DeuteRx Presents DRX-065 for the Treatment of NASH at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
ANDOVER, Mass.--(BUSINESS WIRE)--DeuteRx LLC, a R&D-focused biotechnology company improving racemic small molecule marketed drugs and drug candidates, today announced an upcoming oral presentation at the AASLD Annual Meeting, being held in San Francisco, CA from November 13-17, 2015.
“Pioglitazone is one of the most widely studied drugs in NASH patients. Although clinical trial results are promising, pioglitazone’s use for the treatment of NASH is limited due to the adverse side effects of weight gain and fluid retention. DeuteRx’s preclinical data with the stabilized R-enantiomer of pioglitazone, DRX-065, offers the prospect of separating the undesired weight gain and fluid retention from the beneficial therapeutic properties for NASH,” says Dr. Scott Friedman, consultant to DeuteRx. “DRX-065 represents a potentially significant therapeutic improvement over pioglitazone for NASH patients.”
Oral Presentation Details
Presentation Date/Time: Monday, November 16, 2015; 4:00 – 4:15 p.m. PT
Title: DRX-065, the stabilized R-enantiomer of pioglitazone, is without PPARγ-agonist activity and exhibits the beneficial in vivopharmacodynamic effects for the treatment of NASH
Authors: Sheila H. DeWitt, Vincent Jacques, Lex H.T. Van der Ploeg
About DRX-065 and Non-alcoholic Steatohepatitis (NASH)
In preclinical experiments, DeuteRx demonstrated that DRX-065 has pharmacological properties desirable for the treatment of NASH (mitochondrial function modulation, non-steroidal anti-inflammatory effects, and glucose lowering effects) without the undesired PPARγ-related weight gain side effect. DeuteRx’s issued U.S. Patent #8,722,710 includes composition of matter claims to deuterium-enriched pioglitazone analogs, including DRX-065.
About DeuteRx LLC
DeuteRx is pioneering ‘deuterium-enabled chiral switching’ (DECS), a revolutionary approach to improve racemic (a mixture of two mirror-image compounds or enantiomers) small molecule marketed drugs and drug candidates intended for patients across multiple therapeutic indications. Numerous drugs are still developed and marketed as racemic mixtures because the enantiomers are chemically unstable and rapidly interconvert in vivo. To date, DeuteRx has demonstrated the use of DECS to stabilize the enantiomers of many racemic active ingredients. DeuteRx’s prioritized single enantiomer product assets are DRX-065 for adrenoleukodystrophy and NASH, DRX-164 for multiple myeloma and combination therapy with immuno-oncology drugs, DRX-194 for pediatric sickle cell disease, and DRX-184 for CNS disorders.
DeuteRx is a Boston-based biotechnology company founded in December 2012 as a spin-out company from Deuteria Pharmaceuticals Inc. Deuteria was sold to a major biopharmaceutical company in December 2012.
www.deuterx.com
Wednesday, November 11, 2015
Knowns and unknowns of US drug pricing
Knowns and unknowns of US drug pricing
November 11, 2015 by Joshua P. Cohen,
Plos Blogs
Media scrutiny of high drug costs
In the U.S. spending on drugs represents 10% of overall health care costs.(1) Together, hospital and physician expenditures account for 6 times the spending on drugs.(2) Despite a recent uptick in the rate of drug cost growth, over the past 10 years the pace of hospital and physician expenditures has exceeded prescription drugs.(2) Apparently, these facts do not make for eye-catching headlines. By contrast, the recent surge in the price of drugs targeting hepatitis C, HIV, and various cancer and orphan diseases, is salient and the focal point of media attention. For example, last month's reported 50-fold price increase of Daraprim drew the ire of politicians, policymakers, and patient advocates. Here, we unravel several mysteries surrounding drug pricing and alignment of price and value.
Why is pricing in the U.S. different?
Lack of price controls distinguishes the U.S. from other countries. Moreover, the U.S. does not have a government authority that serves as a single purchaser of drugs and manager of a national formulary. Consequently, the leverage each U.S. purchaser has to exert downward pressure on prices is limited compared to a single-payer system, or multi-payer arrangements in which the government oversees drug procurement. The prices of single-source drugs are on average approximately 30% higher in the U.S. than other comparable industrialized nations.(3)(4)
Higher prices are a driver of higher healthcare costs. However, the impact of higher prices on patient access cuts two ways: They establish incentives for drug manufacturers to launch more drugs earlier (than in markets where there are price controls), which can imply greater access. At the same time, they lead to increases in patient cost-sharing, which can be a barrier to access.
Higher branded drug prices induce a relatively competitive generics market once patents expire, with generics representing over 80% of prescriptions. As such, the U.S. has a higher rate of generic prescriptions than most other industrialized nations.(5) Generics therefore generally serve as a countervailing force to increases in branded prices, as generics are less prone to suboptimal market conditions. Nevertheless, there have been examples of market failure – Daraprim being Exhibit A – when the supply of generics is handled by only one or a few manufacturers.
Although price controls may help reduce the level of spending on drugs and patient cost-sharing they do not resolve the price-value conundrum. This is because of the arbitrary nature of price controls. To illustrate, if policymakers were to impose an arbitrarily chosen $100,000 ceiling on cancer drug prices without reference to the benefits conferred by each individual drug, then there would be no connection between the price ceiling and value. In other words, the price ceiling fails to distinguish between drugs which provide benefits that justify prices at or above $100,000, from those that do not. The use of cost-effectiveness thresholds to exert control over price does incorporate measurement of benefits, and as such constitutes an improvement. However, the numeric ratios that comprise cost-effectiveness thresholds (e.g., £20,000/QALY used by NICE) are set in a similarly arbitrary way and often do not change over time.
How are drugs priced in the US?
The American public is generally not privy to the pricing of drugs – the process by which drugs are priced – or even the negotiated prices at which drugs are bought and sold. This lack of transparency does not, however, preclude researchers from being able to gather evidence (some anecdotal, some revealed in publicly available documents) on the general contours of pricing.
Here's what we do know about how drugs are priced by pharmaceutical companies:
How high can we go?
Media scrutiny of high drug costs
In the U.S. spending on drugs represents 10% of overall health care costs.(1) Together, hospital and physician expenditures account for 6 times the spending on drugs.(2) Despite a recent uptick in the rate of drug cost growth, over the past 10 years the pace of hospital and physician expenditures has exceeded prescription drugs.(2) Apparently, these facts do not make for eye-catching headlines. By contrast, the recent surge in the price of drugs targeting hepatitis C, HIV, and various cancer and orphan diseases, is salient and the focal point of media attention. For example, last month's reported 50-fold price increase of Daraprim drew the ire of politicians, policymakers, and patient advocates. Here, we unravel several mysteries surrounding drug pricing and alignment of price and value.
Why is pricing in the U.S. different?
Lack of price controls distinguishes the U.S. from other countries. Moreover, the U.S. does not have a government authority that serves as a single purchaser of drugs and manager of a national formulary. Consequently, the leverage each U.S. purchaser has to exert downward pressure on prices is limited compared to a single-payer system, or multi-payer arrangements in which the government oversees drug procurement. The prices of single-source drugs are on average approximately 30% higher in the U.S. than other comparable industrialized nations.(3)(4)
Higher prices are a driver of higher healthcare costs. However, the impact of higher prices on patient access cuts two ways: They establish incentives for drug manufacturers to launch more drugs earlier (than in markets where there are price controls), which can imply greater access. At the same time, they lead to increases in patient cost-sharing, which can be a barrier to access.
Higher branded drug prices induce a relatively competitive generics market once patents expire, with generics representing over 80% of prescriptions. As such, the U.S. has a higher rate of generic prescriptions than most other industrialized nations.(5) Generics therefore generally serve as a countervailing force to increases in branded prices, as generics are less prone to suboptimal market conditions. Nevertheless, there have been examples of market failure – Daraprim being Exhibit A – when the supply of generics is handled by only one or a few manufacturers.
