This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.
Risk Of Developing Liver Cancer After HCV Treatment
Screening isn’t necessarily effective for all cancers, but primary liver cancer is one type of cancer where those at high risk, such as persons with hepatitis B or C or cirrhosis, may benefit from screening (the use of tests to look for the presence of disease before symptoms appear). Primary liver cancer, also known as hepatoma or hepatocellular carcinoma (HCC) is the most common form of liver cancer in adults according to the American Cancer Society.
Screening for HCC can begin as young as 40 and involves measuring alpha-fetoprotein (AFP) blood levels and conducting a liver ultrasound every 6-12 months. AFP is a tumor maker and its levels in the body are measured by a blood draw. AFP is often elevated in liver cancer or cirrhosis of the liver. The levels will go down on someone who has been treated for liver cancer and AFP is thus useful for determining response to treatment, or a possible recurrence if the levels rise after treatment.
In a healthy normal adult, AFP levels are less than 10 nanograms per milliliter. Of note, AFP is also elevated in pregnancy, and other cancers such as ovarian and testicular cancers. An ultrasound of the liver is a painless and non-invasive test that uses sound waves to create an image of the liver and internal organs. These images are then viewed by a radiologist to check for any masses or abnormalities that may not be felt during physical exam or felt by the patient, since the liver is shielded by the ribs and often not easy to palpate during an exam.
Cancer screening can save lives by catching it early and in a more treatable stage. Knowing what factors can make a person high risk as well as knowing the available screening tests is the first step toward reducing the mortality of primary liver cancer.
These include:
Gender: HCC is more common in men than women
Race/ethnicity: in the United States, Asican Americans and Pacific Islanders have the highest rates of liver cancer, followed by Native Americans and Hispanics/Latinos.
Having cirrhosis of the liver.
Having chronic viral hepatitis
Heavy alcohol use
Obesity
Type 2 diabetes
What is Behind the Headlines?
We give you the facts without the fiction. Professor Sir Muir Gray, founder of Behind the Headlines, explains more...
Cannabis use 'genetically linked' to schizophrenia
Study finds people predisposed to [schizophrenia] and drug users share common genes,” the Mail Online reports. A new study suggests that ‘schizophrenia’ genes are associated with cannabis use.
It has long been known that there is an association between cannabis use and schizophrenia – but the “direction of travel” has been hotly debated.
Does cannabis use trigger the onset of schizophrenia in vulnerable individuals? Or are people with a genetic predisposition to develop schizophrenia more likely to use cannabis than the population at large (possibly as a coping mechanism)?
This latest study suggests that the latter may be the case; at least in some people. The study involved 2,082 healthy adults whose genetic make-up was examined for risk factors for schizophrenia.
People with more genetic risk factors (carrying more of the DNA variants that have been associated with schizophrenia) were more likely to have reported ever using cannabis.
However, it is important to note that none of the people in the study actually had a diagnosis of schizophrenia. In addition, as this is a cross-sectional study (see below), it cannot definitively answer the question of cause and effect.
A person’s risk for schizophrenia, or for cannabis use, are likely to be influenced by a complex mixture of genetic factors (including those not identified or examined here), lifestyle and environmental factors.
Where did the story come from?
The study was carried out by researchers from the Institute of Psychiatry, King’s College London; Queensland Brain Institute and QIMR Berghofer Medical Research Institute, Australia; the Department of Developmental Psychology and EMGO Institute for Health and Care Research, Amsterdam; the Washington University School of Medicine.
It was funded by the UK Medical Research Council and National Institute for Health Research; the Australian National Health, Medical Research Council and Australian Research Council; the Centre for Research Excellence on Suicide Prevention (CRESP – Australia); and the Netherlands Organization for Health Research and Development.
The study was published in the peer-reviewed medical journal Molecular Psychiatry.
The Mail Online reported the story accurately and informatively.
What kind of research was this?
This was a cross-sectional study using data collected in a larger cohort study. It aimed to assess the association between cannabis use and the level of genetic predisposition for schizophrenia.
As it is a cross-sectional study it is only able to describe this association and cannot prove cause and effect. That is whether the genetic predisposition caused them to use cannabis or that conversely, cannabis would cause them to develop schizophrenia.
What did the research involve?
A group of 2,082 unrelated healthy adults were recruited from the large Australian Twin Registry studies.
The participants were asked questions over the telephone on their cannabis (marijuana) use, including:
Did you ever use marijuana?
How old were you the very first time you tried marijuana (not counting the times you took it as prescribed)?
How many times in your life have you used marijuana (do not count times when you used a drug prescribed for you and took the prescribed dose)?
The genotype (each person’s genetic make-up) was obtained. These were compared with samples from a large Swedish study which has identified a number of single nucleotide polymorphisms (SNPs), DNA sequence variations, that are believed to increase the risk of developing schizophrenia.
The presence of more than one of these SNPs gives a “polygenic” (multiple gene variants) risk factor, and some SNPs are associated with a particularly higher risk (having the most significant associations with schizophrenia).
These risk scores were analysed in comparison with the answers to the cannabis questions to look for any associations.
In the second part of the study, the researchers looked at the polygenic risk scores of 990 twins (just over a third were identical twins).
They took the mean polygenic risk score from each pair of twins and used this to predict whether neither, one or both twins used cannabis.
What were the basic results?
Out of the 2,082 adults included in the study, 1,011 (48.6%) had ever used cannabis. The mean age of starting cannabis was 20.1 (95% Confidence Interval [CI] 19.7 to 20.5) and the mean number of times they’d used cannabis over their lifetime was 62.7 (95% CI 19.7 to 20.5).
