14 million medical conditions in US yearly on smoking causes

Smoking cigarettes is frequently crucial for you to regarding 14 zillion important health issues among National the elderly annually, a fresh verify proves.

Of which range is frequently greater than the specific U. Ersus. Centres with regards to Disease Handle besides Prevention's (CDC) really previous evaluation, within the 12 months 2000, which in turn found in which National the elderly lived with 12. 7 zillion smoking-attributable situation.

Significant obstructive pulmonary condition (COPD) — such as situation such as severe bronchitis besides emphysema — comprises more than one half within the professional medical occasions as a result of tobacco use, the specific gurus found.

"The condition issue linked to cigarettes in the united states remains enormous, besides existing costs indicate in which COPD could possibly be tremendously underreported within health and fitness survey info, " had written the specific gurus, exactly who published their very own final results yesterday (Oct. 13) within the record JAMA Inner Cures.

Info from a CDC's Land broad Wellness Interview Examine at first offered in which 6. 9 zillion more mature us citizens lived with this mixed 10. 9 zillion smoking-attributable health issues, which includes COPD, varieties of most cancers, cardiovascular system violence besides diabetes. However real volume of situation is keen better due to the fact this particular survey will depend on individuals self-reports, besides COPD is frequently underreported, the specific gurus stated.

So that you can tend to be the real reason for this particular room, the specific gurus — led through Ruben Rostron, within the U. Ersus. Ingredients besides Pill Administration's Core with regards to Smoking cigarettes Goods — furthermore considered info via yet another CDC survey, the specific Land broad Health insurance and Nutrition Exam Examine. In such a survey technique, avid gamers are not just interviewed, yet furthermore undergo bodily tests, which includes this lung operation test out called spirometry that may be acquainted with find COPD.

Driven by in which info, Rostron besides co-workers expected in which occasions linked to COPD are actually 70 % greater than the number of occasions based on self-reported info. Ones gurus expected in which 14 zillion National the elderly experienced this smoking-related issue within last year.

Deficiency of COPD diagnoses could possibly be caused by existing scientific recommendations, the specific gurus stated. Researchers tend to be well-advised to utilize spirometry to attempt folks who document signals by way of example wheezing besides severe shhh. However health professionals ought to not really screen folks who is not going to document most of these signals due to the financial besides health care bills fees.

"Individuals having slowly proceeding down asthmatic operation or perhaps folks that have cultivated common for you to different college diplomas linked to severe air passage impediment may not document most of these situation for you to medical professionals and consequently might not exactly maybe become processed with regards to or perhaps clinically determined to have COPD, " the specific gurus within the verify had written.

Smoking cigarettes is the key basis for avoidable dying in the united states. Cigarette fumes consists of quite a few discovered cancer cancer causing carcinogens. Smoking cigarettes is frequently reason with regard to 85 % linked to lung varieties of most cancers, and it has also been linked to varieties of most cancers in lots of other sorts of organs, which includes, lately, the specific hardworking lean meats besides intestinal tract.

Eating certain fats might offset some heart risk from weight gain

If you're going to overindulge and gain weight, at least try to make sure the extra calories come from unsaturated fats, a new study suggests.

When lean people pack on even a few extra pounds, heart disease risk factors in the bloodstream change – some for the better if the excess food contains unsaturated fats, versus saturated fats, researchers found.

Even a moderate weight gain of about three pounds for lean, young people clearly increased markers of heart disease risk factors like insulin resistance as well as signs of impaired vascular function, said senior author Dr. Ulf Riserus of the Unit for Clinical Nutrition and Metabolism at Uppsala Science Park in Sweden.

But unsaturated fats in the diet improved cholesterol levels despite the extra calories and weight gain, which is surprising, Riserus told Reuters Health by email.

For seven weeks, two groups of healthy, relatively lean adults ages 20 to 38 were told to keep to their habitual exercise level and daily diets, adding three to four muffins to their diets each day.

