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Week Ending: August 18th , 2007
Alan Franciscus
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August 11th, 2007
Province blamed for Vegreville hospital woes
http://www.edmontonsun.com
By BROOKES MERRITT, SUN MEDIA
The East Central Health authority's last man standing says the province - not the rural health authority - is ultimately to blame for health care cock-ups in Vegreville that saw thousands of patients potentially exposed to HIV and hepatitis B and C.
John Hunter, the only one of ECH's 12-member board who didn't resign after Health Minister Dave Hancock placed the region under direct government control, said so in a letter addressed to media and rural politicians yesterday.
Writing on behalf of the entire former board, Hunter urges the government to more clearly define the authority of health authorities over faith-based institutions that help run health-care facilities.
In the Vegreville case, where St. Joseph's hospital was found to have been ignoring sterilization standards, Hunter suggested a power struggle between the ECA and the faith-based service provider contributed to a break-down in services.
"The view of the (faith-based) group was that the health authority was a funding organization that should keep its nose out of day-to-day operations of the hospital," Hunter told Sun Media.
"The health authority has practices and procedures relating to (issues such as sterilization). The difficulty in enforcing them is that we were not welcome by the other institution. It was difficult for us to monitor what was going on."
Hunter's letter demands the government clarify the roles and responsibilities of health authorities outlined in its current agreement with faith-based organizations.
"They should still have input on ethical matters. But regional health authorities should have clear authority over the provision of all health services," he said.
"In our region, apart from consulting on ethical matters, I personally believe (faith-based groups) have outlived their usefulness in modern hospitals."
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Tests urged for tattoo shop clients
http://cnews.canoe.ca
By IAN ROBERTSON, SUN MEDIA
The Toronto Sun
'Low' risk of infection, health inspector says as parlour reopens
OSHAWA -- While customers are being urged to get tested for hepatitis B, C and HIV, a tattoo and body-piercing parlour has reopened one week after health inspectors closed it down for failing sterilization tests.
Up to 2,000 clients of who went to Long Horn Custom Bodyart studio between Nov. 17 to Aug. 1 will get letters from Durham Region's health department urging them to get blood tests.
The official whose staff shut the almost 16-year-old business before its autoclave sterilizing equipment passed new tests for residual spores, stressed "we have no evidence of transmission of infectious diseases, but because of the potential use of non-sterile equipment, there is a risk -- which we believe to be relatively low."
In an interview, environmental health manager Ross MacEachern said the most likely of the deadly trio to have survived 128C steamtreatments -- which should be at 132C -- is Hep B.
Owners of establishments that do piercings, including hair salons and jewelry stores, are supposed to notify his department if a monthly spore strip sample fails a private laboratory's test.
But MacEachern said the province lacks regulations or penalties for those who fail to report.
The health ministry is reviewing a 1998 protocol for tattooing and body piercing.
Long Horn has a good reputation, MacEachern said, but Durham's first-ever close-down order under the Health Protection and Promotion Act was made when records showed "it hasn't been one failure ... it's been on and off."
This only surfaced with staff doing routine inspections, which he said are made once a year, sometimes twice.
One of the conditions for reopening the shop is the department's requirement for owner Hugh Towie to notify staff of a future test failure, MacEachern said.
"We've been contacted by many, many customers, which are up in arms and ... are terrified," the tattooed owner said outside his studio.
"After I talked to them briefly about our procedures and what we've been going, it puts them a bit at ease, but at the end of our conversations, I do tell them go see a doctor," Towie said.
Stressing the importance of getting his reputation back, he also wants people to be aware "there's been a new protocol put in place."
Only new sterilized one-use needles have ever been used, Towie said. "What we do sterilize is tubes and tools." Despite best efforts, he said, "there is still the risk of the four degrees in temperature" from Nov. 17 to Aug. 1.
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August 13th, 2007
Growing health concerns prompt county to target tattoo parlors for regulation
http://www.macombdaily.com
By Jameson Cook
Macomb Daily Staff Writer
Ordinance in development as chain shop sued for Hepatitis C infection
Macomb County officials are in the early stages of drafting a law to regulate tattoo parlors to protect people from contracting an infectious disease.
The measure comes in response to growing worry about contaminated tattoo instruments causing infectious blood diseases such as Hepatitis B, Hepatitis C and HIV, said county Health Department officials.
"There's a concern not just in Macomb County but statewide that there are health issues," said Gary White, director of environmental health.
Dr. Kevin Lokar of the county health department said the primary concern is the body artists' tools.
"The ordinance will focus primarily on the appropriate disinfection of instruments, and encourage the use of disposable instruments when possible," Lokar said.
Health officials, however, say they haven't had an increase in complaints about people in Macomb County being infected at tattoo parlors, although there are concerns about budding tattoo artists working out of their home or in makeshift shops.
Established shops use disposable needles and take other precautions to guard against potential health concerns.
Unhealthy accusations
Even a well-established parlor isn't immune from accusations.
Inkslingers Tattooing on Van Dyke in Center Line and its owner were recently sued in Macomb County Circuit Court by a Redford woman who claims she contracted Hepatitis C from unsanitary conditions, either from a needle that was not sterile or transfer of blood, in September 2004.
Barbara Clayborn and her husband, Ledon, accuse Inkslingers of exposing her to the disease, which can cause serious problems and death. Owner John Motyka and the several Inkslingers shops in Macomb County also were named.
"It (Hepatitis) shortens your life expectancy," said Clayborn's attorney, Howard Victor.
Hepatitis C attacks the liver and can lead to cirrhosis and liver cancer. Symptoms include jaundice, fatigue, dark urine, abdominal pain, nausea and loss of appetite, according to the Centers for Disease Control and Prevention.
Risk factors are injection drug use, blood transfusions performed before a certain time, acupuncture and electrolysis.
Clayborn, 39, is being treated for symptoms by a doctor, Victor said.
Inkslingers has such a good reputation that celebrities like Kid Rock, Britney Spears and members of the Dixie Chicks have been tattooed at Inkslingers in metropolitan Detroit.
Motyka said he has not been served with the lawsuit and said he would not comment until after reading it.
Victor said there is no other reason to explain Clayborn's exposure to the disease. She was last tested in June 2004 before she tested positive in June 2005, Victor said.
"She didn't have any other tattoos or exposure to blood or have sex with someone with Hepatitis C," he said.
She went to the tattoo parlor to alter a "Betty Boop" figure on her shoulder, said Victor. The artist was a male and she couldn't recall his name. But she was led to believe that he was a "traveling artist," not a regular artist at the shop.
She was tested in 2005 after "having complaints of fever, fatigue and pain on her right side," Victor said.
Victor said the case shows the potentially risky nature of tattoos.
"A lot of kids go into tattoo parlors after a couple of drinks or on a whim, and a lot of them don't realize the side effects," Victor said.
Risk undetermined
Tattooing remains a popular form of body art. A 2006 survey by the Pew Research Center showed that 40 percent of those aged 26 to 40 had at least one tattoo and 36 percent of those aged 18 to 25 had one or more tattoos.
Scientific studies about whether tattooing increases the risk for Hepatitis C appear inconclusive.
