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Week Ending: October 31, 2009
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October 25, 2009
New Law Would Allow Local Pharmacies to Sell Over-the-Counter Needles
http://www.santacruzsentinel.com
By Kurtis Alexander
SANTA CRUZ -- An ordinance being drafted by a county supervisor would make it OK for pharmacies to sell needles without a prescription, a practice currently barred in much of the county because of the implications for intravenous drug use.
Supervisor John Leopold, who plans to introduce the new law as soon as next week, says making sure clean needles are available, even if they're being used illegally, is a proven way of preventing the spread of blood-borne diseases like AIDS and Hepatitis C.
"This is good health policy," said Leopold, who before entering politics worked as the director of the Santa Cruz AIDS Project.
With last month's suspension of the AIDS Project needle-exchange program, a method for many drug users in the county to get sterile syringes, Leopold says his ordinance is timely.
"With the future of the exchange in question, we have to figure out another way," he said. "Having pharmacies participate will help us meet this basic health need."
A 2004 state law allows counties across California to choose whether to permit the sale of over-the-counter syringes. While Santa Cruz County opted to do so, the decision did not include cities where the bulk of county pharmacies exist.
"Without the local jurisdictions approving this, it hasn't had the kind of effect we've wanted," said Merle Smith, the AIDS Project's current executive director.
The new ordinance is written to allow pharmacies in the cities, not just the unincorporated areas, to sell over-the-counter syringes.
Smith, who had to shut the agency's needle-exchange program because of state budget cuts, supports Leopold's proposal.
A survey by Oakland-based Rose Associates suggests that while only 17 percent of those using needle exchanges have recently bought a syringe at a pharmacy, 80 percent would.
"Expanded access through pharmacies is nothing but good," said Valerie Rose, a community health consultant who conducted the survey, which included Santa Cruz County.
According to the Drug Policy Alliance Network, a third of all reported AIDS cases in the United States have been among injection drug users and their sexual partners.
About 700 people in Santa Cruz County are living with AIDS, according to the AIDS Project.
Under the proposed county ordinance, the Health Services Agency would work with pharmacies choosing to sell over-the-counter needles. The agency, said Community Health Service Director Leslie Goodfriend, would make sure needles were being properly disposed of as well as ensure health information, about disease testing and making safer choices, was provided to drug users.
State law allows the county to permit the sale of up to 10 needles to individuals without prescriptions or collecting personal information.
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Liver Cancer Rates Rising Alarmingly, Say Doctors
http://www.ctv.ca
It's a cancer that gets little attention, but it should, because liver cancer has become one of the fastest growing cancers in Canada.
While many cancers spread to the liver in the final stages, doctors are now concerned about the increase in the number of cancers that start in the liver.
Each year in Canada, over 1,700 people are diagnosed with primary liver cancer and those numbers are growing, doctors say. Yet many cases can be prevented and others cured if only those at risk were regularly tested.
Liver cancer rates are thought to be rising because of increased rates of hepatitis C infection, obesity and type 2 diabetes.
Dr. Sean Cleary, a surgeon at Toronto General Hospital, says he's seen a huge jump in liver cancer cases.
"We've seen a significant rise in our cases that need to come to surgery, an increase of perhaps 200 per cent in the last five years," he tells CTV News.
The patient he was treating the day we came to see him was a middle-aged man whose silent cancer wasn't discovered until it had engulfed much of his liver. Dr. Cleary had to remove half of the vital organ in a bid to extend the man's life.
If caught early, liver cancer tumours can be easily treated, but if they are larger than three centimetres in diameter, the prognosis is poor. Cleary says too often they're caught late, so that about one-third to one-half of the cases he sees are untreatable.
"This means we are picking them up to late, we are catching them too late," he says.
The man Cleary treated had had hepatitis, which can damage the liver and allow cancer to grow. But the man had not been going for routine screenings; his liver cancer was found through other medical tests.
Doctors say liver cancer is a silent cancer that can grow for years causing no symptoms until it's too late.
Hepatitis C patient Michele also was recently diagnosed with liver cancer. She, too, was having tests for another problem when doctors found five tumours in her liver.
"It was frightening and I didn't know what to expect," she says, adding no one told her hepatitis C put her at higher risk of developing liver cancer.
"I had no idea that I would end up with liver cancer; that was a big shock," she says.
Hep C is caused by a virus transmitted by blood-to-blood contact, through shared needles, tattoo needles and sexual contact. It's estimated that in Canada, about 243,000 people have hep C, but because there are often no symptoms, nearly 20 per cent don't know they're infected.
Doctors also say more new cases of liver cancer are being triggered by diabetes and obesity. Obese patients often develop fatty livers that seem to increase their risk of liver cancer and their risk of death from liver cancer. Alcohol too, can lead to liver cirrhosis, which has been shown to increase cancer risk.
The key to lowering cancer rates, says cancer researcher Dr. Morris Sherman of the University Health Network, is to monitor patients who are at risk for liver disease, from age 50 on with yearly liver ultrasounds.
He notes that many countries already recommend regular liver screening, which allows doctors to find cancer in the early stages.
"If we get these things when they are small, the chance of survival is 90 per cent," he says.
But instead, he says, many of those most at risk aren't being tested.
"I would say no more than 30 per cent of patients are getting identified. So 70 per cent of patients are NOT getting adequate screening," he says.
"I'd like physicians to be aware of this and screen at a regular basis," he says, noting that he expects that with rising rates of hepatitis B and C infection, there will be a further 50 per cent increase in new liver cancer cases over the next 10 years.
As for Michelle, the cancer's damage to her liver is so extensive, she is now waiting for a liver transplant.
"I think it is important that people know you should get tested for this, because I don't want a lot of people stuck in this situation," she says.
"We need more doctors to get on the bandwagon and start testing them."
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Most Hepatitis C Infections amongst Gay Men in Sydney Linked to Injecting Drug Use
www.aidsmap.com
Michael Carter
Injecting drug use is the behaviour most associated with hepatitis C virus infection in both HIV-positive and HIV-negative gay men in Sydney, a study published in the online edition of Sexually Transmitted Infections shows.
The Australian researchers also found that rates of hepatitis C infection about ten times higher in HIV-positive men than they were in HIV-negative men.
Although no new hepatitis C infections were detected in men with HIV, there were five in the HIV-negative men, and the investigators found that many of these men had reported sex with an HIV-positive man, use of sex toys, fisting, and ulcerative sexually transmitted infections.
Hepatitis C is a blood-borne virus and its main mode of transmission is injecting drug use. Sexual transmission of the virus is thought to be rare. However there have recently been outbreaks of hepatitis C amongst HIV-positive gay men and sex seems to be the most likely mode of transmission.
It seems that sexual activity that involves contact with blood is associated with the transmission of hepatitis C in HIV-positive gay men, for example fisting, use of sex toys, and unprotected anal sex, especially in the context of recreational drug use and group sex.
Investigators in Sydney, Australia wished to obtain a better understanding of the transmission of hepatitis C in gay men.
They therefore analysed the results of two studies – one involving HIV-negative men, the other men with HIV – to determine the prevalence, incidence, and risk factors for hepatitis C.
Study populations
A total of 1,427 HIV-negative men recruited to the Health in Men (HIM) study and 245 HIV-positive men from the Positive Health study were included in the investigators’ analyses.
Information from the HIM study from 2001-2007 was studied, with the Positive Health study providing testing data from 2005-2007.
Both these studies were therefore able to analyse the results of tests for hepatitis C conducted since the sexual transmission of the epidemic became apparent in HIV-positive gay men in Europe in around 2002.
Injecting drug use strongly associated with hepatitis C in HIV-negative men
At baseline, 15 HIV-negative men were infected with hepatitis C. This provided a prevalence of approximately 1%. The investigators note that this prevalence is comparable to that in the general Australian population. I
njecting drug use was strongly associated with infection with hepatitis C (OR = 56.18; 95% CI 12.55-251.5). Only two of the hepatitis C-infected men did not report this behaviour, and the investigators note that these men both had tattoos or piercings, a possible mode of hepatitis C transmission.
Other characteristics associated with an increased risk of hepatitis C infection on entry to the study were older age, number of sexual partners, initiating anal sex at a younger age, and a history of sex work.
There were five new infections with hepatitis C during the study, providing an incidence rate of 0.11 per 100 person years.
Only one of the men newly-infected with hepatitis C reported injecting drug use. Four of the men (including the individual with a history of injecting drugs) said that they had sex with an HIV-positive man prior to their infection with hepatitis C.
As regards other sexual risk factors, unprotected anal sex was reported by one man, three said that they had used sex toys, and one reported fisting. Syphilis and infection with genital herpes were each reported by one individual.
High hepatitis C prevalence in HIV-positive gay men
Hepatitis C prevalence was much higher in the HIV-positive cohort. At baseline, 23 individuals were co-infected, providing a prevalence of 9.39%. Questions about injecting drug use were answered by 18 men, and 16 said that they had a history of such behaviour.
Despite the contemporary epidemic of sexually transmitted hepatitis C amongst HIV-positive gay men in northern Europe, there were no new infections with this virus during follow-up in this cohort.
The investigators note that HIV-positive gay men have historically had a higher prevalence of hepatitis C virus than their HIV-negative peers. For example, in a 1980s Sydney clinic cohort, 12% of those with HIV were infected with hepatitis C compared to 4% of HIV-negative men.
Although low, the incidence of what seems to be sexually acquired hepatitis C in HIV-negative gay men was in Sydney than has been reported in a number of other recent studies.
The low numbers of infections made statistical analysis difficult. There was only a weak association with unprotected anal sex with an HIV-positive man. However, the investigators noted that two of the recently infected men reporting sex with an HIV-infected man were diagnosed with syphilis or genital herpes. They therefore suggest “as both…are ulcerative sexually transmitted infections, these data suggest that the presence of ulcers may have facilitated hepatitis C transmission.”
“In these highly sexually active cohorts of homosexual men prevalent hepatitis C infection was almost ten times more common in HIV-positive men, and was related to injecting drug use in about 90% of cases in both HIV-negative and HIV-positive men”, comment the investigators.
Sexual risk factors seemed to be involved in the few new infections they identified, and the investigators conclude, “more carefully designed studies are warranted to elucidate whether the increase in the hepatitis C epidemic in homosexual men in some settings is attributable to sexual transmission or to increases in other risky behaviours, such as injecting drug use, and body piercing and tattooing.”
Reference
Jin F et al. Prevalence, incidence and risk factors for hepatitis C in homosexual men: data from two cohorts of HIV negative and HIV positive men in Sydney, Australia. Sex Transm Infect (online edition), 2009.
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October 26, 2009
Vaccination Program Cuts HBV Infection in Children of Foreign-Born Asian Parents
www.medscape.com
NEW YORK (Reuters Health) Oct 23 - The hepatitis B virus (HBV) infant vaccination program in the US appears to have reduced chronic infection, morbidity and mortality among populations at high risk, a paper in the October 9th issue of the journal Vaccine suggests.
