WOBURN, Mass.--(BUSINESS WIRE)--February 04, 2014--
ArQule, Inc. (Nasdaq: ARQL) today reported the announcement by its partner, Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151) of the initiation of a Phase 3 clinical trial evaluating tivantinib (ARQ 197) in Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma treated with one prior sorafenib therapy.
The trial is a randomized, double-blind placebo-controlled study to compare progression-free survival (PFS) in patients treated with tivantinib with those treated with placebo. Kyowa Hakko Kirin plans to enroll approximately 160 patients in this study.
"With the commencement of this study, two Phase 3 trials are now ongoing worldwide to evaluate the impact of tivantinib therapy in second line HCC," said Brian Schwartz, M.D., chief medical officer of ArQule. "We are also enrolling patients in the ongoing pivotal, randomized, double-blind METIV-HCC trial, being conducted in the West by ArQule and our partner, Daiichi Sankyo Co., Ltd., under a Special Protocol Assessment (SPA) agreement."
About MET and Tivantinib (ARQ 197)
Tivantinib is an orally administered, selective inhibitor of MET, a receptor tyrosine kinase, which is currently in Phase 2 and 3 clinical trials. In certain healthy adult cells, MET is present in low to normal levels to support natural cellular function, but in some cancer cells, MET is inappropriately and continuously activated. When abnormally activated, c-Met plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. The activation of certain cell signaling pathways, including MET, has also been associated with the development of resistance to EGFR inhibitors such as cetuximab.
Pre-clinical data have demonstrated that tivantinib inhibits MET activation in a range of human tumor cell lines and shows anti-tumor activity against several human tumor xenografts. In clinical trials to date, treatment with tivantinib has been generally well tolerated and has shown clinical activity in the tumors studied. Tivantinib has not yet been approved for any indication in any country.
About ArQule, Inc. and its Partners for the Development of Tivantinib
On December 19, 2008, ArQule and Daiichi Sankyo Co., Ltd. signed a license, co-development and co-commercialization agreement to co-develop tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, areas for which Kyowa Hakko Kirin has exclusive rights for development and commercialization under an exclusive license agreement signed with ArQule in 2007.
About ArQule
ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company's targeted, broad-spectrum products and research programs are focused on key biological processes that are central to human cancers. ArQule's lead product, in Phase 2 and Phase 3 clinical development, is tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor tyrosine kinase. The Company's pipeline includes: ARQ 092, designed to inhibit the AKT serine/threonine kinase and ARQ 087, designed to inhibit fibroblast growth factor receptor (FGFR). ArQule's current discovery efforts, which are based on the ArQule Kinase Inhibitor Platform (AKIP(TM)), are focused on the identification of novel kinase inhibitors that are potent and selective against their targets.
This press release contains forward-looking statements regarding the METIV-HCC clinical trial with tivantinib in hepatocellular carcinoma (HCC) conducted with Daiichi Sankyo and the Phase 3 clinical trial with tivantinib in HCC conducted by Kyowa Hakko Kirin as well as the Company's agreements with both Daiichi Sankyo and Kyowa Hakko Kirin. These statements are based on the Company's current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. There can be no assurance that tivantinib alone or in a combination therapy will demonstrate promising therapeutic effects in pivotal or other trials; in addition, tivantinib may ultimately not demonstrate an appropriate safety profile in later stage or larger scale clinical trials, such as METIV-HCC or the Kyowa Phase 3 trial in HCC, including among patients with underlying cirrhosis and compromised liver function, as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing tivantinib that could lead the Company, Daiichi Sankyo or Kyowa Hakko Kirin to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from analyses of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities, and regulatory authorities may disagree with the Company's view of the data or require additional data or information or additional studies. In addition, the planned timing of completion of clinical trials like METIV-HCC or the Phase 3 HCC trial conducted by Kyowa Hakko Kirin is subject to the ability of the Company or its partners to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome ongoing or emergent regulatory issues and address other technical hurdles and issues related to the conduct of the trials for which each of them is responsible that may not be resolved promptly, or at all. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future. Moreover, Daiichi Sankyo and Kyowa Hakko Kirin have certain rights to unilaterally terminate the tivantinib license agreement with the Company. If it were to do so, the Company might not be able to complete development and commercialization of tivantinib on its own. For more detailed information on the risks and uncertainties associated with the Company's drug development and other activities, see the Company's periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.
CONTACT: ArQule, Inc.
William B. Boni, 781-994-0300
Tuesday, February 4, 2014
Monday, February 3, 2014
Hepatitis C: Gilead, in talks to bring Sovald (sofosbuvir) into India
Gilead, local generic players in talks to bring hepatitis C drug into India
California-based drug-maker Gilead Sciences Inc is in discussions with a handful of local pharmaceutical companies to bring its much anticipated oral Hepatitis C drug Sovaldi (sofosbuvir) into India.
“We are going to give licence to Indian companies, so there will be Indian production of our hepatitis C product. We are in discussions right now. We hope to announce those in the next couple of months,” Gregg H Alton, Gilead’s Executive Vice- President, Corporate and Medical Affairs, told Business Line.
Gilead’s move comes at a time when the patent on sofosbuvir is being contested at the Kolkata patent office. The opposition was filed late last year by US-based legal group I-MAK (Initiative for Medicines, Access & Knowledge).
On how the drug would be priced, Alton said the imported and locally-made versions would be pegged lower than the current standard of care with existing generic products, estimated at $2,500 (around ₹1.5 lakh) for six months.
Gilead proposes to peg its imported branded product at about $2,000, he indicated, adding discussions were under way with patient-groups before the price is finalised. “We’ll be substantially less than that (current standards of care), and we’ll be more effective, less toxic and easier to use and without side-effects… We leave it up to the Indian companies to bring the price down – should they choose to do that,” he added.
You need three or more companies to compete against each other to truly get the cost down, and “so, we’ll be working probably with three-to-five different companies”, he said. In the US, Gilead’s drug is priced at $84,000 for 12 weeks.
Gilead’s soon-to-be sealed deal will include royalty payments and cover about 60 low and middle-income countries, he said, adding details were discussed during their latest visit to India.
Without getting into details on the patent case, Alton said: “We will defend the patents, but at the same time, we are going to be pushing very hard to enable generic production in India with multiple companies.”
By traditional timelines, it would take at least two years before the product is available in India, said Alton.
Clinical trials to test the drug on the local population have been approved and efforts are on to fast-track this process, he added.
About 15 sites have been identified to run Phase III trials on the drug, involving about 120 people.
Touted to be among “the biggest breakthroughs in medicine in the last 10 years”, Alton said the drug was launched in the US last December, and Gilead and its partners were working to bring it to India soon.
Source-
(This article was published on February 3, 2014)
Sunday, February 2, 2014
The Mediterranean Diet For Liver Disease
There are few things about which I am obsessive, one is bedbugs, the other is dieting.
For decades advertisements have inspired or tricked us, me mostly, into trying a number of crazy diets.
For whatever reason folks, years ago, I never met a diet I didn't try.
