe injection practices. A syringe would be reused on a patient and then used to draw anesthesia from a vial intended for just one patient. The vial would be used on other patients, potentially spreading disease.
Lawyers for some 600 former patients of the Shadow Lane facility, and Desert Shadow Endoscopy, 4275 Burnham Ave., say their clients have tested positive for the virus because of the injection practices.
Thousands of patients have retained attorneys.
No one knows for sure how many of the patients will eventually test positive for the blood-borne disease as a result of practices at the clinic.
Public health officials estimate that roughly 4 percent of the patients would have had the often silent disease before their treatment at the clinic began, because of the older age of typical clinic patients. Regular screening since 1992 of the blood supply used for infections has reduced the rate of infection.
The 4 percent figure means that about 1,600 of the 40,000 patients notified would test positive for hepatitis, based on projections by the Centers of Disease Control and Prevention, according to Brian Labus, senior epidemiologist of the Southern Nevada Health District.
Despite the current emphasis on liver conditions, Goodman said he would like UCLA to have a broader role.
"I think the people who live here want the very best in medicine," Goodman said. "We want to be a world-class city. "
A few years ago, Goodman was among several Nevada public figures pushing for the Cleveland Clinic and the University of Pittsburgh Medical Center, established academic medical centers, to set up shop here.
Sibert said UCLA's involvement in Las Vegas now would be "far more modest" than the kind of partnership Goodman had envisioned. Both institutions, recognized internationally for overall health care, were interested in opening full-scale operations in Las Vegas.
"Those projects were grand, but they raised some anxiety among doctors and hospitals,'' Sibert said. "We're really not here to take their daily bread."
Added Benefits
Kayali said a hepatology program here would help educate both the public and the medical community.
"People need to know what hepatitis C really means, how people develop complications, what impact it has on the liver, and whether or not one can give it to their partners,'' he said, adding that a critical component of the partnership is teaching young medical students how to treat liver disease.
The Centers for Disease Control have reported that only 20 percent of people with hepatitis C have symptoms of the disease.
Common routes of infection include the sharing of needles in drug use, needle stick accidents among health care workers, and blood to blood contact that might occur during sexual activity.
Not to be overlooked is how having a hepatology center at the Nevada medical school would make life easier for Southern Nevadans dealing with a serious disease.
Said Julie Humeston, a registered nurse and director with Loma Linda University's Transplantation Institute, "They shouldn't have to drive three hours to come to us."
Contact reporter Paul Harasim at pharasim@reviewjournal.com or 702-387-2908. Contact reporter Annette Wells at awells@reviewjournal.com or 702-383-0283.
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April 14th, 2007
Hepatitis C: Identification Of A Protein That Inhibits The Virus
http://www.sciencedaily.com
ScienceDaily (Apr. 17, 2008) — Scientists in the Laboratoire Hépatite C of the Institut de Biologie de Lille in collaboration with INSERM Unit 602 and a laboratory at Stanford University have provided evidence of a protein, called EWI-2wint, that inhibits the hepatitis C virus at an early stage of its infective cycle. This research suggests possible new perspectives for the development of therapies to block the virus before it enters a cell.
Hepatitis C is a major public health problem that affects some 130 million people throughout the world. In France , where there are about 5000 new cases each year, it is estimated that half a million people could be affected by this disease. The causal agent is the hepatitis C virus (HCV) which targets cells in the liver called hepatocytes. HCV infection is usually chronic (60% to 80% of cases) and in the long term can lead to the development of cirrhosis and liver cancer.
Unlike the hepatitis A and B viruses, there is no vaccine to combat this virus. Furthermore, the treatments employed are only of limited efficacy (the failure rate reaches around 40%), and they involve considerable side effects. It is therefore crucial to develop new antiviral compounds to control this infection.
HCV uses at least three receptors to enter and infect a hepatocyte. One of these receptors is the CD81 protein, which has the particular characteristic of associating with numerous other proteins. It was by studying these CD81 partner proteins that the researchers identified the EWI-2wint protein, which prevents the recognition of CD81 by the hepatitis C virus and inhibits it at a very early stage in its infective cycle. This protein is present in other types of cells, which could explain why they are not infected by HCV. Discovery of the role of EWI-2wint in hepatocytes has demonstrated the complexity of the mechanisms of entry of HCV into its target cells, and opens the way to new therapeutic approaches.
Journal reference: The CD81 partner EWI-2wint inhibits hepatitis C virus entry. Vera Rocha-Perugini, Claire Montpellier, David Delgrange, Czeslaw Wychowski, François Helle, André Pillez, Hervé Drobecq, François Le Naour, Stéphanie Charrin, Shoshana Levy, Eric Rubinstein, Jean Dubuisson, Laurence Cocquerel. PLoS One. April 2, 2008.
This research was supported by the ANRS.
Adapted from materials provided by CNRS.
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Nearly 80,000 syringes handed out in Marin program, a drop from previous years
http://www.marinij.com
Brad Breithaupt
Marin health aides last year handed out nearly 80,000 clean syringes, a decline in the number of needles in the free needle-exchange program that targets the spread of AIDS and hepatitis C among local drug users. The fiscal year total reflected the third consecutive annual drop since 2003-04, when the program swapped 95,477 used syringes for clean ones.
Officials believe the decline may be due in part to a pilot pharmacy program called Syringe Access, in which needles are sold without prescriptions at local pharmacies.
It's all part of a "harm-reduction philosophy," said Andy Fyne, community relations manager for the Marin AIDS Project, which runs Marin's needle-exchange program.
By providing local drug users with clean syringes, program workers and volunteers reduce the spread of HIV, hepatitis C and other blood-borne diseases by drug users sharing needles. The program, called Point Program, also hands out information about drug-abuse counseling, Fyne said, stressing the needle-exchange program provides his agencies' counselors and volunteers direct contact with intravenous drug users who would otherwise be hard to reach.
During 2006-07, 77 people entered risk-reduction counseling and referrals to drug-treatment programs as a result of contacts made in the needle exchange program, according to a county report presented to the Board of Supervisors last week.
Most of the swaps take place at weekly stops for the big blue van that serves as the Point Program's mobile office.
On Monday nights, it can be found in a commuter parking lot in Mill Valley. It is parked at the end of a side street off Rowland Boulevard in Novato on Thursday nights. The Marin AIDS Project office, at 910 Irwin St. in San Rafael, also trades needles from noon to 4 p.m. weekdays and 5:30 to 8 p.m. Tuesdays.
Marin's program, launched to combat the spread of AIDS, is nearly 20 years old.
