Sanders Asks VA to Break Patents on Gilead and AbbVie Hep C Drugs

The ongoing debate over the cost of prescription drugs took another twist as U.S. Sen. Bernie Sanders (I-VT.) has asked the U.S. Department of Veterans Affairs to use emergency powers to break – or override – the patents on high-priced hepatitis C medicines sold by several drug makers, including Gilead Sciences.


The prices have caused a firestorm as both public and private payers complain the treatments are straining their budgets. Sanders notes the VA stopped enrolling veterans who need treatment for hepatitis C due to budget constraints. The agency has already reallocated $400 million on hepatitis C drugs, but needs additional funding.

“I cannot think of another situation where the government-use provision [of the law that allows the VA to break the patents] should be applied,” Sanders wrote in a letter to Robert McDonald, the U.S. Department of Veterans Affairs Secretary. “Our nation’s veterans cannot, and should not, be denied treatment while drug companies rake in billions of dollars in profits.”

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Lake County Health Department Holds Free Hepatitis Health Fair on May 19

In observance of National Hepatitis Testing Day, the Lake County Health Department and Community Health Center (LCHD/CHC) will host a free hepatitis health fair in conjunction with Abbvie, Orasure Technologies, Walgreens, Salix Pharmaceuticals, American Liver Foundation Great Lakes Division, the YWCA Lake County, GlenLake Nursing and Rehabilitation Center and the Lake County Stands Against Stigma Coalition. The event will take place on Tuesday, May 19, in the lobby of the County Building, 18 N. County Street in Waukegan, from 9:00 a.m. to 2:00 p.m. The Centers for Disease Control and Prevention is recommending that everyone born between 1945 and 1965, in the Baby Boomers generation, get a blood test for hepatitis C. This recommendation calls for one-time testing of Baby Boomers.

Program staff will provide information and education about hepatitis B and C prevention, care and treatment. Free blood pressure screenings will be offered. Participants can also receive general information related to overall health and wellbeing. Free hepatitis C and HIV tests will also be offered at the LCHD/CHC Sexually Transmitted Infections program's (STI) office the day of the event at 2400 Belvidere Road in Waukegan. Please call 847-377-8450 for more information.

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Pa. Law Prohibits Needle Exchanges That Can Save Lives

Tens of thousands of Pennsylvanians crave daily injections of heroin. Beyond the threat of overdose is the threat of being exposed to HIV and hepatitis C, both deadly and expensive illnesses that are easily spread through contaminated needles.

But in Pennsylvania, distributing sterile syringes is a criminal act.

For years, Dianna Pagan feared that giving out clean syringes in Reading would land her in jail. Officials there recently agreed to let her needle exchange operate, though she’s faced numerous setbacks for more than a decade, including being shut down following the threat of prosecution.

Read more: http://www.nbcphiladelphia.com/news/health/Pa-Law-Prohibits-Needle-Exchanges-That-Can-Save-Lives-303210321.html#ixzz3ZnJgqziW

UK: NHS denies lifesaving drug to 5,000 patients it gave infected blood: Sofosbuvir has been approved by regulators but victims are STILL waiting for treatment

• Thousands of victims were infected by hepatitis C through imported blood 
• Breakthrough drug Sofosbuvir was approved by regulator NICE in January 
• But NHS England is delaying treatment for patients until at least August 

Thousands of patients who contracted a deadly disease through contaminated blood in the biggest scandal in NHS history are being denied a lifesaving drug.

About 7,500 victims are known to have been infected with hepatitis C in the 1970s and 1980s through imported blood products taken from high-risk donors such as prostitutes and prisoners.

A breakthrough drug called Sofosbuvir was approved in January by drugs regulator NICE and patients were told they would have to wait until April to get the ten-week course of tablets, which costs £45,000. 

But NHS England has decided on a further delay until August to ensure all patients have equal access to treatment.

Read more: http://www.dailymail.co.uk/health/article-3075151/NHS-denies-lifesaving-drug-5-000-patients-gave-infected-blood-Sofosbuvir-approved-regulators-victims-waiting-treatment.html#ixzz3ZhNPqkvn

The VA’s Hepatitis C Problem

Martin Dames is a highly decorated veteran of the Vietnam War. He received the Bronze Star for heroism in the combat zone and three Purple Hearts for injuries he suffered while fighting. He made it out alive, only to find out years later that those combat wounds got him infected with the hepatitis C virus (HCV), a deadly blood-borne pathogen discovered in 1989 that claims about 19,000 lives annually, a large number of them veterans. That number is growing every year.

A chronic infection in around 80 percent of cases, HCV often shows no signs of its corrosive presence until extensive liver scarring occurs after decades of infection. In some cases, the disease isn’t found until it has led to cirrhosis—advanced and potentially lethal amounts of scarring. Infection with the virus is a leading cause of liver cancer and transplants in the U.S.