The researchers found a significant association between a person’s extent of genetic predisposition for schizophrenia and their reported use of cannabis. People who had used cannabis had higher genetic risk scores for schizophrenia than those who had never used cannabis. The strongest associations were found between the higher risk SNPs and ever use of cannabis.
However, the results showed that the genetic risk factors they assessed only predicted a small amount of a person's risk of using cannabis. This meant that other factors have more of an influence on whether a person uses cannabis.
In the secondary analysis, twin pairs where both reported using cannabis had the greatest polygenic risk factors for schizophrenia.
Pairs where only one of them used cannabis had an intermediate level of risk factors, and the lowest burden was in those where neither used cannabis.
How did the researchers interpret the results?
The researchers say this study shows “that to some extent the association between cannabis and schizophrenia is due to a shared genetic aetiology [cause] across common variants. They suggest that individuals with an increased genetic predisposition to schizophrenia are both more likely to use cannabis and to use it in greater quantities.”
Conclusion
This study shows an association between genetic risk factors for schizophrenia and cannabis use. However, as it is a cross-sectional study, it cannot answer the often debated cause and effect question of whether cannabis use increases risk of schizophrenia, or whether there is a common genetic predisposition to both.
The study cannot prove that cannabis use is a risk factor for developing schizophrenia.
It also cannot prove that the genetic risk factors (SNPs – variations in the DNA sequence that have been associated with schizophrenia) also directly increase the risk of using cannabis. As the researchers’ results suggested, the genetic risk factors they assessed only predicted a small amount of a person's risk of using cannabis. There may be many other factors involved. A complex mixture of genetics (including DNA variations not examined here), lifestyle and environmental factors is likely to contribute to a person’s risk of developing schizophrenia, and to their risk of using cannabis.
It should also be noted that none of the participants in the study actually had a diagnosis of schizophrenia. Though the SNPs thought to increase the genetic risk of developing schizophrenia were identified in a large Swedish cohort study, the authors do point out that they may not be accurate.
They say that in this Swedish sample from which these SNPs were identified, use of cannabis may have been more common among the people who had schizophrenia than in the controls without schizophrenia.
They say this could mean that the SNPs actually increase risk of cannabis use rather than risk of schizophrenia.
A further limitation of the study is that cannabis use was self-reported which may give rise to inaccuracies in the estimated level of use. Also people may not have been willing to disclose any use of an illegal substance during a telephone interview.
Cannabis may not be as dangerous as other drugs (including legal drugs such as tobacco and alcohol) but it is certainly not safe. There are many negative effects of cannabis, including a risk of developing dependency, its tendency to reduce motivation and concentration, and the likelihood that it reduces male fertility.
Furthermore, the risks of the tobacco and nicotine which are usually consumed at the same time need to be taken seriously. Read more information about the health risks associated with cannabis.
Hepatitis C Infection May Have 'Silver Lining' for Transplant Patients
WEDNESDAY, June 25, 2014 (HealthDay News) -- The liver-damaging hepatitis C virus may come with an unexpected benefit for patients who need a liver transplant due to the infection, a new European study reports.
The virus appears to restrain a dangerous immune system response that can otherwise cause the body to reject the new liver, according to findings published June 25 in Science Translational Medicine.
This effect allowed about half of a small group of liver transplant patients to stop taking drugs that suppress their immune system, said lead author Felix Bohne, a postdoctoral fellow with the Institute of Virology at the Technical University of Munich Hemholtz Center Munich, Germany.
"It is always a hard thing to translate results from clinical studies into the everyday treatment of patients, but our study clearly shows that hepatitis C-infected liver recipients can discontinue the immunosuppressive medication," Bohne said.
Hepatitis Foundation International (HFI) called the research "encouraging news for people who may need a liver transplant."
"This is exciting research that shows the hepatitis virus changes the immune system in such a way to protect these liver transplants from being rejected by the body," said Dr. Gregory Pappas, medical director for HFI. "This is good news for many of HFI's constituents and those who will need a liver transplant and/or who have been infected with hepatitis C."
Doctors must typically use immunosuppressive drugs to help a body accept a new organ, but these medications often do more harm than good for hepatitis C patients who receive a new liver, experts say.
In background information supplied with the study, the researchers explained that because the immune system is suppressed by medications, hepatitis C actually flourishes after a transplant, causing rapid damage to the new liver.
However, if the immune-suppressing drugs are not given, hepatitis C appears to help a liver recipient accept the new organ -- even better than immunosuppressive medications would.
All this is due to a common viral trick that hepatitis C uses to avoid getting spotted by the immune system. According to the new study, the virus "rewires" immune cells to reduce their function -- essentially performing the immune-squelching work that immunosuppressive drugs do.
"This is part of the virus' immune evasion strategy and can be observed in a part of patients developing chronic hepatitis C," Bohne said.
The result is an environment in which immune response is blunted against the replacement liver because hepatitis C has taught the body to ignore the new organ.
In a study of 34 people with hepatitis C who received a new liver, Bohne and his colleagues found that 17 were able to stop taking their immunosuppressive medications without suffering organ rejection.
Might the same process occur with other infectious viruses? Bohne is doubtful. He said that while other viruses can suppress the immune response, few focus their efforts on one organ the way that hepatitis C focuses on the liver.
Dr. Thomas Schiano, medical director of liver transplant for Mount Sinai Health System, said the very small study "does give us some confidence as to us to be able to wean people off of immunosuppression."
But he added that new breakthroughs in hepatitis C treatment may make the point moot, anyway.
"Effective new medicines are probably going to make this not as pertinent," Schiano said. "If we are able to get rid of the hepatitis C in a majority of patients, that will provide further confidence to transplant surgeons to get patients off of immunosuppression."
