Aa
Any non-cirrhotic people getting Harvoni + Riba?
Hi All,
I know that 12 weeks Harvoni + Riba is only recommended for cirrhotics, but I wonder if in practice people and their docs are adding the Riba, just for extra insurance?
I am genotype 1b, PI experienced, ifn experienced, non-cirrhotic F1. The Gilead ION2 study gives my category of person an 87% chance of SVR with 12 weeks Harvoni alone.
I say NO WAY JOSE!
So I am debating my options. What I'd really like to know is if anybody non-cirrhotic has done 12 weeks Harvoni + Riba, were you 1a or 1b and what the outcome was?
Many thanks,
dointime
I know that 12 weeks Harvoni + Riba is only recommended for cirrhotics, but I wonder if in practice people and their docs are adding the Riba, just for extra insurance?
I am genotype 1b, PI experienced, ifn experienced, non-cirrhotic F1. The Gilead ION2 study gives my category of person an 87% chance of SVR with 12 weeks Harvoni alone.
I say NO WAY JOSE!
So I am debating my options. What I'd really like to know is if anybody non-cirrhotic has done 12 weeks Harvoni + Riba, were you 1a or 1b and what the outcome was?
Many thanks,
dointime
I can't tell you how glad I am to hear that the synthroid is history for you! As you know, many people ended up with permanent thyroid damage from interferon. You are SO lucky considering all the ifn that you have had. We are both lucky in that the new treatments do not include interferon. I would rather get run over by a bus than do that stuff again.
dointime
dointime
The good news is that YES, the thyroid thing is history. I did manage to wean off of it (Synthroid) without any recurrence of the hypothyroidism. Went to see the endocrinologist initially. Then, after I had weaned myself off with constant repeat labs as I was doing it.., I provided him wth all the labwork reports and told him exactly what I did. He was fine with it. It's very well know that interferon can affect the thyroid and in my case, I'd had this happen with the thyroid temporarily acting up-one other time in the past-after the another interferon treatment. And back then, it had settled down again to normal.., just like this time. I am DEFINITELY never using Interferon for Hep C treatment ever again because my body just can't take it anymore. But, somewhere down the road, I will probably retreat with some other pills to try again to get an SVR. Whether it will be Harvoni, or not, is not yet decided. Who knows, by the time I'm ready to do anything again, there might be something else even better approved. There are lot's of things still be worked on in research. Susan400
Hi Susan, great to hear from you and that your liver is holding up and giving you time. You don't mention the thyroid thing. I hope you managed to get that under control.
I will be doing Harvoni one way or another. The Indian generic supply of Sofosbuvir is now well established so generic Harvoni should be easy enough to obtain, unless Gilead tries to enforce even more draconian restrictions on the Indian supply. With Gilead, who knows. Seems they will go to any lengths to make obscene bucks. Thanks for your wish that they would just give me the Harvoni. It made me smile, but I think he!! will freeze over before that happens!
dointime
I will be doing Harvoni one way or another. The Indian generic supply of Sofosbuvir is now well established so generic Harvoni should be easy enough to obtain, unless Gilead tries to enforce even more draconian restrictions on the Indian supply. With Gilead, who knows. Seems they will go to any lengths to make obscene bucks. Thanks for your wish that they would just give me the Harvoni. It made me smile, but I think he!! will freeze over before that happens!
