Telapravir

[tryin2btough]

I went in for my 6 month after treatment check up, and received the worst news...my viral count is back up. My Doctor told me a few options one of which is waiting for a new treatment that is in the third stage of trails they use the drug  Tealpravir in conjunction with interfuron and ribaviran. It is supposed to have a better sucess rate and less side effects...I was the 'poster child' for side effects with my first round, you name it I got it. Has anyone heard more about this drug or know anyone involved in trails??
Thank you
Oh I am 52 and have bridging fibrosis now, and I really am willing to go through hell...again.....if I have to to live

[tryin2btough]

Thank you it did make me smile :)

[oneatenuff]

Doc called me in late November to offer the VX-950 trial.  (I had been waiting for years for that particular trial.)   I was devastated that there was no way possible that I could make the appointment or even think about the trial  (death in family.)  Doc assured me I shouldn't worry at all that I couldn't do THAT particular trial and told me there were other PI trials coming up that looked just as promising as VX-950, and if I didn't want in on those trials I was doing well enough to wait until VX was approved.  (He anticipated in a few years.)  If he thinks I can wait two years, I can.   A good doc (hepatologist) will monitor your labs and will know if you can or cannot wait and will also know that there's no doubt that VX-950 is "curing" people.  If a patient can wait a few years to treat with a much more promising drug vs. treating again with 72 weeks of something that didn't work, that patient might have a better reason to "watch and wait."   You can always decide to not wait and to treat sooner than VX is approved  (but with VX and others on the horizon, I would personally want that decision to be based on labs that are going from good to bad, i.e. no time left to wait.)

Good luck.

[concernedfriend582]

Out of curiosity it seems that most of the chat on the net will have the PI approved by late 2010? Any thoughts on this?

[thegypsy9164]

I came stright to the bottow and didn't read the other responses here.  Vertex Pharmaceuticals (you can yahoo them) is the drug company that is trying to get approval for Telepravir and is hosting the trials through participating physicians groups.

They are running me out of work here right now so I'll have to get back.

J. Johnson

[AmeliaFufu]

     Only wanted you to know that I will be praying for you and sending you only possitive energy.  As a good friend always signs off to me
Sending you HEALING POWER, HEALING POWER, HEALING POWER.
If nothing else I hope it brought a smile to your face and that is healing too.
Ameliafufu

[mnl1]

I started the Telaprevir trail on Dec. 26 at that point I a had a starting vl. 5mil - stage 1 grade 2. I am 53 yrs. old and went in to treatment in decent shape. My 4 wk PCR was UND and my 8 wk. was UND-- that I believe is pretty good results. I have experienced sx-- rash, itching, a heaviness in my chest that won't go away as if I had bronchitis I am fatigued at times but have not missed a day of work and manage on most days to make it to the gym at 4:30am. I think it is the Telaprevir that causes the rash but I found it to be treatable with lotions and plenty of water.


I think the chances of 30% cure with SOC as opposed to 75 or 80% with the PIs are something to wait for or get into a trial if you can. I believe going into treatment exercising and taking care of yourself can really help with the sx.

Hope this helps.

[susan400]

There seems to be some debate on the particular patient retreating with another P.I.   I had a well respected hepatologist suggesting to me to retreat with Telaprevir, using all 3 drugs, once Telaprevir becomes approved.  AND he knows that I was exposed to Telaprevir for those 4-6 weeks.  However, he feels that since it was for just for a short period of time and that by the time that they are approved that resistant would probably not come into play.  However, I don't want to use the Telaprevir again and feel that by using the Boceprevir once it's approved that I will have an even lesser chance of resistance.  Also, I've always responded better to Peg-Intron than, I have to Pegasys and Boceprevir using Peg-Intron.  So, that's what I intend to do, whether it works or not, will be left to be determined by what happens with my treatment at that time.  I feel that I don't have a lot to lose and much to gain since I've already done this 10 other times and nothing else has worked.  