"In 1988, the Advisory Committee on Immunization Practices (ACIP) recommended hepatitis B surface antigen (HBsAg) screening for all pregnant women," Dr. Carrie M. Shuler, of the Centers for Disease Control and Prevention, Atlanta, and colleagues write.
"In 1991, to prevent horizontal transmission in households and to further reduce missed opportunities to prevent HBV infection, ACIP recommended hepatitis B vaccination for all infants, preferably beginning at birth and regardless of the HBsAg status of the mother," they add.
The researchers performed a follow-up seroprevalence study during 2001 to 2004 in an Asian immigrant community in Georgia to assess the impact of universal maternal HBsAg screening and infant vaccination in preventing HBV infection among U.S.-born children of foreign-born Asian parents. This was modeled after a 1985 study conducted in a similar population during the era before routine infant vaccination.
Inclusion criteria required that households have at least one parent born in Korea, China, Laos, Cambodia, or Vietnam, and at least one U.S.-born child older than 12 months of age (study children).
A total of 989 subjects (563 adults and 426 children) were enrolled in the study. Of these, four adults were U.S.-born and 72 children were foreign-born. Therefore, 354 children were considered study children, and 635 subjects were foreign-born or adult participants (non-study children).
The authors note that 88% of the 354 study children lived in a household with at least one person with serological evidence of chronic or resolved HBV infection. Overall, 25.9% of study children lived in a household with a chronically infected person.
"Although the prevalence of chronic HBV infection among foreign-born adults was 11% in both the 1985 study and this study, only 0.8% of the U.S.-born children in our study had chronic HBV infection, compared with 4.3% of the children in the 1985 study; an 81% reduction," Dr. Shuler and colleagues explain. "The overall HBV infection burden among children decreased as well, with only 1.1% of children born after 1991 having evidence of resolved infection, compared with 12.5% of the children studied in 1985."
After controlling for chronic infection among household members, predictors of infection among study children included being born to a chronically infected mother (adjusted odds ratio 63.2) and being born before 1992 (adjusted OR 9.5). There was no statistical association between infection in study children and having a chronically infected father, other adult, or child in the household.
Compared to children born before the universal infant vaccination recommendation, those born after 1991 were more likely to have received the recommended three doses of the hepatitis B vaccine during infancy.
Vaccine 2009;27:5942-5947.
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Healthcare System Wastes up to $800 Billion a Year
www.reuters.com
By Maggie Fox, Health and Science Editor
WASHINGTON (Reuters) - The U.S. healthcare system is just as wasteful as President Barack Obama says it is, and proposed reforms could be paid for by fixing some of the most obvious inefficiencies, preventing mistakes and fighting fraud, according to a Thomson Reuters report released on Monday.
The U.S. healthcare system wastes between $505 billion and $850 billion every year, the report from Robert Kelley, vice president of healthcare analytics at Thomson Reuters, found.
"America's healthcare system is indeed hemorrhaging billions of dollars, and the opportunities to slow the fiscal bleeding are substantial," the report reads.
"The bad news is that an estimated $700 billion is wasted annually. That's one-third of the nation's healthcare bill," Kelley said in a statement.
"The good news is that by attacking waste we can reduce healthcare costs without adversely affecting the quality of care or access to care."
One example -- a paper-based system that discourages sharing of medical records accounts for 6 percent of annual overspending.
"It is waste when caregivers duplicate tests because results recorded in a patient's record with one provider are not available to another or when medical staff provides inappropriate treatment because relevant history of previous treatment cannot be accessed," the report reads.
Some other findings in the report from Thomson Reuters, the parent company of Reuters:
- Unnecessary care such as the overuse of antibiotics and lab tests to protect against malpractice exposure makes up 37 percent of healthcare waste or $200 to $300 billion a year.
- Fraud makes up 22 percent of healthcare waste, or up to $200 billion a year in fraudulent Medicare claims, kickbacks for referrals for unnecessary services and other scams.
- Administrative inefficiency and redundant paperwork account for 18 percent of healthcare waste.
- Medical mistakes account for $50 billion to $100 billion in unnecessary spending each year, or 11 percent of the total.
- Preventable conditions such as uncontrolled diabetes cost $30 billion to $50 billion a year.
"The average U.S. hospital spends one-quarter of its budget on billing and administration, nearly twice the average in Canada," reads the report, citing dozens of other research papers.
"American physicians spend nearly eight hours per week on paperwork and employ 1.66 clerical workers per doctor, far more than in Canada," it says, quoting a 2003 New England Journal of Medicine paper by Harvard University researcher Dr. Steffie Woolhandler.
Yet primary care doctors are lacking, forcing wasteful use of emergency rooms, for instance, the report reads.
All this could help explain why Americans spend more per capita and the highest percentage of GDP on healthcare than any other OECD country, yet has an unhealthier population with more diabetes, obesity and heart disease and higher rates of neonatal deaths than other developed nations.
Democratic Senator Charles Schumer said on Sunday that Senate Democratic leaders are close to securing enough votes to pass legislation to start reform of the country's $2.5 trillion healthcare system.
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How Does Emodin Protect Rat Liver from Fibrogenesis?
www.medicalnewstoday.com
In the last decade, advances in the understanding of genes promoting hepatic stellate cell (HSC) activation are impressive. However, there are few breakthroughs in therapeutic intervention of hepatic fibrogenesis. Efficient and well-tolerated antifibrotic drugs are lacking and current treatment of hepatic fibrosis is limited to withdrawal of the noxious agent. Research identifying innocuous antifibrotic agents is of high priority and urgently needed. Emodin is efficacious in the management of hepatic fibrosis. However, the mechanisms underlying its effects remain to be elucidated.
A research team from China established rat models of experimental hepatic fibrosis by injection with CCl4; the treated rats received emodin via oral administration at a dosage of 20 mg/kg twice a week at the same time. Rats injected with olive oil served as a normal group. Histopathological changes were observed by hematoxylin and eosin staining. The activities of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in serum and hepatic hydroxyproline content were assayed by biochemical analyses. The mRNA and protein relevant to hepatic stellate cell (HSC) activation in the liver were assessed using real-time reverse transcription-polymerase chain reaction, immunohistochemistry, western blotting and enzyme-linked immunosorbent assay. Their study was published in the World Journal of Gastroenterology.
The results showed that the degree of hepatic fibrosis increased markedly in the CCl4 group compared to the normal group, and decreased markedly in the emodin group compared to the CCl4 group according to METAVIR scale compared with those in the normal control group. The activities of serum ALT and AST were significantly higher in rats injected with CCl4. The activities of serum ALT and AST were significantly reduced by administration of emodin. Compared with the normal controls, hepatic hydroxyproline content was significantly higher in rats injected with CCl4. Hepatic hydroxyproline content was significantly reduced in the rats treated with emodin at 20 mg/kg. Emodin significantly protected the liver from injury by reducing serum AST and ALT activities and reducing hepatic hydroxyproline content. The mRNA levels of transforming growth factor-b1 (TGF-b1), Smad4 and a-SMA in liver tissues were significantly down-regulated in SD rats that received emodin treatment. Furthermore, significant down-regulation of serum TGF-b1 protein levels and protein expression of Smad4 and a-SMA in liver tissues was also observed in the rats. Emodin inhibited HSC activation by reducing the abundance of TGF-b1 and Smad4.
The researchers drew a conclusion that emodin is active as an antifibrogenic drug to reduce the biological effects of TGF-b1 in ongoing fibrogenesis. Emodin, the main active monomer isolated from Giant Knotweed Rhizome, may be an attractive therapeutic agent for the treatment of fibrotic liver diseases.
Reference:
Dong MX, Jia Y, Zhang YB, Li CC, Geng YT, Zhou L, Li XY, Liu JC, Niu YC. Emodin protects rat liver from CCl4-induced fibrogenesis via inhibition of hepatic stellate cells activation. World J Gastroenterol 2009; 15(38): 4753-4762 http://www.wjgnet.com/1007-9327/15/4753.asp
Source: Ye-Ru Wang, World Journal of Gastroenterology
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Good-news Monday: Damaged Liver, but Prodigious Heart
http://www.theprovince.com/
By Elaine O'Conno
When Karen Stacey found out she had hepatitis C, she set about helping others as she waits
Karen Stacey is waiting for a liver transplant, but she hasn't been waiting idly.
The 50-year-old Vancouver hepatitis C sufferer first found out she was infected with the virus about five years ago, and has been waiting for a transplant for more than a year as her health deteriorates.
Instead of feeling sorry for herself, the mother of two has spent her time working to raise awareness of the blood-borne disease, which is estimated to affect up to 300,000 Canadians, by promoting testing and screening, and trying to help smooth the way for liver-transplant patients through her registered charity, the Happy Liver Society.
Stacey was infected with the illness in the 1970s, while receiving a blood transfusion after a tragic stillbirth. (Blood in Canada has only been screened for the hepatitis C virus since 1990.) But the disease can take decades to develop, and it wasn't until 2004 that she found out she was a carrier. "I started feeling really rotten. I was getting really dizzy and throwing up and having a hard time remembering things," she recalled. After a year of unexplained symptoms, her doctors wanted to simply put her on anti-depressants. But, Stacey recalls, she knew it wasn't in her head. "I knew something was wrong with me and I was having incredible pain in my abdomen all the time. Then they said it was because I had a hernia but I didn't believe that either." That something was hepatitis C, a disease that primarily targets the liver, leading in some cases to cirrhosis, liver failure or liver cancer. An estimated 90,000 to 300,000 Canadians are thought to be infected with hepatitis C, although many do not know they are carriers until after they develop symptoms and get tested. According to the Canadian Liver Foundation, common symptoms of the disease include fevers, jaundice, abdominal pain, nausea and dark urine. The infection can also trigger other illnesses such as diabetes, eye and thyroid disease and non-Hodgkin's lymphoma.
Most people contract the disease through pre-1990 blood transfusions and organ transplants, through intravenous drug use with infected needles or unsterilized tattoo or body-piercing equipment.
Shortly after a blood test delivered her diagnosis, Stacey began raising awareness of the disease. She started small, with a hot-dog fundraiser in 2006 at her work at Save-on-Foods at Park and Tillford Mall in North Vancouver. She raised $1,200 that went to buy grocery gift certificates for liver patients in a local support group. She also made the rounds at local malls signing up more than 500 people as liver and organ donors — since only 17 per cent of British Columbians sign up for organ donation, even though many more say they support the practice in principle.
In 2008, she founded the Happy Liver Society to formalize her work and fundraising and, learning that there were no affordable accommodations for liver patients in the city, along the lines of the Easter Seals or Ronald McDonald houses, she founded her own. Using an award from a government tainted-blood settlement, in 2008 she purchased a condo a block from Vancouver General Hospital and named it Stacey House. She furnished it and lets it out to out-of-town liver patients staying in the city for treatments and post-operative outpatient care (which can last up to three months) after transplants, at a minimal cost of $25 a day.
"I felt like it was blood money and I didn't think I was going to make it past that year to be honest. So I decided I was going to use to the money to help other patients," Stacey said. "I believe that, when things happen, there is always a reason. So I thought this is why this happened to me, because I was supposed to help."
