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Abbvie Drugs Approved
The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. 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.
Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).
“The new generation of therapeutics for hepatitis C virus is 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. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.”
Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014.
Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis. In different trials, participants were randomly assigned to receive Viekira Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.
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. Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of participants who received Viekira Pak at the recommended dosing achieved SVR. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily.
The most common side effects reported in clinical trial participants were feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping.
Viekira Pak is the eleventh new drug product 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. Viekira Pak 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.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. 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.
Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).
“The new generation of therapeutics for hepatitis C virus is 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. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.”
Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014.
Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis. In different trials, participants were randomly assigned to receive Viekira Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.
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. Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of participants who received Viekira Pak at the recommended dosing achieved SVR. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily.
The most common side effects reported in clinical trial participants were feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping.
Viekira Pak is the eleventh new drug product 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. Viekira Pak 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.
Ask the insurance lady at your docs office to send the study Lynn referenced to the insurance company.
Hi Glen
I relapsed on Sovaldi /Olysio and am now on Harvoni for 24 weeks. I did have to fight with my insurance they said no because they considered me a non response or partial response. I responded quite well was und at week 4 but relapsed 12 weeks post. Only thing was I treated for 12 weeks which was the protocol at the time. It has since (November) been revised to 24 weeks for patients with cirrhosis which I believe could have made the difference for me and probably others.
There is no evidence of Sovaldi resistance per clinical trials. There is clinical trial evidence in a small trial of 14 patients who failed Sovaldi Riba that all 14 acheived SVR 12 after treating with Harvoni.
http://www.gilead.com/news/press-releases/2013/12/us-food-and-drug-administration-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-chronic-hepatitis-c
Trial participants achieved SVR12 rates of 76-92 percent. In all Phase 3 studies of Sovaldi, no viral resistance to the drug was detected among patients who relapsed following completion of therapy.
http://www.ncbi.nlm.nih.gov/pubmed/25364884
Re-treatment of Chronic Hepatitis C Virus Genotype 1 Infection After Relapse: An Open-Label Pilot Study.
From the newest AASLD guidelines dated 12/19/14
(see page 87)
http://www.hcvguidelines.org/fullreport
Recommended regimen for patients who have advanced fibrosis, in whom a previous sofosbuvir-containing regimen has failed.
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with or without weight-based RBV (1000 mg [75 kg]) for 24 weeks is recommended for patients who have cirrhosis, in whom a previous sofosbuvir-containing regimen has failed.
Rating : Class IIa, Level C
I did find the info about the prior treatment with Incevek (Telaprevir)
on the next page 88
The following regimens are NOT recommended for patients with HCV genotype 1
infection, in whom prior treatment that included an HCV protease inhibitor has failed.
Any interferon-free regimen containing an HCV protease inhibitor
Simeprevir
Paritaprevir
(Paritaprevir is part of the new AbbVie Combo VIEKIRA PAK)
So it looks like you can't do the VIEKIRA PAK won't work.
Bottom line per the AASLD guidelines you need to be on Harvoni 24 either with or with out Ribavirin.
I relapsed on Sovaldi /Olysio and am now on Harvoni for 24 weeks. I did have to fight with my insurance they said no because they considered me a non response or partial response. I responded quite well was und at week 4 but relapsed 12 weeks post. Only thing was I treated for 12 weeks which was the protocol at the time. It has since (November) been revised to 24 weeks for patients with cirrhosis which I believe could have made the difference for me and probably others.
There is no evidence of Sovaldi resistance per clinical trials. There is clinical trial evidence in a small trial of 14 patients who failed Sovaldi Riba that all 14 acheived SVR 12 after treating with Harvoni.
http://www.gilead.com/news/press-releases/2013/12/us-food-and-drug-administration-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-chronic-hepatitis-c
Trial participants achieved SVR12 rates of 76-92 percent. In all Phase 3 studies of Sovaldi, no viral resistance to the drug was detected among patients who relapsed following completion of therapy.
http://www.ncbi.nlm.nih.gov/pubmed/25364884
Re-treatment of Chronic Hepatitis C Virus Genotype 1 Infection After Relapse: An Open-Label Pilot Study.
