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Week Ending: January 6th , 2007
Alan Franciscus
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December 31st, 2006
Awareness and Testing for Hepatitis C Are Increasing, UK
http://www.medicalnewstoday.com
A new report from the Health Protection Agency shows that the number of people newly diagnosed with hepatitis C has increased; from 2,116 in 1996, to 7,580 in 2005. New figures also show that testing for hepatitis C has increased overall, for example, in GP surgeries', testing has increased by almost 60 per cent between 2002 and 2005.
The latest estimates on the number of adults infected with hepatitis C showed there were around 231,000 in 2003. Many of these infected people do not realise they have the virus as it can take years or even decades for symptoms to appear. Early treatment, however, is effective at clearing the virus in the majority of people. It is therefore important that individuals at risk are tested by their GP or other health services.
Dr Helen Harris, a Hepatitis C expert from the Agency said “This is the second annual report on Hepatitis C from the Health Protection Agency, summarising current knowledge of the infection and the action being taken to tackle it. Hepatitis C is very under-diagnosed simply because people are unaware that they are carrying it. By increasing awareness of the infection, more people will be tested, will receive earlier and more effective treatment, and they can avoid passing it on to others.”
“We estimate that almost 6 in 10 people with hepatitis C injected drugs at some point in their past. If someone has ever shared equipment for injecting drugs - even if it was a long time ago, and even if they only did it once or twice - they could be at risk from hepatitis C. A simple blood test can establish whether someone has ever been infected with the virus”
Professor Pete Borriello, Director of the Agency's Centre for Infections said,”Testing for hepatitis C has increased significantly, however there is still much work to be done as a significant number of individuals remain undiagnosed. If you don't know you've got it, you can't do anything about it. Health services should consider this as they formulate strategies to increase testing.”
The report highlights the Department of Health's hepatitis C awareness campaign, FaCe It, which has now reached over 16 million people. The exhibition campaign visits cities across England and features large photographic portraits of people living with Hepatitis C.
Hepatitis C in England - An Update 2006 is published by the Health Protection Agency and contributors. To see a full copy of the report, click here: http://www.hpa.org.uk/publications/2006/hepc_2006
Contributions to the report were received from a number of people from the Health Protection Agency as well as The Department of Health, The National Treatment Agency for Substance Misuse and The Trent Hepatitis C Cohort Study Group. Anyone who thinks they might be at risk of infection should contact their doctor or nurse or call the Hepatitis C Information Line on 0800 451 451 or visit http://www.hepc.nhs.uk
Between 70-80% of adults with hepatitis C become chronically infected. The preliminary estimates for 2003 suggest that 0.53% of the 15-59 year age group in England and Wales were chronically infected. Although prevalence estimates in older individuals are less secure, as the major risk factor for hepatitis C is injecting drug use, we expect the prevalence in older individuals to be lower than in the 15-59 year old population. Similarly, the prevalence in children under 15 years is expected to be very low.
Sentinel surveillance suggests that testing in GP surgeries has increased by almost 60% because 8584 individuals were tested in nine sentinel laboratories in 2005 compared to 5382 individuals being tested in the same laboratories in 2002.
Laboratory confirmed diagnoses for hepatitis C rose from 6341 in 2003 to 7580 in 2005. This indicates that the rate of diagnoses has risen and therefore that more diagnostic testing is taking place.
Hepatitis means swelling or inflammation of the liver. The most common causes of hepatitis are viral infections. Hepatitis C infection (also known as Hep C or HCV) is one such virus that can cause long-lasting infection and can lead to liver disease. The UK is the only major developed nation showing an upward trend in the number of deaths from liver disease.
Health Protection Agency (UK)
http://www.hpa.org.uk/
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$1B Hepatitis C Compensation Agreement Completed and Now Proceeds to Courts, Canada
http://www.medicalnewstoday.com
Canada’s New Government is one step closer to finalizing compensation to individuals infected with hepatitis C from the blood system prior to January 1, 1986, and after July 1, 1990.
The Honourable Tony Clement, Minister of Health, said today that the federal government and plaintiffs’ counsel have concluded the final settlement agreement which will now proceed to the Courts for scrutiny and approval.