Port Coquitlam resident Shay Moyer, who has a close friend suffering liver disease from a hepatitis-C infection, says Stacey's determination is an inspiration to fellow patients.
"She has an inner strength, though, that keeps her going," says Moyer, a Society board member who went to school with Stacey. "Even on days when she can hardly get herself out of bed she manages to do so and when she does her day is filled with creating the next idea to raise money to keep the Stacey House running. Karen even manages to find time to visit others that are ill and bring them some of her homemade meals or simply encourage them to eat and build their strength."
Next week (Nov. 5), the Society is holding a fundraiser at the Red Robinson Theatre at the Boulevard Casino in Coquitlam, featuring an auction and a concert with classic rockers the Headpins and Prism, both B.C.-based bands. Meanwhile, as her wait for a new liver drags on and her health declines — there are almost 30 people on the waiting list ahead of her — Stacey is trying to remain optimistic.
"I honestly don't think I would be alive today if I didn't start this," she says of the Society. "It gave me purpose."
You can help Donations to the Happy Liver Society can be made at VanCity branches, account number 549-725, branch 8. For more information visit www.happyliversociety.org.
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October 27, 2009
ZymoGenetics Initiates Phase 2 Clinical Trial of PEG-Interferon lambda in Hepatitis C with Bristol-Myers Squibb
www.pharmabiz.com
ZymoGenetics, Inc. (NASDAQ: ZGEN) today announced the initiation of a Phase 2 clinical trial of PEG-Interferon lambda (IL-29) and ribavirin in treatment-naïve patients with chronic hepatitis C virus (HCV) infection (the “EMERGE” study). The first patient has been dosed in the study, triggering a $70 million milestone payment to ZymoGenetics from Bristol-Myers Squibb Company (NYSE:BMY), pursuant to the terms of a previously announced collaboration agreement.
“In the Phase 1b clinical trial, PEG-Interferon lambda demonstrated robust antiviral activity and was well tolerated in patients with genotype 1 hepatitis C,” said Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “Because PEG-Interferon lambda binds to a unique receptor, it has the potential to treat HCV without many of the treatment-limiting side effects associated with current interferons.”
The EMERGE study is an international, randomized multi-center clinical trial that will enroll approximately 50 patients in the first, open label portion that will explore a wide range of doses to be tested in the second part of the study. The second part of the study is designed to enroll approximately 500 patients. Weekly subcutaneous doses of PEG-Interferon lambda will be administered for up to 48 weeks. The study will assess the safety and antiviral efficacy of PEG-Interferon lambda compared to PEGASYS®. All patients will also receive daily ribavirin. The primary endpoint of the trial is the proportion of patients who achieve undetectable levels of HCV RNA after 12 weeks of therapy (cEVR). Sustained virological response (SVR) defined as undetectable levels of HCV 24 weeks after treatment will also be assessed.
PEG-Interferon lambda
PEG-Interferon lambda (IL-29) is a novel type 3 interferon in development for hepatitis C. The native human protein Interferon lambda is generated by the immune system in response to viral infection. In a Phase 1b clinical trial in patients with relapsed HCV, administration of PEG-Interferon lambda over four weeks in combination with ribavirin was shown to be well-tolerated and resulted in significant antiviral activity.
About ZymoGenetics
ZymoGenetics is focused on the creation of novel protein drugs to improve patient care and address unmet medical needs. The company’s strategy is to discover, develop and commercialize its products independently, in collaboration with partner companies or through out-licensing. ZymoGenetics developed and markets RECOTHROM® Thrombin, topical (Recombinant), a synthetic version of a human blood-clotting enzyme used to stop bleeding during surgery. The company is developing a proprietary portfolio of immune-based product candidates. PEG-Interferon lambda is a novel type-3 interferon in clinical development for the treatment of chronic hepatitis C infection. Interleukin-21 is a novel cytokine in clinical development for the treatment of metastatic melanoma and renal cell carcinoma. Several other proprietary product candidates are in preclinical development. In addition, ZymoGenetics has licensed rights to multiple clinical and preclinical drug candidates being developed by other companies. For further information, visit www.zymogenetics.com.
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Effects of Heroin Use Include Disease, Death
http://www.theprogressnews.com/
By Josh Woods Staff Writer
This week The Progress has partnered with Clearfield-Jefferson Heroin Task Force to help educate our readers on what we can do as a community to address heroin and other drug use in conjunction with Red Ribbon Week. Red Ribbon Week, started in 1985, is the largest, most visible prevention awareness campaign in the nation. It was started after the torture and brutal murder of Drug Enforcement Administration Agent Enrique "Kiki" Camerena during an undercover investigation of a multimillion-dollar narcotic manufacturing operation. In recognition of Red Ribbon Week, The Progress and Heroin Task Force encourage you to tune in each day to learn about heroin, its effects and consequences, community involvement and drug treatment. Today, our series provides a look at the effects of heroin and other opiates.
Heroin and other opiates can have a number of detrimental effects to the human body. Heroin use has been linked to Hepatitis C, AIDS, mental health issues, withdrawal, overdose and death.
Dr. Tuesdae Stainbrook, DuBois Regional Medical Center Infectious Disease Coordinator, said sharing heroin needles creates a great risk of passing on infectious disease.
"When I first got here six years ago I noticed there were a lot of young people here with Hepatitis C," said Dr. Stainbrook. "Most of the Hep C cases were from IV drug use ... 80-90 percent of new infections were from it."
Hepatitis C can cause liver disease, inflammation of blood vessels and sores and affect one's joints and kidneys. It can also worsen diabetes. The two most common symptoms are fatigue and right upper quadrant pain, Dr. Stainbrook said.
"The average from the time Hepatitis C is acquired until the time end stage liver disease occurs is 20 years," said Stainbrook.
Currently, with the sponsorship of Clearfield-Jefferson Drug & Alcohol Commission, free Hepatitis C screenings are offered throughout both counties. A home access test paid for through a Bureau of Drug and Alcohol state grant and Roche Pharmaceuticals determines if one has been exposed to Hepatitis C. A second screening, a PCR test or viral load test, paid for with a donation from DRMC, determines whether one has chronic Hepatitis C.
Rural Health Outreach Coordinator Dana Johnson stressed the testing is strictly confidential and if anyone has any risk factors it is important that they take advantage of the free testing. Testing sites are located throughout Clearfield and Jefferson counties. Appointments may be scheduled by contacting the Drug and Alcohol Commission at 371-9002. Johnson said those who engage in high-risk behaviors should be tested every six months.
"The sooner they are diagnosed the more successful the treatment will be," said Dr. Stainbrook. "We're trying to educate people that earlier treatment leads to a better chance of success for preventing liver disease, cirrhosis and cancer. The less fibrosis or scar tissue they have the better."
Hepatitis C is treated with two medications, regulated interferon and Ribivirin, depending on the genotype. Stainbrook said there are six genotypes of the virus and genotypes 1, 2 and 3 are the most common in the United States. Genotype 1, the most common, takes 12 months to treat. Genotypes 2 and 3 are treated in six months. The success rate of treatment depends on age, sex, the amount of liver damage and whether or not the patient is a smoker, a drinker or is coinfected.
Like Hepatitis C, sharing heroin needles can also pass on HIV and AIDS. All three are passed on through the exchange of bodily fluids. There are no vaccinations for either Hepatitis C or HIV, Stainbrook said.
"Not everyone who has Hep C has HIV and not everyone that has HIV has Hep C," said Stainbrook. "The national average is 30 percent. That's how many are coinfected. We don't see that trend here. There's just not a lot of HIV cases in this area."
Clearfield-Jefferson Mental Health/Mental Retardation Crisis Specialist Mary Brown said the negative impact of heroin on mental health is that it affects stability. She said there is no way of knowing if illicit drug use can be specifically linked to mental health issues; however, such use might cause negative long-term effects to the brain.
"Simply put, if someone already has mental health concerns taking a drug that messes with the mind is adding extra instability," said Brown.
Drug-addicted people with mental health issues are referred to the Drug and Alcohol Commission in addition to mental health counseling.
"It depends on the severity," said Brown. "For some people we recommend outpatient treatment. For others we recommend inpatient treatment."
Information provided by the National Institute on Drug Use says opiates in general can cause drowsiness/nausea, constipation, confusion, sedation, respiratory depression and arrest, addiction, unconsciousness, coma and death. Because heroin's purity is uncertain it carries an increased risk of accidental overdose. Symptoms of heroin use include slow breathing, tiny pupils and coma.
Dr. Mohamed Hassan, DuBois Regional Medical Center neonatologist and Neonatal Intensive Care Unit medical director, said heroin can also affect pregnancies.
Expectant mothers who use heroin can pass on the drug to their fetus through the umbilical cord. Dr. Hassan said once the cord is cut, babies whose mothers use heroin or methadone can experience withdrawal symptoms. A mother's heroin use can cause a baby to have neurological and gastrointestinal problems as well as heart arrhythmia. Neurological problems include excessive crying, irritability and seizures. Seizures, Hassan said, can cause brain damage.
Babies born to opiate-addicted mothers are closely monitored for withdrawal symptoms for five to seven days after birth, Hassan said. If a baby is identified as having withdrawal symptoms, NICU staff uses a scoring system every four hours to monitor its withdrawal. Babies who have withdrawal are administered a calculated dose of morphine for two to six weeks. The dosage is reduced by 10-20 percent every three or four days, he said.
Hassan said 28 babies were identified as having drug withdrawal symptoms last year at DRMC and the hospital averages one to two per month. He said hospitals typically recommend opiate-addicted mothers seek methadone treatment, because continued heroin use is extremely harmful to a fetus. Quitting heroin or other illicit drugs cold turkey might cause the mother to suffer withdrawal, which, in turn, would be detrimental to their pregnancy.
"I always tell (drug-addicted) mothers if they have visited a methadone clinic that is a good indication that they are trying to help themselves and the baby," said Hassan. "There is a misconception that Children and Youth Services is going to step in and take their baby away. That is a myth.
"I always tell the (drug-addicted) mothers we are just here to help you. There is no judgment or lack of respect. We treat you just like any other person. I believe motherhood is motherhood between anyone. Mothers should understand we are here to help."
For more information about heroin or other drugs contact Clearfield-Jefferson Drug & Alcohol Commission at 1-800-892-9002 or visit the U.S. Drug Enforcement Administration or National Institutes on Drug Abuse Web sites at http://www.dea.gov/concern/heroin.html and http://www.nida.nih.gov/.
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Hepatitis C Coinfection Doesn't Increase Risk of Progression to AIDS
www.aidsmap.com
Michael Carter
A meta-analysis of over 30 studies involving in excess of 100,000 patients with HIV has shown that hepatitis C co-infection does not increase the risk of progression to AIDS. The study is published in the November 15th edition of Clinical Infectious Diseases, and is now available online.