The researchers provided the 240-calorie muffins, with half their energy from fats. One group of 19 adults received muffins made with sunflower oil, polyunsaturated fatty acids (PUFA), while the other group of 20 people ate muffins made with palm oil, a saturated fat. The muffins were otherwise identical.

After seven weeks, each group had gained between two and three percent of their body weight, about 3.5 pounds (1.5 kilos) each, and waist girth increased by about one percent, but blood pressure did not change significantly.

This level of weight gain in the short term is probably not dangerous at all, Riserus said, but if weight accumulates over time, especially abdominal fat, there can be health consequences.

Based on blood tests, the sunflower oil group had lower cholesterol and lipid levels at the end of the study than they had at the beginning of the study. For the palm oil group, cholesterol went up, according to the results in the Journal of the American Heart Association.

Both groups showed signs of increased insulin resistance, a diminished ability to process blood sugar that can be a warning sign for diabetes onset.

Riserus and his team had previously found that the type of fat in the diet determined how much of the excess calories were stored as abdominal fat and liver fat, he said.

“If the high-caloric diet was based on unsaturated fats rather than saturated fats, very little fat was stored as liver and abdominal fat, whereas the opposite was true for the diet high in saturated fats,” he said.

Saturated and unsaturated fats have different molecular effects on the liver, he said. Unsaturated fats signal the liver to take up cholesterol from the blood, he said.

“We believe our results are very relevant considering that a large part of most populations are in caloric excess and gradually gain weight over time,” Riserus said. “Although weight gain should be avoided, the results basically tell us that we may benefit from having enough unsaturated fats in our diets, irrespectively of how many calories we eat.”

The results support the American Heart Association recommendation to replace some saturated fats in the diet, like fatty beef, butter and cheese, with unsaturated fats like vegetable oils and nuts, he said.

“I do not think people usually plan for weight gain, but, as we know, it just happens quite commonly,” said Ursula Schwab, an associate professor of nutrition therapy at the University of Eastern Finland in Kuopio.

“So, by following the guidelines regarding dietary fat, unintentional weight gain can be less harmful than in cases when the recommendations on the quality of dietary fat is not followed,” Schwab told Reuters Health by email. She was not involved in the new study.

All dietary polyunsaturated fats are beneficial, she said, but that is not necessarily the case for supplements.

In addition to sunflower oil, rapeseed oil and canola oil are good sources of polyunsaturated fats, Riserus said.

http://www.foxnews.com/health/2014/10/16/eating-certain-fats-might-offset-some-heart-risk-from-weight-gain/

Women more likely than men to have anxiety, depression after heart attack

Heart attacks can impact women’s mental health more severely than men’s, suggests a new study from Lithuania.

The study, which followed 160 patients admitted to Vilnius University Hospital Santariskiu Clinics with a heart attack, found that six months later, the women had a greater risk of having anxiety and depression than the men did, Medical News Today reported.

“Women are misrepresented in many clinical studies on myocardial infarction (heart attack) even though they often have worse outcomes,” said study author Pranas Serpytis. “Our study shows that women are more likely to develop anxiety and depression after myocardial infarction than men, but until now this issue has been largely unnoticed.”

According to the Centers for Disease Control and Prevention (CDC), about 720,000 Americans have a heart attack each year.  Heart disease is the leading cause of death among women— accountable for 1 in every 4 female deaths.

In their study, researchers interviewed patients one month after they had a heart attack. They collected and analyzed their medical histories, and looked for instances of mental illness, high blood pressure, diabetes, and previous heart attacks. They also considered other risk factors for cardiovascular disease, such as smoking and a lack of physical activity.

Study authors used the Hospital Anxiety and Depression Scale (HADS) to assess patients. A score of 0-7 indicates no depression or anxiety, while a score of 8-10 points to possible depression and anxiety. A score of 11 or higher suggests mild to moderate levels of depression and anxiety.

While men had an average depression score of 6.87, women’s average score was 8.66. For anxiety, men had an average score of 7.18, and women had an average score of 8.20.