A second, related study in the same journal issue found that laboratory-engineered immune cells can help treat serious viral infections that threaten to cause rejection in organ transplant patients.
A team led by Dr. Ann Leen, of Texas Children's Hospital in Houston, said they've developed a technique to rapidly produce immune cells capable of fighting of up to five different viruses known to cause organ rejection, including Epstein-Barr virus and herpes virus.
The engineered cells eliminated nearly all viruses from a small group of patients, the researchers reported.
"These viruses are a big source of graft [new organ] failure. This is something clearly worth exploring further," Schiano said. "The cost associated with this would be mitigated by all the money we spend to protect against rejection."
A new estimate suggests that, for private insurers, the impact of new
hepatitis C treatments – including Sovaldi and any forthcoming
medications – on medical costs will eventually decline, as will the
impact on the growth in spending on overall health care. The notion is
largely based on the current pricing for Sovaldi, which assumes
forthcoming drugs would be similarly priced.
Two factors will be at work, according to PricewaterhouseCoopers
Health Research Institute. Besides lowering the overall cost of treating
hepatitis C sufferers, the market research firm maintains that the
actual number of patients will gradually decline over the next decade as
more patients are treated, including those whose physicians are waiting
for better medications to become available.
International Conference on Viral Hepatitis (ICVH) 2014 Helen-Maria Lekas, PhD, Gloria J. Searson, MSW, Alyson L. Harty, RN, BSN, William Thompson June 23, 2014 Editor's Note: During the International Conference on Viral Hepatitis, held in New York, some of the participants in a panel discussion titled "Patient Perspectives on What Providers Need to Know About Stigma and Other Barriers to Hepatitis Care"[1] convened afterwards for a discussion. During the conversation, they discussed the stigma surrounding hepatitis C and some of the barriers to diagnosis and treatment for patients.
Living With Hepatitis C
Helen-Maria Lekas, PhD: My name is Helen-Maria Lekas. I am from Columbia University, and I am in New York at the International Conference on Viral Hepatitis. I'm here with a panel of experts, including Gloria Searson, Alyson Harty, and William Thompson. I would like to start by asking you about stigma. As patients and experts living with hepatitis C virus (HCV) infection, what do you want your providers to know about the stigma associated with the disease?
Gloria J. Searson, MSW: Stigma is horrible. I don't want to be looked at or judged, and I don't want you to bring your biases into the room with us. I just want you to treat me as a human being and take care of the problem.
Alyson Harty, RN, BSN: I agree, from both the provider and patient perspective. When I was 17 and I found out I had HCV, I didn't want to tell any of my friends. You don't want your friends knowing that you have a virus because it's often associated with other viruses that have a broad stigma against them, and there is no need. You got it -- however you got it, you got it -- let's solve the problem.
Dr. Lekas: What can providers do to ameliorate the stigma associated with HCV?
William Thompson: One thing that I find very important is the support group that I go to. We get a lot of information from the doctor and we also get a lot of information from other patients. To me, stigma is like "sticks and stones can break my bones." It doesn't really affect me. I don't think anybody can say anything to me that would make me feel bad about my condition, especially when you have conditions yourself. It's all up to the individual in how you feel about it.
Persisting Barriers to Diagnosis and Treatment
Dr. Lekas: I'm very glad to hear that you don't internalize other people's stigmatizing attitudes. If we leave stigma aside, what are some of the other barriers that patients are encountering in getting care for HCV?
Ms. Searson: Patients don't have the same care teams available to them for HCV that they did for other diseases. One of the good things about HIV was that they had funding and manpower to help deal with teaching the patient things that the doctor may not have been able to get through to the patient, or convince the patient of the urgency of something. They even had someone there to provide the education and support so that they can buy into the fact that they had the disease. There are some systemic barriers that we have to fix in healthcare in general. It is disproportionately dispensed in different areas, in different ways, and we have to make sure that people can access the same things wherever they are geographically. That's one of the largest barriers. The treatments are good, but we can't just take them without understanding them. So, who is going to provide that education is the key.
Dr. Lekas: Do you think that patients with HCV know about the new treatments coming down the pipeline?
Ms. Harty: It varies. You have your highly educated patients who know that they have HCV and who have been following the disease and the press releases, and then you have patients who were told back in the late 1990s and early 2000s that they have this problem but nothing can be done about it. There is a wide variety, and we need re-education for those patients who were turned away from care. For example, they may have been told that because they were black or obese that the treatment wouldn't work for them. We need to relink these patients back to care, as well as screen the 80% of patients who we know haven't been tested.
Ms. Searson: The campaigning and awareness are out there for those who access social media or the Internet or who watch television, but there is a whole group of people who do not access information the way it is being disseminated. If you are not in the healthcare system or working with a substance abuse group, a senior population, or a veterans' group, you still may be out of the loop for hepatitis. We need the healthcare team around patients who get HCV to understand them as a whole -- where they are and what may or may not be necessary for this particular patient to get through treatment. The pills and the medications only address one barrier, and that's the biological barrier. They don't address the personal issues or the systemic barriers, and they certainly don't address the infrastructure and lack of healthcare providers able to deal with this disease.
Improving on the HIV Model for Hepatitis C
Dr. Lekas: Would you propose a team-based approach for hepatitis C, like that for HIV, with a provider, a medical physician, and a nurse?
Ms. Harty: We need a lot more funding for that. Personally, working in a private office, I know that we don't have the funds to hire a psychiatrist. I am the social worker, psychiatrist, and nurse -- all of the above. It takes a lot of manpower to put people through this therapy, and the providers also need more support from the states and the private insurers who don't pay for psychological therapy unless the patient has Medicaid and can access a therapist. It is very hard for privately insured people to get the psychological therapy that they need.
Dr. Lekas: Do you think the HIV model is a good one?