However, the researchers did find that in the period since effective anti-HIV treatment became available, co-infected patients still have a 35% higher risk of death compared to patients who only have HIV. The investigators believe that that “the major contributor to mortality among coinfected subjects during the HAART [highly active antiretroviral therapy] era is likely to be liver disease.”
Antiretroviral therapy means that many people with HIV can look forward to a long and healthy life. However, the predicted prognosis of individuals co-infected with HIV and hepatitis C is significantly shorter than that of patients who are infected with HIV alone..
Indeed, liver-related disease is now an important cause of death in HIV/hepatitis co-infected patients. Although there is a lot of evidence showing that HIV accelerates the course of hepatitis C disease, there is less agreement about the effect of hepatitis C on HIV disease progression.
A team of US investigators therefore conducted a meta-analysis of 37 studies published before April 2008 to see what impact hepatitis C had on HIV disease progression and overall mortality.
Ten of the studies were conducted in the era before effective antiretroviral therapy became available. There included 4413 co-infected patients and 10,213 individuals who were only infected with HIV.
These studies showed that before HIV treatment became available, co-infected patients had a modestly reduced risk of HIV disease progression compared to individuals who were HIV-monoinfected.
The investigators then looked at the studies conducted after 1996 when effective antiretroviral therapy first became available. These studies included 25,319 co-infected patients and 61,697 individuals only infected with HIV.
When combined, these studies showed that co-infected patients had a 35% increase in their of death compared to mono-infected patients (95% confidence interval [CI]: 1.11-1.63).
Co-infected patients who were older, or who were taking antiretroviral therapy had an especially elevated risk of death.
Moreover, the longer an individual was living with co-infection, then the greater was their risk of death.
However, the results of the seven studies that only assessed progression to AIDS showed that co-infected and mono-infected patients had an equal risk of this outcome.
Seven studies reported on the impact of HIV disease progression when this was defined as either diagnosis with AIDS or death. These studies showed that co-infected patients had a 49% increase in their risk of progression to these outcomes compared to mono-infected individuals (95% CI: 1.08-2.05).
“The majority contributor to mortality among coinfected subjects during the HAART (highly active antiretroviral therapy) era is likely to be liver disease”, comment the investigators. They emphasise that there was no difference in the risk of progression to AIDS.
“The meta-analysis did not demonstrate increased risks of developing AIDS-defining events among coinfected patients”, conclude the investigators. They recommend that “future studies that attempt to examine mortality among coinfected subjects should attempt to determine the relative contributions of (1) hepatitis C viremia as a surrogate marker for liver disease risk, (2) whether injecting drug use is current…, and (3) whether broader application of hepatitis C treatment positively impacts mortality in coinfected individuals.”
Reference
Chen T-Y et al. Meta-analysis: increased mortality associated with hepatitis C in HIV-infected persons is unrelated to HIV disease progression. Clin Infect Dis 49 (10): 1605-1615, 2009.
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October 28, 2009
Vertex Hepatitis C Drug Wipes Out Virus for Toughest-to-Treat Patients
http://www.xconomy.com
Luke Timmerman
Vertex Pharmaceuticals (NASDAQ: VRTX) is vying to set a new standard of care for hepatitis C in some of the toughest patients to treat, and today it is reporting some surprisingly strong evidence that suggests the drug is working like researchers hoped it would over the long haul.
The Cambridge, MA-based biotech company offered an interim peek at results from 117 patients who took its telaprevir compound after they failed to fully respond to standard therapy. Vertex looked at “null responder” patients who didn’t respond at all to prior therapy, and found that 16 out of 28 of them, or 57 percent, achieved a clinical cure after they got telaprevir in combination with another round of standard treatment. The clinical cure, known formally as sustained viral response, is achieved when the hepatitis C virus disappears from the blood for a full 24 weeks after the course of treatment.
Telaprevir had about the same effectiveness rate for patients who partially responded to an earlier round of treatment (55 percent achieved clinical cure), while that rate shot up to 90 percent for patients who initially were helped by standard therapy, but ended up relapsing later. These results were from a study known as ‘107. Comparing separate clinical trials can be a dubious exercise because of apples-to-oranges issues, but the clinical cure rates Vertex is reporting today are higher than what it announced in April at a conference of the European Association for the Study of the Liver, in a separate study that also enrolled tough-to-treat patients, called Prove 3.
Side effects from this latest batch of results were consistent with what Vertex has seen in prior studies. Eight of the 117 patients quit taking their medication because of side effects, including four who dropped out because of rash, and one who cited anemia.
For those who are new to the Vertex story, here’s a quick refresher on why this all matters. Telaprevir is aiming to be a first-of-its-kind protease inhibitor against hepatitis C, a chronic liver disease. If it can deliver in the final stage of clinical trials, it will change the standard of treatment for the disease just as an earlier generation of antivirals did for HIV infection. The market is potentially huge, because an estimated 3.2 million people in the U.S. have hepatitis C infections, and about 650,000 have failed to get better after the standard treatment.
Telaprevir must be combined with a pair of standard drugs, pegylated interferon alpha and ribavirin, which have to be taken for almost a year, and cause flu-like symptoms that make patients feel miserable. The Vertex drug is eagerly awaited by physicians and patients because it has shown in earlier trials that it can almost double the cure rate for patients when added to standard therapy, and cut the duration of therapy in half for patients who are new to treatment. If approved, the product could generate $2.6 billion in U.S. sales as soon as 2013, according to the investment firm Cowen & Company.
Vertex is running pivotal clinical trials that it hopes will clear the way for the U.S. market introduction of telaprevir in 2011, which could potentially give it the first-mover advantage against deep-pocketed competitors like Schering-Plough and Roche. But besides being first, Vertex wants to set the highest bar for therapy, by recruiting the most difficult patients to treat—the so-called null responders who didn’t see any improvement on prior therapy. If it can confirm the results from this preliminary study in an ongoing pivotal study of 650 patients, called Realize—that it can truly cure more than half of the null responders—then Vertex could have a significant advantage that it hopes will give physicians great confidence in its drug for all kinds of patients.
“It’s important to keep in mind that this was a small study, there was no control, so it has those weaknesses,” says Robert Kauffman, Vertex’s chief medical officer. “But it really does suggest to us that we are on the right track in our ongoing Phase III trial. If those results are confirmed in the Phase III trial, then this will be a real advance in treatment.”
Still, there are caveats. One of the important things that Vertex learned from this smaller study, known as ‘107, is that the tough-to-treat patients need to stay on a full 48-week long combination regimen with the interferon and ribavirin. That’s how long patients need to take the existing drugs now, Kauffman says.
This was a point of a lot of discussion within the company, because one of telaprevir’s big advantages in the so-called “naïve” patient population was that it allows patients to cut their course of therapy down to 24 weeks, meaning they don’t have to endure the flu-like symptoms for nearly as long as with the standard therapy. The pivotal study for naïve patients is still designed to test that supposed advantage, but Vertex has found that tougher-to-treat patients are better off staying on the full 48-week long regimen, and enduring all that goes with it, to achieve the clinical cure rates, Kauffman says.
“The null responders really do respond more slowly. They have to stick with the regimen longer,” he says.
This latest batch of data came out too late to be presented at this weekend’s upcoming meeting of the American Association for the Study of Liver Diseases in Boston, Kauffman says. Vertex has other data that it expects to announce in Boston from telaprevir studies, he says.
Luke Timmerman is the National Biotechnology Editor for Xconomy.
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Doctor Tied to Hepatitis Flap Loses License
http://www.nydailynews.com
BY Glenn Blain
Daily News Albany Bureau
ALBANY - After a two-year battle, state officials have yanked the license of a New York City anesthesiologist whose carelessness caused 14 people to be infected with hepatitis.
Dr. Brian Goldweber's last-ditch effort to keep his license failed this week when a state review board upheld an earlier ruling and determined he acted with "gross and repeated negligence and incompetence."
Goldweber's license was suspended in May 2007, after city and state officials suspected he was responsible for hepatitis outbreaks at two Manhattan clinics where he worked.
Officials determined Goldweber reused medicine vials and syringes that should have been used only for a single patient.
Goldweber's lawyer, Barbara Ryan, did not return a call for comment.
In arguments before state health officials, Goldweber blamed the outbreak on another doctor's reuse of forceps.
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Hepatitis C Drugs Kill the Virus...and Your Sex Drive
http://industry.bnet.com
By Trista Morrison
As the American Association for the Study of Liver Diseases (AASLD) kicks off its annual confab this week, all eyes will be on efforts to revolutionize the standard of care for hepatitis C.
Most HCV patients are treated with ribavirin and pegylated interferon, a combination that often comes under fire for its 40 percent to 50 percent cure rate and significant side effects including anemia, infections, depression and anxiety. And now, according to research published in the journal Gastroenterology, there’s another side effect to add to that list…one that may warrant a new nickname for the HCV regimen: urdixaflop.
According to the study, 38 percent to 48 percent of men reported that their sexual function was worse after a course of ribavirin and pegylated interferon. The men also saw declines in sexual desire, sexual satisfaction, erectile function and ejaculatory function. Viagra-maker Pfizer is sure to be all over this…
In all seriousness, the data are just one more reason folks are so excited about Phase III drugs like Vertex Pharmaceuticals‘ telaprevir and Schering-Plough’s boceprevir. The two are protease inhibitors that could offer a much-needed new option in HCV, which is why they take center-stage at every major medical meeting where HCV is on the agenda.
This year’s AASLD conference should be no exception, although analysts also are watching competing protease inhibitors like Schering’s SCH-900518, Boehringer Ingelheim’s BI-201335 and Tibotec’s TMC-435350.
For now, the protease inhibitors are being studied as add-ons to ribavirin and interferon, but experts are eager for ways to reduce or eliminate reliance on the standard of care. One such approach, which combined a protease inhibitor with a polymerase inhibitor, made a huge splash at another liver meeting this spring, and updated data are coming at AASLD.
Immunotherapy also may offer a way either to build on or avoid standard of care. GlobeImmune is presenting data at AASLD from a Phase II study combining its HCV vaccine with both ribavirin and interferon, while Idera Pharmaceuticals has data showing its IMO-2125 may be able to stimulate natural interferon production, making that part of the regimen unnecessary.
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Liver Removed and Re-Implanted for Cancer Treatment
www.medicalnewstoday.com
Distinguished transplant and cancer surgeon, Alan Hemming, MD, has been recruited to the University of California, School of Medicine to launch a multidisciplinary center for the treatment of advanced liver disease at the UC San Diego Medical Center and Moores UCSD Cancer Center. This innovative program is designed to offer adult and pediatric patients in the western United States a single destination for the treatment of complex liver disease, from advanced diagnostics to experimental medical therapies and novel approaches for liver resection and transplantation.
"Whether you are suffering from liver failure, or primary or secondary liver malignancy, there are new combinations of treatment that can be delivered to you at UCSD Medical Center," said Hemming, professor of surgery and Chief of Transplantation and Hepatobiliary Surgery. "If you have been told that you have untreatable liver disease, there is hope for you here. As a world-recognized academic medical center, UC San Diego has the expertise, resources and skill to take on the most difficult cases."
