HCV Drugs —Alan Franciscus, Editor-in-Chief

AbbVie's VIEKIRA PAK Approval & AASLD 2014

In this month’s HCV Drugs we have news on AbbVie’s drug approval of their HCV drugs, and, yes, more coverage from the American Association for the Study of Liver Diseases (AASLD).  In Lucinda’s Snapshots column this month, information on Janssen’s AASLD presentations is included.

AbbVie
On December 19, 2014 the Food and Drug Administration (FDA) approved AbbVie’s 3D combination—VIEKIRA PAK—to treat HCV genotype 1 patients.   On December 23, 2014, the 3D combination was approved by Health Canada as HOLKIRA PAK. AbbVie conducted phase 3 trials in about 2,300 patients and the cure rates were over 90%.  Included in the FDA label was information about HIV/HCV coinfection and liver transplantation treatment results.  For more information, visit our website for new VIEKIRA PAK fact sheets, FDA Approved Prescribing Information and detailed information from their phase 3 studies included in past issues of our HCV Advocate monthly and mid-monthly newsletters. 

        VIEKIRA PAK

Gilead
GS-5816 is a new investigational NS5A inhibitor being developed by Gilead.  It has activity across all genotypes (pan-genotypic).  In the current studies, it is being combined with sofosbuvir (polymerase inhibitor) with and without ribavirin.

Safety and Efficacy of Treatment with Sofosbuvir plus GS-5816 With and Without Ribavirin for 8 or 12 Weeks in Treatment-Naïve Patients with Genotype 1-6 HCV Infection—T Tran et al.

Summary:  The combination of sofosbuvir plus GS-5816 without ribavirin produced high cure rates in all genotypes. 

Gilead continues to study sofosbuvir in combination with other investigational compounds—in this case with GS-5816, an NS5A inhibitor. 

Part A of the current study comprised 8 arms—all arms received sofosbuvir plus GS-5816 at either 25 mg or 100 mg without ribavirin for 12 weeks. Included in the study were treatment-naïve patients without cirrhosis.  There were two parts (A and B) of the study.  Part A had six treatment arms that included genotypes 1 through 6.  Listed below are the number of patients and cure rates. 

• Genotype 1:  55 patients:  96% to 100%
• Genotype 2:  21 patients: 91% to 100%
• Genotype 3:  54 patients 93%
• Genotype 4:  14 patients 86% to 100%
• Genotype 5:  1 patient 100%
• Genotype 6:  9 patients 100%

Part B of the study included only genotype 1 and 2 patients.  There were also 8 arms in Part B, but the genotype 1 non-cirrhotic patients received only 8 weeks of treatment at the same doses.  Half of the patients in the study received ribavirin.   Genotype, number of patients and cure rates are listed below:

• Genotype 1:  59 patients no ribavirin 83% to 87%; 61 patients (81% - 83%) with ribavirin
• Genotype 2:  52 patients no ribavirin 87% to 90%; 51 patients (88%) with ribavirin

The combination of sofosbuvir and GS-5816 with and without ribavirin was safe and well-tolerated.  The most common side effects were fatigue, headache, and nausea.

The combination of sofosbuvir (400 mg) and GS-5816 (100 mg) has been co-formulated into one pill taken once daily.  It is currently in phase 3 clinical trials to be studied with and without ribavirin for the treatment of HCV genotype 1, 2, 3, 4, 5, and 6.  

Comments:  Sofosbuvir and GS-5816 has been co-formulated into 1 pill taken once-a-day and is in phase 3 clinical trials with and without ribavirin for a treatment duration of 12 weeks for genotype 1 through 6.  Another study being conducted in genotype 3 patients is comparing the treatment duration of 12 vs. 24 weeks.

AASLD/ IDSA/IAS-USA Recommendations
Check out the updated HCV Guidance from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America that include Harvoni and VIEKERA PAK. Seven sections of the HCV Guidance have been extensively revised based on newly available therapies and data: Initial, Retreatment, Monitoring, and Unique Populations (HIV/HCV Coinfection, Cirrhosis, Post-Liver Transplantation, and Renal Impairment).
www.hcvguidelines.org


http://hcvadvocate.org/news/newsLetter/2015/advocate0115.html#2

Death rates from viral hepatitis among U.S. adults aged 18 years or older, 1999 - 2011

CDC reports that the death rate from viral hepatitis rose 2.2 times among men aged 45-64 years from 1999 to 2011 and 2.3 times among women in that same age group.

CDC reports that the death rate from viral hepatitis rose 2.2 times among men aged 45-64 years from 1999 to 2011 and 2.3 times among women in that same age group. Specifically, the death rate for viral hepatitis for men aged 45-64 increased from 11.9 to 26.5 per 100,000 population, while the death rate for women aged 45-64 increased from 3.7 to 8.4 per 100,000. For men aged 18-44 years, the death rate decreased 60% during the study period, and the death rate for women aged 18-44 dropped 46% from 2003 to 2011. The death rate did not change for women over age 65, but it increased 40% for men in that age group from 2004 to 2011.

Morbidity and Mortality Weekly Report (01/02/15)

Source:  http://www.pharmacist.com/death-rates-viral-hepatitis-among-us-adults-aged-18-years-or-older-19992011

CVS will cover Gilead hepatitis C treatment over new AbbVie drug

CVS Health Corp., one of the largest U.S. managers of drug benefits, said it would give the hepatitis C treatment from Gilead Sciences Inc. preferred status and cover a new competing treatment from AbbVie Inc. only as an exception, CNBC reported on Monday.