Susan400

[pjhep80]

phase III is it, there are no phase IV trials

[Tippyclubb]

How did you get into the trial, and what stage was your hep at ?
==========================

I found out which hospital in my area had the best known liver dept, and if they participated in clinical trials.  I went there and had a biopsy done stage 1 , grade 2.  I asked to be put on the list for upcoming clinical trials.  I received 4 calls to enter trials but I declined them all.  I was not in any hurry to treat, plus I had my eye on the Vertex trial.  They finally called and boy did I get lucky it was a NO placebo trial--the only one they have ever done.  I could not say no.

Vertex and Boceprevir are both in Phase 3 and I don't know if they do Phase 4 trials.  Maybe some will know and answer that.  You can go to www.clinicaltrials.gov for information.

Susan is 100 % correct when your doing the PI's you must be receiving all three meds to up the success rate.  One more thing about PI's if you don't SVR you can't treat with PI"s again.  The virus becomes resistant so its a one shot deal.

To Willy:  Oops sorry!

[Willy50]

I was responding to the lead post in which TVT said that their doctor said that Teleprevir;
"better sucess rate and less side effects".  By the way....In Europe they hit an 80%+ SVR rate.

The sides..... well....the discontinuation rate speaks to that.  It is a harder treatment.  One sees it particularly in the beginning.  There are many more dropouts in triple therapy than in the SOC control arms.  A marked improvement however is comparing the dropouts in 24 week triple therapy vrs the 48 weeks that one generally must do when one treats w/ SOC.  Even so..... fewer drop outs with SOC in 48 weeks.

Generally speaking however; the pain is worth it.  They have an unprecedented response and success rate.  Currently the first Phase 3 trial has/had a 8 week triple therapy course of treatment followed by 16 weeks of SOC.  If the results are comparable to the 12 &12 study we may see shorter courses of triple therapy and therefore fewer dropouts.

best,
Willy

[susan400]

For me, when I was in the Telaprevir trial, I was in Prove 3 (Group C), which was the no Riba group;  all I got was the Telaprevir and Peg.  I got the horrible rash 2 weeks into treatment, so I am sure beyond a shadow of a doubt that it was the Telaprevir; since there was no Riba involved in my treatment.  I've treated 10 times now and I've never cleared.  The key to using the Protease inhibitors is to use all 3 drugs in order for that 75% clearance to come into play.  Also, of note, the rash was not caused by the interferon because I've never had this horrific rash on any of my other treatments except for the one with the Telaprevir.  Also, there was no other cause that it could have been because I had not changed anything new in the weeks leading up to my rash, except for the adding of the Telaprevir.  In other words, no new detergents, creams, foods, etc.    I just wanted to clarify my experience with the Telaprevir rash and that I did know that it was that drug that caused it for me.  I also have a horrific reaction to Penicillin and almost died from it, so, I do believe that there's certain drugs that don't agree with certain people.  For me, personally, the next thing that I'm going to be trying will be the Boceprevir.  BTW, I also have had bridging fibrosis, for the past 7 yrs.  So, it is possible to have the bridging for awhile and as long as you're trying to take care of yourself, you can buy some time.  Like diet, exercise, rest, avoiding stress where possible, avoiding substances like alcohol and drugs.  Prayer....    Susan400

[tryin2btough]

I am leaning for the wait....the thought of another 72 weeks of tx is not the best thing I can imagine. It is hard after doing so much for all that time to now sit and wait, I am also thinking of trying some of the natural treatment while waiting for Tela to become available. How did you get into the trial, and what stage was your hep at ? Insomnia I can deal with, I also had rash with riba so you are probably right about it being what is causing it. Is the regime you are going through the standard for Tela, my doctor gave me the name to look into but had little information of his own because it is so new(He is a wonderful Dr very supportive, he even gave me his number and had me call him at home during tx!) I think you people doing the trails are our best information...thank you!!! for doing what you are doing.

