Zydus, Gilead Sciences, SoviHep, Sofosbuvir, Ledipasvir, HCV, Liver Gilead Sciences And Zydus Launch SoviHep Hepatitis C Drug

American biotechnology firm Gilead Sciences and Indian pharmaceutical company Zydus launched SoviHep, a drug for treating Hepatitis C.

On Tuesday, March 17, Zydus issued a statement that confirmed it has signed a non-exclusive agreement with Gilead Sciences, which will enable the company to manufacture sofosbuvir, trade name SoviHep, as well as fixed-dose combination of sofosbuvir/ ledipasvir for circulation in more than 90 countries, which includes India. The drug will be marketed by Zydus Heptiza, which is a specialty division in the group.

Hepatitis C may affect the quality of life for patients. Pankaj Patel, Managing Director and Chairman of the Zydus Group, reveals that the launch of SoviHep will provide better treatment for the disease and improve the quality of life for millions of people.

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Hepatitis C Therapeutic Development and Pipeline Review H1 2015 Research Report

RnRMarketResearch.com adds "Hepatitis C - Pipeline Review, H1 2015" therapeutic market research report of 639 pages with latest updates, data and information to its online business intelligence library.

The report "Hepatitis C - Pipeline Review, H1 2015" provides an overview of the Hepatitis C's therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Hepatitis C, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Hepatitis C and special features on late-stage and discontinued projects.

Hepatitis C is a liver disease caused by the hepatitis C virus. The virus can cause both acute and chronic hepatitis infection, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. There are many types of hepatitis C virus. The most common in the U.S. is type 1. No type is more serious than any other, but they respond differently to treatment. Hepatitis C is an increasing public health concern in the United States and throughout the world. Symptoms of Hepatitis C include jaundice, stomach pain, loss of appetite, nausea and fatigue. 3, 50,000 to 5, 00,000 people die each year from hepatitis C-related liver diseases. 

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Urgent Hepatitis Alert — Lucinda K. Porter, RN

An urgent matter is weighing on me. I need your help; we need your help; you need to help. I know that sounds audacious, but approximately two people die every hour in the U.S. from hepatitis C. If you don't help, who will? 

Hepatitis C deaths are rising along with the incidence of new hepatitis C infections. However, we have an unprecedented opportunity. President Obama has asked for an increase in funding for services to address some of the issues related to viral hepatitis. Representatives Mike Honda, Hank Johnson, and Judy Chu are asking all House Representatives to sign an important letter supporting this funding. (The letter is below.)

What I am asking is very simple but must be done immediately. Ask your representative in Congress to fight against the hepatitis B and C epidemics. This will take you a couple of minutes, and if enough of us do it, it may change history and save lives. Here are the steps:

• Call your Congressional Representative through the Congressional Switchboard at (202) 224-3121. 
• Ask to be connected to your Representative. Once you are connected to the office, ask to speak to the staff person who handles health care issues.
• Whether you speak to that person live or leave a voicemail, tell them:

1. Your name
2. Where you live and that you are a constituent
3. That you would like the Representative to sign the "Dear Colleague" letter from Representatives Honda, Johnson, and Chu supporting increased funding for viral hepatitis  
4. A brief message why this issue is important to you (You have it, someone you know has it, you are concerned about your community, or however you are touched by viral hepatitis)
5. Tell them they can sign the letter by contacting Helen Beaudreau in Representative Honda's office or Scott Goldstein in Representative Johnson's office.
6. The deadline to sign-on is the end of the day on March 19 
7. Thank him/her

Please call your Congressional Representative immediately after reading this. If you are tempted to wait, think about the nearly 18,000 people who die every year from hepatitis C who might be alive if we had acted earlier. 