For many years, county supervisors had to declare a local public health emergency every two weeks to legally keep the program alive. The declaration exempted the swap from prosecution for distributing syringes without a prescription.
In 2006, a new state law permitted the local programs as a public health emergency measure, but the law required annual reports to the local county boards of supervisors, rather than having to approve bi-weekly resolutions.
The local report, written by Sparkie Spaeth, the county communicable health and prevention manager, noted that only three cases of HIV that were diagnosed last year listed intravenous drug use as a possible risk factor.
"These numbers have been fairly consistent over the past three years, and demonstrate both the success of and the ongoing need for the Point Program in the Marin community," she wrote.
In 2005, the AIDS Project Los Angeles reported that nearly 20 percent of AIDS cases and half of hepatitis C cases in California could be traced back to injection drug use and the sharing of unsanitary needles.
Spaeth's 2006-07 report estimates that 16 percent of the participants are younger than 30. Sixty-two percent of the people seeking exchanges are male.
Ninety percent are white, 6 percent black and 3 percent Latino.
Since 2005, Marin also has participated in a five-year state demonstration project that allows cities and counties to permit pharmacists to sell 10 or fewer syringes to a customer without prescriptions.
Fourteen Marin pharmacies are participating in the program, which includes distribution of pamphlets about prevention, testing and treatment services along with the syringes.
John Fenech, who heads the Point Program, said the recent drop in needle exchanges may be the result of the pharmacy program, Syringe Access, and its strong support among Marin pharmacies.
"I would say that Syringe Access is part of it," he said.
The Point Program, he said, also helps assure that used needles are disposed of safely. Those turned in are incinerated by a health waste disposal firm.
Fenech said the Marin program makes a difference, preventing the spread of HIV/AIDS and hepatitis C and getting some people to give up drugs.
"No doubt about it," he said.
Information about the Marin AIDS Project's Point Program needle exchange can be found at www.marinaidsproject.org
Contact Brad Breithaupt via e-mail at bbreithaupt@marinij.com
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April 15th, 2007
New Treatments Help Fight Liver, Colon Cancer
www.forbes.com
MONDAY, April 14 (HealthDay News) -- A new drug duo might help prevent colorectal cancer, and the powerful new cancer drug Sutent may slow the progression of liver cancer.
So conclude two studies presented Monday at the American Association for Cancer Research annual meeting in San Diego.
In the first report, researchers found that a two-drug regimen made up of low doses of difluoromethylornithine (DFMO) plus sulindac, a non-steroidal anti-inflammatory drug (NSAID), cut the risk of colorectal adenomas by up to 95 percent. Colorectal adenomas are an early sign of colon cancer.
"We really think we are on track to develop a medical means to prevent colon cancer," lead researcher Dr. Frank L. Meyskens, a professor of medicine at the University of California, Irving, told reporters during a Monday afternoon teleconference.
Meyskens believes the drug combo could be used for people at high risk for colon cancer to prevent the disease from developing. It could also be used by those who have already had colon cancer, to help prevent its return, he said.
In the phase III trial, researchers studied 375 people with a history of colorectal polyps. They randomly assigned patients to a combination of DMFO and sulindac or placebo. Patients were followed for three years.
Patients taking the combination of drugs saw a 70 percent reduction in the risk of a new adenoma compared with patients receiving placebo.
For people who had advanced adenomas, the risk of developing new adenomas was reduced by 92 percent among those on the drug combination, Meyskens said.
Moreover, patients taking the drug combination who had had large adenomas saw a 90 percent reduction in their risk of developing new adenomas compared with patients taking placebo.
"The real home run was that we had a 95 percent decrease in new adenomas in those patients who had multiple adenomas," Meyskens said. "So, 17 patients in the placebo group had more than one adenoma, compared with only one patient in the treatment group," he said.
The rate of risk reduction was so high that the trial's Data Safety and Monitoring Board stopped the trial early so that everyone could benefit, the researchers noted. In addition, there was no difference between people getting the medications and placebo in terms of side effects requiring hospitalization, gastrointestinal side effects, cardiovascular side effects or temporary hearing loss, a rare side effect of DMFO.
In the second study, the researchers showed that sunitinib (Sutent) appears effective in slowing tumor growth and cutting the risk of metastases in patients with hepatocellular liver cancer, researchers report.
Sutent, a member of a family of cancer drugs that also includes Gleevec (imatinib), has proven effective against kidney cancer and a type of malignancy called gastrointestinal stromal tumors. Recent studies have also linked Sutent to higher heart risks, so experts say cancer patients and their doctors must weigh its risks and benefits.
The new study focused on hepatocellular liver cancer. "Hepatocellular cancer is a very challenging cancer to deal with," lead researcher Dr. Andrew Zhu, an assistant professor of medicine at Harvard Medical School said during the Monday afternoon teleconference. "It is a very common cancer worldwide, and it is the third leading cause of cancer mortality," he said. "The cancer most likely results from having had a hepatitis B infection."
The prognosis associated with this cancer is very poor, Zhu noted. "The average survival is six to eight months," he said.
In the study, 34 patients with advanced liver cancer were given Sutent daily for four weeks with two weeks off before the next round of treatment. Sutent works by targeting receptors in cancer cells called VEGFR2, c-Kit and FLT3. These receptors are also present in normal cells.
The drug appears to work by controlling the growth of blood vessels, which is how this type of liver cancer is able to spread so rapidly.
At 12 weeks, one patient had a partial response and 17 saw their disease stabilize. Progression-free survival lasted an average of four months, and overall survival was 10 months, the researchers report.
"Even though the response rate to make the tumor smaller was observed in only one patient, 50 percent of the patients had stable disease and are doing well," Zhu said. "Sunitinib can be safely given, with close monitoring, to the majority of these patients," he said.
The treatment was well-tolerated, and there were low rates of all blood disorders, the researchers report. Because Sutent has been associated with increased risk of heart problems, all patients taking Sutent -- but especially those who have risks for heart disease -- need careful monitoring and treatment for high blood pressure and other signs of heart problems.
In a third report, researchers from the Kimmel Cancer Center at Thomas Jefferson University in Philadelphia found that blood pressure-lowering drugs called angiotensin receptor blockers appear to retard pancreatic cancer cell growth and cause malignant cells to die.
This type of drug is able to inhibit the function of the hormone angiotensin II in the pancreas. The same receptor is found in pancreatic cancer cells. In laboratory experiments, the researchers found that the drug was able to block the production of a growth factor called VEGF, which helps spur the growth of tumor blood vessels.