In my twenties I inhaled the cabbage soup diet, gave up eating anything white during Christmas, even juiced for a few days, and really committed to that cookie diet.
In my thirties I embraced Dr. Atkins’ Diet Revolution, eggs became my dinner, bacon became my steak, and the water weight I lost impressed my scale.
In my late thirties at a Weight Watchers meeting I met a handsome vegetarian, I dumped the meat, he dumped me, and I moved on to Jenny Craig. Such is life.
In any event, with age comes wisdom. One day, I sat down and looked at my own medical history along with my families, took a few notes to present to my physician. At my very next appointment we discussed any risk factors for disease, such as heart disease and diabetes. Long story short, in the end because of my history of HCV and high risk for diabetes he suggested I try the Mediterranean diet, I took his advice.
The Mediterranean Way Of Eating - My First Non-Diet Approach To Eating Right
For the last fifteen years I have adopted the Mediterranean way of eating, commonly referred to as the Mediterranean diet. Although, it isn't really a diet, the name evolved as a way to reference a group of healthy foods, or a diet pattern used by people whose countries border the Mediterranean Sea. In these countries, especially Greece, people eat a lot of fruits, vegetables, legumes fish and olive oil. According to years of research, people living in this region suffer less than most Americans from cancer and cardiovascular disease.
Everyone should eat a healthy, balanced diet to maintain their health, especially people living with chronic illness. Maintaining a healthy weight is especially important if you have HCV, the risk for developing scarring of the liver; fibrosis and cirrhosis is higher in people who are obese and living with the virus.
Diets come and go, as do hot vegetarians, but for people with liver disease eating foods proven to help preserve, or even improve overall liver health is worth the effort.
Today close to 30% of American adults have nonalcoholic fatty liver disease (NAFLD). In people living with hepatitis C it rises to around 40% and even higher in people with genotype 3. Often referred to in the medical world as HCV-induced steatosis, 60% to 80% people with genotype 3 have moderate or severe steatosis.
So What Is HCV-induced Steatosis?
Fatty liver disease (steatosis) is a build-up of excess fat in the liver cells, and in some cases may trigger inflammation of the liver. HCV-induced steatosis develops due to a combination of viral and host factors. Viral factors are genotype specific, with genotype 3 viral-induced steatosis the most common, up to 80% of people with genotype 3 have moderate to severe steatosis. Chronic hepatitis C also alters glucose metabolism resulting in insulin resistance (IR), further promoting hepatic steatosis, which outside of genotype 3 infection has been associated with more advanced liver disease, according to a review published in last months issue of the Journal of Viral Hepatitis.
Another study published in Nutrition 2013, found HCV patients who participated in a diet and exercise program lowered their grade of steatosis and remarkably, their fibrosis score.
For most people, I raise my hand in shame, diets are something we jump on and jump off, but eating right is better accomplished when we make it more of a lifestyle. Rather it originated on the boarder of the Mediterranean Sea, or here in the U.S., it only works when we embrace it as a way of life.
America - Suggested Nutrition Guidelines
In the United States the USDA Dietary Guidelines for Americans, is intended to help people choose an overall healthy diet, based on five food groups. The dietary guide is put together jointly by the Department of Health and Human Services (HHS) and the Department of Agriculture (USDA). A committee of scientific experts review the guide which is incorporated into a scientific evidence-based report, the next edition will be released in 2015.
The dietary recommendations are aimed at preventing two major health problems in the U.S., which are obesity and heart attacks. Obesity can sneak up on us overtime, the older we get the more calories we consume, more than the body burns. Obesity in turn can cause numerous health problems, such as heart disease, stroke, liver disease, arthritis, high blood pressure, gout, gallstones, and even certain cancers.
In June 2011, the USDA launched a visual guideline depicting a place setting using the five food groups, called MyPlate. It proved successful and replaced our some twenty year old food pyramid.
Check out this interactive website; ChooseMyPlate, find tons of advice on nutrition, watch a few videos, grab a recipe or take part in an educational program.
Follow MyPlate on twitter for daily tips.
Cooking according to MyPlate guidelines is possible in any culture, rather you come from Europe, Asian or American. In the video Cris Comerford, the White House Executive Chef prepares an authentic Filipino dish following the MyPlate guidelines and portion size.
For Chef Comerford's recipes, go here:
http://www.letsmove.gov/blog/2013/05/...
Healthy and Traditional Asian American and Pacific Islander Cuisine
Shrimp, Chicken and Vegetable Fried Rice
Links:
ChooseMyPlate.gov features practical information and tips to help Americans build healthier diets
- MyPlate Videos
- Healthy Eating on a Budget
- SuperTracker
- 10 Tips Nutrition Education Series
- Sample Menus and Recipes
- Daily Food Plans
- Partnering Program
Clinical research has demonstrated adhering to a diet plan with foods named in the Mediterranean diet may help preserve memory as we age, reduced both liver fat and inflammation, help protect against liver cancer, may have potential benefits for people chronically infected with hepatitis, reduce the risk for diabetes, heart attack and stroke - Whew! Provided next.is a research summary of the above mentioned health benefits, followed up with a link to each original article and research.
Mediterranean Diet and MemoryOmega-3 fatty acids are also known to benefit the brain and nervous system. A study in the journal Neurology, January 2013, reported adhering to a Mediterranean diet may help to preserve memory.
U.S. researchers studied 17,478 people with an average age of 64 by monitoring their eating habits, and testing their mental ability over a four year period. In that time, 7% developed problems with their memory and ability to think. Those who ate a Mediterranean diet had a 19% reduced risk of mental impairment.
Mediterranean Diet and Liver Disease
Previous studies have suggested the Mediterranean Diet has additional benefits for people with liver disease, for instance a study published in the July 2013 issue of the Journal of Hepatology demonstrated patients with nonalcoholic fatty liver disease who followed the diet for six weeks not only significantly improved insulin sensitivity, but reduced both liver fat and inflammation.
Mediterranean Diet, Hepatocellular Carcinoma and Viral Hepatitis
This is exciting, according to a study found in the Journal of Hepatology, November 2013;
A closer adherence to the Mediterranean diet appears to be protective against HCC (liver cancer). Our results also point to potential benefits from adhering to a Mediterranean dietary pattern for patients chronically infected with hepatitis viruses.
Read the full article over at NATAP, abstract here.
Mediterranean Diet and Diabetes
A recent study found patients at high risk for diabetes due to pre-existing cardiovascular conditions reduced the risk for diabetes by 40% by adhering to the traditional Mediterranean diet high in extra-virgin olive oil intake. View the study; Prevention of Diabetes With Mediterranean Diets: A Subgroup Analysis of a Randomized Trial, published in Annals of Internal Medicine - January 2014.
Mediterranean diet and Heart Attack and Stroke
2013-Mediterranean diet and Heart Attack and Stroke:
Published in the February 2013 online issue of the New England Journal of Medicine, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events (heart attack, stroke, cardiovascular death) by close to 30%, among people with high cardiovascular risk.
A total of 7447 persons were in the study (age range, 55 to 80 years); 57% were women. None had cardiovascular disease when they enrolled in the study, but they did have a high cardiovascular risk.
