Senator Kirk Joins American Legion to Raise Hepatitis C Awareness for Veterans

Kirk’s Veterans Bill Passed by Appropriations Committee Funds $900 Million Worth of Groundbreaking New Hepatitis C Treatments; Veterans Suffer From Hepatitis C at a Rate Three Times That of the Civilian Population

Summit, Ill. --(ENEWSPF)--May 29, 2015.  In an effort to raise hepatitis C virus (HCV) awareness for veterans, U.S. Senator Mark Kirk (R-Ill.) joined Marty Conatser, Adjutant of the American Legion Department of Illinois, Paul Gardner, Senior Vice Commander of the American Legion Department of Illinois, and Argo Summit Post Commander Reggie Rice at a free Hepatitis C testing event in Summit, IL. Service Officers from the American Legion and representatives from the Department of Veterans Affairs were also present to counsel veterans on VA benefit claims and recommend next steps for HCV medical care to any veterans that tested positive for the virus.

“In the Department of Veterans Affairs we have cured more people of Hepatitis C in the last 16 months than in the last 16 years,” Senator Kirk said. “We will continue work to make sure that those who wore the uniform can have a better life.”

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Lee County Health Department offers Hep C rapid test

Also looks into creating a needle exchange in response to heroin increase in county 

 DIXON – It's not just law enforcement agencies that are taking a proactive approach to Lee County's increased heroin usage — the health department is making strides, too.

This week, the Lee County Health Department started offering rapid screening for Hepatitis C. It's an action that Administrator Cathy Ferguson hopes will stave off any future heroin-related public health crises, like the one that southeastern Indiana has seen.

According to the latest figures, there are now 162 people in Indiana who have been diagnosed with HIV as part of an outbreak that, officials say, stemmed from the sharing of heroin needles.

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Meeting Report Now Available: Hepatitis C among African Americans

African Americans are among the populations prioritized by the Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis (Action Plan) which outlines steps to educate communities about the benefits of viral hepatitis prevention, care, and treatment as well as actions to enhance healthcare provider knowledge about populations disproportionately impacted. A two-day forum convened by HHS in March 2015 focused on strengthening the response to hepatitis C in African American communities and included participation from over 30 organizations from across the country. The Action Plan is a national plan that requires the participation and engagement of many partners in order to achieve its goals and the newly released forum report includes themes and strategic considerations that all stakeholders can use to address the important health disparity of hepatitis C among African Americans in the United States.

Read the full report from the HHS Forum on Hepatitis C in African American Communities (PDF 8.4MB)

- See more at: https://blog.aids.gov/2015/05/meeting-report-now-available-hepatitis-c-among-african-americans.html#sthash.8N3zjGUp.dpuf

Phase I/II Opdivo (nivolumab) Trial Shows Bristol-Myers Squibb’s PD-1 Immune Checkpoint Inhibitor is First to Demonstrate Anti-Tumor Activity In Patients With Hepatocellular Carcinoma

• Interim results show favorable safety profile of Opdivo, and durable responses in previously-treated patients
• Overall survival rate of 62% at 12 months observed at this interim analysis
• Hepatocellular carcinoma is the second most frequent cause of cancer-related death worldwide and remains an area of significant unmet medical need
• Patients with hepatocellular carcinoma who have relapsed or have disease progression, following standard of care, have a median survival with best supportive care of ~7 to 8 months

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from an interim analysis of CA209-040, a Phase I/II dose-ranging trial evaluating the safety and anti-tumor activity of Opdivo (nivolumab) in previously-treated patients with hepatocellular carcinoma (HCC) or advanced liver cancer. Initial findings demonstrated that the estimated survival rate in evaluable patients (n=47) was 62% at 12 months. Results also show the safety profile of Opdivo is generally consistent with that previously-reported for Opdivo in other tumor types. These data will be featured today, May 29, during the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) press briefing at 1:00 – 2:00 p.m. CDT and presented on Saturday, May 30 from 8:27 a.m. – 8:39 a.m. CDT (Late Breaking Abstract #101).