Ms. Harty: Definitely.
Ms. Searson: Yes, especially because this is a complicated thing to explain, and you want to have people you can trust, like we have with case managers in HIV. But here is one thing I would like to see be different from the HIV model: We did not bring the case managers along in the science, so they were not able to offer the support to patients around understanding the disease and the importance of medication, because they were left out of the education. If you create a team, then all of them have to have the necessary information. In HIV, that is where we made some missteps; we kept the science separated from the prevention and services, and there was no interaction. The patient was better known by the people who knew the least about the disease itself and the benefits of treatment. Without that knowledge, how could those who have the confidence of the patient convince the patient of the importance of being treated? That is why we have people who are still not detectable, as well as the continuing struggles of being on multiple regimens, because the patients didn't get buy-in from the people that they trust.
Mr. Thompson: At the facility that I go to, Mount Sinai, the doctors work as a team. They all discuss the patient and reach a conclusion about where they are going with the patient and what their expected results are. They are very informative. I didn't know that I had stage 4 cirrhosis or that it could be stabilized. To me, stage 4 meant I was going to continue to decline. I didn't know that the liver repairs itself, and that with the elimination of the HCV infection the liver can regroup and reverse, to a point -- it's not going to be a completely healthy liver again. But I learned all of this from the doctors and the team where I get care. How well the doctors work together depends on the facility that you go to.
Dr. Lekas: With the massive restructuring of our healthcare system, this is a good note to end on. How HCV treatment will be integrated into this restructuring is an important issue.
New Zealanders to support Hepatitis Foundation says Governor
Media release from the Hepatitis Foundation: The Governor-General has encouraged New Zealanders to support The Hepatitis Foundation of New Zealand in its long-term goal of eradicating chronic hepatitis B and C in New Zealand
Hepatitis Foundation Monday 23 June 2014, 10:23AM Media release from the Hepatitis Foundation
The Governor-General has encouraged New Zealanders to support The Hepatitis Foundation of New Zealand in its long-term goal of eradicating chronic hepatitis B and C in New Zealand.
“As Patron, I’m proud to be associated with a not-for-profit organisation like The Hepatitis Foundation of New Zealand because it epitomises core New Zealand values: a commitment to public good and the care and support of New Zealanders,” said Lt Gen The Rt Hon Sir Jerry Mateparae, GNZM, QSO, Governor-General of New Zealand.
Sir Jerry Mateparae spoke of the Foundation’s achievements and its exciting future ahead, as he celebrated the 30th anniversary of The Hepatitis Foundation of New Zealand at his residence, Government House.
Thirty years ago, hepatitis B was rife amongst New Zealand’s children. Thanks to the unrelenting efforts of Sandy Milne, MBE, founder of The Hepatitis Foundation of New Zealand, thousands of children were spared from contracting this disease, which was easily contracted in playgrounds.
The Foundation’s work in the field of hepatitis B led to the roll-out of the free hepatitis B vaccine across New Zealand, the first sovereign nation to introduce universal hepatitis B vaccination for all children. Today, the Foundation has over 17,500 people with chronic hepatitis B or C enrolled in their free national programmes, with an aim to increase to 35,000 in the next five years.
“The hepatitis B immunisation programme protects children from contracting hepatitis B. Nowadays, we rarely see any New Zealander under the age of 25 infected with hepatitis B and we’ve got Sandy Milne to thank for that,” said John Hornell, CEO of The Hepatitis Foundation of New Zealand.
“It’s also a very exciting time in the field of hepatitis C. A new generation of drugs have been developed that are highly tolerable and effective at curing hepatitis C. The eradication of hepatitis C in New Zealand is now an achievable goal.”
One hundred and sixty people attended the event at Government House, hosted by Their Excellencies. Attendees included Mayor Celia Wade-Brown of Wellington, Mayor Tony Bonne of Whakatane, medical specialists, general practitioners and people living with chronic hepatitis B or C.
About 150,000 New Zealanders live with chronic hepatitis B or C and many don’t realise they have it. Chronic hepatitis are the leading causes of liver transplantation and liver cancer in New Zealand. The Foundation encourages anyone at risk of hepatitis to contact the Foundation for a free test on 0800 33 20 10 or via www.hepatitisfoundation.org.nz.
People at risk of hepatitis B are those who are over 25 and of Māori, Pacific Island, or Asian ethnicity. Also at risk are people whose mother or close family has hepatitis B, or if they live with someone who has hepatitis B.
For hepatitis C, those at risk are people who have ever injected drugs, ever received a tattoo or body piercing using unsterile equipment, had medical attention overseas or immigrated from a high risk country, had a blood transfusion prior to 1992, have ever been in prison, or were born to a mother with hepatitis C.
The Hepatitis Foundation of New Zealand is a not-for-profit organisation whose mission is to improve health outcomes for people living with chronic hepatitis B or C in New Zealand.
Happy Saturday everyone, hopefully you have time to catch up on some weekend reading. Don't forget to check out June's index of Hepatitis Newsletters, and hot topics.
Today we offer an update on our horrific VA system, recent data on HCV risk factors pertaining to Vietnam veterans, and a few links to other problems at VA medical facilities.
We begin with the study assessing HCV risk factors among U.S. Military veterans
from the Vietnam era. The purpose of the study was to investigate HCV risk factors among Vietnam veterans compared to nonveterans. The authors noted past studies mostly
took place within the VA
system, this study looked at 4,636 HCV patients who received care outside the VA. The study suggested; "Vietnam War era veterans did not report a higher prevalence of common
hepatitis C risk factors — including injection drug use — compared with
nonveterans, but they may have faced risk factors specific to their
military service." The paper was published in the Journal of Community Health last April and featured in the June issue of Healio's "HCV Next"
These findings are important on so many levels, it finally illustrates to the VA that many Vietnam veterans were infected through known military risk factors. The social stigma of living with HCV is difficult enough, but even more so for our Vietnam veterans. Sadly, for decades, veterans have reported the VA presumed they were infected through intravenous drug use - unless they could prove otherwise.