“This step marks a milestone in our commitment to get money into the hands of those infected, prior to1986 and after July 1, 1990, as quickly as possible,” said Minister Clement. “Two steps remain before these people begin to receive compensation payments. The first is to seek approvals of the Courts in British Columbia, Alberta, Quebec and Ontario, where the class actions are filed. The second step is the creation of the administrative structure to receive and to evaluate applications.
“We are working as quickly as possible to provide compensation to the class,” said Minister Clement
The federal government will set aside $1.023 billion (composed of $962 million for compensation, $20 million in administrative costs, $37.29 million in legal fees plus applicable taxes, and $500,000 in disbursements plus applicable taxes) for the pre-1986/post-1990 final settlement agreement, which is based, to the extent possible, on parity with the federal share of compensation for those infected from 1986-1990.
The final settlement agreement sets out the guidelines for providing compensation to the pre-1986/post-1990 class. It expands on the details already provided by Prime Minister Stephen Harper on July 25, 2006, and includes the benefit schedules.
Health Canada and counsel representing the pre-1986/post-1990 class will provide further information as it becomes available. Class members are advised to contact their class counsel for details on the settlement. The information on how to apply will be issued at a later date as it becomes available, and it will be posted as well on the Health Canada Web site.
http://www.hc-sc.gc.ca
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January 1st, 2007
Inovio Biomedical Partner Tripep Applies for Phase I Study of Hepatitis C DNA Vaccine
http://www.newsrx.com/
Vaccine Weekly NewsRx.com
2007 JAN 3 -- Inovio Biomedical Corp. (INO), a company enabling the development of DNA vaccines using electroporation-based DNA delivery, announced that its partner, Tripep, AB, of Sweden, has filed an application for a phase I clinical study with the Swedish Medical Products Agency.
The application is designed to permit initial clinical testing of Tripep's proprietary DNA vaccine, ChronVac-C, administered using Inovio's MedPulser DNA Delivery System. This combination is designed to activate a T-cell response capable of clearing hepatitis C virus. Tripep intends to conduct a phase I clinical study in healthy volunteers at the Center for Gastroenterology at Karolinska University Hospital in Sweden beginning in early 2007.
"Our partnership with Tripep has rapidly moved this vaccine from concept to initial clinical evaluation in less than a year," stated Avtar Dhillon, MD, Inovio's president and CEO. "This vaccine trial represents the first study in man of an infectious disease vaccine delivered with electroporation and we are excited about the product's potential."
DNA vaccines have the potential to by-pass the numerous problems that plague conventional vaccines. For example, DNA vaccines may be better in stimulating cellular immunity necessary to fight chronic infection or diseases such as cancer. Despite this promise, vaccination using DNA plasmids alone, without enhanced delivery, has not been shown to reach the threshold for clinical benefit.
Intramuscular delivery of DNA vaccines using Inovio's proprietary electroporation technology has been shown in primate studies to boost the immune response by orders of magnitude over DNA plasmid alone. Plasmid-based vaccines induced higher levels of antibodies and T-cell responses when delivered via electroporation, suggesting the potential to provide better protection from infectious diseases such as HIV and hepatitis.
This article was prepared by Vaccine Weekly editors from staff and other reports.
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January 2nd, 2007
Caregiving: Lawford Says Get Tested – 2
http://www.upi.com/
By ALEX CUKAN
UPI Health Correspondent
ALBANY, N.Y., Jan. 2 (UPI) -- There is a stigma associated with hepatitis C, or HCV, and that stigma is keeping people from getting tested and getting the treatment that could save their lives.
The stigma comes because most people get HCV from illegal drug use -- even inhaling drugs through a straw, tattoos done under unsanitary conditions and blood-to-blood contact during sex -- but people also get the virus from blood transfusions or major surgery before 1992 as well as needle-stick accidents among healthcare workers and dialysis.
HCV is the most common chronic, blood-to-blood viral infection in the United States. It is the most common chronic infectious disease in Europe and North America and affects an estimated 170 million people worldwide -- four times more prevalent than HIV, the virus that causes AIDS.
"You have to get tested for hepatitis C; it won't be picked up during regular blood work. People have to be proactive and ask for the test -- you are not going to know by the way you feel," Christopher Kennedy Lawford told UPI's Caregiving.
Lawford, a 51-year-old actor and author of Symptoms of Withdrawal: A Memoir of Snapshots and Redemption, was tested for HCV in 2001 some 15 to 20 years after he had been infected. He is sharing his experience of being diagnosed and successfully treated for HCV as part of a national education campaign called Hep C STAT! for Stop, Test And Treat. The campaign encourages individuals to stop and consider their own risk factors, get tested and, if infected, talk to a liver specialist about available treatment options.
