Monday, June 20, 2011

Monday Hepatitis News;Stereotyping Patients Also Virginia high incidence of Hepatitis C

State health official report that West Virginia has one of the highest incidence of Hepatitis C in the nation.

What is Hepatitis C? Can it be cured?

Here's Dr. John Phillips with answers in this week's WV Heath Report.





Stereotyping Patients, and Their Ailmentsy
DANIELLE OFRI, M.D.
When Mr. S. was doing time at Rikers Island in the early 1990s, he was given a standard battery of tests for the medical ailments that run rampant behind bars — AIDS, hepatitis, tuberculosis. He received the unwelcome news that he was H.I.V. positive, though his T-cell count was still in the normal range.
After his release from prison, he made his way to our hospital’s H.I.V. clinic. He took his medications and showed up for his appointments, but he almost never got lab tests, since decades of drug use had obliterated his veins.
Despite the other medical assaults on his body — diabetes, hypertension, hepatitis C, stubborn leg ulcers — his immune system remained intact..Continue reading..
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Acute Hepatitis A evades immune system more effectively than chronic cousin

Finding points new direction for study of chronic Hepatitis C
Chapel Hill, NC – Ongoing research into the problem of how Hepatitis C becomes a chronic disease has uncovered a deeper mystery about its sister strain, Hepatitis A.

Hepatitis C is a continuing public health problem, which is difficult to measure because symptoms occur months to years after infection. The World Health Organization estimates as many as 2 to 4 million people in the United States may have chronic Hepatitis C, and most do not know they are infected. More than a third of those who are long-term carriers may develop chronic liver disease or liver cancer.
"Hepatitis viruses have co-evolved with humans over a very long period of time and they are good at evading the immune system, but nobody understands how Hepatitis C becomes a chronic infection," says Stanley M. Lemon, MD, professor of microbiology and immunology and a member of UNC Lineberger Comprehensive Cancer Center and the Center for Translational Immunology.

Lemon and his colleagues thought that Hepatitis C might become chronic by disrupting the host's interferon response – part of the innate immune system that protects the body against any kind of 'foreign' invader.
However, their study, published on-line in the Early Edition of the journal Proceedings of the National Academy of Sciences U.S.A., came up with some surprising findings.
In comparing data from experiments with Hepatitis A and Hepatitis C, the team found that Hepatitis A virus, which causes only acute, self-limited disease, is more efficient at inhibiting the host's interferon response, and that the virus can actually linger in the body for almost a year.

"These results undermine the theory that evasion of the interferon response is a key mechanism in the development of chronic Hepatitis C – the outcome of infection with these viruses is very different, highlighting how little we understand the unique environment within the liver for virus-host interactions," Lemon notes.
"It is actually the acute infection, Hepatitis A, that is stealthier at evading the interferon response."

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In addition to Lemon, the research team included Zongdi Feng, Ph.D., and Daisuke Yamane, D.V.M, Ph.D. from UNC-Chapel Hill; Robert Lanford, PhD, of the Texas Biomedical Research Institute and the Southwest National Primate Research Center; Deborah Chavez, MS, and Bernadette Guerra, BS, from the Texas Biomedical Research Institute; Kathleen Brasky, DVM, of the Southwest National Primate Center; Yan Zhou, PhD, and Christopher Walker, PhD, of the Center for Vaccines and Immunity at Nationwide Children's Hospital in Columbus, OH; and Alan Perelson, PhD, from Los Alamos National Laboratory.
The research was funded by the National Institutes of Health.


Solution for Jackson Memorial may be found in Tampa

TAMPA -- Eddie Colon, 47, is the kind of patient likely to cost any public hospital huge sums. He’s an unemployed pipefitter with a chronic disease, hepatitis C. With no health insurance, he long avoided seeing a doctor.

In Miami-Dade County, many such cases result in worsening symptoms until the patient is rushed to a Jackson Health System public hospital for expensive treatment funded by taxpayers.

Not Colon. He lives in Tampa, which has a half-penny sales tax for healthcare. Miami-Dade does, too, but there’s a difference. In Miami-Dade, all the local tax money goes to Jackson. In Tampa’s Hillsborough County, the money goes to a health plan for the uninsured that allows county residents like Colon to get free care from doctors and clinics, where primary care is far cheaper than a hospital stay.

In Colon’s case, he joined the county plan eight months ago, received an ID card and began regular visits to a Tampa General clinic, where he received free meds. The result: No expensive ER visits.

Read more: http://www.miamiherald.com/2011/06/18/2273440/solution-for-jackson-memorial.html#ixzz1PplUiUY3


New Hepatitis C drug cures local patient

If you or someone you know has Hepatitis C, you'll be interested to know the FDA approved a new drug to help cure the liver disease.