"This is really exciting because the role of this receptor has never been known," lead researcher Dr. Hwyda Arafat said in a prepared statement. "It's never been connected to cell division or apoptosis. We're also now further exploring the mechanisms involved. The exciting thing is that this receptor already has so many available pharmaceutical blockers on the market." Ultimately, the group hopes to be able to test these agents in human trials, she said.
More information
For more information on cancer, visit the American Cancer Society.
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Avalere Health Data Finds Four-Tier System Growing Among Medicare Part D Plans
http://www.earthtimes.org
WASHINGTON, April 15 /PRNewswire/ -- Avalere Health today reminded consumers to pay close attention to all aspects of their Medicare prescription drug plan, including on which "tier" or group their medications are covered. Avalere data released from its proprietary DataFrame(R) database show that an overwhelming majority of Medicare health plans are now using a system that places some of the most expensive drugs in newly created fourth and fifth tiers. Drugs in the higher tiers can cost consumers significantly more money than a three tier, fixed co-payment system.
Consumers traditionally pay fixed amounts, or co-pays, when purchasing prescription drugs, and these co-pays are typically lumped into three groups: generics, preferred brands, and non-preferred brands. However, Medicare Part D drug plans have revolutionized the shape of the market by placing more expensive drugs into additional tiers. According to Avalere, 86% of all Medicare Part D plans use four (and sometimes five) tier plan structures, versus only 10% of commercial health plans.
"Health plans are trying to balance competing demands of access to medications and low cost, but the result is that patients with serious illnesses are paying more," said Dan Mendelson, president of Avalere Health. "It's a trend that's starting to push into the commercial world too."
Using its proprietary DataFrame database, which houses information about every Medicare drug plans' drug coverage and associated benefits, found that on average, Medicare Part D beneficiaries pay 25 percent to 35 percent of the cost of Tier 4 drugs compared with commercial plan beneficiaries who pay a fixed fee of about $71. Specialty drugs found in Tier 4 formularies can cost in excess of $600 per month.
"People with cancer, multiple sclerosis, hepatitis C, rheumatoid arthritis, and anemia should be paying very close attention to tiering in Medicare," said Mendelson.
Other facts released by Avalere:
- Among Medicare's top 10 Part D plans, 9 use Tier 4 formularies;
- The average co-payment for 4th Tier drugs in the Medicare community is $70;
- The average co-payment for 3rd Tier or non-preferred drugs in the Medicare community is $40;
- Medicare patients generally pay about $20 for preferred prescriptions, and $10 for generic drugs.
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April 16th, 2007
Liver Gene Expression Signature Predicts Chronic Hepatitis C Response to Therapy
www.medscape.com
NEW YORK (Reuters Health) Apr 08 - Chronic hepatitis C patients who respond to combination therapy with pegylated interferon and ribavirin show a different liver gene expression signature than nonresponders, according to a report in the April Gut.
Because of the side effects and treatment cost of combination therapy for chronic hepatitis C, the authors explain, identification of probable virological nonresponders with reliable markers before therapy is "mandatory."
Dr. Tarik Asselah from University of Paris VII, AP-HP Beaujon Hospital, Clichy, France and colleagues sought to identify a liver gene expression signature that could predict treatment outcome in patients with chronic hepatitis C before treatment.
From a set of 58 genes associated with liver gene expression dysregulation during chronic hepatitis C in humans, the researchers identified a 2-gene classifier (IFI27 and CXCL9) that gave the highest overall accuracy in distinguishing sustained viral responders (SVR) from nonresponders (NR).
Specifically, this 2-gene classifier correctly identified 23 of 26 SVR and 8 of 14 NR patients in the training set and 14 of 29 SVR and all 9 NR patients in the independent test set, the authors report.
Similarly, a 3-gene classifier (IFI27, CXCL9, and IFI-6-16) proved accurate in 80.0% of the training set and 72.4% of the independent test set.
"Our study demonstrated that NR and SVR patients have different gene expression profiles prior to treatment," the authors conclude.
"The genes included in the signature encode molecules secreted in the serum and provide a logical functional approach for the development of serum markers to predict response to treatment," they add.
Gut 2008;57:516-524.
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Adiponectin Predicts Steatosis and Response to IFN in Chronic HCV
www.medscape.com
NEW YORK (Reuters Health) Apr 07 - Lower adiponectin levels are associated with a higher risk of liver steatosis and a lower rate of response to interferon (IFN)-alpha treatment in patients with chronic hepatitis C, according to a report in the March issue of the American Journal of Gastroenterology.
Recent studies have shown an association between nonalcoholic steatohepatitis (NASH) and reduced serum adiponectin, the authors explain, but the relationship between IFN-alpha treatment and serum adiponectin has not been examined in detail.
Dr. Theodoros A. Zografos and associates from University of Thessaly, Larissa, Greece evaluated whether various features of chronic hepatitis C, including the presence of steatosis and the response to treatment, could be linked to serum adiponectin and tumor necrosis factor (TNF)-alpha levels.
Among 83 patients with chronic hepatis C, those with steatosis had significantly higher TNF-alpha levels than those without steatosis, the authors report, but adiponectin levels did not differ significantly between the 2 groups.
After adjustment for hepatitic C virus (HCV) genotype, however, lower serum adiponectin and longer disease duration were independent predictors of steatosis grade in patients infected with HCV genotype 1. In patients with HCV genotype 3, lower adiponectin and increased body mass index (BMI) were independently associated with steatosis grade.
Alterations in serum adiponectin level were not associated with response to antiviral drugs, the researchers note, but patients infected with HCV genotype 3 had significantly higher serum adiponectin levels at the end of IFN-alpha therapy.
Moreover, virological responders to IFN-alpha treatment had significantly higher serum adiponectin before the beginning of therapy than did nonresponders, and lower serum adiponectin and HCV genotype 1 were the only independent variables that predicted no virological response to IFN-alpha treatment.
"This study suggests that in chronic hepatitis C patients infected with HCV genotype 3, a direct effect of the virus may result in decreased adiponectin levels," the investigators write.
"Serum adiponectin and TNF-alpha at baseline seem to be independent predictors of liver steatosis irrespective of HCV genotype, while adiponectin is also an independent predictor of the achievement of end-of-treatment virological response," they conclude.
Am J Gastroenterol 2008;103:605-614.
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SciClone to Hold Symposium on New Therapies in Liver Cancer and Hepatitis C Virus
http://money.cnn.com
Three Leading Physicians to Present Data on Thymalfasin
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that it will hold a symposium titled "New Therapies in Liver Cancer and Hepatitis" during the 43rd annual meeting of the European Association for the Study of the Liver (EASL) in Milan, Italy. SciClone and Sigma-Tau will host the meeting on April 24, 2008, from 11:00 a.m. to 12:00 p.m. local time in Hall Yellow 1 in the Milan Convention Center.