Although price controls may help reduce the level of spending on drugs and patient cost-sharing they do not resolve the price-value conundrum. This is because of the arbitrary nature of price controls. To illustrate, if policymakers were to impose an arbitrarily chosen $100,000 ceiling on cancer drug prices without reference to the benefits conferred by each individual drug, then there would be no connection between the price ceiling and value. In other words, the price ceiling fails to distinguish between drugs which provide benefits that justify prices at or above $100,000, from those that do not. The use of cost-effectiveness thresholds to exert control over price does incorporate measurement of benefits, and as such constitutes an improvement. However, the numeric ratios that comprise cost-effectiveness thresholds (e.g., £20,000/QALY used by NICE) are set in a similarly arbitrary way and often do not change over time.
How are drugs priced in the US?
The American public is generally not privy to the pricing of drugs – the process by which drugs are priced – or even the negotiated prices at which drugs are bought and sold. This lack of transparency does not, however, preclude researchers from being able to gather evidence (some anecdotal, some revealed in publicly available documents) on the general contours of pricing.
Here's what we do know about how drugs are priced by pharmaceutical companies:
How high can we go?
When deciding upon a new drug's list price, companies perform a pre-approval assessment prior to regulatory approval, positioning the drug relative to comparators, which includes an evaluation of the anticipated price sensitivity of payers, patients, and healthcare providers.
What added benefits does it provide?
What added benefits does it provide?
If companies believe the drug provides additional benefits compared to existing treatment, this will be incorporated in the price point offered at launch. Furthermore, if companies anticipate a high willingness to pay on the part of payers because of a certain property the drug has – targets a rare disease, has a novel mechanism of action, addresses an unmet medical need – this will be reflected in the list price.
What does it cost to make?
When pricing a new drug, companies take marginal cost of production into account, i.e., the cost of producing each additional unit, such as a pill or vial. The marginal cost of production is significantly higher for large-molecule biologics than small-molecule pharmaceuticals, because the manufacturing process is more complex. Marginal cost of production is distinct from the cost of drug development. The former is a function of production once a drug is approved, while cost of development refers to resources allocated to developing a new drug prior to its approval.
What about R&D and its relation to price?
The rationale that we intentionally omit from the list above is cost of development. Some in industry have justified high prices of branded drugs as a way of recouping investment in drug development. This is a flawed argument, however. While a company's revenue from its portfolio of marketed products will have to exceed its operating costs in order to remain a going concern, the level of investment in a product should bear little or no relation to its market price. It is a sunk cost. In a competitive market setting, purchasers do not pay for a product's cost of research. They pay for a product's perceived value relative to other products. Hence, asserting that the reason a product is x dollars is because so much effort was put into it is inconsistent with market principles. Critics of the current system of pricing where price and value may not be optimally aligned suggest therefore that drug prices should be value- and not cost-based. This implies the need to establish measures of a drug's value.
Then what?
Once a manufacturer sets a price payers express a willingness to pay at that price or not. A negotiation will likely ensue resulting in a transaction price lower than the list price. Mutually agreed upon transaction prices are value-based to the extent that they reflect how much purchasers are willing to pay for a drug, provided several key assumptions underlying a competitive market hold.
But does price = value?
Notably, by design the pharmaceutical market lacks certain features of a competitive market. First, drugs are patented as single-source (branded) monopoly products for a period of marketing exclusivity. It is during this period without generic competition that companies can charge a price that is higher than the marginal cost of production. Second, third-party insurance shields patients from the actual cost of prescription drugs, which may encourage higher prices. Third, the existence of asymmetries in information between suppliers and purchasers of drugs, as well as prescribers and users, drives a wedge between price and value. Buyers cannot readily ascertain the value of the drugs offered.
What are the alternatives?
The Drug Abacus developed by Peter Bach of the Memorial Sloane Kettering Cancer Center is one proposed solution to establish the value of newly approved drugs.(6) Based on data drug manufacturers submit to FDA for approval, the Drug Abacus enables a patient or healthcare provider to decide a drug's value, based on a number of factors which include a willingness to pay amount for added life years conferred by the drug, perceived toxicity, convenience, rarity of disease targeted, and novelty of mechanism of action. As a gauge to align price and value the Drug Abacus is a useful first step. However, it suffers from an overly optimistic view of what is known about a drug's real-world effectiveness at launch.
Summary
Drug pricing is complex, and its impact on healthcare systems varied. Absent a competitive market, a drug's price and value may differ.While the Drug Abacus is a good first step as a gauge to align price and value, it will rely on the generation of significantly more safety and effectiveness evidence than currently exists, not only at launch but also post-launch. Moreover, the evaluation of evidence will have to take place in a dynamic setting, i.e., over time, in order to better align price and value. In this respect, pay-for-performance arrangements may be an option in cases in which there is great uncertainty at launch. Here, payers collect real-world data on a drug's safety and effectiveness post-launch and price is linked to outcomes.
What about R&D and its relation to price?
The rationale that we intentionally omit from the list above is cost of development. Some in industry have justified high prices of branded drugs as a way of recouping investment in drug development. This is a flawed argument, however. While a company's revenue from its portfolio of marketed products will have to exceed its operating costs in order to remain a going concern, the level of investment in a product should bear little or no relation to its market price. It is a sunk cost. In a competitive market setting, purchasers do not pay for a product's cost of research. They pay for a product's perceived value relative to other products. Hence, asserting that the reason a product is x dollars is because so much effort was put into it is inconsistent with market principles. Critics of the current system of pricing where price and value may not be optimally aligned suggest therefore that drug prices should be value- and not cost-based. This implies the need to establish measures of a drug's value.
Then what?
Once a manufacturer sets a price payers express a willingness to pay at that price or not. A negotiation will likely ensue resulting in a transaction price lower than the list price. Mutually agreed upon transaction prices are value-based to the extent that they reflect how much purchasers are willing to pay for a drug, provided several key assumptions underlying a competitive market hold.
But does price = value?
Notably, by design the pharmaceutical market lacks certain features of a competitive market. First, drugs are patented as single-source (branded) monopoly products for a period of marketing exclusivity. It is during this period without generic competition that companies can charge a price that is higher than the marginal cost of production. Second, third-party insurance shields patients from the actual cost of prescription drugs, which may encourage higher prices. Third, the existence of asymmetries in information between suppliers and purchasers of drugs, as well as prescribers and users, drives a wedge between price and value. Buyers cannot readily ascertain the value of the drugs offered.
What are the alternatives?
The Drug Abacus developed by Peter Bach of the Memorial Sloane Kettering Cancer Center is one proposed solution to establish the value of newly approved drugs.(6) Based on data drug manufacturers submit to FDA for approval, the Drug Abacus enables a patient or healthcare provider to decide a drug's value, based on a number of factors which include a willingness to pay amount for added life years conferred by the drug, perceived toxicity, convenience, rarity of disease targeted, and novelty of mechanism of action. As a gauge to align price and value the Drug Abacus is a useful first step. However, it suffers from an overly optimistic view of what is known about a drug's real-world effectiveness at launch.
Summary
Drug pricing is complex, and its impact on healthcare systems varied. Absent a competitive market, a drug's price and value may differ.While the Drug Abacus is a good first step as a gauge to align price and value, it will rely on the generation of significantly more safety and effectiveness evidence than currently exists, not only at launch but also post-launch. Moreover, the evaluation of evidence will have to take place in a dynamic setting, i.e., over time, in order to better align price and value. In this respect, pay-for-performance arrangements may be an option in cases in which there is great uncertainty at launch. Here, payers collect real-world data on a drug's safety and effectiveness post-launch and price is linked to outcomes.
