Monday, August 29, 2011

Hepatitis C Monday News Ticker; Paediatric HCV, Two New Drugs for Chronic Hepatitis C and More

New On The Blog;
Canada-Victrelis;New Hep C drug priced out of reach of most patients
Maternal hepatitis B and hepatitis C carrier status influences perinatal outcomes
Fatigue In HCV Infection: A Review (1989-2011)

In The News

Clinic: Patients Might Have Been Exposed To Hepatitis, HIV
Victims Potentially Exposed Between 2006 To 2011
Updated: 1:50 pm CDT August 29, 2011
MADISON, Wis. -- Dean Clinic officials said on Monday that a former employee might have exposed some patients to blood-borne diseases like hepatitis and HIV during the last five years.
Clinic officials released a news release on Monday saying that they've informed state and local health officials about the results of their internal review. They said that the employee conducted "inappropriate use of insulin demonstration pens and finger stick devices" during patient visits between 2006 and 2011. They're now contacting 2,345 patients to check if they were exposed to hepatitis B, hepatitis C and HIV.

Officials said that they will either call or send letters and have prepared to answer patients' questions. They said that they conduct the necessary testing and coordinate "follow-up care and support patients' needs."

Dean leaders said that they're committed to helping those affected.
"Dean Clinic is committed to supporting our patients. There is nothing more important to us than the health, well-being and safety of the people we serve," said Dr. Craig Samitt, president and CEO of Dean Clinic, in the news release. "Our goal is to ensure that those who may have been affected by the inappropriate use are promptly informed, tested and supported."
As a result of these incidents, officials said that they're "reeducating patient care staff on the proper use of these types of devices, enhancing our auditing and monitoring procedures related to these devices and improving our process for routinely observing the clinical practices of our staff."
Stay tuned to WISC-TV and Channel 3000 for continuing coverage.

HIV Donor's Organs Transplanted Into Patients
UK, Monday August 29, 2011
A hospital in Taiwan has apologised after organs from an HIV positive donor were transplanted into five patients in a case described as "appalling negligence".
The five are now being treated with anti-viral drugs but experts say it is very likely they will contract HIV.

And their treatment will be further complicated due to the fact they must take medication to stop their new organs being rejected.
There are also concerns among the medics who performed the operations that they may have also contracted HIV.

The family of the 37-year-old donor, surnamed Chiu, chose to donate his organs after he fell to his death in northern Hsinchu city last week.
But the relatives said they were not aware that he was an HIV carrier.
Chiu went into a coma on August 24 and his liver, lungs two kidneys and heart were transplanted to five patients on the same day.

Four of the transplants took place at the National Taiwan University Hospital (NTUH) in Taipei, while the heart operation was carried out at another hospital.
Continue reading..

Hepatitis C Drug
Written by Kristi Runyon
Monday, 29 August 2011 10:47
Hepatitis C is a potentially curable form of hepatitis and some recent advances have improved those odds. Learn more about the newest treatment that can rid the body of this chronic infection.

Hepatitis C Hepatitis C (HCV) is an inflammatory disease that affects the liver. It’s caused by infection with the hepatitis C virus. Most people don’t have any symptoms until significant liver damage has occurred. By then, patients may develop jaundice (yellowish coloring of the skin and whites of the eyes), swelling in the stomach or ankles, fatigue, easy bruising, slower blood clotting time, fever, loss of appetite, diarrhea and dark colored urine.

According to the Centers for Disease Control and Prevention, about 17,000 people become infected with HCV each year. Many of those who are newly diagnosed were actually infected 30 to 40 years ago, but didn’t know it because the virus generally doesn’t cause any symptoms for a long time. Some risk factors include: being born to a mother with HCV, having received a blood transfusion or organ transplant before July 1992, having more than one sex partner, using illegal drugs, getting a tattoo with contaminated needles or accidental stick with a needle used on a person with HCV.

HCV is very difficult for the body to clear and about 75 to 85 percent of patients develop a chronic infection. Currently, 3.2 million Americans are believed to have chronic HCV. Up to 20 percent of them will develop liver cirrhosis within 30 years. Nearly 5 percent will die from either liver cirrhosis or liver cancer.

