Saturday, October 11, 2014

HCV Newsetters: Everything you need to know about Gilead's Harvoni

HCV Newsetters: Everything you need to know about Gilead's Harvoni

Unless you have been out of the country, or living high on a mountain peak, you're more than aware we had some exciting news yesterday.

Drum roll please.....

The FDA approved Gilead’s much anticipated drug Harvoni (ledipasvir/sofosbuvir), our first combination pill approved for the treatment of chronic HCV genotype 1 infection, without interferon or ribavirin.

Gilead has published both U.S. Prescribing Information and Patient Information, on their support website. In addition check out HCV Advocates new factsheet; Genotype 1 Treatment: Harvoni (Sofosbuvir & Ledipasvir).

Worth A Click
FiercePharma
By Carly Helfand
Payers hit back at Gilead for $94,500 price tag on brand-new hep C combo pill

New York Times
By Andrew Pollack

Public Radio
By Bill Chappell
New Hepatitis C Pill Promises Faster Treatment, At A Higher Cost

Web MD
By Brenda Goodman, MA
Hep C Combo Pill May Cure Those Who Can Afford It


Healio

Two-drug, 12-week treatment successful for genotype 1 HCV

NATAP
AASLD/EASL NY HCV Special Conference: 
Therapeutic Challenges: Decompensated Cirrhosis and Liver Transplantation

Nature Reviews
Scott L. Friedman, Eamonn M. M. Quigley, Keith A. Sharkey, Joseph J. Y. Sung & David C. Whitcomb
The past 10 years of gastroenterology and hepatology—reflections and predictions

The Wall Street Journal
Bruce Japsen
As Hepatitis Pill Harvoni Joins Sovaldi, States Erect Medicaid Hurdles

Viohl & Associates
The Sovaldi®Squeeze:High Costs Force Tough State Decisions. 

New Hepatitis C Drug is FDA Approved: Harvoni (Combo Lepidasvir and Sofosbuvir)
by on 10/10/2014
Yet another hepatitis C drug has been approved by the FDA, a great day for those who suffer from hepatitis C. A combination of Ledipasvir and Sofosbuvir, this new drug, called Harvoni, is the latest entry by Gilead, leading the way in curing hepatitis C.



Uploaded October 10 by Joe Galati, M.D.


Everything you need to know about Harvoni

In this edition of Newsletters we begin with an article written by HepMag's Benjamin Ryan covering everything you need to know about Gilead's Harvoni.

Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.

Featured Article
by Benjamin Ryan
The first once-daily fixed-dose combination therapy to treat hep C has hit the scene, with neither interferon nor ribavirin in tow.

Articles Of Interest
Sovaldi-Ledipasvir Better Shields the Liver Than Today’s Hep C Meds

Newsletter
Current Issue
Hep’s latest mag is all about how to overcome hepatitis C and help others fight it, too.

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New At Healio

October 2014 print edition of HCV Next



"HCV Next" offers information on a range of topics, which include diagnosis, new combination therapies, side effects, drug/drug interaction, guidelines, fatty liver disease and more.

October Table of Contents

COVER STORY
The Evolution of Special Populations in HCV

EDITORIAL
Bridging the Gap: New Clinical Trials Planned for Children with HCV
Philip Rosenthal, MD; Yen Pham, MD

TREND WATCH


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The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education

What's New At HCV Advocate
Check out our new Easy C Fact Series
Factsheet on Genotype 1 Treatment: Harvoni (Sofosbuvir & Ledipasvir)

HCV Meets Managed Care Health Insurance (2014)
As this country plays catch-up with the other industrialized nations that make health insurance available to everyone, a lot of people are getting coverage for the first time. Unfortunately, the health plans being offered today are complicated; they are virtually all Managed Care Plans. Also, unlike countries that cover everyone under one plan, our health coverage is handled primarily through health insurance companies so there are major differences in coverage and what an insured person is expected to pay out-of-pocket.
Read more..

Alan Franciscus, Editor-in-Chief
We have incorporated some important new information into one of HCSP’s Fact Sheets in our HCV Transmission and Prevention Section. 

October Newsletter


Alan Franciscus, Editor-in-Chief
In this month’s column, I will provide a short overview of phase 3 data from sofosbuvir plus ledipasvir. It is important to know, however, that when approved the FDA may add or change the cure rates and add additional warnings or restrictions to the use of the medications based on their review of the clinical trial data.
Read more...

Lucinda K. Porter, RN
This month, Lucinda discusses the AASLD and IDSA’s recommendations assigning high treatment priority to those with high risk of HCV transmission. When we reduce HCV transmission, we reduce the prevalence, which benefits us all. 
Read more...

Alan Franciscus, Editor-in-Chief
One of the most important decisions that anyone with hepatitis C (HCV) will make is about HCV treatment. In the past, it has been a difficult decision because of the significant side effects, long treatment duration and modest cure rates. 
Read more...


