Thursday, June 4, 2015
NIH suspends operations in its Clinical Center Pharmaceutical Development Section
NIH suspends operations in its Clinical Center Pharmaceutical Development Section
The National Institutes of Health (NIH) Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) due to the discovery of serious manufacturing problems and lack of compliance with standard operating procedures. Upon receipt of a complaint, Food and Drug Administration (FDA) representatives inspected the PDS between May 19 and May 29, and found a series of deficiencies that will require the NIH Clinical Center to take a number of corrective actions.
The facility makes products for certain clinical research studies conducted in the hospital and collaborating facilities. In April, two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination. Vials made from the same batch were administered to six patients, although it is unknown whether those or other vials were contaminated. The six patients have been notified and are being followed closely for any signs of infection. At this time, none has developed signs of infection or illness.
“This is a distressing and unacceptable situation,” said NIH Director Francis S. Collins, M.D., Ph.D. “The fact that patients may have been put in harm’s way because of a failure to follow standard operating procedures in the NIH Clinical Center’s Pharmaceutical Development Section is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible.”
Among the problems the FDA identified in their inspection were deficiencies in the physical facility, including flaws in the air handling system, and operational failures including inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures. Deficiencies of lesser significance were identified in the Clinical Center Pharmacy. The FDA inspection reports are available here: http://www.cc.nih.gov/phar/pdfs/483.pdf (PDF - 1.31KB).
The following steps are being taken immediately to protect patients:
Operations of The Pharmaceutical Development Section have been suspended and no products will be made or distributed until all problems are fully understood and corrected. Materials produced by the Section are being systematically tested for contamination.
Of the participants in the 46 studies that are potentially affected, approximately 250 are currently scheduled to receive products manufactured by the PDS. NIH has notified the individual principal scientists responsible for each of those protocols, and is in the process of notifying the participants in these protocols. The vast majority of these patients are not immediately due for treatment and NIH is working to secure alternative sources for the products.
An external group of experts in microbiology and sterile manufacturing practices will be appointed to conduct a thorough review, including an assessment of all standard operating procedures, policies, staffing, and training, and make recommendations to the NIH director on the corrective actions required.
In addition to the immediate steps NIH is taking, it will provide an interim corrective action plan to the FDA by Friday, June 19, 2015.
“Our first responsibility is the safety and care of our patients,” said Dr. Collins. “NIH leadership is determined to identify and correct all of the deficiencies that have led to this situation.”
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Appalachia gripped by hepatitis C epidemic, bracing for HIV
Appalachia gripped by hepatitis C epidemic, bracing for HIV
ASSOCIATED PRESS
Two-hundred miles north, Scott County, Indiana, is grappling with one of the worst American HIV outbreaks among injection drug users in decades. Kentucky, with the nation's highest rate of acute hepatitis C, might be just a few dirty needles away from a similar catastrophe.
"One person could be Typhoid Mary of HIV," said Dr. Jennifer Havens, an epidemiologist at the University of Kentucky's Center on Drug and Alcohol Research, who has studied Perry County drug users for years as the hepatitis rate spiraled through small-town drug circles there. An explosion of hepatitis C, transmitted through injection drug use and unprotected sex, can foreshadow a wave of HIV cases.
Two-hundred miles north, Scott County, Indiana, is grappling with one of the worst American HIV outbreaks among injection drug users in decades. Kentucky, with the nation's highest rate of acute hepatitis C, might be just a few dirty needles away from a similar catastrophe.
"One person could be Typhoid Mary of HIV," said Dr. Jennifer Havens, an epidemiologist at the University of Kentucky's Center on Drug and Alcohol Research, who has studied Perry County drug users for years as the hepatitis rate spiraled through small-town drug circles there. An explosion of hepatitis C, transmitted through injection drug use and unprotected sex, can foreshadow a wave of HIV cases.
Tuesday, June 2, 2015
June Newsletters: The Current State of Hepatitis C Therapy, Pain associated with hepatitis C and More...
Welcome to this month's collection of newsletters, published by a small group of volunteers dedicated to spreading awareness and information to people living with viral hepatitis.
The Current State of Hepatitis C Therapy
In the premier issue of; Quarterly Supplement to GI & Hepatology News we are offered a look see at; The Current State of Hepatitis C Therapy, presented by Vandana Khungar, M.D., M.Sc. and K. Rajender Reddy, M.D.