From the newest AASLD guidelines dated 12/19/14
(see page 87)
http://www.hcvguidelines.org/fullreport
Recommended regimen for patients who have advanced fibrosis, in whom a previous sofosbuvir-containing regimen has failed.
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with or without weight-based RBV (1000 mg [75 kg]) for 24 weeks is recommended for patients who have cirrhosis, in whom a previous sofosbuvir-containing regimen has failed.
Rating : Class IIa, Level C
I did find the info about the prior treatment with Incevek (Telaprevir)
on the next page 88
The following regimens are NOT recommended for patients with HCV genotype 1
infection, in whom prior treatment that included an HCV protease inhibitor has failed.
Any interferon-free regimen containing an HCV protease inhibitor
Simeprevir
Paritaprevir
(Paritaprevir is part of the new AbbVie Combo VIEKIRA PAK)
So it looks like you can't do the VIEKIRA PAK won't work.
Bottom line per the AASLD guidelines you need to be on Harvoni 24 either with or with out Ribavirin.
So your saying that I cannot take the new drugs from Abbvie because I relapsed from the Sovaldi-Olysio.This is bad news because I already left a voicemail for the insurance lady at my doctors office for her to look into this treatment since it is now FDA approved.I guess I have to call her and tell her to cancel.This whole process is so draining and depressing sometimes I am ready to give up but I wont give those sob's from Cigna the satisfaction that they were able to sweep me under the rug and still collect their bi weekly fees from me.
Glen
Glen
My best advice is to keep bothering Cigna, on a daily basis, to give Gilead that letter in the correct format. Also, send Cigna the AASLD update and treatment guidelines. I believe it says if you failed Sovaldi, as well as any other treatment with a PI, like Incivek, you can't use one of the Abbvie drugs....must be a resistance issue. There is also a small study that has been published showing treatment with Harvoni on 14 patients who relapsed on sovaldi. All 14 got an SVR with Harvoni. If you have a lawyer in your family or a friend with a law degree, speak to them about sending Cigna a "persuasive" letter.
I am on the road and will be home tonight. If you can't find the guidelines or the study on line and no one pops up to give the links to you, I will do it tonight. Hang in there.
I am on the road and will be home tonight. If you can't find the guidelines or the study on line and no one pops up to give the links to you, I will do it tonight. Hang in there.
Hello
I have been trying for many months to get on treatment.I am geno 1A stage 4 cirrhosis who finally cleared for the 1st time since starting treatments in the 80s on sovaldi-olysio only to relapse immediately.After 3 letters of denial from my insurance company for coverage (Cigna) and even though I meet all of Gileads qualifications they still won't give me Harvoni because one of the letters of denial has to be stated in a certain way which Cigna has not done.I would like to have my doctors office try for Viekira Pak.Is there any reason that my insurance company can say that this new drug will not help me as they have done with Harvoni,their reason is since I relapsed on the sovaldi then I would probably relapse on the Harvoni.I know they just don't want to pay for it but if this new drug has proven results wouldn't they have to give me a chance with it?I am getting desperate and time definitely is not on my side.The cramps are violent now and I have to sleep sitting upright cause the cramps happen when I lay down usually accompanied by a nosebleed.Throw in the itching (prurosis) and sleep is impossible.Will Abbvie have an assistance program when Cigna tells me that Viekira Pak won't help me either.