Dr. Joshua P. Cohen joined the Tufts Center for the Study of Drug Development in 1999. He was appointed research associate professor in 2014. As a health economist he examines public policy issues that concern prescription drug reimbursement and patient access to biopharmaceuticals. His areas of research include the impact of evidence-based medicine and comparative effectiveness research on prescribing and reimbursement decisions, pharmacy benefits management as it relates to personalized medicine, uptake of biosimilars in the U.S. and Europe, patient access to biopharmaceuticals in the U.S. and Europe, and progress in drug development targeting neglected diseases. Dr. Cohen writes and speaks regularly at international academic and trade conferences on these topics.
References
Keehan et al. 2015: http://content.healthaffairs.org/content/early/2015/07/15/hlthaff.2015.0600
CMS: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsHistorical.html
OECD: http://www.oecd.org/health/healthpoliciesanddata/49084355.pdf
Cohen et al. 2013:http://content.healthaffairs.org/content/32/4/762.abstract
IMS Health:
Bach 2015: https://hbr.org/2015/10/a-new-way-to-define-value-in-drug-pricing
This story is republished courtesy of PLOS Blogs: blogs.plos.org.
Related On This Blog
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.
Keehan et al. 2015: http://content.healthaffairs.org/content/early/2015/07/15/hlthaff.2015.0600
CMS: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsHistorical.html
OECD: http://www.oecd.org/health/healthpoliciesanddata/49084355.pdf
Cohen et al. 2013:http://content.healthaffairs.org/content/32/4/762.abstract
IMS Health:
Bach 2015: https://hbr.org/2015/10/a-new-way-to-define-value-in-drug-pricing
This story is republished courtesy of PLOS Blogs: blogs.plos.org.
Related On This Blog
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.
$14 Million PCORI Research Grant Awarded to Montefiore and Einstein to Fund Hepatitis C Research
$14 Million PCORI Research Grant Awarded to Montefiore and Einstein to Fund Hepatitis C Research
To view the original version on PR Newswire, visit:
http://www.prnewswire.com/news-releases/14-million-pcori-research-grant-awarded-to-montefiore-and-einstein-to-fund-hepatitis-c-research-300176311.html
SOURCE Montefiore Health System
The Patient-Centered Outcomes Research Institute Funds Unique Study on Care for Those Who Inject Drugs
NEW YORK, Nov. 11, 2015 /PRNewswire-USNewswire/ -- A research team at Montefiore Health System and Albert Einstein College of Medicine led by Alain Litwin, M.D., was awarded $14 million by the Patient-Centered Outcomes Research Institute (PCORI) to determine how best to treat hepatitis C among people who inject drugs (PWID), a group with a high rate of infection. A follow up portion of the study will also seek to understand why some patients develop resistance to therapies for the hepatitis C virus (HCV), which causes the damaging liver disease.
"This study has major implications for controlling hepatitis C infection and reinfection rates," said Dr. Litwin, attending physician, internal medicine, Montefiore Health System and professor of medicine, Albert Einstein College of Medicine. "Unfortunately, people who inject drugs rarely get effective, safe treatments because there is a concern that they won't take their medication or that they might become reinfected. Determining the best model of care will help us avert grave consequences of chronic infection for many people and reduce the spread of the virus in the communities we serve and beyond."
The national, multi-site study, titled Patient-Centered Models of HCV Care for People Who Inject Drugs, will involve 1,000 PWID infected with HCV. Investigators will compare two models of care that have proven effective: directly observed treatment (DOT), where patients take medication in front of a staff member, and the Patient Navigator (PN) model, where patients take their medications home and receive support and education from public health workers. The research team will evaluate which model produces the best results and is preferred by patients.
Guided by a national stakeholder group led by the Centers for Disease Control and Prevention, the study will be conducted in conjunction with John Hopkins Bloomberg School of Public Health, Warren Alpert Medical School of Brown University, Harvard Medical School, University of Cincinnati College of Medicine, University of Washington School of Medicine, University of California, San Francisco, University of New Mexico Health Sciences Center, and The New York City Department of Health and Mental Hygiene. Other key stakeholders in the study include Treatment Action Group, National AIDS Treatment Advocacy Group, Harm Reduction Coalition, National Alliance for Medication Assisted Recovery, Medication Assisted Recovery Services, Hepatitis Support and Mentor Group, Project Inform, Hepatitis Education Project, National Viral Hepatitis Roundtable, New York State Department of Health, New York City Department of Health, Gilead Sciences, OraSure Technologies, Quest Diagnostics, and Monogram Biosciences.
An estimated 146,500 New Yorkers and 2.7 million Americans have chronic hepatitis C, although about half do not know that they are infected. Hepatitis C is a liver disease that results from infection with the hepatitis C virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong condition. Hepatitis C is usually spread when blood from a person infected with hepatitis C enters the blood stream of someone who is not infected. Today, people most often become infected with hepatitis C by sharing needles or other equipment to inject drugs. In additional to conducting research to help doctors better care for those with addictions, Montefiore offers an array of substance abuse programs.
This award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
NEW YORK, Nov. 11, 2015 /PRNewswire-USNewswire/ -- A research team at Montefiore Health System and Albert Einstein College of Medicine led by Alain Litwin, M.D., was awarded $14 million by the Patient-Centered Outcomes Research Institute (PCORI) to determine how best to treat hepatitis C among people who inject drugs (PWID), a group with a high rate of infection. A follow up portion of the study will also seek to understand why some patients develop resistance to therapies for the hepatitis C virus (HCV), which causes the damaging liver disease.
"This study has major implications for controlling hepatitis C infection and reinfection rates," said Dr. Litwin, attending physician, internal medicine, Montefiore Health System and professor of medicine, Albert Einstein College of Medicine. "Unfortunately, people who inject drugs rarely get effective, safe treatments because there is a concern that they won't take their medication or that they might become reinfected. Determining the best model of care will help us avert grave consequences of chronic infection for many people and reduce the spread of the virus in the communities we serve and beyond."
The national, multi-site study, titled Patient-Centered Models of HCV Care for People Who Inject Drugs, will involve 1,000 PWID infected with HCV. Investigators will compare two models of care that have proven effective: directly observed treatment (DOT), where patients take medication in front of a staff member, and the Patient Navigator (PN) model, where patients take their medications home and receive support and education from public health workers. The research team will evaluate which model produces the best results and is preferred by patients.
Guided by a national stakeholder group led by the Centers for Disease Control and Prevention, the study will be conducted in conjunction with John Hopkins Bloomberg School of Public Health, Warren Alpert Medical School of Brown University, Harvard Medical School, University of Cincinnati College of Medicine, University of Washington School of Medicine, University of California, San Francisco, University of New Mexico Health Sciences Center, and The New York City Department of Health and Mental Hygiene. Other key stakeholders in the study include Treatment Action Group, National AIDS Treatment Advocacy Group, Harm Reduction Coalition, National Alliance for Medication Assisted Recovery, Medication Assisted Recovery Services, Hepatitis Support and Mentor Group, Project Inform, Hepatitis Education Project, National Viral Hepatitis Roundtable, New York State Department of Health, New York City Department of Health, Gilead Sciences, OraSure Technologies, Quest Diagnostics, and Monogram Biosciences.
An estimated 146,500 New Yorkers and 2.7 million Americans have chronic hepatitis C, although about half do not know that they are infected. Hepatitis C is a liver disease that results from infection with the hepatitis C virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong condition. Hepatitis C is usually spread when blood from a person infected with hepatitis C enters the blood stream of someone who is not infected. Today, people most often become infected with hepatitis C by sharing needles or other equipment to inject drugs. In additional to conducting research to help doctors better care for those with addictions, Montefiore offers an array of substance abuse programs.
This award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
To view the original version on PR Newswire, visit:
http://www.prnewswire.com/news-releases/14-million-pcori-research-grant-awarded-to-montefiore-and-einstein-to-fund-hepatitis-c-research-300176311.html
SOURCE Montefiore Health System
Faster, Cheaper Hep C Cures on the Horizon?
