Just read this which is interesting. Although most will need to be onn a 12 week program, some even longer; there is an exception that will allow you to be on an 8 week program:
HARVONI for eight weeks can be considered in treatment-naive patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL.
I just did bloodwork so I'll be curios to see. Although my labs for liver functions are always normal, I tend to have a very high Viral load.
shadow10cats said
Oct 10, 2014
I just really hope this "Harvoni" is all they've touted it to be. That the side effects are as minimal as they have reported. I've tried treatment twice. First with the old peglated interferon and ribavirin - then years later with the Telaprevir, Ribavirn & interferon. Both were horrendous & I ended up stopping under a month!
I have been waiting and waiting since for something like this. And I promised myself this is it. 2014 or bust. If I can clear up the brain fog and get my energy back I will be so grateful.
Will post anything I find regarding ins coverage or financial help. Please do the same
Have a great weekend!!
ps: I thought Harvoni sounded like that scooter they created to get around the city on. Goofy name for a $95+ drug!
Dzdayscomin said
Oct 10, 2014
Good luck to all of you to get this med, and hoping it works for you.
Many have tried other tx's and have been waiting for this day to get on your road to freedom, happy trails to you !
Duane
Isiscat2011 said
Oct 10, 2014
Thanks, Gator Man. I feel like I have been preparing for trial for the past 6 months. Now it is showtime! Don't know what the verdict will be but ready to kick some dragon butt.
Gator Man said
Oct 10, 2014
Gals and Guys,
I truly hope Harvoni ends up being the "silver bullet" for those waiting to be treated for the first time, but especially for those who have relapsed with prior therapies. Good luck to everyone! May tx be in your immediate future and the dragon slayed in the next few months!
patiently_waiting said
Oct 10, 2014
Actually I think the Harvoni is what they used to use to smooth over ice rinks, before they came up with the Zamboni. ;) Whatever the name it's great news and another step toward marginalizing HCV.
Matt Chris said
Oct 10, 2014
Yea , exciting day.
Has anyone seen the new FDA NDC (National drug Code) for Harvoni?
matt
pl1952 said
Oct 10, 2014
Beyond excited! Hey Matt, the name reminded me of food (as usual lol): Harvoni Macaroni! I've got to wait a bit longer till December to see my doctor, but I can't wait to see the developments..
Ro said
Oct 10, 2014
This is such wonderful LONG awaited news!!! Hoping we all get approved and cured!
Matt Chris said
Oct 10, 2014
YAAAHHHOOO!!!
I was eating lunch and checked the the FDA and they had 2 new approvals but not Gilead's then waited 15 minutes and check again and there is was, 1 pill daily Hep-C drug. Appoved.
The name sounds like a strange italian accordian type of instrument. LOL
Now the fun comes with the Insurance companies
matt
skewedButNotBroken said
Oct 10, 2014
Now it's time to circle the wagons and get ready to battle the insurance companies!!!!!!!!!!!!!!!
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 FDAs 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.
Harvonis 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 participants 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 Harvonis 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 FDAs 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 nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
-- Edited by Mugsy on Friday 10th of October 2014 07:09:52 PM
Isiscat2011 said
Oct 10, 2014
Hi Bills:
The name Harvoni is what S/L is being called in Europe. The US could have a different name, although it is likely Gilead selected the name Harvoni because it also passed US regulations, so it will be the same here.
Your insurance situation is the type the patient assistance programs were designed to help with. You will be approved because you have advanced liver disease. The issue will be your co-pay. Gilead's Support Path Program will pay up to 20% for 12 weeks. This assumes your household income is <100K. Another payment assistance program may pick up the rest if that doesn't cover it. This information is subject to change of course.
If I was you I would try to get a sooner doctor's appointment unless your doc is already working on the pre-authorization. The drugs should be available immediately and the wait time will be for arranging payment.
Your doc and the pharmacy will help with the insurance issues.
Here is a link to the Support Path Program: http://www.mysupportpath.com/
BTW, pursuant to the Affordable Care Act, insurance policies can no longer have separate deductibles for medical and pharmacy. The Rx co-pay should, therefore, be applied to your deductible.
shadow10cats said
Oct 10, 2014
Gilead Sciences Wins FDA Approval for New Harvoni Hepatitis C Pill
Now we see which Ins get on board.
And how long that takes........
Come on Cdphp!!!
Bills said
Oct 10, 2014
Hello and Happy Oct 10th.
I knew we'd all be here today
I seeing there is this laps in this Oct 10th date and actual prescriptions being given. My Doc saw me mid Sept and made my next appt. for Nov 19th He said they didn't name it and there will be a awaiting time My relapse was in Feb 2013 I've been counting days. I'm trying to understand why over 2 months to get a script. I just called like I was talking to a consumer relations complaint line. WHy ?WHy! When? I need to know when LOL.
Well I see they got the name here Harvoni. That's easier to say then everything else we been taking. I saw a good point I should think about maybe waiting just a little longer will get some of the bugs out on the insurance side I'd hate to get a bad deal being impatient.