Regardless of gender, study participants with depression were almost six times more likely to die in the six months after a heart attack, compared with patients who weren’t depressed.

"Major depression follows myocardial infarction in approximately 18 percent of cases and is an important predictor of disability and poor quality of life in the year post-myocardial infarction," Serpytis said.

Study authors also noted that smoking increased the risk of anxiety, while a lack of exercise was linked to depression.

The average HADS score for anxiety among smoking patients was 10.16, compared with an average score of 7.3 for patients who had never smoked and 4.55 for patients who stopped smoking more than two years before. No link was found between smoking and depression following a heart attack.

The 64 percent of patients who were physically inactive had an average HADS depression score of 8.96.

"Our study suggests that encouraging patients to quit smoking and increase their physical activity levels should reduce their risks of anxiety and depression after myocardial infarction,” Serpytis said. “More research is needed on the links between myocardial infarction and mental health problems."

Serpytis and his colleagues presented their findings at the annual meeting of the Acute Cardiovascular Care Association, a part of the European Society of Cardiology, in Geneva, Switzerland.

Joe Galati, M.D./Harvoni Hepatitis C Therapy New FDA Approval and Patient Information

Published on Oct 14, 2014

Joe Galati, M.D.

Harvoni was was approved by the FDA last week, for the treatment of chronic hepatitis C. A fixed dose of Ledipasvir and Sofosbuvir, this is the first once daily, 2-drug therapy. Dr. Galati reviewed the dosing of Harvoni based on the presence or absence of cirrhosis, and whether you have been treated previously.

information on internet about: UCLA researchers find obesity accelerates aging of the liver

Using a novel biological aging clock, UCLA researchers find obesity accelerates aging of the liver

Finding may explain why obese people suffer from early onset of many age-related diseases, including liver cancer.

Using a recently developed biomarker of aging known as an epigenetic clock, UCLA researchers working closely with a German team of investigators have found for the first time that obesity greatly accelerates aging of the liver.

This finding could explain the early onset of many age-related diseases, including liver cancer, in obese subjects Although it had long been suspected that obesity ages a person faster, it hadn't been possible to prove the theory, said study first author Steve Horvath, a professor of human genetics at the David Geffen School of Medicine at UCLA and a professor of biostatistics at the UCLA Fielding School of Public Health.

Using the epigenetic clock Horvath developed last year, he and Jochen Hampe from the University Hospital Dresden showed that carrying excessive weight can negatively impact select human tissues. "This is the first study that evaluated the effect of body weight on the biological ages of a variety of human tissues," Horvath said. "Given the obesity epidemic in the Western world, the results of this study are highly relevant for public health."

The findings appear Oct. 13, 2014, in the early online edition of the peer-reviewed journal Proceedings of the National Academy of Sciences.

Horvath's aging clock uses a previously unknown time-keeping mechanism in the body to accurately gauge the age of diverse human organs, tissues and cell types. He and his collaborators focused on a naturally occurring process called methylation, a chemical modification of the DNA molecule. Horvath used this epigenetic clock to measure the biological age of several tissues. The aging clock proved accurate in matching biological to chronological age in lean subjects. But liver tissues from obese subjects tended to have a higher biological age than expected.

In this study, Horvath looked at almost 1200 human tissue samples, including 140 liver samples, to study the relationship between epigenetic age acceleration and body weight. While obesity doesn't affect the epigenetic age of fat, muscle or blood tissue, he and his collaborators found that, on average, the epigenetic age of the liver increased by 3.3 years for every 10 Body Mass Index (BMI) units.

For example, a woman who is 5 feet 5 and weighs 140 pounds has a BMI of 23.3. A woman the same height but weighing 200 pounds would have a body mass index of 33.3. Her liver would be about three years older than the woman who weighed 140 pounds, the study found.