Sorry my question is so long Glen
I have been trying for many months to get on treatment.I am geno 1A stage 4 cirrhosis who finally cleared for the 1st time since starting treatments in the 80s on sovaldi-olysio only to relapse immediately.After 3 letters of denial from my insurance company for coverage (Cigna) and even though I meet all of Gileads qualifications they still won't give me Harvoni because one of the letters of denial has to be stated in a certain way which Cigna has not done.I would like to have my doctors office try for Viekira Pak.Is there any reason that my insurance company can say that this new drug will not help me as they have done with Harvoni,their reason is since I relapsed on the sovaldi then I would probably relapse on the Harvoni.I know they just don't want to pay for it but if this new drug has proven results wouldn't they have to give me a chance with it?I am getting desperate and time definitely is not on my side.The cramps are violent now and I have to sleep sitting upright cause the cramps happen when I lay down usually accompanied by a nosebleed.Throw in the itching (prurosis) and sleep is impossible.Will Abbvie have an assistance program when Cigna tells me that Viekira Pak won't help me either.
Sorry my question is so long Glen
So sorry about that double post. Guess I want to be heard eh?
For some reason my comment didn't show so I thought I had forgotten to post it. It's called brain fog?
For some reason my comment didn't show so I thought I had forgotten to post it. It's called brain fog?
Actually, the reason I went with Sovaldi and Olysio rather than waiting for Harvoni was I could see the handwriting on the wall as being a tightening of access for those of us on Medicaid. Now with the AbbVie price, I also fear many will be put out to pasture but perhaps that is as it should be for those of us who are older and for those who are poor.
As far as the NPO's go, I know they all are full of passion and work unbelievably hard. However, main stream political action alone is not going to work to give access to those without decent insurance. In some states patients themselves have started rallying and I just read how in Spain patients gathered together for a sit-in to protest lack of treatment.
http://elpais.com/elpais/2014/12/18/inenglish/1418924229_428567.html
Bernie Sanders is making some noise, but who in power listens to Bernie Sanders.
As far as the NPO's go, I know they all are full of passion and work unbelievably hard. However, main stream political action alone is not going to work to give access to those without decent insurance. In some states patients themselves have started rallying and I just read how in Spain patients gathered together for a sit-in to protest lack of treatment.
http://elpais.com/elpais/2014/12/18/inenglish/1418924229_428567.html
Bernie Sanders is making some noise, but who in power listens to Bernie Sanders.
Actually, the reason I went with Sovaldi and Olysio rather than waiting for Harvoni was I could see the handwriting on the wall as being a tightening of access for those of us on Medicaid. Now with the AbbVie price, I also fear many will be put out to pasture but perhaps that is as it should be for those of us who are older and for those who are poor.
As far as the NPO's go, I know they all are full of passion and work unbelievably hard. However, main stream political action alone is not going to work to give access to those without decent insurance. In some states patients themselves have started rallying and I just read how in Spain patients gathered together for a sit-in to protest lack of treatment.
http://elpais.com/elpais/2014/12/18/inenglish/1418924229_428567.html
Bernie Sanders is making some noise, but who in power listens to Bernie Sanders.
As far as the NPO's go, I know they all are full of passion and work unbelievably hard. However, main stream political action alone is not going to work to give access to those without decent insurance. In some states patients themselves have started rallying and I just read how in Spain patients gathered together for a sit-in to protest lack of treatment.
http://elpais.com/elpais/2014/12/18/inenglish/1418924229_428567.html
Bernie Sanders is making some noise, but who in power listens to Bernie Sanders.
All the financial analysts are saying there will be no price war. So, what we have to hope for is that Abbvie keeps its promise to do a better job with access for everyone. We will know soon enough.
Have a happy holiday and I pray for a Christmas Miracle SVR for you!
Have a happy holiday and I pray for a Christmas Miracle SVR for you!
I am thinking hopefully they will get into a war on the cost which will drive the cost down. I am scared to death they are going to get sick if this and put a lot of us out to pasture. If I have to treat again I will know inext month and hopefully get started again before the end of June which is when our insurance runs for the year. HOWEVER, I am hoping for 8-week SVR and then 12-week SVR. My 4-Week was still UND. You know what I want for Christmas.
Hearing the price was upsetting. But let's wait to hear the news about the patient assistant programs and what Arrangements AbbVie has made with the payers. It may not be as bleak as you fear. We have been promised some exciting news in the next week or two. As soon as we can, we will share it with everyone.