Lucinda K. Porter, RN
Lucinda reviews studies on depression and HCV disease progression, mother-to-child transmission, healthcare utilization and racial differences in progression to cirrhosis and HCC. 
Read more...

Website Plan & Survey Report
Alan Franciscus, Editor-in-Chief
Find out what the results of our recent survey were; what we are going to do about them, and who won the autographed copy of Lucinda's book Hepatitis C One Step at a Time. 
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HBV Advocate: for accurate, timely and cutting-edge information on HBV treatment and vaccines.

In This Issue
Chronic Hepatitis B Remains Public Health Challenge in U.S. 
Epidemiologists Become Molecular Detectives to Investigate HBV Outbreaks
Telbivudine Effectively Prevents Infection of Newborns Born to Infected Mothers
GGT Blood Test Reveals Fibrosis and Cirrhosis in Hepatitis B Patients
Early Research Combining Antivirals with a Protein "De-activator" Shows Promise
Diabetes Dramatically Increases Liver Cancer Risk in Cirrhotic Patients
Tenofovir Linked to Higher Rates of Bone Loss than Entecavir
Liver Cancer Risk Factors Do Vary Between Racial Groups
European Study Confirms Coffee Dramatically Lowers Liver Cancer Risk

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HepCBC’s MONTHLY NEWSLETTER

The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001. The monthly newsletter contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.

Articles In This Issue Include:

Stakeholder Summit / News
HepCBC Open House
Local Programs
SVR Honour Roll
Compensation
Coming Up 
AND MORE!!

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Liver Lowdown is the monthly general interest e-newsletter of the American Liver Foundation.

Acetaminophen is the most commonly used pain medication in the U.S., but it's also the leading cause of acute liver failure. We've partnered with the Acetaminophen Awareness Coalition to educate the public about safe usage...

Did you know October is liver awareness month, click here to see 13 ways to a healthy liver!

Patient Information

Newsletter

FEATURE: PRIMARY SCLEROSING CHOLANGITIS
This month we focus on primary sclerosing cholangitis (PSC), a chronic disease that slowly damages the bile ducts. We welcome your thoughts and comments and invite you to share your experiences.

PATIENT PROFILE
To look at healthy 25-year-old Alison Cubbellotti now, you would never know that only five years ago she was near death. She was diagnosed with primary sclerosing cholangitis at age nine. But she has survived and thrived. Read about her inspirational story.

HAPPENINGS/AROUND TOWN
The American Liver Foundation hosts many events throughout the year and we invite you to take part. With our Liver Life Walks, Flavors, transplant reunions and webinars, there is something for everyone. Here is what we have been up to during the last few weeks.

ANNOUNCEMENTS
The American Liver Foundation is proud to advocate for and support all those affected by liver disease. We are pleased to share some recent news that help us in our efforts.

RECIPE OF THE MONTH
Looking for a delicious recipe to try tonight? We have one for you! Have a recipe to share? We would love to hear from you.

CALENDAR OF EVENTS
ALF hosts a number of events throughout the year to support liver disease awareness. Check our events calendar and find one to participate in.

October Issue Not Yet Published....


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GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors.

View Current Issue (Vol. 8 No. 10 October 2014): PDF | Interactive Issue

In This Issue
Unnecessary cancer screening in U.S.
A substantial proportion of older adults in the United States undergo unnecessary and even harmful screening for colon, prostate, breast, and cervical cancer, contrary to clear guidelines that are widely recognized and well publicized, according to two separate studies published online in JAMA Internal Medicine.

Herbal-supplement liver injuries on the rise for 10 years
Serious liver injury from herbal and dietary supplements–including those used by bodybuilders – has risen signifcantly over the past decade.

Drug combos increase upper GI bleeding risk
Combining nonsteroidal anti-inflammatory drugs with selective serotonin reuptake inhibitors increased the risk of upper gastrointestinal bleeding by up to 190% beyond the baseline risk found for NSAID monotherapy, researchers reported in the October issue of Gastroenterology.



Read breaking news stories now: visit the GI & Hepatology News website.

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The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community. 


In this Newsletter
Upcoming Events
Training
Policy Watch
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Tools & Resources
Journal Articles & Reports
Connect with the NYC Hep Community

Fair Pricing
Treatment Action Group (TAG) &TheBody.com.
Tracy Swan on Hep C med fair pricing 

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Our newsletter is sent out for free electronically on the 1st of every month.
Our mission is to educate the general public about hepatitis C and to provide resources and support for those affected by the virus. Hep C Connection offers a helpline to answer your questions regarding hepatitis C (HCV). You can expect respect, patience & understanding, in clear, jargon-free language from our staff & volunteers. Call 1-800-522-HEPC (4372) today!