The participants were broken down into three cohorts. The first group followed a Mediterranean diet with extra-virgin olive oil, the second a Mediterranean diet supplemented with nuts, and the last group (control) followed a low-fat diet. Statistical analysis showed that compared to those following the control (low-fat) diet, participants on the Mediterranean diet with extra-virgin olive oil were 30% less likely to experience a cardiovascular event, and those on the Mediterranean diet with nuts were 28% less likely. Researchers reported on the importance of the results "... the results of the PREDIMED trial are of utmost importance because they convincingly demonstrate that a high vegetable fat dietary pattern is superior to a low-fat diet for cardiovascular prevention."
Read the article, here
2014-Mediterranean diet: lower risk of peripheral artery disease (PAD):
A multicenter study that previously reported a reduction in heart attack and stroke with a Mediterranean diet supplemented with extra-virgin olive oil or with nuts now also reports a lower risk of peripheral artery disease (PAD), according to a study in the January 22/29 issue of JAMA.
"To our knowledge, this is the first randomized primary prevention trial to suggest an association between a dietary intervention and [reduction in] PAD. These results are consistent with previous observational studies and relevant from a public health perspective," the authors write.
Read the article here..........
****Related- Feb 2014:Increased prevalence of coronary artery disease risk markers in patients with chronic hepatitis C – a cross-sectional study
Chronic hepatitis C is a global health problem and has been associated with coronary artery disease. Our aim was to examine the prevalence of coronary artery disease risk markers including endothelial biomarkers in patients with chronic hepatitis C and matched comparisons without manifest cardiovascular disease or diabetes in a cross-sectional design.
Mediterranean Diet and Longevity A few months ago, an observational study published in the Annals of Internal Medicine , November 2013 issue, suggested middle-aged women who follow a Mediterranean diet may live longer.
The 15 year study primarily funded by the National Cancer Institute, National Institutes of Health, examined 10,670 women aged late 50s and early 60s.
The purpose of the study was to examine the association between dietary patterns in midlife and prevalence of healthy aging.
In the end, after 15 years, middle-aged women who followed the Mediterranean diet had a 40% more chance to live up to age 70, then those who followed a different eating style.
Read more about the history of the diet, here.
What Is the Mediterranean Diet?
Excerpt: The Mediterranean Diet and Good Health
There is no one typical Mediterranean diet. Many countries border the Mediterranean Sea and variations in the Mediterranean diet exist between these countries. However, according to the American Heart Association, traditional Mediterranean diets have the following characteristics in common:
An abundance of plant foods:
Fruits
Vegetables
Breads and cereals
Potatoes
Beans, nuts, and seeds
Olive oil used as a common monounsaturated fat source
Low-to-moderate amounts of fish and poultry
Small amounts of red meat
Low-to-moderate amounts of dairy products (mostly cheese and yogurt)
Low-to-moderate amounts of eggs (zero to four times per week)
Low-to-moderate amounts of wine (one to two glasses of wine per day), normally consumed with meals
* Skip the wine if you hepatitis C or advanced liver disease
Comparison With the American Diet
The American diet is characterized by:
Animal products daily, as main source of protein
White starches, predominantly
Moderate to low in fruits and vegetables
High in saturated and trans fats
Unlike the typical American diet, the traditional Mediterranean diet is high in fiber and low in saturated fat. However, the Mediterranean diet is not necessarily low in total fat. But, the types of fats emphasized in the Mediterranean diet are "healthy" monounsaturated fats, like those found in olive oil, which do not raise cholesterol levels.
Links:
Mediterranean diet: A heart-healthy eating plan
Mayo Clinic Staff
How to Follow the Mediterranean Diet
Offers a quick guide
The Mediterranean diet: 4 recipes to try
You've heard the health benefits of the fruit & fish-packed Mediterranean diet, now it's time to test it out in the kitchen. We turned to ‘Cook Yourself Sexy’ chef Candice Kumai for these delicious recipes, loaded with omega-3s and nutrients.
The goal of healthy eating is to develop a plan that you can maintain for life. For people living with hepatitis C, keeping your weight under control can lower your risk for developing fibrosis, liver cancer, and diabetes.
Whatever healthy plan you try, or use now, may you remain safe, healthy and happy.
Until next time, Tina
Friday, January 31, 2014
AbbVie Amazing All-oral Regimen: 100--96 percent cure rates mostly in 12weeks even in patients w-cirrhosis
In AbbVie's Interferon-free late-stage studies of 6 phase 3 trials most HCV genotype 1 participants achieved an impressive 99% cure rates in 12 weeks. AbbVie said it will file for regulatory approval early in the second quarter, expecting to launch in late 2014.
AbbVie Completes Largest Phase III Program of an All-Oral, Interferon-Free Therapy for the Treatment of HCV Genotype 1
- Ninety-nine percent SVR(12) rates with and without ribavirin in certain patient types
- Even in difficult-to-treat patients (cirrhotic patients) achieved 92-96 percent SVR(12) rates
- AbbVie expects U.S. launch in 2014
NORTH CHICAGO, Ill., Jan. 31, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced the completion of its phase III clinical program and released results of four additional studies designed to assess AbbVie's investigational all-oral, interferon-free therapy with and without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. These results described below confirm previously reported AbbVie data and further demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in these GT1 patients.
AbbVie Phase III Clinical Program Results
Study
|
Patients
|
Treatment Regimen
|
SVR12
|
PEARL-II
(12 weeks)
|
GT1b treatment-experienced
(N=179)
|
AbbVie regimen + RBV (n=88)
|
97%
(85/88)
|
AbbVie regimen only (n=91)
|
100%
(91/91)
| ||
PEARL-III
(12 weeks)
|
GT1b treatment-naive
(N=419)
|
AbbVie regimen + RBV (n=210)
|
99%
(209/210)
|
AbbVie regimen only (n=209)
|
99%
(207/209)
| ||
PEARL-IV
(12 weeks)
|
GT1a treatment-naive
(N=305)
|
AbbVie regimen + RBV (n=100)
|
97%
(97/100)
|
AbbVie regimen only (n=205)
|
90%
(185/205)
| ||
TURQUOISE-II
(12 & 24 weeks)
|
GT1 treatment-naive
and treatment-experienced with compensated cirrhosis
(N=380)
|
AbbVie regimen + RBV, 12 weeks (n=208)
|
92%
(191/208)
|
AbbVie regimen + RBV, 24 weeks (n=172)
|
96%
(165/172)
| ||
SAPPHIRE-I
(12 weeks)
|
GT1 treatment-naive
(N=631)
|
AbbVie regimen + RBV (n=473)
|
96%
(455/473)
|
SAPPHIRE-II
(12 weeks)
|
GT1 treatment-experienced
(N=394)
|
AbbVie regimen + RBV (n=297)
|
96%
(286/297)
|
"The
outcomes of AbbVie's comprehensive phase III studies in 2,300 patients
across 25 countries demonstrate how our investigational regimen performs
across a broad spectrum of genotype 1 patients, including those with
compensated liver cirrhosis," said Scott Brun,
M.D., vice president, pharmaceutical development, AbbVie. "The high
rates of response and tolerability of our regimen, coupled with the low
rates of discontinuation are promising."
