[EASL Press Release] Launch of the MEP Friends of the Liver Interest group to tackle a silent epidemic

[EASL Press Release] Launch of the MEP Friends of the Liver Interest group to tackle a silent epidemic

Brussels 27th May - The MEP Friends of the Liver Interest Group (1) was launched today at the European Parliament in Brussels in an event hosted by the Member of the European Parliament (MEP) Dr Cristian-Silviu Busoi (EPP, RO), calls on the European Parliament to use its significant powers raise awareness about liver disease and advocate for EU policies to ensure that all patients have access to the best treatments and medicines.

Previously chaired by Stephen Hughes from the UK Labour Party, the group was formed in February 2013 and has been reformed after the election of the new Parliament in 2014. The new co-chairs are Romanian EPP member, Dr Cristian-Silviu Busoi and Dr Biljana Borzan, an S&D group member from Croatia. Subsequent meetings will look at the role of food and obesity in liver disease and its links with diabetes and heart disease and the need for an EU strategy on viral hepatitis (HCV) and access to medicines for HCV.

Liver disease is a neglected and growing public health problem. Besides well-known diseases such as liver cirrhosis, it also includes Hepatitis B (HBV) & Hepatitis C (HCV), liver cancer and fatty liver disease. (2) "As a doctor and policy maker, who has seen the extent of liver disease across the EU, I delighted to be chairing this important and needed Friends of the Liver group," said Mr. Busoi.

Preventing these deaths would have enormous benefits for Europe’s citizens as well as saving the EU and Member States’ economies billions of Euros in health and social care costs. Not to mention the benefits from development of diagnostics and safer new drugs that could treat and save patients and be marketed around the world. "Liver disease is a huge problem in the EU and I am looking forward to working with the Friends of the Liver group to help fix that," said Ms Borzan, Co-Chair of the group.

The European Association for the Study of the Liver (EASL) (3) will be the Secretariat of the newly formed group. In December 2014, EASL launched the ’Research Roadmap for Liver Disease (HEPAMAP) - Case study for chronic diseases & research’ (4). The HEPAMAP stresses the need for further research on liver disease and calls on policy makers to step up their efforts to tackle the disease and its links with lifestyle and other disease, like cardiovascular conditions and cancer. "Liver disease is a silent epidemic affecting millions of patients that needs more attention at EU level. EASL looks forward to working with the Friends of the Liver group to change this," concluded Mr Laurent CASTERA, EASL Secretary-General.

(1) The MEP Friends of the Liver Interest group in the European Parliament is a group of MEPs with an interest in liver disease and its underlying causes. The aim of the group is to raise awareness amongst their colleagues and the European Commission of liver disease and to identify and advocate for European Union policies that can help prevent it and improve treatment.

(2) In the European region there are an estimated 15 million people suffering from HBV and almost 8 million EU citizens are infected with HCV. There are 47,000 deaths in the EU each year from liver cancer and 170,000 deaths from liver cirrhosis. We estimate that over 100 million EU residents suffer from fatty liver disease due to obesity and overweight.

(3) The European Association for the Study of the Liver (EASL) is a membership organisation for hepatology health professionals based in Geneva (Switzerland). EASL currently has just over 4,000 members from over 100 countries. The EASL annual congress now attracts over 10,000 participants and is the biggest medical liver congress in the world. EASL will celebrate its 50th anniversary in 2015.

(4) HEPAMAP: Prospects for Liver Disease Research in the EU

Contact
Fiona Godfrey, Director of European Public Affairs at European Association for the Study of the Liver (EASL) on +35 269 149 0948. Twitter: @fjgodfrey

Future meetings will take place on a regular basis. Follow the group on Twitter to stay updated @MEPLiverGroup #LiverFriends

 

 

Source:  http://www.epha.org/a/6360

Minnesota prison inmates sue to gain access to costly hepatitis C medications

Two prisoners have sued the state, highlighting a national dilemma: tax money going for expensive treatments.

Two inmates are suing the ­Minnesota Department of Corrections seeking access to costly drug treatments for hepatitis C, a serious liver condition that in many cases can be cured with a new generation of medications.