Treating HCV Doctors generally only treat HCV when the disease become chronic. The standard treatment is a combination of pegylated interferon alfa (PEG, or peginterferon) and ribavirin (RBV). PEG is given by weekly injection. RBV is an oral medication taken daily.
Researchers say the two-drug combination successfully cures HCV in only 40 percent of cases. So better treatments are being investigated.

Recently, the FDA approved two new drugs for HCV – boceprevir and telaprevir. Both drugs are in a class of medications, called protease inhibitors, which inhibit replication of the HCV virus. However, when used alone, the virus quickly develops a resistance to the drugs. So doctors are now adding a protease inhibitor to the standard treatment, allowing them to attack the HCV virus with a triple punch. David Bernstein, M.D., Hepatologist with North Shore University Hospital, Manhasset, NY, says the total treatment time is 6 or 12 months, depending upon the patient’s response to the therapy. All three medications are given for the first three months, then the protease inhibitor is discontinued. Patients continue to take the other two medications as directed for the remaining treatment time.

There are six different genotypes of HCV. The protease inhibitors only work against type 1. However, that is the most common type in the U.S. and it is the strain that is most resistant to treatment. Bernstein cautions the protease inhibitors still don’t work for everyone. However, cure rates with the triple therapy are up to 79 percent.
Research compiled and edited by Barbara J. Fister

For information about the new drugs: boceprevir -
telaprevir -

For general information on hepatitis C: American Liver Foundation, Centers for Disease Control and Prevention, Hepatitis Foundation International, National Institute of Diabetes and Digestive and Kidney Diseases,

Portal vein thrombosis influences outcomes for pediatric liver transplant candidates in the USA
The latest issue of Liver Transplantation evaluates portal vein thrombosis and outcomes for pediatric liver transplant candidates and recipients in the United States.
The effect of occlusive portal vein thrombosis on the mortality of pediatric liver transplant candidates and recipients is poorly defined.

Dr Seth Waits and colleagues from Michigan, USA studied the relationship between portal vein thrombosis and waiting-list and posttransplant survival rates with data from the Scientific Registry of Transplant Recipients.
In all, 5087 liver transplant candidates and 3630 liver transplant recipients were evaluated during the period.

Portal vein thrombosis patients had a lower survival rate in the posttransplant period
Liver Transplantation

The research team found portal vein thrombosis in 1% of the liver transplant candidates, and in 4% of the liver transplant recipients.
Portal vein thrombosis was not associated with increased wait-list mortality.
Conversely, portal vein thrombosis patients had a significantly lower unadjusted survival rate in the posttransplant period.

The team observed that portal vein thrombosis was independently associated with increased posttransplant mortality in multivariate models.

Dr Waits' team concludes, "The presence of portal vein thrombosis in pediatric liver candidates was not associated with increased wait-list mortality but was clearly associated with posttransplant mortality, especially in the immediate postoperative period."
Liver Transplant 2011: 17(9): 1066–1072
29 August 2011

Woman hospitalised by abortion
Lateline - 26/08/2011 A woman is in a critical condition in a Melbourne hospital after a late-term abortion at a clinic previously implicated in a hepatitis C scandal.

AJN, American Journal of Nursing:
September 2011 - Volume 111 - Issue 9 - p 22
doi: 10.1097/01.NAJ.0000405053.00454.26

Drug WatchTwo New Drugs for Chronic Hepatitis C
More From Drug Watch @ AJN
New Drug to Treat HIV Infection
New Drug for Type 2 Diabetes

From Journal of Viral Hepatitis
The Impact of Mode of Acquisition on Biological Markers of Paediatric Hepatitis C Virus Infection
K. England; C. Thorne; H. Harris; M. Ramsay; M.-L. Newell
Authors and Disclosures
Posted: 08/29/2011; J Viral Hepat. 2011;18(8):533-541.
© 2011 Blackwell Publishing

Discussion Only;
The impact of mode of acquisition on biological markers of HCV infection in the largest comparison of vertically and parenterally infected children to date was investigated. A significantly higher mean ALT z-score in vertically vs parenterally infected and a significantly higher mean ALT z-score in children infected before 12 months of age, regardless of mode of acquisition, was found. This latter association did not remain when only parenterally infected children were investigated which may be because of small numbers but may also indicate that the differences between groups are not completely explained by age at infection but may be related more directly to the mode of acquisition of infection itself.