Text of "Dear Colleague" letter:

The Honorable Tom Cole

Chairman

Subcommittee on Labor, Health and Human Services

United States House

Washington, D.C., 20515

The Honorable Rosa DeLauro

Ranking Member

Subcommittee on Labor, Health and Human Services

United States House

Washington, D.C., 20515

Dear Chairman Cole and Ranking Member DeLauro:

As you begin deliberations on the Fiscal Year 2016 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill, we respectfully request that you allocate $62.8 million for the Division of Viral Hepatitis (DVH) at the Centers for Disease Control and Prevention (CDC), consistent with the President's FY2016 budget request and an increase of $31.5 million over the FY2015 level.

The CDC's 2010 professional judgment (PJ) budget recommended $90.8 million annually from FY2011-FY2013, $170.3 million annually from FY2014-FY2017, and $306.3 million annually from FY2018-FY2020 in order for DVH to comprehensively address the viral hepatitis epidemics. While past increases have been helpful, these have only been small steps toward building a more comprehensive response to viral hepatitis. Our recommendation of $62.8 million is in line with the needs determined by the PJ and the goals of the Viral Hepatitis Action Plan, but pales in comparison to the CDC's PJ. These increased funds would be used to:

• Expand adoption of CDC/United States Preventive Services Task Force (USPSTF) recommendations for hepatitis B and hepatitis C testing and linkage to care by health systems and providers to prevent disease and premature death; 
• Develop monitoring systems and prevention strategies to stop the emerging hepatitis C epidemic among young persons and others at risk;
• Enhance vaccination-based strategies to eliminate mother-to-child transmission of hepatitis B; and
• Strengthen state and local capacity to detect new infections, coordinate prevention activities, provide feedback to providers for quality improvement, and track progress toward prevention goals.

The need to enhance and expand these prevention efforts is growing more urgent. The hepatitis B virus (HBV) and hepatitis C virus (HCV) are the leading causes of liver cancer - one of the most lethal, expensive and fastest growing cancers in America. As many as 5.3 million people in the U.S. are living with HBV and/or HCV and 65-75% of them are undiagnosed. Approximately 175,000 veterans are living with HCV, and at least 30,000 of them have liver cirrhosis (scarring of the liver); yet as many as 40,000 veterans may be infected with HCV and not know it. Without an adequate comprehensive surveillance system, these estimates are only the tip of the iceberg. There are at least 18,000 deaths annually attributed to hepatitis-related liver disease or liver cancer, and hepatitis is the leading non-AIDS cause of death in people living with HIV. In fact, nearly 25 percent of HIV-positive persons are also infected with HCV and nearly 10 percent with HBV.

These epidemics are particularly alarming because of the rising rates of new infections and high rates of chronic infection among disproportionately impacted racial and ethnic populations. They present a dramatic public health inequity. For example, Asian Americans comprise more than half of the known hepatitis B population in the United States and, consequently, maintain the highest rate of liver cancer among all ethnic groups. American Indian/Alaska Native communities have the highest incidence rates of HCV among all races and ethnicities. HCV is twice as prevalent among African Americans as among Caucasians. Additionally, African American and Latino patients are less likely to be tested for HCV in the presence of a known risk factor, less likely to be referred to treatment for subspecialty care and treatment, and less likely to receive antiviral treatment. Recent alarming epidemiologic reports indicate a rise in HCV infection among young people throughout the country. Some jurisdictions have noted that the number of people ages 15 to 29 being diagnosed with HCV infection now exceeds the number of people diagnosed in all other age groups combined. Alarmingly, 35 out of 41 responding states reported increases in persons newly infected with HCV from 2010-2012.

Further, the "baby boomer" population (those born between 1945 through 1965) currently accounts for three out of every four cases of chronic HCV. As these Americans continue to age, they are likely to develop complications from HCV and require costly medical interventions that can be avoided if they are tested earlier and provided with curative treatment options. It is estimated that this epidemic will increase costs to private insurers and public systems, such as Medicare and Medicaid, from $30 billion in 2009 to over $85 billion in 2024, and account for additional billions of lost productivity due to the millions of workers suffering from chronic HBV and HCV. Over the last three years, CDC and the USPSTF have worked to align their recommendations for hepatitis screening, recommending screening vulnerable groups for HCV and one-time testing of all baby boomers.