Known for his lifesaving surgical skills, Hemming is one of the few surgeons in the country who has treated otherwise unresectable liver cancer by temporarily removing the patient's entire liver for reconstruction. After removing and cooling the liver, Hemming performs the meticulous process of tumor removal and blood supply reconstruction. Upon completion, the tumor-free liver is "re-implanted" into the body. This novel form of resection provides the possibility of cure for patients with few other options.
Hemming has performed more than 500 liver transplants such as split, living-related, and domino procedures, including a successful liver transplant for one of the smallest recipients in the world – an infant weighing just over four pounds. A gifted surgeon, Hemming has performed more than 900 liver resections. He specializes in all aspects of hepatobiliary surgery including both open and laparoscopic liver resection for tumors, resection of the pancreas and bile duct, and portal decompressive procedures.
"The San Diego region is now home to one of the United States' leading surgeon-scientists in the field of transplantation," said Mark Talamini, MD, professor and chair of the department of surgery at UCSD Medical Center. "Bringing together an internationally recognized team of surgeons, radiologists, gastroenterologists, hepatologists, oncologists and nurses, Hemming's vision is to offer patients a customized path to treatment for every form and stage of liver disease."
Among Hemming's plans are to develop an adult living donor program for liver transplant, an expanded program for primary and metastatic liver cancer and a clinical research program to explore new technologies and their application to liver surgery. He was recently co-principle investigator in an assessment of image-guided liver surgery with Memorial Sloan Kettering Cancer Center and the University of Pittsburgh Medical Center. His plans include bringing the development of such new technologies to UCSD.
Prior to coming to UC San Diego, Hemming was the Chief of Transplantation and Hepatobiliary Surgery at the University of Florida where he developed one of the nation's fastest growing treatment centers for hepatobiliary disease. Under his leadership, the program's surgeons were able to aggressively resect and cure up to a third of patients who had been identified as unresectable by other institutions.
Hemming earned his medical degree from and completed his general surgery residency at the University of British Columbia in Vancouver, British Columbia. He completed his internship at St. Michael's Hospital in Toronto. He completed fellowship training in both hepatopancreaticobiliary surgery and liver transplantation from the University of Toronto, Toronto Hospital in Ontario.
An NIH-funded researcher, Hemming is named to both America's Top Doctors for Cancer as well as America's Top Doctors. He has authored multiple book chapters and more than 100 peer-reviewed publications in the areas of advanced liver surgery techniques, liver transplantation and the care of patients with hepatobiliary disease.
Hemming currently sits on the ethics committee of the American Society of Transplant Surgeons. He is also member of the American Surgical Association, the Southern Surgical Association, the Society of Surgical Oncology, and the American Hepatopancreaticobiliary Association.
Source: University of California
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October 29, 2009
SCYNEXIS to Present HCV Data on Novel Cyclophilin Inhibitor SCY-635 at AASLD Annual Meeting
http://www.drugs.com
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Oct 28, 2009 - Drug discovery company SCYNEXIS, Inc. today announced that supportive data from a preclinical study of the Company's lead product candidate for hepatitis C (HCV), SCY-635, will be presented in a poster session at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in Boston, MA, October 30-November 3, 2009. SCYNEXIS plans to initiate a Phase 2a combination trial of SCY-635 in patients with HCV in the second quarter of 2010. SCY-635 is a non-immunosuppressive cyclosporin analog that has demonstrated potent suppression of plasma viremia when given as monotherapy to adults with chronic hepatitis C virus infection.
Presentation at AASLD:
Tuesday, November 3, 8:00 AM – 1:00 PM ET: HCV Therapy: Preclinical and Clinical Development Session
- Abstract 1595 entitled “Antiviral Activity of the Non-Immunosuppressive Cyclophilin Inhibitor SCY-635 in Combination with Investigational and Approved Anti-HCV Agents” will be presented by SCYNEXIS. In preparation for the Phase 2a clinical trial, the in vitro antiviral activity of SCY-635 was evaluated in multiple two-drug combinations in this preclinical study. The activity of SCY-635 was investigated in combination with non-nucleoside polymerase inhibitors, nucleoside polymerase inhibitors, protease inhibitors (boceprevir, telaprevir), ribavirin and interferon alpha 2b.
About SCYNEXIS
SCYNEXIS is a premier drug discovery and development company delivering effective and innovative drug pipeline solutions to pharmaceutical and global health partners. The Company, which is located in Research Triangle Park, North Carolina, is also developing a proprietary internal pipeline based on cyclophilin inhibitors, a class of drugs that hold significant potential for the treatment of a broad range of diseases. Please visit our website at www.scynexis.com
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Women Are at Greater Risk Than Men of Graft Loss after Undergoing Liver Transplantation for Hepatitis C-Related Liver Disease
www.reuters.com
Women Are at Greater Risk Than Men of Graft Loss After Undergoing Liver Transplantation for Hepatitis C-related Liver Disease Presentation: Sunday, November 1, 2009, 8:00 am Eastern Time in Boston, MA
ALEXANDRIA, Va. and BOSTON, Oct. 29 /PRNewswire/ -- Although women with chronic hepatitis C virus (HCV) infection are at lower risk for developing cirrhosis, researchers who compared outcomes for men and women after having liver transplantation found that women have a significantly increased risk of overall graft loss and graft loss from recurrent HCV than men. "Given the higher rate of graft losses due to recurrent HCV and higher risk of developing advanced HCV, our results highlight the need for close monitoring of HCV disease progression after liver transplantation and the appropriate timing of interventions, such as HCV treatment," said Jennifer Lai, MD, lead investigator for the study.
In this study to be presented at the annual meeting of the American Association for the Study of Liver Diseases, data were analyzed from four experienced liver transplant centers in the United States, which included 850 patients who underwent liver transplantation from March 2002 through December 2007 for HCV-related liver disease. Not only were women at greater risk of graft loss from all causes and recurrent HCV, but they experienced increased rates of advanced HCV-related liver disease compared with men.
These differences were not explained by differences in baseline recipient or donor characteristics, or rates of acute rejection after transplantation. "However," said Dr. Lai, "understanding the factors contributing to this gender difference is critical to improving post-transplant outcomes for all patients with HCV."
Based on this multicenter study, further studies are needed to evaluate modifiable donor factors and post-transplant therapeutics that influence outcomes. There may be a future role for gender-specific models to optimize post-transplant outcomes in women. "Whether we should have a more intensive approach to monitoring for and management of recurrent HCV would improve outcomes in women will need to be established in future studies," said Dr. Lai.
In addition, Dr. Lai discussed future research on this topic, "We found recipient age to be a stronger predictor of outcome for women than for men, and we noted that women had higher rates of having a sex-mismatch donor liver than men. A more in depth analysis of the role of recipient-donor sex mismatch is planned. In addition, we found that women had significantly increased rates of acute rejection and although this factor did not account for differences in graft outcomes in our study, we believe sex differences in frequency of rejection and response to rejection treatment warrant further study."
Abstract title:
Hepatitis C virus (HCV) infected females are at higher risk of graft loss after liver transplantation (LT): A multicenter cohort study
SOURCE American Association for the Study of Liver Diseases (AASLD)
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House Unveils $894 Billion Healthcare Bill
www.reuters.com
By John Whitesides and Donna Smith
WASHINGTON (Reuters) - Democratic leaders in the U.S. House of Representatives released a healthcare reform bill on Thursday that includes a government-run insurance plan and imposes a tax on the wealthiest Americans to help pay for it.
Democrats said the nonpartisan Congressional Budget Office estimated that the bill would cost $894 billion over 10 years -- below President Barack Obama's target of $900 billion -- and reduce the deficit by $30 billion over the same period.
Obama welcomed the House legislation, saying it would benefit millions of small businesses.
The measure, the product of weeks of closed-door talks to merge three pending health bills in the House, will be submitted to the full House for debate as early as next week. The Senate is considering its own version of healthcare reform bill.
"The bill is fiscally sound, will not add one dime to the deficit as it expands coverage, implements key insurance reforms and promotes prevention and wellness across the health system," House Speaker Nancy Pelosi said in a ceremony to unveil the bill on the steps of the U.S. Capitol.
The proposed new government-run "public" insurance option, a flashpoint in the debate over Obama's top domestic priority, uses reimbursement rates negotiated with doctors and hospitals, a setback for House liberals led by Pelosi who wanted a stronger version to compete with insurers.
Pelosi failed to gain the 218 votes needed to pass a version of the government-run plan using lower rates pegged to Medicare, the government's health insurance program for the elderly, and could face resistance from liberals who preferred this plan.
The healthcare measure being prepared for debate in the Senate also includes a public insurance option based on negotiated reimbursement rates, but unlike the House bill it would allow states to decline to participate.
The House version of the healthcare overhaul would require individuals to buy insurance and all but the smallest employers to offer health coverage to workers.
It would offer subsidies to help uninsured people purchase insurance through newly created exchanges, and would expand eligibility for the government's Medicaid health insurance program for the poor to people with incomes up to 150 percent of the official poverty level.
The House bill includes a 5.4 percent surtax on individuals making more than $500,000 and couples earning more than $1 million, which an aide said would bring in about $460 billion over 10 years to help pay for covering the uninsured.
The bill also would eliminate the antitrust exemption for the insurance industry.
(Editing by Will Dunham)
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Celsion and Yakult Honsha Announce Treatment of First Patient in Japan in Celsion's Global Phase III ThermoDox(R) Trial for Primary Liver Cancer
www.medicalnewstoday.com
Celsion Corporation (NASDAQ: CLSN) and Yakult Honsha Co., Ltd. (Tokyo: 2267) announced today that the first patient has been enrolled and treated in Japan as part of Celsion's global Phase III ThermoDox HEAT trial for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer.
Yakult is the exclusive licensee of Celsion's ThermoDox for the Japanese territory and is responsible for funding clinical trials in Japan and obtaining regulatory and marketing approval. The clinical data from the Japanese cohort will be incorporated into Celsion's overall ThermoDox Phase III study results and is also intended to support a potential marketing approval submission by Yakult in Japan.
"Yakult's rapid start up of clinical sites and the enrollment of the first Japanese patient is a testament to their oncology expertise and strong commitment to commercialize ThermoDox in Japan," stated Michael H. Tardugno, Celsion's Chief Executive Officer. "With Yakult's recent decision for participation to the study to include Japanese sites we expect to see an acceleration of patient enrollment and the potential to significantly decrease ThermoDox's time to market in Japan should the data support registration."
"ThermoDox holds the potential to become a significant drug in our pharmaceutical portfolio and an important addition to our oncology franchise," stated Dr. Kiyoshi Terada, Head, Pharmaceutical Division/Senior Managing Director, and Member of the Board of Yakult. "Yakult's decision to invest in ThermoDox was based on the remarkable evidence of clinical activity demonstrated in early stage clinical trials. ThermoDox holds great promise for those afflicted with HCC, as currently there is no chemotherapeutic standard of care."
