Rewind: News and Views
In The News
What would you do if you had a potentially lethal illness, knew of a "miracle" cure which would most likely fix the problem in three months by taking one pill a day, but you couldn't afford to buy the medicine from the drug company which owned the patent? This is the position that "Patient Zero" found himself in. And he, with a doctor and a group of campaigning mates, found an answer – one that they believe costs up to 30 times less than the drug company might expect them to pay.
CDC
State Reporting Requirements for Viral Hepatitis
Health Care Industry Mergers Side Effect of Affordable Care Act
Many are worried that the huge consolidations will dampen competition and push up health care prices over time...
Why people don't trust drug makers
Insurers and pharmacy benefit managers - not drug companies - are the ones who determine what patients pay for medications. Consider the controversy surrounding the hepatitis C drug Sovaldi. When the medicine came on the market, it quickly became ...
Many veterans who fought to protect and defend our country are still fighting to get the support they need from the federal government...
Insurers and pharmacy benefit managers - not drug companies - are the ones who determine what patients pay for medications. Consider the controversy surrounding the hepatitis C drug Sovaldi. When the medicine came on the market, it quickly became ...
Rhode Island Medicaid Denied 65% of Hep C Treatment Requests in 2015
It's a move that, while saving the state millions of dollars, is keeping hundreds of sick patients from accessing a cure.
It's a move that, while saving the state millions of dollars, is keeping hundreds of sick patients from accessing a cure.
Concern about drug costs has been particularly acute for state Medicaid programs, which face both limited budgets and high Hepatitis C prevalence among beneficiaries (higher than in the general population). And perhaps with good reason: In 2014, the ...
The FDA has designated the SOF/VEL combination as “breakthrough therapy” status, granted to “investigational medicines that may offer major advances in treatment over existing options,” the statement said.Results showed that 98% of patients in the first three trials achieved the efficacy endpoint. In the ASTRAL-4 study, 94% of patients in the SOF/VEL plus ribavirin group achieved sustained virological response at 12 weeks. The rates of success in patients receiving the SOF/VEL combination for 12 or 24 weeks were 83% and 86%, respectively. The most common adverse effects were fatigue, nausea, and headache.
September 17, 2015 | By John Carroll
Gilead has already made a megablockbuster fortune out of its hepatitis C cure. But the race to cure patients faster (and probably cheaper) is still on. And Achillion today posted some new data from small studies that show its NS5A inhibitor odalasvir (or ACH-3102) could feature prominently in one of the new cocktail therapies now in development at Johnson & Johnson...
September 23, 2015
A once-daily, fixed-dose combination of sofosbuvir (SOF) plus velpatasvir (VEL) had high success rates for the treatment of all six genotypes of hepatitis C virus, manufacturer Gilead Sciences reported.
In three of four phase III trials (ASTRAL-1, ASTRAL-2, and ASTRAL-3), 1,035 HCV patients were given the drug combination for 12 weeks. In the fourth trial (ASTRAL-4), 267 HCV patients with decompensated cirrhosis were randomized to receive either the SOF/VEL combination for 12 weeks with or without ribavirin or 24 weeks of just SOF/VEL. The primary efficacy endpoint for all studies was a sustained virological response at 12 weeks, the company said in a statement.
The FDA has designated the SOF/VEL combination as “breakthrough therapy” status, granted to “investigational medicines that may offer major advances in treatment over existing options,” the statement said.Results showed that 98% of patients in the first three trials achieved the efficacy endpoint. In the ASTRAL-4 study, 94% of patients in the SOF/VEL plus ribavirin group achieved sustained virological response at 12 weeks. The rates of success in patients receiving the SOF/VEL combination for 12 or 24 weeks were 83% and 86%, respectively. The most common adverse effects were fatigue, nausea, and headache.