Experts in the field of liver disease will discuss ZADAXIN®, generically referred to as thymalfasin or thymosin alpha 1, and its therapeutic benefits as a treatment for the hepatitis C virus (HCV) and liver cancer.
- Enrico Garaci, M.D., Professor of Microbiology at the University of Rome "Tor Vergata" in Rome, Italy will present the immunomodulatory activities of thymalfasin against infectious agents.
- Alessia Ciancio, M.D., Professor in the Department of Gastroenterology at the University of Torino in Torino, Italy will discuss the treatment of hepatitis C non-responders with pegylated interferon, ribavirin and thymalfasin.
- Robert Gish, M.D., Medical Director of the Liver Disease Management and Transplantation Program at the California Pacific Medical Center in San Francisco will detail treatment of hepatocellular carcinoma (liver cancer) with TACE plus thymalfasin.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN is currently being evaluated in late-stage clinical trials for the treatment of hepatitis C and malignant melanoma. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage and broaden its portfolio in the rapidly growing Chinese pharmaceutical market by in-licensing or acquiring the marketing rights to other products, such as DC Bead™. For the U.S. market, SciClone's other clinical-stage drug development candidates are RP101 for the treatment of pancreatic cancer and SCV-07 for the treatment of hepatitis C. For more information about SciClone, visit www.sciclone.com.
Corporate Contact:
Erin Murphy
SciClone Pharmaceuticals, Inc.
(650) 358-3437
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Clinic placed on hold
http://www.rgj.com
By Anjeanette Damon
adamon@rgj.com
State officials have ordered a Lake Tahoe surgical center to stop seeing patients after federal inspectors discovered unsafe infection-control practices there during a surprise visit this week.
The inspection was the second in a month to find problems at the Lake Tahoe Surgical Center in Zephyr Cove.
State and federal inspectors refused to comment on the specific violations found Monday, saying the report would be made public after it is formally delivered to the center.
"The infectious disease control problem that was observed by (federal inspectors), they felt, put patients in immediate jeopardy," said Steve George, spokesman for the Nevada Department of Health and Human Services.
No disease transmission has been linked to the unsanitary practices at the clinic, George said.
The clinic, owned by South Lake Tahoe-based Barton HealthCare System and the Lake Tahoe Orthopedic Institute, must remained closed for surgical procedures and other patient care until the problems are corrected. That could be as long as 10 days, state officials said.
"We need the assurance that the infection-control deficiencies have been abated, meaning they are no longer occurring," said Martha Framsted, spokeswoman for the state health division.
In a written statement, a spokeswoman for Barton HealthCare System, said there was "never any risk to patient safety or breach of sterile precautions" at the center.
"We are confident that, while the state surveyors are being extremely cautious and rightfully so for patient safety, the Lake Tahoe Surgery Center has been and continues to be an extremely safe, professional center where patient safety is our paramount concern," said Linda Thompson, Vice President of Foundation and Public Relations.
She said the clinic adopted a plan to correct the additional violations Tuesday.
Patients scheduled for surgery at the center are being referred to Barton Memorial Hospital until the clinic can solve its problems.
Health officials stressed that no infections have been tracked back to the clinic. If patients who have been treated at the clinic are concerned about their health, they should see their doctors, George said.
Monday's inspection by the Centers for Medicare & Medicaid services was part of a continuing state and federal effort to root out unsafe practices at Nevada surgical centers in the wake of the recent hepatitis C outbreak linked to an endoscopy center in Las Vegas.
A state inspection in March turned up a raft of problems at the Lake Tahoe clinic, including poorly trained staff, improper sterilization techniques and failure to develop an acceptable plan for preventing disease transmission at the facility.
In response, the clinic voluntarily closed for four days to train its staff and develop the proper procedures. But federal inspectors conducting a follow-up inspection to ensure the necessary changes had been made discovered additional violations, prompting the state to close the center.
The state did not completely close the clinic, allowing it to stay open for administrative purposes such as responding to patient medical records requests.
On Tuesday morning, the clinic remained open and staffed. By afternoon, however, they had locked the doors and posted a sign saying: "Currently under survey process."
The move by state health officials to halt surgeries at the center is largely unprecedented. The decision follows a policy change prompted by public outrage over the Las Vegas hepatitis C outbreak.
The state came under fierce criticism earlier this year for failing to close the Endoscopy Center of Southern Nevada after finding unsafe injection practices had infected at least six patients with hepatitis C.
Since then, the state has changed its procedures. The Lake Tahoe clinic is the second center to receive a cease and desist order since the hepatitis C outbreak.
RGJ freelancer Kathryn Reed contributed to this story.
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Hepatitis B tied to bile duct cancer outside liver
http://news.yahoo.com
NEW YORK (Reuters Health) - The results of a study published in the International Journal of Cancer suggest there is an association between hepatitis B virus (HBV) infection and an increased risk of extrahepatic bile duct cancer.
The extrahepatic bile duct collects bile from the liver, but is located outside of the liver. It joins with another duct coming from the gallbladder to form the common bile duct, which carries bile to the small intestine. Cancers of the extrahepatic bile duct are unusual and very difficult to treat.
In a population-based study conducted in Shanghai, Dr. Ann W. Hsing, of the National Cancer Institute, Bethesda, Maryland, and colleagues examined the prevalence of HBV and hepatitis C infection in 417 patients with biliary tract cancers, 517 with biliary stones, and 762 randomly selected healthy comparison subjects.
Among the population controls, HBV infection was detected in 7.3 percent. Patients with extrahepatic bile duct cancer were more likely to test positive for HBV (14.2 percent). This, in turn, resulted in a 2.4-fold increased risk of extrahepatic bile duct cancer.
There was no significant association between HBV and gallbladder cancer, bile duct stones and gallbladder stones.
The team found a low prevalence of HCV infection in this population (2 percent), which limited the ability to estimate the association between this infection and biliary disease.
HBV induces liver cancer primarily by causing chronic inflammation and tissue destruction with regeneration of liver cells, Hsing's team notes. A similar process may be involved in bile duct cancers," they suggest.
SOURCE: International Journal of Cancer, April 15, 2008.
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UPDATE 1-ViroPharma ends development of hepatitis C drug
http://www.reuters.com/
April 16 (Reuters) - ViroPharma Inc (VPHM.O: Quote, Profile, Research) said it discontinued the development of its experimental hepatitis C drug due to safety concerns.
ViroPharma, which was developing the drug, HCV-796, with Wyeth (WYE.N: Quote, Profile, Research), said it does not expect to continue to collaborate with Wyeth on future development of hepatitis C treatment candidates.
