Aa
Help Me,Viekira Pak or Harvoni
Ok,I have been trying for the last 6 months to get meds.My background is I was a lifetime non responder who finally got negative on sovaldi-olysio only to relapse immediately.I am geno 1A with stage 4 cirrhosis.Things have gotten really bad without going into detail but I am in a lot of pain and I can't deal with the leg cramps anymore,they are beyond ridiculous.I had 3 letters of denial from my insurance company (Cigna) who wouldn't even word one of them correctly as a prior authorization appeal so that Gilead could send me the Harvoni.It wouldn't of cost Cigna a dime to just word it differently yet they would rather me die.Just lovely folks over there.Now finally Gilead is leaning toward helping me with Harvoni,I will get the call this Monday.And Abbvie who I have been talking to is also going to let me have their new Viekira Pak hopefully this coming week.MY dilemma is my doc wants me to also take ribavirin for the 24 weeks.The Viekira Pak comes with the riba but if I get the Harvoni which I would prefer to take I would have to wait all over again to get the riba,And who knows how long that is going to take.There is no way if I had the Harvoni in my possession that I am not going to take it.I would take the riba whenever it showed up but I have to stop this hepatitis ASAP.I havn't asked my doc but I know he would tell me do not take the Harvoni until you get the ribavirin.I could develop tumors waiting for the riba.Is the Viekira Pak the right direction for someone in my condition or am I better off with the harvoni.And you should know that I will tell my doc that I will wait for the riba to arrive before I take the Harvoni but that will be a lie.I'm taking those pills the minute they arrive and I will take the riba along with them whenever they arrive.I would appreciate your feedback especially on the Viekira Pak and if it is beneficial to somebody with my background since it is brand new and I know little about it.
Glen
Glen
Dear Friends ; this is mourad from Egypt
kindly find the following sheet
http://www.bcbstx.com/pdf/rx/hepc_secgen_pa_progsum_070115_pending_tx.pdf
kindly find the following sheet
http://www.bcbstx.com/pdf/rx/hepc_secgen_pa_progsum_070115_pending_tx.pdf
I am presently taking the Viekira Pack with Ribavirin. I also have heart condition. After five weeks I was experience pressure on my heart and having problems breathing. It turns out that I was suffering from Anemia which was cause by the Ribavirin. Had to have a transfusion to bring me to normal. Also my blood presuure drop really low. 97/57/ due to lack of Red Blood cells. Went from 1200mg daily to 200mg of Ribavirin and still experiencing Anemia. I finally got off completely in order to avoid another hospital stay. In my case blood work has do be done to monitored the Anemia. Also those with heart conditions check drugs that conflict with Viekira. For example Calcium blockers, diaretics.Drugs are listed in the Viekira Pack. I am passing this information for those with heart conditions.If you feel and side effect that are absolutely horrible call your doctor and in my case stop the the medication and get blood work. Look froward to your comments
Thank you all for what is very important information to me.You have changed my mind with the info provided and I am going to call Sara from Gillead first thing tomorrow even though she promised she would be calling me tomorrow and beg her to get the Harvoni to me this week.I am also calling my doctors office after you told me that the ribo is now generic and easier to get that I will pay for it if that will get it to me sooner.As for you Susan I wish you luck with those SOB's from Cigna.They said I was a hopeless case cause I relapsed on the S&O and when they were off the hook for paying for my Harvoni,all they had to do was word one of my denial letters in a specific way and I would of gotten it ages ago.I wouldn't have cost them a dime and Gilead would have sent me the meds but the SOB's insisted on burying me anyway.I wonder if those people from Cigna can suppose what Hell looks like.Oh yeah,you can detect bitterness.
Thank you everyone Glen
Thank you everyone Glen
Maybe I read this too fast....
but it seems to me that we do not always get good medical advice, or that what insurance will provide, isn't always in our best interests.
First off.... you failed every TX and just failed Sovaldi/Olysio?
Did you take riba with that?
Had I been your doctor, I might have added riba to ensure, as a cirrhotic past responder you had that extra boost of riba.
But then again...... had I been your doctor, I would have advised you to wait a few months and get Harvoni when it was approved.
It seems to me, that as a past TX failure what you need to do is 24 weeks of Harvoni. I would strongly consider adding riba to it.
It seems to me that this is your last best option.
If you fail this time, the options look bleak.
==========
You just failed a course of treatment with a PI.