[Tippyclubb]

This is my first time treating.  I will be on Telaprevir for 12 weeks along with Peg and Riba.  After 12 weeks I will drop the Tela and continue with Peg, Riba for another  3 months.  After 24 weeks I will be told to stop all meds or to continue tx for another 24 weeks depending upon which group I am placed in.

If your doctor suggested doing Telaprevir I would definitely consider that option, as oppose to doing the extended tx of 72 weeks.  Personally, I would opt for the shorter period of time of putting this poison in your system.

To: Willy50

Perhaps you did not read the one line in my post correctly about sides from Tela

Other than the rash I do believe that is the only sx from Tela, for me anyway.
=======================================

Emphasis on FOR ME.  I take Tela 3x daily and 2 of those times I take them with Riba.  When I take the Riba is when I experience nausea, insomnia ( like now 2:45 am ). Recently, a few days after taking the shot I experience extreme fatigue, nausea, and sometimes a headache.  It usually last for 24 hours and then I feel ok.  Once a day I take Tela with no other pills and I never feel any different.  So this is why I don't think the sx from Tela are not that bad.  I can only speak from how it affects me.  It may affect others differently.

As for the rash, honestly I can't say if its the Riba or Tela.  I saw the trial nurse today and she suspects it's the Riba because the rash is not severe and said if it were the Tela it would have spread more by now.  She also said shes not 100% certain of that either. So who knows.  I guess when I am off the Tela in 4 weeks and the rash is there I will know its the Riba rash for sure.

[Willy50]

I think Telaprevir will be approved in about 2 years.  If you take care of yourself you may be fine waiting (your doc can tell you).  Boceprevir should be approved right on the heels of Telaprevir; so you may have two choices and more data to make the better choice for you.

Sorry; I would not expect less sides with Telaprevir since the TX is still interferon and riba..... and then one more drug added.  How could the sides be easier?  One large difference is that with Telaprevir one might TX for only 24 weeks and have a good chance at SVR.

You can google or use the board search engine and search out past threads in this forum.  There are a *few* of them.

best,
Willy

[tryin2btough]

That is one problem I did not get I ran low but never enough for 'helpers' My counts all through treatment looked good my enzymes good, levels good. I had all kinds of reactions,  but inside things were looking pretty positive. I looked into the clinicle trails, none around here however....what was your lenght on regular ( interfuron, Riba) treatment and did you treat once? My other option was going back on tx and trying for a year and a half, some new data has shown better results with the xtended time....I just dont know what to do..I was so positive it would work...

[Tippyclubb]

One more thing you need to know about Vertex Trial is they do not allow rescue drugs.  If you had problems with your blood counts going down during treatment and needed the helper drugs , its not a option.  They will reduce your Riba instead.

[Tippyclubb]

I am in the Telaprevir trial right now--going into week 8.  There are several other people in the same trail on the forum also, and they may chime in.  There also have been some people in the trail who completed it and are now SVR.  One of them is Andiamo and he treated 8 or 9 times before finally being SVR with Telaprevir.  

Yes, they say the success rate is higher --I believe it 75%, along with the possibility of shorter treatment period.  In most cases the virus is UND by week 4--well according to the responses on this forum anyway, which is important to have RVR to be able to get into the 6 month tx group.  

One of the side effects of Tela is the rash, which I have now.  So far I have been able to keep it under control with lotions, creams, and anti itch meds.  I have heard in some people the rash will become so bad they have to stop tx, but that is a very small percentage of people.  Other than the rash I do believe that is the only sx from Tela, for me anyway.

I would definitely keep my eye on the results of Vertex Phase 3 trial.  Another PI that is getting good results is Bocepervir , which I do not believe causes the rash like Tela.
Keep your eye on both of them.  You can google both of them for more info.  There are several people on the forum currently in the Scherring Plough Boceprevir trial also and having good results.