We appreciate the Committee's support for viral hepatitis prevention, in particular the increased support to prioritize the identification of people living with HBV and HCV who are unaware of their status. We strongly encourage you to sustain your commitment this year. We have the tools to prevent the major causes of liver disease and liver cancer - a hepatitis B vaccine and effective treatments that reduce disease progression, new diagnostics for HCV and treatments that increase cure rates to over 90%, and even more medical advances for HBV and HCV in the research pipeline. Making this relatively modest investment in the prevention and detection of viral hepatitis represents a key component in addressing a vital public health inequity and will ensure more Americans receive the appropriate health care, strengthen our public health infrastructure, and combat the devastating and expensive complications caused by viral hepatitis.

Sincerely,

Reposted with permission from Hep Magazine  http://blogs.hepmag.com/lucindakporter/2015/03/urgent_hepatitis_ale.html

CMMC hosts Living with Viral Hepatitis

LEWISTON — “Living with Viral Hepatitis” is the subject of a special program set for Saturday, March 23, at Central Maine Medical Center.

Lindsay Ventura, community outreach and education manager for the New England division of the American Liver Foundation, will discuss the liver and its functions as well as provide a clear comparison of hepatitis A, B and C. The discussion will be geared for those who either have the hepatitis C virus or are at risk for contracting the virus. The program will cover information regarding risks, treatment options and living with hepatitis C.

Ventura holds a bachelor’s degree in psychology and education from Northeastern University in Boston. She previously worked as a research assistant in the Division of Preventive Medicine at Boston’s Brigham and Women’s Hospital.

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UK: Five former patients of HIV-scare dentist Desmond D'Mello test positive for hepatitis C

Five former patients of a dentist at the centre of the biggest recall in NHS history have tested positive for hepatitis C, it emerged.

Health chiefs wrote to 22,000 people treated by Desmond D’Mello urging them to undergo tests after he breached hygiene regulations.

The 60-year-old dentist was secretly filmed failing to wash his hands or change equipment between appointments at his practice.

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Snapshots —Alan Franciscus, Editor-in-Chief

Read about fast rate of fibrosis progression after seroconversion, compassionate use of sofosbuvir for post-transplant, and transplant delisting after being cured of HCV.

Abstract: Liver Fibrosis Progression in Hepatitis C Virus Infection After Seroconversion—A Butt et al.
  Source: JAMA Intern Med.2015;175(2):178-185.  doi:10.1001/jamainternmed.2014.6502

The current study analyzed electronic records from the Veterans Administration between 2002 and 2012.  Among the 610,514 records 1,840 patients were found to be HCV positive, and the HCV negative patients were matched for age, race and sex.  People with HIV, HBV, with less than 24 months of follow-up, liver cancer or cirrhosis were excluded from the analysis.  The HCV patients in the study had an initial HCV negative antibody test, but later tested positive for an HCV antibody test and a positive HCV viral load indicating active HCV infections.  The control group had 2 HCV negative antibody tests indicating HCV negative status.

Fibrosis scarring was found to start early after initial infection—452 patients developed cirrhosis, and 85 patients developed decompensated cirrhosis (end-stage liver disease). 

After 10 years of follow-up—18.4% of the HCV patients developed cirrhosis vs. 6.1% of the patients without hepatitis C.  Nine years after diagnosis of hepatitis C, 1.79% developed decompensated cirrhosis vs. 0.33% in the group without hepatitis C.

One very interesting finding was that white race was associated with a 51% increased risk of developing cirrhosis.

 

Editorial Comments:  This is the first study (to my knowledge) that has shown a fibrosis progression after initial infection.  It should also wake us up to the need for treatment soon after exposure or immediately after the onset of chronic infection to prevent any damage to the liver.