Comparing biological markers of HCV infection in vertically and parenterally infected children is problematic in the light of the often substantial differences in populations in terms of age at infection, age at study entry, treatment profile, likelihood of clearance of viraemia or genotype. In the children from the cohorts studied here, four times as many parenterally than vertically infected children received HCV treatment; this may be because of more severe disease in parenterally infected children because of their age or mode of acquisition, as suggested by the finding here of a higher proportion with two or more markers of disease progression. Alternatively, their older age at diagnosis may make them more eligible for the treatment while vertically infected children, who were followed from birth, will have started on a regime of clinical monitoring without treatment. Although HCV therapy is well adhered to in the paediatric population, the unpleasant side effects and the potential impact on growth make the decision to treat a complex one.[18] There could also be bias in terms of the individual clinic or national treatment policies, especially given the continually evolving nature of information on paediatric HCV treatment and the ongoing debate about when to initiate treatment.[19]

This debate on when to initiate treatment is partly fuelled by knowledge that some children spontaneously clear viraemia without treatment. In this study, there was no effect of mode of acquisition on clearance of viraemia in contrast to some previous studies.[20] However, parenterally infected children in the UK National HCV Register were not followed up from the time of infection and possibly a large number of those who cleared viraemia did so before diagnosis or study entry. Therefore, any estimate of clearance here and elsewhere, likely underestimates the true proportion clearing viraemia in parenterally infected groups. Of note, however, the high clearance rates in parenterally infected groups are reported in this and other studies[9,21,22] which would presumably be even higher if those who cleared viraemia prior to diagnosis could be included. It may therefore be the case that parenterally infected children are more likely to clear the virus than vertically infected children but it is unlikely that this can be substantiated as follow-up from infection in parenterally infected children is rare.

No differences were found in the HCV genotype profiles of vertically and parenterally infected children in contrast to Jara et al. who found genotype 1b more frequently in children with transfusion-acquired HCV and genotype 3 more frequently in vertically infected children from seven European countries.[23] It is possible that this is because of differences in the years at which infection occurred and may reflect changes in the genotype profile of the HCV epidemic in Europe as suggested recently.[24] A higher proportion of children with genotypes other than type 1 achieved a SVR to therapy, as has been reported by other paediatric studies.[24]

Additionally, in univariable logistic regression, children with genotype 1 were more likely to have consistently elevated ALT levels and consistently positive HCV RNA PCR results, although the associations did not reach statistical significance likely because of small numbers. This finding does however support those of Harris et al. who suggested that type 1 infections may be more aggressive than types 2 or 3[25] and those of a previous EPHN study which found that intrauterine vertical transmission was more likely to occur from mothers with genotype 1.[26]

As no differences in the genotype profile of vertically and parenterally infected children were found here, it is unlikely that any differences in biological or clinical markers of HCV infection between groups can be attributed to the possible differences in HCV progression by genotype.
In multivariable logistic regression, no association between consistently raised ALT z-scores and mode of acquisition was found, possibly because of a lack of power, although the odds ratio remained below one, indicating higher ALT z-scores in vertically infected children. ALT levels have been shown to peak in the first 2 years of life in vertically infected children[27–29] and to adjust for this peak and any other differences resulting from age at measurement, ALT z-scores were used. The finding of increased ALT z-scores in vertically infected children adjusted for age is similar to an Australian study in which significantly higher geometric mean ALT levels in 16 vertically vs 15 parenterally infected children in the first 5 years of life were found, again after accounting for the early peak in ALT levels.[20]

Significant positive associations were found between consistently high ALT z-scores and both consistent HCV RNA viraemia and ever having evidence of hepatomegaly. There was also a higher odds of having consistently positive HCV RNA PCRs in children ever having evidence of hepatomegaly but not significantly so. The associations between these three markers of HCV-related disease progression support previous studies indicating that they may define a group of children with evidence of chronic progressive HCV or who are at increased risk of rapid or more severe progression.[2] In this analysis, similar proportions of parenterally and vertically infected children had evidence of two or more of these markers of infection. Similarly, no difference was found in the proportion with two or more markers and age at infection, in either all children or just the parenterally infected group. This lack of association with mode of or age at acquisition may have been because of combining the markers of infection into this summary variable and also the small number (15 children) of parenterally and vertically infected children with evidence of two or more markers of infection.