Some 3.5 million Americans are infected, including an estimated 234,000 veterans. Approximately 174,000 veterans in government care have been diagnosed with hepatitis C, but an additional 50,000 are thought to carry the infection unbeknownst to them. For treatment, those veterans who know they are sick must go to the U.S. Department of Veterans Affairs (VA) and its health care services extension: the Veterans Health Administration (VHA), the largest provider of hepatitis C care in the nation. The VHA serves nearly 9 million patients at over 1,700 sites, but as Dames and many other veterans.

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Evolution of Treatment for HCC: Sorafenib and Beyond

The small molecule multikinase inhibitor sorafenib remains the only molecularly targeted therapy approved by the FDA for the treatment of hepatocellular carcinoma (HCC). Ongoing clinical trials are diligently testing the potential for novel targeted agents or combination therapies to further improve patient outcomes in this setting.

Sorafenib tosylate (Nexavar) was approved by the FDA in late 2007 for the treatment of unresectable HCC, a decision based on the findings of the Sorafenib HCC Assessment Randomized Protocol (SHARP) trial.¹According to this multicenter, double-blind, phase III study, a randomized protocol of either sorafenib or placebo in 602 advanced, untreated patients with HCC, sorafenib led to statistically significant improvement in overall survival compared with placebo.

- See more at: http://www.targetedonc.com/publications/hcc-monitor/2015/may-2015/Evolution-of-Treatment-for-HCC-Sorafenib-and-Beyond#sthash.OlPiai0z.dpuf

Snapshots, by Alan Franciscus, Editor-in-Chief

Article: Depression rather than liver impairment reduces quality of life in patients with hepatitis C—LD Silva, et al
  Source: Rev Bras Psiquiatr. 2015 Jan-Mar;37(1):21-30. doi: 10.1590/1516-4446-2014-1446

 

Results and Conclusion: In the current study there were 124 patients (72 females; 52 males; mean age 53 yo).  The patients were given various clinical and psychiatric evaluations.  No patients were receiving HCV treatment.  Various in-person interviews were given to determine socio-economic information, health-related quality of life, income, smoking, alcohol and drug use. 

The study results found that 30.6% had major depressive disorder, which is consistent with other studies. The degree of major depressive disorder and other psychiatric disorders found in people with hepatitis C is associated with health-related quality of life rather than tied to the degree of liver fibrosis.  The authors noted that more attention needs to be devoted to “the implementation of integrated medical, psychiatric, and [that] psychological care may be helpful.”

 

The Bottom Line: Up to 70% of people with chronic hepatitis C have depressive disorders—this is a seven-fold higher rate than the general population.

 

Editorial Comment: Does HCV cause depression?  Many experts believe that the hepatitis C virus causes depression, but the exact mechanism hasn’t been completely understood.  There have been some studies that have shown that the hepatitis C virus passes the blood-brain barrier and there have been viral particles found in brain tissue.  Another possible reason for depressive disorders could potentially be the results of the immune system cells fighting off the virus in brain tissue.   

Regardless of what causes depression in people with hepatitis C, it is clear that curing hepatitis C also can increase the quality of life leading to a wide variety of improvements in health including mental health. It’s time that we recognize that we should treat everyone with hepatitis C regardless of the degree of liver damage—hepatitis C is NOT just a liver disease.

 

Article: Changes in characteristics of hepatitis C patients seen in a liver center in the United States during the last decade—N Talaat et al.
  Source: Journal of Viral Hepatitis Volume 22,Issue 5, pages 481–488, May 2015

 

Results and Conclusion: This was a retrospective study of the records of patients seen in liver clinics 1998-1999 (Era-1) compared to the records of patients seen 2011-2012 (Era-2)

The current study sought to describe the characteristics of people with HCV who were newly referred to liver clinics in Era-1 (538 patients). The records from Era-1 patients were compared to those of patients who were seen in Era-2 (810 patients).  Advanced liver disease was defined as cirrhosis, decompensated cirrhosis, or liver cancer.  

The patients in Era-2 were older (median age 56 vs 45 years), more likely to be Black (17.2% vs 11.6%) and had a longer interval between diagnosis and referral (median 4 years vs 2 years).  Genotype 1 was similar in both Era’s, but genotype 1a was 39.9% vs 53.8% in Era-2.  

Even though there was a higher percentage of treatment-experienced patients in the Era 2 patient group, the comparison showed that more than three quarters of the patients had never been treated.    

Era-2 patients were more likely to have advanced disease at referral (61.6% vs 51.5%)—with an   eightfold higher prevalence of HCC or liver cancer (21.6% vs 2.6%).

 

The Bottom Line:  The changes in the Era-2 patients points to important trends in the hepatitis C population.  These changes occurred over a relatively short period of time:   

• The majority of patients identified had not been treated.
• More patients had HCV genotype 1a – generally a more difficult genotype/subtype to treat.  This also reflects a change in the demographics of the HCV population of the United States.
• The aging of the HCV population is reflective of more advanced disease including an eight-fold increase in liver cancer.

Editorial Comment:  This study speaks volumes.  In this short period of time there has been a major advance in the rate of liver disease progression—most notably the increase in liver cancer is frightening.  


http://hcvadvocate.org/news/newsLetter/2015/advocate0515.html#4