Other risk factors associated with military service include; emergency battle-related transfusions using unscreened blood, exposure to
blood/body fluid in the field, or blood exposure through the multidose vaccination
process, tattoos, sharing razors or non-sterile instruments.
Transmission Of HCV
Not
until 1990 was a screening test for hepatitis C developed, many people were infected with HCV by receiving blood products or a transfusion before 1990-1992. During this
time approximately 30,000 people received
letters from the
Red Cross saying that they were infected with hepatitis C through
contaminated blood. Officials estimated two hundred and fifty thousand
people were at
risk through earlier blood transfusions in the 1980's.
Provided below we have a few links to previous problems at VA medical facilities, and an interesting 2013 video from The Daily Show, with comedian Jon Stewart discussing the VA, legionnaires outbreak,
exposure to hepatitis and the failure to monitor mental health patients at a few hospitals. Finally, the study; Vietnam era vets may not be at higher risk for HCV than nonvets, and an update from CNN on our troubled VA health care system.
Links
June 2011 VA hospitals in Miami, Murfreesboro, Tenn., and Augusta, Ga. First VA colonoscopy case goes to trial after Miami vet contracted hepatitis C
A Coral Gables U.S. Air Force vet who says he contracted hepatitis C
from a colonoscopy done at the Miami VA hospital with improperly cleaned
equipment will press his claim in a Miami federal court.
More than 11,000 U.S. veterans received colonoscopies with improperly
cleaned equipment at VA hospitals in Miami, Murfreesboro, Tenn., and
Augusta, Ga., between 2004 and 2009. Of the veterans who had the
procedure at the three facilities, five have tested positive for HIV, 25
for hepatitis C and eight for hepatitis B. In Miami, 11 additional
suits charging emotional distress have been settled out of court for
undisclosed amounts, the U.S. Attorney’s office said. Nine malpractice
suits have been filed in Tennessee. Officials in Georgia couldn’t say
how many have been filed there. None has gone to trial until now.
Related - June 2012 Hepatitis B-Court ruled against Tennessee veteran who claims he contracted HBV at Murfreesboro VA hospital
In the latest legal setback, a federal appeals court has ruled against a
Tennessee veteran who claims he contracted hepatitis B after employees
at the Murfreesboro VA hospital negligently failed to properly clean
colonoscopy equipment. The ruling could have an impact on similar
lawsuits against the VA.
April 2011 John Cochran Veterans
Medical Center in St. Louis, MO Ohio panel wants more VA tests for clinic patients
The lack of "adherence to sterilization practices" or
"inadequate practices" at VA dental center was reported in 2011. During 2009 to 2010 notification letters sent to 1,812 veterans who may
have been exposed to hepatitis B, hepatitis C and HIV; when a breach in
protocol instrument processing took place at the John Cochran Veterans
Medical Center in St. Louis, MO. The Associated Press reported in March
2011 that most of the 1,812 veterans potentially exposed have been
tested with no infections connected to the dental clinic.
Of Interest Video: Daily Show Takes on the VA
In this 2013 video, talk show host Jon Stewart begins with checking on the progress of the VA's
backlogged benefits, however, instead the comedian discovered problems
at numerous VA hospitals.
Vietnam War era veterans did not report a higher prevalence of common hepatitis C risk factors — including injection drug use — compared with nonveterans, but they may have faced risk factors specific to their military service, according to new study data.
“Vietnam era veterans may have other HCV exposure risk factors in their history, other than injection drug abuse,” study researcher Joseph A. Boscarino, PhD, MPH, a senior scientist at Geisinger Health System Center for Health Research in Danville, Pa., told Infectious Disease News.
“Most important, they do not appear to have higher rates of injection drug abuse than comparable nonveterans. Also, a number of these vets report they got HCV through their military service during the Vietnam War era. We don't know if this is true or not, and more research may be required to answer this question more definitively.”
Joseph A. Boscarino
Previous studies suggest that Vietnam era veterans have higher rates of HCV infection, which is attributed to a greater prevalence of injection drug use. However, the researchers said most of these studies have been conducted among patients in the Department of Veteran Affairs health care system, which most veterans do not use.
Patients that use the VA health care system also tend to be different demographically.
To assess HCV risk factors among Vietnam era veterans vs. nonveterans, Boscarino and colleagues surveyed 4,636 HCV patients who received care in four health care systems outside the VA. Among the male respondents (n=2,638), 22.5% served in the US military at some point from 1964 to 1975. These Vietnam era veterans were more likely to be older (P<.001), more educated (P<.001), less often foreign born (P=.009), and more often married (P<.001) vs. nonveterans.
Vietnam era veterans actually had a lower prevalence of injection drug use compared with nonveterans (54% vs. 58%; P=.16). Other common risk factors for HCV infection, including occupational risk factors (P=.18), medical procedures (P=.61) and blood transfusions or organ transplantations (P=.94), were not more common among Vietnam era veterans. The researchers found that nonveterans were more likely than veterans to report sex with men (P=.013) as a risk factor for infection, but the prevalence was low (2.4% vs. 0.6%).
Analyses indicated that Vietnam era veterans were more likely to report “other” risk factors as the source of their infection (P<.001) — namely, exposure to vaccinations during their military service. The researchers said that during the Vietnam War era, service members received multiple injections, typically with pneumatic injectors, as they moved through vaccination lines, and bleeding was not uncommon. This method of vaccination was later phased out by the military.