The prevalence of comorbidities in parenterally infected children is high given the nature of their infection during receipt of medical treatment[30] and this may have been influential in terms of the child's ability to mount an initial or continued immune response to HCV infection. In contrast, vertically infected children, although acquiring infection during immune development may benefit from persistence of maternal antibodies.[20,31] These mechanisms require specific investigation and although evidence from this analysis does not support substantial differences between the vertically and the parenterally infected groups, until they can be further defined it is important that the potential differences between them are recognized in a clinical setting. This study also highlights the growing need for epidemiological data on parenterally infected children and the difficulties in analyzing such data. Recent estimates suggest that 40% of HCV infections worldwide are acquired via unsafe medical injections and a great number of these occur in children. It is therefore vital that knowledge of disease progression in parenterally infected children is accurate and that the differences between vertically and parenterally infected groups are clarified to inform more accurate and individualized clinical management.
Read More;
Abstract and Introduction
Materials and Methods

In Case You Missed It

TAG Offers New Guide to Clinical Trials for People with Hepatitis C
The Treatment Action Group (TAG) has produced a new booklet for people considering...

Remembering Jack Layton: full of energy and compassion
remember the first time I met Jack in Ottawa. Six of us infected before 1986 and after 1990 with hepatitis C because of tainted blood went to Ottawa during the Paul Martin Liberal government.

Outsourcing Pharmaceuticals

More Than Half Of CRO Sales Are Made Outside The US

Cancer drug shortages getting worse, FDA says
Most of these are generic drugs given by injection and used in hospitals to treat serious conditions such as breast and testicular cancer. These shortages are putting patients at risk and compromising their care, experts say.
"FDA has been monitoring shortages for the last six years, and in 2010 we saw a large spike in shortages, which was a large jump from the year before," said Valerie Jensen, associate director of the Drug Shortage Program in FDA's Center for Drug Evaluation and Research. "That's what we are continuing to see in 2011. We are still seeing these large numbers of injectable drug shortages." Continue reading...

MORE: Drug shortages set to reach record levels

Stem Cells

Links; Recommended: Stem Cell Blogs

Five Scientists Receive Stem Cell Research Grants

SAN JOSE, Calif., Aug. 29, 2011 /PRNewswire/ -- BD Biosciences, a segment of BD (Becton, Dickinson and Company), has announced the latest round of winners of the BD Biosciences Research Grant Program.

"BD Biosciences continues to support promising young U.S. and European scientists at critical junctures of their careers," said Robert Balderas, Vice President of Biological Sciences, BD Biosciences. "No biomedical discovery has shown as much promise, so early in its development, as stem cell research. We are pleased, by funding these researchers, to support efforts to treat and cure serious illnesses."

Michael Choi, M.D., Assistant Professor of Medicine at Harvard Medical School, is investigating the conversion of non-liver cells into functional hepatocytes through a combination of transcription factors and microRNAs. Specifically, he will identify transcription factors and microRNAs that help convert or differentiate fibroblasts, embryonic stem cells or endodermal (early liver precursor) cells into hepatic progenitor cells. The long-term goal is a ready source of cells to repair livers damaged from injury or disease.
Continue reading....

Stem cells: distinguishing hype and hope
With the bewildering amount of news about stem cells, how do we tell the difference between hype and hope?

New research validates clinical importance of leukemia stem cells
Aug 29
Research published today focuses on patients and shows that acute myeloid leukemia (AML) contains rare cells with stem cell properties, called leukemia stem cells (LSC), that are better at predicting clinical outcome than the majority of AML cells, showing for the first time that LSCs are significant not just in experimental models but also in patients. Stem Cell Network of Canadian National Centres of Excellence, Terry Fox Foundation, Ontario Institute for Cancer Research, Canadian Cancer Society Research Institute

In cell culture, like real estate, the neighborhood matters
Ever since scientists first began growing human cells in lab dishes in 1952, they have focused on improving the chemical soup that feeds the cells and helps regulate their growth. But surfaces also matter, says Laura Kiessling, a professor of chemistry at the University of Wisconsin-Madison.