WebMD Health News
Reviewed by Arefa Cassoobhoy, MD, MPH
Nov. 10, 2015 -- In an ecstatic post to her Instagram followers yesterday, Pamela Anderson revealed that she’s been cured of hepatitis C.
She’s short on specifics, but tells other people who are infected not to lose hope and promises that the cure she got “will be more available soon.”
Is she right?
To find out, we reached out to Raymond Schinazi, PhD. He’s the director of the Laboratory of Biochemical Pharmacology at Emory University in Atlanta.
Schinazi has had a hand in developing five lifesaving antiviral drugs, including sofosbuvir (Sovaldi), one of several new treatments that can wipe out hepatitis C infections in nearly everybody who takes them. (He reportedly made $440 million when he sold the rights to that drug to the pharmaceutical company Gilead.)
Reviewed by Arefa Cassoobhoy, MD, MPH
Nov. 10, 2015 -- In an ecstatic post to her Instagram followers yesterday, Pamela Anderson revealed that she’s been cured of hepatitis C.
She’s short on specifics, but tells other people who are infected not to lose hope and promises that the cure she got “will be more available soon.”
Is she right?
To find out, we reached out to Raymond Schinazi, PhD. He’s the director of the Laboratory of Biochemical Pharmacology at Emory University in Atlanta.
Schinazi has had a hand in developing five lifesaving antiviral drugs, including sofosbuvir (Sovaldi), one of several new treatments that can wipe out hepatitis C infections in nearly everybody who takes them. (He reportedly made $440 million when he sold the rights to that drug to the pharmaceutical company Gilead.)
Tuesday, November 10, 2015
Antivirals May Reduce the Need for Recurrent Transplants in HCV
Antivirals May Reduce the Need for Recurrent Transplants in HCV
Michael R. Page, PharmD, RPh
Publish Date: Tuesday, November 10, 2015
Direct-acting antivirals may help eradicate hepatitis C virus in patients who recently had a liver transplant, reducing the need for further transplants.
Hepatitis C virus infection (HCVI) creates a need for more liver transplants in Westernized countries than any other disease.
Reinfection of a transplanted liver with HCV may result in a second, third, or even fourth transplant as the virus destroys each new transplanted organ. More than one-fourth (27%) and up to 42% of all repeat liver transplants performed in the United States are a result of HCVI-related graft damage.
After a transplant, the course of liver damage is much more aggressive due to use of immunosuppressive therapy. Within 5 years of the initial transplant, approximately 80% to 95% of patients develop chronic hepatitis, and 10% to 28% of patients develop cirrhosis.
Nearly half (42%) of patients with cirrhosis will develop decompensated liver disease within 1 year. Liver supplies are limited, and often a second transplant is unavailable. An estimated 15,000 patients die of HCV-related complications in the United States each year.
With effective treatments for HCVI, the need for repeat liver transplants is expected to shrink in coming years.
A reduced need for liver transplant may help shrink the lifetime cost of HCV. Current estimates place the lifetime costs at $65,000 to $270,000 per patient.
In patients who have had a liver transplant for an initial case of HCV, traditional peginterferon-based therapy results in sustained viral response (SVR), or functional cure, in 10% to 25% of patients. These results are improving with the availability of direct-acting antivirals (DAAs).
In a 103-patient trial, the combination of sofosbuvir and ribavirin led to more than half (59%) of all patients experiencing SVR. A much higher cure rate occurred in a subgroup of patients with early HCV recurrence—nearly three-fourths (73%) of these patients achieved SVR.
Subsequently, a 40-patient open-label trial of sofosbuvir and ribavirin in patients with early HCV recurrence after a transplant showed similar results, with SVR occurring in 70% of treated patients.
Similarly, a study of Viekira Pak (ombitasvir, paritaprevir, dasabuvir, and ritonavir) in a 34-patient subgroup of the CORAL-1 trial revealed a 97% rate of SVR in patients who had previously received a liver transplant and had a mild recurrence of HCVI.
A growing body of evidence supports use of DAA therapy in patients who have undergone a liver transplant to eradicate any remaining HCV to reduce the need for further transplants.
Both sofosbuvir-based regimens and Viekira Pak appear to have important applications in the conservation of limited liver supplies through HCV eradication after an initial liver transplant.
Reference
Mitchell O, Gurakar A. Management of Hepatitis C Post-liver Transplantation: a Comprehensive Review. J Clin Transl Hepatol. 2015;3(2):140-148.
Michael R. Page, PharmD, RPh
Publish Date: Tuesday, November 10, 2015
Direct-acting antivirals may help eradicate hepatitis C virus in patients who recently had a liver transplant, reducing the need for further transplants.
Hepatitis C virus infection (HCVI) creates a need for more liver transplants in Westernized countries than any other disease.
Reinfection of a transplanted liver with HCV may result in a second, third, or even fourth transplant as the virus destroys each new transplanted organ. More than one-fourth (27%) and up to 42% of all repeat liver transplants performed in the United States are a result of HCVI-related graft damage.
After a transplant, the course of liver damage is much more aggressive due to use of immunosuppressive therapy. Within 5 years of the initial transplant, approximately 80% to 95% of patients develop chronic hepatitis, and 10% to 28% of patients develop cirrhosis.
Nearly half (42%) of patients with cirrhosis will develop decompensated liver disease within 1 year. Liver supplies are limited, and often a second transplant is unavailable. An estimated 15,000 patients die of HCV-related complications in the United States each year.
With effective treatments for HCVI, the need for repeat liver transplants is expected to shrink in coming years.
A reduced need for liver transplant may help shrink the lifetime cost of HCV. Current estimates place the lifetime costs at $65,000 to $270,000 per patient.
In patients who have had a liver transplant for an initial case of HCV, traditional peginterferon-based therapy results in sustained viral response (SVR), or functional cure, in 10% to 25% of patients. These results are improving with the availability of direct-acting antivirals (DAAs).
In a 103-patient trial, the combination of sofosbuvir and ribavirin led to more than half (59%) of all patients experiencing SVR. A much higher cure rate occurred in a subgroup of patients with early HCV recurrence—nearly three-fourths (73%) of these patients achieved SVR.
Subsequently, a 40-patient open-label trial of sofosbuvir and ribavirin in patients with early HCV recurrence after a transplant showed similar results, with SVR occurring in 70% of treated patients.
Similarly, a study of Viekira Pak (ombitasvir, paritaprevir, dasabuvir, and ritonavir) in a 34-patient subgroup of the CORAL-1 trial revealed a 97% rate of SVR in patients who had previously received a liver transplant and had a mild recurrence of HCVI.
A growing body of evidence supports use of DAA therapy in patients who have undergone a liver transplant to eradicate any remaining HCV to reduce the need for further transplants.
Both sofosbuvir-based regimens and Viekira Pak appear to have important applications in the conservation of limited liver supplies through HCV eradication after an initial liver transplant.
Reference
Mitchell O, Gurakar A. Management of Hepatitis C Post-liver Transplantation: a Comprehensive Review. J Clin Transl Hepatol. 2015;3(2):140-148.
Grazoprevir, Elbasvir Combination Effective for Patients With Hepatitis C, Kidney Disease: Presented at Kidney Week
Grazoprevir, Elbasvir Combination Effective for Patients With Hepatitis C, Kidney Disease: Presented at Kidney Week
By Nancy A. Melville
By Nancy A. Melville
Source
SAN DIEGO -- November 10, 2015 -- The combination of grazoprevir (GZR) and elbasvir (EBR), in a single tablet, shows strong efficacy in the treatment of hepatitis C virus (HCV) in patients with stage 4 or 5 chronic kidney disease (CKD), researchers reported here at Kidney Week 2015, the Annual Meeting of the American Society of Nephrology (ASN).