Read an overview of HCV testing, natural history, management and new regimens used for treating both experienced and treatment naive HCV patients.
HCV Advocate has a collection of must read articles this month, including continuing EASL 2015 coverage by Alan Franciscus, Editor-in-Chief. In addition Lucinda K. Porter, RN writes about pain associated with hepatitis C in part 1 of her two-part series.
Check out this month's selection of blog updates and a few videos as well.
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.
June Issue:
EASL 2015: Part 2
Alan Franciscus, Editor-in-Chief
In part 2 of our European Association for the Study of the Liver (EASL) coverage I will wrap up with a brief overview of some of the remaining data including AbbVie’s 2D combo to treat genotype 1b, a study of advanced liver disease found in people who are newly diagnosed, Harvoni to treat genotype 4/5 and Merck’s new therapy to treat genotype 1, 4 or 6.
New Advocate Colors, and updated Guide to Preparing for Treatment
Alan Franciscus, Editor-in-Chief
New HCV Advocate Newsletter and Website colors—we have a new color scheme for our newsletter that is a preview of the colors for our new website. Our new Website will be launched on September first. We have also combined "Preparing for Treatment" part 1 and 2 into a Guide.
Alan Franciscus, Editor-in-Chief
New HCV Advocate Newsletter and Website colors—we have a new color scheme for our newsletter that is a preview of the colors for our new website. Our new Website will be launched on September first. We have also combined "Preparing for Treatment" part 1 and 2 into a Guide.
June Issue:
EASL 2015: Part 2Alan Franciscus, Editor-in-Chief
In part 2 of our European Association for the Study of the Liver (EASL) coverage I will wrap up with a brief overview of some of the remaining data including AbbVie’s 2D combo to treat genotype 1b, a study of advanced liver disease found in people who are newly diagnosed, Harvoni to treat genotype 4/5 and Merck’s new therapy to treat genotype 1, 4 or 6.
Read more...
HealthWise: Hepatitis C and Pain—Part 1
Lucinda K. Porter, RN
Part 1 of a two-part series Lucinda will discuss pain associated with hepatitis C, including curing hepatitis C, the pain associated with extrahepatic manifestations and the use of painkillers as well as the risks related to painkillers.
HealthWise: Hepatitis C and Pain—Part 1Lucinda K. Porter, RN
Part 1 of a two-part series Lucinda will discuss pain associated with hepatitis C, including curing hepatitis C, the pain associated with extrahepatic manifestations and the use of painkillers as well as the risks related to painkillers.
Read more...
Alan Franciscus, Editor-in-Chief
Read about prevalence and risk factors for patient-reported joint pain, DAA treatment guidance for HIV/HCV coinfected people, and HAV & HBV vaccine rates among young PWID.
Alan Franciscus, Editor-in-Chief
Read about prevalence and risk factors for patient-reported joint pain, DAA treatment guidance for HIV/HCV coinfected people, and HAV & HBV vaccine rates among young PWID.
Read more...
New Viral Hepatitis Numbers from the CDC
Alan Franciscus, Editor-in-Chief
The Centers for Disease Control and Prevention (CDC) released new estimates on the acute and chronic cases of hepatitis A, B and C. The good news is that the numbers for Hep A and B are leveling off. The bad news is that the numbers for Hep C are continuing to rise. Deaths from HCV and especially the age group that it is hitting is alarming and very sad.
New Viral Hepatitis Numbers from the CDC
Alan Franciscus, Editor-in-Chief
The Centers for Disease Control and Prevention (CDC) released new estimates on the acute and chronic cases of hepatitis A, B and C. The good news is that the numbers for Hep A and B are leveling off. The bad news is that the numbers for Hep C are continuing to rise. Deaths from HCV and especially the age group that it is hitting is alarming and very sad.
Read more...
Patient Assistance
Alan Franciscus, Editor-in-Chief
Are you having trouble with getting the medications? Try the patient assistance programs for information and assistance.
Patient Assistance
Alan Franciscus, Editor-in-Chief
Are you having trouble with getting the medications? Try the patient assistance programs for information and assistance.