Filed in federal court this month, the lawsuit taps into a national debate over how prison systems can afford the costly new drugs, some of which carry a sticker price of $1,000 per pill and $90,000 for the full treatment.

In a written statement, the Corrections Department said that it could not comment on the lawsuit, but added: “It is not true that offenders do not have access to the new ­medications.”

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Help-4-Hep expands its Peer-to-Peer Hepatitis C Counseling Services by offering new mobile and web app

San Francisco, CA -- May 19, 2015 – Help-4-Hep, a non-profit, peer-to-peer helpline where counselors work with patients to meet the challenges of hepatitis C, is launching today a new web and mobile app to bring its highly effective peer counselling services as well as a new self-care tool to more people affected by hepatitis C.  

Hepatitis C is a silent and potentially deadly liver disease and a serious health issue affecting our population. For up to 80% of people who contract hepatitis C, the illness moves into a long-term phase called chronic hepatitis C. Up to 5 million people in the United States today are living with chronic hepatitis C, and more people in the US die from the disease than from HIV. In recognition of the importance of creating awareness and educating the general public about this illness, this May is Hepatitis Awareness Month and today is Hepatitis Testing Day.

Help-4-Hep’s web and mobile app was developed in partnership with patient intelligence health solution provider, Self Care Catalysts (SCC). The Help-4-Hep app is part of Self Care Catalyst’s popular Health Storylines platform, leveraged by a wide number of patient communities to improve self-care and management of chronic conditions.

The app provides a suite of self-care tools for people living with chronic hepatitis C to help them better manage their illness and prepare for their treatment journey. It offers tools such as the ability to log lab tests, includes a food diary to help manage diet and nutrition and a mood tracker, allowing people living with hep C to chronicle their emotions and feelings. Individuals can also call the Help-4-Hep hotline directly from the app and discuss their condition with their counsellor.

Help 4 Hep aims to support more individuals living with hep C who are waiting for treatment. Physicians and nurses can also benefit from recommending the app to support their patients between visits.

“It’s incredibly important for people with chronic hepatitis C to take control of their health by tracking day to day routines and behaviors such as the amount of sleep and exercise they are getting and by eating well.  We are truly excited to be able to extend our network of support into the web and mobile world, so we can reach and help more people affected by hepatitis C,” says Dennis Simon, Managing Partner, Help-4-Hep.

Help-4-Hep’s web and mobile app is officially launching today on Hepatitis Testing Day. It is free and available on desktop, laptop, mobile and tablet devices. Interested users can sign-up on the Web, or download the app from the App Store℠ or from Google Play™. The app is available both in Canada and the US.

About Help-4-Hep
Help‑4‑Hep is a non-profit, peer-to-peer helpline where counselors work with patients to meet the challenges of hepatitis C head-on. Callers talk one-to-one with a real person, typically someone who's had hepatitis C touch their own life. And they talk about the specifics of their particular situation. The phone call, support and information are all provided free of charge. Help-4-Hep is also the creator of the The Support Partnership - a network of nationally recognized nonprofits that have nearly 100 years of combined experience with peer helplines, hepatitis C support, education, testing, treatment and advocacy. For more information visit http://www.help4hep.org/. For counselling support call the Help-4-Hep hotline toll free at 877-Help-4-Hep.

About Self Care Catalysts
Self Care Catalysts is a patient solutions, intelligence and analytics company that enables healthcare innovation. We are committed to advocating for patients and consumers when it comes to healthcare decisions. Our belief is that when patients are informed, respected, and engaged, they make better choices. Better choices mean better health outcomes.
Our mission is to build innovative, patient-centered, and technology-driven self-care solutions that will enable patients to continue managing their care outside of the clinical setting.

Links/URLS
Self Care Catalysts on Twitter https://twitter.com/sccatalysts

Press Release Source:  http://www.help4hep.org/app/

HealthWell Foundation Co-pay Assistance

HealthWell Foundation’s New Fund BringsFinancial Relief to Underinsured PeopleLiving with HepatitisC

New Hepatitis C Fund – AWelcome Announcement During Hepatitis Awareness Month

Gaithersburg, Md. – 20 May, 2015 – The HealthWell Foundation®, an independent non-profit that provides a financial lifeline for inadequately insured Americans, today announced the launch of a new fund to assist people living with hepatitis C (also known as HCV).