The company said the risk associated with potential liver toxicity posed too high a hurdle to merit further development of the drug.
ViroPharma halted the mid-stage trial of HCV-796 in August 2007 after some patients developed elevated liver enzymes, a warning signal for liver damage.
ViroPharma shares, which closed at $9.62 Wednesday on Nasdaq, fell 6 percent to $9.05 in trading after the bell. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Vinu Pilakkott)
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Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Data Presentations at European Association for the Study of the Liver (EASL) Annual Meeting
http://www.earthtimes.org
KENILWORTH, N.J., April 17 /PRNewswire-FirstCall/ -- Schering-Plough Corporation , a leader in advancing the science and treatment of chronic hepatitis C virus (HCV) infection, announced today that final results of the IDEAL study as well as from several other clinical studies with PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy will be presented at the European Association for the Study of the Liver (EASL) 43rd annual meeting in Milan, Italy, April 23-27. PEGINTRON combination therapy is a current standard of care in the treatment of chronic hepatitis C. A total of 36 data presentations, including nine oral presentations, highlighting Schering-Plough hepatitis medications will be presented at EASL 2008.
The IDEAL (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy) study is the first large, randomized, clinical study comparing the leading therapies for chronic hepatitis C: PEGINTRON and REBETOL combination therapy vs. Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) combination therapy,(1) as well as a lower dose of PEGINTRON plus REBETOL in an investigational combination regimen. Pegasys and Copegus were dosed in accordance with their approved U.S. labeling in this study of more than 3,000 U.S. genotype 1 patients. Results showed that sustained virologic response (SVR), the primary endpoint of the study, was similar for all three treatment regimens. The study also showed in a secondary endpoint that fewer patients treated with both PEGINTRON regimens relapsed after the end of treatment compared to those receiving Pegasys and Copegus.
Final results will be presented for the EPIC3 study, in which more than 2,000 hepatitis C patients with moderate to severe fibrosis or cirrhosis who failed prior treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy were retreated with PEGINTRON combination therapy. PEGINTRON combination therapy is the first and only pegylated interferon combination therapy approved in the European Union (EU) for retreating both hepatitis C relapsers and nonresponders.
Researchers also will present the final results of the COPILOT study, which evaluated the investigational use of low-dose PEGINTRON as maintenance therapy in chronic hepatitis C nonresponder patients with fibrosis or cirrhosis. The goal of maintenance therapy in this very hard-to-treat patient population is to prevent or delay the progression of liver disease, liver cancer or death.
Schering-Plough also is exploring novel therapeutic approaches to treating hepatitis C with boceprevir, its investigational oral HCV protease inhibitor currently in Phase II clinical development. Oral presentations of boceprevir data will include interim results from the HCV SPRINT-1 study in treatment-naive hepatitis C patients and final results of the HCV RESPOND-1 study in patients who were "null" responders to previous peginterferon and ribavirin combination therapy.
Key Data Presentations at EASL
PEGINTRON Oral Presentations
- Final results of the IDEAL (Individualized Dosing Efficacy versus flat dosing to Assess optimaL pegylated interferon therapy) Phase IIIb study. Sulkowski, M. et al. Late-Breaker Parallel Session 16, Saturday, April 26, 4:45 p.m. Hall A.
- Sustained viral response (SVR) is dependent on baseline characteristics in the retreatment of previous alfa interferon/ribavirin (I/R) nonresponders (NR): final results from the EPIC3 program. Poynard, T. et al. Late-Breaker Parallel Session 16, Saturday, April 26, 4:00 p.m. Hall A.
- Colchicine versus peginterferon alfa 2b long term therapy: results of the 4 year COPILOT trial. Afdhal, N.H. et al. General Session 1, Thursday, April 24, 3:10 p.m., Hall A.
PEGINTRON Poster Presentations
- Sustained virologic response after peginterferon alfa-2b and ribavirin treatment predicts long-term clearance of HCV at 5-year follow-up. Manns, M. et al.
- Platelet count predicts sustained viral response (SVR) in the retreatment of previous interferon/ribavirin non-responders (NR): results from the EPIC3 program. Poynard, T. et. al.
- Impact of viral load and cirrhosis on treatment outcome in HCV genotype 3-infected patients: results of the Canadian POWeR program. Marotta, P.J. et al.
The EASL Inaugural Poster Session and Welcome Reception will take place in the Poster Hall on Thursday, April 24, beginning at 7:00 p.m.
Boceprevir Oral Presentations
- Boceprevir (B) combination therapy in null responders (NR): response dependent on interferon responsiveness. Schiff, E. et al. General Session 3, Saturday, April 26, 9:30 a.m., Hall A.
- Interim results from HCV SPRINT-1: RVR/EVR from Phase II study of boceprevir plus PEGINTRON (peginterferon alfa-2b)/ribavirin in treatment-naive subjects with genotype-1 CHC. Kwo, P. et al. Late-Breaker Parallel Session 16, Saturday, April 26, 5:45 p.m. Hall A.
- Clonal analysis of mutations selected in the HCV NS3 protease domain of genotype 1 non-responders treated with boceprevir (SCH503034). Susser, S. et al. Parallel Session 7, Friday April 25, 5:00 p.m., Hall 000.
Schering-Plough Media/Advocate Roundtable
- Treating HCV Now and in the Future -- the Right Therapy for the Right Patient: What are the implications of the IDEAL study? Saturday, April 26, 6:30-8:00 p.m., Milan Convention Center, Room 4.
- An expert panel of leading clinical investigators, key opinion leaders and advocates will lead a roundtable discussion following a review of the results of the IDEAL study and other recent clinical studies to address the implications for current therapy and future treatment regimens. Audience participation and Q&A are encouraged.
Schering-Plough Satellite Symposium at EASL
- From Initial Therapy to a Second Chance: A Comprehensive Guide to HCV Treatment Sunday, April 27, 8:30-10:00 a.m., Milan Convention Center, Hall B.
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April 18th, 2007
Promising trials of hepatitis C drug
http://www.odt.co.nz
By JOHN GIBB and NZPA
INTERNATIONAL attention will soon focus on a promising new drug co-invented by University of Otago Prof Robin Smith, with results of a clinical trial involving hepatitis C patients being released next week.
Release of the clinical results would prove ‘‘a significant milestone for the whole project,’’ after what had proved a ‘‘very rewarding experience’’ in helping create the drug, Prof Smith, of the Otago chemistry department, said in an interview.