The CDC says: "Although some studies have found an association between tattooing and (Hepatitis C) infection in very selected populations, it is not known if these results can be generalized to the whole population."
The CDC says less than 1 percent of people who reported to the CDC's "sentinel surveillance system" provided a history of being tattooed.
However, a study of 626 patients (for an unrelated health issue) from the early 1990s that was released in 2003 found that more than 20 percent of the more than 100 people who had a tattoo tested positive for Hepatitis C. Thirty-three percent of those patients had acquired their tattoos in a commercial tattoo parlor, according to the study at the University of Texas Southwestern Medical Center.
Only 3.5 percent of patients with no tattoos had Hepatitis C, according to the study.
The study, however, also concluded that those who contracted Hepatitis C suffered less-severe symptoms than those who injected drugs, and suffered no more symptoms than those with tattoos who did not test positive. Dr. Robert Haley, lead author of the study, attributed that to tattoo needles carrying a "smaller viral load" and not injecting directly into the blood stream.
Dr. Lokar of the county health department said that his office has not seen an increase in reports of dirty tattoo parlors. He said his department only "occasionally" receives inquiries from people asking about the health risks of tattooing.
Regulations on horizon
In drafting the ordinance, county officials are expected to seek input from those in the tattoo industry. A committee consisting of industry representatives, building department officials, health officials and others will review the ordinance.
White said he expects the ordinance to go before the county commissioners late this year or early next year.
Lokar said he expects established tattoo shops to favor the regulations to prevent shops that charge a lower price for poorer quality work. Officials estimate there are about 30 shops in the county.
Christina Richey, owner of Excalibur Tattoos and Body Piercing on Harper Avenue in Clinton Township, said she supports an ordinance to regulate tattoo parlors to help reduce temporary operations that may use inexperienced artists.
"We get so many people in here who get their tattoo at one of these little shops, and we've got to fix them," Richey said. "A good tattoo ain't cheap."
Richey said her shop uses disposable needles and has the ink tubes regularly sterilized and checked monthly by an outside entity.
The ordinance will require parlors to obtain an annual license or permit for a fee and pass inspections. The fee has not yet been determined. White said he did not know whether the fee revenues will support the number of inspectors required.
Lokar said he believes well-run, clean tattoo parlors will look favorably on an ordinance to help weed out unsanitary shops.
The ordinance will be modeled after those passed in a handful of communities in Michigan, such as Ingham County, Lokar said.
The last countywide ordinance passed in Macomb was in 2002 when the board adopted legislation requiring sewer disposal and water supply systems to be inspected upon the sale of property.
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New treatment for chronic hepatitis C leads to less side effects: study
http://english.people.com.cn
A study result made public Monday by the Chinese University of Hong Kong reveals that combination of interferon beta-1a and ribavirin treatment for chronic hepatitis C creates less side effects.
Chronic hepatitis C is an important cause of liver cirrhosis and liver cancer. Currently, the standard treatment of chronic hepatitis C is combination of peginterferon-alfa and ribavirin, which, however, leads to common adverse effects including fever and flu-like symptoms, injection site reaction, depression and bone marrow suppression. This decreases patients' compliance and in turn reduces the treatment effect, the university said.
The university hence carried out a three-year study to assess the use of interferon beta-1a and its combination with ribavirin in the treatment of Asian chronic hepatitis C patients.
About 250 Asian chronic hepatitis C patients with active disease were recruited and randomly assigned into two groups which received placebo treatment and interferon beta-1a plus ribavirin combination treatment respectively for 12 weeks, it said.
The result shows that interferon beta-1a and ribavirin combination treatment can achieve a similar rate of viral clearance but a low rate of adverse event and patient discontinuation as compared to the existing peginterferon-alfa based treatment.
The university recommended that interferon-beta-1 and ribavirin combination treatment be considered as an alternative to the existing peginterferon-alfa based therapy for Asian patients with chronic hepatitis C infection.
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Australia Bans Novartis's Prexige on Liver Worries
http://www.therapeuticsdaily.com
Reuters Health
By Douwe Miedema
ZURICH (Reuters) - Australia's drugs regulator banned the use of Novartis's Prexige because of liver problems in patients using the painkiller, the watchdog said, including two deaths and two liver transplants.
The country's Therapeutic Goods Administration (TGA) had received eight reports of serious liver side effects associated with the use of the drug, also known as Lumiracoxib, which was approved for use in Australia in July 2004.
"It seems that the longer people are on the medicine, the greater the chance of liver injury. The TGA is, therefore, advising people to stop taking the Lumiracoxib immediately," the TGA said in a statement on Saturday.
Novartis would comply with the authorities, a spokesman said, but it continued to believe the drug had a positive benefit/risk profile in the treatment of patients with osteoarthritis and acute pain.
Prexige, which had modest sales of $52 million in the first half of the year, is approved in more than 50 countries, and is currently being rolled out in Europe.
There were no plans to pull the drug elsewhere, the spokesman said, and the company would also proceed to file the drug for marketing approval in the United States.
Liver failure was a rare, but known, side-effect of all drugs of the type that Prexige belongs to, so-called COX-2 inhibitors, as well as of other non-steroidal anti-inflammatory drugs (NSAIDs), the spokesman said.
COX-2s have been under a cloud since Merck & Co. Inc withdrew Vioxx in 2004 after studies found it raised the risk of heart attack. There have also been worries about other NSAIDs.
Prexige had initially been seen as a blockbuster seller for Novartis, but analysts' expectations collapsed following the Vioxx withdrawal, and there were doubts whether Prexige would ever win U.S. approval.
Novartis has been plagued by a number of drug setbacks this year, delaying the launch of its diabetes drug Galvus because of safety concerns, and also evaluating the launch of a generic version of its Lotrel blood pressure treatment.
The group also cut its 2007 guidance after it withdrew bowel drug Zelnorm from U.S. shelves in March.
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August 14th, 2007
Researchers from Chiang Mai University, Department of Pediatrics report recent findings in hepatitic B vaccines
http://www.therapeuticsdaily.com
Virus Weekly - Aug. 14, 2007
Investigators publish new data in the report "Antibody response to hepatitis B re-vaccination in HIV-infected children with immune recovery on highly active antiretroviral therapy." According to a study from Chiang Mai, Thailand, "Despite a history of hepatitis B virus (HBV) vaccination prior to highly active antiretroviral therapy (HAART), most of HIV-infected children do not have protective antibody to HBV infection. The efficacy of an additional booster dose in children with immune recovery on HAART remains unknown."
"This study was conducted to determine the response rate of HBV antibody after re-vaccination in HIV-infected children with immune recovery on HAART. Sixty-three successfully HAART-treated HIV-infected children with history of prior HBV vaccination received 10microg doses of recombinant HBV vaccine (Government Pharmaceutical Organization-Merieux Biological Product, Bangkok, Thailand) intramuscularly at 0, 2 and 6 months. The vaccine response rates were 17.4, 82.5, and 92.1% at 2, 6 and 7 months after the first dose of vaccine, respectively. Plasma HIV RNA level below the limit of detection at the time of re-vaccination was associated with successful vaccine response," wrote M. Lao-araya and colleagues, Chiang Mai University, Department of Pediatrics.