"This does not sound like a lot, but it is actually a very strong effect," Horvath said. "For some people, the age acceleration due to obesity will be much more severe, even up to 10 years older."
Horvath also found that rapid weight loss induced by bariatric surgery did not reverse the accelerated aging, at least in the short term.

Going forward, Horvath and his team want to determine if the premature epigenetic aging of liver tissue in obese people can be prevented to possibly reduce their risk of diabetes and liver cancer. They plan to work on models that allow them to dissect the exact molecular mechanisms behind this aging process - which is not known at this point - in order to find the right targets for therapy and prevention.

"The increased epigenetic age of liver tissue in obese individuals should provide insights into common liver-related comorbidities of obesity, such as insulin resistance and liver cancer," the study states. "These findings support the hypothesis that obesity is associated with accelerated aging effects and stresses once more the importance of maintaining a healthy weight."

###

The study was funded by the National Institutes of Health (NIA/HIH 5RO1AG04511-02), the Virtual Liver Network, the Christian-Albrechts-University Kiel and the University Hospitals Schleswig-Holstein and Dresden in Germany.

Source

Of Interest
Dr. Muir is Associate Professor of Medicine, Clinical Director, Hepatology Fellowship Director, Gastroenterology & Transplant Hepatology at Duke University

Dr. Muir discusses the importance of liver health and treatment

 

AMCollege Gastro

Recruiting HCV Clinical Trial: Simeprevir, Daclatasvir and Sofosbuvir Genotype 1 or 4 and Decompensated Liver Disease

Related: Medivir: Simeprevir, Sofosbuvir and Daclatasvir Phase II IMPACT Study Initiated to Treat Genotype 1 and 4 Hepatitis C Patients

IMPACT Phase II study for chronic hepatitis C Is Now Recruiting In Texas
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease

Hepatitis C, Chronic
Phase 2
Drug: Simeprevir
Drug: Daclatasvir
Drug: Sofosbuvir
ClinicalTrials.gov Identifier:
NCT02262728

Purpose

The purpose of this study is to assess the efficacy of a 12-week regimen containing simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the liver function is insufficient) due to genotype 1 or 4 Hepatitis (inflammation of the liver) C virus (HCV) infection by assessing sustained virologic response 12-weeks after the end of study drug treatment (SVR12).

This is an open-label (all people know which treatment the participants receive) Phase 2 study to investigate the efficacy, safety and pharmacokinetics of simeprevir, daclatasvir and sofosbuvir in treatment-naive (participants have never received HCV treatment with any approved or investigational agent) and treatment - experienced (participants have failed at least one previous course of [Pegylated] interferon [(Peg)IFN], with or without Ribavirin) participants. The total study duration for each participant will be approximately 276 weeks. The study will consist of 3 parts: Screening Phase (approximately 4 weeks) and open-label treatment Phase (from Week 4 to 16) and follow-up Phase (until 5 years after the actual end of study drug treatment). Participants will receive simeprevir (150 milligram [mg] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks. Efficacy will be primarily evaluated by percentage of participants with SVR12. Participants' safety will be monitored throughout the study.

Estimated Enrollment: 40

Locations

United States, Texas

Recruiting
San Antonio, Texas, United States

Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

questions: JNJ.CT@sylogent.com

If AbbVie Discounts its Hep C Drug, Would Pricing Reach a Tipping Point?

If AbbVie Discounts its Hep C Drug, Would Pricing Reach a Tipping Point?
By ED SILVERMAN

For instance, in an investor note, Sanford Bernstein analyst Geoff Porges wrote that Gilead left AbbVie “less room to start a price war” than some may have expected. How so? Gilead priced the eight-week regimen at $63,000, which means average pricing for Harvoni would be about $80,000, assuming that as many as 45% of the patients with most common form of the virus use the drug for eight weeks.

This is actually less than what most insurers are now paying for Sovaldi, which costs $84,000 for a 12-week regimen, but must be taken with another drug. This pushes the cost to somewhere between $95,000 or so and $160,000, depending upon which medication is added. In short, the Gilead maneuver may place added pressure on AbbVie to consider aggressive pricing.