"Many in my generation who engaged in adventuresome behaviors, perhaps 20 years ago and maybe even just once -- having put their past behind them -- may not know that these activities leave them at risk for hepatitis C today. Until my diagnosis, I was one of those people." said Lawford.
"After the initial shock of the news, I decided to fight back. Now, four years after successfully completing treatment, there is no trace of the virus in my blood.
"One in five people has something in their past that puts them at risk for hepatitis C," said Lawford. "If you have a risk factor, it doesn't matter which one -- get tested."
HCV can remain in your body and stay dormant. Some of those infected will develop liver disease -- cirrhosis -- and some may die of liver cancer, said Lawford.
Liver cancer is lethal, with untreated patients rarely surviving more than one year.
After reading Part 1 of this series, some took issue with the virus being linked to risk factors such as illegal drug use, tattoos or having more than 10 sexual partners.
One reader wrote that she holds a support group for those with HCV in a small rural U.S. town. She said that people with HCV are afraid to be open about their disease for fear of discrimination and stigma.
"One local doctor informed a woman's husband about her condition before informing her -- he contacted her husband to tell him his wife must have been using drugs or sleeping around because that was the only way she could have gotten the virus," she wrote. "When she came to my group she was distraught as she had done neither."
Another reader wrote of her experience being diagnosed with HCV.
"The doctor walks over and proceeds to listen to my breathing. First, my chest, next my back. Now, I have a tattoo that is on my left shoulder. I forget it's there, as I got it when I was 18. I was then in my 30s, with two kids in elementary school, one in junior high. The doctor sees the tattoo and her whole demeanor changed -- right before my eyes!" she wrote.
"Suddenly she starts looking at me with this air of disgust ... she proceeds to tell me that 'they' need people 'like me' to hold up as an example to others about the dangers of this kind of lifestyle, and on and on. What kind of lifestyle? What is she talking about? Then she said, 'You probably have AIDS!'"
This column has noted other appalling examples of a doctor's lack of bedside manner before, but no one knows better than I that the disease can strike anyone. One of my closest friends, Rick, died of liver cancer -- most likely caused by hepatitis B or C -- when he was 23.
For information: www.hepcstat.com
Next: Rick's mystery illness
Alex Cukan is an award-winning journalist, but she always has considered caregiving her real work. UPI welcomes comments and questions about this column. E-mail: consumerhealth@upi.com
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Diet Seen to Affect Liver Cancer Risk
http://www.cancerpage.com
By David Douglas
NEW YORK JAN 02, 2007 (Reuters Health) - Certain foods, among them milk and fruit, appear to reduce the risk of developing hepatocellular carcinoma (HCC), according to Italian researchers.
Their study, Dr. Renato Talamini told Reuters Health, "indicated that diet has a relevant role in the risk of this cancer. As for other types of cancer, particularly fruits and vegetables seem to confer a protective effect."
As reported in the December 15th issue of the International Journal of Cancer, Dr. Talamini of Istituto Nazionale Tumori, Aviano and colleagues conducted a hospital-based study of 185 HCC patients and 412 controls without neoplastic disease.
Responses to dietary questionnaires showed a significant inverse correlation between intake of various foods and HCC risk. After adjustment, the odds ratio with high intakes of milk and yoghurt was 0.28. For white meat, it was 0.44, for eggs, the corresponding value was 0.31 and for fruit, it was 0.48. However, overall the apparently protective effects of vegetables did not reach significance.
The researchers observe that the findings held good for patients with hepatitis B and hepatitis C virus infection.
Summing up, Dr. Talamini added that from an HCC prevention point of view one should "adopt a correct diet, rich in fruits and vegetables." Also important, he added, "is limiting consumption of alcohol beverages and avoiding HCV infection by practicing safe sex and eliminating needle sharing."
SOURCE: Int J Cancer 2006;119:2916-2921
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Scientists on a Mission to Bring Cheap Drugs to the World's Poorest Countries
http://education.guardian.co.uk
Sarah Boseley, health editor
The Guardian
· Indian trials for low cost hepatitis C treatment
· Researchers pioneer 'ethical pharmaceuticals'
Until recently, hepatitis C, a potentially fatal blood-borne infection that could affect as many as 500,000 people in the UK, was treated with the antiviral drug ribavirin, together with interferon.
