Aa
new meds
HI I have just read the good news regarding Europe passing the new drug. I stopped tx on 23rd Dec last year after 10 weeks as I was having daily panic attacks and ending up in a & e all the time, hahallucinating etc. my specialist.said that I would end up in a psychiatric ward if I didnt stop. I would like to know when I could start the new drug and if I would have to still have interferon/ribavirin. anyone who knows more about this please respond. Thx
Thanks for your link to the slide presentation. Always like reading all available info.
As far as resistance to Sovaldi, the data at this time shows that it has a high resistance barrier to mutation and also low chance of cross resistance. In both NEUTRINO and FISSION trials, deep sequencing analysis of patients taking sofosbuvir who relapsed after having a virologic response showed no evidence of resistance-associated variants.
Granted, never say never, however right now it appears that if retreatment of HCV is required due to a relapse using sovaldi, that Sovaldi can be used again in combination with another med. In slide 6, it shows that the NS5B (Sovaldi) has NO RAVs in the sovaldi/ledipasvir arms.
If treat with Sovaldi and Olysio and relapse, treatment with sovaldi and ledipasvir apprears to still be a viable option.
As far as resistance to Sovaldi, the data at this time shows that it has a high resistance barrier to mutation and also low chance of cross resistance. In both NEUTRINO and FISSION trials, deep sequencing analysis of patients taking sofosbuvir who relapsed after having a virologic response showed no evidence of resistance-associated variants.
Granted, never say never, however right now it appears that if retreatment of HCV is required due to a relapse using sovaldi, that Sovaldi can be used again in combination with another med. In slide 6, it shows that the NS5B (Sovaldi) has NO RAVs in the sovaldi/ledipasvir arms.
If treat with Sovaldi and Olysio and relapse, treatment with sovaldi and ledipasvir apprears to still be a viable option.
Hi Will! Remember I'm new to all this, only diagnosed this past sept. I've done the research but have had my hep docs support with every decision. He also consults with a panel of experts...some of the best on the east coast....who are with an Institute of Excellence facility.
In deciding to go ahead with tx regardless of Q80K, the results from the cosmos trial for F4 (I'm cirrhotic and not comfortable waiting) Sovaldi/Olysio w/ RIBA at 93% and Sovaldi/Olysio w/o RIBA at 100%. So I'll take 91% all day.
When looked at by HCV GT1 subtype, the results show that patients with the Q80K polymorphism did not fare as well. In cohort 1, 89% of patients with that polymorphism achieved an SVR12, compared with 100% of those with GT1a or 1b without Q80K. In cohort 2, 91% of those with the polymorphism achieved an SVR4, compared with 100% of the patients with GT1a or 1b who did not have Q80K.
http://3.bp.blogspot.com/-2QKP0QqdYls/UnlRpfr3eCI/AAAAAAAAKxc/EO0uCLJxXwQ/s1600/so.PNG
As far as retreating, note results from Ion....
The Phase 3 ION studies are randomized, open-label Phase 3 clinical trials evaluating the efficacy and safety of a once-daily fixed-dose combination of SOF/LDV for 8, 12 or 24 weeks, with and without RBV, among 1,952 genotype 1 HCV patients. The studies included patients who were treatment-naïve or who had ***failed previous treatment, including protease inhibitor-based regimens.*** The primary endpoint for each study was SVR12. Complete results from all three studies will be presented at a future scientific conference.
The ION-2 study evaluated 440 treatment-experienced genotype 1 HCV patients who had failed past therapy with regimens containing Peg-IFN (including Peg-IFN ***plus a protease inhibitor***). Patients received SOF/LDV with or without RBV for 12 or 24 weeks.
I also know someone personally that failed with boceprevir, a PI, and three months later started and cleared on Ion2 trial. A lot of people I've talked to think Sovaldi is so powerful that decreased effect on Olysio isn't huge.
You're right...not much to go on right now.
Remember too when Gilead got approval there was a caveat to be able to treat off label.
Personally I think we are in that interim period where the new drugs aren't all approved and it's hard politically and financially to kick peg/RIBA to the curb. JMHO.
I'm comfortable with my decision for me....and totally respect what others decide for themselves.
Anyway, as Food Lion tiger says....just my 2 cents. :)
In deciding to go ahead with tx regardless of Q80K, the results from the cosmos trial for F4 (I'm cirrhotic and not comfortable waiting) Sovaldi/Olysio w/ RIBA at 93% and Sovaldi/Olysio w/o RIBA at 100%. So I'll take 91% all day.