“Hepatocellular carcinoma is an aggressive and fatal cancer, comprising 90 percent of all liver cancer in adults worldwide with limited therapeutic options for patients with advanced stage disease; no treatment advances have been made for patients who fail to respond or progress on the current standard of care,” said Anthony B. El-Khoueiry, MD, lead study author and associate professor of clinical medicine and phase I program director at the University of Southern California Norris Comprehensive Cancer Center. “These preliminary data are encouraging and support the ongoing evaluation of nivolumab in this patient population, as they show promising preliminary survival data, and durable partial or complete response in one out of five nivolumab-treated patients, with many others experiencing stable disease.”

More than 700,000 people around the world are diagnosed with HCC each year with a majority of all HCC cases caused by infection with the hepatitis B virus (HBV) or hepatitis C virus (HCV), making HBV/HCV the most common risk factor for liver cancer worldwide. Patients with advanced HCC receiving the current standard of care have a median overall survival of less than 1 year. For patients who have relapsed or have disease progression, median survival with best supportive care is approximately 7 to 8 months.

“Bristol-Myers Squibb’s experience in hepatitis and Immuno-Oncology make us poised as leaders to advance Opdivo into additional studies of hepatocellular carcinoma,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Opdivo has demonstrated improvements in survival in a number of different tumor types. We are excited that this trial has shown the potential that this may extend to advanced liver cancer and hope to confirm these findings in future trials.”

About the CA209-040
CA209-040 is a Phase I/II dose-ranging trial that evaluated the safety and anti-tumor activity of Opdivo in patients with HCC, the majority of whom had received prior treatment. The trial included 47 HCC patients who were enrolled into one of three treatment arms depending on whether or not they were infected with HCV or HBV. Patients enrolled in the trial received Opdivo doses ranging from 0.1 – 10 mg/kg intravenously every 2 weeks for up to 2 years. The primary objective was safety, tolerability, dose limiting toxicities, and maximum tolerated dose. Anti-tumor activity was a secondary objective (using RECIST 1.1 criteria), and overall survival was an exploratory objective.

As of this interim analysis, 62% of patients in the study were still alive after 12 months. Eight (19%) patients (of 42 evaluable patients) achieved a complete or partial response, meaning that the size of their tumors measured at baseline decreased by 30–100% with Opdivo treatment. In patients with response, duration of response ranged from more than 1.4 – 12.5 months. Seventeen patients remained on study treatment and 30 discontinued treatment due to progressive disease (n=26), complete response (n=2), or adverse events (n=2).

CA209-040 is the first trial to characterize the safety profile of Opdivo monotherapy in patients with HCC, including those with HCV and HBV infections. In the trial, safety and tolerability were well-characterized, with the frequency and intensity of treatment-related adverse events (AEs) being consistent across Opdivo dose levels. The majority of side effects were mild to moderate in nature with abnormal liver enzymes (19% AST and 15% ALT), rash (17%) and elevation of amylase (15%) and lipase (17%) being the most common; the abnormal liver enzymes and elevated amylase and lipase were not accompanied by any significant clinical symptoms. Grade 3–4 treatment-related AEs were infrequent (19%). There were no treatment-related deaths reported.

About Opdivo
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as monotherapy or in combination with other therapies – in which more than 8,000 patients have been enrolled worldwide.

Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world on July 4, 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. In the U.S., the U.S. Food and Drug Administration (FDA) granted its first approval for Opdivo for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. On March 4, 2015, Opdivo received its second FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Read complete press release here

 

Merck Submits U.S. New Drug Application for Grazoprevir/Elbasvir, an Investigational Once-Daily, Single Tablet Combination Therapy, for Treatment of Chronic Hepatitis C Genotypes 1, 4, and 6 Infection

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for grazoprevir/elbasvir (100mg/50mg), an investigational once-daily, single tablet combination therapy for the treatment of adult patients with chronic hepatitis C genotypes (GT) 1, 4 or 6 infection. Within 60 days of submission, the FDA will determine whether it will accept for review Merck's application as filed. The company plans to submit additional license applications in the European Union and other markets by the end of 2015.

