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Alan Franciscus
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated March 17, 2015

Thursday, May 28, 2015

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 CongressTM 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.

Wednesday, May 27, 2015

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.

Read more....

[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

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

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.”

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.

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 Brings Financial Relief to Underinsured People Living with Hepatitis C
New Hepatitis C Fund – A Welcome 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/