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AbbVie for people with previous experience of Incivek or Victrelis
Hi All,
Now that the AbbVie non-ifn combo is approved I am thinking of going for it - however - it contains the NS3 protease inhibitor paritaprevir. I treated in 2007 with Incivek, then known as VX-950, which is also an NS3 protease inhibitor. Having scoured the literature for information on whether I need to be worried about resistance issues if I use AbbVie, my conclusion is that nobody knows for sure. There has been no trial of AbbVie using people with previous experience of an NS3 protease inhibitor.
So I am turning to my best source of information - the good folks on this forum - to ask this question:
If you have ever treated with Incivek or Victrelis and failed to get SVR, is your doc going to let you retreat with the AbbVie non-ifn combo?
OR
Has your doctor turned you down for the AbbVie combo on the grounds of possible resistance issues?
Thanks for any info that you have,
dointime
Now that the AbbVie non-ifn combo is approved I am thinking of going for it - however - it contains the NS3 protease inhibitor paritaprevir. I treated in 2007 with Incivek, then known as VX-950, which is also an NS3 protease inhibitor. Having scoured the literature for information on whether I need to be worried about resistance issues if I use AbbVie, my conclusion is that nobody knows for sure. There has been no trial of AbbVie using people with previous experience of an NS3 protease inhibitor.
So I am turning to my best source of information - the good folks on this forum - to ask this question:
If you have ever treated with Incivek or Victrelis and failed to get SVR, is your doc going to let you retreat with the AbbVie non-ifn combo?
OR
Has your doctor turned you down for the AbbVie combo on the grounds of possible resistance issues?
Thanks for any info that you have,
dointime
Best Answer
Pooh gave you the entire scoop. Great job, Pooh. Please discuss this with your treating doc. Take the AASLD Guidelines with you for back up. If I were you, I would go for Harvoni. Even if it has been taken off your pharmacies preferred formulary, most of them will let you use Harvoni if the Abbvie drugs are contraindicated, which in your case, is likely to be true.
I relapsed on Incivek over a year ago. I don't have confidence in my GI for several reasons, but for one reason in particular, he wanted me to treat with Sovaldi + Simeprevir. I kept looking for results from testing for that scenario, but never found any. Ultimately I just started seein a bunch of relapses from people in my situation that went on it, on here and made my own decision not to follow my GI's advice. I am pretty sure you would experience a resistance issue and that was what I was affraid of as well. This is why I am now in my fifth week of Harvoni. Hoping this goes well. Hep C 30 years, gt 1a, IL28b TT, twice failed interferion + Rib, and once relapsed on Incivek, biopsy stage 2 grade 2-3. viral load 600,000
AWorriedMom and Dee -
Thanks for flagging the Merck drugs anyway. The upcoming C-EDGE phase 3 trial results should be interesting. I wonder if they will give stats for a subgroup of people with previous experience of a protease inhibitor - as that is what I really need to know,
All the best,
dointime
Thanks for flagging the Merck drugs anyway. The upcoming C-EDGE phase 3 trial results should be interesting. I wonder if they will give stats for a subgroup of people with previous experience of a protease inhibitor - as that is what I really need to know,
All the best,
dointime
Hi, could this be one of them? For naive and difficult to treat.
http://www.mercknewsroom.com/news-release/research-and-development-news/merck-announces-results-phase-2-study-investigational-chr
http://www.mercknewsroom.com/news-release/research-and-development-news/merck-announces-results-phase-2-study-investigational-chr
I can't give you any more info because I don't have it yet. I am sorry. What I meant was that we had a meeting with Merck and they talked with us about Merck2 and Merck3 and pointed out that these drugs were trialed (Phase 2, I believe) in all kinds of populations. So the trial results will cover many different scenarios. We will get info on what happens to people who are taking the Merck drugs as well as methadone or bupe, for example. I'm thinking there was probably very few exclusions to get in to the trial. I was looking for patient information from people who may have been in, or considered entering one of those trials.
"Has anyone looked at the Merck trials? They look like they are quite comprehensive the way they are broken down."
Merck has Grazoprevir (MK-5172) (Protease Inhibitor) in combo with Elbasvir (MK-8742) (NS5A Inhibitor) in phase III. Are these the drug trials that you mean? I am not really getting what you mean about the Merck trials. Do you have a link and/or could you explain a bit more please?
dointime
Merck has Grazoprevir (MK-5172) (Protease Inhibitor) in combo with Elbasvir (MK-8742) (NS5A Inhibitor) in phase III. Are these the drug trials that you mean? I am not really getting what you mean about the Merck trials. Do you have a link and/or could you explain a bit more please?
dointime
Has anyone looked at the Merck trials? They look like they are quite comprehensive the way they are broken down.
strongly agree.
It may be in another thread but there is a phase 2b trial, abbvie for g-1 in trials. I rather think they will open it to past PI failures.
First it has to succeed in SOC failures and naives,
SVR-12 data in march or april....I think.
these compounds were built to work against the resistant sub-species which PI failures cultivate.
I would guess Gilead and others are working on comparable treatments.
There may be trial slots, but we are a ways away from the finish line.
Further, if you wait a spell someone my create an off label bolt together treatment for PI failures; Sovaldi and Daclatasvir and riba, for instance.
You may not want to jump at the first thing available, as DT said.
Good things are coming.
It may be in another thread but there is a phase 2b trial, abbvie for g-1 in trials. I rather think they will open it to past PI failures.
First it has to succeed in SOC failures and naives,
SVR-12 data in march or april....I think.
these compounds were built to work against the resistant sub-species which PI failures cultivate.
I would guess Gilead and others are working on comparable treatments.
There may be trial slots, but we are a ways away from the finish line.