Abstract: Sofosbuvir compassionate use program for patients with severe recurrent hepatitis C following liver transplantation—X. Forns et al.
  Source: Hepatology.  2014 Dec 29. doi: 10.1002/hep.27681. [Epub ahead of print]

Hepatitis C resides in the liver and blood.  As a consequence, if someone receives a transplant the new liver is always re-infected with the hepatitis C virus.  Due to many factors including the use of immunosuppressant drugs (to prevent rejection of the organ by the body) the virus multiplies out of control.  Many times (but not always) there is severe and quick disease progression.  Unless there is another donated liver available, the person may face death. 

Compassionate use is a program that allows the use of drugs untested in a particular population, i.e., post-transplant patients, which may help save lives when there are no other available options.  In this case sofosbuvir and ribavirin was given for 24 to 48 weeks to people who had severe recurrent HCV disease after a liver transplant.  The patients in the study were expected to live less than a year.  The decision to add pegylated interferon was left up to the judgment of the treating physician.  

At the time of the analysis (January 1, 2014) there were 92 patients assessed, 54 (59%) patients achieved SVR12 (virologic cure).  Those with early recurrent hepatitis C were more likely to achieve SVR12 (73%) than those with cirrhosis (43%).  More than half of the patients who achieved a cure had clinical improvement, more than a fifth were unchanged and only 3% of the patients were worse.  Eighteen percent of patients had serious adverse events (side effects).

 

Editorial comments:  These results are excellent for patients who are very difficult to treat.  The 73% cure rate of those who were treated early on after recurrent hepatitis C means that everyone with hepatitis C at the time of transplant should be treated as soon as it is safe.  However, we should not have to wait—treat well before the need for a transplant, and no one with hepatitis C should ever have to face this potentially life-threatening (and expensive) transplant procedure again.

Article: Letter from the Frontline: Patient with decompensated hepatitis C virus–related cirrhosis delisted for liver transplantation after successful sofosbuvir-based treatment—I Ruiz et al.
  Source:  Liver Transplantation Volume 21, Issue 3, pages 408–409, March 2015

This was a case study of one patient who was listed for a liver transplant in October 2013. The patient was a 67-year-old woman with HCV genotype 4 and decompensated cirrhosis.  She was treatment experienced (null responder) to pegylated interferon plus ribavirin and had weekly paracentesis (she had to have fluid drained from her abdominal cavity due to ascites), and moderate encephalopathy (brain disorder caused by the build-up of ammonia and toxins in the brain) that required several hospitalizations.

Treatment consisted of sofosbuvir plus ribavirin for 24 weeks.  After 8 weeks, of treatment the woman’s viral load was undetectable.  The treatment was well tolerated.  The patient achieved a cure and her encephalopathy, ascites and liver disease improved to the point that she was taken off the transplant list. 

The authors commented that (to their knowledge) this is a first—a patient with hepatitis C related decompensated cirrhosis was delisted from the transplant list.   

 

Editorial comment:  In the past interferon and ribavirin was given but was poorly tolerated for people with end-stage liver disease.  In fact, treatment with interferon and ribavirin could lead to more severe disease progression and death. 

The two studies above provide proof that all-oral therapy provides safe and effective treatment.  Now, we just need to provide treatment to everyone with hepatitis C so that no one has to suffer from end-stage liver disease and the need for a liver transplant. 


http://hcvadvocate.org/news/newsLetter/2015/advocate0315_mid.html#2

Hepatitis C Drugs Will 'Strain Budgets' at Current Prices: Study

The new therapies have remarkably high cure rates

MONDAY, March 16, 2015 (HealthDay News) -- New hepatitis C drugs promise cure rates above 90 percent, but could prove to be budget-busters for public and private health insurers, a new analysis finds.

Recently approved drugs for chronic hepatitis C have been heralded as a breakthrough that could make the liver disease "rare" in the United States. But with prices topping $1,000 per pill, government and private insurers are balking -- often putting limits on which patients qualify for coverage.

Now two new studies in the March 16 Annals of Internal Medicine conclude that for individual patients, treatment with the pricey pills is "cost-effective." That's a calculation that takes into account the years of better health and quality of life people will likely enjoy.

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