When looked at by HCV GT1 subtype, the results show that patients with the Q80K polymorphism did not fare as well. In cohort 1, 89% of patients with that polymorphism achieved an SVR12, compared with 100% of those with GT1a or 1b without Q80K. In cohort 2, 91% of those with the polymorphism achieved an SVR4, compared with 100% of the patients with GT1a or 1b who did not have Q80K.
http://3.bp.blogspot.com/-2QKP0QqdYls/UnlRpfr3eCI/AAAAAAAAKxc/EO0uCLJxXwQ/s1600/so.PNG
As far as retreating, note results from Ion....
The Phase 3 ION studies are randomized, open-label Phase 3 clinical trials evaluating the efficacy and safety of a once-daily fixed-dose combination of SOF/LDV for 8, 12 or 24 weeks, with and without RBV, among 1,952 genotype 1 HCV patients. The studies included patients who were treatment-naïve or who had ***failed previous treatment, including protease inhibitor-based regimens.*** The primary endpoint for each study was SVR12. Complete results from all three studies will be presented at a future scientific conference.
The ION-2 study evaluated 440 treatment-experienced genotype 1 HCV patients who had failed past therapy with regimens containing Peg-IFN (including Peg-IFN ***plus a protease inhibitor***). Patients received SOF/LDV with or without RBV for 12 or 24 weeks.
I also know someone personally that failed with boceprevir, a PI, and three months later started and cleared on Ion2 trial. A lot of people I've talked to think Sovaldi is so powerful that decreased effect on Olysio isn't huge.
You're right...not much to go on right now.
Remember too when Gilead got approval there was a caveat to be able to treat off label.
Personally I think we are in that interim period where the new drugs aren't all approved and it's hard politically and financially to kick peg/RIBA to the curb. JMHO.
I'm comfortable with my decision for me....and totally respect what others decide for themselves.
Anyway, as Food Lion tiger says....just my 2 cents. :)
Pam & maddie.
It is correct that the reasearch shows that if one has the Q80 mutation that there is really no relavance when the NS5B (sovaldi ) is used in combination with Olysio
(see below) You may have to join to view below ,if you have not already,however it is free to do so)
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Keeping%20Up/Interactive%20Virtual%20Presentation/IVP/Pages/Page%201.aspx
. (go to the 3rd section ,slide 2 discusses this)
However it does say somewhere in that whole presentation(forgive me I can not remember which sect.) that if one has already tried
either of the proteases(Inci or Vic) that there may be Protease resistant mutations and given that it would seem knowlegable Hepa's may be reluctant to start Olysio(a protease) until one has had the Genosure resistance test,and if there is such resistance then waiting until the NS5A(ledipasvir) can be combined with Sovaldi .
Also Pam when you say:
"researching I've found this shouldn't create any resistance. Ion study included those that previously failed with PI tx. "
Am I not correct that the Ion -1 was for Tx. Exp that had already failed A "protease" (either Inci or Vic) and then in that study did Sovaldi + Led ipasivir (a NS5B plus the NS5A)
How would that mean , if given one fails to have success with Sovaldi/Olysio that one could do Sovaldi again (when there has been no trials to date with NS5B(sovaldi ) failures?.
Possibly I have missed something......
Sorry jenn did not mean to hijack either ,good luck....
Will
It is correct that the reasearch shows that if one has the Q80 mutation that there is really no relavance when the NS5B (sovaldi ) is used in combination with Olysio
(see below) You may have to join to view below ,if you have not already,however it is free to do so)
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Keeping%20Up/Interactive%20Virtual%20Presentation/IVP/Pages/Page%201.aspx
. (go to the 3rd section ,slide 2 discusses this)
However it does say somewhere in that whole presentation(forgive me I can not remember which sect.) that if one has already tried
either of the proteases(Inci or Vic) that there may be Protease resistant mutations and given that it would seem knowlegable Hepa's may be reluctant to start Olysio(a protease) until one has had the Genosure resistance test,and if there is such resistance then waiting until the NS5A(ledipasvir) can be combined with Sovaldi .
Also Pam when you say:
"researching I've found this shouldn't create any resistance. Ion study included those that previously failed with PI tx. "
Am I not correct that the Ion -1 was for Tx. Exp that had already failed A "protease" (either Inci or Vic) and then in that study did Sovaldi + Led ipasivir (a NS5B plus the NS5A)
How would that mean , if given one fails to have success with Sovaldi/Olysio that one could do Sovaldi again (when there has been no trials to date with NS5B(sovaldi ) failures?.