Continue Reading @ WSJ....

Related On The Blog
Reducing the cost of new hepatitis C drugs

An index of articles pointing the reader to current controversy over the price of Harvoni (ledipasvir/sofosbuvir) and Sovaldi.
The situation has Medicaid plans and insurers nationwide groping for the right balance. Worldwide patients are unable to afford treatment, while others wait in the wings on coverage. 

Fair Pricing Coalition Welcomes Approval of Gilead Sciences’ Combination Tablet for Hepatitis C, Urges a Uniform Price for Curative Treatment

Fair Pricing Coalition Welcomes Approval of Gilead Sciences’ Combination Tablet for Hepatitis C, Urges a Uniform Price for Curative Treatment
Posted on October 13, 2014 by jberry

The $63,000 wholesale acquisition cost (WAC) for eight weeks of Harvoni™ (sofosbuvir and ledipasvir) should be extended to 12- and 24-week curative treatment durations.

The Fair Pricing Coalition (FPC) today applauded the October 10, 2014, U.S. Food and Drug Administration (FDA) approval of Harvoni, a combination tablet containing the direct acting antivirals (DAAs) sofosbuvir and ledipasvir for the curative treatment of genotype 1 hepatitis C, and called upon Gilead Sciences to establish a uniform price per cure, regardless of the length of therapy.

The FPC, a coalition of HIV and viral hepatitis treatment activists, recognizes the significant advance in treatment success and convenience of Harvoni, but is disappointed at the Wholesale Acquisition Cost (WAC) of $1,125 per once-daily tablet, or $63,000, $94,500, and $189,000 for an 8-, 12-, and 24-week course of treatment, respectively.

The FPC maintains that these costs, particularly for the 12- and 24- week courses of treatment, are exorbitant. Since they are now published, however, FPC concludes that the WAC of $63,000 for eight weeks of Harvoni, which is projected to be the most common duration of treatment as more people living with genotype 1 hepatitis C learn of their infection and seek care, should be made the uniform cost per cure, regardless of the length of therapy.

Harvoni’s FDA approval follows that of Sovaldi® (sofosbuvir) on December 3, 2013, the price of which was denounced by FPC. The $84,000 WAC ($1,000 per pill) of Sovaldi has since brought rebukes from insurers, activists, government officials, health care providers, and people living with hepatitis C.

While Gilead has contended that the total price for a course of treatment with a Sovaldi-containing regimen was a modest increase compared with previous standards of care, this is an invalid argument based on the incorrect premise that these regimens were appropriately priced to begin with. So, although an eight-week course of Harvoni will result in a lower cost-per-cure than previous regimens, the $1,125 WAC per pill means that coverage for the 50 percent or more of people living with genotype 1 hepatitis C who require 12 or 24 weeks of therapy will be unreasonably costly and therefore potentially unattainable.

“Harvoni is a remarkable breakthrough in hepatitis C treatment,” explained FPC Co-Chair Lynda Dee. “It is easy to take, is associated with cure rates between 94 and 99 percent, is safe and effective in advanced liver disease, is much less toxic than older regimens, and has a manageable drug interaction profile. Yet its price sours our appreciation of these long-awaited agents, particularly now that we have examples that curative treatment is inaccessible to many because of out-of-control escalator drug pricing.”

Gilead’s pricing of Sovaldi, and now Harvoni, puts these medications on a par with the pricing of pharmaceuticals that are much more costly to manufacture and often for rare diseases, despite the fact that Sovaldi and Harvoni are relatively inexpensive to produce, and that at least 3.5 million people are estimated to be living with hepatitis C in the United States. These costs are putting unprecedented pressure on public and private insurers, and stripping patients and providers of the required autonomy to make treatment decisions based on need.