The researchers concluded: "HIV-infected children with immune recovery after HAART are likely to benefit from three-dose HBV re-vaccination."
Lao-araya and colleagues published their study in Vaccine (Antibody response to hepatitis B re-vaccination in HIV-infected children with immune recovery on highly active antiretroviral therapy. Vaccine, 2007;25(29):5324-9).
For more information, contact M. Lao-araya, Faculty of Medicine, Dept. of Pediatrics, Chiang Mai University, Chiang Mai, Thailand.
Publisher contact information for the journal Vaccine is: Elsevier Science Ltd., the Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, Oxon, England.
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USV Identifies Hepatitis C Vaccine Candidate
http://www.therapeuticsdaily.com
Business Line
August 14, 2007 Mumbai, Aug.13 - With work under way on a typhoid vaccine, biopharmaceutical company USV Ltd has identified a prospective Hepatitis C vaccine candidate in its efforts to strengthen its innovative pipeline
There is no Hepatitis C vaccine at present and the prospective vaccine candidate would target the Indian type of the disease, said Mr Prashant Tewari, Managing Director
He expects to commence testing on small animals later this year
The vaccine candidate emerged from internal research, he said, unlike the typhoid vaccine that USV is developing with support from the Department of Biotechnology (DBT)
USV's Rs 670-crore business comprises generic and innovative products and the next few years are expected to see increased activity in both segments
The company expects to clock a turnover of Rs 760 crore for the current fiscal
Typhoid vaccine Last year, USV entered into a licence agreement with Biotech Consortium India Ltd (BCIL), under the aegis of the DBT, for a typhoid vaccine
The first stage of the technology transfer was completed recently, he said
More toxicity tests will be conducted on animals and the typhoid vaccine is set to go into the first phase of trials on humans in late 2008, he added
Developing a vaccine is as time-consuming as developing a chemical medicine
The final product is still several years away, he added
On the company's strategy to develop and commercialise the product, he said: "We will take that call as we go along." However, he added, local companies usually developed a product till Phase II or early proof-of-concept stage, where the product has been tested on about 500 people with the illness
Subsequently, Indian drug companies have been following a strategy where they out-licence the product to a drug company with deep pockets, which can develop the product to its final stage and eventually market it
The company recently operationalised its research centre in Mumbai, with about 200 scientists
It is also awaiting local regulatory approvals to commence human trials on two of its recombinant DNA proteins ' Neseritide and human growth hormone, he said
Generic growth USV expects to see increased activity from its operations in the US, through Indicus Pharma LLC
USV owns about 90 per cent equity in Indicus
The company has a mixed bag of 25 generic products that it is working on, said Mr Tewari
Marketing alliances have been forged with two generic companies to market six products in the US
The products range across therapeutic categories, from acne to diabetes to liver disorder, and involve complex products that are difficult to make, he said, without giving details
The six products will hit the market in the third and fourth quarters of 2008-09 and revenue will flow from these deals in 2009-10, he said
Other products in this kitty are expected to hit the US market over three years
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Immunization: Tracking the Response to Hepatitis B Vaccine
http://www.nytimes.com
By NICHOLAS BAKALAR
A series of hepatitis B vaccinations is a routine part of a child’s vaccination schedule, but no one knows how long immunity lasts among children born to healthy mothers. So researchers decided to measure immunity indirectly by testing the response to a booster shot in 378 healthy children and adolescents who had received hepatitis B vaccinations in infancy.
Over all, 99 percent of the children ages 5 to 7 and 83 percent of those ages 10 to 15 who received a recombinant hepatitis B vaccine responded to the booster, meaning that they showed continuing immunity. Among adolescents who had received a plasma-derived vaccine, 69 percent had an antibody response to the new shot. The older the children were, the more likely their immunity was waning: 97 percent of 5-year-olds had an antibody response, compared with 60 percent of 14-year-olds.
The scientists, writing in the August issue of Pediatrics, said the findings did not mean that children were widely becoming susceptible to hepatitis B infection.
“Newer hepatitis B vaccines with higher doses are given to children today,” said Dr. Anthony E. Fiore, a co-author of the study and researcher at the Centers for Disease Control and Prevention. “There are very low rates of hepatitis B right now among adults and children compared to the 1980s, an indication that the vaccine program continues to work. But we’re continuing to study this to make sure that we don’t see any increase in infection in people who were vaccinated as young children.”
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Features Of Replication Suggest Viruses Have Common Themes, Vulnerabilities
http://www.sciencedaily.com
Science Daily — A study of the reproductive apparatus of a model virus is bolstering the idea that broad classes of viruses - including those that cause important human diseases such as AIDS, SARS and hepatitis C - have features in common that could eventually make them vulnerable to broad-spectrum antiviral agents.
In a study published August 14 in Public Library of Science Biology, a team of researchers from the Howard Hughes Medical Institute (HHMI) at the University of Wisconsin-Madison describes in fine detail how an RNA virus known as flock house virus co-opts a cell's membranes to create an intracellular lair where it can safely replicate its genes.
The results provide strong evidence that at least some of the machinery four of the seven distinct classes of known viruses use to reproduce have common attributes. Such a discovery is important because it reveals a common viral theme that may be vulnerable to disruption and could lead to the development of drugs to treat many different kinds of viral infections, much like antibiotics are used to attack different kinds of bacterial pathogens.
"It turns out that viruses previously thought of as distinct share common features," says Paul Ahlquist, an HHMI investigator and virologist at UW-Madison. "We've found some features of replication that appear to cross over among many viruses."
Using powerful electron microscopy techniques, Ahlquist's group and their collaborators made the first three-dimensional maps of a viral replication complex using flock house virus, which, like all viruses, requires a host cell to make new genetic material and maintain the chain of infection.
In the case of flock house virus, the Wisconsin group found, the virus co-opts intracellular membranes of mitochondria, critical energy-regulating structures found in most eukaryotic cells.
Squeezing into the space between the inner and outer membrane of the double-lined mitochondria, the virus creates tens of thousands of protein-lined, balloon-like pockets where it can make new copies of the viral genome while safe from surveillance and defense mechanisms of the host.
" The virus has developed a very elegant strategy," says Ahlquist. "It creates for itself a new compartment for RNA synthesis, where it can collect its (constituent) components, organize successive steps of replication, and sequester these steps from other processes in the cell, most importantly, host defense responses."
In essence, the virus is reorganizing the cell to make a new intracellular architecture for its own purposes, according to Ahlquist. "The virus is reorganizing the cell to make a new organelle. It is a way to keep out competing processes and alarm-ringers and have a place where it can carry out its processes efficiently and for long periods of time."
The balloon-like sacs or spherules observed by Ahlquist and his colleagues all had narrow necks that transcended the membrane of the organelle to the cytoplasm, the medium inside the cell and in which the organelle is suspended. The neck is a gateway that appears to permit substrates needed for replication to enter and newly made viral genomes to exit.