The once-daily therapy combines a NS3/4A protease inhibitor and an NS5A replication complex inhibitor and is being investigated for a variety of HCV genotypes and in conditions ranging from HIV/HCV co-infection to opiate substitution therapy and liver cirrhosis.
The C-SURFER trial included 224 patients with stage 4 or 5 CKD who were on haemodialysis and had concomitant HCV genotype 1. Patients were randomised to either immediate treatment with GZR/EBR 100 mg/50 mg (n = 111) or deferred treatment, which consisted of placebo for 12 weeks followed by GZR/EBR 100 mg/50 mg.
The sustained virologic response (SVR) rate 12 weeks post-therapy in the GZR/EBR group was 94.6%, compared with 95% in placebo-treated patients after receiving deferred treatment.
The overall SVR rate after 12 weeks was 98.6%, excluding patients who had discontinued for reasons not related to the study drug.
Among 12 patients who failed to achieve SVR at 12 weeks, 3 had a virologic relapse, 1 discontinued due to an adverse event and 8 had administrative reasons.
Serious adverse events were reported in 16 (14%) patients in the GZR/EBR group and in 17 (15%) patients in the placebo group prior to their deferred treatment. The rate of discontinuation due to an adverse event in GZR/EBR-treated patients was 0% versus 4% in placebo-treated patients.
“Once-daily GZR/EBR for 12 weeks was highly effective with a low rate of adverse events in patients with advanced kidney disease and HCV genotype 1 infection,” wrote David Roth, MD, University of Miami, Miami, Florida, and colleagues in their presentation.
Funding for this study was provided by Merck.
[Presentation title: Grazoprevir (GZR)/Elbasvir (EBR) Treatment of Hepatitis C Virus (HCV) Infection in Patients With Chronic Kidney Disease Stage 4/5: Final Results of the C-SURFER Phase 3 Study]
To read more Conference Dispatch articles, click here.
SAN DIEGO -- November 10, 2015 -- The combination of grazoprevir (GZR) and elbasvir (EBR), in a single tablet, shows strong efficacy in the treatment of hepatitis C virus (HCV) in patients with stage 4 or 5 chronic kidney disease (CKD), researchers reported here at Kidney Week 2015, the Annual Meeting of the American Society of Nephrology (ASN).
The once-daily therapy combines a NS3/4A protease inhibitor and an NS5A replication complex inhibitor and is being investigated for a variety of HCV genotypes and in conditions ranging from HIV/HCV co-infection to opiate substitution therapy and liver cirrhosis.
The C-SURFER trial included 224 patients with stage 4 or 5 CKD who were on haemodialysis and had concomitant HCV genotype 1. Patients were randomised to either immediate treatment with GZR/EBR 100 mg/50 mg (n = 111) or deferred treatment, which consisted of placebo for 12 weeks followed by GZR/EBR 100 mg/50 mg.
The sustained virologic response (SVR) rate 12 weeks post-therapy in the GZR/EBR group was 94.6%, compared with 95% in placebo-treated patients after receiving deferred treatment.
The overall SVR rate after 12 weeks was 98.6%, excluding patients who had discontinued for reasons not related to the study drug.
Among 12 patients who failed to achieve SVR at 12 weeks, 3 had a virologic relapse, 1 discontinued due to an adverse event and 8 had administrative reasons.
Serious adverse events were reported in 16 (14%) patients in the GZR/EBR group and in 17 (15%) patients in the placebo group prior to their deferred treatment. The rate of discontinuation due to an adverse event in GZR/EBR-treated patients was 0% versus 4% in placebo-treated patients.
“Once-daily GZR/EBR for 12 weeks was highly effective with a low rate of adverse events in patients with advanced kidney disease and HCV genotype 1 infection,” wrote David Roth, MD, University of Miami, Miami, Florida, and colleagues in their presentation.
Funding for this study was provided by Merck.
[Presentation title: Grazoprevir (GZR)/Elbasvir (EBR) Treatment of Hepatitis C Virus (HCV) Infection in Patients With Chronic Kidney Disease Stage 4/5: Final Results of the C-SURFER Phase 3 Study]
To read more Conference Dispatch articles, click here.
President of Malta presents €1.2 million worth of Hepatitis C medication to government
President presents €1.2 million worth of Hepatitis C medication to government
The President said that she is satisfied that after a year and a half of negotiations and talks, she has managed to get extraordinary prices for this medicine, which totally cures Hepatitis C. The President initially held talks with specialists who made her aware of the new complete cure for Hepatitis C. Further discussions were held with the pharmaceutical company supplying the drug in Malta, A M Mangion Ltd., and Gilead, the global company that developed and manufactured the cure. Following negotiations held both in Malta and abroad, the President succeeded in attaining exceptional rates to provide the cure the cure for Hepatitis C.Continue reading...
Sunday, November 8, 2015
Nov 2015 HCV Newsletter and Blog Updates
In The News
Hospital employees stealing drugs a growing problem, experts say
SALT LAKE CITY - After the discovery that up to 4,800 patients at McKay-Dee Hospital in Ogden may have been exposed tohepatitis C - and that a former nurse who was stealing morphine may have been the source - patients and hospital officials alike ...
The great European drug problem
France secured Europe's lowest price for treatment with the drug that precipitated much of the current debate on pricing, the so-called “miracle drug” for hepatitis C, Sovaldi: it pays €41,000 for a 12-week course, compared to €77,000 in the United States.
Project Inform hosts community/provider event on Hep C
France secured Europe's lowest price for treatment with the drug that precipitated much of the current debate on pricing, the so-called “miracle drug” for hepatitis C, Sovaldi: it pays €41,000 for a 12-week course, compared to €77,000 in the United States.
Project Inform hosts community/provider event on Hep C
On Monday, November 16th, Project Inform, along with five other leading hepatitis advocacy organizations, will host a meeting bringing together front-line hepatitis C providers with community advocates to discuss how they can partner together to increase access to vital services and health care. The event, titled “Beyond the Walls of the Clinic,” will take place during the American Association for the Study of Liver Diseases’s (AASLD) annual meeting in San Francisco, and though not officially affiliated with AASLD, is expected to attract providers who have come from all over the country for the conference
D.C. Week: Drug Prices Raise Hackles in Congress
Also, White House releases official text of controversial Pacific trade deal
Researchers provide updated HBV treatment algorithm
A panel of U.S. hepatologists convened and provided recommendations for updating the treatment algorithm for hepatitis B virus infection, according to a treatment report…
Hepatitis C Still Focus of Liver Meeting
SAN FRANCISCO - The latest trials of combination hepatitis C drugs aimed at specific genotypes will get top billing at this year's Liver Meeting.
Federal Judge Approves Health Department Subpoena inHepatitis C Lawsuit
A federal judge has granted a motion to subpoena the North Dakota Department of Health as part of the ongoing case in the Hepatitis C outbreak in ...
Utah Hospital Warns 4800 People of Possible Hepatitis C Exposure
Health officials started an investigation after a patient had the same rare type of the hepatitis C virus as a nurse who worked in the emergency room.
How the VA chooses who gets Hepatitis C cure
Military veterans are more likely to have Hepatitis C than the general population. According to the Denver VA, 4,000 veterans have been diagnosed in their region, which covers Colorado, Wyoming and Montana.
Actress Pamela Anderson Cures Hepatitis C With Antiviral Medication: Why ...
In 2002, after reportedly sharing a tattoo needle with ex-husband Tommy Lee, Pamela Anderson contracted hepatitis C - a liver disease caused by the hep C virus. The former Baywatch star had been relatively quiet about her diagnosis until opening up to ...