Press Release
Gilead Announces SVR12 Rates from Four Phase 3 Studies Evaluating Fixed-Dose Sofosbuvir/Velpatasvir (GS-5816) Pan-Genotypic
The Food and Drug Administration (FDA) announced that Rebetol(ribavirin; Merck) capsules and PegIntron (peginterferon alfa-2b; Merck) for Injection are being discontinued. The decision is business-related and not due to safety or efficacy issues with the drugs.
Rebetol is a nucleoside analogue indicated for chronic hepatitis C in combination with interferon alfa-2b (pegylated and nonpegylated), in patients ≥3 years of age with compensated liver disease. It is supplied as 200mg capsules in 56-, 70-, and 84-count bottles. The Rebetol discontinuation is effective February 1, 2016.
PegIntron is an antiviral indicated for treatment of chronic hepatitis C in patients with compensated liver disease. It is supplied as 50mcg/0.5mL, 80mcg/0.5mL, 120mcg/0.5mL, and 150mcg/0.5mL single-use vials and single-use pre-filled pens. No effective date is available for the PegIntron discontinuation.
For more information call (888) 463-6332 or visit FDA.gov.
Source
http://www.empr.com/safety-alerts-and-recalls/rebetol-pegintron-to-be-discontinued/article/440426/
Conatus Announces emricasan Phase 2 study reduces liver portal hypertension predominantly due to NASH or HCV
A player in J&J's hep C cocktail helps hustle a quick cure
Rebetol is a nucleoside analogue indicated for chronic hepatitis C in combination with interferon alfa-2b (pegylated and nonpegylated), in patients ≥3 years of age with compensated liver disease. It is supplied as 200mg capsules in 56-, 70-, and 84-count bottles. The Rebetol discontinuation is effective February 1, 2016.
PegIntron is an antiviral indicated for treatment of chronic hepatitis C in patients with compensated liver disease. It is supplied as 50mcg/0.5mL, 80mcg/0.5mL, 120mcg/0.5mL, and 150mcg/0.5mL single-use vials and single-use pre-filled pens. No effective date is available for the PegIntron discontinuation.
For more information call (888) 463-6332 or visit FDA.gov.
Source
http://www.empr.com/safety-alerts-and-recalls/rebetol-pegintron-to-be-discontinued/article/440426/
Conatus Announces emricasan Phase 2 study reduces liver portal hypertension predominantly due to NASH or HCV
A player in J&J's hep C cocktail helps hustle a quick cure
Gilead has already made a megablockbuster fortune out of its hepatitis C cure. But the race to cure patients faster (and probably cheaper) is still on. And Achillion today posted some new data from small studies that show its NS5A inhibitor odalasvir (or ACH-3102) could feature prominently in one of the new cocktail therapies now in development at Johnson & Johnson...
Around The Web
Hepatitis C virus infection: a risk factor for Parkinson's disease
"In summary, our study not only demonstrated a significantly positive association between HCV infection and Parkinson's disease (PD) from a large population-based epidemiological study but also proved the dopaminergic neuronal toxicity by HCV in vitro at the molecular level through an increase in cytokines induced by HCV. Epidemiologically, we found that anti-HCV(+) patients had statistically significant increased risk of developing PD in the population-based study.
"In summary, our study not only demonstrated a significantly positive association between HCV infection and Parkinson's disease (PD) from a large population-based epidemiological study but also proved the dopaminergic neuronal toxicity by HCV in vitro at the molecular level through an increase in cytokines induced by HCV. Epidemiologically, we found that anti-HCV(+) patients had statistically significant increased risk of developing PD in the population-based study.
Revolutionary new drugs to cure hepatitis C virus (HCV) infection represent one of the most important breakthroughs in clinical medicine in recent decades. However, high pricing of these well-tolerated, highly efficacious all-oral regimens and high demand (actual or anticipated) has led many payers in the United States and other countries to exclude people who have recently used illicit drugs, injectable drugs or alcohol (with the definitions of "use" varying by jurisdiction) from access to these treatments
Correspondence
N Engl J Med 2015; 373:1279-1281 September 24, 2015
DOI: 10.1056/NEJMc1506108
To the Editor:
The cure rates associated with sofosbuvir, a new treatment for hepatitis C virus (HCV), have been remarkable.1 However, the high cost of the drug has raised concerns,2 particularly in regard to socioeconomically disadvantaged populations with a high prevalence of HCV infection, such as Medicaid beneficiaries. Demand for new HCV drugs in Medicaid populations drove historic surges in spending on drugs in 2014, the first full year during which sofosbuvir was available since its approval by the Federal Drug Administration (FDA) in late 2013.3 Given its recent introduction to the market, little is known about state-level utilization and spending patterns for sofosbuvir...