Antipodean Pharmaceuticals Inc, a company formed by Auckland-based Antipodean Biotechnology Ltd, recently announced that it had completed a phase 2 clinical trial of the drug, known as Mitoquinone (MitoQ), which was invented at Otago University by Prof Smith and a former Otago colleague, Dr Michael Murphy.
Otago University’s commercialisation company, Otago Innovation Ltd, is a foundation shareholder in Antipodean.
Results of the trial of MitoQ on hepatitis C patients will be presented at the annual conference of the European Association for the Study of the Liver annual meeting, on April 24 (Anzac Day NZ time) in Milan, Italy.
The study on 30 patients with hepatitis C virus not suitable for interferon or ribavirin treatment was conducted by Associate Prof Edward Gane, of Auckland Hospital’s liver transplant unit.
Hepatitis C, a viral infection of the liver, affects more than 170 million people worldwide and is the leading cause of cirrhosis, hepatocellular carcinoma, and liver failure.
Currently available therapies can have significant side-effects and eradicate the virus in only about half the patients.
Prof Smith said the clinical trial outcomes would not be known until next week but he understood a ‘‘very positive result’’ had been achieved.
Further hurdles had to be cleared before MitoQ could be used as a new therapy, but he was gaining great satisfaction in knowing that a drug developed in ‘‘dear old Dunedin’’ was already showing promise in combating hepatitis and, potentially, some other ‘‘serious health conditions,’’ he said.
Hepatitis C is closely associated with damage caused by oxidants to mitochondria, the power packs which provide energy within cells.
MitoQ uses a novel technology, targeting processes which transport and concentrate antioxidants into the mitochondria, where they accumulate at levels up to a thousand times normal.
Dr Barry Snow, head of neurology at Auckland Hospital, has also trialled the drug on a progressive neurological condition, Parkinson’s Disease, in the hope that it could delay disease progression.
The latter trials marked the first time a drug has been fully developed and trialled in New Zealand.
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Conference to focus on hepatitis C patients
http://www.canada.com
Windsor Star
The Hepatitis C Network of Windsor and Essex County is inviting the Windsor community to the Hepatitis C: Building Momentum 2008 International Conference on May 15.
The conference, at the St. Claire Centre for the Arts, will recognize the recent progress made in addressing the needs of persons living with HCV, the development of a provincewide hepatitis C nursing program in Ontario and the enhanced compensation for victims of tainted blood across Canada.
Dr. Stuart Gordon, hepatologist from the department of gastroenterology at Henry Ford Hospital in Detroit, will provide a lecture on updated information regarding HCV non-responders, naive patients and the latest research at Henry Ford Hospital.
An array of additional topics will be discussed during the conference, including instances of hepatitis C in prison populations and an update on the federal compensation package.
The conference runs from 8:30 a.m. to 4 p.m. and registration is $25 per person, $15 for full-time students.
For more information, visit http://hepcnetwork.net
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Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1
http://www.prnewswire.com
Trial Marks Third Study in Company's STEALTH C Clinical Program to Evaluate Nitazoxanide in the Treatment of Chronic Hepatitis C
TAMPA, Fla., April 18 /PRNewswire/ -- Romark Laboratories, a privately held biopharmaceutical company, today announced that it has begun enrolling patients in a U.S. clinical trial to evaluate nitazoxanide for the treatment of chronic hepatitis C. Preliminary data from the study is expected in the second half of 2008.
The study, STEALTH C-3 (Studies to Evaluate Alinia for Treatment of Hepatitis C), is a Phase II randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of nitazoxanide in combination with peginterferon alpha-2a (Pegasys(R), Roche) and ribavirin (Copegus(R), Roche) in treatment naive patients with chronic hepatitis C infected with genotype 1.
The primary objective of STEALTH C-3 is to evaluate sustained virologic response (SVR) with a treatment regimen of 4 weeks of nitazoxanide lead-in therapy followed by 48 weeks of standard of care plus nitazoxanide versus 4 weeks of placebo lead-in followed by 48 weeks of standard of care and placebo. The trial will enroll 60 patients at 15 centers in the U.S.
"Earlier clinical studies in patients with chronic hepatitis C infected with genotype 4 have shown that nitazoxanide improves virologic response rates when used in combination with standard of care," said Dr. Emmet B. Keeffe, Chief Medical Officer of Romark. "This study and our ongoing STEALTH C-2 trial, are designed to evaluate the effect of treatment with nitazoxanide plus standard of care in patients with genotype 1. Future clinical trials will explore new combinations and treatment durations, including current and emerging HCV therapies."
STEALTH C Clinical Development Program
STEALTH C-3 is the latest in a series of clinical trials aimed at gaining a broad understanding of how nitazoxanide may benefit patients with chronic hepatitis C genotype 1 when used in combination with peginterferon and ribavirin. Other studies in the STEALTH C program include the following:
- STEALTH C-2, a randomized, double-blind, placebo-controlled trial currently enrolling up to 60 patients in the U.S. with chronic hepatitis C genotype 1 who have previously failed to respond to the standard of care with peginterferon and ribavirin. This trial is designed to evaluate the effectiveness and safety of nitazoxanide administered 500 mg twice daily for 4 weeks followed by nitazoxanide plus standard of care for 48 weeks compared to placebo for 4 weeks followed by standard of care plus placebo for 48 weeks.
- STEALTH C-1, an international study in 120 treatment-naive and interferon-experienced patients with chronic hepatitis C genotype 4. Interim results from the randomized controlled Phase II clinical trial were presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, MA and demonstrated that 79 percent of interferon-naive patients with chronic hepatitis C genotype 4 receiving nitazoxanide plus the standard of care had a sustained viral response (SVR) at 12 weeks following treatment, compared to 43 percent of patients receiving the standard of care without nitazoxanide. The patients treated with nitazoxanide also experienced no relapse and no more side effects than patients who received the standard of care. Final study results (SVR-24) will be presented at the European Association for the Study of the Liver (EASL) in April 2008.
To learn more about Romark clinical trials currently under way, or to find out if a study is recruiting patients in your area, please visit http://www.romarktrials.com or http://www.clinicaltrials.gov (for the latter, enter the search terms "nitazoxanide hepatitis United States.")
About Romark Laboratories
Romark Laboratories (http://www.romark.com), a privately held biopharmaceutical company, has discovered and developed a new class of small molecule antivirals known as thiazolides. The Company is developing nitazoxanide, the first of the thiazolide class, for the treatment of chronic hepatitis C, and is developing other new thiazolides for treating viral diseases including chronic hepatitis B. Alinia(R) (nitazoxanide) is approved by the U.S. Food and Drug Administration and marketed by Romark for the treatment of infections caused by Cryptosporidium or Giardia.