The drugs are old enough to be out of patent and so can be made cheaply, but the necessary frequent injections of interferon cause serious side effects.
Then in 2003 scientists working for Roche and Schering Plough developed a variation on the drug designed to last longer in the blood and so require fewer injections. The trial results were spectacular - half of the patients were cured. The drug was patented and is sold to the NHS.
The catch, as so often when it comes to cutting edge pharmaceuticals, is cost: the £7,000-a-course price tag is expensive for the NHS and beyond the budgets of developing countries, where the need is greatest.
Enter Sunil Shaunak, professor of infectious diseases at Imperial College, and his colleague from the London School of Pharmacy, Steve Brocchini. Involved in the battle to contain the Aids pandemic from its outset in 1985, Professor Shaunak was committed to finding ways to provide cheap medicines for people in the developing world.
In the case of hepatitis C, Professors Shaunak and Brocchini decided to try to make a different, improved version of the Roche drug which would be cheap and stable in a hot climate. They redesigned the drug, known as pegylated interferon, so that it would have the large sugar molecule which made it last longer in the blood on the inside, rather than the outside. Then they contacted a company called Shantha in Hyderabad, which had made the world's first cost-effective hepatitis B vaccine and was already making the original interferon. Shantha has agreed to make the new medicine and the Indian government will subsidise the clinical trials which have to take place before licensing.
"If it works in India, it will eventually come back to the NHS," said Professor Shaunak. "What we started doing is creating this model of what we call ethical pharmaceuticals."
Professor Shaunak says they want to make a difference - not just create new drugs but see them through to become good medicines to treat people in poor countries. He says the model is not a threat to the pharmaceutical giants, but "if eventually it became a threat to their business, I [would] be very flattered". He wants the idea of the model in the public domain so that other young academic doctors and scientists can use it.
The pair are now working on a drug for visceral leishmaniasis, also known as kala-azar - a fatal disease transmitted by the sandfly. Most cases are in Brazil, Bangladesh, India and the Sudan. The 70- year-old drug commonly used to treat it kills 10% of patients. A new drug, Gilead's patented Ambisome, revives patients within hours of the first injection and has few side effects, but costs $800 (£408).
Gilead's medicine is derived from a very toxic drug called amphotericin B, which, essentially, its scientists inserted into a fat globule, eliminating the toxicity.
Professors Shaunak and Brocchini came up with the idea of putting it into sugar-based polymers instead to make a drug that is stable in hot climates and will cost 2-3% of the price. They have teamed up with the Drugs for Neglected Diseases Initiative (DNDi), a not-for-profit organisation which was the brainchild of Médecins sans Frontières, which will raise the initial money.
Simon Croft of DNDi said the idea was to repackage the drug, making it less toxic but just as effective and cheaper. "It has a long way to go, but it is an exciting concept which is already demonstrated with hepatitis C. Cost is one of the key issues. If patients and health services can't afford it, a potentially good formulation can't be used."
Reformulating a drug was a classic way for multinational pharmaceutical companies to extend the life of a medicine reaching the end of its patent life, he added.
The multinational drug companies already fight bitter battles over their patent rights. Lawyers for the drug giants will take a close interest in any new drug that could potentially damage their profits. The cheap HIV drugs used in Africa are generic copies which it is illegal to bring into Europe or the US, but if ethical pharmaceuticals were licensed as new medicines, they could be sold here.
The Association of the British Pharmaceutical Industry said the key question was whether the new drug was truly innovative. "The issue is around whether he [the researcher] has developed a novel compound which is therefore not covered by the patent on any other product," said Ben Hayes of the ABPI. "Then he or anybody else has the right to patent it." They would, however, still face the considerable challenge and expense of clinical trials before the drug could be licensed first in India and then in the UK. Only then could the NHS consider whether it was worth prescribing, he said.
A spokesman for Roche said yesterday: "Roche is committed to ensuring that as many people as possible can gain access to our medicines, many of which have transformed once deadly diseases into manageable and or even curable conditions. One such example is our commitment to supply HIV drugs to Africa on a not-for-profit basis. It costs the pharmaceutical industry on average £550m to develop a single new medicine. Patents are in place to ensure we have the resources to continue to discover cutting edge advances in the future."