Healthy You

It's official -- chocolate linked to heart health
High levels of chocolate consumption might be associated with a one third reduction in the risk of developing heart disease, finds a study published on today.
The findings confirm results of existing studies that generally agree on a potential beneficial link between chocolate consumption and heart health. However, the authors stress that further studies are needed to test whether chocolate actually causes this reduction or if it can be explained by some other unmeasured (confounding) factor.

The findings will be presented at the European Society of Cardiology Congress in Paris at 10:10 hrs (Paris time) / 09:10 hrs (UK time) on Monday 29 August 2011.
The World Health Organisation predicts that by 2030, nearly 23.6 million people will die from heart disease. However, lifestyle and diet are key factors in preventing heart disease, says the paper.

A number of recent studies have shown that eating chocolate has a positive influence on human health due to its antioxidant and anti-inflammatory properties. This includes reducing blood pressure and improving insulin sensitivity (a stage in the development of diabetes).
However, the evidence about how eating chocolate affects your heart still remains unclear. So, Dr Oscar Franco and colleagues from the University of Cambridge carried out a large scale review of the existing evidence to evaluate the effects of eating chocolate on cardiovascular events like heart attack and stroke.

They analysed the results of seven studies, involving over 100,000 participants with and without existing heart disease. For each study, they compared the group with the highest chocolate consumption against the group with the lowest consumption. Differences in study design and quality were also taken into account to minimise bias.

Five studies reported a beneficial link between higher levels of chocolate consumption and the risk of cardiovascular events. They found that the "highest levels of chocolate consumption were associated with a 37% reduction in cardiovascular disease and a 29% reduction in stroke compared with lowest levels." No significant reduction was found in relation to heart failure.
The studies did not differentiate between dark or milk chocolate and included consumption of chocolate bars, drinks, biscuits and desserts.

The authors say the findings need to be interpreted with caution, in particular because commercially available chocolate is very calorific (around 500 calories for every 100 grams) and eating too much of it could lead to weight gain, risk of diabetes and heart disease.
However, they conclude that given the health benefits of eating chocolate, initiatives to reduce the current fat and sugar content in most chocolate products should be explored.

Off The Cuff

Bird flu fear as strain mutates
Avian flu shows signs of a resurgence, while a mutant strain - able to sidestep vaccines - could be spreading in Asia, the United Nations warns.

Psoriasis 'linked to stroke risk'
People with psoriasis have nearly three times the normal risk of stroke and abnormal heart rhythm, according to scientists in Denmark.
A study of 4.5 million people, published in the European Heart Journal, showed the highest risk was in young patients with severe psoriasis.

Michigan court: Law doesn’t allow pot sales
An appeals court has ruled that Michigan’s medical marijuana law doesn’t permit sales between registered patients.
An appeals court has ruled that Michigan’s medical marijuana law doesn’t permit sales between registered patients.
The ruling, in a case that had been brought against a pot dispensary operated by owners legally allowed to possess and grow the drug, allows local authorities to close similar shops, Reuters reports.

According to the Associated Press:
Compassionate Apothecary, and owners of the mid-Michigan company, claimed they weren’t doing anything illegal because the law allows the “delivery” and “transfer” of marijuana. The business allows its 345 members to sell marijuana to each other, with the owners taking as much as a 20 percent cut. In less than three months, Compassionate Apothecary earned $21,000 before expenses after opening in May 2010.

“The ‘medical use’ of marijuana does not include patient-to-patient ‘sales’ of marijuana. Defendants, therefore, have no authority under the (law) to operate a marijuana dispensary that actively engages in and carries out patient-to-patient sales,” said appeals court judges Joel Hoekstra, Christopher Murray and Cynthia Diane Stephens.

“This ruling is a huge victory for public safety and Michigan communities struggling with an invasion of pot shops near their schools, homes and churches,” State Attorney General Bill Schuette said in a statement. “The court echoed the concerns of law enforcement, clarifying that this law is narrowly focused to help the seriously ill, not the creation of a marijuana free-for-all.”
Michigan is one of 16 states that, along with the District of Columbia, allow marijuana to be used to ease medical conditions. According to the South Bend Tribune, there are an estimated 200 to 300 marijuana dispensaries in Michigan serving the state’s 99,500 residents with medical marijuana cards.

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