SOURCE Romark Laboratories
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Five-year-old boy who sucked on discarded hypodermic needle faces tests for HIV and hepatitis
http://www.dailymail.co.uk
A five-year-old boy found a discarded hypodermic needle on a public footpath which he stabbed his hand with and then sucked.
His horrified mother turned round to see the hypodermic poking out of his mouth as they walked near the West End of Colwyn Bay.
William Feeney must now undergo tests for HIV and hepatitis and his parents face an agonising six-month wait for the results.
William found the hypodermic, with a two-inch long needle, while he and his mother walked home to Rhos-on-Sea.
The incident happened between a footbridge over the A55 and a playground at Parc Penrhos on Wednesday at 6.30pm as they returned from a takeaway.
He was taken to Ysbyty Glan Clwyd, Bodelwyddan, for treatment and must shortly go back for tests to make sure he has not contracted the killer virus HIV or Hepatitis B or C.
Dad Liam Feeney told the Daily Post last night: "It's the worst thing in the world. HIV and Hep C are untreatable. If he has got them his whole life is ruined.
"The chance is small and I'm pretty confident he'll be OK but the doctors can't rule it out."
Liam, 33, a garage boss, said his son was walking home with his mum Kirsty, 25 at the time.
Mr Feeney said: "She had been to a Chinese takeaway to get tea, left the West End and went down Princes Drive and over the footbridge.
"She turned round and realised William had a hypodermic needle in his mouth. She shouted 'Oh my God, what are you doing with that?'"
Kirsty then rang Liam and the family rushed William to Ysbyty Glan Clwyd. Doctors examined William and found a "puncture wound" to his left hand.
He was given a jab for Hepatitis B which will give him immunity. He had a blood sample taken which will be stored and can only be tested for HIV and Hepatitis C in six months.
Mr Feeney added: "What really makes me mad is that if I beat the drug addict up I would get locked up, but the fact that one may have passed HIV on to my son seems to be OK."
He called for police to catch drug users who "roam the streets and do what they want".
Mr Feeney, who works for North Wales Recovery, has complained to Conwy council and North Wales Police about the discovery close to a children's play area.
Rhiw Ward councillor Trevor Stott echoed his disgust and said he was "appalled" by what happened.
He said: "It's appalling and absolutely frightening what can happen to children who don't know any better."
He has now asked the local authority to send workers to the area to tidy it up and ensure there were no more needles.
He said some local residents were afraid to go to bed until it was quiet outside.
He added: "We know there are drug addicts who need treatment but this sort of thing is by mindless people who have got no thought for anyone else's safety."
Conwy County Borough Council said reports of discarded needles were dealt with "as a priority".
A spokeswoman said: "If anyone finds syringes or needles they should phone the council on 01492 575337 so that a trained officer can remove the item. Do not pick it up or touch it."
North Wales Police said the incident was reported to them and was being investigated.
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Reid seeks $26 million for hepatitis scare
http://www.lasvegassun.com
By Lisa Mascaro
Emergency request, a boost in war spending bill, likely to face stiff GOP opposition
Washington — Senate Majority Leader Harry Reid is seeking $26 million in emergency funds from Congress to help deal with the hepatitis C crisis in Southern Nevada, but the request will likely run into political resistance from President Bush and congressional Republicans who oppose tacking any extra spending onto a bill for the Iraq war.
Even Nevada’s other senator, Republican John Ensign, is against it.
The money Reid is requesting would go toward ensuring the estimated 40,000 patients who have been potentially exposed to hepatitis C, hepatitis B and HIV during routine procedures at a private Las Vegas clinic can be tested — even if they have no insurance or ability to pay for the screenings.
Money would also go to the Centers for Disease Control and Prevention to prevent the procedures that caused the outbreak in Nevada from happening elsewhere. The CDC’s director has feared the practice at the Endoscopy Center of Southern Nevada, where medical staff reused syringes and dipped multiple times into single-dose medicine vials, could be the “tip of the iceberg” of poor practices nationwide. Several other states in recent years have had similar crises.
Michael Walsh, director of administration for the Southern Nevada Health District, which would receive $5.25 million, said if the money comes through, “we could be sure the vast majority of people could get tested.”
Although notices have been sent to 40,000 patients of the Endoscopy Center, the district says the number of patients potentially exposed to the virus at that site could be as high as 60,000. Of those, an estimated 15,000 have no insurance or ability to pay for the screening, which costs $200 on average. Some labs are offering free screenings.
The district has also incurred unexpected expenses in its $72 million budget, including the $16 being charged each time a patient calls a help line and talks to an operator. The tally for that service so far is $300,000.
Rep. Shelley Berkley, a Democrat, said partisan politics should not delay getting money to help those in need.
“No one planned for this crisis to strike Southern Nevada and it is more than appropriate to make this request,” Berkley said in a statement.
“While others may want to sit on their hands, I am not willing to wait another nine months or longer for these funds, which are desperately needed,” she said. “Those affected by this exposure incident are not being treated according to political party, so why is partisanship being used as an excuse to fail these patients and their families?”
The best chance Reid has for swiftly securing funds for Nevada is on the emergency war spending bill now moving through Congress. That bill would allocate $108 billion Bush has requested to continue the fighting in Iraq and Afghanistan. War funding has been routinely allocated as emergency spending rather than through traditional budget channels.
Though Democrats have proved unwilling to withhold war funding, as some in the party would like, they are using these bills to carry spending requests. On one of last year’s war spending bills, Reid tried to get funding for various items for Nevada, including to fight the devastating Mormon cricket infestation.
But Bush and other Republicans are agitating against a repeat performance on this bill. During a speech last week, Bush warned Congress against fattening the bill with extras.
“This bill must also be fiscally responsible,” Bush railed from the White House. “It must not exceed the reasonable $108 billion request I sent to Congress months ago.”
If it does, Bush added, “I’ll veto it.”
Republicans in both chambers have started making similar assertions, insisting the bill that comes forward in the next several weeks be free of extras.
Ensign opposes Reid’s legislation because of concern that it “opens the door for 100 senators and 435 congressmen to add home state spending that will put our troops’ funding in danger,” spokesman Tory Mazzola said.
“The question is not if the CDC has an obligation to help Nevadans recover from the hepatitis C scare. It does,” Mazzola said. “The question here is whether we try to add to the CDC’s
$6 billion budget on an emergency bill that is critical to fund our men and women in uniform.”
Republican Rep. Jon Porter supports channeling extra funds to the Health District and the CDC, but is withholding his decision on the Senate request until he sees “how, and if, the additional funding will be presented in the House,” his spokesman said.