Also, Lorren Sandt from Caring Ambassaors has done much for the hep community. From educating (writing her book Choices), to getting people tested so they could make good lifestyle decisions and preserve their liver health until they could get treated, to walking the Hill in Washington, DC and knocking down doors in the Senate. Please don't think the NPO's are not doing any good. Both Lorren and my husband have been working furiously with the Fair LPricing Coalition and many other organizations. They are starting to listen because of people like Lorren and others who work ebpvery day for hep patients.
Also, Lorren Sandt from Caring Ambassaors has done much for the hep community. From educating (writing her book Choices), to getting people tested so they could make good lifestyle decisions and preserve their liver health until they could get treated, to walking the Hill in Washington, DC and knocking down doors in the Senate. Please don't think the NPO's are not doing any good. Both Lorren and my husband have been working furiously with the Fair LPricing Coalition and many other organizations. They are starting to listen because of people like Lorren and others who work ebpvery day for hep patients.
This is very disappointing news as far as I'm concerned. With Abbvie's price being essentially the same as Harvoni's, why would anyone opt for Abbvie. Well, I guess if you're GT 2 or 3, but still this is sad. The side effects are the same but with Harvoni, you don't have to take the Ribavirin and with the cost of Riba included that makes the Viekira Pak more expensive than Harvoni.
Btw, KeepingOn, I have yet to figure out what good Caring Ambassadors does in helping people get treatment. The only thing I've seen them do is rally around getting people to test for Hep C. What good does it do to have more people diagnosed with Hep C when so many people who have been diagnosed for years can't obtain treatment. We need an advocacy group that can break through the politics and get the drugs to those who are presently being warehoused.
Btw, KeepingOn, I have yet to figure out what good Caring Ambassadors does in helping people get treatment. The only thing I've seen them do is rally around getting people to test for Hep C. What good does it do to have more people diagnosed with Hep C when so many people who have been diagnosed for years can't obtain treatment. We need an advocacy group that can break through the politics and get the drugs to those who are presently being warehoused.
Agreed
As I have said I would walk over hot coals of broken glass if it would cure my hep c
Or take every med together interferon, riba, harvoni and the new Abbvie at the same time.
Heck if that wouldn't kill it I guess I should just give up.
Congrats on clearing and on a trial no less!
As I have said I would walk over hot coals of broken glass if it would cure my hep c
Or take every med together interferon, riba, harvoni and the new Abbvie at the same time.
Heck if that wouldn't kill it I guess I should just give up.
Congrats on clearing and on a trial no less!
I had a bit more fatigue than I was used to. I had no nausea or itching. I wanted to get rid of this virus so badly, that I would have put up with anything. After treating for 48 weeks many times....each time a new interferon came out, with adding drugs from another country (thymosin), with high dose Infergen (15mcg daily, instead of 9 mcg 3 X week) I felt like I could do anything for 12 weeks. Actually I drew the 24 week arm, but no one I met at my doc's office had any problems with sides. They all were cirrhotic and got the 12 week arm and all but one got an SVR. It is so worth it.
Wow!!! Thank you so much for doing that research. Great job. I really appreciate it. I kinda knew it wouldn't be 10 pills but couldn't figure out for sure how it would be dosed.
I looked up the number names for ombitasvir, paritaprevir, ritonavir and dasabuvir
ombitasvir = ABT267
paritaprevir = ABT450
ritonavir = ABT450r
dasabuvir = ABT333
The 2 pills once daily is ombitasvir ABT267, paritaprevir ABT450 and ritonavir ABT450r combo pill. The single pill is dasabuvir ABT333 twice daily for a total of 4 pills.
I think we are saying the same thing about the AbbVie 3D combo
I did find out about the hi-dose Ribavirin
"Ribavirin is available in 200 mg, 400 mg, 500 mg, and 600 mg capsules and tablets."