dointime
Hi, just noticed your post and just wanted to say Hi. I'm still non-cirrhotic, but choosing not to do any Harvoni at this time. My liver has not progressed any in fibrosis at all and in fact, per the fibrospect labs and sono, has actually gotten better even though I relapsed. I was consistent with F2-F4 back in Feb. and now it's saying consistent with F1-F2. My other labs are all great. The only abnormality were slightly elevated LFTs, but the ALT is just barely elevated at all, just 3 points over the cutoff. And then, on the sono, the same chronic inflammation of the liver (but it's been that way for years) and then the atherosclerotic plaque of aorta w/o aneurysm (again, for years). So, I'm just wanting to wait. In another year, my doctor and I will assess things. I'll get labs in 6 mon. in between. If you really want to treat again, can you appeal it with your doctor's help and get the Harvoni even w/o being cirrhotic? My insurance company is not inclined to retreat me anyway with all the thousands they just shelled out last summer-and then-w/me relapsing + being non-cirrhotic-they REALLY, REALLY, don't want to approve it and I REALLY,REALLY, don't want to fight them or treat again right now anyway, so..., I wish I could get them to just give it to you! Susan400
OK, I concede that is what they meant.
But I think the whole world of data we have currently is limited. The ION2 and Sirius trials did not have big numbers of people, especially of geno1b. Seems to me that if you are unlucky enough to have these baseline NS5A RAVs then your chances of SVR go down substantially, but less so if you add riba. That does not come out in the trial averages. So in the absence of testing for RAVs I still feel that I want to insure against having them by adding Riba, even though I hate the stuff.
Thanks for the best wishes and congratulations on your SVR.
dointime
But I think the whole world of data we have currently is limited. The ION2 and Sirius trials did not have big numbers of people, especially of geno1b. Seems to me that if you are unlucky enough to have these baseline NS5A RAVs then your chances of SVR go down substantially, but less so if you add riba. That does not come out in the trial averages. So in the absence of testing for RAVs I still feel that I want to insure against having them by adding Riba, even though I hate the stuff.
Thanks for the best wishes and congratulations on your SVR.
dointime
"based on limited data".applies to "add RBV if you already failed sof/sim " but "based on limited data" doesn't apply for those who failed with protease inhibitor telaprevir or boceprevir. for not including RBV as of August 7, 2015 in the guidelines.
Best wishes for achieving SVR
Best wishes for achieving SVR
Hi Lynn & Jimmy,
Thanks guys, really helpful.
This is the one from the new guidelines that relates most to me:
Recommended regimen for patients without cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom prior treatment with an HCV nonstructural protein 3 (NS3) protease inhibitor (telaprevir, boceprevir, or simeprevir) plus PEG-IFN and RBV or simeprevir plus sofosbuvir has failed (no prior NS5A treatment).
Rating: Class I, Level A
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for retreatment of patients with HCV genotype 1 infection, regardless of subtype, who do not have cirrhosis, in whom prior treatment with an HCV protease inhibitor, plus PEG-IFN and RBV has failed. Based on limited data, the addition of weight-based RBV to ledipasvir/sofosbuvir is recommended for patients without cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed.
---------------------------------------------------------------
The reports out of the ION2 and Sirius studies are a bit of a moving target I think. The results reported here are similar but not the same as other reports I have read. It is all so new that I suppose things will be refined for years as we go along, just as happened with the old ifn/riba tx.
I note especially that they say you can add RBV if you already failed sof/sim (not me) but they don't recommend it if you failed telaprevir (like me). So I hear that I shouldn't need to add RBV and that is my answer, but it's based on limited data. I'll see what my doc says now.
dointime
Thanks guys, really helpful.
This is the one from the new guidelines that relates most to me:
Recommended regimen for patients without cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom prior treatment with an HCV nonstructural protein 3 (NS3) protease inhibitor (telaprevir, boceprevir, or simeprevir) plus PEG-IFN and RBV or simeprevir plus sofosbuvir has failed (no prior NS5A treatment).
Rating: Class I, Level A
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for retreatment of patients with HCV genotype 1 infection, regardless of subtype, who do not have cirrhosis, in whom prior treatment with an HCV protease inhibitor, plus PEG-IFN and RBV has failed. Based on limited data, the addition of weight-based RBV to ledipasvir/sofosbuvir is recommended for patients without cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed.