ThermoDox Global Phase III HCC Study
The global Phase III HCC study is evaluating the safety and efficacy of ThermoDox in combination with radiofrequency ablation (RFA) when compared to RFA alone. The trial will enroll up to six hundred patients at clinical sites in Japan, China, Malaysia, Thailand, Philippines, Hong Kong, Korea, Taiwan, Italy, the United States and Canada. By year-end 2009, Celsion expects to have up to sixty clinical sites activated and patient enrollment is expected to complete within the first half of 2010. Additional information can be found at: http://www.clinicaltrials.gov/
About Primary Liver Cancer
Primary liver cancer is a type of cancer that begins in the cells of the liver and is not typically detected early, often resulting in a poor patient prognosis. According to the National Cancer Center of Japan, primary liver cancer is the third leading cause of cancer deaths in Japan among adults and more than 40,000 people are diagnosed with the disease annually. Globally, primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States and is rapidly growing worldwide at approximately 660,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries. The standard first line treatment for liver cancer is surgical resection of the tumor, but 80% to 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.
About ThermoDox
ThermoDox in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
ThermoDox has demonstrated evidence of efficacy in a Phase I study for primary liver cancer. Celsion has been granted FDA Orphan Drug designation for the primary liver indication and the global Phase III study is being conducted under a FDA Special Protocol Assessment. For recurrent chest wall breast cancer, ThermoDox(R) is being evaluated in a pivotal Phase I/II open-label, dose-escalating trial that is designed to measure durable local complete response at the tumor site. Celsion expects to enroll approximately 100 patients in the U.S. within calendar year 2010
ThermoDox® is a registered trademark of Celsion Corporation
Source: Celsion
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NVHR Applauds New Bipartisan Legislation to Increase Awareness, Prevention of Viral Hepatitis
www.reuters.com
Landmark Legislation to Increase Public Awareness of Disease Impacting Over 5
Million Americans
WASHINGTON, Oct. 29 /PRNewswire-USNewswire/ -- Bipartisan legislation introduced today in the US House of Representatives, "The Viral Hepatitis and Liver Cancer Control Act," will increase awareness and prevention of a disease that is already afflicting over 5 million Americans - more than half of whom do not know they are infected - and will help set the stage to avoid tens of billions of dollars in unnecessary health care costs in the coming decade, the National Viral Hepatitis Roundtable (NVHR) said today.
The NVHR is a coalition of public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from viral hepatitis in the United States through strategic planning, leadership, coordination, advocacy, and research.
"We have a wave of chronic liver disease that will crash like a tsunami on the US healthcare system if we do not address this problem now," said Lorren Sandt, Chair of the National Viral Hepatitis Roundtable. "This important legislation will help identify the people who are chronically infected and get them into treatment, which can save millions in future healthcare costs."
The legislation was introduced by Congressman Mike Honda (D-CA) and Congressman Charles Dent (R-PA) and co-sponsored by Representatives William Cassidy (R-LA), Edolphus Towns (D-NY), Anh "Joseph" Cao (R-LA), David Wu (D-OR), Todd Platts (R-PA), Donna M. Christiansen (D-VI), Barbara Lee (D-CA), Bobby Rush (D-IL), George Butterfield (D-NC), and Judy Chu (D-CA).
The Viral Hepatitis and Liver Cancer Control Act would amend the Public Health Service Act to establish, promote, and support a comprehensive prevention, research, and medical management referral program for chronic hepatitis B and chronic hepatitis C virus infection. The bill would provide an initial $90 million in funding in 2011 - with additional funding thereafter - that will increase the ability of the Centers for Disease Control and Prevention (CDC) to support state health departments in their prevention, immunization and surveillance efforts.
Congressman Mike Honda, Democrat of California and Chairman of the Congressional Asian Pacific American Caucus, said, "Chronic Hepatitis B and C are silent killers, poised to strike millions of Americans and it is time for Congress to act in a concerted effort to educate particularly vulnerable communities as well as the general public. For example, due to a number of factors, Asian American & Pacific Islanders have a much higher prevalence rate of hepatitis B and develop liver cancer at a much higher rate than other ethnic groups. However, few in the AAPI community are aware of their risk factors or about how to manage or treat the disease. This bipartisan bill judiciously invests federal money in a balanced, comprehensive approach to viral hepatitis education, prevention, treatment, and management and I look forward to working to pass this legislation."
"The lack of awareness for Hepatitis B and C leads to under diagnosis," said Congressman Mike Cassidy, Republican of Louisiana, who speaks from his unique perspective as a physician who has treated patients with hepatitis B and hepatitis C. "Those infected risk liver failure, which leads to liver transplant or death. As a Hepatologist, I have witnessed first hand the consequences hepatitis can inflict on a patient's health, their families and the nation's health care budget."
The American Association for the Study of Liver Disease (AASLD), of which Congressman Cassidy is a member, strongly supports the bill. "This is a vitally important recognition of the tremendous suffering inflicted by viral hepatitis on the health of Americans, and the urgency of the fight to find better treatments for these liver diseases," said AASLD President, Dr. Scott L. Friedman. AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease.
Hepatitis B and hepatitis C are highly infectious blood-borne viruses that cause liver disease, liver cancer, and premature death. Hepatitis B and hepatitis C are the leading causes of primary liver cancer, one of the most deadly cancers, with five-year survival rates of only 10 percent. While the incidence of many cancers is declining, rates of liver cancer are increasing. Chronic hepatitis B is treatable when detected early and properly managed. In about 50 percent of the cases, chronic hepatitis C can be cured.
An estimated 2 billion people worldwide have been infected with the hepatitis B virus, of whom 400 million are infected chronically. Approximately 170 million people worldwide are infected chronically with the hepatitis C virus. An estimated 5.3 million people living in the United States are infected with either hepatitis B or hepatitis C; tragically more than half are unaware of their status.
SOURCE National Viral Hepatitis Roundtable
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October 30, 2009
Idenix Retains Rights to Hepatitis C Drug
http://www.boston.com
Associated Press
Idenix Pharmaceuticals Inc. in Cambridge says its partner, Novartis AG, will not move ahead with its option to license a potential hepatitis C drug.
The move means Idenix holds on to worldwide rights for IDX-184, the company's lead drug candidate.
"As we continue to develop IDX184, we look forward to seeking a partner that will assist us in maximizing the value of this asset," said Idenix Chairman and CEO Jean-Pierre Sommadossi in a statement late Thursday.
Analysts had expected Novartis -- a Swiss drug maker that has its global research headquarters in Cambridge -- to exercise its option to move the drug further in development, following a positive "proof-of-concept" study several months ago.
Idenix currently receives royalty payments on sales of the hepatitis B drug Tyzeka, sold overseas as Sebivo, from Novartis.
Shares of Idenix closed at $2.50 Thursday.
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HCV Drives Down Kidney Function
www.medpagetoday.com
By Charles Bankhead, Staff Writer, MedPage Today
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
SAN DIEGO -- Hepatitis C infection almost doubles the risk of chronic kidney disease and significantly increases progression to end-stage renal disease, according to data reported here.
The association remained significant regardless of whether chronic kidney disease was defined in terms of creatinine clearance, proteinuria, glomerular filtration rate (GFR), or a combination of the parameters, according to Sanjaya Satapathy, MD, of the Mayo Clinic in Rochester, Minn., and colleagues.
The disparity between patients who have HCV infection and those who don't increased with age, reaching a five-fold difference in the prevalence of chronic kidney disease in patients older than 70, Satapathy said in a presentation at the American College of Gastroenterology meeting.
"There is a higher prevalence of chronic kidney disease and proteinuria in patients with hepatitis C infection," he said. "Baseline viral load is higher in patients with chronic kidney disease and is an independent positive predictor for chronic kidney disease."
"Progression to chronic kidney disease and end-stage renal disease is more rapid in patients with HCV infection," he added. "Progression to chronic kidney disease is independent of diabetes."
"We conclude that hepatitis C is associated with the development of chronic kidney disease and poorer renal survival."
Several lines of evidence have linked HCV infection and kidney disease. HCV has been reported to cause glomerular disease, increase the risk of albuminuria, and accelerate progression of diabetic nephropathy. Additionally, HCV particles or antigens have been identified in glomeruli and tubules, said Satapathy. However, data on the association have been inconsistent.
Satapathy and his colleagues hypothesized that HCV increases the risk of chronic kidney disease and accelerates its progression.
To test the hypothesis they performed a retrospective analysis of medical records on HCV-positive patients seen between January 2003 and October 2006 in a gastroenterology clinic. Patient data were traced back to June 1, 1999 or the date of first visit.
The chart review yielded 552 patients who tested positive for anti-HCV antibodies. They were matched with a 313-patient, non-HCV, control group.
Satapathy and colleagues used two sets of criteria to define chronic kidney disease.
One definition stipulated persistence of proteinuria and/or serum creatinine >1.5 mg/dL in men or >1.3 mg/dL in women for more than three months.
The second definition conformed to the National Kidney Foundation (NKF) guidelines that include structural or functional evidence of kidney damage for three months or GFR <60mL/min/1.73 m2 for three months with or without evidence of kidney damage.
Proteinuria was defined as ≥30 mg/dL by dipstick measurement, and investigators used three months as the cutoff between intermittent and persistent proteinuria.
The HCV and control groups did not differ with respect to baseline characteristics, with the exception of a higher prevalence of HIV infection (7.6% versus 1.3%, P<0.0005) and positive history of injection drug use (23.2% versus 1.9%, P<0.0005) in the HCV group.
At baseline, 3.3% of the HCV group and 3.2% of the control group had chronic kidney disease, as defined by NKF criteria.
At follow-up, the prevalence had increased to 8.3% in the HCV-positive group compared with 4.5% of the control group (P=0.032).
Combining proteinuria with GFR resulted in a prevalence of 9.6% in the HCV group and 5.1% in the control group (P=0.019).
When chronic kidney disease was defined by serum creatinine level, 6.7% of the HCV group and 3.5% of the control group had chronic kidney disease (P=0.049).
Adding proteinuria to serum creatinine resulted in rates of 7.8% and 4.2% in the HCV and control groups, respectively (P=0.037).
Analysis of the data by age groups, showed that 1% to 2% of patients younger than 40 had chronic kidney disease in both the control and HCV groups.
With increasing age, more patients in the HCV group had chronic kidney disease compared with the control group, although none of the differences was statistically significant:
- 40 to 49, 4.6% versus 3%
- 50 to 59, 9.8% versus 5.2%
- 60 to 69, 22.7% versus 10.9% (P=0.083)
- >70, 40% versus 8.3% (P=0.054)
Rates of intermittent proteinuria were similar between the groups, but HCV patients had a significantly greater rate of persistent proteinuria (6.8% versus 2.9%, P=0.024).
HCV had a significant adverse effect on kidney survival compared with the control group, whether defined by onset of chronic kidney disease (P<0.0005) or time to end-stage renal disease (P=0.005). HCV infection had a similar adverse effect on renal survival in patients with and without diabetes.
Satapathy reported that HCV patients who developed CKD had significantly higher baseline viral loads (P=0.006).