The medicine, Incivek, also known as Telaprevir (TVR), almost doubles the chances of curing the serious liver disease compared with current treatments.

If you want to know how well the drug really works, just ask local Decatur man, Quinton Moore. He was cured of Hepatitis C after being on a clinical trial of TVR. Moore credits the drug for saving his life.

“It’s something like people who go to war or are threatened with death," Moore said. "You realize how happy you are to be alive."

Moore, 62, was diagnosed with Hepatitis C two years ago during a routine exam. The Hepatitis C virus is spread through blood from infected individuals. Moore is not exactly sure how he contracted it. But he believes it might have been through helping an injured co-worker on a construction site.

Moore went to see a specialist, Dr. Kimberly Workowski at Atlanta's Emory University. Dr. Workowski encouraged him to enter the TVR clinical drug trial. At the time of the trial he was in the late stages of the liver disease. He had lost a significant amount of weight. However, after completing the trial he is healthy and completely cured.

He has more energy and says in general he’s just a happier person. “You appreciate experiences that you have more. I have sort of a different philosophical look on life. In general, I just enjoy it more.”

Moore says his side effects from the drug were minimal and he encourages anyone who has Hepatitis C to talk to their doctor about TVR.

For more information on Hepatitis C from Atlanta's Emory Healthcare, go to: http://www.emoryhealthcare.org/liver/liver-diseases/hepatitis-c.html

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From Medscape Medical News
Public Supports Universal Hepatitis C Screening
Jim Kling
June 20, 2011 — A new study indicates that patients support universal screening for hepatitis C virus (HCV) infection, even in the absence of prior consent or communication of negative results. The study was published online June 6 in BMC Infectious Diseases.
Between 2.9 and 3.7 million people in the United States are infected with HCV, and about 70% are unaware of it. Between 20% and 30% of the infected patients will go on to develop cirrhosis. HCV is the most common cause of liver failure among liver transplant patients.
Current therapies achieve about a 50% cure rate, and broad implementation could reduce HCV complications by 16% to 42%.
Current screening guidelines direct physicians to screen patients when they have one or more risk factors, such as injected drug use, having received a blood transfusion before 1992, or elevated liver function tests. However, such screening is complicated because patients may not admit to past behaviors such as drug abuse, among other limitations, including not capturing other potential risk factors such as possible remote iatrogenic transmission.
To gauge the public's opinion on potential HCV screening programs, in August 2010 the researchers, led by Phillip O. Coffin, MD, MIA, from the Division of Allergy and Infectious Diseases, University of Washington, Seattle, conducted a survey at 5 outpatient clinics of a major public urban medical center in Seattle. The response rate was 85.8% (200 responses of 233 patients surveyed). The study group had a median age of 47 years and included 55.3% women. Of the participants, 56.3% were white, 32.7% were black, 9.5% said they had been tested positive for HCV, and 2.5% reported testing positive for HIV.
The survey included 3 options: universal testing without being informed of the test or being told of negative results (48% preferred this option); testing with an opportunity to opt out, and without being informed of negative results (37% preferred); and testing based on clinician judgment (15% preferred).
Limitations of the study include the lack of both generalizability and disease confirmation status reported by the participants. In addition, the respondents were not asked all of the same questions, which limited comparisons. This was also a quantitative, not qualitative, analysis, which may alter results.
"[P]atients appear to place a higher priority on being tested than they do on the process of informed consent or the receipt of negative results. These findings should inform the priorities of clinicians, public health officials, and clinical risk managers," the authors conclude.
Dr. Coffin’s work is supported by a grant from the National Institute of Allergy and Infectious Diseases. The authors have disclosed no relevant financial relationships.
BMC Infect Dis. Published online June 6, 2011. Full text


Coffee Improves Response to Hepatitis C Treatment

SUMMARY
Drinking more coffee -- but not tea -- was associated with greater likelihood of response to hepatitis C treatment with pegylated interferon/ribavirin in the HALT-C study.

By Liz Highleyman

Over years or decades, chronic hepatitis C virus (HCV) infection can progress to severe liver disease including cirrhosis and hepatocellular carcinoma. A number of previous studies have found that higher consumption of caffeine or coffee specifically is associated with improved liver health and slower disease progression, but its relationship to hepatitis C treatment response is not fully understood.

As described in the June 2011 issue of Gastroenterology, Neal Freedman from the National Cancer Institute and colleagues looked at the relationship between coffee consumption and treatment response in the HALT-C (Hepatitis C Antiviral Long-Term Treatment against Cirrhosis) trial, which was designed to show whether long-term pegylated interferon maintenance therapy could reduce the risk of liver disease progression in non-responders... Continue reading...