“Merck's submission is based on evidence from our wide-ranging clinical program assessing the efficacy and tolerability profile of grazoprevir/elbasvir in populations with chronic hepatitis C,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories. “This submission to the U.S. FDA is an important milestone as we seek to provide patients with a new treatment option for this serious infection.”

The FDA has previously granted Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis, and for patients infected with chronic HCV GT4. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

The New Drug Application for grazoprevir/elbasvir (100mg/50mg) is based in part upon data from the pivotal C-EDGE clinical trials program, as well as the C-SURFER and C-SALVAGE trials, evaluating grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in patients with chronic hepatitis C infection. Data from these trials were presented at The International Liver Congress^TM 2015 in April 2015.
 
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, once-daily single tablet regimen consisting of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor). As part of Merck’s broad clinical trials program, grazoprevir/elbasvir is being studied in multiple HCV genotypes and in patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, liver cirrhosis and those on opiate substitution therapy.
 
About Merck
Today’s Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
 

Read the complete press release here

Harvoni added benefit for patients with HCV/HIV coinfection

In a manufacturer dossier assessment conducted by the Institute for Quality and Efficiency in Health Care in Germany, Harvoni was deemed to have an added benefit for patients with hepatitis C genotype 1a virus infection and HIV without cirrhosis, according to a press release.

The dossier assessment is a procedural part of the Reform of the Market for Medicinal Products Act, overseen by the Federal Joint Committee (G-BA). The G-BA conducts a commenting procedure once the dossier assessment is complete and then determines the extent of the added benefit determined by the Institute for Quality and Efficacy in Health Care (IQWiG).

The assessment was based on additional data from five clinical studies submitted by Gilead Sciences. The information led the IQWiG to conclude that SVR achieved by patients without HIV coinfection was “transferable” to patients with HIV coinfection without cirrhosis. However, the extent of the added benefit in this population of patients is “non-quantifiable” due to the fact it is unclear in how many patients with undetectable viral load prevention of late complications and liver cancer can be achieved, according to the release.

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Cooperation among viral variants helps hepatitis C survive immune system attacks

Warring armies use a variety of tactics as they struggle to gain the upper hand. Among their tricks is to attack with a decoy force that occupies the defenders while an unseen force launches a separate attack that the defenders fail to notice.

A study published earlier this month in the journal Proceedings of the National Academy of Sciences suggests that the Hepatitis C virus (HCV) may employ similar tactics to distract the body's natural defenses. After infecting patients, Hepatitis C evolves many variants, among them an "altruistic" group of viral particles that appears to sacrifice itself to protect other mutants from the body's immune system.

The findings, reported by researchers from the Georgia Institute of Technology and the Centers for Disease Control and Prevention (CDC), could help guide development of future vaccines and treatments for the virus, which affects an estimated 170 million people in the world. Developing slowly over many years and often without symptoms, Hepatitis C can cause severe liver damage and cancer. There are currently no vaccines for the disease.

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[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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Consumers Sue Anthem for Denying Coverage for a Gilead Hepatitis C Drug

The controversy over the new crop of hepatitis C treatments has taken yet another turn as consumers are starting to file lawsuits against insurers that deny them access to the medicines. Over the past two weeks, two different women alleged that Anthem Blue Cross refused to pay for the Harvoni treatment sold by Gilead Sciences GILD -1.74% because it was not deemed “medically necessary.”

The issue emerges after more than a year of debate over the cost of the medicines and complaints by public and private payers that the treatments have become budget busters. The new hepatitis C treatments, which are sold by Gilead Science and AbbVie, cure more than 90% of those infected and, in the U.S., cost from $63,000 to $94,500, depending upon the drug and regimen, before any discounts.

