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 

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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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