October Newsletter

In This Issue 
Support Groups
2014 Desserts & Delights Online Auction
Free Education Dinner
Articles of Interest
Upcoming Events
 HCV Patient Survey
AASLD/EASL Conference
Financial Resources for HCV Treatment
Clinical Trials
Desserts & Delights Sponsors

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The primary goal of the Caring Ambassadors Program is to help individuals with challenging health conditions to become ambassadors for their own health. We are here to help you—that is now and always will be our singular focus.


Monthly Pubmed Review of the most relevant research on HCV

Hepatitis C Choices
Important link if you are considering the new therapies. Be sure to talk with your doctor about all of your other medications prior to taking any prescription. Treatments for hepatitis C are evolving faster than ever and the Caring Ambassadors Program is actively working on updating Hepatitis C Choices to reflect all of these exciting developments.

While many sections of the book are as relevant as ever, Part 2, which covers Treatment and Management Approaches, is being completely rewritten to reflect new science and current practice. Check back soon for completely updated 2014 5th edition. In the meantime, we strongly recommend that you review the Recommendations for Testing, Managing, and Treating Hepatitis C that were developed by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. These guidelines, which the Caring Ambassadors Program strongly endorses, can be found at www.hcvguidelines.org.





Welcome to the new HCV Action website, the home of the UK’s hepatitis C professional community. 

The HCV Action network brings together health professionals from across the patient pathway, including GPs, specialist nurses, clinicians, drug action teams, public health practitioners, prison healthcare staff and commissioners. We provide resources for commissioners, medical and drug services professionals, promoting good practice in HCV care across the UK.

News
The Hepatitis C Trust
Each winter hundreds of thousands of people see their GP and tens of thousands are hospitalised because of flu. Last winter, Public Health England received reports of 904 people admitted to intensive care or high dependency units with laboratory confirmed flu and, of them, 11% (98 people) 
died.

Of Interest

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As a reminder next month is the 65th Annual Meeting of the American Association for the Study of Liver Diseases, taking place in Boston from November 7th to November 11th. Late-breaking abstracts are now available, in addition, abstract text is published in a special edition of Hepatology.

Wishing you all the best, until next time.

Tina



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Friday, October 10, 2014

U.S. FDA Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir)

Download:
U.S. Prescribing Information
Patient Information 

U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C 

October 10 2014
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

Harvoni Product PhotoHarvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.

Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.

“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”

Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.

Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.

Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.

In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.

The most common side effects reported in clinical trial participants were fatigue and headache.

Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases.

Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source - FDA

U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C

-- Harvoni Achieved Cure Rates (SVR12) of 94-99 Percent in Three Phase 3 Studies
-- Shortens Treatment Duration to Just Eight Weeks for Certain Treatment-Naïve Patients
-- Eliminates Need for Interferon and Ribavirin for Patients with Genotype 1 Hepatitis C

FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 10, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the tradename Sovaldi® in December 2013. Harvoni’s efficacy has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.

The FDA granted Harvoni a Priority Review and Breakthrough Therapy designation, which is given to investigational medicines that may offer major advances in treatment over available therapies.
   
“By providing very high cure rates in as little as eight weeks and completely eliminating the need for interferon and ribavirin, which are challenging to take and tolerate, Harvoni significantly advances treatment for patients with the most common form of hepatitis C in the United States,” said Nezam Afdhal, MD, Director of Hepatology at Beth Israel Deaconess Medical Center, Professor of Medicine at Harvard Medical School and a principal investigator in the Harvoni clinical trials. “For the first time, the vast majority of patients can be cured with a once-daily pill in only eight or 12 weeks.”
   
Harvoni’s approval is supported by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12).
Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94 to 99 percent.
   
“Unlike other serious chronic diseases, hepatitis C can be cured and Harvoni offers patients the potential for a cure in as little as eight weeks,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “Gilead is proud to have played a role in developing a once-daily therapy that is safe, simple and well tolerated. We are now working to ensure rapid and broad access to Harvoni.”
   
Important Safety Information regarding warnings and precautions, adverse reactions and drug interactions is listed below. Zero percent, less than 1 percent and 1 percent of patients treated for eight, 12 and 24 weeks, respectively, discontinued treatment due to adverse events and fewer adverse events were observed in the ribavirin-free arms compared to the ribavirin-containing arms in all ION studies. The most common adverse reactions among patients treated with Harvoni (≥5 percent) were fatigue, headache, nausea, diarrhea and insomnia. For additional study details, and complete dosing information, see the Clinical Studies and Dosage and Administration sections, respectively, of the full Prescribing Information.
   