“As well as meaning that people with chronic hepatitis B or C could avoid having invasive liver biopsies, the associated savings of more than £400 per person ...
Interferon-based therapy still common for HCV among veterans
In a retrospective study, researchers found that the uptake of direct-acting antivirals, specifically Victrelis and Incivek, increased among veterans with HCV over time…
In a retrospective study, researchers found that the uptake of direct-acting antivirals, specifically Victrelis and Incivek, increased among veterans with HCV over time…
Editorial
The guidelines for hepatitis C have been updated twice in the month of August.
The first update incorporated the approval of daclatasvir (Daklinza, Bristol-Myers Squibb) in the United States and, based on that approval, modified treatment recommendations for most of the treatment groups..
Hepatitis C: The Evolution of Treatment
Last week I discussed the history of hepatitis C. This week I focus on the evolution of hepatitis C treatment...
Healthy You
Green Tea Hidden Dangers: Teen Contracts Acute Hepatitis After Drinking Three Cups Per Day
A young woman has contracted hepatitis after drinking three cups of Chinese green tea per day.
Doctors have now warned of the hidden dangers of consuming too much of the herbal tea, which they believe was to blame for the teenager contracting acute hepatitis...
Over long term, diet and exercise are best to prevent diabetes
Metformin Link to Vitamin B12 Deficiency, Neuropathy, in Diabetes
Medscape Medical News, September 25, 2015
Explore calculators, interactive worksheets, and more that will help you take a look at your drinking habits and understand how they may affect your health...
Off Topic
Should Dr Oz, a Prominent Surgeon, Be Fired for Quackery?
Scientists stop and search malware hidden in shortened URLs on Twitter
Intelligent system created to stop and search malware links
Engineering and Physical Sciences Research Council
Cyber-criminals are taking advantage of real-world events with high volumes of traffic on Twitter in order to post links to websites which contain malware.
To combat the threat, computer scientists have created an intelligent system to identify malicious links disguised in shortened urls on Twitter. They will test the system in the European Football Championships next summer. The research is co-funded by the Engineering and Physical Sciences Research Council (EPSRC) and the Economic and Social Research Council (ESRC).
In the recent study the Cardiff University team identified potential cyber-attacks within five seconds with up to 83% accuracy and within 30 seconds with up to 98% accuracy, when a user clicked on a URL posted on Twitter and malware began to infect the device.
The scientists collected tweets containing URLs during the 2015 Superbowl and cricket world cup finals, and monitored interactions between a website and a user's device to recognise the features of a malicious attack. Where changes were made to a user's machine such as new processes created, registry files modified or files tampered with, these showed a malicious attack.
The team subsequently used system activity such as bytes and packets exchanged between device and remote endpoint, processor use and network adapter status to train a machine classifier to recognise predictive signals that can distinguish between malicious and benign URLs.
Dr Pete Burnap, Director of the Social Data Science Lab at Cardiff University, and lead scientist on the research, said: "Unfortunately the high volume of traffic around large scale events creates a perfect environment for Cyber-criminals to launch surreptitious attacks. It is well known that people use online social networks such as Twitter to find information about an event.
"Attackers can hide links to malicious servers in a post masquerading as an attractive or informative piece of information about the event.
"URLs are always shortened on Twitter due to character limitations in posts, so it's incredibly difficult to know which are legitimate. Once infected the malware can turn your computer into a zombie computer and become part of a global network of machines used to hide information or route further attacks.