I am concerned about my insurance I know it has a limit on low copay and goes down to cover 80% in a very short time so using $100K 80% leaves me with $20K copay? I don't know anything about coupons yet which could help but how do they qualify that? Hopefully all you nice people and wanna be dragon slayers will calm me down as usual. I wish all of US the best is getting on the TX a quick RVR and Sweet SVR
BS
Tig said
Oct 10, 2014
Hi BJ,
Harvoni it is. The latest and greatest HCV silver bullet from Gilead. We're all waiting for today's release information. The approval of S/O is dependent on ongoing trials. The releases I've read to date indicate the release price of Harvoni should be set at $96,000 for a 12 week course of Tx. Of course that remains to be seen, because I've seen comments to the contrary. I don't think Gilead will be too greedy considering the backlash they received over Sovaldi alone. But again, we're talking about.....Gilead Hopefully we'll know more today.
Our member Isiscat should be able to add significantly to this discussion. She has been following the FDA reports on this closely.
Tig
shadow10cats said
Oct 10, 2014
Two things have brought me back to this forum today:
1. FDA RESPONSE TO GILEAD'S APPLICATION FOR THE 1-DRUG REGIME:
I have been scouring the web to see if there's any news on the FDA's response to Gilead's drug application for the one-drug pill. So far nothing. On their website they only show approvals up thru the 8th as of today. I'm sure it will be NEWS once they say & they have to respond by today is my understanding. By respond, I mean state their decision to approve or deny. Of course then we still have insurance coverages to wait for. My insurance company, CDPHP of New York, State Employees, has not responded to any of my emails regarding the drug &/or its approval. My liver Dr thinks that they may start with approving only those with the most dire circumstances; side effects, health issues, etc. When I saw him earlier this week he wanted details on how the drug has affected my life & ability to work & daily things. there's the possibility it may be available only to a select few at first. Maybe until the insurance companies see for themselves that it actually works as claimed. They got screwed with Telaprevir and some of the other "miracle -cures" that many started and had to drop out of because the side effects were way worse than expected. So now all those people have to re-treat so insurance companies have to pay out again. I get it. Personally I don't know how they stay in business with the costs of some of these drugs!
2. WHAT THE HECK IS YOUR NAME?:
Just what exactly is the correct name of this "one-pill" that many of us & Gilead is waiting for today? I hear Solvaldi / Ledipasvir / Sofobuvir / and in a Forbes article today they referred to another? Gilead drug called Harvoni??
I have made up my mind that before this year is over I will be on a regime that I can stick with and finish and clear this monster off my back once and for all. If it's not Gilead's one-pill then maybe the cross-over combo of Sovaldi & Olysio which seems to be doing well; although I don't know if my insurance would cover it. It think the FDA approved these 2 being used together tho??? (Question #3)
Just read this which is interesting. Although most will need to be onn a 12 week program, some even longer; there is an exception that will allow you to be on an 8 week program:
HARVONI for eight weeks can be considered in treatment-naive patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL.
I just did bloodwork so I'll be curios to see. Although my labs for liver functions are always normal, I tend to have a very high Viral load.
I just really hope this "Harvoni" is all they've touted it to be. That the side effects are as minimal as they have reported. I've tried treatment twice. First with the old peglated interferon and ribavirin - then years later with the Telaprevir, Ribavirn & interferon. Both were horrendous & I ended up stopping under a month!
I have been waiting and waiting since for something like this. And I promised myself this is it. 2014 or bust. If I can clear up the brain fog and get my energy back I will be so grateful.
Will post anything I find regarding ins coverage or financial help. Please do the same
Have a great weekend!!
ps: I thought Harvoni sounded like that scooter they created to get around the city on. Goofy name for a $95+ drug!
Good luck to all of you to get this med, and hoping it works for you.
Many have tried other tx's and have been waiting for this day to get on your road to freedom, happy trails to you !
Duane
Thanks, Gator Man. I feel like I have been preparing for trial for the past 6 months. Now it is showtime! Don't know what the verdict will be but ready to kick some dragon butt.
Gals and Guys,
I truly hope Harvoni ends up being the "silver bullet" for those waiting to be treated for the first time, but especially for those who have relapsed with prior therapies. Good luck to everyone! May tx be in your immediate future and the dragon slayed in the next few months!
Yea , exciting day.
Has anyone seen the new FDA NDC (National drug Code) for Harvoni?
matt
Beyond excited! Hey Matt, the name reminded me of food (as usual lol): Harvoni Macaroni! I've got to wait a bit longer till December to see my doctor, but I can't wait to see the developments..
This is such wonderful LONG awaited news!!! Hoping we all get approved and cured!
YAAAHHHOOO!!!
I was eating lunch and checked the the FDA and they had 2 new approvals but not Gilead's then waited 15 minutes and check again and there is was, 1 pill daily Hep-C drug. Appoved.