U.S. Patient Support Program
To assist eligible hepatitis C patients in the United States with access to Harvoni, Gilead has added the medicine to its Support Path™ (www.MySupportPath.com) program. The program consists of an integrated offering of support services for patients and providers, among them:
  • Call center staffed with associates trained to help patients and their providers with insurance-related needs.
  • Education and support, including a 24/7 nursing support service line.
  • The Harvoni and Sovaldi Co-pay Coupon Programs, which provide co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs. Most patients will pay no more than $5 per co-pay.
  • The Support Path Patient Assistance Program, which will provide Harvoni and Sovaldi at no charge for eligible patients with no other insurance options.
Gilead also provides support to independent non-profit organizations that provide assistance for eligible federally-insured and privately-insured patients who need help covering out-of-pocket medication costs.
   
To learn more about Support Path for Harvoni or Sovaldi, please visit www.MySupportPath.com or call 1-855-769-7284 between 9:00 a.m. – 8:00 p.m. Eastern, Monday through Friday.
   
IMPORTANT SAFETY INFORMATION
Warnings and Precautions

Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers: Rifampin and St. John’s wort are not recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.
   
Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir (Sovaldi).
   
Adverse Reactions
Most common (≥10%, all grades) adverse reactions were fatigue and headache.
   
Drug Interactions
In addition to rifampin and St. John’s wort, coadministration of Harvoni is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.
Coadministration of Harvoni is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Coadministration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively.
   
Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions, including clinical comments.
   
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.
   
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians and patients may not see advantages of Harvoni over other therapies and may therefore be reluctant to prescribe the product, and the risk that private and public payers may be reluctant to provide coverage or reimbursement for the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
   
U.S. Full Prescribing Information for Harvoni and Sovaldi is available at www.gilead.com.
Harvoni, Sovaldi and Support Path are trademarks or registered trademarks of Gilead Sciences, Inc., or its related companies.

U.S. FDA approves Gilead's $94,500 hepatitis C drug
By Deena Beasley

Fri Oct 10, 2014 4:36pm EDT

(Reuters) - U.S. regulators on Friday approved a new hepatitis C pill from Gilead Sciences Inc, which said it will charge $94,500 for an improved 12-week course of treatment to rid patients of the liver-destroying viral infection.

The daily pill, to be sold under the brand name Harvoni, combines Gilead's $84,000 pill Sovaldi with another drug, ledipasvir, and eliminates the need for two older, side-effect-laden treatments that needed to be taken along with Sovaldi.

Gilead, which has faced a backlash from health insurers over the high cost of its hepatitis C treatments, said the current regimen of Sovaldi plus the older drugs, interferon and ribavirin, has a cost of $94,726.

The company emphasized that the price of the new drug is less than the current regimen, but insurers and other payers said it is still unsustainable.

"Unfortunately, we believe that the price being demanded is still inappropriately high for a product targeting such a large group of patients," said David Whitrap, spokesman for Express Scripts Holding Co, the largest manager of pharmacy benefit programs in the United States. "New innovations do not always require inappropriate, premium pricing."

Hepatitis C, estimated to infect about 3.2 million Americans, is a viral disease that causes inflammation of the liver that can lead to liver failure.

Gilead said nearly half of patients infected with the most common type of hepatitis C - previously untreated, healthier individuals - can be cured after eight weeks of taking Harvoni, compared with 12 weeks for the current Sovaldi regimen.

The cost of treating those patients with the new pill for eight weeks is $63,000.

Wall Street analysts note that the price of Harvoni is lower than the $130,000 or more now needed to treat certain hepatitis C patients with Sovaldi and Olysio, a newer antiviral drug sold by Johnson & Johnson.

"The price of $94,000 is very attractive," said RBC Capital Markets analyst Michael Yee. "At eight weeks of therapy, the cost is about $63,000, which is 30 percent cheaper than Sovaldi."

Deutsche Bank analyst Robyn Karnauskas said Harvoni's pricing came in slightly below her expectations, but is "rational and strongly supportive of sustained market share."

Bristol-Myers Squibb Co said on Tuesday it is no longer seeking U.S. approval for an oral two-drug combination to treat hepatitis C because of competition from rival drugs.

AbbVie Inc is slated to hear from the FDA later this year on its application to market an all-oral hepatitis C regimen.

"As the additional hepatitis C drugs are approved over the next few months, we're looking forward to driving more competition in this space," Express Scripts said.

Gilead is expected to reap nearly $12 billion in hepatitis C drug sales worldwide in 2014. Sovaldi sales have been unprecedented for any first-year drug. 

Gilead shares closed 2 percent lower at $103.73 on Friday.