Through the fund, the HealthWell Foundation will provide copayment assistance for HCV treatment, up to $15,000, to eligible patients who are insured and have annual household incomes up to 500 percent of the federal poverty level. According to the Centers for Disease Control and Prevention, one in 30 baby boomers has HCV.

"The new generation of hepatitis C treatments has brought excitement to patients who have been hoping for a breakthrough," said Krista Zodet, HealthWell Foundation President. "Through the generosity of our donors, our Hepatitis C Fund is able to help more people receive these treatments while minimizing the worry over financial stress."

"Nearly 3.2 million people in the United States and about 150 million people worldwide are chronically infected with HCV," said Tom Nealon, Esq., National Board Chair of the American Liver Foundation, a national patient advocacy organization that promotes education, support and research for the prevention, treatment and cure of liver disease. "The HealthWell Foundation and other independent copay charities play a vital role in seeing that those who are insured but can't afford their medication copay are able to access and stay on treatment."

Download the complete press release here...

Visit the site http://www.healthwellfoundation.org/

Injection Drug Use Fuels Rise In Hepatitis C Cases

May 26, 2015 4:22 PM ET

Kristin Gourlay 

Listen to the Story

 

The rise in injection drug use across the country, especially the eastern U.S., is fueling an outbreak of hepatitis C. Outreach workers are offering clean needles and testing to contain the spread.

Source:  http://www.npr.org/2015/05/26/409804741/injection-drug-use-fuels-rise-in-hepatitis-c-cases

AbbVie Presents New Data for its Investigational Hepatitis C Treatment in Japanese Patients With and Without Cirrhosis

- New data from GIFT-I study presented at the Annual Meeting of the Japan Society of Hepatology

- Primary endpoint of 95 percent and secondary endpoint of 91 percent SVR12 achieved in genotype 1b hepatitis C virus infected Japanese patients without and with compensated cirrhosis, respectively(1)

- 98 percent SVR12 achieved in additional analysis of patients without cirrhosis receiving double-blind placebo for 12 weeks, followed by open-label therapy with AbbVie's investigational treatment(1)

- AbbVie's ribavirin-free treatment for genotype 1 hepatitis C Japanese patients consists of a 12-week, two direct-acting antiviral, fixed-dosed combination of paritaprevir/ritonavir with ombitasvir, dosed once daily

NORTH CHICAGO, Ill., May 26, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) presented new results from the Phase 3 GIFT-I study of its investigational, all-oral, interferon (IFN)- and ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan.¹ GIFT-I evaluated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected Japanese patients, with and without cirrhosis, who were either treatment-naïve or IFN (with or without RBV) treatment-experienced.¹ The primary endpoint was achieved, demonstrating 95 percent (n=106/112) SVR₁₂ in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b HCV infected Japanese patients who were eligible for therapy with IFN and had a high viral load.¹ In study results related to the secondary endpoint, GT1b HCV patients with compensated cirrhosis achieved 91 percent (n=38/42) SVR₁₂.¹

In an additional intent-to-treat (ITT) analysis, SVR₁₂ was achieved in 98 percent (n=104/106) of the GT1b HCV infected patients without cirrhosis (Arm B) who were randomized to initially receive double-blind placebo for 12 weeks, followed by open-label treatment with ombitasvir/paritaprevir/ritonavir.¹ The ITT population included every patient that was randomized to placebo and received at least one dose of active, open-label study drug.

"It is critical to address the burden of hepatitis C in Japan, with GT1b being the most prevalent sub-type of the disease in the country," said Kazuaki Chayama, M.D., Ph.D, professor and head of the Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University. "GIFT-I shows the potential of this treatment to achieve high SVR rates for Japanese patients with GT1b hepatitis C, including those with compensated cirrhosis."