The Abbvie program also utilizes a PI
In theory, you now should have resistant virii that the PI in the Abbvie regimen should not be effective against, or less so.
Further, the Abbvie program tends to me more effective against G-1b
You are a 1a.
I wouldn't consider the abbvie program, not for your situation and the people who have given you warnings in this thread are correct.
IF I could treat off label I would go with Sovaldi, Daclatasvir and riba
In your case, using what is approved would be Harvoni (and riba closely monitored due to your advanced cirrhosis)
I think the riba might end up being critical your your treatment, sice you have also already failed Sovaldi. I think a little extra boost might help, but if you get a good response and the riba starts causing problems I wouldn't worry excessively about diminishing or stopping dosing.
I would advise using both the Gilead and Abbvie toll free lines and confirm these things. They will know more than many doctors.
best,
Willy
but it seems to me that we do not always get good medical advice, or that what insurance will provide, isn't always in our best interests.
First off.... you failed every TX and just failed Sovaldi/Olysio?
Did you take riba with that?
Had I been your doctor, I might have added riba to ensure, as a cirrhotic past responder you had that extra boost of riba.
But then again...... had I been your doctor, I would have advised you to wait a few months and get Harvoni when it was approved.
It seems to me, that as a past TX failure what you need to do is 24 weeks of Harvoni. I would strongly consider adding riba to it.
It seems to me that this is your last best option.
If you fail this time, the options look bleak.
==========
You just failed a course of treatment with a PI.
The Abbvie program also utilizes a PI
In theory, you now should have resistant virii that the PI in the Abbvie regimen should not be effective against, or less so.
Further, the Abbvie program tends to me more effective against G-1b
You are a 1a.
I wouldn't consider the abbvie program, not for your situation and the people who have given you warnings in this thread are correct.
IF I could treat off label I would go with Sovaldi, Daclatasvir and riba
In your case, using what is approved would be Harvoni (and riba closely monitored due to your advanced cirrhosis)
I think the riba might end up being critical your your treatment, sice you have also already failed Sovaldi. I think a little extra boost might help, but if you get a good response and the riba starts causing problems I wouldn't worry excessively about diminishing or stopping dosing.
I would advise using both the Gilead and Abbvie toll free lines and confirm these things. They will know more than many doctors.
best,
Willy
The AASLD guidelines for those who failed with a PI (Telaprevir, Boceprevir, Olysio) are copied and pasted below. Go towards the bottom and you will see that the AASLD does NOT recommend the Abbvie drug regimen for those who failed with another PI. The thinking behind this is that, before we ever started treatment with any PI, even before we treated with Incivek, we already had the resistant strains of HCV in our bodies. When we treated, the wild type virus was eliminated and this made room for the resistant strains to multiply. After TX, those who failed Tx, gradually returned to their "normal: levels of viral strains, with the wild type virus taking over again as the dominant strain. However, even though the resistant strains decrease in number, they are not totally gone. So there is nothing to prevent them from multiplying again once the wild type strain is eliminated. If you treat with the Abbvie drug regimen, you will, in effect, be treating with only part of the regimen because the feeling is that the PI included in the regimen will not work against the resistant strains that you already have in your body. So you would not have the benefit of the entire drug regimen and you would be more likely to fail treatment.
Hopefully you have a good Hepatologist who thoroughly understand all of the aspects of treating people who have failed with the PIs in the past. According to the AASLD guidelines, you should be treating with Harvoni, NOT the Abbvie regimen.
According to the new AASLD guidlines, the Abbvie regimen is NOT recommended for those who failed the PIs.
Recommended regimen for patients without cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and HCV protease inhibitor regimen has failed.
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for retreatment of patients without cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and HCV protease inhibitor regimen has failed.
Rating: Class I, Level A
Two options with similar efficacy in general are recommended for patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and an HCV protease inhibitor regimen has failed.
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for retreatment of patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and HCV protease inhibitor regimen has failed.
Rating: Class I, Level A
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) plus weight-based RBV (1000 mg [75 kg]) for 12 weeks is recommended for retreatment of patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and HCV protease inhibitor regimen has failed.