"In a 2013 report from Microsoft these 'drive-by downloads' were identified as one of the most active and commercial risks to Cyber security.
"At the moment many existing anti-virus solutions identify malware using known code signatures, which make it difficult to detect previous unseen attacks."
Professor Omer Rana, Principal investigator on the project which is also includes Royal Holloway, University of London, City University London, the University of Plymouth and Durham University said:
"We are trying to build systems that can help law enforcement authorities make decisions in a changing Cyber Security landscape. Social media adds a whole new dimension to network security risk. This work contributes to new insight into this and we hope to take this forward and develop a real-time system that can protect users as they search for information about real-world events using new forms of information sources.
"We have the European Football Championships coming up next summer, which will provide a huge spike in Twitter traffic and we expect to stress-test our system using this event."
Professor Philip Nelson, Chief Executive, EPSRC said: "Using social media is an integral part of modern life, vital to organisations, businesses and individuals. The UK needs to operate in a resilient and secure environment and this research will help combat these criminal Cyber-attacks."
Off Topic
Should Dr Oz, a Prominent Surgeon, Be Fired for Quackery?
Scientists stop and search malware hidden in shortened URLs on Twitter
Intelligent system created to stop and search malware links
Engineering and Physical Sciences Research Council
Cyber-criminals are taking advantage of real-world events with high volumes of traffic on Twitter in order to post links to websites which contain malware.
To combat the threat, computer scientists have created an intelligent system to identify malicious links disguised in shortened urls on Twitter. They will test the system in the European Football Championships next summer. The research is co-funded by the Engineering and Physical Sciences Research Council (EPSRC) and the Economic and Social Research Council (ESRC).
In the recent study the Cardiff University team identified potential cyber-attacks within five seconds with up to 83% accuracy and within 30 seconds with up to 98% accuracy, when a user clicked on a URL posted on Twitter and malware began to infect the device.
The scientists collected tweets containing URLs during the 2015 Superbowl and cricket world cup finals, and monitored interactions between a website and a user's device to recognise the features of a malicious attack. Where changes were made to a user's machine such as new processes created, registry files modified or files tampered with, these showed a malicious attack.
The team subsequently used system activity such as bytes and packets exchanged between device and remote endpoint, processor use and network adapter status to train a machine classifier to recognise predictive signals that can distinguish between malicious and benign URLs.
Dr Pete Burnap, Director of the Social Data Science Lab at Cardiff University, and lead scientist on the research, said: "Unfortunately the high volume of traffic around large scale events creates a perfect environment for Cyber-criminals to launch surreptitious attacks. It is well known that people use online social networks such as Twitter to find information about an event.
"Attackers can hide links to malicious servers in a post masquerading as an attractive or informative piece of information about the event.
"URLs are always shortened on Twitter due to character limitations in posts, so it's incredibly difficult to know which are legitimate. Once infected the malware can turn your computer into a zombie computer and become part of a global network of machines used to hide information or route further attacks.
"In a 2013 report from Microsoft these 'drive-by downloads' were identified as one of the most active and commercial risks to Cyber security.
"At the moment many existing anti-virus solutions identify malware using known code signatures, which make it difficult to detect previous unseen attacks."
Professor Omer Rana, Principal investigator on the project which is also includes Royal Holloway, University of London, City University London, the University of Plymouth and Durham University said:
"We are trying to build systems that can help law enforcement authorities make decisions in a changing Cyber Security landscape. Social media adds a whole new dimension to network security risk. This work contributes to new insight into this and we hope to take this forward and develop a real-time system that can protect users as they search for information about real-world events using new forms of information sources.
"We have the European Football Championships coming up next summer, which will provide a huge spike in Twitter traffic and we expect to stress-test our system using this event."
Professor Philip Nelson, Chief Executive, EPSRC said: "Using social media is an integral part of modern life, vital to organisations, businesses and individuals. The UK needs to operate in a resilient and secure environment and this research will help combat these criminal Cyber-attacks."
Hope everyone has a wonderful weekend.
Tina