The virus begins to co-opt the cell as a critical viral protein and viral RNA localize to the budding organelles, Ahlquist explains. "The virus takes over most of the available membrane. The protein creates a shell inside the spherule" to provide stability, and it is this use of a protein shell in replicating viral genes, the Wisconsin virologist suggests, that could be one of several common themes among different groups of viruses.
"Multiple features in the structure and function of these replication compartments appear similar across several virus classes," says Ahlquist. "This includes ways in which cell membranes are used to organize virus replication."
The shared features extend to most RNA viruses and a group known as reverse transcribing viruses, which include retroviruses such as HIV, suggesting a possible evolutionary link from a common ancestor.
The new work was made possible by the use of electron microscope tomography, a technique that can provide detailed cross sections and composite three-dimensional images of structures within the cell. The imaging was conducted at the National Center for Microscopy and Imaging Research at the University of California San Diego by UW-Madison graduate student Benjamin G. Kopek, in collaboration with Guy Perkins and Mark H. Ellisman of UC-San Diego. David J. Miller of the University of Michigan is also a co-author of the paper.
Note: This story has been adapted from a news release issued by University of Wisconsin-Madison.
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Liver Cancer Deaths on the Rise
http://www.dentalplans.com
Related video: A Liver.. and a Life: A Transplant Recipient's Story
Recent news has highlighted the decline in cancer deaths in the United States, and while it is good news that death rates for some of the most common forms of cancer have dropped, the news does not run across the board for all cancers.
In fact, liver cancer deaths have been on the rise in the United States. The American Liver Foundation estimates that 16,780 people in the United States will die this year of liver cancer, an increase of 580 deaths from 2006 and 4,000 deaths from only ten years ago.
"We are overjoyed at the news about the overall decline in cancer deaths," said Dr. James Boyer, chair of the board of the American Liver Foundation. "However it is important not to ignore the very clear fact that liver cancer is one of the few cancers that are claiming more lives."
More than 19,000 cases of liver cancer will be diagnosed this year. Compare that to the 13,000 cases diagnosed in 1997, and one cause for the increase in liver cancer deaths becomes clear.
"Although survival rates for liver cancer are slowly improving, more people are being diagnosed with the disease than ever before," said Boyer.
But what is causing the increasing rates of liver cancer? Most cases of liver cancer are linked to cirrhosis of the liver, a condition caused when scar tissue begins to replace healthy liver tissue. Cirrhosis is a common long-term side effect of long-term, excessive alcohol consumption, as well as hepatitis B, hepatitis C and fatty liver disease.
"The increase in liver cancer is due to the near epidemic rates of many liver diseases," said Boyer. "The hepatitis C virus, for example, is the fourth leading cause of liver cancer-related deaths in the United States.
Both hepatitis B and C are viral infections. Over four million Americans have been infected with hepatitis C, while 1.4 million have been infected with hepatitis B. It is estimated that as much as 20 percent of the American population has fatty liver disease, a side-effect of diabetes and obesity.
Fortunately, both hepatitis B and fatty liver disease can be prevented. There is a vaccine available for hepatitis B and fatty liver disease can be prevented with weight control. For patients with hepatitis C, the risk of liver cancer can be reduced with adequate treatment.
If you are at risk for developing liver cancer, be sure to be vigilant about screening. Early detection of liver cancer is a sure way of increasing your chance of survival.
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Coffee Appears to Lessen Liver Cancer Risk
http://www.medscape.com
News Author: Allison Gandey
August 14, 2007 — A new meta-analysis suggests that drinking coffee may reduce the risk for hepatocellular carcinoma (HCC). But the authors are quick to point out they have not identified a cause-and-effect relationship. "The interpretation of this association remains unclear, and the consequent inference of causality and worldwide public health implications remains open to discussion," they report in the August issue of Hepatology.
Led by Francesca Bravi, ScD, from the Istituto di Ricerche Farmacologiche Mario Negri in Milan, Italy, the investigators evaluated published studies on HCC that included quantitative information on coffee consumption. They identified 10 studies of 2260 patients with liver cancer.
Included in the meta-analysis were 6 case-control studies from southern Europe and Japan and 4 cohort studies, also from Japan. "We observed a 41% reduction in the risk of HCC among coffee drinkers compared with never drinkers, with similar results from case-control and prospective studies," the researchers report. "Moreover, the apparent favorable effect of coffee drinking was found both in studies from southern Europe, where coffee is widely consumed, and from Japan, where coffee consumption is less frequent, and in subjects with chronic liver disease."
Table. Summary of Relative Risk for HCC in Coffee Drinkers*
| Coffee Consumption |
Summary
Relative Risk |
95% CI |
| Drinkers vs nondrinkers (case-control studies) |
0.54 |
0.38 - 0.76 |
| Drinkers vs nondrinkers (cohort studies) |
0.64 |
0.56 - 0.74 |
| Low or moderate drinkers |
0.70 |
0.57 - 0.85 |
| High drinkers |
0.45 |
0.38 - 0.53 |
| Increase in 1 cup of coffee per day (case-control studies) |
0.77 |
0.72 - 0.83 |
| Increase in 1 cup of coffee per day (cohort studies) |
0.75 |
0.65 - 0.85 |
*HCC indicates hepatocellular carcinoma; CI, confidence interval.
The overall relative risk for coffee drinkers vs nondrinkers was 0.59 (95% CI, 0.49 - 0.72) with significant heterogeneity between studies. The overall relative risk for an increase in 1 cup of coffee per day was 0.77 (95% CI, 0.72 - 0.82).
"Observational studies included in this meta-analysis are prone to various other sources of bias and confounding," the authors caution. "Allowance for confounding factors varied among the studies considered in this meta-analysis. However, the fact that the inverse relation persisted after allowance for major risk factors for HCC including history or serological evidence of hepatitis B and C, cirrhosis and other liver diseases, social class indicators, alcohol drinking and tobacco smoking, reassures against major role of confounding or modifying effect."
The investigators point to another important problem of the studies — their reliance on patient self-reports to assess coffee intake. But, they note, recall of coffee drinking has been studied and has been shown to be reproducible and valid.
Dr. Bravi and colleagues conclude that the consistency of an inverse relationship between coffee drinking and the risk for liver cancer across study design and geographic areas weighs against a major role of bias or confounding.
But the investigators emphasize the difficulty in determining causality on the basis of these observational studies alone. "The inverse relation observed may in fact be spurious and due to the fact that subjects with a broad spectrum of digestive tract diseases, liver disorders, and cirrhosis may reduce their coffee consumption."
They explain in their article that coffee has also been related to a reduced risk for liver disease and cirrhosis, a major risk factor or pathogenic step in the process of liver carcinogenesis. "The beneficial effect of coffee consumption on HCC may be due to its inverse relation with cirrhosis, although allowance for clinical history of cirrhosis did not totally account for the inverse association," they note. "Thus, there seems to be a continuum of the favorable effect of coffee on liver enzymes, cirrhosis, and HCC."
The researchers have disclosed no relevant financial relationships.
Hepatology. 2007;46:430-435.
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August 15th, 2007
Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
http://biz.yahoo.com
International Clinical Data to be Presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
TAMPA, Fla., Aug. 15 /PRNewswire/ -- Romark Laboratories announced that it has initiated a phase II clinical trial of Alinia® (nitazoxanide) for treating chronic hepatitis C in the United States.