Rating: Class IIa, Level B
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 regimen containing PEG-IFN, including
Simeprevir, PEG-IFN, and RBV
Sofosbuvir, PEG-IFN, and RBV
Telaprevir or boceprevir, PEG-IFN, and RBV
PEG-IFN and RBV alone
Rating: Class IIb Level A
Monotherapy with PEG-IFN, RBV, or a direct-acting antiviral
Rating: Class III, Level A
Any interferon-free regimen containing an HCV protease inhibitor
Simeprevir
Paritaprevir
Rating: Class IIb, Level A
http://hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Hopefully you have a good Hepatologist who thoroughly understand all of the aspects of treating people who have failed with the PIs in the past. According to the AASLD guidelines, you should be treating with Harvoni, NOT the Abbvie regimen.
According to the new AASLD guidlines, the Abbvie regimen is NOT recommended for those who failed the PIs.
Recommended regimen for patients without cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and HCV protease inhibitor regimen has failed.
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for retreatment of patients without cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and HCV protease inhibitor regimen has failed.
Rating: Class I, Level A
Two options with similar efficacy in general are recommended for patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and an HCV protease inhibitor regimen has failed.
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for retreatment of patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and HCV protease inhibitor regimen has failed.
Rating: Class I, Level A
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) plus weight-based RBV (1000 mg [75 kg]) for 12 weeks is recommended for retreatment of patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and HCV protease inhibitor regimen has failed.
Rating: Class IIa, Level B
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 regimen containing PEG-IFN, including
Simeprevir, PEG-IFN, and RBV
Sofosbuvir, PEG-IFN, and RBV
Telaprevir or boceprevir, PEG-IFN, and RBV
PEG-IFN and RBV alone
Rating: Class IIb Level A
Monotherapy with PEG-IFN, RBV, or a direct-acting antiviral
Rating: Class III, Level A
Any interferon-free regimen containing an HCV protease inhibitor
Simeprevir
Paritaprevir
Rating: Class IIb, Level A
http://hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Thank you for the information. I did not know and am so sorry. All I knew was that Glenn was trying to decide between two tx's.
WM, thank you too.
Dee
WM, thank you too.
Dee
Does this sound odd or contradictory to anyone?
"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"
..........................................
They are saying that safety and efficacy is unknown in decompensated cirrhosis. Aren't patients with Child's Class C and some with Child's Class B. decompensating? I am confused.
"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"
..........................................
They are saying that safety and efficacy is unknown in decompensated cirrhosis. Aren't patients with Child's Class C and some with Child's Class B. decompensating? I am confused.
Ohhhh damn. I just realized who you are. Lynn is absolutely right. Veikira Pak is contraindicated in sovaldi relapsers or non-responders. They believe there is a resistance issue with paritaprevir and sovaldi. I think your only choice is Harvoni and as Lynn states, there was a small trial of sovaldi failures (14 people) that had a 100% SVR rate with Harvoni. You should NOT have to jump through hoops to get ribavirin. It shouldn't cost more than a couple of hundred dollars since it is now generic. And they have patient assistance as well.
Glen,
They should be more willing to prescribe the Riba because it is a generic now and doesn't cost them anywhere near as much as the other drugs. Any chance your doctor's office could fax them a letter requesting that they at the very least provide you with the Riba?
I am going to be in the same boat as my prescription drug coverage is through Cigna. They were great in paying for me with the Sovaldi/Peg/Riba, no problem whatsoever, but now that I relapsed, I know they are going to be balking on paying for another treatment anytime soon. Also, in my case, they are going to be using the argument that 'I don't have that much damage and I can wait..., line'. As far as I know, I don't have any late stage disease going on. The type of Cigna I have is GWH-Cigna. I think there are all different groups with these insurance companies. And they all funnel you into a specialty pharmacy. I'm not planning on retreating for at the very least, a year though. I will keep good thoughts for you in working through all this. I would see if your Dr. could fax that letter though.
Susan400
They should be more willing to prescribe the Riba because it is a generic now and doesn't cost them anywhere near as much as the other drugs. Any chance your doctor's office could fax them a letter requesting that they at the very least provide you with the Riba?
I am going to be in the same boat as my prescription drug coverage is through Cigna. They were great in paying for me with the Sovaldi/Peg/Riba, no problem whatsoever, but now that I relapsed, I know they are going to be balking on paying for another treatment anytime soon. Also, in my case, they are going to be using the argument that 'I don't have that much damage and I can wait..., line'. As far as I know, I don't have any late stage disease going on. The type of Cigna I have is GWH-Cigna. I think there are all different groups with these insurance companies. And they all funnel you into a specialty pharmacy. I'm not planning on retreating for at the very least, a year though. I will keep good thoughts for you in working through all this. I would see if your Dr. could fax that letter though.