HBV Journal Review
HCV Advocate Eblast
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HCV Advocate News & Pipeline Blog
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HCV Advocate Eblast
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HCV Advocate News & Pipeline Blog
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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.
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Good Vibrations
by Oriol R. Gutierrez Jr.
In this issue, find out about the eight major HCV risk factors and other HCV basics, such as how the virus is transmitted and how HCV can be prevented.
Hepatitis C Basics
by Lucinda K. Porter
Hepatitis C virus (HCV) causes an infectious yet curable disease that attacks the liver and results in numerous symptoms.
Hepatitis C Treatment
by Lucinda K. Porter
Treatment for hep C is easier than ever before. In clinical trials, roughly 95 percent of those who took the newest meds were cured.
Pushing His Luck
by Benjamin Ryan
How one man finally hit the jackpot of a hepatitis C-free life
Hep C Blogs
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My Hep C Travel Diary, Hepatitis C Advocate
Last Entry: Hep C Treatment: Minor Side Effects (2015-06-02 06:35:23)
A bit of insomnia. A bit of a loss of appetite, nothing significant but it is noticeable. No head aches or nausea.
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Grace Campbell
A pseudonym for a person living with hepatitis C on Viekira Pak + Ribavirin
Last Entry: Hepatitis C: undetected (2015-06-02 05:32:30)
The email with my results came through today and there it was. Not detected. Two words that mean more than you could imagine.
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Lucinda K. Porter, RN
Author, Hepatitis C Advocate, Health Educator
Last Entry: Extending Hepatitis Awareness Month (2015-05-31 05:54:45)
Today is the last day of Hepatitis Awareness Month. However, hepatitis C is still going to be here tomorrow when the awareness
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Welcome to the Hep Forums, a round-the-clock discussion area for people who have Hepatitis B, C or a co-infection, their friends and family and others with questions about hepatitis and liver health. Check in frequently to read what others have to say, post your comments, and hopefully learn more about how you can reach your own health goals.
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Liver Lowdown is the monthly general interest e-newsletter of the American Liver Foundation.
In accordance with the Foundation’s mission, the e-newsletter is disseminated to provide information about the prevention, treatment and cure of liver disease, as well as the organization’s research and advocacy endeavors.
Liver Lowdown content includes updates about the Foundation’s educational and signature programs; an in-depth focus on specific types of liver disease, and profiles of liver patients’ and caregivers’ personal experiences.
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PATIENT ADVOCATE
Navin Vij, a young doctor from Cleveland, only learned that he had hepatitis C four years ago. Fear was his first response to the news. Read how he turned that fear into action.
READ MORE
RESEARCH
A study being conducted on fish – yes fish— may lead to new treatments for liver cancer. Discover more about this groundbreaking research by Dr. Andrew Cox, an ALF grant recipient.
A study being conducted on fish – yes fish— may lead to new treatments for liver cancer. Discover more about this groundbreaking research by Dr. Andrew Cox, an ALF grant recipient.
HAPPENINGS
ALF supports physician education. Check out our recent CME collaboration with Duke University Medical Center and Medscape. Also, read up on our recent activities, including our attendance of the European Liver Conference and our advocacy efforts in Washington, D.C.
ALF supports physician education. Check out our recent CME collaboration with Duke University Medical Center and Medscape. Also, read up on our recent activities, including our attendance of the European Liver Conference and our advocacy efforts in Washington, D.C.
IN THE NEWS
If you are cured from Hepatitis C, when is it safe to drink alcohol? American Liver Foundation's experts weigh in on this topic and many others in recent news articles and media clips. Get educated.
If you are cured from Hepatitis C, when is it safe to drink alcohol? American Liver Foundation's experts weigh in on this topic and many others in recent news articles and media clips. Get educated.
RECIPE OF THE MONTH
Kale is the new green. This easy and healthful recipe hales from the Hollandhouse Bar & Refuge in Nashville, TN. Try it tonight.
Kale is the new green. This easy and healthful recipe hales from the Hollandhouse Bar & Refuge in Nashville, TN. Try it tonight.
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.
