Australia: Calls for clean needles in West Australian prisons as one in ten inmates test positive for Hepatitis C

BRENDAN TREMBATH: Tests reveal that one in ten inmates in the Western Australia prison system have the infectious disease Hepatitis C.

But a support group says efforts to reduce its prevalence are doomed to fail unless prisoners are given access to clean needles.

Hepatitis WA has renewed calls for the State Government to introduce a needle exchange program.

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Bristol-Myers Squibb Announces Acceptance of New Drug Application for Investigational Daclatasvir for FDA Review for the Treatment of Hepatitis C Genotype 3

The NDA contains data to support approval for daclatasvir in combination with sofosbuvir; would be the first 12-week regimen specifically for the treatment of hepatitis C genotype 3

 

The application is based on a Phase III clinical trial which tested a 12-week, ribavirin-free regimen and resulted in sustained virologic response (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 HCV patients

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the resubmitted new drug application (NDA) for daclatasvir, an investigational NS5A replication complex inhibitor, has been accepted for review by the U.S. Food and Drug Administration (FDA) for use in combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3. The original NDA has been amended to include data from the Phase III ALLY-3 trial, which showed high cure rates for the combination, with sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 HCV patients. SVR12 rates were higher (96%) in non-cirrhotic genotype 3 patients, regardless of treatment history. The FDA will now review the submission within a six-month timeframe.

“The daclatasvir-based NDA seeks to address a high-unmet patient need that still exists despite recent hepatitis C treatment advances. Approximately 9-12% of HCV patients in the U.S. have genotype 3. That’s thousands of individuals in the U.S. who historically have had limited treatment options requiring at least 24 weeks of treatment,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “We also are continuing clinical trials to determine the potential of daclatasvir-based regimens in treating a range of other high unmet-need patients, including those coinfected with HIV, HCV patients with decompensated cirrhosis, and HCV recurrence in post-transplant patients.”

Genotype 3 is estimated to affect 54.3 million people worldwide, and is the second most common hepatitis C genotype after genotype 1 (83.4 million). The more aggressive nature of genotype 3 lies in the damage it causes to the liver, as it is associated with progressive disease, increased rates of steatosis and a disproportionately increased risk of hepatocellular carcinoma.

In the ALLY-3 study, the daclatasvir and sofosbuvir combination regimen was well tolerated, with no deaths, treatment-related serious adverse events, or discontinuations due to adverse events. The most frequent side effects (≥5%) were headache (19.7%), fatigue (19.1%), nausea (11.8%), diarrhea (8.6%), insomnia (5.9%), abdominal pain and arthralgia (both 5.3%). Additionally, there were 17 (11.2%) treatment failures, with 16 relapses post-treatment and 1 rebound at the end of treatment. There were no viral breakthroughs in this ribavirin-free regimen.
 
About ALLY-3: Study Design
This Phase III open-label clinical trial enrolled 152 genotype 3 HCV patients; 101 treatment-naïve patients and 51 treatment-experienced patients in 2 cohorts each received daclatasvir 60 mg and sofosbuvir 400 mg once daily for 12 weeks, with 24 weeks of follow-up. The primary endpoint was SVR12 rates, defined as HCV RNA < LLOQ target detected or not detected at follow-up week 12 in treatment-naïve and treatment-experienced patients.

Read complete press release here

 

Combo Hepatitis C Genotype 3 Tx To Be Reviewed By FDA

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) of daclatasvir in combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3.

The initial NDA now includes data from the ALLY-3 trial (n=152), a Phase 3 open-label study in which patients received daclatasvir 60mg + sofosbuvir 400mg once daily for 12 weeks with 24 weeks of follow-up. The study demonstrated high cure rates for the combination therapy with sustained virologic response 12 weeks after treatment (SVR12) seen in 90% of treatment-naive genotype 3 HCV patients, and in 86% of treatment-experienced patients. SVR12 rates were seen in 96% of non-cirrhotic genotype 3 patients, regardless of treatment history.

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Study details microRNA's role as a double agent during Hep C infection

In the battle between a cell and a virus, either side may resort to subterfuge. Molecular messages, which control the cellular machinery both sides need, are vulnerable to interception or forgery. New research at Rockefeller University has revealed the unique twist on just such a strategy deployed by the liver-infecting Hepatitis C virus - one that may help explain the progression of liver disease and that the researchers suspect may be found more widely in the world of disease-causing viruses.

Led jointly by Charles Rice, the Maurice R. and Corinne P. Greenberg Professor in Virology and head of the Laboratory of Virology and Infectious Disease and Robert Darnell, Senior Attending Physician, Robert and Harriet Heilbrunn Professor, and head of the Laboratory of Molecular Neuro-oncology, the research is described today (March 12) in Cell. It employed a powerful combination of techniques to map the interactions between the virus and a small piece of genetic material - known as miRNA-122 - that is produced almost exclusively by liver cells, which normally use it to regulate expression of their own genes.

"It is well known that once inside a liver cell, the hepatitis C virus must bind to miRNA-122 in order to establish a persistent infection. We found an unanticipated consequence of this interaction: By binding to miRNA-122, the virus acts like a sponge, soaking up these gene-regulating molecules," says first author Joseph Luna, a graduate student with a joint appointment in the labs. "Our experiments showed this has the effect of skewing gene activity in infected liver cells."

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FDA to review re-submitted Bristol-Myers hepatitis C drug

(Reuters) - U.S. regulators have accepted Bristol-Myers Squibb Co's re-submitted marketing application for an experimental hepatitis C treatment after the drugmaker was forced last year to withdraw its initial request.

Bristol-Myers on Thursday said the U.S. Food and Drug Administration will review daclatasvir, its so-called NS5A inhibitor, for use in combination with Gilead Sciences Inc's potent and widely used Sovaldi treatment. It said the FDA is expected to make its decision within six months.

Bristol-Myers originally had sought FDA permission to market daclatasvir in combination with another Bristol drug, asunaprevir. But it abandoned that application due to potential competition from more potent drugs, leaving the FDA without data to gauge the effectiveness of daclatasvir as part of a combination regimen.

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Action Alert! | Urge Your House Representative To Support Increased Hepatitis B and C Funding!

March 12, 2015

NVHR – National Viral Hepatitis Roundtable 

Representatives Mike Honda, Hank Johnson, and Judy Chu are asking all House Representatives to sign an important letter supporting a doubling in funding for hepatitis B and C programs in the Fiscal Year 2016 appropriations bill (see text of letter below). This is the same increase in funding that President Obama recommends in his proposed budget, which was released last month. The deadline for Representatives to sign the letter is end of day, March 19, 2015.

This is an extraordinary opportunity to ask our House Representatives for leadership in the fight against the hepatitis B and C epidemics. The more signatures on this letter, the better chance of securing badly needed funding to expand testing, linkage to care, surveillance, and other vital services.

Please take a few minutes before March 19th to call your House Representative’s office in Washington, DC and ask/him to sign this letter.

How you can help:

You can reach your 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 and (4) a brief message why this issue is important to you. Tell them they can sign the letter by contacting Helen Beaudreau in Representative Honda’s office or Scott Goldstein in Representative Johnson’s office.

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,

Doctors urge Hepatitis C patients to seek help now due to rising costs

INDIANAPOLIS - Doctors say many who have Hepatitis C don't know it.

There is a new cure, but in part, because of its high cost, insurance companies are looking to cut coverage.

Dr. Steven Norris with Community Health says new drugs to the market are a dramatic game changer for Hepatitis C patients who, until now, endured treatments with multiple side effects and a low 20 percent success rate.

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