 (Additional reporting by Bill Berkrot in New York; editing by Tom Brown and Matthew Lewis)
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As Hepatitis Pill Harvoni Joins Sovaldi, States Erect Medicaid Hurdles

As Hepatitis Pill Harvoni Joins Sovaldi, States Erect Medicaid Hurdles
Bruce Japsen
Here are some examples cited of what the Viohl study said some state Medicaid programs are doing to curb Sovaldi costs.... 
several states, including Arizona, have implemented a “once in a lifetime” rule that allows Medicaid patients one opportunity at treatment with Sovaldi 
Alaska requires the patient candidate for Sovaldi to abstain from using drugs and alcohol for at least three months. Then, the patient has to submit to a urine test to verify being drug free 
West Virginia only allows a board certified gastroenterologist, hepatologist or infectious disease specialist to prescribe Sovaldi 
Several states won’t pay for any lost or stolen Sovaldi 
Illinois, which requires patients to meet more than two dozen criteria before they get Sovaldi, will only dispense the drug for two weeks at a time for a total of 12 weeks.

Read the full article here.....


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Protective Factors: A “New” Discovery?


Readers may be interested in de Vries Robbé, Mann, Maruna, and Thornton’s (2014) recent article, "An exploration of protective factors supporting desistance from sexual offending," currently published in the online first section of Sexual Abuse: A Journal Research and Treatment (SAJRT). This is actually one of a series of articles written by de Vries Robbé and various colleagues, but possibly the first in the “series” that specifically focuses on the role of protective factors in work with sexual offenders. In fact, Thornton (one of de Vries Robbé’s co-authors in this case) published an article last year (2013) discussing the implications of a model that recognizes both risk and protective factors in the treatment of adult sexual offenders, asking how treatment tasks might be revised “in light of this new knowledge” (p. 62). Similarly, focusing on the idea of “new knowledge,” Worling and Langton (2014) write that research into protective factors for sexually abusive youth is only in its earliest stages. Actually, Spice and colleagues (2012) might have been the first to point to the complete lack of research into the subject of protective factors, at least with respect to sexually abusive youth, and van der Put and Asscher (2014) are among the first to correct this situation in their study, examining the nature and effect of protective factors in the behavior of sexually abusive youth.

 

The addition of a literature that addresses and incorporates ideas about protective factors, and not just risk factors, in sexual offender assessment is welcome, a topic area to be further addressed in a forthcoming special theme issue of SAJRT. But, it seems important to add that although relatively new to sexual offender risk assessment, the idea is not especially new (and really not even that new to sexual offender assessment and treatment, at least not for those practitioners who work with sexually abusive youth). Although it may be accurate to say our empirical and theoretical examination of protective factors is new, the existence and function of protective factors in assessing risk is certainly not “new knowledge,” as Thornton described it. Rich (2003) wrote about protective factors over a decade ago, and in additional detail in 2009 and 2011. Furthermore, protective factors have been built into several juvenile risk assessment instruments since around 2001 with the introduction of the AIM assessment protocol, used in the UK, and further developed in the AIM2, revised in 2007. Similarly, the SAVRY, a general (non-sexual) adolescent risk instrument in use for over a decade, has included a table of protective factors since the instrument was released in 2002. The J-RAT, a juvenile sexual risk instrument in use since about 2000, has included a protective factor scales since 2012, as does the MEGA, a more recently introduced juvenile sexual risk instrument. Although neither are widely used, Bremer's Protective Factors Scale (1998, 2006) and Gilgun's (1999) Clinical Assessment Package for Client Risk and Strengths offer additional examples of instruments built around the presence of and designed to assess protective factors, both of which have been around for a number of years. In the world of adult sexual risk assessment, the ARMIDILO-S, designed for use in the assessment of intellectually disabled adults, has included an assessment of protective factors since its inception in 2004, as does the currently in-development youth version of the instrument.

 

So, what point is being made here? Just that the recent and happily expanding attention being paid to protective factors in our literature neither represents new knowledge nor recent innovation in the field of risk assessment or treatment. Jessor and colleagues discussed protective factors in understanding troubled adolescent behavior back in 1995, and in 2003 Rutter wrote of the obvious need to pay attention to protective factors, as well as risk factors. Going back a few years earlier still, in their exploration of resiliency among troubled and high-risk children Werner and Smith wrote about protective factors and relationships in 1992. This protective factors, or strength-based, approach to assessment and treatment recognizes that there is more to risk than risk alone, and more to treatment than simply containing risk. Instead, it tells us that we must recognize and assess factors that not only protect against risk, but also increase the likelihood of desistance from continued problem behaviors. It is gratifying to see increasing attention being paid to the presence and nature of protective factors and the mechanisms by which they harness or increase resiliency, but it is also oddly disturbing that we seem to have only recently "discovered" ideas that have actually been there all along, even within our own field. These are not new ideas; we just seem to have not "noticed" them before, or been too busy looking at other things to notice them, or perhaps simply unaware of the larger mental health field and the field of human development around us. It is possible that this has something to do with the formerly very narrow field of vision that has permeated and perhaps defined sexual offender treatment, and especially the treatment of adult sexual offenders.