Republican Rep. Dean Heller, whose district includes most of the northern part of the state but dips into the Las Vegas area, did not return calls and messages seeking comment.
But the party has been clear. “The emergency funding for our troops in Iraq and Afghanistan is for Iraq and Afghanistan,” said a spokesman for Sen. Mitch McConnell of Kentucky, the Republican leader in the Senate.
Reid stands by the request, especially as Nevada faces its own budget problems.
“If ever there was an emergency, this is it,” Reid spokesman Jon Summers said. “We’ve got to first stop the bleeding that is at hand, then prevent it from happening again. I don’t think anyone who’s aware and informed of this situation considers this an extra.”
Meanwhile, the House committee this week heard testimony on a related issue — hospital-acquired illnesses, which officials say are among the 10 leading causes of death in this nation, accounting for 100,000 deaths annually.
A report from the Government Accountability Office, the investigative arm of Congress, has called on the federal Health and Human Services Department to play a greater role in overseeing best practices among health care practitioners. The GAO is likely to next investigate practices at outpatient clinics such as the one in Nevada, where the hepatitis C outbreak occurred.
“Improvements in quality of care over the last decade have been disappointing: Patients continue to suffer harm that is preventable and costly,” testified Dr. Peter J. Pronovost, medical director of the Center for Innovations in Quality Patient Care at Johns Hopkins University, in a statement submitted to the committee. “To alter this reality, we must invest in research which will identify and reliably deliver effective therapies. There is no shortcut.”
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Lyrica Reduced Pain of Fibromyalgia in Patients Regardless of Symptoms of Anxiety or Depression
http://www.therapeuticsdaily.com
CHICAGO--(BUSINESS WIRE)--Apr 16, 2008 - Pfizer's Lyrica reduced pain of fibromyalgia in patients regardless of whether they experienced symptoms of anxiety or depression at the beginning of the study, according to a pooled analysis presented today at the American Academy of Neurology annual meeting. The analysis, which looked at data pooled from previous clinical trials, also showed that patients' self-reported improvements were more closely associated with improvements in pain and sleep than with improvements in fatigue or symptoms of anxiety or depression.
Fibromyalgia is the most common, chronic widespread pain condition in the United States and is thought to result from neurological changes in how patients perceive pain. Fibromyalgia is usually accompanied by poor sleep, stiffness and fatigue.
"The data showed that Lyrica reduced fibromyalgia pain, and alleviating that pain was associated with patients' overall feeling of well-being," said Dr. Lesley Arnold, one of the study's authors and associate professor in the department of psychiatry at the University of Cincinnati Medical Center. "Understandably, many patients with a chronic pain condition such as fibromyalgia also experience depression and anxiety, and importantly we found that Lyrica helped reduce pain in patients regardless of the presence of symptoms of these co-morbid conditions."
About the Analysis
The results are from a retrospective, pooled analysis of data from three placebo-controlled clinical trials (8 weeks, 13 weeks and 14 weeks long) of Lyrica in over 2,000 fibromyalgia patients. These studies randomized patients to receive Lyrica 150 mg, 300 mg, 450 mg or 600 mg or placebo. Patients were asked to measure their pain on a scale of zero to 10; the baseline score for study participants was 6.9 (150 mg, 450 mg, 600 mg) or 7.0 (300 mg). A score of 4.0 to 6.9 is considered moderate pain and a score of greater than 7.0 is considered moderate to severe pain on this 10-point scale.
In the studies, 38 percent of fibromyalgia patients had moderate to severe anxiety symptoms, while 27 percent had moderate to severe depressive symptoms, as assessed using the Hospital Anxiety and Depression Scales (HADS-A or HADS-D). Patients with severe depression or unstable psychiatric conditions were excluded from the studies.
The new analysis confirmed that Lyrica was significantly more effective than placebo in reducing pain in patients with fibromyalgia. Patients receiving 600 mg a day of Lyrica had a pain reduction of 2.08 on the pain scale; 450 mg a day had a reduction of 2.01; 300 mg a day had a reduction of 1.76; 150 mg a day had a reduction of 1.37, and placebo had a reduction of 1.25. Additionally, Lyrica was found to reduce pain in patients regardless of whether they had symptoms of anxiety or depression.
The analysis also examined the relationship between improvements in pain, sleep, fatigue, anxiety and depressive symptoms with patients reporting feeling "much improved" or "very much improved" as measured by the Patient Global Impression of Change (PGIC). The PGIC is a standardized, self-reported tool that measures the change in a patient's overall status ranging from "very much improved" to "very much worse."
Pain reduction was found to have the greatest association on patients reporting improvement as measured by PGIC. The relationships between feeling much or very much improved were strongest for pain and sleep, and less pronounced for fatigue and symptoms of anxiety or depression, but statistically significant for all variables.
The most common side effects in the pooled analysis versus placebo of these three studies were dizziness and somnolence, followed by weight gain, blurred vision and dry mouth.
About Lyrica
In the United States, Lyrica(R) (pregabalin) capsules, CV, is approved for the management of fibromyalgia. Lyrica is also indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia (pain after shingles), and as adjunctive therapy for adults with partial onset seizures. The 600 mg/day is not an approved dosage for Lyrica in the management of fibromyalgia.
Important Safety Information
Lyrica is not for everyone. Lyrica may cause serious allergic reactions. Patients should tell their doctors right away about any serious allergic reaction such as swelling of the face, mouth, lips, gums, tongue or neck or if they have any trouble breathing. Other allergic reactions may include rash, hives and blisters. Patients should tell their doctors about any changes in eyesight, including blurry vision, muscle pain along with a fever or tired feeling, or skin sores due to diabetes.
Some of the most common side effects of Lyrica are dizziness, sleepiness, weight gain, blurred vision, dry mouth, feeling "high", swelling of hands and feet, and trouble concentrating. Patients may have a higher chance for swelling and hives if they are also taking angiotensin converting enzyme (ACE) inhibitors so they should let their doctors know if they are taking these medications. They may have a higher chance of swelling or gaining weight if they are also taking certain diabetes medicines.
Patients should not drive a car or operate machinery until they know how Lyrica affects them. Patients should not drink alcohol while on Lyrica. Patients should be especially careful about medicines that make them sleepy and should also tell their doctors if they are planning to father a child. Patients should tell their doctor if they are pregnant, plan to become pregnant, or are breast-feeding. If they have had a drug or alcohol problem, they may be more likely to misuse Lyrica. Patients should talk with their doctor before they stop taking Lyrica, or any other prescription medication. Lyrica is one of several treatment options for doctors to consider.
For Lyrica prescribing information, please visit www.lyrica.com.
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