GI & Hepatology Newsletter
In This Issue
SOPAH study results are in for alcoholic hepatitis
HCV increases general cancer risk
FDA adds warnings to simeprevir label
Adding enhanced MR to CT might improve HCC diagnosis
NAFLD a stealth trigger of hepatocellular carcinoma
Begin here
Quarterly Supplement to GI & Hepatology News
NAFLD a stealth trigger of hepatocellular carcinoma
Begin here
Quarterly Supplement to GI & Hepatology News
The New Gastroenterologist features updates on hot clinical topics, perspectives on post-fellowship career pathways, primers on pertinent financial and insurance topics, inspiring stories from our GI colleagues, and other resources that will be useful to the young GI community.
Download 2015 Spring Issue Or View 2015 Spring Interactive Version
In This Issue
The Current State of Hepatitis C Therapy
Begin, here
Download 2015 Spring Issue Or View 2015 Spring Interactive Version
In This Issue
The Current State of Hepatitis C Therapy
Begin, here
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.
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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.
Living with Hepatitis C. Live Bold, Live Now! When Paul was in his early 30s, he often found himself feeling fatigued. Hep C, a virus not well known back in 2001, was silently attacking his body. Watch video
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Video - ASCO: Nivolumab for patients with advanced liver cancer
Anthony B. El-Khoueiry, MD
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Updates Around The Web
June Updates
Hep C drug tourism has begun as patients seek Harvoni, Sovaldi overseas..
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.
Begin here.....
Video
Oncology Report: ASCO Conference 2015An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.
Begin here.....
Video
From @PointofCare, Projects in Knowledge and MedPage Today
Video - ASCO: Nivolumab for patients with advanced liver cancer
Anthony B. El-Khoueiry, MD
AJM Hepatitis C Resource Center - Hepatitis C Blog Presents:
An interview with Dr. Lebovics breaking down the key data presented at EASL 2015.
Topics include;
Ledipasvir/Sofosbuvir
Continued use of ribavirin in DAA therapies? Is ribavirin really necessary?
Daclatasvir, Sofosbuvir, and Ribavirin Combination For HCV Patients With Advanced Cirrhosis or Posttransplant Recurrence
What challenges do you think daclatasvir will face should it be approved for use in the US given the current availability of approved DAAs such as ledipasvir/sofosbuvir?
and more...........
Click here to begin
New at Clinical Care Options
Audio - HCV Experienced Patients: Resistance testing, Cirrhosis and Genotype 3 Infection
Topics In This Webinar Include;
HCV therapy in the setting of renal impairment, resistance testing in DAA experienced patients, and the best approach to treat patients with cirrhosis or experienced patients who have genotype 3 infection.
Video Series - Hot HCV Topics
MedPage Today HCV HOT TOPICS - 10 Day Video Series
Ledipasvir/Sofosbuvir
Continued use of ribavirin in DAA therapies? Is ribavirin really necessary?
Daclatasvir, Sofosbuvir, and Ribavirin Combination For HCV Patients With Advanced Cirrhosis or Posttransplant Recurrence
What challenges do you think daclatasvir will face should it be approved for use in the US given the current availability of approved DAAs such as ledipasvir/sofosbuvir?
and more...........
Click here to begin
New at Clinical Care Options
Audio - HCV Experienced Patients: Resistance testing, Cirrhosis and Genotype 3 Infection
Topics In This Webinar Include;
HCV therapy in the setting of renal impairment, resistance testing in DAA experienced patients, and the best approach to treat patients with cirrhosis or experienced patients who have genotype 3 infection.
Video Series - Hot HCV Topics
MedPage Today HCV HOT TOPICS - 10 Day Video Series
Dates: May 18 - June 1, 2015
MedPage Today invited specialists from leading medical institutions to weigh in on the latest advancements in hepatitis C with one question each day for 10 days.
HCV Next
SVR durability using new interferon-free DAAs in comparison to SVR with interferon-based regimens
MedPage Today invited specialists from leading medical institutions to weigh in on the latest advancements in hepatitis C with one question each day for 10 days.
HCV Next
SVR durability using new interferon-free DAAs in comparison to SVR with interferon-based regimens
In this month's issue of HCV Next, Michael S. Saag, MD., writes about SVR durability using new all-oral, interferon-free DAAs in comparison to SVR with interferon-based regimens, noting some experts suggest there may be a difference.
Here is the editorial;The Unintended Consequences of Conservatism
Click here to begin...
