Hep C Discussion Forum

Members Login
Username 
 
Password 
    Remember Me  
Chatbox
Please log in to join the chat!
Hep C Discussion Forum -> On Treatment -> Is Interferon Free Available On Label
Post Info TOPIC: Is Interferon Free Available On Label
Isiscat2011


Guru

Status: Offline
Posts: 1724
Date:
RE: Is Interferon Free Available On Label
Permalink  
 

drexelpbp wrote:

If you relapse on the Solvaldi/Olysio combination would you be eligible to be treated with Solvaldi/ Ledispavir combination?

 Based on currently available information the answer is yes.  



__________________

Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
drexelpbp


Member

Status: Offline
Posts: 24
Date:
Permalink  
 

If you relapse on the Solvaldi/Olysio combination would you be eligible to be treated with Solvaldi/ Ledispavir combination?



__________________
Isiscat2011


Guru

Status: Offline
Posts: 1724
Date:
Permalink  
 

Great explanations about how these new drugs work and I think it is important to understand that almost nothing in life, or certainly in medicine, is guaranteed.  Clinical trials to bring new drugs to market are done over a limited time period with a limited number of people. The best we can do is make an educated guess about when and with what to treat and then hope for the best.  

Having realistic expectations is important with any medical decision because nothing, and I mean nothing, is guaranteed to give everyone a 100% positive outcome with no side effects or long term ramifications.  



__________________

Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Tig


Admin

Status: Offline
Posts: 9284
Date:
Permalink  
 

Hi J,

Sov/Oly is an excellent combination! Olysio is a protease blocker and Ledispavir is a nucleoside blocker. They block replication in different areas and basically Olysio offers more potential for side effects than Ledispavir. The Q80K polymorphism when present can impact success rates but when Sovaldi is the backbone drug, this doesn't matter. Ledispavir isn't affected by this. So in the big picture and from trial results, it appears that Sov/Led will be the most effective, 100% in some reports, but certainly high 90% in most studies and with the fewest side effects. Both of these protocols are highly effective and Sov/Led is simply the next new kid on the block and with each new drug hopefully comes increased chances of success. Don't worry about the differences, the combo you're on is highly effective and desirable!

Tig



__________________

Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

Signature Line Set Up/Abbreviations   Payment Assistance

 
Omnamahshivaya


Senior Member

Status: Offline
Posts: 107
Date:
Permalink  
 

 Ledispavir also inhibits viral replication at the NS5A protein, where Olysio does it at the NS3/4A protein and the word is the 5A site is more effective at replication inhibition.

 

what does this mean Tig? I thought you told me that Olysio/Solvadli was excellent and on par with Led/Solvaldi.

I have no 80Q

 

thanks!



__________________

OMJ - started treatment April 25, 2014

Prior to treatment VL 14 million. Liver Levels Abnormal but under 70.

Sovaldi/Olysio

VL: SOT = 14 million.    SOT +2 weeks = 28

AST/ALT: Normal

Week # 7 = UND
mallani


Guru

Status: Offline
Posts: 3398
Date:
Permalink  
 

Hi Kay,

Tig has covered most of it. Ledipasvir is not affected by the Q80K polymorphism. It blocks the NS-5A replication complex, which is the nerve centre of the whole replication process. This is also a fairly unstable site, so RAV's to NS-5A blockers develop rapidly. As yet, these have not been fully documented. However, if Sovaldi is taken as well, these RAV's do not seem to be a problem (as yet).

The protease site (blocked by Olysio) is found elsewhere in the body. Blocking this site (NS-3) will cause side effects as all protease sites are blocked. In general, the combination of an NS-5A and NS-5B (nucleoside) blocker, should give the fewest side effects. It also appears to be the most potent combination. This is why Sovaldi/Ledipasvir or Sovaldi/Daclatasvir will be the best available treatment.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
Kay


Member

Status: Offline
Posts: 32
Date:
Permalink  
 

Thank you Tig...it makes sense to wait then. Such excellent information ...thank you thank you.