A similar relationship was observed in a second, smaller study reported at the meeting. That study involved 19 HCV-positive patients who had a persistently elevated viral load (>1 million copies/mL) during follow-up for more than 1.5 years and 17 HCV patients who had a persistently low viral load (<10,000 copies/mL) during follow-up.
At the beginning of follow-up, patients in the two groups had similar kidney function (GFR 110 mL/min/1.73 m2 in patients with a high viral load and 96 mL/min/1.73 m2 in the patients with a low viral load), said Fadi Rzouq, MD, of the University of Washington in Seattle.
During 2.6 years of follow-up during which time none of the patients received treatment for HCV, mean GFR decreased by 27.6 mL/min/1.73 m2 in patients with a persistently elevated viral load, whereas GFR declined by <0.2 mL/min/1.73 m2 during 1.9 years of follow-up in the patients who had a persistently low viral load (P=0.003).
The results "point toward the possibility of a direct renal toxicity induced by HCV, although this conclusion needs to be confirmed by more studies," said Rzouq.
Satapathy and co-investigators reported no disclosures.
Rzouq reported no disclosures.
Primary source:
American College of Gastroenterology
Source reference:
Satapathy S, et al "Higher prevalence of chronic kidney disease and poor renal survival in patients with chronic HCV infection" ACG 2009; Abstract 57.
Additional source:
American College of Gastroenterology
Source reference:
Hatoum HH, Rzouq F "The direct impact of hepatitis C viral load on kidney function" ACG 2009; Abstract P192.
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HIV-HCV Coinfected Patients Are More Likely to Experience HCV Relapse after Completing Treatment, Usually within 12 Weeks
www.hivandhepatitis.com
By Liz Highleyman
SUMMARY: HIV-HCV coinfected patients were less likely than HCV monoinfected individuals to clear HCV by the end of interferon-based therapy and more apt to relapse after completing treament, and therefore were less likely to achieve a sustained virological response (SVR), according to a Spanish study published in the November 1, 2009 issue of Clinical Infectious Diseases.
Considerable research has shown that HIV-HCV coinfected people tend to experience faster liver disease progression and respond less well to interferon-based therapy that patients with HCV alone, but there is little data on the rate and timing of hepatitis C virus (HCV) relapse after completing treatment.
In the present retrospective study, researchers at Hospital Carlos III in Madrid, Spain looked at medical record from 604 chronic hepatitis C patients -- 386 of whom were also HIV positive -- treated with pegylated interferon plus ribavirin between 2001 and 2007.
Results
- HIV-HCV coinfected patients achieved an end-of-treatment response less often than HCV monoinfected patients (37% vs 61%, respectively).
- Coinfected patients were also more likely than monoinfected patients to experience relapse following treatment (33% vs 22%, respectively).
- Relapse occurred more often in patients with hard-to-treat HCV genotypes 1 or 4, compared with genotypes 2 or 3.
- In both HIV positive and HIV negative participants, HCV relapse, when it occurred, usually happened before week 12 post-treatment.
- 3 patients tested HCV positive after post-treatment week 12, but genetic analysis indicated that 2 of these cases likely were due to re-infection rather than relapse.
Because coinfected individuals were both less likely to respond by the end of treatment and more likely to relapse, they had a lower likelihood of SVR -- or a cure -- defined as continued undetectable HCV viral load 24 weeks after completion of therapy, the researchers concluded.
Department of Infectious Diseases, Service of Hepatology and CIBERehd, and Service of Pharmacy, Hospital Carlos III, Madrid, Spain; Laboratory of Molecular Epidemiology of Infectious Diseases, National Centre for Microbiology, Instituto de Salud Carlos III, Madrid, Spain.
Reference
J Medrano, P Barreiro, S Resino, and others. Rate and timing of hepatitis C virus relapse after a successful course of pegylated interferon plus ribavirin in HIV-infected and HIV-uninfected patients. Clinical Infectious Diseases 49(9): 1397-1401. November 1, 2009. (Abstract).
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Viewpoint: Safe injection Sites Would Clean Up Ottawa's Ugly Habit
http://centretownnewsonline.ca
By Toni Petter
Canada has always prided itself on being a leader in progressive social policy, but it’s lagging dangerously behind when it comes to managing drug addiction and it couldn’t be more obvious than in the nation’s capital.
This summer, two focus groups were run in Ottawa to determine the feasibility of establishing a safe injection site or sites, due to the recent explosion of crack use as well as the number of HIV and hepatitis C cases.
Although results aren’t expected until next year, it seems unlikely that the same city council that scrapped the crack kit program would approve a safe injection site.
It’s unfortunate, since Ottawa has some of the highest HIV and hepatitis C rates in the country. According to a 2007 city report, 76 per cent of drug users have hepatitis C and 21 per cent HIV, leading some community health scientists to call it an “epidemic.”
Safe injection sites don’t encourage drug use, as some opponents to them suggest. They’re a public health measure aimed at helping drug addicts overcome their addiction one step at a time.
In March, the World Health Organization endorsed sites like in Vancouver’s lower eastside, as means of curtailing the spread of HIV among drug users.
When Vancouver’s program called Insite opened in 2003 under a legal exemption, a condition was that a study be conducted on its impacts.
Insite was found to have had a positive effect on the community.
It emphasized that there had been a decline in the number of HIV and hepatitis C cases and the number of overdose deaths.
Although the city of Ottawa is already providing tools to inject drugs, they’re only going halfway.
In filthy alleys and crack houses there is no moderating how much a user injects or how many veins the city-distributed needle penetrates.
A safe injection site would improve the needle distribution program, by supervising how a needle is used and discarded and would bring users into contact with health services he or she wouldn’t normally have access to.
At the Vancouver site, users are connected with health care services – from care for diseases and infections, to addiction counselling and treatment on a regular basis.
In dollars and cents, the success of Insite translates to a foreseeable $14 million in savings for British Columbia’s health care system in a 10-year period, according to a study published by the Ontario HIV Treatment Network.
The Vancouver facility has not only reduced the level of disease in the community, but has also helped addicts reclaim their lives.
The worst thing you can do is force someone into treatment- it’s a recipe for relapse.
Allowing users to shoot up under supervision buys them the time to decide for themselves when they are ready to seek treatment.
In Vancouver, the treatment facilities operate in the same building as Insite. This eases the transition to recovery when the user decides the time is right.
Research conducted at Insite showed that 1 in 5 people who used the injection facilities entered a detox program.
Safe injection sites aren’t shooting galleries – they’re a lifeline. Vancouver’s program sends the message that a drug addict’s life is worth saving, and it’s a message Ottawa should echo.
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Survey Finds Hepatitic C Patients Adversely Affected by Medications
http://drugstorenews.com
By Alaric DeArment
NEW YORK (Oct. 29) Hepatitis C and the medications used to treat it have a number of adverse affects on the quality of life of patients, according to a recent survey.
According to “The Hepatitis C Survey: Bridging the Caps in HCV Understanding and Treatment” — conducted by TNS and Synovate and sponsored by Novartis and Human Genome Sciences — one area in which the disease exerts a toll on patients is in employment.
Patients in the survey described missing days at work, decrease in productivity and lost income, with 44% of patients taking time off from work and 36% experiencing reduced productivity. Nearly three-quarters of respondents said there was a social stigma associated with the disease, and 31% said they could openly discuss living with the disease with colleagues.
Meanwhile, 52% of patients treated said they were satisfied with their therapy, and 92% of physicians said certain side effects of hepatitis C therapies worsened around the time of injection.
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New Epidemic of Sexually Transmitted Hepatitis C Infection in HIV-Infected Men in NYC
www.reuters.com
Presentation: Sunday, November 1, 2009, 8:00 am Eastern Time in Boston, MA
ALEXANDRIA, Va. and BOSTON, Oct. 30 /PRNewswire/ -- Researchers in New York City are reporting their work uncovering a new epidemic of hepatitis C virus (HCV) infection among men-who-have-sex-with-men (MSM) who have HIV infection. These authors have previously reported unusually rapid fibrosis progression due to new HCV in MSM who have HIV infection and now expand on their findings, demonstrating that sexual transmission rather than injection drug use is the route of infection. Treatment is highly successful if started early in the course of infection, however, they report ominous news about liver disease progression. "This epidemic represents a new clinical syndrome for HCV infection that turns much of our knowledge on its ear: a new risk group becoming infected through a previously rare route of transmission resulting in unprecedented progression of liver fibrosis," said Daniel Fierer, MD, principal investigator on this study.
In an analysis of 21 HCV-infected patients matched with uninfected controls, unprotected receptive anal and oral sex were significantly associated with new HCV infection. Neither current nor prior injection drug use was associated with HCV infection. In addition, treatment with pegylated interferon and ribavirin, initiated within 6 months of diagnosis, was completed in 16 patients with genotype 1 HCV infection; 12 (75%) achieved sustained viral response (SVR), compared to the 15-30% SVR rate expected with chronic genotype 1 HCV infection. Of significant concern, however, 30 patients underwent liver biopsy during the early infection period and 23 (77%) already had moderate fibrosis, making early curative treatment even more important to prevent further progression of liver fibrosis.
Because of these findings, study authors recommend routine screening for acute HCV for all MSM patients with HIV, using a simple and inexpensive algorithm of ALT measurement every 3 months and HCV antibody measurement every 6 to 12 months. "Changing the perception and behavior of physicians and patients is difficult," said Dr. Fierer, "One of the main barriers to early detection is the lack of recognition by physicians and patients alike that HIV-infected MSM are at risk for HCV infection. This lack of perception of the problem results in lack of screening of HIV-infected MSM and therefore lack of timely diagnosis and treatment."
Dr. Fierer thinks the next steps in battling this epidemic are educating HIV providers about the existence of this world-wide epidemic, educating patients at risk that unprotected sex among HIV-infected men is a significant risk for HCV infection, and changing the official recommendations by the US national authorities such as the CDC, HIVMA, etc, as has already been done in Europe and more recently at the state level in New York.
Abstract title:
Characterization of an epidemic of sexually-transmitted acute hepatitis C infection in HIV-infected men in New York City
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Idenix Pharmaceuticals Presents Data on IDX184 for the Treatment of Hepatitis C Virus (HCV)
http://finance.yahoo.com
CAMBRIDGE, Mass., Oct. 30 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced presentations of data on IDX184, a once-daily novel liver-targeted nucleotide prodrug of 2'-methyl guanosine (2'MeG) for the treatment of HCV, at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) currently being held in Boston, Massachusetts.
Data from a three-day, phase I proof-of-concept study evaluating the safety and antiviral activity of IDX184 will be presented. This double-blind, placebo-controlled, monotherapy, dose-escalation study enrolled 41 treatment-naive HCV genotype 1-infected patients into four dosing cohorts (25 mg, 50 mg, 75 mg and 100 mg). IDX184 was well tolerated in this study with no serious adverse events reported and no discontinuations from the study. Patterns of adverse events (AEs) were similar between IDX184- and placebo-treated patients with the most frequent AEs being headache, diarrhea and dizziness. Mean viral load declines ranged from 0.47 log10 in the 25 mg group to 0.74 log10 in the 100 mg group after three days of treatment. In the 75 and 100 mg/day cohorts, patients receiving IDX184 experienced improvements in two key markers of liver injury (AST and ALT), with mean levels of these enzymes decreasing to within normal range. Pharmacokinetic data demonstrated that higher plasma levels of 2'MeG were associated with greater reductions in viral load and ALT levels.