In response, drug makers have been pressured to offer discounts and some state Medicaid programs, for instance, set restrictions before providing coverage to some hepatitis C patients. By setting restrictions, payers hope to limit the number of patients for whom coverage is provided. And this is the tack that Anthem Blue Cross has pursued, according to court documents.

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Canada: Baby Boomer HCV Testing Advocated by BC Legislators in a Big Way!

Victoria, BC, May 25, 2015. From across the aisle and across the province, 16 British Columbia MLAs and 5 staff volunteered to “roll up their sleeves” to get tested for hepatitis C in hopes they can help broaden, normalize and de-stigmatize use of this test. After hearing that 75% of the people with hepatitis C in Canada are in the age cohort born 1945 – 1965, and 44% of the people who have Hep C don’t know it, they decided to show leadership (and courage – who likes needles?) – by getting this simple blood test publicly. The two nurses from Victoria Cool Aid Society and volunteers from HepCBC Hepatitis C Education & Prevention Society said they were surprised at the strong response, and had to turn away three MLAs (Stephanie Cadieux from the government, plus Bill Routley and John Horgan) when they ran out of needles!

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Comment | Benefits of needle exchange programs

Hospitalizations and deaths due to heroin overdoses are on the rise in Kentucky.

According to the Kentucky Injury Prevention and Research Center, the number of Kentuckians hospitalized for heroin overdoses more than doubled from 2011 to 2012. In addition, deaths from heroin overdoses among Kentucky residents have skyrocketed from 12 in 2008 to 215 in 2013. Kentucky also has some of the highest rates of drug overdoses and acute hepatitis C infection in the nation.

This year, the General Assembly enacted and Gov. Beshear signed into law permissive legislation that enables local jurisdictions to establish needle exchange programs (NEP), also known as “harm reduction programs.” To some, a needle exchange may sound like a program that helps intravenous drug users feed their habit. To the contrary, the intent of an NEP is to protect public health and create a path for heroin users to get treatment while preventing the spread of diseases through the sharing of needles.

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Benitec Biopharma signs manufacturing deal for hepatitis C treatment

Benitec Biopharma (ASX:BLT) has entered into an agreement with Maryland-based Omnia Biologics to manufacture material for its current first-in-man clinical trial for its TT-034 hepatitis C treatment.

This ensures the company has enough clinical material to complete the current trial.

The company is also moving to establish its own scalable manufacturing process in collaboration with third parties to supply large markets it is targeting.

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Covered California Votes To Cap What Patients Pay For Pricey Drugs

"Starting in 2016, most people will only have to pay a maximum of $150 or $250 per prescription, per month. These caps are for Covered California's so-called silver and platinum plans. Bronze plans will have caps of $500."

In recent years, expensive specialty medicines used to treat cancer and chronic illnesses have forced some very ill Americans to choose between getting proper treatment and paying their rent.

To ease the financial burden, the California agency that governs the state's Obamacare plans issued landmark rules Thursday that will put a lid on the amount anyone enrolled in one of those plans can be charged each month for high-end medicine.

The agency says its rules, set to take effect in 2016, "strike a balance between ensuring Covered California consumers can afford the medication they need to treat chronic and life-threatening conditions while keeping premiums affordable for all."

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Canada: Personal-care worker struggles after contracting hepatitis C from client

The journey from the good life to bad started in the summer of 2011. Then, nearly 20 years into a career as a personal-care worker, Rowe took a client into her home for weekend care.

The non-communicative client cut herself in the bathroom and while a visiting nurse friend stemmed the bleeding, Rowe began to clean up.

“It’s summer, I’m in flip-flops and I’ve got cracked feet. I’ve got my gloves on, but they aren’t going to do anything for me.”

The client had hepatitis C and an unknowing Rowe contracted the disease.

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UK: NHS England accused of interference over hepatitis C drug

Officials at NHS England have been accused of interfering in a process to decide whether a drug which can cure Hepatitis C should be made available to patients on the health service.

Harvoni, which is a combination of two new generation hepatitis C drugs, is currently being appraised by the National Institute for Health and Care Excellence.