FAQ: Affordable medicines
What are ethical pharmaceuticals?
They are drugs modelled on successful but expensive medicines, that have been structurally modified. It is hoped that the changes will make the new drug more suitable to the hot climates of developing countries but also technically turn it into a novel medicine which is no longer under patent to a big pharmaceutical company.
Can the new drug be manufactured and marketed straight away?
No - as a new drug, it must be put through clinical trials on patients, which will last several years. Then the data must be submitted to a drug regulatory body for a licence.
Won't that cost a lot of money?
The trials of the first drug, for hepatitis C, will be cheaper because they are in India and the government will pay - hepatitis C takes a big toll of economically productive people. Manufacturing will also be cheaper there. Grants from philanthropic bodies like the Wellcome Trust pay for the initial development work in the UK.
How are these drugs different from the cheap generic medicines used against HIV in Africa?
Generics are exact copies of existing medicines. Indian patent law allowed generic manufacture until last year (2006) and world trade rules permitted their sale to poor countries. But India's laws have now changed and it may not be possible to copy new drugs in the future. And for some neglected diseases there are no good existing medicines.
Will the multinational pharmaceutical companies object?
They will if it there is a possibility that a cheap, improved version of one of their drugs will arrive back in the UK, Europe or US where they make their profits. Then the patent lawyers will become involved.
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January 3rd, 2007
Racial Differences Seen in Steatosis in Patients with Hepatitis C
http://www.eurekalert.org/
Caucasian patients with chronic hepatitis C virus (HCV) are more likely to have hepatic steatosis, or fat in the liver, compared to African-American patients. However, steatosis is not associated with HCV treatment response. These findings are published in the January 2007 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., the journal is available online via Wiley InterScience (http://www.interscience.wiley.com/journal
/hepatology).
Hepatic steatosis is common among patients with HCV and often indicates more advanced disease. Researchers, led by Hari Conjeevaram, M.D., M.S. Division of Gastroenterology at the University of Michigan at Ann Arbor, sought to investigate racial differences in the prevalence and severity of hepatic steatosis in patients with HCV, genotype 1. Additionally, they investigated the relationship between steatosis and body characteristics and other measures of insulin resistance. "We also wanted to assess whether the presence and severity of hepatic steatosis and/or insulin resistance were important factors to predict virological response in this population," the authors write.
The researchers studied 194 African-American and 205 Caucasian patients with HCV, genotype 1. All patients were participating in a multi-center prospective study of peginterferon and ribavirin therapy. The researchers compared the prevalence and severity of steatosis and steatohepatitis to demographic, lifestyle and clinical characteristics. They also investigated relationships between sustained virological response and both steatosis and insulin resistance.
The researchers found hepatic steatosis in 61 percent of the African-American patients and 65 percent of Caucasian patients. In a univariable analysis, the steatosis was associated with HOMA-IR (a measure of insulin resistance), body mass index, waist circumference, serum triglycerides, aminotransferase levels, and histological scores for inflammation and fibrosis. After adjusting for those features, they found that African-Americans had a dramatically lower risk of steatosis. For a given degree of overweight and obesity or insulin resistance, African-Americans were approximately half as likely to have hepatic steatosis. After examining patient characteristics and their responsiveness to treatment, the authors report, "insulin resistance and fibrosis are important and obesity and steatosis may be less or not as important."
The results may have been confounded by patients taking oral anti-diabetic agents, and by the possibility that HOMA underestimated the degree of insulin resistance in overtly diabetic patients.
Still, "the importance of these findings is that insulin resistance is a potentially modifiable factor, so that responses to antiviral therapy in hepatitis C may be improved by modulation of insulin signaling and improvements in insulin resistance and glucose control. These possibilities deserve prospective evaluation," they conclude.
###
This work was funded by grants from the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.
Article: "Race, Insulin Resistance and Hepatic Steatosis in Chronic Hepatitis C," Hari S. Conjeevaram, David E. Kleiner, Jay E. Everhart, Jay H. Hoofnagle, Steven Zacks, Nezam H. Afdhal, and Abdus S. Wahed for the Virahep-C Study Group, Hepatology; January 2007 (DOI: 10.1002/hep.21455).
