48 weeks

[mnl1]

I started the Vertex trial Dec. 26, 2008. I am Geno 1A stage 2,  starting VL  5 mil.

The study is blinded but I tested on my own and was UND at 4, 8 and the 12wk mark. There was a possibility of ending treatment at 24 wks but I just received an email letting me know I did not fall into that arm of the trail and need to go 48 wks.

I understand the trail is randomized and the length of treatment has nothing to do with how you are responding as far as the drug company goes.

I have a question for the forum about ending treatment at 24 wks based on RNA tests. Understand I am not saying I am thinking about ending treatment I would just like some thoughts from people who have and are experiencing treatment.

If you were on a trail and you had tests that showed you were UND at the 4th wk and stayed that way till week 24 would you consider ending treatment? Why or why not?

Thanks

[mnl1]

Sorry it took so long to respond...I don't look at the site every day.

I never intended to stop treatment... I was just asking a question... I am committed to what I started and went in fully anticipating 48 wks.

Everything you stated I would agree with. The PCR tests I had were done at Lab Corp and I know they are not the most sensitive test.

I do feel a responsibility to what I started and am thankful to have been able to get into the trial. I don't believe the decision has anything to do with being a fighter or not, fighters use there heads and don't take abuse for no reason.

Thanks for your input.

[Rockerforlife]

Rocker, Will you do 48 if you end up in the 36 group?

im in the 36 group..just waiting for the news if i go the 48...bring on the weapons...im ready to kill...LOL

[newleaf09]

Rocker, Will you do 48 if you end up in the 36 group?  I felt exactly the same way; I'd do ANYTHING and suffer as long as neccessary, but I did not argue when I got randomized into the short group.

[Rockerforlife]

I say fight this thing all you can...no backing down...ill even do 72 weeks of BOC if i had too

[newleaf09]

I believe that if you fell within the criteria for ending at 24 wks, you had a 50/50 chance to be stopped at 24.  I understand that they take those who fit the criteria and match them up by similarity of characteristics (same kind of subjects in both groups) and run them through the computer again.  You went into the continue group.

Something important is this: the quality of the PCR test used to determine that you cleared.  The studies use a very refined test (the boceprevir study uses the Taqman 2.0), one with the greatest degree of accuracy possible.  Do I understand correctly that they have concealed the results of their PCR's from participants?  Probably a good idea, since so many WANT to get out at 24 wks that they will jump out once they have good evidence that they cleared early.  You were smart to have the PCR's run on your own, but you need some confidence that you can completely trust your private PCR results.

A few things to think about:  
1) They've spent a lot of money on you up to this point.  If  you opt out on your own, I don't believe they will waste that data if you've completed all the requirements for the 24 wk. subjects.  I think they will just shift it over to the 24 wk. group when they crunch the numbers.  They will follow you up the same as the others, to get the data.
2) Before I even started considering jumping out, there was a poster (on SOC) on this forum who thought he had done so well that he stopped himself at 36 wks (I may not be remembering the numbers exactly).  He did not end up staying clear and regretted his decision.  In your case, that would be 24 wks. of misery down the tubes.  Could you live with that and having to start over?
3) The aim of all the protease inhibitor studies is to prove that genotype 1's can be successfully treated with 24 wks. of medication + SOC.   They've sunk a fortune into that aim.  You know there must be something to it, but I'm unsure if they've published any results for the success of 24 TX with PI's.  You may not be able to decide with complete ease unless you can find some of that data.

[Rockerforlife]

I will find out if i stop at wk 36 this coming Friday..im in the Boceprevir non-RESPONDER trial...i will do the 48 weeks if im offered...i fight to win,i cleared after starting the BOC

[mnl1]

Thanks guys for your responce to the question. I know it is an important decision and you don't want anyone or anything to influence that but it helps to know what others are thinking.

My thought process at this time is that I want other people to benifit from the trail data but on the other hand I don't want to continue to put toxic drugs in my system if I don't have to. The drug companys are not basing your individual case on your results, it is just a number to them and so at some point I think you have to look at your own situation and make a decision from there.

[annieCinMD]

I'm in a trial, too. Just crossed over to the study drug ( a protease inhibitor + Ritonavir). That is one of the big hopes for the PI,s - shortening the length of TX for genotype 1s. I would have treated years ago if I had been a genotype 2. 24 is just so much easier to take. I'd be almost done!  Unfortunately, I don't get the 24 week option, but I'm glad to be on the study drug. I will do the full 48. I figure the data that is gathered could make it easier for others down the road.

[newleaf09]

Tippyclubb and I have discussed this a little.  I know we are both a little uncomfortable about having an influence on such an important decision.

That said, I am in the boceprevir trial.  I go to the clinic tomorrow to find out if I'm in the 24 wk arm (really 28, because it starts with 4 wks. SOC to prime the system).  After recently looking at a number of trial protocols at clinicaltrials.gov I noticed that the aim of all of the protease inhibitor trials, even the new generation drugs still in Phase 2 trials, is to shorten treatment to 6 mos. for responsive genotype 1's.  I cleared before I even started the boceprevir.  I have, in addition, had 6 months of boceprevir.  I hope I end up randomized to the 24 wk. arm.  If not, I think my decision is already made.

[Tippyclubb]

So far it seems not many get into that 6 month group.  I am a month away from finding out my fate.  It will be interesting to read replies from your post as I am curious to know the same thing.  If I am placed into the 48 group it will be a long hard decision whether to stay the course or stop.  After all, the buzz about Telaprevir is that, its suppose to shorten your treatment time.