The
AbbVie investigational regimen consists of the fixed-dose combination
of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg),
dosed once daily, and ABT-333 (250mg) with or without ribavirin
(weight-based), dosed twice daily. The combination of three different
mechanisms of action interrupts the HCV replication process with the
goal of optimizing SVR rates across different patient populations. In
May of 2013, AbbVie's regimen with and without ribavirin for HCV GT1 was
designated as a Breakthrough Therapy by the U.S. Food and Drug
Administration (FDA). AbbVie is on track to begin major regulatory
submissions early in the second quarter of 2014. AbbVie will disclose
detailed study results at future scientific congresses and in
publications.
About Study M13-389 (PEARL-II)
PEARL-II
is a global, multi-center, randomized, open-label, controlled study to
evaluate the efficacy and safety of 12 weeks of treatment with AbbVie's
regimen with and without ribavirin in non-cirrhotic, GT1b HCV-infected,
treatment-experienced adult patients.
The study population consisted of 179 GT1b treatment-experienced patients with no evidence of liver cirrhosis: 91 patients randomized to the regimen without ribavirin for 12 weeks, and 88 patients randomized to the regimen with ribavirin for 12 weeks. In the ribavirin-free arm, 100 percent (n=91/91) of patients achieved SVR12, while 97 percent (n=85/88) achieved SVR12 in the ribavirin-containing arm.
The study population consisted of 179 GT1b treatment-experienced patients with no evidence of liver cirrhosis: 91 patients randomized to the regimen without ribavirin for 12 weeks, and 88 patients randomized to the regimen with ribavirin for 12 weeks. In the ribavirin-free arm, 100 percent (n=91/91) of patients achieved SVR12, while 97 percent (n=85/88) achieved SVR12 in the ribavirin-containing arm.
The
most commonly reported adverse events were fatigue and headache.
Discontinuations due to adverse events were reported in none of the
patients in the ribavirin-free arm and two (2 percent) patients in the
ribavirin-containing arm. There were no patients in either arm of the
study that experienced virologic relapse or breakthrough.
About Study M13-961 (PEARL-III)
PEARL-III
is a global, multi-center, randomized, double-blind, placebo-controlled
study to evaluate the efficacy and safety of 12 weeks of treatment with
AbbVie's regimen with and without ribavirin in non-cirrhotic, GT1b
HCV-infected, treatment-naive adult patients.
The study population consisted of 419 GT1b treatment-naive patients with no evidence of liver cirrhosis: 209 patients randomized to the regimen without ribavirin for 12 weeks, and 210 patients randomized to the regimen with ribavirin for 12 weeks. Following 12 weeks of treatment, 99 percent receiving the regimen without ribavirin (n=207/209) and 99 percent receiving the regimen with ribavirin (n=209/210) achieved SVR12.
The study population consisted of 419 GT1b treatment-naive patients with no evidence of liver cirrhosis: 209 patients randomized to the regimen without ribavirin for 12 weeks, and 210 patients randomized to the regimen with ribavirin for 12 weeks. Following 12 weeks of treatment, 99 percent receiving the regimen without ribavirin (n=207/209) and 99 percent receiving the regimen with ribavirin (n=209/210) achieved SVR12.
The
most commonly reported adverse events were headache and fatigue. No
patient discontinued study drug due to adverse events. Virologic relapse
or breakthrough was noted in none of the patients receiving the regimen
without ribavirin and 0.5 percent of patients receiving the regimen
with ribavirin.
About Study M14-002 (PEARL-IV)
PEARL-IV
is a global, multi-center, randomized, double-blind, placebo-controlled
study to evaluate the efficacy and safety of 12 weeks of treatment with
AbbVie's regimen with and without ribavirin in non-cirrhotic, GT1a
HCV-infected, treatment-naive adult patients.
The study population consisted of 305 GT1a treatment-naive patients with no evidence of liver cirrhosis: 205 patients randomized to the regimen without ribavirin for 12 weeks, and 100 patients randomized to the regimen with ribavirin for 12 weeks. Following 12 weeks of treatment, 90 percent of patients receiving the regimen without ribavirin (n=185/205) and 97 percent receiving the regimen with ribavirin (n=97/100) achieved SVR12.
The study population consisted of 305 GT1a treatment-naive patients with no evidence of liver cirrhosis: 205 patients randomized to the regimen without ribavirin for 12 weeks, and 100 patients randomized to the regimen with ribavirin for 12 weeks. Following 12 weeks of treatment, 90 percent of patients receiving the regimen without ribavirin (n=185/205) and 97 percent receiving the regimen with ribavirin (n=97/100) achieved SVR12.
The
most commonly reported adverse events were fatigue, headache and
nausea. Discontinuations due to adverse events were reported in two (1
percent) patients receiving the regimen without ribavirin and no
patients in the ribavirin-containing arm. Virologic relapse or
breakthrough was noted in 8 percent of patients receiving the regimen
without ribavirin and 2 percent of patients receiving the regimen with
ribavirin.
About Study M13-099 (TURQUOISE-II)
TURQUOISE-II
is the first phase III study completed exclusively in GT1 cirrhotic
patients investigating an all-oral, interferon-free regimen. It is a
global, multi-center, randomized, open-label study evaluating the
efficacy and safety of 12 or 24 weeks of treatment with AbbVie's regimen
with ribavirin in cirrhotic, GT1a and GT1b HCV-infected,
treatment-naive and treatment-experienced adult patients.
The study population consisted of 380 GT1a and GT1b, treatment-naive and treatment-experienced patients with compensated cirrhosis: 208 patients randomized to the regimen with ribavirin for 12 weeks, and 172 patients randomized to the regimen with ribavirin for 24 weeks. Following 12 weeks of treatment, 92 percent of patients (n=191/208) achieved SVR12. Following 24 weeks of treatment, 96 percent of patients (n=165/172) achieved SVR12.
The study population consisted of 380 GT1a and GT1b, treatment-naive and treatment-experienced patients with compensated cirrhosis: 208 patients randomized to the regimen with ribavirin for 12 weeks, and 172 patients randomized to the regimen with ribavirin for 24 weeks. Following 12 weeks of treatment, 92 percent of patients (n=191/208) achieved SVR12. Following 24 weeks of treatment, 96 percent of patients (n=165/172) achieved SVR12.
The
most commonly reported adverse events were fatigue, headache and
nausea. Discontinuations due to adverse events were reported in four (2
percent) patients receiving the regimen with ribavirin for 12 weeks and
four (2 percent) patients in the 24-week arm. Virologic relapse or
breakthrough was noted in 6 percent of patients in the 12-week arm and 2
percent in the 24-week arm.
Additional information about AbbVie's phase III studies can be found on www.clinicaltrials.gov.
Additional information about AbbVie's phase III studies can be found on www.clinicaltrials.gov.