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Interferon-Treated Hepatitis C Patients Likely to Experience Retinopathy
http://www.eurekalert.org
Rockville, Md. -- Persons with chronic hepatitis C being treated with Interferon (IFN) are at risk of developing retinopathy as early as two weeks into treatment according to the results of a new study published in the January 2007 issue of Investigative Ophthalmology & Visual Science (IOVS).
Researchers from the Departments of Ophthalmology and Hepatology at Asahikawa Medical College in Japan measured the changes in vessel diameter and blood velocity and calculated retinal blood flow (RBF) and wall shear rate (WSR) using a laser Doppler velocimetry in 36 patients with chronic hepatitis C who were treated with high-dose IFN. Sixty-one percent of these patients developed asymptomatic retinopathy, including retinal hemorrhage and cotton-wool spots, during treatment. Retinopathy was first diagnosed two to 16 weeks after the start of treatment and resolved at the end of treatment in all but nine patients.
Of these patients, all experienced an increase in blood velocity, RBF, and WSR. The increased RBF was associated with anemia induced by IFN treatment. The increase in WSR in patients with retinopathy especially indicates that endothelial dysfunction may play an important role in IFN-induced retinopathy as shear stress should be constant under physiologic conditions.
Read this article online at http://www.iovs.org/cgi/content/full/48/1/368.
IOVS is published by the Association for Research in Vision and Ophthalmology (ARVO). For more information, logon to www.IOVS.org.
ARVO is a membership organization of more than 11,500 eye and vision researchers from over 70 countries. Established in 1928, the Association encourages and assists its members and others in research, training, publication and dissemination of knowledge in vision and ophthalmology. ARVO's headquarters are located in Rockville, Md. For more information about ARVO, logon to www.arvo.org.
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HIV/HCV Coinfected Individuals Have An Increased Risk of Cardiovascular Disease
http://www.aidsmap.com
Michael Carter
Coinfection with hepatitis C virus increases the risk of cardiovascular disease in HIV-positive individuals, according to an American study published in the January 11th edition of AIDS. The investigators found that the relationship between hepatitis C infection and an increased risk of cardiovascular diseases, such as hardening of the arteries, stroke and heart attack persisted even when they adjusted for factors including age, gender, race, blood pressure, drug use and smoking.
Numerous studies have found a connection between chronic infections and an increased risk for cardiovascular disease. However, there are conflicting data regarding any such association and infection with hepatitis C.
Heart disease is an increasing concern for people with HIV. Many HIV-positive individuals are benefiting from the prolonged prognosis that antiretroviral therapy makes possible. But this means that some individuals are now living long enough to develop cardiovascular illnesses, and an association has been found between the use of antiretroviral therapy and a long-term risk of increased metabolic disorders and heart disease. In addition, many HIV-positive individuals (as much as 30% in some cohorts) are coinfected with hepatitis C virus. The investigators from the HIV-Live (HIV-Longitudinal Inter-relationships of Viruses and Ethanol) study therefore wished to see if there was any association between coinfection with hepatitis C virus in a prospective cohort of HIV-positive patients with a history of substance abuse.
A total of 395 individuals were included in the investigators’ analysis. Exactly half of the study population was coinfected with hepatitis C.
Patients were asked to complete a questionnaire about their health and specify if they had ever been told by their doctor that they have hardening of the arteries (atherosclerosis); had a stroke; or, had a heart attack. Data were also gathered on the patients’ age, gender, race, current CD4 cell count, weight, adherence to antiretroviral therapy, blood pressure, alcohol consumption, drug use and housing status. Patients were also asked to state if they had diabetes, renal disease, or lipodystrophy.
Coinfected individuals were significantly older than patients who only had HIV (44 versus 41 years), and had a higher prevalence of health complaints including diabetes (10% versus 4%), cirrhosis (10% versus 3%), heart attack (7% versus 1%) and cardiovascular disease (11% versus 3%). All these differences were statistically significant (p < 0.05).
After adjusting their results for age, the association between hepatitis C coinfection and both cardiovascular disease and heart attack persisted (odds ratios: 4.65 and 12.86 respectively). The investigators then looked to see if any possible confounding factors including gender, race, alcohol consumption, current CD4 cell count, antiretroviral therapy, lipodystrophy, or the use of illicit substances such as crack, cocaine or injected drugs affected these results. They write, “when individual cofounders were added separately to the age-adjusted models, the relationship between hepatitis C and cardiovascular disease remained unchanged”.