 

An increasing awareness of protective factors, and an increasing prominence in our research, is welcome. However, protective factors have been there all along; they have already been “discovered.” The current task involves, not discovery, but better understanding protective factors, empirically and in clinical practice, including not only what we should count as protective factors, but also how they work and, importantly, how they interact with one another and how they interact with risk factors. It is this focus that most represents the area of new knowledge – not the discovery of protective factors, but instead how they work, and under what circumstances.

 
Phil Rich, EdD., LICSW

 

References


Bremer, J. F. (1998).  Challenges in the assessment and treatment of sexually abusive adolescents.  The Irish Journal of Psychology, 19, 82-92.   doi: 10.1080/03033910.1998.10558172

Bremer, J. (2006). Protective Factors Scale: Determining the level of intervention for youth with harmful sexual behavior. In D. S. Prescott (Ed.). Risk assessment of youth who have sexually abused (pp 195-221). Oklahoma City, OK: Wood & Barnes.

de Vries Robbé, M., Mann, R. E., Maruna, S., & Thornton, D. (2014). An exploration of protective factors supporting desistance from sexual offending. Sexual Abuse: A Journal of Research and Treatment. Advance online publication. doi: 10.1177/1079063214547582

Gilgun, J. F. (1999). CASPARS: Clinical assessment instruments that measure strengths and weaknesses in children and families. In M. C. Calder (Ed.), Working with young people who sexually abuse: New pieces of the jigsaw puzzle (pp. 50-58). Dorset, England: Russell House Publishing.

Jessor, R., Van Den Bos, J., Vanderryn, J., Costa, F. M., & Turbin, M. S. (1995).Protective factors in adolescent problem behavior: Moderator effects and developmental change. Developmental Psychology, 31,923-933.         

Rich, P. (2003). Understanding juvenile sexual offenders: Assessment, treatment, and rehabilitation. Hoboken, NJ: John Wiley & Sons.

Rich. P. (2009). Juvenile sexual offenders: A comprehensive guide to risk evaluation. Hoboken, NJ: John Wiley & Sons.

Rich, P. (2011). Understanding juvenile sexual offenders: Assessment, treatment, and rehabilitation (2nd. ed.). Hoboken, NJ: John Wiley & Sons.

Rutter, M. (2003). Crucial paths from risk to causal mechanisms. In B. B. Lahey, T. E. Moffitt, & A. Caspi (Eds.) Causes of conduct disorder and juvenile delinquency (pp. 3-24): Guilford Press.
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Friday, September 19, 2014

The Community and the “Cure”

In a recent television interview, a talk-show host asked boxer Mike Tyson why people should take his opinions seriously when he is a “rapist.” This referred to a crime that Tyson committed over two decades ago. Tyson’s response was swift and characteristic of his career; he insulted the interviewer and challenged him to a fight. Although the situation was unfortunately and entirely unnecessary, it demonstrated what research has found: people change, and violence and aggression are more likely to persist than sexual abuse. Mike Tyson may have persisted in many undesirable behaviors, but he has apparently desisted from further sexual abuse. Tyson objected to the label “rapist,” and perhaps we should as well.

In the interest of accurate language, Mike Tyson is a person who has been violent towards others in and out of the boxing ring. Sexual abuse is an area where, as Bill Marshall (personal communication, September 11, 2014) recently observed, our labels stick like glue. It is fascinating that the interviewer used this particular label rather than asking, “Why should people take your opinions seriously when you’ve bitten off parts of your opponents’ ears and assaulted strangers on the side of the highway?” Perhaps part of the answer lays in public ignorance about how sexual re-offense does – and more importantly – does not happen.

Relevant to this is a study (in press) that merits close attention. Karl Hanson, Andrew Harris, Leslie Helmus, and David Thornton studied 7,470 sexual offenders from 21 samples and found that:

The risk of sexual recidivism was highest during the first few years after release, and decreased substantially the longer individuals remained sex offence-free in the community. This pattern was particularly strong for the high risk sexual offenders (defined by Static-99R scores). Whereas the 5 year sexual recidivism rate for high risk sex offenders was 22% from the time of release, this rate decreased to 4.2% for the offenders in the same static risk category who remained offence-free in the community for 10 years. The recidivism rates of the low risk offenders were consistently low (1% to 5%) for all time periods. The results suggest that offence history is a valid, but time dependent, indicator of the propensity to sexually reoffend.

Certainly, official records of re-offense underestimate the true rate of sexual crimes. However, the overall trends in this study reflect what we already know from numerous other studies around the globe. Most sexual offenders are not known to re-offend, and only a small minority is at truly high risk. This presents many opportunities for reconsidering our current approaches to management, including the use of strategies that reduce risk, protect communities, and help assist those affected by sexual abuse that are more efficient and cost-effective than the many ineffective strategies in place today (e.g., residence restrictions).