__________________
Tig


Admin

Status: Offline
Posts: 9284
Date:
Permalink  
 

Hi Kay,

There are a number of differences between Ledispavir and Olysio, namely the rates of success with Ledispavir are near perfect with Sovaldi, 100% across many reports, but as we've seen, Olysio is in the mid to high 90's in reports as well, but every point is important. Sov/Led will be offered as a combined medication, said to be a single pill, once daily dose and will be offered with full approval, no dealing with the "Off Label" headaches that Sov/Oly has been causing so many people to begin with.  Ledispavir also inhibits viral replication at the NS5A protein, where Olysio does it at the NS3/4A protein and the word is the 5A site is more effective at replication inhibition. I'm not sure how Ledispavir is affected by the Q80K polymorphism, but with Sovaldi, if it does, it wouldn't matter anyway. I'll have to read more on that and Malcolm will know more on that as well as other information I'm not aware of. Basically Kay, Sovaldi and Ledispavir will be a more effective combination, provided by a single manufacturer, in a single pill. I believe from reports released that the price isn't going to be very attractive, but none of them are. But the proof of high to near perfect performance rates, no off label issues to deal with and minimal side effects over a 12 week course of treatment makes it look very promising indeed. 

Tig



__________________

Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

Signature Line Set Up/Abbreviations   Payment Assistance

 
Kay


Member

Status: Offline
Posts: 32
Date:
Permalink  
 

Thank you Tig that helps...may I ask why you would prefer the Sovaldi and Ledispavir combo? Is it more effective, less side effects? 



__________________
Tig


Admin

Status: Offline
Posts: 9284
Date:
Permalink  
 

Hi Kay,

Yes, the only current available Interferon free treatment is Sov/Oly as an off label approach, but there has been a fast track request to get that combo FDA approval sooner than later because of all the trouble getting it approved recently. I believe if you were able to wait, I'd prefer the Sovaldi and Ledispavir combo coming soon. Looks like approval in Oct/Nov and hopefully they'll start dispensing quickly. I've read several reports claiming the desire to avoid Interferon by the patient for any reason qualifies as an "Interferon intolerance qualification". That doesn't mean your insurance carrier will approve it for that reason alone, but it helps with any appeal. Generally one of the main qualifiers for Sov/Oly now is advanced fibrosis and if that is documented on the initial request, it's often approved. There have been multiple denials and appeal processes since these two drugs were released, so I believe from what I've seen, they (insurance) is approving the off label requests more often and  those that have had to appeal an initial denial are getting approved. So I think it's improving, certainly far better than how it started out.

Tig



__________________

Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

Signature Line Set Up/Abbreviations   Payment Assistance

 
Kay


Member

Status: Offline
Posts: 32
Date:
Permalink  
 

Forgive my ignorance I should probably know this.

 

Is there a regimen available now that is interferon free? Riba free? I am hearing about Sovaldi and Olysis. From what I understand it is for anyone who is not a candidate for interferon...and that could mean I dont wan to take it....that makes me not a candidate. Is this only being dispensed like this S&O off label? Or is this an approved regimen for those not wanting interferon.

I have waited for years now because I am very afraid of interferon. I was thinking I needed to wait until fall for the one a day pill that is coming but is there something now with over 90% efficacy that is interferon free? Riba free? 



__________________
Page 1 of 1  sorted by
 
Quick Reply

Please log in to post quick replies.
Hep C Discussion Forum -> On Treatment -> Is Interferon Free Available On Label
Legal Disclaimer:

THIS FORUM, IT'S OWNERS, ADMINISTRATORS, MODERATORS AND MEMBERS DO NOT AT ANY TIME GIVE MEDICAL ADVICE AND IN ALL CASES REFER ANYONE HERE TO SEEK APPROPRIATE MEDICAL ADVICE FROM THEIR DOCTOR.