The FPC recognizes that Gilead Sciences is maintaining their free medications program for low-income, uninsured patients, and expanding subsidies that greatly minimize out-of-pocket expenditures, such as co-payments and co-insurance costs, associated with the placement of Harvoni and Sovaldi in specialty drug tiers. Yet these programs are unable to address all disparities of access to treatment due to excessive pricing, resulting in a two-tiered system of care based on insurance coverage and ability to pay.

“Many resource-constrained programs, such as Medicaid, have only been covering Sovaldi-containing regimens for patients with advanced liver disease, despite the fact that people with early stages of disease can transmit the virus to others and may suffer health consequences if treatment is delayed,” said Murray Penner, FPC Co-Chair. “People living with hepatitis C who seek access to these medications are also being required to undergo degrading evaluations related to drug and alcohol use, factors which have not been scientifically substantiated as determinants of the success or failure of treatment. It remains unclear if the reduced cost associated with eight weeks of Harvoni treatment will mollify these programs and we fear these restrictions will be extended, particularly for those requiring 12 or 24 weeks of treatment.”

“A remarkably safe, effective, and easy-to-take tablet means that if it is financially accessible to the many millions of people who desperately need it, we can actually imagine eliminating this insidious disease nationally and globally,” said Dee. “Gilead has failed to comprehend that pricing its curative treatments beyond what the market can bear is a shortsighted business tactic and a failed public health opportunity, both to the detriment of people living with hepatitis C.”

Gilead U.S. Patient Assistance Programs

Gilead Patient Assistance Programs

Our U.S. patient assistance programs help make Gilead therapies accessible for uninsured individuals and those who need financial assistance.

Support Path™ assists eligible hepatitis C patients in the United States access Sovaldi® (sofosbuvir) or Harvoni® (ledipasvir/sofosbuvir). The program consists of an integrated offering of support services for patients and providers, among them:

A 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 Sovaldi and Harvoni Co-pay Coupon Programs, which provide co-pay assistance for eligible patients with private insurance who need assistance paying for their out-of-pocket medication costs. 

Most patients will pay no more than $5 per co-pay.

The Support Path Patient Assistance Program will provide Sovaldi and Harvoni at no charge for eligible patients with no other insurance options.

To learn more about Support Path for Sovaldi® and Harvoni®, please call 1-855-769-7284, Monday through Friday between 9:00 a.m. and 8:00 p.m. (Eastern Time).

Click here.....

Harvoni FDA APPROVED

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 (ledipasvir and sofosbuvir)

Gilead has published both U.S. Prescribing Information and Patient Information, on their support website.

In addition check out HCV Advocates new factsheet for; Genotype 1:Treatment: Harvoni (Sofosbuvir & Ledipasvir), other factsheets include; Sovaldi: Genotype 1 Triple Therapy, Sovaldi: Genotype 2 & 3 and Sovaldi: Genotype 4 Triple Therapy

In case you missed it; HCV Newsetters: Everything you need to know about Gilead's Harvoni

Unique 'pay if you clear' proposal for new hepatitis drug

Unique 'pay if you clear' proposal for new hepatitis drug 

By Reevel Alderson 

BBC Scotland's social affairs correspondent 

The NHS in Scotland could be reimbursed for the cost of a new hepatitis drug if sufferers fail to clear the virus.

The novel proposal was revealed after the drug Olysio was cleared for use by the Scottish Medicines Consortium (SMC).
The drug's manufacturer claims the move would help cut prescribing costs.

It is estimated Scotland wastes up to £44m each year on medicines for all conditions that are unused, ineffective or are taken incorrectly.
The 'Pay If You Clear' scheme would come into effect if patients treated with the drug do not become free of the hepatitis C virus (HCV) after 12 weeks.

SMC has approved the drug, whose generic name is simeprevir, for use within NHS Scotland. The 'Pay If You Clear' scheme is awaiting a formal decision by NHS Scotland. 

Appropriate treatment

The drug will be used to treat patients with chronic HCV infection, including those for whom treatment has previously failed.