Research - Publications
A New Era of Therapy for Hepatitis C Virus Infection
Current Opinion in Infectious Diseases, November 9, 2015
Hepatitis C virus-associated neurocognitive and neuropsychiatric disorders: Advances in 2015
Neurocognitive dysfunction, sleep disturbance, depression, fatigue and reduced quality of life are common manifestations of chronic hepatitis C virus (HCV) infection. Neuropsychological performance is impaired in HCV patients, in the absence of structural brain alterations on conventional magnetic resonance imaging (MRI). Brain metabolic and microstructural changes are easily detected by in vivo proton magnetic resonance spectroscopy and perfusion-weighted/diffusion tensor MRI, enabling detection of brain dysfunction in clinically asymptomatic subjects. The regional distribution of metabolic changes indicates an exclusive involvement of telencephalic areas, but not the diencephalon or brainstem. HCV is likely to play a major pathogenic role in these disorders.
Alcoholic Hepatitis and HCV Interactions in the Modulation of Liver Disease
Alcoholic liver disease and chronic HCV infection together are the most common causes of liver disease, and can promote rapid disease progression. How should patients with these concurrent diseases be treated?A New Era of Therapy for Hepatitis C Virus Infection
Current Opinion in Infectious Diseases, November 9, 2015
Hepatitis C virus-associated neurocognitive and neuropsychiatric disorders: Advances in 2015
Neurocognitive dysfunction, sleep disturbance, depression, fatigue and reduced quality of life are common manifestations of chronic hepatitis C virus (HCV) infection. Neuropsychological performance is impaired in HCV patients, in the absence of structural brain alterations on conventional magnetic resonance imaging (MRI). Brain metabolic and microstructural changes are easily detected by in vivo proton magnetic resonance spectroscopy and perfusion-weighted/diffusion tensor MRI, enabling detection of brain dysfunction in clinically asymptomatic subjects. The regional distribution of metabolic changes indicates an exclusive involvement of telencephalic areas, but not the diencephalon or brainstem. HCV is likely to play a major pathogenic role in these disorders.
Alcoholic Hepatitis and HCV Interactions in the Modulation of Liver Disease
November 06, 2015
November 05, 2015
Hepatitis C virus infection: Are there still specific problems with genotype 3?
This article reviews the complex relationship between hepatitis C virus (HCV) genotypes and the possible complications in chronically infected patients. We discuss recent updates on the epidemiology and clinical aspects of HCV genotype 3 infection, including the currently available therapies. We also describe model systems to study the HCV genotype-specific molecular mechanisms.
Therapy With Direct-Acting Antivirals for Genotype 3 Patients: Interferon's Last Gasp? Commentary
Hepatitis C virus (HCV) genotypes (GTs) 2 and 3 account for approximately 40% of infections by this virus worldwide.1 Patients with HCV GT3 have more rapid disease progression and are less responsive to treatment than those with GT2,2 and GT3 infection is considered relatively difficult to cure with the available direct-acting antivirals
A retroactive study presented at the 2015 Annual Meeting for the American College of Gastroenterology (ACG) suggests that diabetes increases the risk for hepatocellular carcinoma. Hepatocellular carcinoma is the most common form of liver cancer. The disease generally occurs secondary to hepatitis C infection or in cirrhosis from other causes.
Clinical Trial
Harvoni for Acute Hepatitis C
Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection (SWIFT-C)
ClinicalTrials.gov Identifier:
NCT02128217
Find Way to Focus on Dietary Supplement Safety, Experts Say
A former principal deputy commissioner of the U.S. Food and Drug Administration is proposing a solution to the current gridlock over the regulation of dietary supplements: Focus less on whether these vitamins, minerals and herbal extracts actually do what they claim and instead take important steps to improve their safety
November Newsletters
NYC Hep C Task Force
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
Newsletter
November 2015 Hep Free NYC Newsletter
In This Newsletter
Upcoming Events
Congratulations NYC Hepatitis Leaders!
New Tools
News
Training & Technical Assistance
Journal Articles & Reports
Begin here
HCV Advocate
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.
Read The HCV Advocate Daily
Current edition
Newsletter
In This Issue
Snapshots
by Alan Franciscus, Editor-in-Chief
Read about a study predicting how many people can be treated to get the best bang for the buck, the worldwide transmission (people to people) of viral hepatitis and HIV, and the need for services for people who inject drugs due to HCV disease progression due to lack of access to HCV treatment.
Harvoni Treatment Choices and Outcomes
by Pieter R
Read about one man’s story of his struggles with working with his medical providers to treat hepatitis C to optimize his treatment outcome.
HealthWise: Hepatitis C: Letting Go of Fear
by Lucinda K. Porter, RN
Three studies that look at treating people with advanced liver disease and re-treatment of people who had been previously treated with direct-acting antiviral medications but did not achieve a cure.
Sam’s Story
by Alan Franciscus, Editor-in-Chief
I talked with Sam about his journey from being diagnosed with hepatitis C to trying to get treated with the new HCV antivirals. His story, unfortunately, isn’t new especially when it comes to fighting for treatment.
Hepatitis C Workshop Schedule
We are winding down our HCV workshops. If you live in or near Houston or Tyler Texas please join us for a day of education and fun!
Click here to read this issue.
October Mid-Month
Dr. David Mazoff Retires
Disability & Benefits: Open Enrollment Final
The Five: Clinical Trials
Snapshots
What’s New! Tattoos fact sheets now on this site
HepCBC Hepatitis C Education and Prevention Society
HepCBC’s MONTHLY NEWSLETTER
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.
November Newsletter
hepc.bull -- 11 2015
Stay Connected
GI & Hepatology News
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.
GI & Hepatology Newsletter
November 2015 PDF (
14.6MB) | November 2015 Interactive Version
LIVER DISEASES
Read this months newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services
November Newsletter
Keep Your Skin Healthy Protecting Your Outer Self
Download a PDF version of NIH News in Health
In Case You Missed It
Are you a veteran & can't get Hepatitis C medications? We're working on a story & want to hear from you.
NICE announces recommendations on new hepatitis C drugs
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure for hepatitis B and helping to improve the lives of those affected worldwide through research, education and patient advocacy. Visit www.hepb.org
Shop Carefully for the Best Insurance Plan When You Have Hepatitis B
Nov 2 – Over the next two months it’s open enrollment for Medicare recipients and those selecting or updating Obamacare and insurance plans. Be sure to shop carefully, and consider medication and care that may be related to a hepatitis B infection.
CyTuVax Starts Phase I Clinical Trial With The HBAI20 Hepatitis B Vaccine For Non-Responders
Effective vaccination for persons that do not respond to standard Hepatitis B vaccines
Maastricht, The Netherlands, 03 November 2015 – CyTuVax, a life science company focusing on the development of cancer, viral and bacterial vaccines, today announced the start of a phase I clinical trial assessing the safety and efficacy of its lead product, a Hepatitis B HBAI20 vaccine for non-responders to standard Hepatitis B vaccines. This trial will be conducted at the Ease Travel Clinic by the Department of Medical Microbiology of the MAASTRICHT UMC and is coordinated by Dr. A.M. L. Oude Lashof, MD PhD, Internist and Consultant Infectious Diseases of Maastricht UMC. The trial, for which 36 subjects are being recruited, will start in the course of October 2015 and data are expected to be published in Q3 of 2016.
Read more....
Welcome to my website and blog. My name is Lucinda Porter and I am a nurse committed to raising awareness about hepatitis C. I believe that we can create a world free of hepatitis C. We do this together, one step at a time.
Hepatitis C: A Letter to Friends, Family Members, and Caregivers
If you are reading this, perhaps someone you know is living with hepatitis C.
Hepatitis C and Quality of Life
What does quality of life mean to you? Is it your health, happiness, financial security, spiritual wellness, or social well-being? It usually means different things to different people. In healthcare, researchers use surveys to measure the quality of life related to health, abbreviated as HRQOL. When applied to hepatitis C, HRQOL is an important concern.