Although more research is needed, Boscarino said clinicians can play an important role in the management of HCV in veterans.
“Clinicians need to be aware that the VA will provide disability compensation for vets for HCV, if the vet can submit a supportable claim to the VA for HCV infection related to military service,” Boscarino said.
“In some cases, clinicians may be able to help vets submit a claim to the VA related to their particular case. Ultimately, this may be difficult because these potential exposures occurred decades ago, but the veterans will appreciate this support from clinicians.” – John Schoen
Disclosure: See the study for a full list of financial disclosures.
Source - Healio
Performance reviews at troubled VA showed no bad senior managers
By Tom Cohen and Curt Devine, CNN
updated 10:08 PM EDT, Fri June 20, 2014
Washington (CNN) -- No matter what you call it -- bonuses, incentives, market or performance pay -- the Department of Veterans Affairs gave out a lot to senior managers in recent years despite sometimes deadly waits for health care and other problems faced by American veterans.
A top VA official confirmed to a congressional committee on Friday that 78% of VA senior managers qualified for extra pay or other compensation in fiscal year 2013 by receiving ratings of "outstanding" or "exceeds fully successful," and that all 470 of them got ratings of "fully successful" or better.
Such widespread laudatory performance appraisals occurred shortly before CNN started reporting in November how veterans waited excessive periods for VA health care, with some dying in the process. The VA has acknowledged 23 deaths nationwide due to delayed care.
In Phoenix, CNN reported in April that the VA used fraudulent record-keeping -- including an alleged secret list -- that covered up the waiting periods.
That didn't stop the head of the Phoenix VA medical center, Sharon Helman, from getting an $8,500 bonus last year.
Helman's bonus got rescinded earlier this year after the VA controversy made headlines. She was placed on administrative leave but continues to receive her salary, said Gina Farrisee, the VA assistant secretary for human resources and administration, at a House Veterans' Affairs Committee hearing.
Questionable bonuses
Panel chairman Jeff Miller, a Florida Republican, cited numerous examples of what he characterized as unwarranted bonuses to VA officials overseeing a department with such problems in recent years:
• The medical center director in Dayton, Ohio, receiving a bonus exceeding $10,000 despite an investigation of veterans getting exposed to hepatitis B and C at the facility;
• The former director of the VA regional office in Waco, Texas, getting more than $53,000 in bonuses when the average processing time for disability claims increased to what Miller called "inexcusable levels."
• The director of the Pittsburgh health care system getting a top performance review and a regional director getting a $63,000 bonus despite a legionella outbreak in the Pittsburgh VA health care system that led to six patient deaths.
"To the average American, $63,000 is considered to be a competitive annual salary, not a bonus," Miller said.
Farrisee offered administrative explanations about the bonus system that did little to satisfy committee members. In particular, the Helman case in Phoenix got a lot of attention, with legislators from both parties asking how it could happen.
She explained how the bonus should never have been given because Helman was being investigated in connection with the problems at the Phoenix VA facility, and therefore the extra money was eligible to be rescinded.
Can't go back
However, Farrisee said in almost all other cases, a performance rating and resulting bonus can't be rescinded later on.
"If we knew what we knew today at that time, it is unlikely that their performance would have reflected what it reflected at the time the reports were written," she said when asked by Miller about going back to change the performance review results.
However, "you cannot go back and change a rating once it has been issued to an employee as the final rating," Farrisee said, adding that was the law rather than a government rule.
An exasperated Miller called it a law that needed to change as part of an overhaul of a culture throughout the VA motivated more by performance bonuses than serving veterans.
"We can't keep doing it the way it's been being done," he said, to which Farrisee responded: "I concur, Mr. Chairman."
The controversy, with multiple investigations and increasing revelations of problems with newly returned veterans getting care on a timely basis, caused retired Army Gen. Eric Shinseki to resign on May 30 as Veterans Affairs secretary.
His successor, interim Secretary Sloan Gibson, has ruled out any bonuses for senior managers in 2014 as part of initial steps intended to get more immediate care for hundreds of thousands of waiting veterans.
Updated figures
Earlier this week, an updated audit revealed about 177,000 veterans were still waiting at least two months for an appointment at VA medical centers.
Gibson said some of the delays on the audit update appeared worse than previously reported because hospital administrators were beginning to use proper scheduling procedures that accurately reflected the number of veterans waiting.
For example, the update showed more than 43,000 veterans waiting longer than 120 days for an appointment, compared to 13,000 listed earlier this month.
According to Gibson, more appointments have been added, but some VA hospitals lack the capacity to see patients quickly, which also contributed to a spike in the figures.
The VA has reached out to 70,000 veterans waiting for appointments in order to get them into clinics, he said.
At this point, the VA's Office of Inspector General is investigating 69 facilities for allegations that administrators altered appointment data or used secret waiting lists to make patient wait times appear shorter in order to earn financial bonuses.
Farrisee said Friday that schedulers sought to meet their performance goal -- and therefore qualify for bonuses -- by showing veterans got appointments within 14 days.
An internal audit by the VA called that 14-day goal implemented under Shinseki's leadership unattainable and reported 13% of schedulers were instructed to manipulate data in some form.
Gibson has eliminated the 14-day target for the Veterans Health Administration, which has more than 1,700 facilities that serve almost 9 million veterans each year.
June Hepatitis C Newsletters: Two New Drugs Under FDA Review, Treatment Side Effects And So Much More....
Each month this blog provides a link to Hepatitis Newsletters, published by advocacy groups
devoted to increasing awareness and information about viral
hepatitis. In addition, a rewind of hot topics, research and news is offered with a focus on HCV.