The manufacturer, Janssen, will pay for pre-treatment blood tests for patients to predict whether the drug is likely to be effective before treatment is initiated.

Continue reading the main story

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

Harvoni, a Hepatitis C Drug From Gilead, Wins F.D.A. Approval

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

by Lucinda Porter

Harvoni: A Page in Hepatitis C Treatment’s History Books

Clinical Care Options
By Jordan J. Feld, MD, MPH

Delivering on the Promise: Maximizing SVR in the Real World

Healio

Perspective: FDA approves Harvoni for HCV treatment

Fair Pricing Coalition
Fair Pricing Coalition Welcomes Approval of Gilead Sciences’ Combination Tablet for Hepatitis C, Urges a Uniform Price for Curative Treatment

EASL 2014
ION-3: 8 weeks of sofosbuvir plus ledipasvir effective in genotype 1 infection

DDW 2014

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

NATAP

Jules Levin
Sovaldi\ledipasvir+vedroprevir Study in treatment-experienced gt1 cirrhotics - 8 weeks

ION-1 NAIVES & ION-2 Treatment-Exp SVR Rates - RBV Cirrhotics/Ethnicity/ baseline NS5A resistance 

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 Dr. Joe Galati 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

FDA Approves Gilead’s Hep C Drug Harvoni (Ledipasvir/Sofosbuvir)

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.

Connect With Us On Twitter and Facebook

 

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

5 QUESTIONS
A Conversation with Hetal A. Karsan, MD

COVER STORY
The Evolution of Special Populations in HCV

EDITORIAL

The Disappearance of 'Special' Populations

FEATURE

Guidance on When and in Whom to Initiat HCV Therapy

HCV RX

A Look at Drug Cost, Financial Assistance Opportunities
Leah Molloy, PharmD

IN THE JOURNALS
Hispanic Veterans with HCV at Increased Risk for Cirrhosis, HCC
Patients with Chronic HCV at Increased Risk for Low Muscle Mass
Half of Patients with HIV Not Screened Regularly for HCV
Study Finds Rising Incidence of HCV in Yourn, Non-Urban Injection Drug Users
ARFI Accurately Detected Liver Fibrosis Stage in Patients with HCV
Birth Cohort Testing Strategy Identified More HCV Infection than Elevated ALT
High sCD 163 Levels Predicted Fibrosis in Patients with HCV, HBV

MEETING NEWS COVERAGE

Awareness of HCV Treatments, Transmission Low among Swiss MSM
Minimal Severe, Serious Adverse Events Reported with '3D' HCV Regimen
HCV, Alcohol-Use Disorder Heightens Risk for Liver-Related Mortality
SAPPHIRE-I, II: Treatment Sustained Despite Hyperbilirubinemia in Some HCV Patients

PEDIATRIC HCV

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

TREND WATCH

Societies Provide Tools to Meet New Competency Requirements

World Hepatitis Alliance Launches HCV Quest
Discontinuation of Telaprevir Expected in October
European Commission Approves Daclatasvir Across Multiple Genotypes

  

HCV Advocate Newsletter

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. 

Read more...

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.

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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. 

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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. 

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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. 

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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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Living Well with Hepatitis B

HBV Advocate: for accurate, timely and cutting-edge information on HBV treatment and vaccines.

October - HBV Journal Review

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 Hepatitis C Education and Prevention Society

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.

October Newsletter

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.

Know Your Dose

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

September Edition

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.

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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.

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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.

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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.

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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.

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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.

READ MORE

October Issue Not Yet Published....

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GI & Hepatology News

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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NYC Hep C Task Force

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. 

October 2014 NYC Hep ABC Newsletter

In this Newsletter
Upcoming Events
Training
Policy Watch
In the News
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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Hep C Connections

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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Caring Ambassadors

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.

News Updates

CAP Hepatitis C Literature Review

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.

Free Online Book

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

People with hepatitis C urged to take up free flu vaccination

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

Cold, Flu, or Allergy?

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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

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 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)