Upset over Vertex trial

Ok,

I've been expecting to get my viral load counts, date of UND, etc from Vertex at or shortly after week 24 and was told today by research team overseeing my treatment that they (Vertex) won't tell me any of that until I have completed the treatment.  I'm tempted (out of anger) to tell Vertex to kiss my royal arse and to shove it up theirs (dropping out of treatment in the process).  

Now I understand that sort of reaction could be considered an over reaction so I needed to vent in order to keep from telling the hand that's feeding me to quit feeding me.
Joey

[thegypsy9164]

Add to the above the fact that this 26th week shot on Friday slammed me harder that I can remember, layed me out all weekend and limited me to only 3 1/2 hours at work today.

ARRGGGHHHH!
JJ

[jdwithhcv]

Joey, that must be torture!  I feel for you.  It would make me CRAZY!!!  Is there anyone you can appeal to?

jd

[HCA]

I am also participating in the phase 3 telaprevir trial,and just coming up to week 24.
The only data I am expecting is viral negative or not at week 24.
Unless you ran your own tests you will not know your virological response and whether you need to continue to week 48.
The consolation is you are getting a great deal of very expensive medication free of charge and ahead of the pack.

[Tippyclubb]

Vertex will not give you any viral load information until the trial is over.  They will tell you your UND at 6 months, but that's useless information because if your not Und you would not be allowed to continue for 48 weeks.

Seeing as you did not have any private pcr's done and don't know if you were RVR and UND by week 4 its not a good ideal to drop out now.  Too risky.  Now that your done with Telaprevir the worst is behind you.  Those were the hardest 3 months for me.  Plus your over half way done now.  Hang in there.

Hope you start feeling better soon.  I know I had good weeks and bad weeks.  Throughout all of it I only missed one day of work.  You'll find the strength to continue on.  Hang in there.

[Isobella]

I agree with Tippy.  Unless you know you were RVR, it's too risky to stop.  Seems for some the middle of tx is like coasting along.  Hopefully that will be the case with you and #26 was just an exception.

The good news is that at this point, you know you were UND at week 12 and week 24, otherwise they would have stopped you. Also, you would have had to had a 2 log drop by 4 weeks in order to continue.  So at this point, you can assume you met all the SOC milestones to continue.  Stinks to have to go 48, but worth it in the long run.

I just finished 48 weeks in the Vertex trial as well.  I am 5 days past my last riba.....and I gotta tell you...life is good.  So hang in there, it's worth it.

Almost forgot....they are allowed to give you the starting vl, if you hadn't already gotten it.

Good luck to you =)


SVR for all,

Isobella

[Rockerforlife]

Why does the Boceprevir trials give us all the info up front?

[annieCinMD]

The 518 trial tells everything, too. I know which arm I'm in, and that I'm getting the real McCoy as far as the drugs go. Of course, I would probably feel much better if I got the placebo arm.

[Isobella]

Who knows why they all have different guidelines.

That's what the small print is all about.

[Willy50]

Hey sorry about your plight, but I agree that you should just stay the course.  You may also find that they end TX at week 24 and also don't tell you what arm you were in, nor the reason for stopping.

I believe they will give many people the same non-informational answer until the study is unblinded.  Both successes and failures alike won't get the answer from Vertex until the trial is unblinded.  That means until the last person of the control arm (if your trial has one w/ SOC) gets their 6 month EOT PCR.

That may be one reason to get one; so you'll know.   I think it will help you stay the course.

Yes, you should have gotten one, a private one at week 4 or even earlier.  

By the way, I think it was decided before the trial started that this was to be blinded a long time; check your agreement.

By the way also...... if you do get a private PCR it is forbidden in the trial agreement to post the data on forums; it is considered a public disclosure and they consider it along the lines of releasing data.  They monitor these boards and have spoken to members here before about it.

just a word to the wise......

best,
Willy