Across all study arms, three patients (n=3/363) discontinued treatment due to adverse events.¹ The most commonly reported adverse events (>5 percent in any arm) were nasopharyngitis, headache, peripheral edema, nausea, pyrexia and decreased platelet count.¹

"We are pleased to present full results from GIFT-I, which provide further insight into our hepatitis C treatment currently under priority review by the Japanese health authorities," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "We know physicians weigh the risks and benefits of HCV treatments for their patients as they look for an option that offers a potential cure. These data will help guide clinicians in their decision making and support AbbVie's goal of bringing an interferon- and ribavirin-free treatment to people living with genotype 1 hepatitis C in Japan."

In Japan, approximately 1.5 to 2 million people are living with HCV.² Genotype 1 is the most common HCV genotype in Japan with 60 to 70 percent of patients infected and, of those, about 95 percent are infected with the GT1b sub-type.³ AbbVie studied its two direct-acting antiviral treatment regimen without RBV in Japan due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b.

AbbVie's investigational, two direct-acting antiviral treatment consists of ombitasvir/paritaprevir/ritonavir and is currently under priority review by the Japanese Ministry of Health, Labour and Welfare.

About GIFT-I Study
GIFT-I comprises 363 patients in two sub-studies. In sub-study 1, 321 genotype 1b (GT1b) patients without cirrhosis, both treatment-naïve and interferon (IFN) [with or without ribavirin (RBV)] treatment-experienced, were randomized to receive either ombitasvir/paritaprevir/ritonavir (Arm A) [OBV/PTV/r] or placebo (Arm B) [2:1 randomization ratio, stratified by treatment history, past response, viral load and IFN eligibility]. Patients initially randomized to placebo (Arm B) then received OBV/PTV/r for an additional 12 weeks of open-label treatment. Sustained virologic response was assessed 12 weeks post-treatment (SVR₁₂) as a primary efficacy endpoint in a sub-group of previously untreated, non-cirrhotic GT1b patients who were eligible for therapy with IFN and had a high viral load, defined as an HCV RNA level ≥ 100,000 IU/mL and received at least one dose of the double-blind, active study drug.¹

In sub-study 2, 42 GT1b treatment-naïve and IFN (with our without RBV) treatment-experienced patients with compensated cirrhosis received open-label treatment for 12 weeks (Arm C) with SVR₁₂ and assessed as a secondary efficacy endpoint.¹

One patient from each arm (n=3/363) experienced on-treatment virologic failure [Arm A, 0.5% (n=1/215); Arm B, 0.9% (n=1/106); Arm C, 2.4% (n=1/42)].¹ Across all arms, eight patients (n=8/354) experienced post-treatment relapse [Arm A, 2.4% (n=5/209); Arm B, 1.0% (n=1/105); Arm C, 5.0% (n=2/40)].¹  

About AbbVie's Investigational Two Direct-Acting Antiviral HCV Treatment
For the treatment of genotype 1 chronic hepatitis C virus (HCV) infection in Japan, AbbVie's investigational, two direct-acting antiviral treatment consists of the fixed-dosed combination of paritaprevir/ritonavir (150/100 mg) with ombitasvir (25 mg), dosed once daily.

AbbVie's chronic HCV treatment combines two direct-acting antivirals, each with a distinct mechanism of action that targets and inhibits specific HCV proteins of the viral replication process.

About AbbVie's HCV Clinical Development Program in Japan
AbbVie's HCV clinical development program in Japan focuses on our investigational, two direct-acting antiviral treatment and is designed with the goal of achieving high SVR rates in chronic HCV infected patients, including additional genotypes and patients with compensated cirrhosis.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

Ombitasvir/paritaprevir/ritonavir is an investigational product and its safety and efficacy have not been established in Japan.

Additional information about AbbVie's clinical development program in Japan can be found on www.clinicaltrials.gov.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Read the complete press release here

FDA Grants Breakthrough Therapy Designation for Genotype 1 Hepatitis C Therapy

The daclatasvir-sofosbuvir regimen for the treatment of genotype 1 hepatitis C patients was granted amended Breakthrough Therapy Designation by U.S. Food and Drug Administration (FDA). In the beginning of 2015, the FDA had planned to remove Breakthrough-Therapy Designation for the daclatasvir-sofosbuvir treatment since other therapies were available and had higher success for other genotypes. However, the FDA revised its first decision and decided to continue the development of this therapy for the genotype 1 hepatitis C patients addressed in ALLY-1 Trial due to its promising results.

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