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It's official! FDA press release just now!
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm
FDA News Release
FDA approves first combination pill to treat hepatitis C
For Immediate Release
October 10, 2014
Release
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.
“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”
Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.
Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.
Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.
In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.
The most common side effects reported in clinical trial participants were fatigue and headache.
Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###
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Page Last Updated: 10/10/2014
FDA News Release
FDA approves first combination pill to treat hepatitis C
For Immediate Release
October 10, 2014
Release
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.
“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”
Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.
Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.
Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.
In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.
The most common side effects reported in clinical trial participants were fatigue and headache.
Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###
Inquiries
Media
Stephanie Yao
301-796-0394
Consumers
888-INFO-FDA
Share
Share on facebook Share on twitter Share on email
0
FDA News Release feed
View FDA Voice blog
Related Information
FDA: Approved Drugs: Questions and Answers
FDA: Drug Innovation
FDA: What’s New at FDA in Hepatitis
CDC: Hepatitis C Information for the Public
Page Last Updated: 10/10/2014
Thank you Lynn. I haven't seen the gastroenterologist at a transplant facility as of yet. Closes, is out of state. I have been referred by a gastroenterologist that doesn't have transplant facility. December is my appt.
I have had to retire , collect SSDI and scramble for insurance. Couldn't travel well . Hanging by a thread . I am sure every has had too. I have regained some strength, with diet and supplements. Also doctors meds for ascites,portal hypertion, all the good stuff that comes with this.
Thanks again, just wasn't sure if I could qualify for newest treatments.
Nena
I have had to retire , collect SSDI and scramble for insurance. Couldn't travel well . Hanging by a thread . I am sure every has had too. I have regained some strength, with diet and supplements. Also doctors meds for ascites,portal hypertion, all the good stuff that comes with this.
Thanks again, just wasn't sure if I could qualify for newest treatments.
Nena
Hi Nenan
From the prescribing information sheet
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf
8.7 Hepatic Impairment
No dosage adjustment of HARVONI is required for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C). Safety and efficacy of HARVONI have not been established in patients with decompensated cirrhosis [see Clinical Pharmacology (12.3)].
And from the FDA press release last Friday
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Talk to your doctor to see if they feel Harvoni is the right choice for you. I assume you are under the care of a gastroenterologist associated with a liver transplant center. If you are not, you need to get a referral to a liver transplant center ASAP
Best of luck to you
Lynn
From the prescribing information sheet
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf
8.7 Hepatic Impairment
No dosage adjustment of HARVONI is required for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C). Safety and efficacy of HARVONI have not been established in patients with decompensated cirrhosis [see Clinical Pharmacology (12.3)].
And from the FDA press release last Friday
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Talk to your doctor to see if they feel Harvoni is the right choice for you. I assume you are under the care of a gastroenterologist associated with a liver transplant center. If you are not, you need to get a referral to a liver transplant center ASAP
Best of luck to you
Lynn
New Magic drug's name is : HARVONI
tx is easier, name is easier.
In worst group, there is %94 SVR Chance.
From daily interferon in early 90's to one daily pill .
From 10% SVR Chance to at least 94% SVR Chance.
Thank you science!
tx is easier, name is easier.
In worst group, there is %94 SVR Chance.
From daily interferon in early 90's to one daily pill .
From 10% SVR Chance to at least 94% SVR Chance.
Thank you science!
Exciting news that makes the post treatment waiting game less stressful! Here's hoping and praying the insurance companies get on board!
HeoCandme- I love it! I will think of it as Spaghettios from now on!
HeoCandme- I love it! I will think of it as Spaghettios from now on!
Called my VA pharmacist today. She told me that the VA is working with Gilead for pricing for us veterans. There are 20 of us on her list. As was said, hopefully we can get a contract with them. Ihope that if they do approve the lower price, it won't be just for us who are nearing 'end-stage' of this horrible disease.
Thought this blog entry provides some good information:
http://blogs.hepmag.com/lucindakporter/2014/10/harvoni_what_you_nee.html
Hopefully, this new drug will be our Plan B but we will need to wait a little longer to find out as the doctor is waiting for some more information on how trial transplant patients did with this new drug, Harvoni.
After taking Sovaldi and Ribavirin for 24 weeks and then relapsing, I think it will be a lot more nerve-wracking this time around. But he is prepared to do whatever it takes to finally get rid of this insidious virus.
Best of luck to all who will be starting this new treatment in the near future.
To those who are still waiting, hang in there, your day will come, too.
Nan
http://blogs.hepmag.com/lucindakporter/2014/10/harvoni_what_you_nee.html
Hopefully, this new drug will be our Plan B but we will need to wait a little longer to find out as the doctor is waiting for some more information on how trial transplant patients did with this new drug, Harvoni.
After taking Sovaldi and Ribavirin for 24 weeks and then relapsing, I think it will be a lot more nerve-wracking this time around. But he is prepared to do whatever it takes to finally get rid of this insidious virus.
Best of luck to all who will be starting this new treatment in the near future.
To those who are still waiting, hang in there, your day will come, too.
Nan
Hey Lynn. Good luck to you on this one. My prayers and a boatload of hope for YOU and everyone this go round....I'm relieved as hell cause if this doesn't work then onto plan B for me as well.....Never loose your Fighting spirit. Love to all
Peace
Deb
Peace
Deb
Well hopefully we can get this into the hands of those of us who need this without too much BS. Hopefully insurance companies can work with Gilead to arrive at a reasonable cost. If Gilead can work with third world country's they should be able to work with Americans.
Good luck to you as well
As for me moving forward to plan "B" as plan "A" did not work
As for me moving forward to plan "B" as plan "A" did not work
More news
http://www.thestreet.com/story/12910212/1/gilead-sciences-wins-fda-approval-for-new-harvoni-hepatitis-c-pill.html
Excerpt:
Investors expects Harvoni to be priced at around $95,000 for 12 weeks of treatment, suggesting $63,000 for eight weeks.
http://www.thestreet.com/story/12910212/1/gilead-sciences-wins-fda-approval-for-new-harvoni-hepatitis-c-pill.html
Excerpt:
Investors expects Harvoni to be priced at around $95,000 for 12 weeks of treatment, suggesting $63,000 for eight weeks.
My backup plan is the O/S does not work. Still Undet. Hoping for the best, but looking to the future.
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