The name sounds like a strange italian accordian type of instrument. LOL
Now the fun comes with the Insurance companies
matt
Now it's time to circle the wagons and get ready to battle the insurance companies!!!!!!!!!!!!!!!
U.S. Food and Drug Administration
Protecting and Promoting Your Health
News & Events
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 FDAs 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.
Harvonis 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 participants 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 Harvonis 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 FDAs 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 nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###
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-- Edited by Mugsy on Friday 10th of October 2014 07:09:52 PM
Hi Bills:
The name Harvoni is what S/L is being called in Europe. The US could have a different name, although it is likely Gilead selected the name Harvoni because it also passed US regulations, so it will be the same here.
Your insurance situation is the type the patient assistance programs were designed to help with. You will be approved because you have advanced liver disease. The issue will be your co-pay. Gilead's Support Path Program will pay up to 20% for 12 weeks. This assumes your household income is <100K. Another payment assistance program may pick up the rest if that doesn't cover it. This information is subject to change of course.
If I was you I would try to get a sooner doctor's appointment unless your doc is already working on the pre-authorization. The drugs should be available immediately and the wait time will be for arranging payment.
Your doc and the pharmacy will help with the insurance issues.
Here is a link to the Support Path Program: http://www.mysupportpath.com/
BTW, pursuant to the Affordable Care Act, insurance policies can no longer have separate deductibles for medical and pharmacy. The Rx co-pay should, therefore, be applied to your deductible.
Gilead Sciences Wins FDA Approval for New Harvoni Hepatitis C Pill
Now we see which Ins get on board.
And how long that takes........
Come on Cdphp!!!
Hello and Happy Oct 10th.
I knew we'd all be here today
I seeing there is this laps in this Oct 10th date and actual prescriptions being given. My Doc saw me mid Sept and made my next appt. for Nov 19th He said they didn't name it and there will be a awaiting time My relapse was in Feb 2013 I've been counting days. I'm trying to understand why over 2 months to get a script. I just called like I was talking to a consumer relations complaint line. WHy ?WHy! When? I need to know when LOL.
Well I see they got the name here Harvoni. That's easier to say then everything else we been taking. I saw a good point I should think about maybe waiting just a little longer will get some of the bugs out on the insurance side I'd hate to get a bad deal being impatient.
I am concerned about my insurance I know it has a limit on low copay and goes down to cover 80% in a very short time so using $100K 80% leaves me with $20K copay? I don't know anything about coupons yet which could help but how do they qualify that? Hopefully all you nice people and wanna be dragon slayers will calm me down as usual. I wish all of US the best is getting on the TX a quick RVR and Sweet SVR
BS
Hi BJ,
Harvoni it is. The latest and greatest HCV silver bullet from Gilead. We're all waiting for today's release information. The approval of S/O is dependent on ongoing trials. The releases I've read to date indicate the release price of Harvoni should be set at $96,000 for a 12 week course of Tx. Of course that remains to be seen, because I've seen comments to the contrary. I don't think Gilead will be too greedy considering the backlash they received over Sovaldi alone. But again, we're talking about.....Gilead
Hopefully we'll know more today.
Our member Isiscat should be able to add significantly to this discussion. She has been following the FDA reports on this closely.
Tig
Two things have brought me back to this forum today:
1. FDA RESPONSE TO GILEAD'S APPLICATION FOR THE 1-DRUG REGIME:
I have been scouring the web to see if there's any news on the FDA's response to Gilead's drug application for the one-drug pill. So far nothing. On their website they only show approvals up thru the 8th as of today. I'm sure it will be NEWS once they say & they have to respond by today is my understanding. By respond, I mean state their decision to approve or deny. Of course then we still have insurance coverages to wait for. My insurance company, CDPHP of New York, State Employees, has not responded to any of my emails regarding the drug &/or its approval. My liver Dr thinks that they may start with approving only those with the most dire circumstances; side effects, health issues, etc. When I saw him earlier this week he wanted details on how the drug has affected my life & ability to work & daily things. there's the possibility it may be available only to a select few at first. Maybe until the insurance companies see for themselves that it actually works as claimed. They got screwed with Telaprevir and some of the other "miracle -cures" that many started and had to drop out of because the side effects were way worse than expected. So now all those people have to re-treat so insurance companies have to pay out again. I get it. Personally I don't know how they stay in business with the costs of some of these drugs!
2. WHAT THE HECK IS YOUR NAME?:
Just what exactly is the correct name of this "one-pill" that many of us & Gilead is waiting for today? I hear Solvaldi / Ledipasvir / Sofobuvir / and in a Forbes article today they referred to another? Gilead drug called Harvoni??
I have made up my mind that before this year is over I will be on a regime that I can stick with and finish and clear this monster off my back once and for all. If it's not Gilead's one-pill then maybe the cross-over combo of Sovaldi & Olysio which seems to be doing well; although I don't know if my insurance would cover it. It think the FDA approved these 2 being used together tho??? (Question #3)
Thanks in advance for any info & responses!
Take care & be Well
BJ