willing to wait on vertex but for how long

[colts]

Will be getting biopsy results this tues.With consistant alts healthy life style ect.I cant help but be reluctantly optamistic thier will be minor damage.In this case after learning about this promising new vertex drug I am very excited about everythins I heard.My question is does anyone know what the steps that remain to make this product available for market and how long this could take I understand it is hard to know for sure but you people amaze me with your knowlege about just about everythins.Thats why I am grateful for this forum and all of you.I will probably wait for this drug as long as it wont be more than 5 yrs as I am 40 yrs old.

[jmjm530]

First see how much liver damage you have. You may not be able to wait five years or you may be able to wait a lot longer than five years.

As to Vertex (Telaprevir), no one can give you an exact date for approval, or even if it will be approved -- but five years is a very consertative estimate, from what surmise. Probably Telaprevir will be out on the market in some form in 2-3 years.

But two things regarding that. First, just because it hits the market, doesn't mean you have to jump on it right away, especially if you have little or no liver damage. Telaprevir will still be initially dosed with peg interferon and possibly ribavirin. Treatment times no doubt will be shorter and cure rates higher, but you would still be exposing yourself to interferon and perhaps ribavirin. Many doctors look forward to a newer generation of treatments without interferon, so if you have little or no liver damage, one reasonable approach is to keep on monitoring your liver and waiting for that newer generation of drugs. On the other hand, if your biopsy suggests you should treat sooner, you might start looking around for Telaprevir trials which would give you an opportunity to get the drug prior to FDA approval.

All the best,

-- Jim

[chcnme]

Hi Colts.  Nice to meet you.  Sorry to meet you this way, but this seems to be the way all of us on Hep C forums meet :)

Anyhow.... this (link below)  is a "module" off hcvadvocate that's pretty good to listen to.  

As far as how long it will be - it seems experts' opinions vary on this, but it's for sure I believe that most hepatologists are definitely weighing "newer treatments" into the picture when helping patients make the decision to treat now or to wait.  

My research coordinator at Duke (RC for VX-950)  said it would be at least three years or longer before VX -950  was on the market  (she said this about 6 months ago when talking to me about a trial of HCV 796).   How she was able to make this assumption about VX 950 - I don't know, but she did  (and she was adamant that it would be that long and even added -- "if ever").  

I've had the virus 33 years (acquired it at a very young age).  I'm female, almost 48.  Biopsy is 2003 was grade 3/ stage 2.  A recent fibrosure suggested only grade 1-2 stage 1-2.   My labs (with the exception of low platelets for the past 3 years)  are OK  (normal - liver functions OK, kidney functions OK, wbcs and rbcs OK, bili, alk phos, albumin, etc).  I've been in watch and wait mode and trial since 2005 - Duke doc totally OK with this and a second hepatologist is, as well -- WITH the understanding if my labs start getting funky or there is something to suggest my liver is going down hill -- that I will begin SOC and not wait on "better treatments").  But for now, all is ... status quo, it seems.

Copy and paste this URL into your browser.

http://www.hcvadvocate.org/Modules/Module%202/player.html

If it doesn't pull the module up, then go here and see "HCSP Training Module 2: Making Treatment Decisions. It's pretty good.  Might help you some in making the decision.  

http://www.hcvadvocate.org/

Best of luck in your decision.  

[Willy50]

Vertex says that if all goes well they could file for a NDA (I think that's new drug application) by the end of 2008.  I've heard that the review process varies but that all depends of how clear cut the drugs safety and effectiveness is.  I'll just guess that it could be in early 2009.  That's about 2 years.  I don't claim to know.  Neither Vertex or the FDA could tell you today and so you know how much value my opinion has.  My premise is that everything must go text book smooth.  I've also heard up to double that amount of time.  We'll know more and more as this trial process goes on.

best,
Willy