The clinical trial is designed to evaluate the effectiveness and safety of Alinia tablets administered in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin) in 60 patients with chronic hepatitis C genotype 1 who have failed to respond to standard therapy (peginterferon and ribavirin). Pegasys and Copegus are being provided under a collaborative agreement between Romark and F. Hoffmann-La Roche Ltd.
"We are excited to be participating in this clinical trial," said David Nelson, M.D., Associate Professor of Medicine, Medical Director of Liver Transplantation, and Chief of the Hepatobiliary Disease Section at the University of Florida. "There is a critical need for new therapies for patients with hepatitis C, particularly those who have already failed existing therapies."
The company also announced that interim data from an international clinical trial in patients with chronic hepatitis C will be communicated at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in early November 2007.
"Initiation of the US study and communication of our international data represent important milestones for our development program," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark who invented nitazoxanide and is leading its clinical development. "We are enthusiastic about the results to be presented at the upcoming AASLD meeting and the opportunity to develop an important new treatment for patients suffering from chronic hepatitis C."
The company's STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis C) development program is being directed in collaboration with the Division of Gastroenterology and Hepatology at Stanford University School of Medicine by Emmet B. Keeffe, M.D., Jeffrey S. Glenn, M.D., Ph.D. and Dr. Rossignol who is also a Stanford affiliate.
Nitazoxanide is the first of a new class of small molecule drugs called the thiazolides that target cell signaling pathways used in viral replication. Data related to the in vitro activity of nitazoxanide against virus replication in hepatitis C virus (HCV) replicons was presented earlier this year at the 20th International Conference on Antiviral Research.
Stephen A. Harrison, M.D., Chief of Hepatology at Brooke Army Medical Center in Fort Sam Houston, Texas, said, "The potential for use of nitazoxanide in the treatment of chronic hepatitis C is exciting. To better optimize treatment outcomes for patients, we need new antiviral drugs that can be used safely and effectively in combination with existing drugs or with other new drugs in development."
STEALTH C Clinical Development Program
The US and international clinical trials described above comprise part of the company's STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis C) clinical development program, a series of clinical trials designed to evaluate the safety and efficacy of Alinia tablets in combination with peginterferon or peginterferon and ribavirin in patients with chronic hepatitis C.
The STEALTH C-1 trial, conducted in Egypt in interferon-experienced and naive patients with chronic hepatitis C genotype 4, is a phase II randomized controlled trial evaluating the effectiveness and safety of three treatment regimens: (i) Alinia administered 500 mg twice daily for 12 weeks followed by Alinia-Pegasys combination therapy for 36 weeks, (ii) Alinia 12 weeks followed by Alinia-Pegasys-Copegus combination therapy for 36 weeks and (iii) Pegasys- Copegus combination therapy for 48 weeks (standard of care). The study randomized 120 patients. Patients enrolled in this trial have reached the end of treatment and are undergoing follow-up for sustained virologic response. Data from the STEALTH C-1 clinical trial is expected to provide important efficacy and safety data that will guide the continuing development of nitazoxanide for treating chronic hepatitis C. Interim data from this trial will be presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in early November 2007.
The STEALTH C-2 trial is a randomized double-blind placebo-controlled trial conducted in the United States in 60 patients with chronic hepatitis C genotype 1 who have previously failed to respond to peginterferon and ribavirin combination therapy. This trial is designed to evaluate the effectiveness and safety of Alinia administered 500 mg twice daily for 4 weeks followed by Alinia-Pegasys-Copegus combination therapy for 48 weeks compared to placebo for 4 weeks followed by placebo-Pegasys-Copegus combination therapy for 48 weeks (standard of care).
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), a virus spread through direct contact with the blood of infected people. Chronic HCV infection may cause liver cirrhosis or hepatocellular carcinoma. An estimated 3.2 million people in the U.S. are chronically infected by hepatitis C virus. Globally, an estimated 170 million people are chronically infected, with three to four million persons newly infected each year, according to the World Health Organization.
About Romark Laboratories
Romark Laboratories, L.C. (www.romark.com) is a biotechnology company committed to the discovery and development of innovative new small molecules for treating infectious diseases, cancers, and autoimmune diseases.
About Alinia
Alinia (nitazoxanide) is indicated in the United States for treatment of diarrhea caused by Cryptosporidium parvum or Giardia lamblia in patients 1 year of age and older. Alinia has not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients. The most common adverse events reported by patients receiving Alinia have been abdominal pain, diarrhea, headache and nausea. In controlled trials, the frequency of these events has been similar to patients receiving a placebo.
Source: Romark Laboratories, L.C.
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Vertex Drug Could Be Huge
http://www.thestreet.com
By Adam Feuerstein
Senior Writer
BOSTON -- The on-and-off love affair between Wall Street and Vertex Pharmaceuticals (VRTX) is on again.
Shares of the Cambridge, Mass.-based biopharmaceutical firm have jumped 35% since the end of June as investors grow more confident that telaprevir, Vertex's experimental hepatitis C drug, will be a game-changing blockbuster.
On Tuesday, Vertex Chief Medical Officer John Alam and CFO Ian Smith gave me an update on telaprevir. The body language of both men was very confident. Of course, Vertex executives have a reputation for being too cocky for their own good. This is especially true for CEO Joshua Boger -- and it's gotten him in some trouble with Wall Street in the past.
But in talking with Alam and Smith, the message came through loud and clear that a rational analysis of the information on telaprevir is convincing enough to erase any doubts about the drug's efficacy. This is a drug that will significantly increase the number of patients who can be cured of hepatitis C.
Equally important, telaprevir will help cure these patients in half the time required today, they believe.
In other words, telaprevir is going to be a big drug. Just how big -- $2 billion in sales? $3 billion? $4 billion? -- remains to be seen.
An important meeting of liver disease specialists in early November will be the venue for the release of the latest telaprevir clinical data from ongoing phase II clinical trials. This is a key meeting for Vertex and one that will be closely followed by investors.
In recent trading, Vertex shares were up more than 3% to $36.35. With an enterprise value of $4 billion already, Vertex isn't cheap, given that telaprevir hasn't yet started phase III studies (they're expected toward the end of the year) and approval is still two to three years away.
But if telaprevir lives up to its promise and generates sales on the upper side of the $2 billion-to-$4 billion range, Vertex at $36 and change might look fairly undervalued.
For more background on Vertex and telaprevir, check out this previous column, but here's a quick recap:
Telaprevir is a pill designed to attack hepatitis C by inhibiting the protease enzyme, one of the key enzymes the virus uses to copy itself. This "direct antiviral" approach differs from current hepatitis C drugs, which boost the immune system's ability to tamp down and eliminate the virus.
The current standard of care for hepatitis C patients is a weekly injection of long-acting alpha interferon combined with daily oral doses of a generic drug, ribavirin. A normal treatment course for Type 1 hepatitis C (the most prevalent form) takes 48 weeks to complete. But the standard treatment cures only about 40% of patients, and many patients find the side effects, such as flu-like symptoms, anemia and depression, difficult to tolerate.