Globally,
approximately 160 million people are chronically infected with
hepatitis C[1]. AbbVie's multinational HCV program is the largest
all-oral, interferon-free clinical program in GT1 patients being
conducted to date[2]. GT1 (with subtypes 1a and 1b) is the most
prevalent genotype worldwide.
AbbVie's HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without ribavirin with the goal of producing high SVR rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without ribavirin with the goal of producing high SVR rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.
ABT-450
was discovered during the ongoing collaboration between AbbVie and
Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and
regimens that include protease inhibitors. ABT-450 is being developed by
AbbVie for use in combination with AbbVie's other investigational
medicines for the treatment of HCV.
Safety Information for Ribavirin and Ritonavir
Ribavirin and ritonavir are not approved for the investigational use discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
Ribavirin and ritonavir are not approved for the investigational use discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
There are special safety considerations when prescribing these drugs in approved populations.
Ritonavir
must not be used with certain medications due to significant drug-drug
interactions and in patients with known hypersensitivity to ritonavir or
any of its excipients.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score ≥ 6.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score ≥ 6.
See approved product labels for more information.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some
statements in this news release may be forward-looking statements for
purposes of the Private Securities Litigation Reform Act of 1995. The
words "believe," "expect," "anticipate," "project" and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2012 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2012 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission.
AbbVie
undertakes no obligation to release publicly any revisions to
forward-looking statements as a result of subsequent events or
developments, except as required by law.
[1] Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15.
[1] Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15.
[2] Comparison based on review of data from www.clinicaltrials.gov for phase 3a programs of Gilead, BMS and BI as of November 15, 2013.
RELATED LINKS
http://www.abbvie.com
Thursday, January 30, 2014
Scientists Make New, Less Controversial Type of Stem Cell
Published on Jan 30, 2014
View all videos @ GeoBeats News
Related Article:
Stem cell breakthrough may be simple, fast, cheap
By Elizabeth Landau, CNN
Related Article:
Stem cell breakthrough may be simple, fast, cheap
By Elizabeth Landau, CNN
CNN) -- We run too hard, we fall down, we're sick -- all of this puts stress on the cells in our bodies. But in what's being called a breakthrough in regenerative medicine, researchers have found a way to make stem cells by purposely putting mature cells under stress.
Two new studies published Wednesday in the journal Nature describe a method of taking mature cells from mice and turning them into embryonic-like stem cells, which can be coaxed into becoming any other kind of cell possible. One method effectively boils down to this: Put the cells in an acidic environment.
"I think the process we've described mimics Mother Nature," said Dr. Charles Vacanti, director of the laboratory for Tissue Engineering and Regenerative Medicine at Brigham & Women's Hospital in Boston and senior author on one of the studies. "It's a natural process that cells normally respond to."
Both studies represent a new step in the thriving science of stem cell research, which seeks to develop therapies to repair bodily damage and cure disease by being able to insert cells that can grow into whatever tissues or organs are needed. If you take an organ that's functioning at 10% of normal and bring it up to 25% functionality, that could greatly reduce the likelihood of fatality in that particular disease, Vacanti said.........
Chronic hepatitis B patients with normal alanine transaminase and hepatic fibrosis
Chronic hepatitis B patients with normal alanine transaminase and hepatic fibrosis
(Full Text)
Chronic hepatitis B (CHB) may lead to cirrhosis, hepatocellular carcinoma and premature death. Elevated alanine transaminase (ALT) levels ≥ the upper limit of normal (ULN) are a major determinant for initiating anti-viral therapy.
However, ALT levels alone may not be predictive of hepatic fibrosis.
Dr Nguyen and colleagues from California determined the proportion of chronic hepatitis B patients with ALT ≤40 IU/L and liver fibrosis stage ≥2.
Secondary goals include subgroup analysis by hepatitis B e antigen (HBeAg) status, high hepatitis B virus (HBV) DNA levels, Asian ethnicity, lower ULN of ≤30 IU/L (males) and 19 IU/L (females), and advanced age.
The team identified studies in EMBASE and MEDLINE (1/1990–6/2012) using the search criteria “Hepatitis B”[Mesh] OR “Hepatitis B virus”[Mesh] OR “Hepatitis B, Chronic”[Mesh])) AND “Alanine Transaminase”[Mesh]) and abstracts containing the term ‘hepatitis’ from recent major U.S. gastroenterology and liver society meetings.
Among 9 studies, the team found that a significant proportion of chronic hepatitis B patients with ALT levels ≤40 IU/L had significant fibrosis irrespective of HBeAg status, high HBV DNA levels, ethnicity or age, although this proportion may be higher in patients older than 30–40 years old.
The research team observed that the corresponding proportion was 28% even when the newer ULN of 30 IU/L (males) and 19 IU/L (females) was applied.
Dr Nguyen's team concludes, "Approximately one fifth of chronic hepatitis B patients with ALT ≤40 IU/L may have significant hepatic fibrosis."
"The approach to such patients should be individualized, as further evaluation and treatment may be appropriate."
Aliment Pharmacol Ther 2014: 39(4): 349–358
30 January 2014
February's issue of the Alimentary Pharmacology & Therapeutics investigates the proportion of chronic hepatitis B patients with normal alanine transaminase ≤40 IU/L and significant hepatic fibrosis.
(Full Text)
Chronic hepatitis B (CHB) may lead to cirrhosis, hepatocellular carcinoma and premature death. Elevated alanine transaminase (ALT) levels ≥ the upper limit of normal (ULN) are a major determinant for initiating anti-viral therapy.
However, ALT levels alone may not be predictive of hepatic fibrosis.
Dr Nguyen and colleagues from California determined the proportion of chronic hepatitis B patients with ALT ≤40 IU/L and liver fibrosis stage ≥2.
Secondary goals include subgroup analysis by hepatitis B e antigen (HBeAg) status, high hepatitis B virus (HBV) DNA levels, Asian ethnicity, lower ULN of ≤30 IU/L (males) and 19 IU/L (females), and advanced age.
 |
| Approximately one fifth of patients with ALT ≤40 IU/L may have hepatic fibrosis |
| Alimentary Pharmacology & Therapeutics |
Among 9 studies, the team found that a significant proportion of chronic hepatitis B patients with ALT levels ≤40 IU/L had significant fibrosis irrespective of HBeAg status, high HBV DNA levels, ethnicity or age, although this proportion may be higher in patients older than 30–40 years old.
The research team observed that the corresponding proportion was 28% even when the newer ULN of 30 IU/L (males) and 19 IU/L (females) was applied.
Dr Nguyen's team concludes, "Approximately one fifth of chronic hepatitis B patients with ALT ≤40 IU/L may have significant hepatic fibrosis."
"The approach to such patients should be individualized, as further evaluation and treatment may be appropriate."
Aliment Pharmacol Ther 2014: 39(4): 349–358
30 January 2014
AHF to Ask States to Block Gilead’s $1,000 per Pill Hepatitis Drug From Medicaid Formularies
AHF to Ask States to Block Gilead’s $1,000 per Pill Hepatitis Drug From Medicaid Formularies
Gilead is not the original developer of Sovaldi, its new Hepatitis C medication that will cost $84,000 for a 12-week course of treatment; instead, it bought the drug developer, rival company Pharmasett, for $11 billion cash in 2011. Gilead now seeks a bonanza on a financial investment by gouging cash-strapped government programs, treating states like Gilead’s own private—rigged—stock market.