So I assume 1 each morning and night either 500mg or 600mg weigh based.
So counting on my fingers that is 2 combo pills together , 2 dasabuvir pills separately , and 2 ribavirin divided dose so that would be 6 pills total.
Here is a good article from the University of Washington if anyone is interested clinical trial results and a slide deck summary.
http://www.hepatitisc.uw.edu/page/treatment/drugs/3d
ombitasvir = ABT267
paritaprevir = ABT450
ritonavir = ABT450r
dasabuvir = ABT333
The 2 pills once daily is ombitasvir ABT267, paritaprevir ABT450 and ritonavir ABT450r combo pill. The single pill is dasabuvir ABT333 twice daily for a total of 4 pills.
I think we are saying the same thing about the AbbVie 3D combo
I did find out about the hi-dose Ribavirin
"Ribavirin is available in 200 mg, 400 mg, 500 mg, and 600 mg capsules and tablets."
So I assume 1 each morning and night either 500mg or 600mg weigh based.
So counting on my fingers that is 2 combo pills together , 2 dasabuvir pills separately , and 2 ribavirin divided dose so that would be 6 pills total.
Here is a good article from the University of Washington if anyone is interested clinical trial results and a slide deck summary.
http://www.hepatitisc.uw.edu/page/treatment/drugs/3d
Ok, I think you are misunderstanding. I just pulled out my old clinical trial papers. I took, ABT450r, ABT267, ABT333 and ribavirin. One of those drugs, can't remember which, was dosed AM and PM. The other 2 are dosed once daily. So that is a total of 4 pills plus ribavirin. Let's hope the ribavirin is high dose so that is not 5 or 6 more pills. The FDA package insert is written poorly and it does sound like all three are taken twice a day. But, I am 99% sure that is not true.
Ok I missed the ribavirin hi-dose part not familiar with that just the 200 mg riba Yes it is 1000 to 1200 weight dependent.
I don't know much about the newer dosing forms for Riba haven't taken riba since 2003 when I was a null responder again. Say in 2005 the last time I treated before this new generation of meds
But still 2 each ombitasvir, paritaprevir, ritonavir pills in the morning and 1 dasabuvir two times a day for 4 pills total if I am reading the instructions correctly.
You too happy holidays
I don't know much about the newer dosing forms for Riba haven't taken riba since 2003 when I was a null responder again. Say in 2005 the last time I treated before this new generation of meds
But still 2 each ombitasvir, paritaprevir, ritonavir pills in the morning and 1 dasabuvir two times a day for 4 pills total if I am reading the instructions correctly.
You too happy holidays
I think I ma have unintentionally misled you. When I said 4 pills, I meant there are four different pills but some have to be taken more than once.....the ribavirin and I also took one of the others twice daily.
Where does it say the ribavirin is 5-6 pills a day? I thought I read 1000-1200 mg a day depending on weight. If it is high dose, it should be less pills. Anyway, we will know soon. Have a great weekend.
I am just reading this and Ribavirin is 5 to 6 pills a day in itself
Recommended dosage: Two ombitasvir, paritaprevir, ritonavir 12.5/75/50
mg tablets once daily (in the morning) and one dasabuvir 250 mg tablet
twice daily (morning and evening) with a meal without regard to fat or
calorie content.
Recommended dosage: Two ombitasvir, paritaprevir, ritonavir 12.5/75/50
mg tablets once daily (in the morning) and one dasabuvir 250 mg tablet
twice daily (morning and evening) with a meal without regard to fat or
calorie content.
I really don't think it will be 10 pills a day. Abbvie has been worried about pill burden and I didn't take 10 pills when I was in their trial. I am pretty sure that ritonavir is compounded with one of the other drugs, so that is really one pill. And, they said the ribavirin is high dose.
The patient assistance program and insurance coverage looks good. We will know more next week. Keeping fingers crossed for everyone.
The patient assistance program and insurance coverage looks good. We will know more next week. Keeping fingers crossed for everyone.
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