Here is the editorial;The Unintended Consequences of Conservatism
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Healthy You
ACP Internist provides news and information for internists about the practice of medicine and reports on the policies, products and activities of ACP
Current Issue - June Issue
Changing thinking on chronic fatigue
By Charlotte Huff
A recent report might shed some diagnostic insight on the profound fatigue, unrefreshing sleep, and other nagging symptoms that could indicate myalgic encephalomyelitis/chronic fatigue syndrome.
FDA UPDATE
Warnings on using hep C drugs with amiodaroneBy Stacey Butterfield
This update covers combining amiodarone, sofosbuvir, and another direct-acting antiviral for hepatitis C, as well as the approval of a non-invasive test to aid in the diagnosis of gastroparesis.
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Your Health is a FREE e-newsletter from Johns Hopkins.
Your Health This Month:
Getting a Better Night’s Sleep
What You Need to Know About Sleep
Don’t underestimate the value of a good night’s sleep. Missing high-quality sleep increases your risk for depression, obesity, type 2 diabetes, high blood pressure and a myriad of other health issues.
Learn the keys to a better night’s sleep.
Facebook Chat: Answers from a Johns Hopkins Expert
Dr. Susheel Patil of the Johns Hopkins Sleep Disorders Center answered user-submitted sleep-related questions on the Johns Hopkins Medicine Facebook page on May 12.
View the question-and-answer session here.
Are You at Risk for Gallstones?
An estimated 25 million American adults have gallstones, and nearly 1 million new cases are diagnosed each year. Are you at risk? Here's a look at the symptoms of gallstones, how they're diagnosed and treated, and the role of diet in their development -- plus 6 steps you can take to help prevent them.
CONTINUE READING
Before, During, and After Hepatitis C
Pacific Hepatitis C Network (PHCN)
The Pacific Hepatitis C Network’s mission is to strengthen the capacity of individuals and organizations throughout British Columbia to prevent HCV infections and improve the health and treatment outcomes of people with HCV.
One of its projects is the Hepatitis C Treatment Information Project your web-based hepatitis C treatment information toolkit for entering into that world and building your understanding about hep C treatment.
This resource contains information and resources about hepatitis C treatment, including:
information about currently approved treatments in BC information about new and emerging drugs and drug combinations for treating hep C information about the drug approval process in Canada and BC resources to help in getting ready for treatment, including stories from people who have been treated.
Share Your Story
Your Health is a FREE e-newsletter from Johns Hopkins.
Your Health This Month:
Getting a Better Night’s Sleep
What You Need to Know About Sleep
Don’t underestimate the value of a good night’s sleep. Missing high-quality sleep increases your risk for depression, obesity, type 2 diabetes, high blood pressure and a myriad of other health issues.
Learn the keys to a better night’s sleep.
Facebook Chat: Answers from a Johns Hopkins Expert
Dr. Susheel Patil of the Johns Hopkins Sleep Disorders Center answered user-submitted sleep-related questions on the Johns Hopkins Medicine Facebook page on May 12.
View the question-and-answer session here.
Sign up for your free newsletter, here....
Weekly Podcast
Are You at Risk for Gallstones?
An estimated 25 million American adults have gallstones, and nearly 1 million new cases are diagnosed each year. Are you at risk? Here's a look at the symptoms of gallstones, how they're diagnosed and treated, and the role of diet in their development -- plus 6 steps you can take to help prevent them.
CONTINUE READING
Of Interest
Before, During, and After Hepatitis C
Inspiring video series : Hepatitis C Personal Stories
The Pacific Hepatitis C Network’s mission is to strengthen the capacity of individuals and organizations throughout British Columbia to prevent HCV infections and improve the health and treatment outcomes of people with HCV.
One of its projects is the Hepatitis C Treatment Information Project your web-based hepatitis C treatment information toolkit for entering into that world and building your understanding about hep C treatment.
This resource contains information and resources about hepatitis C treatment, including:
information about currently approved treatments in BC information about new and emerging drugs and drug combinations for treating hep C information about the drug approval process in Canada and BC resources to help in getting ready for treatment, including stories from people who have been treated.
Share Your Story
The number of treatment stories has been growing during the past 5 years as thousands of people have participated in clinical trials for hepatitis C Direct Acting Antivirals (DAAs). As data from these clinical trials continues to emerge, so do the personal treatment stories and experiences of people who have been treated with these new drugs.