At $1,000 per pill, Sovaldi price is 1,100% more than Gilead’s AIDS drug combination Stribild ($80 per pill); pharmacy industry sources say Solvaldi’s price suggests a retail markup of 279,000% over production costs.
January 29, 2014 06:53 PM Eastern Standard Time
WASHINGTON--(BUSINESS WIRE)--In a series of letters to be sent to state Medicaid directors starting today, AIDS Healthcare Foundation (AHF) President Michael Weinstein will ask the state directors to block Gilead Sciences’ new $1,000-per-pill Hepatitis C drug Sovaldi (sofosbuvir) from inclusion on their respective state Medicaid and other drug formularies. The drug was approved by the F.D.A. on December 6, 2013 and Gilead immediately announced that it would price the drug at $84,000 for a twelve-week course of treatment—or $1,000 per tablet—making it one of the most expensive drugs ever marketed. Suggested treatment guidelines also require that Sovaldi be used with another drug, ribavirin (a nucleoside inhibitor), further adding to the cost of the prohibitively expensive course of treatment.
“With regard to Sovaldi, it’s time we stopped thinking of Gilead as a drug company and recognize them for what they are here: a pharmaceutical hedge fund bent on exploiting government-funded drug programs like Medicaid and ADAP at the expense of the American taxpayer.”
“When is enough, enough? At $1,000-per-pill, Sovaldi is priced 1,100% more than Gilead’s most expensive AIDS drug, Stribild, its four-in-one AIDS drug combination, which was priced at $80 per pill a year ago when it came to market,” said Michael Weinstein, President of AIDS Healthcare Foundation. “At that time, Stribild’s price was 35% more than Atripla, the company’s best selling combination HIV/AIDS treatment, and made Stribild the highest priced first-line combination AIDS therapy. Now, Gilead has set a new benchmark for unbridled greed with its outrageous price for Sovaldi—a price that some pharmacy industry sources suggest represents a retail markup of 279,000% over the cost of actually producing the drug.”
In his letter to state Medicaid directors, Weinstein wrote, “Gilead is charging a higher price for this drug even though the cost to produce it is small. According to industry reports, Gilead produces Sovaldi for approximately $1.00 per gram (with only 10 to 30 grams needed to successfully treat patients with Hepatitis C).1 This represents a retail markup of over 279,000%. (NOTE: With only 10 to 30 grams of Sovaldi needed for successful treatment, the difference from the $30 production cost for Gilead’s full course of treatment—30 grams x $1.00 per gram—to $84,000 for the 12-week treatment program represents a retail markup of 279,000%.)
Weinstein’s letter to state Medicaid directors also reminds them that, “Gilead did not pay to research and develop Sovaldi. In 2011, it purchased Pharmasset, the company that had already developed the drug, for $11 billion in cash. The pricing of Sovaldi is being driven by Gilead’s desire to recoup its investment in Pharmasset, and assumes it can accomplish this by charging Medicaid and other taxpayer-funded programs whatever it wants.”
“Gilead is now seeking a bonanza on a financial investment—not on its R&D costs of a drug—by gouging cash-strapped government programs, essentially treating states like its own private—rigged—stock market,” added Weinstein. “With regard to Sovaldi, it’s time we stopped thinking of Gilead as a drug company and recognize them for what they are here: a pharmaceutical hedge fund bent on exploiting government-funded drug programs like Medicaid and ADAP at the expense of the American taxpayer.”
AHF’s letter to State Medicaid Directors on Gilead’s Sovaldi:
Re: Formulary Status of Sovaldi and Forthcoming Hepatitis C Medications
AIDS Healthcare Foundation (AHF) is deeply concerned about the fiscal impact of new FDA approved Hepatitis C medications on your Medicaid program, and the effect of that impact on the health care of people in your state. The first of these new medications, Gilead Sciences’ Sovaldi, is exorbitantly priced at $1,000 per pill.
While the approval of Sovaldi and similar treatments is a welcomed advancement for people in need of better treatment for Hepatitis C, the unjustifiably high price manufacturers are seeking to charge for these medications will unnecessarily drive up health care costs and limit access to potentially lifesaving care. Therefore, AHF urgently requests that your Medicaid program deny Sovaldi and other new Hepatitis C medications from being added to your state formulary until these drugs are made affordable.
AHF believes that the price Gilead is charging for Sovaldi is not remotely justified. For one, it is exponentially more expensive than medications for other severe chronic conditions. For example, Gilead’s own Stribild, a costly new four-in-one combo treatment for HIV/AIDS, is $80 per pill. At $1,000 per pill, Sovaldi costs 1,100% more than Stribild, the most-expensive AIDS combo drug on the market.
In addition, Gilead is charging a higher price for this drug even though the cost to produce it is small. According to industry reports, Gilead produces Sovaldi for approximately $1.00 per gram (with only 10 to 30 grams needed to successfully treat patients with Hepatitis C).2 This represents a retail markup of over 279,000%.
Finally, Gilead did not pay to research and develop Sovaldi. In 2011, it purchased Pharmasset, the company that had already developed the drug, for $11 billion in cash. The pricing of Sovaldi is being driven by Gilead’s desire to recoup its investment in Pharmasset, and assumes it can accomplish this by charging Medicaid and other taxpayer-funded programs whatever it wants.
Private drug plans have taken notice of these facts—along with community outrage over the cost of Sovaldi—and have delayed paying for the drug until Gilead agrees to significantly lower the price. For example, Express Scripts, CVS Caremark, Catamaran Inc., and Aetna are all taking steps to block or delay the use of Sovaldi.3 Given this, AHF believes it is imprudent for your state to cover this medication until a better price is available.
Most critically, by taking action to ensure a better price your state will not be putting patient health at risk. There are alternative (and less expensive) treatments for Hepatitis C already available. In addition, Gilead’s patient assistance program provides the treatment for free to people making less than $100,000 a year who cannot access it elsewhere. These steps, while not ideal, will ensure patients continue to receive the care they need until newer medications are made affordable.
Once again, AHF urgently requests you to take action on this matter by denying Sovaldi and other unjustifiably high-priced Hepatitis C medications from your drug formulary until an affordable price is available.
About AIDS Healthcare Foundation
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 279,000 individuals in 32 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.