But at a meeting at NICE on April 1, it is claimed that two senior NHS England officials reminded those attending that they had to take into account the cost to the health service when deciding whether to approve any treatment.

This is, in fact, not true. NICE does not focus on affordability but rather on cost-effectiveness.

- See more at: http://blogs.channel4.com/victoria-macdonald-on-health-and-social-care/nhs-england-accused-interfering-approval-hep-drug/3011#sthash.rkyi6yYa.dpuf

6 Things People With Hepatitis C Wish You Knew

You might know someone living with hepatitis C and not even realize it. 

Having a chronic hepatitis C infection can affect a person’s day-to-day life more than you may expect. Hepatitis C is the most common blood-borne virus in the United States, with more than 3 million people infected, according to the Centers for Disease Control and Prevention (CDC). But even with such high numbers, patients feel there’s a lot of misinformation about this infectious disease.

Here’s what people diagnosed with hepatitis C want you to know about their illness:

1. Hepatitis C is a serious disease. “You can’t put your head in the ground,” says Joe Benko, 64, an Army veteran from Allentown, Pennsylvania, who learned he had the virus while donating blood. “If you have hepatitis C, you have to be proactive and approach it. That’s the only way to get rid of it."

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As insurers limit access to hep C drugs, patients and doctors bristle

Doctors are finding themselves in tense situations as they try to prescribe new hepatitis C drugs to patients eager for a cure while health plans limit coverage to manage the costs of the medications.

Many health insurers have established prior-authorization criteria generally limiting access to the drugs to patients whose disease has progressed to at least Stage 3 fibrosis (just before the onset of liver cirrhosis).

The sticker prices of a course of treatment of the drugs range as high as $95,000. To mitigate the burden, major health insurers and pharmacy benefit management companies have entered special pricing agreements with Gilead for its new hepatitis C drugs Harvoni and Sovaldi or AbbVie for its competing drug Viekira Pak.

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Will the J&J Deal With Achillion Transform the Hep C Market?

As drug makers jockey for their share of the fast-growing hepatitis C market, the deal between Johnson & Johnson JNJ -0.35% and Achillion Pharmaceuticals ACHN -15.26% has Wall Street analysts rethinking forecasts.

The deal, which was announced late yesterday after a Twitter rumor had Gilead Sciences GILD -0.35% buying Achillion, calls for J&J to invest $225 million and assume responsibility for development costs. Ultimately, the value of the agreement could reach $1.1 billion, depending on milestones reached.

For J&J, the move may help reposition the company as a player in the hepatitis C market. And for Achillion, the collaboration provides a deep-pocketed partner for a company that some saw as a buyout target. But to what extent will this transform the hepatitis C market and what are the implications for the other drug makers? Here are what some of the wags are saying…

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High Cost of Sovaldi Hepatitis C Drug Prompts a Call to Void Its Patents

Activists in several countries are seeking to void patents on the blockbuster hepatitis C drug Sovaldi, saying that the price being sought by the manufacturer, Gilead Sciences, was prohibitive.

The Initiative for Medicines, Access and Knowledge, a legal group in New York, is expected to announce Wednesday that it has filed challenges in Argentina, Brazil, China, Russia and Ukraine. In all those countries except China, the organization is being joined by local patient advocacy groups.

The actions are a sign that the controversy over Sovaldi is spreading beyond the United States, where the $84,000 charge for a course of treatment has strained Medicaid budgets, to middle-income countries.

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Dasabuvir in hepatitis C: Indication of added benefit in certain patients

Better virologic response in 3 of 10 patient groups / extent of added benefit unclear

Institute for Quality and Efficiency in Health Care

The drug dasabuvir (trade name Exviera) has been available since January 2015 for the treatment of adults with chronic hepatitis C infection. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this drug offers an added benefit over the appropriate comparator therapy.