Transplant

Pregnancy After Liver Transplant Raises Risk of Graft Loss

PHILADELPHIA – Women who become pregnant after receiving a transplanted liver face an elevated risk of graft rejection, especially during or immediately following the pregnancy, based on a review of 161 U.S. cases.

"The data suggest poorer outcomes for both mothers and their newborns in female liver recipients with risk factors for graft loss within 5 years post pregnancy," Dr. Carlo B. Ramirez said at the American Transplant Congress. "The findings highlight the high-risk nature of this group, warranting closer follow-up of both mother and child," said Dr. Ramirez, a transplant surgeon at Thomas Jefferson University, Philadelphia.
Of the 161 women who became pregnant following a liver transplant and were enrolled in the National Transplantation Pregnancy Registry (in place since 1991), 16 (10%) lost their graft within 5 years following their first posttransplant pregnancy. The pregnancy and the 3 months following pregnancy posed a particular risk, with half of the women who eventually lost their graft experiencing rejection during that time. In a multivariate model that took into account baseline risk factors, women with a liver transplant faced a 14-fold increased risk for graft loss during the pregnancy, Dr. Ramirez said.

"A lot of patients who have a stable equilibrium with their graft may destabilize under stress. It is possible that there is low-grade, clinically insignificant rejection in some of these patients prior to pregnancy" that then becomes exacerbated by the stress of pregnancy, commented Dr. Jean C. Emond, professor of surgery and director of transplantation at Columbia University in New York. Dr. Emond suggested that a liver biopsy prior to pregnancy might be warranted to assess the stability of the transplant.

Other risk factors for graft loss included younger age of the mother and low gestational age at the time of delivery. In the multivariate analysis, the risk for graft loss fell by a statistically significant 26% for each additional year of age for the mother. Graft loss fell by a statistically significant 5% for each additional week of gestational age when delivery occurred.

Among the 16 women who lost their graft during pregnancy or the following 5 years, their average age when they conceived was 22 years old, compared with an average age of 28 years old among the 145 women who did not lose their graft. Average gestational age at delivery was 33 weeks among the women who lost their graft, and 37 weeks among the women who did not lose their graft.

The average age of the women at the time they received their liver transplant was 18 years among those who later lost their grafts, and 23 years among those who retained their grafts. However, the average time between transplantation and conception was an identical 4.3 years in both groups.

The only other risk factor for graft loss that approached statistical significance in the multivariate model was viral hepatitis as the etiologic agent for the liver failure that led to the transplants. Viral hepatitis was the cause of liver failure for six (38%) of the women who lost their grafts following pregnancy, and for 23 (16%) of the women who did not lose their grafts. In the multivariate model, viral hepatitis as the cause of liver failure was linked with a nearly fourfold increased risk for women losing their graft during or after pregnancy, but this relationship failed to meet the standard criterion for statistical significance, Dr. Ramirez said.
The congress was sponsored by the American Society of Transplant Surgeons. Dr. Ramirez said he had no disclosures. The National Transplantation Pregnancy Registry has been supported by grants from Novartis, Astellas, Genentech, Pfizer, Teva, and Sandoz.

Hepatitis C Worldwide

Number of Hepatitis C Patients Triples from 2002 to 2010 in Korea
Patients with the Hepatitis C virus in Korea increased almost three-fold from 2002 to 2010.

The number of the Hepatitis C patients topped over 5,600 as of last year.

The 2002 figure only stood at around 1,900, according to the Korea Centers for Disease Control and Prevention.

The health authority warns that the virus is easily transmitted through daily activities, especially through sharing the same tooth brush, nail clippers, or razors, and that the virus could lead to chronic liver disease, including cancer.

Unlike Hepatitis A and B, the C virus does not have an available vaccine, nor have noticeable symptoms in the first phase of the disease, so regular blood tests are recommended.

Pharmaceutical

BioPlus 'Pharmacy HepatitisRx Assist For Victrelis (boceprevir)/Victrelis (boceprevir)
(BioPlus), one of the nation's leading specialty pharmacies, is announcing today enhancements to their hepatitis C patient support program called HepatitisRxAssist. The FDA's  recent approval of two new drugs for the treatment of the hepatitis C virus (HCV) – Victrelis (boceprevir) from Merck and Incivek (telaprevir) from Vertex – makes this program more useful than ever for hepatitis C patients.