"With favorable safety data and good antiviral activity for IDX184 in HCV patients, these early results are encouraging," said Dr. Jacob Lalezari, principal investigator in the study, Director of Quest Clinical Research and an Assistant Clinical Professor of Medicine at UCSF/Mount Zion Hospital. "Nucleotides may become an essential component of future STAT-C combinations for the treatment of hepatitis C. IDX184 has shown a promising early profile and should be evaluated in longer-term, combination trials."
Results will also be presented from in vitro studies evaluating the combination of IDX184 with other direct-acting antivirals or standard-of-care agents, interferon and ribavirin. These in vitro studies suggest that when IDX184 is combined with compounds from different classes, the antiviral activity may be enhanced, and in some combinations, synergistic. Specifically, the triple combination of IDX184, interferon and ribavirin showed strong synergy in vitro. These in vitro studies also suggest that the combination of IDX184 with other compounds from different classes may suppress the emergence of resistance.
"The in vitro combination data for IDX184 are promising," said David Standring, executive vice president of biology for Idenix. "We look forward to assessing this potential synergy in the next clinical study evaluating IDX184 in combination with pegylated interferon and ribavirin in HCV genotype 1-infected patients."
About IDX184
IDX184 is a novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of infections caused by hepatitis C virus. For further information about Idenix, please refer to www.idenix.com.
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Hepatitis B Does Not Increase Risk for Pancreatic Cancer
http://www.eurekalert.org
DETROIT – A Henry Ford Hospital study found that hepatitis B does not increase the risk for pancreatic cancer – and that only age is a contributing factor.
The results contradict a previous study in 2008 that suggested a link between pancreatic cancer and previous hepatitis B infection. Hepatitis B is an inflammation of the liver caused by a viral infection.
Study results will be presented at the American Association for the Study of Liver Diseases' Annual Meeting in Boston.
Using data from Henry Ford Health System, physicians looked at more than 74,000 patients who were tested for hepatitis B between 1995 and 2008. In the overall analysis, only age was found to be a significant predictor for pancreatic cancer.
"We looked at the incidence of pancreatic cancer among hepatitis B-infected patients over a 13-year period and found that we could not confirm a higher risk for those with a previous exposure to hepatitis B, as a prior study suggested," says Jeffrey Tang, M.D., gastroenterologist at Henry Ford Hospital and lead author of the study.
"When other factors are considered – such as age, race, sex, HIV status, and the presence of diabetes – only older age and presence of diabetes proved significant, whereas prior exposure to hepatitis B was no longer an important variable."
According to the National Cancer Institute, more than 35,000 people in the U.S. die of pancreatic cancer each year and 42,000 new cases are diagnosed. The survival rates for patients with pancreatic cancer are poor.
An estimated 800,000 to 1.4 million people have chronic hepatitis B infection, according to the Centers for Disease Control and Prevention. In 2007, an estimated 43,000 people in the United States were newly infected with hepatitis B, although many cases are not reported because many people do not have symptoms.
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Brown & Toland Supports Fight against Hepatitis B
http://www.earthtimes.org
SAN FRANCISCO, Oct. 30 /PRNewswire/ -- House speaker Nancy Pelosi is scheduled to speak about Hepatitis B on Saturday, joining Brown & Toland and a growing coalition of community groups and healthcare partners that are raising awareness about this silent epidemic.
Hepatitis B can cause liver cancer and damage, or if untreated, death. The San Francisco Hep B Free campaign, of which Brown & Toland is a part, promotes hepatitis B screening, vaccination and treatment among Asian American and Pacific Islanders (API) who are disproportionately infected. One in 10 has the virus.
"Hepatitis B is a serious but preventable disease. We at Brown & Toland are working hard to educate more people about this lesser known virus," said John Fisher, chair of the Hep B Free Marketing Committee and Brown & Toland marketing manager.
State Assemblywoman Fiona Ma and San Francisco Mayor Gavin Newsom serve as co-chairs of the initiative. The campaign is raising awareness in San Francisco but has proven instrumental in changing national hepatitis B healthcare policy as well: As a result of Hep B Free's work, the CDC updated its guidelines on screening and prevention.
Brown & Toland Physicians recently earned an award for its work with the initiative. Working with Asian community organizations, political leaders and health partners (including California Pacific Medical Center, the Asian Liver Center at Stanford University and the San Francisco Department of Public Health), Brown & Toland helped coordinate the super hero-themed advertising campaign that highlights the importance of prevention and treatment.
About Brown & Toland
Brown & Toland Physicians has 1,500 doctors caring for close to 160,000 HMO patients and 120,000 PPO patients. Brown & Toland receives numerous awards for its medical excellence and preventative health care services. For more about Brown & Toland, visit www.brownandtoland.com.
SOURCE Brown & Toland
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Extending Treatment after Liver Transplant May Benefit Patients with Hepatitis C Recurrence
http://www.eurekalert.org
DETROIT – Extending hepatitis C treatment for liver transplant patients beyond current practice results in high rates of clearance of the hepatitis C virus from the blood, as well as a low rate of relapse, according to a Henry Ford Hospital study.
"We found that patients who achieved a sustained virological response were more likely to have had extended treatment," says Kimberly Brown, M.D., Division head of Gastroenterology at Henry Ford Hospital and senior author of the study.
"In addition, prolonging treatment for 52 weeks after patients were virus negative, resulted in a relapse rate of only 8 percent." This is in contrast to typical relapse rates of 30-35 percent in non transplant patients treated with standard therapy.
Study results will be presented during an oral presentation Oct. 31 at the American Association for the Study of Liver Diseases' Annual Meeting in Boston.
The study looked at 241 consecutive liver transplant patients from 1999-2006. Patients were offered treatment if they tested positive hepatitis C, had recurrent hepatitis C with at least Stage I fibrosis on biopsy, and stable immunosuppression for a minimum of three months. Patients received either non-pegylated interferon tiw or pegylated interferon weekly in combination with ribavirin.
Of the study patients with hepatitis C, 66 were eligible for treatment, and 22 achieved sustained virological response. Only two patients (8 percent) relapsed.
After week 24 of treatment, 35 percent of patients who achieved a sustained virologic response became virus negative.
"These results call into question previous studies which suggested 'stop rules' at weeks 12 and 24 when there is no response to inferferon and ribravirin," says Dr. Brown. "Our results suggest that even if patients are positive at week 24, there is still a 35 percent chance that they can achieve sustained viral clearance. We think this may be beneficial to extend treatment beyond the standard 48 weeks total."
According to the U.S. Department of Health & Human Services, more than 16,000 liver transplants were performed last year and there are currently almost 18,000 Americans on the liver transplant list.
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For Adult-to-Adult Living Donor Liver Transplantation, Left Side Grafting Is Procedure of Choice
www.medicalnewstoday.com
A recent study by doctors at Shinshu University, School of Medicine, in Japan determined that left side grafting has lower risk to donors compared to grafts taken from the right lobe, and it appears to be the procedure of choice for adult-to-adult living donor liver transplantation (LDLT). Researchers also found that graft size was not the only cause behind "small-for-size graft syndrome," a severe complication resulting in organ malfunction and transplant failure. These findings appear in the November issue of Liver Transplantation, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.
In the current study, Toshihiko Ikegami, M.D. and colleagues report on the outcomes of the 120 adult LDLTs they performed through October 2007. Patients were divided into two groups: group S consisted of 33 patients who received liver grafts < 35% of their standard liver volume (SLV), and group L consisted of 87 patients who received liver grafts ≥35% of their SLV.
Results show the 1- and 5-year survival rates in group S were 80.7% and 64.2% respectively; and in group L 90.8% and 84.9%, with no significant difference between groups. Between 1 and 5 years after LDLT, 7 patients died with causes of death including cerebral infarction, recurrence of liver cancer, uterine cancer, and sepsis. "These deaths occurred in patients with good liver function who had resumed their normal lives," commented Dr. Ikegami. "The causes of death were not related to insufficient graft size."
Past studies have recommended a graft volume to recipient standard liver volume (GV/SLV) ratio of >40% and a graft-to-recipient weight ratio (GRWR) of ≥ 0.8% to achieve good graft and recipient survival rates. In the current study patients in group S had a good survival rate, despite a GV/SLV ratio below 35% and a GRWR not exceeding 0.8%. Dr. Ikegami points out, "Our research shows small graft size does not appear to be the only cause of small-for-size graft syndrome. The prognosis of recipients with liver grafts < 35% of their SLV is comparable to that of recipients with larger grafts."
According to the U.S. Department of Health and Human Services, 3,549 deceased donor and 249 LDLTs (5%) were performed in 2008. In Japan, 99% of all liver transplantations use living donors. The authors speculate that the lower percentage of LDLTs in the U.S. could be attributed to a highly publicized donor death in 2002 and that it is conceivable that the next donor death in Japan could lead to a similar resistance in that country. "We feel that left side grafts should be used more frequently in adult-to-adult LDLT, considering the lower risk to donors compared to right lobe grafts," recommended Dr. Ikegami.
Currently, the United Network for Organ Sharing (UNOS), an organization that facilitates all organ transplants in the U.S., indicates there are close to 16,000 patients on the waiting list to receive a liver. "As the world faces an incredible growth of patients requiring life-saving liver transplantation to treat their end stage liver disease, the need for LDLT will continue due to a lack of adequate alternative sources," said David Mulligan, M.D., from the Mayo Clinic Hospital in his editorial also published in the November issue of Liver Transplantation. "I believe we (liver transplant surgeons) should share techniques and learn new strategies as Dr. Ikegami's team reported, employing them in a balanced practice to achieve optimal results for recipients and donors so that both right and left liver grafts may be effectively transplanted in the appropriate clinical situations," added Dr. Mulligan.
Article:
"Prognosis of Adult Patients Transplanted with Liver Grafts <35% of Their Standard Liver Volume," Toshihiko Ikegami, Yuichi Masuda, Yasunari Ohno, Atsuyoshi Mita, Akira Kobayashi, Koichi Urata, Yuichi Nakazawa, Shirou Miwa, Yasuhiko Hashikura, Shinichi Miyagawa. Liver Transplantation; Published Online: October 29, 2009 (DOI: 10.1002/lt.21716); Print Issue Date: November 2009.
Editorial:
"Living Donor Liver Transplantation and Donor Graft Size: How small can we go to reduce risk to the donor and at what cost to the recipient?" David Mulligan. Liver Transplantation; Published Online: October 29, 2009 (DOI: 10.1002/lt.21922); Print Issue Date: November 2009
Source: Dawn Peters, Wiley-Blackwell
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