Shares in Gilead rose nearly 3 percent after the report that CVS would favor the treatment, which can cost about $84,000, or $1,000 per pill. Its cost has spurred a national debate about whether drug prices had soared too high.

Two weeks ago, the nation's largest drug benefits manager, north St. Louis County-based Express Scripts Holding Co., said it would cover a competing, newly approved treatment from AbbVie rather than Gilead, and Gilead shares fell sharply.

Read more...

Patient Advocate Foundation Offers New CareLine for Hepatitis C Patients

PAF aims to expand care for Hepatitis C patients by offering a new toll-free CareLine providing personalized case management support.

HAMPTON, Va., Jan. 5, 2015 (GLOBE NEWSWIRE) -- Patient Advocate Foundation (PAF) – a national, non-profit organization providing professional case management services to patients facing healthcare access issues, is pleased to announce the launch of a new Hepatitis C CareLine, providing individualized, sustained assistance to patients diagnosed with Hepatitis C.  The CareLine will provide help to patients across the country to resolve healthcare access and insurance issues, at no charge to the patient.

This new program joins Patient Advocate Foundation's existing suite of CareLine programs, furthering PAF's commitment to helping patients with chronic, debilitating or life-threatening illness navigate the healthcare industry. In 2013, Hepatitis diagnoses ranked in PAF's top ten list of diseases reported by patients seeking help through the case management team. Through the Hepatitis C CareLine, dedicated case managers will serve as a direct resource for Hepatitis C patients assisting them with benefit coordination, educational and financial resources, help accessing the latest available treatment, navigation through the appeals and reimbursement processes, as well as other patient services. This new program joins Patient Advocate Foundation's existing copayment support for Hepatitis B and Hepatitis C patients offered through its Co-Pay Relief program.

"Patient Advocate Foundation is committed to helping Hepatitis C patients maintain financial stability while consistently accessing needed treatments and prescribed medical care," says PAF CEO, Alan Balch, Ph.D.  "By directly connecting Hepatitis C patients with the correct resources and negotiating on their behalf, we believe PAF can make a difference for patients in the Hepatitis C community."

Any patient or medical provider interested in learning more about Patient Advocate Foundation's Hepatitis C CareLine should call 800-532-5274 or visit hepatitisc.pafcareline.org/. The CareLine will offer live service to patients Monday through Thursday from 8:30 AM – 8:00 PM ET and Friday from 8:30 AM – 7:00 PM ET. Bi-lingual case managers are available to assist Spanish speaking callers.

For more information about Patient Advocate Foundation and their mission to improve healthcare access to all patients, please visit www.patientadvocate.org.

About Patient Advocate Foundation (PAF)
Patient Advocate Foundation is a national non-profit organization that seeks to safeguard patients through effective mediation assuring access to care, maintenance of employment and preservation of their financial stability. PAF services are available to all patients, patient families, and medical professionals without charge. Patient Advocate Foundation serves patients from all 50 states, and has physical locations at many of the top patient referral states including Texas, Florida, California, and Virginia.

Erin Singleton, 757-952-0561

- See more at: http://globenewswire.com/news-release/2015/01/05/695010/10114015/en/Patient-Advocate-Foundation-Offers-New-CareLine-for-Hepatitis-C-Patients.html#sthash.8zCnU8i3.dpuf

Ky. heroin bills raise hope, face skepticism

As the Kentucky General Assembly gears up for a shortened session and to tackle heroin legislation, many anti-heroin activists say proposed bills don't go far enough. 

One of the leading bills proposed to combat Kentucky's heroin epidemic gives an addict a better chance at receiving treatment if he is arrested than if he tries to check into a rehab clinic.

Another of the multiple proposals is expected to include a provision that would allow needle exchanges, an approach favored by public health officials trying to ward off the spread of hepatitis or HIV, but abhorred by conservatives not willing to appear soft on crime.

A third ups the criminal penalties for dealing heroin and other opiates without increasing any funding for treatment for addicts.

Read more....

Drug Prices to Get More Expensive -- Corporate Outlook

"If anything, 2015 list prices will grow more quickly than in 2014," said Richard Evans, a former drug-industry pricing official now an analyst at SSR Health LLC.

The $1,000-a-day price of a new hepatitis C pill has put more attention on the rising cost of drugs.

Yet the hefty price tags of new medicines like Sovaldi from Gilead Sciences Inc., weren't the only culprit in higher drug costs, according to drug-industry analysts. Price increases on older drugs played a big part, too--and the costs are expected to keep soaring.

Brand-name drug prices surged 14% in the 12 months through the end of the third quarter in 2014, adding $32 billion to drug spending, said Elliot Wilbur, a Needham & Co. analyst. Generic drugs, which are supposed to be an instrument for cutting drug spending, have also increased.

Read more: http://www.nasdaq.com/article/drug-prices-to-get-more-expensive--corporate-outlook-20150104-00034#ixzz3NyJmCyAw

New drugs offer hope, barriers for hepatitis C patients

For patients with hepatitis C, the last year has brought great hope: New drugs that are highly effective with few side effects. But their high cost has led Medicaid officials in Pennsylvania and other states to put up barriers for patients, treating only the sickest ones and leaving many others to wait.

"This is an unprecedented approach we've had to take with these drugs," said Terri Cathers, pharmacy director for Pennsylvania's Office of Medical Assistance Programs. "We've not done this before for other treatments as long as I've been in the business."

The approach, she said, is a direct result of the cost, which can range up to $150,000 per patient.

Read more at http://www.philly.com/philly/health/20150104_New_drugs_offer_hope__barriers_for_hepatitis_C_patients.html#HAz2fKXJskLoLyFP.99