Telaprevir is being combined with interferon and ribavirin to create a more potent and less time-consuming hepatitis C treatment regimen. Three large phase II studies are under way, investigating various treatment schedules. The most promising combination right now treats hepatitis C patients for 12 weeks with the triple combination (telaprevir, interferon and ribavirin) followed by 12 weeks of interferon and ribavirin on their own.
That's 24 weeks of total treatment, or half the current standard of care.
Cutting treatment time is great, but the top priority for telaprevir will be to improve hepatitis C cure rates beyond the current low-40% range for Type 1 patients.
What will the cure rate (known formally as the sustained virologic response, or SVR) for telaprevir be after 24 weeks of treatment?
Cowen analyst Rachel McMinn believes telaprevir will boost SVR to the 50%-to-60% range in the current phase II studies, on the basis of modeling of currently available clinical data.
And when Vertex runs its pivotal phase III study later this year, telaprevir cure rates could jump into the 70% range, she says.
"An SVR rate of 60% for telaprevir would represent an approximate 50% improvement over the cure rate for hepatitis C patients today," says McMinn. Such an improvement, she adds, would trigger widespread adoption of the drug. "It would be a huge commercial success."
McMinn is one of the best hepatitis C analysts on Wall Street. She recently moved from Piper Jaffray to Cowen, where she picked up coverage of Vertex with an outperform rating. (She also made a great call on ViroPharma (VPHM) last week, downgrading the stock the day before the company's hepatitis C drug HCV-796 blew up over toxicity issues.)
I asked Alam and Smith if they were comfortable with the analyst's prediction for telaprevir's cure rate, which, by the way, is in line with other Wall Street analysts. While not wanting to endorse a specific number, both said they felt that an SVR rate in the 50%-to-60% range was entirely possible from the current phase II studies -- and that even higher SVR rates were achievable in phase III.
Remember: The SVR data from the ongoing phase II studies will be presented Nov. 2 through Nov. 6 at the annual meeting of the American Association for the Study of Liver Disease.
Something else helping Vertex these days is that some of the competitors developing new hepatitis C drugs are stumbling. InterMune (ITMN) is developing a drug similar to telaprevir, but its clinical program has been slow out of the blocks, with delays to the start of human clinical trials.
ViroPharma's drug looks dead because of problems with liver toxicity, while both Coley Pharmaceuticals (COLY) and Anadys Pharmaceuticals (ANDS) have been forced to shelve their respective drugs because of safety issues.
But don't think Vertex won't have competition. In fact, there are other hepatitis C drugs still moving well through clinical trials, but right now, telaprevir has a fairly commanding lead. If sustained, that could complicate efforts by other companies to get their hepatitis C drugs approved.
Adam Feuerstein writes regularly for RealMoney.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships.
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Test May Help Identify Liver Cancer
http://patient.cancerconsultants.com/
According to the results of a study conducted in China, testing for specific changes to proteins in the blood may help to identify liver cancer in patients with hepatitis B-related cirrhosis of the liver. These results were published in the journal Hepatology.
The liver is the largest organ in the body and is responsible for over 500 functions. These include the secretion of glucose, proteins, vitamins, and fats; the production of bile; the processing of hemoglobin; and the detoxification of numerous substances.
Hepatocellular carcinoma (HCC) is the most common type of liver cancer. Risk of HCC is greatly increased among patients with hepatitis B- or hepatitis C-related cirrhosis of the liver.
To improve the early detection of HCC in patients at high risk of the disease, researchers in China conducted a study among 450 patients with hepatitis B-related cirrhosis or fibrosis of the liver. The study evaluated whether assessment of glycans (polysaccharides) attached to proteins in the blood could distinguish patients with and without HCC.
The researchers found one glycan that was significantly more abundant in patients with HCC than in patients without HCC, and one glycan that was significantly less abundant in patients with HCC than in patients without HCC. The combination of these measures was as accurate in identifying HCC as the commonly used alfa-fetoprotein test. Furthermore, the combined measure provided information about HCC stage.
The researchers conclude that this test may provide a supplemental, noninvasive method of detecting HCC in patients with hepatitis B-related cirrhosis of the liver. Further studies, however, are needed.
Reference: Liu X-E, Desmyter L, Gao C-F et al. N-glycomic changes in hepatocellular carcinoma patients with liver cirrhosis induced by hepatitis B virus. Hepatology [early online publication]. August 7, 2007.
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Inovio Biomedical Partner Tripep Receives Approval to Initiate Phase I/II Study of Novel Vaccine for Hepatitis C Virusadvertisement
http://news.moneycentral.msn.com
Inovio Biomedical Corporation INO, a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced today that its partner, Tripep AB of Sweden, received approvals from the Swedish Medical Products Agency and local ethics committees to initiate a Phase I/II clinical trial of a novel DNA vaccine designed to treat chronically infected hepatitis C virus (HCV) patients. The trial will test Tripep's proprietary DNA vaccine, ChronVac-C(R), administered using Inovio's MedPulser(R) DNA Delivery System, in 12 subjects already infected with HCV. The trial will be conducted in Sweden at two Karolinska University Hospitals, the Center for Gastroenterology in Solana and the Infections Clinic in Huddinge, beginning in October 2007.
"This is the first human study in the world in which a DNA vaccine against an infectious disease is being administered by in vivo electroporation. This technology has worked out very well in all animal models that have been evaluated and we are happy that after only 18 months of collaboration with Inovio we are able to start clinical studies in humans," said Tripep's CEO, Jan Nilsson.
"Initiation of Tripep's hepatitis C DNA vaccine trial will mark our fifth partnered clinical trial using Inovio's proprietary non-viral DNA delivery technology," stated Dr. Avtar Dhillon, Inovio's president and CEO. "We are pleased to be working with investigators at the world-renowned Karolinska Institute to test this novel approach to treat hepatitis C infections, which are responsible for a large number of liver cancers each year."
About Inovio's Immunotherapy Products
DNA-based immunotherapies including DNA vaccines have the potential to by-pass inherent scientific obstacles of conventional vaccines that prevent their development for cancer and chronic infectious diseases such as HIV and hepatitis C. Pre-clinical data has indicated the ability of Inovio's technologies to effectively deliver and significantly enhance the potency of such immunotherapies without the potential safety concerns of viral systems.
Inovio's DNA-based immunotherapy products consist of DNA plasmids and the Elgen and MedPulser DNA delivery systems. DNA plasmids are designed to express antigens that can induce an immune response specific to a cancer or infectious disease-causing organism. These plasmids are created synthetically and readily manufactured using well-established bacterial fermentation and purification technology. After a plasmid is delivered into muscle or tumor cells, production of the desired antigens may induce a preventive or therapeutic immune response against the intended disease. Inovio's advanced electroporation devices facilitate delivery and expression of these plasmid DNA-based immunotherapeutics and have in primate studies and/or interim Phase I data significantly enhanced antibody and T-cell immune responses relative to plasmid DNA delivered by other methods, suggesting the potential to provide better protective or therapeutic effects against complex infectious diseases and cancers.