1 NPR,"$1,000 Pill For Hepatitis C Spurs Debate Over Drug Prices.” December 2013. http://www.npr.org/blogs/health/2013/12/30/256885858/-1-000-pill-for-hepatitis-c-spurs-debate-over-drug-prices
2 NPR,"$1,000 Pill For Hepatitis C Spurs Debate Over Drug Prices.” December 2013. http://www.npr.org/blogs/health/2013/12/30/256885858/-1-000-pill-for-hepatitis-c-spurs-debate-over-drug-prices
3 Bloomberg: At $84,000 Gilead Hepatitis C Drug Sets Off Payer Revolt http://www.bloomberg.com/news/2014-01-27/at-84-000-gilead-hepatitis-c-drug-sets-off-payer-revolt.html
Contacts
AIDS Healthcare Foundation
Los Angeles, CA, USA
Ged Kenslea
Communications Director
+1-323-791-5526 [mobile]
+1-323-308-1833 [work]
gedk@aidshealth.org
or
AIDS Healthcare Foundation
Washington, DC, USA
Tim Boyd
Director of Domestic Policy
+1-213-590-7375 [mobile]
timothy.boyd@aidshealth.org
Gilead is not the original developer of Sovaldi, its new Hepatitis C medication that will cost $84,000 for a 12-week course of treatment; instead, it bought the drug developer, rival company Pharmasett, for $11 billion cash in 2011. Gilead now seeks a bonanza on a financial investment by gouging cash-strapped government programs, treating states like Gilead’s own private—rigged—stock market.
At $1,000 per pill, Sovaldi price is 1,100% more than Gilead’s AIDS drug combination Stribild ($80 per pill); pharmacy industry sources say Solvaldi’s price suggests a retail markup of 279,000% over production costs.
January 29, 2014 06:53 PM Eastern Standard Time
WASHINGTON--(BUSINESS WIRE)--In a series of letters to be sent to state Medicaid directors starting today, AIDS Healthcare Foundation (AHF) President Michael Weinstein will ask the state directors to block Gilead Sciences’ new $1,000-per-pill Hepatitis C drug Sovaldi (sofosbuvir) from inclusion on their respective state Medicaid and other drug formularies. The drug was approved by the F.D.A. on December 6, 2013 and Gilead immediately announced that it would price the drug at $84,000 for a twelve-week course of treatment—or $1,000 per tablet—making it one of the most expensive drugs ever marketed. Suggested treatment guidelines also require that Sovaldi be used with another drug, ribavirin (a nucleoside inhibitor), further adding to the cost of the prohibitively expensive course of treatment.
“With regard to Sovaldi, it’s time we stopped thinking of Gilead as a drug company and recognize them for what they are here: a pharmaceutical hedge fund bent on exploiting government-funded drug programs like Medicaid and ADAP at the expense of the American taxpayer.”
“When is enough, enough? At $1,000-per-pill, Sovaldi is priced 1,100% more than Gilead’s most expensive AIDS drug, Stribild, its four-in-one AIDS drug combination, which was priced at $80 per pill a year ago when it came to market,” said Michael Weinstein, President of AIDS Healthcare Foundation. “At that time, Stribild’s price was 35% more than Atripla, the company’s best selling combination HIV/AIDS treatment, and made Stribild the highest priced first-line combination AIDS therapy. Now, Gilead has set a new benchmark for unbridled greed with its outrageous price for Sovaldi—a price that some pharmacy industry sources suggest represents a retail markup of 279,000% over the cost of actually producing the drug.”
In his letter to state Medicaid directors, Weinstein wrote, “Gilead is charging a higher price for this drug even though the cost to produce it is small. According to industry reports, Gilead produces Sovaldi for approximately $1.00 per gram (with only 10 to 30 grams needed to successfully treat patients with Hepatitis C).1 This represents a retail markup of over 279,000%. (NOTE: With only 10 to 30 grams of Sovaldi needed for successful treatment, the difference from the $30 production cost for Gilead’s full course of treatment—30 grams x $1.00 per gram—to $84,000 for the 12-week treatment program represents a retail markup of 279,000%.)
Weinstein’s letter to state Medicaid directors also reminds them that, “Gilead did not pay to research and develop Sovaldi. In 2011, it purchased Pharmasset, the company that had already developed the drug, for $11 billion in cash. The pricing of Sovaldi is being driven by Gilead’s desire to recoup its investment in Pharmasset, and assumes it can accomplish this by charging Medicaid and other taxpayer-funded programs whatever it wants.”
“Gilead is now seeking a bonanza on a financial investment—not on its R&D costs of a drug—by gouging cash-strapped government programs, essentially treating states like its own private—rigged—stock market,” added Weinstein. “With regard to Sovaldi, it’s time we stopped thinking of Gilead as a drug company and recognize them for what they are here: a pharmaceutical hedge fund bent on exploiting government-funded drug programs like Medicaid and ADAP at the expense of the American taxpayer.”
AHF’s letter to State Medicaid Directors on Gilead’s Sovaldi:
Re: Formulary Status of Sovaldi and Forthcoming Hepatitis C Medications
AIDS Healthcare Foundation (AHF) is deeply concerned about the fiscal impact of new FDA approved Hepatitis C medications on your Medicaid program, and the effect of that impact on the health care of people in your state. The first of these new medications, Gilead Sciences’ Sovaldi, is exorbitantly priced at $1,000 per pill.
While the approval of Sovaldi and similar treatments is a welcomed advancement for people in need of better treatment for Hepatitis C, the unjustifiably high price manufacturers are seeking to charge for these medications will unnecessarily drive up health care costs and limit access to potentially lifesaving care. Therefore, AHF urgently requests that your Medicaid program deny Sovaldi and other new Hepatitis C medications from being added to your state formulary until these drugs are made affordable.
AHF believes that the price Gilead is charging for Sovaldi is not remotely justified. For one, it is exponentially more expensive than medications for other severe chronic conditions. For example, Gilead’s own Stribild, a costly new four-in-one combo treatment for HIV/AIDS, is $80 per pill. At $1,000 per pill, Sovaldi costs 1,100% more than Stribild, the most-expensive AIDS combo drug on the market.
In addition, Gilead is charging a higher price for this drug even though the cost to produce it is small. According to industry reports, Gilead produces Sovaldi for approximately $1.00 per gram (with only 10 to 30 grams needed to successfully treat patients with Hepatitis C).2 This represents a retail markup of over 279,000%.
Finally, Gilead did not pay to research and develop Sovaldi. In 2011, it purchased Pharmasset, the company that had already developed the drug, for $11 billion in cash. The pricing of Sovaldi is being driven by Gilead’s desire to recoup its investment in Pharmasset, and assumes it can accomplish this by charging Medicaid and other taxpayer-funded programs whatever it wants.
Private drug plans have taken notice of these facts—along with community outrage over the cost of Sovaldi—and have delayed paying for the drug until Gilead agrees to significantly lower the price. For example, Express Scripts, CVS Caremark, Catamaran Inc., and Aetna are all taking steps to block or delay the use of Sovaldi.3 Given this, AHF believes it is imprudent for your state to cover this medication until a better price is available.
Most critically, by taking action to ensure a better price your state will not be putting patient health at risk. There are alternative (and less expensive) treatments for Hepatitis C already available. In addition, Gilead’s patient assistance program provides the treatment for free to people making less than $100,000 a year who cannot access it elsewhere. These steps, while not ideal, will ensure patients continue to receive the care they need until newer medications are made affordable.