Recent Posts
VA HUNGRY HIPPOS–TOMAH STYLE
HADIT.COM’S RADIO SHOW–SMC KNOWLEDGE
HEPATITIS GRAPHIC ON SIDE EFFECTS
LZ CORK–BUTCH FINALLY GETS HIS COMP & PEN EXAMS
BVA–SQUIDLEYONE JOINS THE P&T CLUB
29 years of hepatitis, 5 failed treatments...It's time to go from HepC to HepFree
The Transplants
I received the call at 8:39 PM
I was expecting a call from my parents when the phone rang. When I saw it was from a restricted number, I started off apologizing saying "Yea, I meant to call you back sooner, sorry about that." A little confused, the man asked my name.
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.
Harvoni for Acute Hepatitis C
Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection (SWIFT-C)
ClinicalTrials.gov Identifier:
NCT02128217
Healthy You
Toxic, Not Healthy: Surprising Liver Dangers of Herbal Products
By Marie Suszynski
Reviewed by Judy Mouchawar, MD, MSPH
Seemingly healthy herbal teas and supplements can carry the risk of drug-induced liver injury.
Drug-induced liver injury, a form of liver disease, is on the rise as herbal and dietary supplements have become more popular over the last decade, according to the American College of Gastroenterology.Toxic, Not Healthy: Surprising Liver Dangers of Herbal Products
By Marie Suszynski
Reviewed by Judy Mouchawar, MD, MSPH
Seemingly healthy herbal teas and supplements can carry the risk of drug-induced liver injury.
VIDEO: Survey results reveal lack of awareness of heart disease risk among women
Gilead Sciences Inc.’s blockbuster hepatitis C medicine Sovaldi may trigger an abnormally slow heartbeat and put patients at risk of passing out, according to French doctors who said treatments containing the drug should be used with caution.
Holly S. Andersen, MD, director of education and outreach for the Ronald O. Perelman Heart Institute at New York-Presbyterian Hospital and scientific advisor to the Women’s Heart Alliance, spoke with Healio.com at the AHA Scientific Sessions about a national campaign launched to reduce the number of women dying from heart disease. In this video, Andersen offers sobering statistics on how unaware and passive women are on the topic of the heart disease, the stigma that discourages discussion and how physicians can create a dialogue with patients on “a disease that is largely preventable.”
Find Way to Focus on Dietary Supplement Safety, Experts Say
A former principal deputy commissioner of the U.S. Food and Drug Administration is proposing a solution to the current gridlock over the regulation of dietary supplements: Focus less on whether these vitamins, minerals and herbal extracts actually do what they claim and instead take important steps to improve their safety
November Newsletters
NYC Hep C Task Force
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
Newsletter
November 2015 Hep Free NYC Newsletter
Upcoming Events
Congratulations NYC Hepatitis Leaders!
New Tools
News
Training & Technical Assistance
Journal Articles & Reports
Begin here
HCV Advocate
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.
Read The HCV Advocate Daily
Newsletter
by Alan Franciscus, Editor-in-Chief
Read about a study predicting how many people can be treated to get the best bang for the buck, the worldwide transmission (people to people) of viral hepatitis and HIV, and the need for services for people who inject drugs due to HCV disease progression due to lack of access to HCV treatment.
Harvoni Treatment Choices and Outcomes
by Pieter R
Read about one man’s story of his struggles with working with his medical providers to treat hepatitis C to optimize his treatment outcome.
HealthWise: Hepatitis C: Letting Go of Fear
by Lucinda K. Porter, RN
Three studies that look at treating people with advanced liver disease and re-treatment of people who had been previously treated with direct-acting antiviral medications but did not achieve a cure.
Sam’s Story
by Alan Franciscus, Editor-in-Chief
I talked with Sam about his journey from being diagnosed with hepatitis C to trying to get treated with the new HCV antivirals. His story, unfortunately, isn’t new especially when it comes to fighting for treatment.
Hepatitis C Workshop Schedule
We are winding down our HCV workshops. If you live in or near Houston or Tyler Texas please join us for a day of education and fun!
Click here to read this issue.
In Case You Missed It
October Mid-Month
Dr. David Mazoff Retires
Disability & Benefits: Open Enrollment Final
The Five: Clinical Trials
Snapshots
What’s New! Tattoos fact sheets now on this site
HepCBC’s MONTHLY NEWSLETTER
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.
November Newsletter
hepc.bull -- 11 2015
Topics
Viral Hepatitis in the Americas
Ministers of health from across the Americas have recently committed their countries to important new public health actions including a plan to address viral hepatitis. Viral Hepatitis in the Americas
HOLKIRA (VIEKIRA) PAK & TECHNIVIE: NEW COVERAGE AND RISKS
“Maybe the government will now understand how necessary it is to treat people before they develop cirrhosis.”—Joan King, hepc.bull Editor
ERADICATING CURABLE DISEASES
by Shakuntala Soden, PhD, HepCBC Education Project Mgr. (based in Vancouver)
Recently, the influential publication The Economist (10 October 2015) ran an article about the need to eradicate seven diseases from the world. Hepatitis C was one of them. The Economist highlighted the fact that hepatitis C currently kills half a million people a year, although treatments are now almost 100% effective.
Don't Miss....
Lisa Harnois Eradicating Curable Diseases Why Test?
SOF-VEL
Conferences
HCV, DVT and Strokes
Honour Roll
View All Newsletters, Here
Stay Connected
GI & Hepatology News
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.
GI & Hepatology Newsletter
November 2015 PDF (
14.6MB) | November 2015 Interactive VersionLIVER DISEASES
Sofosbuvir reduces liver fibrosis - Multiple measures of fibrosis were reduced in small study.
Hep C drove steep rises in cirrhosis, HCC, and related deaths
High ALT/AST ratio linked to fatty liver risk in HCV
NASH a key indicator for liver transplantationRead this months newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services
November Newsletter
Keep Your Skin Healthy Protecting Your Outer Self
Skin is your first layer of defense against the outside world, and it can also give important clues to your overall health. Learn to take good care of your skin, so your skin can keep taking good care of you.
In Case You Missed It
Are you a veteran & can't get Hepatitis C medications? We're working on a story & want to hear from you.
Email us stacey@harrishealth1.com
Welcome to the October/November 2015 edition of the Liver Lowdown. Click on the links below and check out our featured stories for the month!
FEATURE- LIVER CANCER AWARENESS
This issue of Liver Lowdown focuses on liver cancer. Two top specialists answer your questions about liver cancer, a courageous patient tells how he turned down a liver transplant to save another; and American Liver Cancer launches a Liver Cancer Awareness Campaign with advertising on taxi tops and on buses.
READ MORE
BASIC LIVER CANCER Q&A
Are there different types of liver cancer? Find out the answer to this and other questions.
READ MORE
LIVER CANCER RISK FACTORS Q&A
Should you be screened for liver cancer? Learn the facts.
READ MORE
LIVER CANCER TREATMENT Q&A
What options exist for Liver Cancer Treatment? Get current information.
READ MORE
UNLEASH YOUR CREATIVITY FOR A GOOD CAUSE
Giving Tuesday is just around the corner. Get involved.
READ MORE
PATIENT STORY
Art Clark risked his life to save another.
READ MORE
RECIPE OF THE MONTH
Looking for a delicious recipe to try tonight? We have one for you! Have a recipe to share? We would love to hear from you.
READ MORE
FEATURE- LIVER CANCER AWARENESS
This issue of Liver Lowdown focuses on liver cancer. Two top specialists answer your questions about liver cancer, a courageous patient tells how he turned down a liver transplant to save another; and American Liver Cancer launches a Liver Cancer Awareness Campaign with advertising on taxi tops and on buses.
READ MORE
BASIC LIVER CANCER Q&A
Are there different types of liver cancer? Find out the answer to this and other questions.
READ MORE
LIVER CANCER RISK FACTORS Q&A
Should you be screened for liver cancer? Learn the facts.
READ MORE
LIVER CANCER TREATMENT Q&A
What options exist for Liver Cancer Treatment? Get current information.