PHCN is asking people who have been through these new treatments and who want to share their treatment stories and experiences to do so here.
You have forged the path and now we’re asking anyone who is interested to come back and tell others what the landmarks are – emotions, side effects, support, diet – whatever it was for you. Whatever your treatment stories with new hep C drugs are, if you would like to share it, we would love to hear it and share it on this website.
We can help with spelling and grammar after you submit your piece so, even if they are not your strengths, WRITE US YOUR STORY!!
PHCN is asking people who have been through these new treatments and who want to share their treatment stories and experiences to do so here.
You have forged the path and now we’re asking anyone who is interested to come back and tell others what the landmarks are – emotions, side effects, support, diet – whatever it was for you. Whatever your treatment stories with new hep C drugs are, if you would like to share it, we would love to hear it and share it on this website.
We can help with spelling and grammar after you submit your piece so, even if they are not your strengths, WRITE US YOUR STORY!!
Hep C treatment stories from the edge can be written and submitted here.
Contact us with any questions.
Contact us with any questions.
Until next time.
Tina
Hepatitis C/Interview with Dr. Lebovics; What challenges do you think daclatasvir will face should it be approved for use in the US......
An interview with Dr. Lebovics breaking down the key data presented at EASL 2015.
Topics include;
Ledipasvir/Sofosbuvir
Continued use of ribavirin in DAA therapies? Is ribavirin really necessary?
Daclatasvir, Sofosbuvir, and Ribavirin Combination For HCV Patients With Advanced Cirrhosis or Posttransplant Recurrence
What challenges do you think daclatasvir will face should it be approved for use in the US given the current availability of approved DAAs such as ledipasvir/sofosbuvir?
and more...........
Click here to begin
This blog is supported by Elsevier Multimedia Publishing and the American Journal of Medicine (AJM), and serves as a companion to their comprehensive, online, global educational initiative, the AJM Hepatitis C Resource Center (hepcresource.amjmed.com).
Recent posts
- Dr. E Lebovics: Post-EASL 2015 HCV Interview
- Beneficial Effect of Statins on HCV Infection
- Barriers to Accessing HCV Therapies in the US
- EASL 2015 Hepatitis Research: Dr A. Ploss
- Pooled safety data: ledipasvir/sofosbuvir: HCV-1
- Largest DAA study to date in HCV genotype 4
- Special Interview on HCV: Dr. S. Wiktor of WHO
- New list: free peer-reviewed HCV articles: May 8
- Newly Updated EASL 2015 HCV Guidelines
Hepatitis Cruise, India Trips - Patients Get Extreme to Obtain Hepatitis Drug
Hepatitis Cruise, India Trips
Patients Get Extreme to Obtain Hepatitis Drug That's 1% the Cost Outside U.S.
by Shannon Pettypiece
Ketaki Gokhale
His plan: Dock a cruise ship flying an Indian flag off the coast of Miami. Stock the ship with versions of Sovaldi sold in India for $83,000 less than the U.S. retail price for 12 weeks of treatment. Ferry U.S. patients to the boat and send them home with the potentially life-saving medicines at a huge discount.
The only wrinkle in his plan wasn’t the absurdity of a pharmacy benefit manager manning and operating a cruise ship full of drugs from India. The problem, after doing some quick research into the idea, was that it would probably violate U.S. drug re-importation laws that limit the value of drugs brought into the country to $1,500 -- the price of one and a half Sovaldi tablets in the U.S., said Steve Miller, chief medical officer at Express Scripts, who came up with the idea.
Patients Get Extreme to Obtain Hepatitis Drug That's 1% the Cost Outside U.S.
by Shannon Pettypiece
Ketaki Gokhale
His plan: Dock a cruise ship flying an Indian flag off the coast of Miami. Stock the ship with versions of Sovaldi sold in India for $83,000 less than the U.S. retail price for 12 weeks of treatment. Ferry U.S. patients to the boat and send them home with the potentially life-saving medicines at a huge discount.
The only wrinkle in his plan wasn’t the absurdity of a pharmacy benefit manager manning and operating a cruise ship full of drugs from India. The problem, after doing some quick research into the idea, was that it would probably violate U.S. drug re-importation laws that limit the value of drugs brought into the country to $1,500 -- the price of one and a half Sovaldi tablets in the U.S., said Steve Miller, chief medical officer at Express Scripts, who came up with the idea.