Once again, AHF urgently requests you to take action on this matter by denying Sovaldi and other unjustifiably high-priced Hepatitis C medications from your drug formulary until an affordable price is available.
About AIDS Healthcare Foundation
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 279,000 individuals in 32 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.
1 NPR,"$1,000 Pill For Hepatitis C Spurs Debate Over Drug Prices.” December 2013. http://www.npr.org/blogs/health/2013/12/30/256885858/-1-000-pill-for-hepatitis-c-spurs-debate-over-drug-prices
2 NPR,"$1,000 Pill For Hepatitis C Spurs Debate Over Drug Prices.” December 2013. http://www.npr.org/blogs/health/2013/12/30/256885858/-1-000-pill-for-hepatitis-c-spurs-debate-over-drug-prices
3 Bloomberg: At $84,000 Gilead Hepatitis C Drug Sets Off Payer Revolt http://www.bloomberg.com/news/2014-01-27/at-84-000-gilead-hepatitis-c-drug-sets-off-payer-revolt.html
Contacts
AIDS Healthcare Foundation
Los Angeles, CA, USA
Ged Kenslea
Communications Director
+1-323-791-5526 [mobile]
+1-323-308-1833 [work]
gedk@aidshealth.org
or
AIDS Healthcare Foundation
Washington, DC, USA
Tim Boyd
Director of Domestic Policy
+1-213-590-7375 [mobile]
timothy.boyd@aidshealth.org
Wednesday, January 29, 2014
AASLD Launches new online guidance for the treatment of hepatitis C
Culture Shock: Web-Based Hep C Tx Guidelines
Published: Jan 30, 2014
The website was developed and will be run jointly by the American Association for the Study of Liver Diseases, the Infectious Diseases Society of America, and the International Antiviral Society-USA.
A panel of 26 experts will keep clinicians on top of HCV treatment options, spokesmen for the three societies told MedPage Today before the site went live.
He told MedPage Today that the site will contain information -- not only on approved uses, but also on specific off-label drug combinations that have not been through the FDA approval process.
That's because it's not realistic to get specific approval for all possible combinations in all possible patient types, Saag said. A major advantage of the new website, he said, is that the panel can look at all the evidence and "craft [regimens that] experts in the field would be using."
Indeed, the first iteration of the site suggests a combination of two new drugs -- simeprevir (Olysio) and sofosbuvir (Sovaldi) -- that is not specifically approved by the FDA, although both drugs are on the market, according to Donald Jensen, MD, of the University of Chicago Medical Center and a spokesman for the liver society.
Continue reading @ MedPage Today or access the complete report by clicking here.
AASLD/IDSA Launches up-to-date guidance for the treatment of hepatitis C
Online Expert Advice for Clinicians Treating Hepatitis C Now Available at HCVguidelines.org
Today, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), in collaboration with the International Antiviral Society- USA (IAS-USA), announced the launch of a new website, HCVguidelines.org, that will offer up- to-date guidance for the treatment of hepatitis C virus (HCV) infection.
It is estimated that between 3 and 4 million Americans are infected with HCV and have chronic liver disease as a result. The most recent generation of direct-acting antivirals has the potential to cure most patients with HCV. However, the rapid pace of drug development has left medical providers and insurance companies unsure what the optimal treatments are. The guidance provided through HCVguidelines.org will assist clinicians in using these and other treatments in the care of their patients. HCVguidelines.org is the result of an ongoing collaboration between the two medical professional societies and IAS-USA.
New sections will be added, and the recommendations will be updated on a regular basis as new information becomes available. An ongoing summary of "recent changes" will also be available for readers who want to be directed to updates and changes.
The Guidance was developed by a Panel of HCV experts in the fields of hepatology and infectious diseases, using an evidence-based review of information that is largely available to healthcare practitioners, access the complete report by clicking here.
Full Report Menu
Full Report
INTRODUCTION
METHODS
HCV TESTING AND LINKAGE TO CARE
COMING SOON: In Whom and When to Initiate Treatment
INITIAL TREATMENT OF HCV INFECTION IN PATIENTS STARTING TREATMENT
RETREATMENT OF PERSONS IN WHOM PRIOR THERAPY HAS FAILED
COMING SOON: Monitoring Patients Who Are On or Have Completed Therapy
UNIQUE PATIENT POPULATIONS
COMING SOON: Management of Acute HCV Infection
REFERENCES
WEBSITE POLICIES
Published: Jan 30, 2014The website was developed and will be run jointly by the American Association for the Study of Liver Diseases, the Infectious Diseases Society of America, and the International Antiviral Society-USA.
A panel of 26 experts will keep clinicians on top of HCV treatment options, spokesmen for the three societies told MedPage Today before the site went live.
He told MedPage Today that the site will contain information -- not only on approved uses, but also on specific off-label drug combinations that have not been through the FDA approval process.
That's because it's not realistic to get specific approval for all possible combinations in all possible patient types, Saag said. A major advantage of the new website, he said, is that the panel can look at all the evidence and "craft [regimens that] experts in the field would be using."
Indeed, the first iteration of the site suggests a combination of two new drugs -- simeprevir (Olysio) and sofosbuvir (Sovaldi) -- that is not specifically approved by the FDA, although both drugs are on the market, according to Donald Jensen, MD, of the University of Chicago Medical Center and a spokesman for the liver society.
Continue reading @ MedPage Today or access the complete report by clicking here.
AASLD/IDSA Launches up-to-date guidance for the treatment of hepatitis C
Online Expert Advice for Clinicians Treating Hepatitis C Now Available at HCVguidelines.org
Today, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), in collaboration with the International Antiviral Society- USA (IAS-USA), announced the launch of a new website, HCVguidelines.org, that will offer up- to-date guidance for the treatment of hepatitis C virus (HCV) infection.
It is estimated that between 3 and 4 million Americans are infected with HCV and have chronic liver disease as a result. The most recent generation of direct-acting antivirals has the potential to cure most patients with HCV. However, the rapid pace of drug development has left medical providers and insurance companies unsure what the optimal treatments are. The guidance provided through HCVguidelines.org will assist clinicians in using these and other treatments in the care of their patients. HCVguidelines.org is the result of an ongoing collaboration between the two medical professional societies and IAS-USA.
New sections will be added, and the recommendations will be updated on a regular basis as new information becomes available. An ongoing summary of "recent changes" will also be available for readers who want to be directed to updates and changes.
The Guidance was developed by a Panel of HCV experts in the fields of hepatology and infectious diseases, using an evidence-based review of information that is largely available to healthcare practitioners, access the complete report by clicking here.
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Full Report
INTRODUCTION
METHODS
HCV TESTING AND LINKAGE TO CARE
COMING SOON: In Whom and When to Initiate Treatment
INITIAL TREATMENT OF HCV INFECTION IN PATIENTS STARTING TREATMENT
RETREATMENT OF PERSONS IN WHOM PRIOR THERAPY HAS FAILED
COMING SOON: Monitoring Patients Who Are On or Have Completed Therapy
UNIQUE PATIENT POPULATIONS
COMING SOON: Management of Acute HCV Infection
REFERENCES
WEBSITE POLICIES
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