READ MORE
UNLEASH YOUR CREATIVITY FOR A GOOD CAUSE
Giving Tuesday is just around the corner. Get involved.
READ MORE
PATIENT STORY
Art Clark risked his life to save another.
READ MORE
RECIPE OF THE MONTH
Looking for a delicious recipe to try tonight? We have one for you! Have a recipe to share? We would love to hear from you.
READ MORE
This October, the National Institute for Health and Care Excellence (NICE) published its guidance on the use of three new hepatitis C treatments; ledipasvir-sofosbuvir (Harvoni), ombitasvir-paritaprevir-ritonavir (Viekirax) with or without dasabuvir (Exviera), and daclatasvir (Daklinza).
In focus: The Hepatitis C Trust helpline
The Hepatitis C Trust’s national helpline,
which is staffed solely by people who have or
have had hepatitis C, acts as a vital resource
for patients (and families of patients) who are
seeking advice, support and information on
the virus.
View newsletter archive
Blogs Around The Web
View newsletter archive
Blogs Around The Web
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure for hepatitis B and helping to improve the lives of those affected worldwide through research, education and patient advocacy. Visit www.hepb.org
Shop Carefully for the Best Insurance Plan When You Have Hepatitis B
Nov 2 – Over the next two months it’s open enrollment for Medicare recipients and those selecting or updating Obamacare and insurance plans. Be sure to shop carefully, and consider medication and care that may be related to a hepatitis B infection.
Read more.
Arbutus Provides an HBV Pipeline Update
Nov 2 – Arubutus Biopharma Corp. provided an update of the company’s HBV pipeline for drugs focused on a cure for chronic hepatitis B, with exciting goals and milestones for 2016 and 2017.
Arbutus Provides an HBV Pipeline Update
Nov 2 – Arubutus Biopharma Corp. provided an update of the company’s HBV pipeline for drugs focused on a cure for chronic hepatitis B, with exciting goals and milestones for 2016 and 2017.
Read more.
Paper-Based Test Could Diagnose Hepatitis B
Nov 2 – Scientists have developed a new paper device that analyzes DNA and could rapidly and inexpensively assess disparate conditions including hepatitis B, which could help diagnose people in low-income areas.
Paper-Based Test Could Diagnose Hepatitis B
Nov 2 – Scientists have developed a new paper device that analyzes DNA and could rapidly and inexpensively assess disparate conditions including hepatitis B, which could help diagnose people in low-income areas.
Read more.
New Model for Hepatitis B Helps Identify Potential New Therapeutic Approach
Nov 2 – A promising new approach for treating hepatitis B has been reported by researchers at Hiroshima University, who have developed a new animal model of the disease using “humanized” livers.
New Model for Hepatitis B Helps Identify Potential New Therapeutic Approach
Nov 2 – A promising new approach for treating hepatitis B has been reported by researchers at Hiroshima University, who have developed a new animal model of the disease using “humanized” livers.
HBV Advocate’s Blog
Check Out Our Other Sites
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Hepatitis & Tattoos
Tattoo Blog
HCV Advocate News & Pipeline Blog
Check Out Our Other Sites
HBV Advocate
HCV Advocate
Hepatitis & Tattoos
Tattoo Blog
HCV Advocate News & Pipeline Blog
CyTuVax Starts Phase I Clinical Trial With The HBAI20 Hepatitis B Vaccine For Non-Responders
Effective vaccination for persons that do not respond to standard Hepatitis B vaccines
Maastricht, The Netherlands, 03 November 2015 – CyTuVax, a life science company focusing on the development of cancer, viral and bacterial vaccines, today announced the start of a phase I clinical trial assessing the safety and efficacy of its lead product, a Hepatitis B HBAI20 vaccine for non-responders to standard Hepatitis B vaccines. This trial will be conducted at the Ease Travel Clinic by the Department of Medical Microbiology of the MAASTRICHT UMC and is coordinated by Dr. A.M. L. Oude Lashof, MD PhD, Internist and Consultant Infectious Diseases of Maastricht UMC. The trial, for which 36 subjects are being recruited, will start in the course of October 2015 and data are expected to be published in Q3 of 2016.
Read more....
View more @ HBV Advocate Blog
Creating a World Free of Hepatitis C
by LUCINDA PORTERWelcome to my website and blog. My name is Lucinda Porter and I am a nurse committed to raising awareness about hepatitis C. I believe that we can create a world free of hepatitis C. We do this together, one step at a time.
If you are reading this, perhaps someone you know is living with hepatitis C.
Hepatitis C and Quality of Life
What does quality of life mean to you? Is it your health, happiness, financial security, spiritual wellness, or social well-being? It usually means different things to different people. In healthcare, researchers use surveys to measure the quality of life related to health, abbreviated as HRQOL. When applied to hepatitis C, HRQOL is an important concern.
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VA claims blogger
Recent Posts
VA HUNGRY HIPPOS–TOMAH STYLE
HADIT.COM’S RADIO SHOW–SMC KNOWLEDGE
HEPATITIS GRAPHIC ON SIDE EFFECTS
LZ CORK–BUTCH FINALLY GETS HIS COMP & PEN EXAMS
BVA–SQUIDLEYONE JOINS THE P&T CLUB
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The Transplants
I received the call at 8:39 PM
I was expecting a call from my parents when the phone rang. When I saw it was from a restricted number, I started off apologizing saying "Yea, I meant to call you back sooner, sorry about that." A little confused, the man asked my name.
Blogs At HepMag.com
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.
David Pieper
Greg Jefferys
My Hep C Travel Diary, Hepatitis C Advocate
Indian Generic Harvoni Release Date
Well after all the worry and confusion the final release date for Gilead licensed Indian generic Harvoni is here! Thanks in large part to the early release of Twinvir in Bangladesh which appears to have put a bit of a bomb under the Indian authorities to speed up the process. So instead of us all wondering if the release of generic Harvoni was going to be blocked by Gilead or delayed until next year it has
HIV/Hep C Co-infection activist; on treatment
Anxiety at the end of treatment
The next few weeks, leading up to my first post-treatment blood test, are going to be the hardest yet in my hep C journey, so I'm taking it
Anxiety at the end of treatment
The next few weeks, leading up to my first post-treatment blood test, are going to be the hardest yet in my hep C journey, so I'm taking it
Greg Jefferys
My Hep C Travel Diary, Hepatitis C Advocate
Indian Generic Harvoni Release Date
Well after all the worry and confusion the final release date for Gilead licensed Indian generic Harvoni is here! Thanks in large part to the early release of Twinvir in Bangladesh which appears to have put a bit of a bomb under the Indian authorities to speed up the process. So instead of us all wondering if the release of generic Harvoni was going to be blocked by Gilead or delayed until next year it has
moved forward!
Hepatitis, Liver Disease Support Coach
What We Can Learn from Geese and Bikers about Hep C
The geese of New England are currently migrating, honking through the sky on their miraculous journey south for the winter.
Lucinda K. Porter, RN
Author, Hepatitis C Advocate, Health Educator
Hepatitis C Treatment Updates are the Strongest Yet
If the links that I visit the most had visible tread marks, the deepest would likely be at hcvguidelines.org. The full name, Recommendations for Testing, Managing, and Treating Hepatitis C, is a living document provided by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), in collaboration with the International Antiviral Society-USA (IAS-USA). When looking for treatment info, it's my hep C "go to source."
Click here
Author, Hepatitis C Advocate, Health Educator
Hepatitis C Treatment Updates are the Strongest Yet
If the links that I visit the most had visible tread marks, the deepest would likely be at hcvguidelines.org. The full name, Recommendations for Testing, Managing, and Treating Hepatitis C, is a living document provided by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), in collaboration with the International Antiviral Society-USA (IAS-USA). When looking for treatment info, it's my hep C "go to source."
Click here
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Tina
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