Continue reading...
Hep C drug tourism has begun as patients seek Harvoni, Sovaldi overseas
Tracy Staton
So, companies that set up medical-related trips abroad--which often means plastic surgery or joint replacements these days--are starting to put together channels for hepatitis C treatment. Doctors who'll prescribe to foreign patients, for instance. One Indian company that specializes in sourcing hard-to-find drugs has been getting dozens of calls every day since the first generics rolled out there
Hep C drug tourism has begun as patients seek Harvoni, Sovaldi overseas
Tracy Staton
Now, say hello to hep C tourism. As Jonathan Edelheit, CEO of the Florida-based Medical Tourism Association, toldBloomberg, "I know people who have hepatitis C and the only thing they can think about is getting this drug. There is definitely a high interest in going abroad."
So, companies that set up medical-related trips abroad--which often means plastic surgery or joint replacements these days--are starting to put together channels for hepatitis C treatment. Doctors who'll prescribe to foreign patients, for instance. One Indian company that specializes in sourcing hard-to-find drugs has been getting dozens of calls every day since the first generics rolled out there
June Updates
Reducing the cost of new hepatitis C drugs
Daclatasvir, Harvoni (ledipasvir/sofosbuvir)/Sovaldi/Viekira Pak.
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.
FDA Addresses Concerns on Approval of Drugs to Treat Chronic Hepatitis C
FDA Addresses Concerns on Approval of Drugs to Treat Chronic Hepatitis C
Treatment options for chronic hepatitis C, a serious and life-threatening infection, have improved substantially and several new regimens with shorter durations and improved efficacy and safety profiles are now available.
Groups have raised concerns about the evidence used to support the approval of some newer drugs, however, and the issue has been used to cast doubt on their efficacy and even to question treatment or deny reimbursement.
To address these concerns, the US Food and Drug Administration’s Division of Antiviral Products in the Center for Drug Evaluation and Research (CDER) has published a paper that highlights the agency’s scientific approaches and regulatory processes that support the development and approval of promising drugs to treat hepatitis C.
“FDA’s approach to evaluation of recent hepatitis C drugs underscores the Agency’s flexibility in considering innovative or alternative trial designs for drugs that have demonstrated highly promising outcomes in early phase development,” said Dr. Poonam Mishra, deputy director for Safety, Division of Antiviral Products/Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research and lead author of the Hepatology paper. “Expedited approaches can be used without compromising efficacy standards for drugs that demonstrate breakthrough therapy potential.”
DOI: 10.1002/hep.27880
Treatment options for chronic hepatitis C, a serious and life-threatening infection, have improved substantially and several new regimens with shorter durations and improved efficacy and safety profiles are now available.
Groups have raised concerns about the evidence used to support the approval of some newer drugs, however, and the issue has been used to cast doubt on their efficacy and even to question treatment or deny reimbursement.
To address these concerns, the US Food and Drug Administration’s Division of Antiviral Products in the Center for Drug Evaluation and Research (CDER) has published a paper that highlights the agency’s scientific approaches and regulatory processes that support the development and approval of promising drugs to treat hepatitis C.
“FDA’s approach to evaluation of recent hepatitis C drugs underscores the Agency’s flexibility in considering innovative or alternative trial designs for drugs that have demonstrated highly promising outcomes in early phase development,” said Dr. Poonam Mishra, deputy director for Safety, Division of Antiviral Products/Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research and lead author of the Hepatology paper. “Expedited approaches can be used without compromising efficacy standards for drugs that demonstrate breakthrough therapy potential.”
DOI: 10.1002/hep.27880
Monday, June 1, 2015
What are the co-factors that increase severity of HCV disease and how should they be managed?
MedPage Today invited specialists from leading medical institutions to weigh in on the latest advancements in hepatitis C with one question each day for 10 days. In this installment, we asked: "What are the co-factors that increase severity of HCV disease and how should they be managed?"
Watch Video Here
Our participants are:
Watch Video Here
Our participants are:
Andrew H. Talal, MD, professor of medicine, University at Buffalo
Andrew J. Muir, MD, associate professor of medicine, Duke University
Gregory T. Everson, MD, professor of medicine, University of Colorado
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