According to the findings, there are indications of an added benefit in patients who have not yet developed cirrhosis of the liver and who are infected with the hepatitis C virus (HCV) genotype 1a. In case of genotype 1b, this only applies to treatment-naive, but not to treatment-experienced patients. The extent of added benefit is non-quantifiable, however. No added benefit can be derived from the dossier for seven other Patient groups.

Differentiated approvals result in a large number of patient groups Dasabuvir is only approved in combination with other drugs (ombitasvir/paritaprevir/ritonavir and/or ribavirin). The Summaries of Product Characteristics specify partly different treatment regimens both for these drugs or drug combinations and for the respective comparator therapies. This results in as many as ten patient groups for this benefit assessment, which mainly differ in type of virus, pretreatment and stage of disease.

Two direct comparative studies All ten groups were reflected in the dossier compiled by the drug manufacturer, but the data were informative for only three of these groups. The benefit assessment was based on two randomized controlled approval studies (MALACHITE I and II), in which dasabuvir in combination with ombitasvir/paritaprevir/ritonavir and/or ribavirin was directly compared with triple therapy consisting of telaprevir, pegylated interferon and ribavirin.

In compliance with the approval, the new fixed-dose combination was administered in the intervention arm for a period of 12 weeks, whereas treatment in the comparator arm could last up to 48 weeks, depending on response to the treatment.

Patients in the intervention arm were free of the virus more frequently These two studies provided conclusive results for patients who have not yet developed cirrhosis of the liver and who are infected with a virus of genotype 1a or 1b. In genotype 1a, this applies both to treatment-naive patients and to patients who had relapsed after initially successful treatment. In genotype 1b, appropriate data were available only for treatment-naive patients.

In these three patient groups, the data showed a statistically significant difference in sustained virologic response (SVR) in favour of the new fixed-dose combination. IQWiG derived an indication of an added benefit from this. Its extent is non-quantifiable, however. It remained unclear in how many patients in whom the virus is no longer detectable, late complications, and liver cancer in particular, can actually be prevented.

Quality of life: advantage in treatment-naive patients For the first time in the assessment of a hepatitis C drug, the manufacturer dossier contained evaluable data on health-related quality of life, which is of particular importance regarding interferon, which is considered to be very burdensome. These data on quality of life showed an advantage of dasabuvir at least for the duration of treatment. This applies to certain treatment-naive genotype 1a or 1b patients, but not to treatment-experienced patients (genotype 1a). It depends on the severity of the disease whether they have an advantage and how big this advantage is.

IQWiG derived a hint of an added benefit with differing extent from these data.

Data on side effects partly not conclusively interpretable The important differences in treatment duration between intervention and control arm, which could be up to 36 weeks, partly made it impossible to interpret differences in side effects. Since the observation periods also differed, the results were probably biased.

Regarding the robustness of the data, however, there were exceptions in certain patient groups or aspects of side effects (serious adverse events and treatment discontinuation). In each case, the results were in favour of the new fixed-dose combination.

IQWiG therefore sees a hint or an indication of lesser harm in treatment-naive genotype 1b patients and an indication of lesser harm in treatment-experienced genotype 1a patients for individual aspects of side effects. Overall, greater or lesser harm is not proven.

Robust data were lacking for further patient groups The dossier contained no suitable data for the remaining seven patient groups (genotype 1). Since direct comparative studies were lacking, the manufacturer referred to results on dasabuvir, in which the drug was not tested against the appropriate comparator therapy, however. No systematic comparison with data on the appropriate comparator therapy was conducted. Since there was also no systematic search for studies on the comparator therapies, it can be assumed that the data were incomplete.

Overall, an indication of a non-quantifiable added benefit can be derived from the dossier for three patient groups: patients without cirrhosis of the liver infected with genotype 1a (treatment-naive and treatment-experienced) and with genotype 1b who have not been pretreated.

G-BA decides on the extent of added benefit This dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.

###

An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website » http://www.gesundheitsinformation.de, published by IQWiG, provides easily understandable German-language information.