---------------------------------------------------------------
The reports out of the ION2 and Sirius studies are a bit of a moving target I think. The results reported here are similar but not the same as other reports I have read. It is all so new that I suppose things will be refined for years as we go along, just as happened with the old ifn/riba tx.
I note especially that they say you can add RBV if you already failed sof/sim (not me) but they don't recommend it if you failed telaprevir (like me). So I hear that I shouldn't need to add RBV and that is my answer, but it's based on limited data. I'll see what my doc says now.
dointime
"The Gilead ION2 study gives my category of person an 87% chance of SVR with 12 weeks Harvoni alone " That averaged probably included cirrhotics
From the above link ION-2
The SVR12 rate with 12 weeks of ledipasvir-sofosbuvir was 94% without ribavirin and 96% with ribavirin. Both groups of patients who received 24 weeks of therapy had an SVR12 rate of 99%. For patients with cirrhosis, the SVR rates were lower with 12 weeks of therapy (86% with ledipasvir-sofosbuvir and 82% with ledipasvir-sofosbuvir with ribavirin) compared with the respective 95% and 100% SVR rates with 12 weeks in patients who did not have cirrhosis.
From the above link ION-2
The SVR12 rate with 12 weeks of ledipasvir-sofosbuvir was 94% without ribavirin and 96% with ribavirin. Both groups of patients who received 24 weeks of therapy had an SVR12 rate of 99%. For patients with cirrhosis, the SVR rates were lower with 12 weeks of therapy (86% with ledipasvir-sofosbuvir and 82% with ledipasvir-sofosbuvir with ribavirin) compared with the respective 95% and 100% SVR rates with 12 weeks in patients who did not have cirrhosis.
From the same link in flyinlynn's reply
adding RBV is only recommended for non cirrhotic for this situation.
Based on limited data, the addition of weight-based RBV to ledipasvir/sofosbuvir is recommended for patients without cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed.
Since you are only F1 no need to add a drug that may have more harmful side effects if not necessary.
for more through info including slides review
besides ion2 also look at ion 3
http://www.hepatitisc.uw.edu/page/treatment/drugs/ledipasvir-sofosbuvir
Best wishes for achieving SVR
adding RBV is only recommended for non cirrhotic for this situation.
Based on limited data, the addition of weight-based RBV to ledipasvir/sofosbuvir is recommended for patients without cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed.
Since you are only F1 no need to add a drug that may have more harmful side effects if not necessary.
for more through info including slides review
besides ion2 also look at ion 3
http://www.hepatitisc.uw.edu/page/treatment/drugs/ledipasvir-sofosbuvir
Best wishes for achieving SVR
Hi
Per the lastest revision to the AASLD guidelines for RETREATMENT OF PERSONS IN WHOM PRIOR THERAPY HAS FAILED
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
if you scroll down just a bit you will see new information highlighted for GT 1b I guess this was just changed on 8/7/15 the first one about daclatasvir is highlighted
Several options with similar efficacy are recommended for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed (listed in alphabetic order; see text).
Daily daclatasvir (60 mg) plus sofosbuvir (400 mg) for 12 weeks is recommended for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class IIa, Level B
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level A
Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) for 12 weeks is recommended for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level A
Daily simeprevir (150 mg) plus sofosbuvir (400 mg) for 12 weeks is recommended for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class IIa, Level B
Per the lastest revision to the AASLD guidelines for RETREATMENT OF PERSONS IN WHOM PRIOR THERAPY HAS FAILED
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
if you scroll down just a bit you will see new information highlighted for GT 1b I guess this was just changed on 8/7/15 the first one about daclatasvir is highlighted
Several options with similar efficacy are recommended for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed (listed in alphabetic order; see text).
Daily daclatasvir (60 mg) plus sofosbuvir (400 mg) for 12 weeks is recommended for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class IIa, Level B
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level A
Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) for 12 weeks is recommended for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level A
Daily simeprevir (150 mg) plus sofosbuvir (400 mg) for 12 weeks is recommended for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class IIa, Level B
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