Phase II PI drug trial - comments?

[Trish77]

This is the drug trial I'm being screened for currently.  I will find out in two weeks.  If I get in, things will move VERY fast as last date for first dose is March 3rd and likely will be before that.  

I've seen others comment on how their own drug trials demanded some level of secrecy on the part of the participants so I asked about that .. and there are no demands of me in that regard.  

I'd be interested in any comments - positive, negative, "are ya nuts?" variety....doesn't matter.  Don't hold back now.  :)

http://clinicaltrials.gov/ct2/show/NCT00517439?term=hepatitis+toronto&rank=42

Thanks.

Trish

[dointime]

I started the phase II VX950 trial in January 2007, followed by SOC.  I've been off the meds now for about 6 months and feel almost normal again.

I think that somebody else here said that the trial was to be a double blind, so thanks for mentioning that it is actually unblinded.  That is so much better as it gives you many more choices if things are not going quite as you would wish.

Bear in mind that it is your right to drop out of the trial at any time if you believe that your tx needs can no longer be met within the trial protocol, for instance if you should need rescue drugs or wish to increase your interferon or ribavirin dose.  I'm not recommending you do this, heavens no, but it is your right.

dointime  

      

[Trish77]

Hi foo...yes, they told me that my response will be unblinded, as in I'll know all along the results of each VL test, if that's what you mean.

Good luck getting into Phase III of Teleprevir.  I just can't wait anymore.  Mentally, I have to do treatment like yesterday.  If I don't get into this drug trial I'm figuring I'll start regular SOC instead about the same time I would have started the trial.  That's my hope, if I don't get in.  I just can't wait anymore.

[Trish77]

Thanks for your comments.

I also think the arms with half dose interferon are the riskier ones and the only ones that give me concern. Thanks for commenting on that because I don't know as much as I'd like about INF. However, I'd be much more concerned about a lower dose of riba and all of these are weight-based.  Although...my original dosage was going to be 1400mg and I'll get 1200mg on this trial.  So...it's less than I'd like but still okay.  I'm doing it anyway and I'm hoping I don't draw the "short straw" but I knew I could and eyes wide open for the MOST part here.  Filling in some blanks between now and when I get the yay or nay.

How long ago did you do the Phase II VX950?  

I had Hep B in my late teens, very mild and it cleared on it's own.  The study nurse doesn't think that will disqualify.  I know one other person in the same boat who has been in plenty of drug trials so I should be okay but I'm waiting to see on that score.

[dointime]

I have a comment about some arms of this trial using half doses of interferon, ie. 90 micrograms pegasys instead of the normal 180.  

We do know already that R1626 can induce neutropenia and that this is the major reason for dose reductions and discontinuations.  We also know that interferon can cause neutropenia.  I am speculating that Roche are trying to mitigate the neutropenia problem by the dose reduction of interferon.  

I remember the VX950 trials when everybody said how great it would be if we could do away with the riba.  Well it would have been great except that it didn't work.  Now I'm thinking how great it would be if we could get away with a half dose of interferen - but will it work?  So I think that the half dose interferon arms are the riskier ones in this trial, from the point of view of efficacy.  

dointime      

[dointime]

This is the R1626 trial.  As Jim points out, we don't know a lot about this drug as yet, so you would be in the same position as anybody doing the first tranche of a phase 2 drug trial.

All I can tell you is that I was in that same early stage of the telaprevir drug trials.  At that stage, some of the arms will work and some might not.  I drew the short straw (the no-riba arm) and was not cured.  Others drew the triple therapy and went on to SVR.  So if you do the phase 2 trial then you just have to hope you'll be among the lucky ones.  A phase 3 trial is a lot better because the safety and efficacy are much better understood, so there's a better chance of getting something that will work.

So I guess it is down to your particular circumstances, and whether you want to roll the dice and take your chances with this trial, without knowing what your chances really are.  It's great that you are coming on here and keeping us informed about it.  

Best of luck,
dointime.    

        

[jmjm530]

Haven't heard of this drug but haven't been lately haven't been following newer drugs that closely. A quick search shows that it is being "fast tracked" which is interesting since Telaprevir isn't, as I understand it.

What I couldn't find are any SVR results, which would make me pause, esp if you had time to wait. On the other hand, Telaprevir does have some SVR results and other PI's (Boclavier (sp)?) should have them soon, I think.

Is your doc also tied into the Telaprevir trials? If so, you might ask for a comparision, i.e. why this drug over Telaprevir. . If not, you still might ask the same question, esp as to Telaprevir's track record compared to this drug. Also, since your doc seems connected with this new drug, you might inquire if it might make sense to wait out this phase and then jump in based on results. There are seven arms, so a lot of variables at this point.

Here are a few links and hopefully someone else can add more:

http://www.hivandhepatitis.com/hep_c/news/2006/101706_a.html
http://www.hivandhepatitis.com/2006icr/easl/docs/050206_c.html
http://www.natap.org/2006/AASLD/AASLD_13.htm