Susan400
For anyone thinking about Viekira Pak this comes from the prescribing information sheet
Who should not take VIEKIRA PAK?
Do not take VIEKIRA PAK if you:
• have severe liver problems
• take any of the following medicines:
• alfuzosin hydrochloride (Uroxatral®)
• carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) • efavirenz (Atripla®, Sustiva®)
• ergot containing medicines including:
ergotamine tartrate (Cafergot®, Ergomar®, Ergostat®, Medihaler®, Migergot®, Wigraine®, Wigrettes®)
dihydroergotamine mesylate (D.H.E. 45®, Migranal®)
methylergonovine (Ergotrate®, Methergine®) • ethinyl estradiol-containing medicines:
combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen Lo®, Ortho Evra®
hormonal vaginal rings such as NuvaRing®
the hormone replacement therapy medicine, Fem HRT® • gemfibrozil (Lopid®)
• lovastatin (Advicor®, Altoprev®, Mevacor®)
• midazolam, when taken by mouth
• phenytoin, (Dilantin®, Phenytek®)
• phenobarbital (Luminal®)
• pimozide (Orap®)
• rifampin (Rifadin®, Rifamate®, Rifater® Rimactane®)
• sildenafil citrate (Revatio®), when taken for pulmonary artery
hypertension (PAH)
• simvastatin (Simcor®, Vytorin®, Zocor®)
• St. John’s wort (Hypericum perforatum) or a product that contains St.
John’s wort
• triazolam (Halcion®)
• have had a severe skin rash after taking ritonavir (Norvir®).
Looks like good to know info
Who should not take VIEKIRA PAK?
Do not take VIEKIRA PAK if you:
• have severe liver problems
• take any of the following medicines:
• alfuzosin hydrochloride (Uroxatral®)
• carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) • efavirenz (Atripla®, Sustiva®)
• ergot containing medicines including:
ergotamine tartrate (Cafergot®, Ergomar®, Ergostat®, Medihaler®, Migergot®, Wigraine®, Wigrettes®)
dihydroergotamine mesylate (D.H.E. 45®, Migranal®)
methylergonovine (Ergotrate®, Methergine®) • ethinyl estradiol-containing medicines:
combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen Lo®, Ortho Evra®
hormonal vaginal rings such as NuvaRing®
the hormone replacement therapy medicine, Fem HRT® • gemfibrozil (Lopid®)
• lovastatin (Advicor®, Altoprev®, Mevacor®)
• midazolam, when taken by mouth
• phenytoin, (Dilantin®, Phenytek®)
• phenobarbital (Luminal®)
• pimozide (Orap®)
• rifampin (Rifadin®, Rifamate®, Rifater® Rimactane®)
• sildenafil citrate (Revatio®), when taken for pulmonary artery
hypertension (PAH)
• simvastatin (Simcor®, Vytorin®, Zocor®)
• St. John’s wort (Hypericum perforatum) or a product that contains St.
John’s wort
• triazolam (Halcion®)
• have had a severe skin rash after taking ritonavir (Norvir®).
Looks like good to know info
I just read you are in liver failure.
Viekira is not recommended for Child B or C only child A cirrhotics.
Full prescribing information sheet
http://www.rxabbvie.com/pdf/viekirapak_pi.pdf
INDICATIONS AND USAGE
VIEKIRA PAK with or without ribavirin is indicated for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection including those with compensated cirrhosis. VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor. (1)
Limitation of Use: VIEKIRA PAK is not recommended for use in patients with decompensated liver disease. (1)
Viekira is not recommended for Child B or C only child A cirrhotics.
Full prescribing information sheet
http://www.rxabbvie.com/pdf/viekirapak_pi.pdf
INDICATIONS AND USAGE
VIEKIRA PAK with or without ribavirin is indicated for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection including those with compensated cirrhosis. VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor. (1)
Limitation of Use: VIEKIRA PAK is not recommended for use in patients with decompensated liver disease. (1)
Hi Glen
I am similar to you GT 1a w/ cirrhosis, multiple null responder interferon/ riba and relapsed on Sovaldi Olysio after 12 weeks treatment at 12 weeks post viral load test.