Inovio is poised to deliver advanced DNA-based immunotherapies, devices and know-how in this rapidly advancing field. The company is actively licensing its technology to pharmaceutical and biotechnology companies and supporting early stage clinical studies arising from its own research efforts or through academic collaborations.
About Hepatitis C and ChronVac-C
Hepatitis is a disease characterized by inflammation of the liver. Hepatitis C virus (HCV) is a major cause of acute hepatitis. HCV is spread primarily by direct contact with human blood, the major causes worldwide being the use of unscreened blood transfusions and re-use of inadequately sterilized needles and syringes. As many as 70% - 90% of newly infected patients may progress to develop chronic infection (WHO: 2002). Of those with chronic liver disease, 5% - 20% may develop cirrhosis. About 5% of infected persons may die from the consequences of long term infection (due to liver cancer or cirrhosis). Globally, an estimated 170 million people are chronically infected with HCV, which represents a reservoir sufficiently large for HCV to persist, and 3 to 4 million persons are newly infected each year. In the US, while new incidences of HCV have dropped dramatically, an estimated 4.1 million (1.6%) Americans have been infected with HCV, of whom 3.2 million are chronically infected (Centers for Disease Control and Prevention: 2006).
HCV infections in the liver do not trigger an immune response very effectively. Certain antiviral therapies, while expensive, are somewhat effective in treating hepatitis C, but there is no vaccine currently available to prevent hepatitis C. ChronVac-C(R) is designed to be a therapeutic DNA vaccine that can stimulate the body's immune system. Animal experiments have demonstrated that ChronVac-C vaccination activated B-cells and T-cells (the latter being regarded as the most significant to clearing the chronic infection relating to hepatitis C) that killed cells producing HCV protein. In humans, the ChronVac-C DNA plasmid will be injected into muscle tissue, where vaccinations are usually given, and taken up by muscle cells with the assistance of Inovio's electroporation-based DNA delivery system. These muscle cells would be expected to then produce predetermined proteins that may activate the body's immune system to attack all cells producing HCV proteins.
About Tripep AB
Tripep AB is a Swedish biotechnology research company that develops and commercializes candidate drugs based on patented and proprietary technologies. Its main focuses are research and clinical development of ChronVac-C(R), a therapeutic vaccine against hepatitis C; preclinical research focusing on the development of therapeutic and prophylactic vaccines against influenza A and HIV; and the RAS(R) technology platform. More information is available at www.tripep.se. Contact Jan Nilsson, CEO, at +46 8 449 8480 or jan.nilsson@tripep.se.
About Inovio Biomedical Corporation
Inovio Biomedical INO is focused on developing multiple DNA-based immunotherapies and commercializing its Selective Electrochemical Tumor Ablation (SECTA) therapy. Inovio is a leader in developing human applications of electroporation, using brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. Interim human data has shown that Inovio's DNA delivery technology can significantly increase gene expression and immune responses from DNA vaccines. Immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, the U.S. Army, National Cancer Institute, and International Aids Vaccine Initiative. The SECTA therapy for locally treating solid tumors is designed to selectively kill cancerous cells and minimize cosmetic or functional detriments often caused by surgical removal of predominantly healthy tissue typically treated around a tumor. Inovio's technology is protected by an extensive patent portfolio covering in vivo electroporation. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans and that results from one study may necessarily not be reflected or supported by the results of other similar studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio's technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2006, our 10-Q for the six months ended June 30, 2007, and other regulatory filings. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products. Contact Information: Inovio Biomedical Corporation Investor Relations Bernie Hertel, 858-410-3101 or Media Relations Jeff Richardson, 805-491-8313.
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August 16th, 2007
FDA Announces Baraclude (entecavir) is Not Recommended for HIV/HBV Co-infected Patients Who Are Not Also Receiving HAART Due to the Potential for the Development of HIV Resistance
http://pharmalive.com
ROCKVILLE, Md., Aug. 16, 2007--FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the following sections of the Baraclude prescribing information: BOXED WARNINGS, MICROBIOLOGY/Antiviral Activity against HIV (human immunodeficiency virus), WARNINGS/Co-infection with HIV, PRECAUTIONS/Information for Patients, and Patient Package Insert. Baraclude therapy is not recommended for HIV/hepatitis B virus (HBV) co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) due to the potential for the development of HIV resistance.
Read the letter below. The label is attached.
August 2007
IMPORTANT DRUG WARNING
Dear Healthcare Professional:
Bristol-Myers Squibb would like to inform you that therapy with BARACLUDE® (entecavir) is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) due to the potential for the development of HIV (human immunodeficiency virus) resistance.
Accordingly, the BARACLUDE Full Prescribing Information has been updated to include the following information in the boxed WARNINGS1:
"Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). See WARNINGS: Co-infection with HIV."
In addition, the MICROBIOLOGY section of the BARACLUDE Full Prescribing Information has been revised to include the following additional information:
Antiviral Activity against HIV
"A comprehensive analysis of the inhibitory activity of entecavir against a panel of laboratory and clinical human immunodeficiency virus type 1 (HIV-1) isolates using a variety of cells and assay conditions yielded EC50 values ranging from 0.026 to >10 ?M; the lower EC50 values were observed when decreased levels of virus were used in the assay. In cell culture, entecavir selected for an M184I substitution in HIV reverse transcriptase at micromolar concentrations, confirming inhibitory pressure at high entecavir concentrations. HIV variants containing the M184V substitution showed loss of susceptibility to entecavir."
Consistent with clinical practice guidelines for chronic hepatitis B management,2,3 the WARNINGS section of the BARACLUDE Full Prescribing Information has been updated with the following information:
"Before initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use."
Other changes in the WARNINGS and PRECAUTIONS sections and PATIENT INFORMATION have been made consistent with the information described above. Please refer to the enclosed BARACLUDE Full Prescribing Information, including boxed WARNINGS, for more information.
Bristol-Myers Squibb remains committed to providing you the most current and accurate information available for our products.
686US07LD21001 08/07
If you have any questions about this new information or require additional medical information, please contact Bristol-Myers Squibb at 1-800-321-1335.
If you have had a patient who experienced an adverse event following, or coincident with the use of BARACLUDE (entecavir), please contact Bristol-Myers Squibb at 1-800-321-1335 or the FDA MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787).
Please refer to the accompanying Important Information about BARACLUDE and the enclosed BARACLUDE Full Prescribing Information, including boxed WARNINGS.
Sincerely,
Freda C. Lewis-Hall, M.D.
Senior Vice President, US Medical Affairs
Bristol-Myers Squibb
BARACLUDE is a registered trademark of Bristol-Myers Squibb Company.
Enclosure: BARACLUDE Full Prescribing Information
REFERENCES
1. BARACLUDE (entecavir) Full Prescribing Information, Bristol-Myers Squibb Company, Princeton, New Jersey.®
2. Lok AS, McMahon BJ. AASLD practice guidelines: chronic hepatitis B. Hepatology 2007;45:507-39.
3. Department of Health and Human Services. Supplement to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. April 30, 2007. Available at: http://aidsinfo.nih.gov/Guidelines/
GuidelineDetail.aspx?MenuItem=
Guidelines&Search=Off&GuidelineID
=7&ClassID=1. Accessed June 27, 2007.