Axium is pleased to add VictrelisTM and IncivekTM to the HEPVisionsSM program
“Axium is pleased to add VictrelisTM and IncivekTM to the HEPVisionsSM program,” said Mark Montgomery, President and CEO of Axium Healthcare Pharmacy. “The new triple therapy regimen is complex and expensive. Careful patient education, monitoring, and adherence are keys to successful treatment.”
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FDA And A New ‘Global Strategy’ For Imports
Beset by an inability to thoroughly monitor pharmaceutical ingredients and production around the world, the FDA has declared a new ‘global strategy’ to cope with the fast-paced industry changes that are straining its resources. And in issuing a 37-page report on the topic, the agency says the step reflects a lack of “resources to adequately keep pace with the pressures of globalization.”

To illustrate the point, the FDA says that imports of pharmaceutical products have grown rapidly, at approximately 13 percent annually over the past seven years and accounted for more than 350,000 import lines in 2009. This volume accounted for approximately 30 percent by value of pharma products used annually. And the rise in imports has contributed to a growing trade deficit in pharma products....continue reading..

Curb deceptive marketing gigs: Delhi High Court
NEW DELHI: Companies looking to encash on a rival's reputation by launching a phonetically similar brand beware! The Delhi High Court has warned that such deceptive marketing techniques need to be curbed.
The court's warning came during the hearing on a dispute involving two pharmaceutical companies.

Justice VK Jain restrained Omax Healthcare Pvt. Ltd. from making a cough syrup under the brand name Orex as it sounded like Pfizer Products' popular cough syrup by the name Corex.

Holding that companies cannot cash in on reputation of popular brands by deceptive means, the court said: "A competitor cannot usurp the goodwill and reputation of another by adopting a mark similar to the established mark of its competitor and thereby cause injury to the reputation and business of that person."

"Any attempt on the part of another person to encash upon the brand value generated by another person needs to be curbed by the court," said Justice Jain in his order delivered earlier this month.

Directing Omax Healthcare to pay Rs.1 lakh as punitive damages, the court said: "It is difficult to dispute that the mark Orex is phonetically so close and similar to the word Corex that it may not be possible for an ordinary buyer of a cough expectorant to distinguish the products.

"In fact, the defendants (Omax Healthcare) have adopted four out of the five words in the registered trade mark Corex of the plaintiff (Pfizer) as its trade mark. So punitive damages have to be paid," the judgment said.

"The courts also need to ensure that there is no confusion in the mind of the consumer as to the source of the product which he is buying. The customer needs to be assured that he buys the same product which he prefers and identifies by its name," the court observed.

Pfizer, a multi-national pharmaceutical company, moved court seeking injunction against Orex saying that its Corex cough syrup was one of their top selling products and was a highly sought after drug for treatment.

It also alleged that there was likelihood of customers getting induced to believe that the product offered by the defendant was of the same quality as the product of the plaintiff.

"We cannot be oblivious of the fact that despite statutory requirements, the chemist and druggist in our country do not hesitate in selling drugs such as cough syrups and expectorants, without insisting upon prescription by a medical practitioner, even if such a prescription is statutorily required," the court said.

"Drugs such as cough syrups are available over the counter without medical prescription and such similarity in brands would make an impression that they were buying the product of the company which is reputed and well-known," the court said.

Drugs giant GlaxoSmithKline has launched an investigation into its Augmentin antibiotic after China became the latest Asia-Pacific country to withdraw the medicine over safety fears. 

GSK said it was working with regulators across the region after China claimed to have found traces of diisodecyl phthalate (DIPD) – a compound used to make plastics more flexible – in the syrup form of Augmentin.
The drug is commonly prescribed to children. GSK sold £291m-worth of Augmentin, in its various forms, to emerging markets last year – though it is a small contributor to a group with annual sales of £28bn.
A company spokesman said: “GSK is currently in discussion with a number of regulatory agencies in the Asia Pacific region, some of whom have also conducted tests.
“The amount of phthalates identified as present in Augmentin syrup samples tested is very low; some tests have found none and the highest level reported by the authorities is 88 parts per million.
“Even this highest result is significantly lower than the levels that the US and European authorities deem as presenting no risk to humans.”
Earlier this month, Taiwan and Hong Kong told GSK to recall Augmentin after it was found to contain DIPD.
There has also been a wider crackdown by authorities in the region over the plasticiser, which is commonly found in the environment.
Hong Kong banned several Taiwanese drinks, while Taiwan has recalled nearly half a million bottles of sports drinks and fruit juice over fears they contained the chemical.
The GSK spokesman added: “Augmentin has been available to patients for more than 25 years to treat a variety of bacterial infections.
“We do not believe that the identification of DIPD at these levels represents any new safety information about the medicine.”
China’s halting of Augmentin sales comes only days after GSK strengthened its presence in the country by taking full control of influenza vaccine maker Shenzhen GSK-Neputnus Biologicals in a £24m deal.
It bought out the 51pc stake held by its local partner.
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