The investigators acknowledge that their study had limitations, in particular that patients were asked to self-report their health histories. Nevertheless, they conclude, “among HIV-infected individuals, co-infection with hepatitis C may be independently associated with an increased risk of cardiovascular disease.”
Reference
Freiberg MS et al. The association between hepatitis C infection and prevalent cardiovascular disease among HIV-infected individuals. AIDS 21: 193 - 197, 2007.
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January 4th, 2007
An Oral Exam for Hepatitis C?
http://www.redherring.com
By Rachel Barron
OraSure and Schering-Plough to develop the first salvia test to detect the dangerous liver disease.
Pamela Anderson, the overly-buxom Baywatch veteran is known for a lot of things. And among them is her unwanted status as a poster child for hepatitis C. In 2002, she announced she got the potentially fatal liver disease while sharing a tattoo needle with ex-husband and rocker Tommy Lee.
Ms. Anderson got the bad news after a blood test confirmed it. OraSure Technologies is trying to offer folks an easier way to detect the disease. On Thursday, the company said it inked a deal with healthcare company giant Schering-Plough to develop an oral hepatitis C test.
Such oral tests are far from new for OraSure. OraSure makes mouth swab HIV tests that within 20 minutes deliver results in the comfort of a healthcare provider’s office.
The company has also been gaining attention lately for its efforts to make an over-the-counter HIV test, which would allow folks in the privacy of their own home to determine if they are positive for the virus that causes AIDS (see Studies Start for Home HIV Test and Testing for HIV at Home).
But the company’s latest efforts focus on teaming up with hepatitis C treatment maker Schering-Plough to develop and market the first oral test to detect hepatitis C virus antibodies.
The deal calls for Schering-Plough to reimburse OraSure for a portion of the costs needed to develop the test. Schering-Plough will also pony up promotional support so the two can co-brand the product for the U.S. physicians' office market.
Orasure will still be the folks to sell the test. As well, “we retain the rights in all markets,” said Ron Ticho, the company’s vice president of strategic marketing.
Although the companies won’t disclose any financial details, OraSure said the agreement is set to last for two years, starting when the test hits the commercial markets.
“The (hepatitis C virus) test has a significant commercial and medical value, and is going to help identify more individuals who are infected,” Mr. Ticho said. Part of the test’s draw is the obvious ability to pass on current detection methods, which include a needle or stick prick.
Hepatitis C is a liver disease caused by the hepatitis C virus, and is spread by contact with the blood of an infected person. It is also the most common blood-borne infection in America, affecting about 4 million people in the country, according to the Centers for Disease Control and Prevention.
Globally, an estimated 170 million people, or 3 percent of the world's population, are chronically infected with the disease, and three to four million people are newly infected each year, according to the World Health Organization.
Currently there is no vaccine to protect against the infection.
But for those who work in the healthcare trenches trying to curb infection rates, the company collaboration points to a long-awaited technology that might finally come to be.
“That’s just about the best news I’ve heard in a long time,” said Alan Franciscus, founder of the San Francisco non-profit organization the Hepatitis C Support Project.
With hepatitis C early detection is key. Once people know they have the virus “they can take precautions to keep healthy and manage their disease effectively,” Mr. Franciscus says.
Hepatitis C is often described as a “silent epidemic” because people infected with the disease usually show no symptoms. It is estimated that only 25 percent of hepatitis C cases have been diagnosed.
Mr. Franciscus sees OraSure’s test possibly making a real dent in the ability to improve detection rates. The fact that a phlebotomist won’t be need to draw blood opens new doors as to who can administer the test.
As well, “It’s got to be cheaper,” he suspects. Although OraSure wouldn’t reveal any potential prices, Mr. Franciscus said some of the savings will come from not needing to pay a phlebotomist and the proceeding lab tests. If a person does have a positive result, blood tests will be needed to confirm a diagnosis.
Wall Street also appeared to like the move sending OraSure stock up $0.59, or 7.24 percent, to $8.74. Schering-Plough also saw an incremental boost of $0.19, or 0.81 percent, to $23.72.
But both Wall Street and Mr. Franciscus will have to wait to for the companies’ collaboration to bear the fruit of the deal.
Again keeping a rather tight lip OraSure wouldn’t state how far along it is with the test’s development. The only thing Mr. Ticho would say is the company has done feasibility tests, and the product development process is going extremely well.
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