These findings should prompt all professionals and the lay public to reflect on their beliefs about people who sexually abuse. Until recently, Colorado statutes stated that, “there is no cure for sex offending,” as though it were a disease instead of a preventable behavior. Likewise, by the time someone reads this blog, it is highly likely that they have heard the expression “once a sex offender always a sex offender.” Although even one sex crime is one too many, this study shows that short-term and intensive strategies for preventing sexual re-offense (such as high-quality treatment and sensible community supervision) are more likely to be effective than long-term, passive, and as-yet unproven methods such as Internet registries. 

Further, this study shows the opposite side of a familiar coin. Prisons and other forms of punishment do not actually reduce crime (Smith, Goggin, & Gendreau, 2002). However, time spent successfully in the community is associated with desistance from crime. Recent research has highlighted the success of many community-based programs and their emphasis on developing a balanced, self-determined lifestyle (Wilson et al, 2009). This study points to the importance of using treatment and supervision to expedite desistance-related processes (such as stability, staying occupied, having prosocial supports, and implementing plans for self-improvement) rather than simply as tools for monitoring behavior.

Human beings naturally default to detecting and managing risks in the short term.  Current research into assessment methods has helped us become even more adept at understanding and categorizing these risks. Developing effective means to ensure long-term public safety has taken longer. The most effective means for managing risks has presented far more challenges in our research and practice as well as the way we think about individual cases (such as Mike Tyson). Hanson and his colleagues’ findings point to the next steps we can take in supplementing our knowledge of risk with skillful reintegration.

As a final note, it is again important to note that not every crime is detected. However, it is noteworthy that these findings extend across all risk categories in a large sample and speak to the importance of allocating our most intensive resources to those who need them the most.

David S. Prescott, LICSW

References

Hanson, R.K., Harris, A.J.R., Helmus, L., & Thornton, D. (in press). High risk sex offenders may not be high risk forever. Journal of Interpersonal Violence.

Smith, P., Goggin, C., & Gendreau, P. (2002). The effects of prison sentences and intermediate sanctions on recidivism: General effects and individual differences.Research Report 2002-01. Ottawa, ON: Solicitor General Canada.

Wilson, R. J., Cortoni, F., Picheca, J. E., Stirpe, T. S., & Nunes, K. (2009). Community-based sexual offender maintenance treatment programming: An evaluation. (Research Report R-188). Ottawa, ON: Correctional Service of Canada.
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Wednesday, September 17, 2014

Peak Week: The End


No matter what happens on the 27th, I'm a winner.



No trophy or top five placement could top the sense of accomplishment I'm going to feel after stepping on stage. Not only accomplishment, but knowing that I've inspired at least one person.



And I know I have because at least once a week at my gym I get to see Tammy, and she tells me every time how proud she is of me and what an inspiration
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Friday, September 5, 2014

Exploring the Emotions Behind Genital Cutting

62 years ago, in 1952, Wilhelm Reich said, “Take that poor penis. Take a knife—right? And start cutting. And everybody says, “It doesn’t hurt.” Everybody says, “No, it doesn’t hurt.” Get it? That’s an excuse, of course, a subterfuge. They say that the sheaths of the nerve are not yet developed. Therefore, the sensation in the nerves is not yet developed. Therefore, the child doesn’t feel a thing. Now, that’s murder! Circumcision is one of the worst treatments of children. And what happens to them? You just look at them. They can’t talk to you. They just cry. What they do is shrink. They contract, get away into the inside, away from that ugly world.”
Reich lived from 1897 to 1957. He was an Austrian physician who was a pioneering psychoanalyst and considered one of Freud’s best students. However, over time, he became disappointed with the results that could be achieved with Freud’s method of free association. This prompted him to develop a very different framework for understanding people and emotions.
I am a board-certified psychiatrist and for more than 40 years have been using the unique and very effective treatment that Reich created. I also train psychologists and other psychiatrists to practice this therapy. It’s very different from any other treatment for emotional disorders that you may have heard of.  And even if you have heard of Wilhelm Reich, or have some knowledge of the therapy that he pioneered, his method of treatment is often misunderstood and, unfortunately, misrepresented. It makes use of a verbal interchange that’s different from other methods of psychotherapy. It seeks to make the patient aware of the particular manner in which they approach the world. Reich called it “character analysis.” The treatment also allows the release emotions, primarily sadness and anger, in a controlled way, in the safety of the therapist’s office.
Reich discovered that emotional traumas are not forgotten, even when they occur very early in life and remain out of conscious awareness. Physical pain is traumatic for everyone, but for an infant or young child, the shock to their system can be terrible. This is the reason why Reich, although Jewish, spoke out so vehemently against circumcision.
Just how it is that events from the distant past can be locked away somewhere in the body remains a mystery. Nevertheless, the traumas of childhood, if severe enough, are never forgotten. They stay stuck in us—in our “armor” as Reich called it—and exert their damaging effect throughout life. This fact, that the past is not forgotten, is virtually unknown. Early childhood traumas, not chemical imbalances, are the root cause of lifelong dissatisfaction and unhappiness, as well as many severe emotional disorders, including schizophrenia.
Now what is very interesting and remarkable (and in fact this still amazes me, as it did Reich) is, in the course of this therapy, patients may actually re-experience their earliest traumas. I have seen men re-live their circumcision, with all the pain and terror they suffered. In a few minutes I am going to play a clip of one of my patients speaking about his experience when he re-lived his circumcision during therapy. I had him filmed for this conference.  
But first, I am going to show you a clip of him on the therapy couch during the course of a typical session. This clip comes from a documentary film that was made some years ago. What you are going to see may be a bit shocking, but please know that Bob has always left every session much relieved and in fine shape.