I started Harvoni 11/18 after a battle with Express Scripts. I have talked with my doctor about adding Riba and that is currently in work.
Here are my thoughts
http://www.hcvguidelines.org/full-report/retreatment-box-summary-recommendations-patients-whom-previous-treatment-has-failed
The newest treatment guidelines 12/19/14 for prior gt 1a w/cirrhosis to a Sovaldi based treatment is only Harvoni.
I read somewhere although I can't find it right now that Olysio is in the same class of protease inhibitor as one ont the meds in Viekira Pak which could have resistance issues I am not even sure if we can take Viekira pak. There is no resistance issue with Sovaldi.
There has been no testing of Viekira Pak for Sovaldi relapse patients. The was a very small trial (14 patients) with Harvoni 100% SVR.
Viekira Pak Turquoise 2 results for gt 1a w/cirrhosis prior null responder to interferon riba 93% SVR
Harvoni ION 2 trial same group 24 weeks with or without riba 99%
So that is why in my non medical opinion feel Harvoni is the best option for us both. If possible I would keep fighting for Harvoni. The best would be to start with the riba unless your doctor says ok to start without the riba and add later.
How long ago were you dx with cirrhosis? I was dx 7 years ago and had to have esophageal banding in late 2011.
Good luck to you whichever way you go
Lynn
I am similar to you GT 1a w/ cirrhosis, multiple null responder interferon/ riba and relapsed on Sovaldi Olysio after 12 weeks treatment at 12 weeks post viral load test.
I started Harvoni 11/18 after a battle with Express Scripts. I have talked with my doctor about adding Riba and that is currently in work.
Here are my thoughts
http://www.hcvguidelines.org/full-report/retreatment-box-summary-recommendations-patients-whom-previous-treatment-has-failed
The newest treatment guidelines 12/19/14 for prior gt 1a w/cirrhosis to a Sovaldi based treatment is only Harvoni.
I read somewhere although I can't find it right now that Olysio is in the same class of protease inhibitor as one ont the meds in Viekira Pak which could have resistance issues I am not even sure if we can take Viekira pak. There is no resistance issue with Sovaldi.
There has been no testing of Viekira Pak for Sovaldi relapse patients. The was a very small trial (14 patients) with Harvoni 100% SVR.
Viekira Pak Turquoise 2 results for gt 1a w/cirrhosis prior null responder to interferon riba 93% SVR
Harvoni ION 2 trial same group 24 weeks with or without riba 99%
So that is why in my non medical opinion feel Harvoni is the best option for us both. If possible I would keep fighting for Harvoni. The best would be to start with the riba unless your doctor says ok to start without the riba and add later.
How long ago were you dx with cirrhosis? I was dx 7 years ago and had to have esophageal banding in late 2011.
Good luck to you whichever way you go
Lynn
I think you are right..you should go with the pack. If you can get it faster than Harvoni|Riba. You have really had such a hard time with Cigna. It is so unfair. Take Care Dee
Thanks again Mom
It just seems logical to go with the Viekira Pak simply because of the ribo.If you knew what I have been going through physically and mentally you would understand why I would take the Harvoni immediately.I am going through liver failure and it isn't pretty.
Glen
It just seems logical to go with the Viekira Pak simply because of the ribo.If you knew what I have been going through physically and mentally you would understand why I would take the Harvoni immediately.I am going through liver failure and it isn't pretty.
Glen
Just a P.S. Have a discussion with your doc about which he feels would be best for you. I hate to recommend one over the other as I am not a medical provider and I would feel,awful if someone chose a treatment because I suggested it and then they didn't have the desired result. I've been told that both treatments are equally as good, but I don't have any special knowledge.
I am not a doctor. I can "hear" your frustration and sense your impatience. But, I am begging you not to start Harvoni without ribavirin if that is what your doc wants you to take. I know nothing about the interactions of these drugs and no one knows for sure how or why Ribavirin works. And I don't understand the kinetics. But, my gut says do not start the ribavirin late. You will not develop tumors waiting a couple of weeks or even a couple of months. Things just do not progress that fast with HCV. I am a 1a, as well, and If you do AbbVie, I amglad you will do all 24 weeks. I was lucky and got the 24 week arm and we had a higher success rate that the 1a's who did 12 weeks. I think the difference was 89% in the 12 week arm and 96% in the 24 week arm......or very close to that. Good luck.
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