Hello folks, hope you are all enjoying your summer! We begin with this months issue of "HCV Next" recently published online over at Healio.com.
Designed as an in-depth specialty clinical information website, Healio.com features the industry’s best news reporting, dynamic multimedia, question-and-answer columns, CME and other educational activities in a variety of formats.
HCV Next will bridge the gap between
cutting edge news and the patient with HCV, by seeking to provide
physicians with peer context and perspective on the latest research
developments. Topics that will be discussed regularly in HCV Next
are diagnostics, drug/drug interaction, combination therapies,
guidelines, practice management issues, regulatory aspects, coding,
general economic issues and treatment of patients in special populations
and those with comorbidities.
There is a lot going on at the American Liver Foundation and we invite you to join us in our many events. With our Liver Life Walks, Flavors, transplant reunions and webinars, there is a lot to be a part of. Here is what we have been up to during the last few weeks.
Most people don't associate liver disease with children. Yet thousands are diagnosed with liver disease each year. Read about three kids who not only survived but thrived.
The
hepc.bull, has been “Canada’s hepatitis C journal” since the late
1990′s and has been published nonstop since 2001. The monthly newsletter
contains the latest research results, government policy changes,
activities and campaigns you can get involved in, articles by patients
and caregivers, and a list of support groups plus other useful links.
The
New York City Hepatitis C Task Force is a city-wide network of service
providers and advocates concerned with hepatitis C and related issues.
The groups come together to learn, share information and resources,
network, and identify hepatitis C related needs in the community.
Committees form to work on projects in order to meet needs identified by
the community.
PREP-C Psychosocial Readiness & Preparation for Hep C Treatment:
Online assessment and guidance interactive tool. Now a shorter version for less complicated cases.
GI
& Hepatology News is the official newspaper of the AGA Institute
and provides the gastroenterologist with timely and relevant news and
commentary about clinical developments and about the impact of
health-care policy. The newspaper is led by an internationally renowned
board of editors.
In This Issue
PEARL-II: Oral ‘3D’ effective in HCV with prior tx failure
The investigational “3D” combination of oral antiviral drugs achieved a
cure rate that was amazing in the phase III PEARL-II trial involving
noncirrhotic patients with hepatitis C virus genotype 1b who had
previously failed pegylated interferon– based therapy.
Larazotide soothes in celiac trial
Larazotide acetate, a first-in-class oral medication developed
specifically to treat celiac disease, reduced both gastrointestinal and
non-GI symptoms in patients who were symptomatic despite being on a
gluten-free diet in a 74-site, randomized, double-blind phase II study.
NAFLD mortality higher in normal-weight patients
Lean patients with nonalcoholic fatty liver disease had a higher
overall mortality than did overweight or obese patients with NAFLD,
according to a review of 1,090 biopsy-confirmed patients in the United
States, Australia, Thailand, and Europe.
Stay connected
Hep C Connections - Website
Our mission is to educate the general public about hepatitis C and to
provide resources and support for those affected by the virus. Hep C
Connection offers a helpline to answer your questions regarding
hepatitis C (HCV). You can expect respect, patience &
understanding, in clear, jargon-free language from our staff &
volunteers. Call 1-800-522-HEPC (4372) today!
In This Issue
Diversity is Needed in Clinical Trials
Featured HCV Clinical Trials
South Denver Gastroenterology, PC is currently enrolling patients for:
A phase 3 trial to investigate the efficacy and safety of a 12 week regimen of simeprevir in combination with sofosbuvir in patients that have or have never gone through treatment, with chronic HCV genotype 1 infection, and that have cirrhosis...
Eight Colorado Organizations Offered Free Hepatitis C Testing to the Public
The
HCV Advocate newsletter is a valuable resource designed to provide the
hepatitis C community with monthly updates on events, clinical research,
and education.
Affordable Care Act (ACA) – Special Enrollment Periods
Jacques Chambers, CLU,
Benefits Consultant
Posted June 16, 2014
When health insurance companies agreed to cover everyone that applies under the Affordable Care Act (ACA),
regardless of their health or medical history, they wanted some
arrangement so people couldn’t wait until they felt sick to buy
insurance. That was resolved by limiting enrollment to certain Open
Enrollment Periods....
The
HCV Action network has launched a new website and issued an Action Update reviewing the fast track funding from NHS England for Sofosbuvir.
The
HCV Action network brings together health professionals from across the
patient pathway, including GPs, specialist nurses, clinicians, drug
action teams, public health practitioners, prison healthcare staff and
commissioners. We provide resources for commissioners, medical and
drug services professionals, promoting good practice in HCV care across
the UK.
Welcome to the new HCV Action website, the home of the UK’s hepatitis C
professional community. Browse our tailored resource libraries, view our
case study map or find out more information here>
This
HCV Action good practice case study gives an overview of a successful
'Positive Support' service for hepatitis C patients. Run by Addaction
and based in Motherwell, the service provides informed advice, active
support and treatment to otherwise isolated people with hepatitis C
living in Lanarkshire, Scotland. The case study gives a breakdown of the
issues the project aims to address; how the project works, and its
outputs and outcomes.
Hepatitis C news,
is an online community for those living with hepatitis C. Join us for
news, views and features about hep C, read the real-life experiences of
our guest bloggers, and learn about living well with the condition.
New In June @ Hepatitis C News
25 years on
This year marks the 25th anniversary of the identification of the hepatitis C virus.
TRIO is an independent, not-for-profit, international organization
committed to improving the quality of life of transplant candidates,
recipients, their families and the families of organ and tissue donors.