Possibly I have missed something......
Sorry jenn did not mean to hijack either ,good luck....
Will
Thank you and thanks for sharing the other news....I'm loving these success stories! Two things convinced me to go ahead 1) according to Cosmos study my chance of SVR goes from 100% to 91%. I'll take that! 2) researching I've found this shouldn't create any resistance. Ion study included those that previously failed with PI tx.
Soooo....worse case is that I slow the progress and retreat with the combo 'miracle drug' in fall/winter.
Best case....I am und and cured!!
Best of luck with your test!
Soooo....worse case is that I slow the progress and retreat with the combo 'miracle drug' in fall/winter.
Best case....I am und and cured!!
Best of luck with your test!
I think you are making the right decision. I had blood drawn but don't know result as of yet. I saw a post on another HCV discussion site that someone on the sovaldi/olysio tested undetected 2 weeks after starting the combo. He has the Q80K mutation.
Good morning! And apologies Jennifer for high jacking your thread...
It appears I do have Q80K mutation but after consulting with a panel of hep docs, they support going ahead with the treatment. So that's what I'm doing. Prescription has been written and as long as Aetna doesn't balk, I should start as soon as drugs show up on my doorstep. :)
It appears I do have Q80K mutation but after consulting with a panel of hep docs, they support going ahead with the treatment. So that's what I'm doing. Prescription has been written and as long as Aetna doesn't balk, I should start as soon as drugs show up on my doorstep. :)
I'm one of the ones that have gotten a prescription off label for Sovaldi/Olysio. If you're not in a medical emergency requiring immediate treatment I would encourage you to stay on top of the new drugs coming out...There is a one pill combo due to be approved later this year in the US with close to 100% success rate and with little to no side effects.
I personally would do anything possible not to go down the interferon and RIBA road. Of course I respect everyone's decision to do what they think is right for them....Best of Luck!
I personally would do anything possible not to go down the interferon and RIBA road. Of course I respect everyone's decision to do what they think is right for them....Best of Luck!
Olysio is the brand name for Simeprevir in the US and
Sovaldi is the brand name for Sofosbuvir in the US
Sovaldi is the brand name for Sofosbuvir in the US
Thx for your comments. I am in the UK. my specialist said it was the ribavirin that caused the panic attacks. What is olysio?
I would contact your hep specialist and ask about it and if appropriate get on a list get an appointment time close to the actual time it's available to patients. . It probably will take some time to get answers.
this is the treatment conditions approved
Genotype 1, 4, 5 or 6 CHC Sovaldi + RBV + peg-IFN 12 weeks
Sovaldi + RBV Only for use in patients ineligible or intolerant to peg-IFN
24 weeks
Genotype 2 CHC Sovaldi + RBV 12 weeks
Genotype 3 CHC Sovaldi + RBV + peg-IFN 12 weeks
Sovaldi + RBV Only for use in patients ineligible or intolerant to peg-IFN
24 weeks
Patients with CHC awaiting liver transplantation
Sovaldi + RBV Until liver transplantation
Some people have got their doctor to proscribe Solvaldi and Olysio off-label in the US. The European Commission I believe has some method that doctors through their country can apply for off label or not yet approved drugs for compassionate use depending on the severity and need for quick treatment.
What country do you live in?
Hopefully other members living there will also add info if they become aware of additional info for your country.
Since I live in the US i really can't add any more to this and I wish you the best.
this is the treatment conditions approved
Genotype 1, 4, 5 or 6 CHC Sovaldi + RBV + peg-IFN 12 weeks
Sovaldi + RBV Only for use in patients ineligible or intolerant to peg-IFN
24 weeks
Genotype 2 CHC Sovaldi + RBV 12 weeks
Genotype 3 CHC Sovaldi + RBV + peg-IFN 12 weeks
Sovaldi + RBV Only for use in patients ineligible or intolerant to peg-IFN
24 weeks
Patients with CHC awaiting liver transplantation
Sovaldi + RBV Until liver transplantation
Some people have got their doctor to proscribe Solvaldi and Olysio off-label in the US. The European Commission I believe has some method that doctors through their country can apply for off label or not yet approved drugs for compassionate use depending on the severity and need for quick treatment.
What country do you live in?
Hopefully other members living there will also add info if they become aware of additional info for your country.
Since I live in the US i really can't add any more to this and I wish you the best.
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