As this clip showed, the past remains alive. Now as for circumcision, it is so extremely harmful because it occurs so early in life. The younger the child, the less are the defense mechanisms to deal with pain. As an adult, or even an older child, we have the sum of our intellect and our experiences to put shocking events in some context and perspective.
The next clip I am going to play shows Bob telling about re-living his circumcision. This was just filmed.



So now I want to turn to a different subject, and the topic of my talk, which is the unconscious cruelty that drives humans to circumcise newborns and children.
All of us here today understand that cutting the genitals of children is not just unnecessary—-but barbaric—-and there’s not a single, rational argument to support it. However, because there are so many sides to the issue, people can’t see circumcision for what it really is. They are confused because of the social and cultural factors, the demands of religion, the medical justifications—and so on. But I’d like to touch on one aspect that is almost never considered— the forces that drive people and institutions to support this practice.
Can any sense be made of what it is that impels people to brutally cut the genitals of defenseless newborns and young children, male and female alike? For the answer to this question I again look to the work of Wilhelm Reich. One of his most important contributions is his exposition of what he termed the “emotional plague.” It’s a very complex subject and I will try to do it a bit of justice in the next few minutes. But if any audience can grasp this concept, I think this one will.
Reich maintained that within our society, and in fact in all patriarchal societies, there are certain individuals that he called emotional plague characters. These people have very specific characteristics and ways of behaving. They are intelligent, extremely competent, aggressive, and endowed with a high energy level. And they are very good at getting themselves into positions of authority and power so they can tell others what to do for their own good.
Emotional plague characters, big and small, have existed throughout history. They are not just the Hitlers and Stalins, but also the petty tyrant school teachers who terrorizes the children in their class; the religious leaders, who mandate right and proper behavior; the supervisors everywhere that keep those under them in constant fear; the heads of organizations that put into effect policies that restrict personal freedom, and so on.
The emotional plague is not just confined to individuals but also becomes institutionalized. This can be seen in many of our law-making bodies that, more and more, dictate how we should live, again, for our own good.
The reasons behind this behavior are too complex to go into here, but what can be said is that plague characters, because of the particular way they were raised, are disturbed and very angry people. But they are unaware of their anger. They are not like the average neurotic who suffers quietly to themselves. In fact, they don’t suffer much at all because they act out their anger, which is unconscious, on the social scene. This is not something they choose to do. They are driven to act this way. And they really believe they are doing the right thing.
Seeing others who are lively, happy, and enjoying themselves creates in them not pleasure, as it would with a healthy person, but jealousy and resentment. These feelings are so intense that the only way they can stop them is by going out into the world and stopping people from having pleasure. This is what makes these individuals feel better.
What makes the emotional plague so effective, and so dangerous, is that their arguments are extremely well rationalized and always “partly right.” We can see with regard to circumcision how this “partly right” confuses: Maybe my boy should look like the other boys. Maybe, as a Jew, I should have my son circumcised. Maybe the doctors are right that my boy could get infections. It’s the partly right that confuses, and prevents us from seeing what’s right in front of our eyes.
Because the emotional plague hates pleasure in others, and seeks to stamp it out, children, who by their very nature are lively, happy people are a prime target. So is natural sexuality. Circumcision targets both children and natural sexuality.
So what can be done? Reich said the only way to combat the emotional plague is to expose it. This doesn’t mean pointing fingers and calling people “plague characters.” It means exposing the work of the plague to the truth. Consistently making people aware of the lies that allow this practice to continue.
Also, to keep our focus on educating the public and the upcoming generation of doctors and others who will re-shape existing policies. We have truth on our side, and the children of the future will be the beneficiaries of our efforts.

This lecture was presented at the 13th International Symposium on Genital Autonomy and Children’s Rights, held at the University of Colorado in Boulder on July 24-26, 2014. The conference provided a forum for discussion about the genital alteration of infants and children from religious, medical, human rights, and other perspectives. Speakers from around the world reported on the approaches they have taken, and the progress that has been made, for protecting male, female, and intersex children from medically unnecessary genital alteration.


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