More English-language information will be available soon (Sections 2.1 to 2.7 of the dossier assessment as well as subsequently published health information on » http://www.informedhealthonline.org). If you would like to be informed when these documents are available, please send an e-mail to » info@iqwig.de.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

Press Release Source: http://www.eurekalert.org/pub_releases/2015-05/ifqa-dih052015.php

Doctors say needle sharing could trigger hepatitis C outbreak

"I shared a needle with him once," Barnes said.  And that was all it took.

WOODBURY, TN (WSMV) -The number of heroin addicts is on the rise, and it's not just a problem for the addicts. Doctors fear it could trigger an outbreak of hepatitis C.

"I was on methadone for years, oxycontin, meth, amphetamines," said Clayton Barnes, an addict and hepatitis C patient from Kentucky.

But heroin is the one addiction that would change Barnes' life forever, landing the 26-year-old at Addiction Campuses' treatment center in Woodbury.

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Australia: Lives Could Be Saved with New Hepatitis C Therapy

In a letter to the Medical Journal of Australia, a Monash University-led team is asking for hepatitis C virus patients to gain improved access to drugs to prevent liver related deaths.

Hepatitis C virus (HCV) infection is a major public health burden in Australia, with estimates of 230,000 people chronically infected.

The research team are calling for the government to subsidize a new therapy which has high cure rates, known as direct acting antiviral (DAA) therapy.

Read more ...

Achillion Enters Into Worldwide Collaboration for Hepatitis C With Janssen

- Transactions include up to $1.1 billion in potential development, regulatory and sales milestone payments and a separate equity investment -

- Achillion eligible for tieredroyalties between mid-teens and low-twenties on future worldwide sales -

- Janssen responsible for all development costs within the collaboration and all subsequent costs related to commercialization of the assets -

- Conference call scheduled for today at 5:00 p.m. ET -

NEW HAVEN, Conn., May 19, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that it has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422, and sovaprevir.

"We are excited to collaborate with Janssen for the worldwide development of our HCV assets in combination with their HCV portfolio. We believe that Janssen's renowned expertise in HCV development and commercialization enables a synergistic opportunity to rapidly advance our combined HCV assets toward the market while simultaneously achieving an optimized treatment regimen for all HCV patients," said Milind Deshpande, Ph.D., President and Chief Executive Officer of Achillion. "Furthermore, we believe that their investment in Achillion through Johnson & Johnson Innovation - JJDC allows us to maximize the value from our HCV portfolio and also positions us to become a leader in complement factor D inhibition, applying our broad platform to a wide number of complement-related diseases. We believe this strategy provides an ideal scenario to create further value for our shareholders."

Under the terms of the agreement, Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Achillion is eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones. Achillion is also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales. Janssen will be responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets.

A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration.

Additionally, in an equity transaction separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation - JJDC, Inc. will invest $225 million in Achillion and, in return, receive approximately 18.4 million newly issued, unregistered shares of Achillion at a price of $12.25 per share.

The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. Transitional clinical development and technology transfer activities under the collaboration are expected to take place over the next several months.

Centerview Partners acted as exclusive financial advisor to Achillion. Leerink Partners also advised the Company. WilmerHale acted as legal counsel for Achillion in connection with the transactions.

Conference Call
Achillion will host a conference call and simultaneous webcast on Tuesday, May 19, 2015 at 5:00 p.m. Eastern time. To participate in the conference call, please dial (866) 205-4820 in the U.S. or (419) 386-0004 for international callers. A live audio webcast of the call will be accessible at http://www.achillion.com or http://ir.achillion.com. Please connect to Achillion's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

A replay of the webcast will be available for 30 days on www.achillion.com. Alternatively, a replay of the conference call will be available starting at 8:00 p.m. Eastern time on May 19, 2015, through 11:59 p.m. Eastern time on May 25, 2015 by dialing (855) 859-2056 or (404) 537-3406. The replay passcode is 51773113.

Read the rest of this press release here: http://ir.achillion.com/releasedetail.cfm?releaseid=913980