Further, if you wait a spell someone my create an off label bolt together treatment for PI failures; Sovaldi and Daclatasvir and riba, for instance.
You may not want to jump at the first thing available, as DT said.
Good things are coming.
H Susan,
Thanks for your well wishes for me. I think what you are doing is wise. There are going to be more people who have failed in with an NS3 protease and Sovaldi. I don't think the Sovaldi leaves resistant variants behind so you are ok there. If I do the Harvoni and fail then that would be bad because the NS5A in Harvoni does leave resistant variants behind. That would mean I would possibly have resistance to both major classes of drugs. I think there might be a long wait for a tx which could overcome that. So the next choice for both of us really needs to have almost 100% confidence of working.
All the best to you,
dointime
Thanks for your well wishes for me. I think what you are doing is wise. There are going to be more people who have failed in with an NS3 protease and Sovaldi. I don't think the Sovaldi leaves resistant variants behind so you are ok there. If I do the Harvoni and fail then that would be bad because the NS5A in Harvoni does leave resistant variants behind. That would mean I would possibly have resistance to both major classes of drugs. I think there might be a long wait for a tx which could overcome that. So the next choice for both of us really needs to have almost 100% confidence of working.
All the best to you,
dointime
As you know, I was in the same 'group' as you were with the Telaprevir(Incivek) trials, The NO-RIBA group. As you also know, I recently did the Sovaldi/Peg/Riba and relapsed. On the previous AASLD recommendations from last year, they didn't have this Harvoni and they were recommending people like me, to do the Peg/Riba/Sovaldi. Now they know...
This is why I'm not intending to jump back into another treatment. I realize that others may have further progression than I do and can't afford to wait. But, I am waiting. I need for this stuff to have had more people doing it who are past Protease failure/and Sovaldi relapsers, in order for me to make a wise decision. After all, I've failed TX 12 times now and it's a bit ridiculous for me not to take my time and wait this out. With that being said, if my liver started getting a lot worse, I would have to rethink it. Also, my husband's insurance company and PAL aren't really going to be excited about spending another 80,000+/- on a patient like me w/o all these failures under my belt and non-cirrhotic. Anyhow, I hope that they can arrange the funding for you in the UK for the Harvoni. I really want to see you succeed in viral clearance and get SVR!
Susan400
This is why I'm not intending to jump back into another treatment. I realize that others may have further progression than I do and can't afford to wait. But, I am waiting. I need for this stuff to have had more people doing it who are past Protease failure/and Sovaldi relapsers, in order for me to make a wise decision. After all, I've failed TX 12 times now and it's a bit ridiculous for me not to take my time and wait this out. With that being said, if my liver started getting a lot worse, I would have to rethink it. Also, my husband's insurance company and PAL aren't really going to be excited about spending another 80,000+/- on a patient like me w/o all these failures under my belt and non-cirrhotic. Anyhow, I hope that they can arrange the funding for you in the UK for the Harvoni. I really want to see you succeed in viral clearance and get SVR!
Susan400
Thanks so much for the information. It gets very confusing after a while.
I am guessing that Sovaldi must be different and that is why people who fail Sovaldi/Olysio can then take Harvoni despite the fact that it contains Sovaldi.
If you look at all the people who were given interferon and riba over and over again it is really confusing :)
Thanks again.
Good luck dointime
Dee
I am guessing that Sovaldi must be different and that is why people who fail Sovaldi/Olysio can then take Harvoni despite the fact that it contains Sovaldi.
If you look at all the people who were given interferon and riba over and over again it is really confusing :)
Thanks again.
Good luck dointime
Dee
I just looked at your profile. I see you were in the No Riba arm when you did Triple Med Tx with Incivek. That may explain why you failed Tx or, at least, part of the reason you failed Tx. . Those who did not receive Riba did a lot worse (in terms of SVR rates) than those who received Riba.
Hopefully you can get Harvoni and attain SVR this time around.
Best of luck.
Hopefully you can get Harvoni and attain SVR this time around.
Best of luck.
pooh - I meant to mark your answer as best but seem to have screwed it up and also lost my whole reply so - starting again -
Thanks for this great answer. It is exactly what I need. I somehow failed to find it in all my searches. By the way, congratulations on your SVR!
Dee - great to hear from you!
AWorriedMom - thanks for chiming in here. I will take a copy of these guidelines along to the doc. Although I am in the UK I suspect I will have the same issues proving that I need the more expensive Harvoni - if the funds can even be found to pay for my tx.
dointime
Thanks for this great answer. It is exactly what I need. I somehow failed to find it in all my searches. By the way, congratulations on your SVR!
Dee - great to hear from you!
AWorriedMom - thanks for chiming in here. I will take a copy of these guidelines along to the doc. Although I am in the UK I suspect I will have the same issues proving that I need the more expensive Harvoni - if the funds can even be found to pay for my tx.
dointime
I attained SVR with Triple Tx (Interferon, Ribavirin, and Incivek). However, I keep up on the new treatments and guidelines.
The AASLD guidelines for those who failed with a PI 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.
If I were you, I would go to a 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
The AASLD guidelines for those who failed with a PI 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.
If I were you, I would go to a 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
Hi there! Nice to see you. I wish I had a definite answer for you. I had read at one time on here that there was a test to see if the Incivek had caused any resistance. I also read that even if it did, it could resolve in 2 to 3 years.
If I were you I would try it. It can't hurt to ask. People who treated with Sovaldi and relapsed are going on to Harvoni.
I am sure others will answer soon. I just wanted to say hello.
Dee
If I were you I would try it. It can't hurt to ask. People who treated with Sovaldi and relapsed are going on to Harvoni.
I am sure others will answer soon. I just wanted to say hello.
Dee
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