Through the TRIO Headquarters and a network of chapters, TRIO serves
its members in the areas of: Awareness, Support, Education, and
Advocacy. This TRIO web site is filled with information about these
areas and our many programs, including local chapter contact
information, so wander around these pages to learn more about TRIO or
contact your local TRIO chapter. If you still don't find answers to what
you are looking for, please email us at info@trioweb.org or call 1-800-TRIO-386.
HepatitisWA (Inc) is a non-profit community-based organisation providing
free services to the community. HepatitisWA aims to assist in obtaining
the best possible care and support for people affected by hepatitis,
reducing discrimination and stigma directed at people living with viral
hepatitis and raising community awareness in relation to hepatitis. Visit our website to learn more about viral hepatitis.
The HepatitisWA Newsletter is a quarterly publication; with each
edition we endeavour to capture new developments in hepatitis B and C
treatment, management and other relevant topics.
• Shannon's Story - Personal Perspective
• Going Viral - Viral Hepatitis News
• C the person not the disease - Feature
• Is an $84,000 hepatitis treatment drug too expensive? - Feature
• Current hepatitis C treatments - Community News
• Live Healthy with hepatitis C - Health & Lifestyle
• Hepatidings: HepatitisWA Community Activities - Community News
• WASUA's Domain: WASUA's Health Service
• HepatitisWA Peer Support Group - Advert
After a medical error, patients want an explicit statement that an error occurred,
what happened, and the implications for their health. They want an outright apology,
not a statement of regret. Work from global organizations is refining the right way
to disclose errors.
More
Four years since health care reform became law, there is finally enough information
to grade how well enrollment is going. It will be many more years before the program
can be judged an overall success, however.
More
Gastroesophageal reflux disease can be diagnosed in the office, without the need for
expensive tests such as endoscopy. Learn how to make the right diagnosis while avoiding
confounding symptoms that might steer a patient toward the wrong specialist.
More
Between 2001 and 2012, Ed continued to research the new and developing treatments for Hep C. Ed regularly had his blood drawn to determine the progress of the disease, and had a liver biopsy to determine the level of fibrosis in the liver and provide his physician an assessment of histology; both important factors to consider in the management and treatment of the disease. In 2012, Ed was placed on the then current treatment cocktail of interferon injections (once per week), Ribavirin (six capsules, three each twice a day), and Victrelis (two capsules, four times a day). Due to the various risk factors, his genotype and a compromised liver, it was determined that Ed would be on this treatment regimen for a total of 48 weeks, a month shy of a year.
Merck is starting a tender offer today to buy all of the outstanding
shares of hepatitis C treatment maker Idenix Pharmaceuticals.
Whitehouse Station-based Merck announced earlier this month that it
would pay about $3.85 billion for the Cambridge, Mass.-based company.
Merck is hoping that teaming Idenix's hepatitis C medicines with its
experimental drugs will produce lucrative combo therapies that quickly
cure most patients with the blood-borne virus afflicting tens of
millions.
Hepatitis C has become one of the hottest categories in drug research
as companies race to develop a combination therapy without injections
and debilitating side effects. Some have had their promising candidates
fail after extensive testing, due to dangerous side effects, but Gilead
Sciences is already raking in billions of dollars from its
groundbreaking new drug, Sovaldi.
Merck said Friday that once the tender offer closes, Idenix
stockholders will receive $24.50 in cash for each Idenix share validly
tendered and not withdrawn in the offer.
Idenix shares finished at $23.99 in Thursday.
The tender offer expires on Aug. 4, unless extended.
The boards of Merck and Idenix have approved the deal, which is
expected to close in the third quarter. Idenix will become a Merck
subsidiary.
In the race to find a faster cure for hepatitis C, Bristol-Myers Squibb Co said it will test its experimental antiviral drug combination with Gilead Sciences Inc's blockbuster drug Sovaldi, hoping to cut treatment time to four weeks.
Boehringer Ingelheim on Friday announced that following a strategic
review the company has decided against moving forward in the field of
hepatitis C. As such, the drugmaker indicated that it will withdraw all
regulatory filings for faldaprevir, which had been granted accelerated assessment by the European Medicines Agency, and will discontinue further development of the protease inhibitor.
All treatment-naive and previously treated participants using a combination pill containing Gilead Science's hepatitis C virus polymerase inhibitor sofosbuvir and NS5A inhibitor ledipasvir, without ribavirin, for 12 weeks achieved sustained virological response in a Phase 3 study in Japan, where most hepatitis C patients have HCV genotype 1b.
It remains uncertain whether systematic screening for hepatocellular carcinoma leads to a survival advantage in patients with chronic liver disease,...
Editor's Note: The treatment for hepatitis C is evolving rapidly, and
interferon-free options are now finally possible, with impressive
sustained viral response (SVR) rates. Medscape spoke with Donald M.
Jensen, MD, Professor of Medicine and Director of the Department of
Hepatology at the University of Chicago, about the new and forthcoming
treatment options for hepatitis C, some of which were presented at the
recent Digestive Disease Week (DDW) meeting; the collaboration of care
among providers in the treatment of patients; and an assessment of the
cost now versus the prior standard of care....
The aim of this study was to evaluate efficacy of the direct-acting protein inhibitor sofosbuvir in combination with RBV in treatment-naive patients with HCV genotype 1. What were the findings?
This consensus guideline provides expert opinion on the current best standard of care with available agents at this point in the rapid evolution of hepatitis C therapy.
This report outlines a care model which utilizes videoconferencing and case-based learning to enhance primary care provider capacity to treat HCV infection among underserved populations.
Direct acting antiviral agents provide new opportunities for treatment of HCV recurrence, but are there pitfalls? American Journal of Transplantation, June 2014
How long can hepatitis C virus live on a surface and still maintain its ability to infect?..
Connie M. Welch
Hep C Warriors Friday Forum Support Group
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