Indication and Important Safety Information about BARACLUDE® (entecavir) Tablets
INDICATION:
BARACLUDE is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-naïve and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease, and on more limited data in adult patients with HIV/HBV co-infection who have received prior lamivudine therapy.
IMPORTANT SAFETY INFORMATION:
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.
• Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including BARACLUDE. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
• Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). Before initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients.
• BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use.
• Dosage adjustment of BARACLUDE is recommended for patients with a creatinine clearance <50 mL/min, patients with age-related decreases in renal function, and those on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
• Since entecavir is primarily eliminated by the kidneys, coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
• The safety and efficacy of BARACLUDE in liver transplant recipients are unknown. Renal function must be carefully monitored both before and during treatment with BARACLUDE in a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus.
• Patients should be advised that treatment with BARACLUDE (entecavir) has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
• There are no adequate and well-controlled studies of BARACLUDE administered to pregnant women. BARACLUDE should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits. There are no studies on the effect of BARACLUDE on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV. Women should be instructed not to breast-feed if they are taking BARACLUDE.
• Safety and effectiveness of BARACLUDE in pediatric patients below the age of 16 years have not been established.
The most common adverse events of moderate to severe intensity among patients treated with BARACLUDE in clinical trials included: headache (4%), fatigue (3%), diarrhea (1%), and dyspepsia (1%).
The recommended dose of BARACLUDE is 0.5 mg once daily in nucleoside-naïve adults and 1 mg once daily in lamivudine-refractory adults. BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal). The optimal duration of treatment with BARACLUDE for patients with chronic hepatitis B infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.
Please see enclosed Full Prescribing Information, including boxed WARNINGS.
Downloads
Baraclude_PI_jul2407.pdf
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August 17th, 2007
Fundraiser will benefit hepatitis clinic
http://www.fredericknewspost.com
By Jennifer Hill
News-Post Staff
IF YOU GO
WHAT: “Be Proud of Frederick” fundraiser for the Frederick County Hepatitis Clinic
WHEN: 6 to 9 p.m. Sunday
WHERE: Danielle’s restaurant, Everedy Square and Shab Row in downtown Frederick.
DETAILS: 100 tickets are available for $7 each. Get them at the door or in advance at the restaurant or the clinic.
The Frederick County Hepatitis Clinic is hosting a fundraising night this weekend.
"It's going to be a great evening to come out and enjoy the weather and the food with some friends to support a good cause," said Victor Buckwold, president of the clinic's board of directors.
The clinic is opening the event to the public to thank the Frederick community for its continued support and to raise awareness about hepatitis C.
The fundraiser will feature a bluegrass acoustic band, "The Yardslippers," and a 50/50 raffle.
One hundred tickets at $7 each will be available at the door or in advance at the clinic or at the restaurant. All proceeds from ticket sales will go to the clinic. Danielle's restaurant, where the event is being held, will also donate a portion of the evening's food and bar tab to the clinic.
"Danielle's is just a great place to be in the summertime," said Constance Callahan, executive director of the clinic.
This is the first time the clinic has hosted a fundraiser with entertainment, Callahan said. The clinic tries to be creative with its fundraising to draw large corporations and small businesses alike.
"We want them (business and civic leaders) to know that we're here as a nonprofit clinic that may be taking care of their employees, friends or family," Callahan said. "It takes all of us to take care of each and every one of these patients."
Hepatitis C is a curable disease that is killing more people in Frederick County than HIV, said clinic founder Dr. Michael Rudman.
The clinic is in its seventh year of operation.
"When we first started, one out of 16 first-time patients were terminally ill," Rudman said. "Now it's one out of seven. At one time, they were treatable. Now, their conditions are irreversible."
The clinic is almost exclusively volunteer-run. With only three physicians who donate their time, more volunteer medical staff is always needed.
Frederick County Hepatitis Clinic has 1,450 patient visits per year, and the cost of each patient's treatment is about $40,000, Rudman said. The clinic is not affiliated with county or state government, and relies on grants and donations to provide $1.5 million worth of goods and services.
"We get by the skin of our teeth," he said.
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Roche Joins Forces With Enon Tabernacle Baptist Church to Provide Free Hepatitis C Testing to the Community
http://www.examiner.com
PHILADELPHIA, Aug. 17 - Roche representatives will work together with the Enon Tabernacle Baptist Church from Saturday, August 18 - Sunday, August 19 to educate the church community about the hepatitis C virus (HCV), including risk factors, the importance of getting tested and possible treatment options.
Preparations will begin on Friday, August 17 when ministry leaders, church volunteers, and Roche representatives convene to review education and testing logistics regarding HCV.
"African Americans have the highest rate of infection with hepatitis C in the country. We are committed to educate and provide free hepatitis C testing to the members of Enon Tabernacle Baptist Church and other local residents to prevent future infections," said Senior Pastor Rev.
Dr. Alyn E. Waller, Enon Tabernacle Baptist Church, Philadelphia, PA.
For the past four years, Roche has worked primarily with African-American community churches nationwide to establish HCV testing programs in congregations across the country. In 2006, screening events took place in 30 communities of faith, and an additional 80 events are scheduled in 2007, with the program also extending to Hispanic and Egyptian churches.
"At Roche, we are dedicated to improving the lives of patients and to the communities where they live and worship," said Frank Griffith, Brand Director, Interferons Marketing, Roche. "By providing this congregation with the tools and information it needs to execute HCV education and screenings, it can successfully sustain this valuable community program in the future."
About HCV
According to the American Liver Foundation, more than four million people in the United States are or have been infected with hepatitis C, and an estimated 70 percent are not aware they have the virus.
Hepatitis C is one of six identified hepatitis viruses that cause the liver to become inflamed, which interferes with its ability to function, and is generally considered to be among the most serious of the six hepatitis viruses.(1) HCV is transmitted primarily through direct exposure to blood through an opening in the skin or mucus membrane. The hepatitis C virus infects the liver, causing inflammation resulting in damage of the liver tissue.(2) Many people with chronic hepatitis C have no symptoms of liver disease, but if symptoms are present they are usually mild; may come and go over time; and be hard to recognize as related to hepatitis C. Symptoms may include fatigue, liver pain, nausea, poor appetite or muscle and joint pains.(3) Contact your physician if you experience any of these symptoms.
Additional information about hepatitis C can be found by calling the American Liver Foundation at toll-free 800-GO-Liver (465-4837) or 888-4HEP-USA (443-7872), by visiting its Web site at www.liverfoundation.org or by visiting Roche's site: www.pegasys.com.
(1) Mayoclinic.com. September 14, 2005. http://www.mayoclinic.com/health/hepatitis-c/DS00097. Accessed on July 25, 2006.
(2) American Liver Foundation. Copyright 2002-2003. http://www.liverfoundation.org/db/articles/1063 . Accessed on July 26, 2006
(3) National Digestive Diseases Information Clearinghouse (NDDIC). February 2003.
http://digestive.niddk.nih.gov/ddiseases
/pubs/chronichepc/index.htm#C.
Accessed on July 26, 2006.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2006, Roche was named one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.
SOURCE Roche
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