a message to Vertex

[anon2007]

It is my understanding that Vertex people read this forum.  This is a mesage for you:

Those of us in Prove 3 that end up in one of the 48 week arms, A or B will be faced with a difficult choice at week 24.  We have all failed treatment with SOC and those of us that are relapsers, responded, some with a 2 log drop at week 12.

Vertex has chosen not to lift the blind for these groups, so we will not know if we have a placebo or not until week 48.  Many of us will have survived the 12 week test, since we have on previous treatments reached a 2 log drop at week 12. Almost all of us on the placebo will relapse after 48 hellish weeks of treatment.  While the CEO made a point about how valuable our blood tests are to them and their stock price, what about the value to us – the volunteers?

To make things more complex, the CEO of Vertex has chosen to go public with the fact that Vertex has enough information to know that 12+12 = 24 weeks total of triple therapy will be the optimum treatment length.  I am sure this is great for the stock price, but shows tremendous lack of caring for those of us in the trial;  do they have any idea what these drugs do to us and our families?

If they do, they have to lift the blind for the 48 week arm at week 24, so that we can make an educated decision about continuing the grueling treatment protocol with the chance of relapsing at the end for the second or third time.

[dointime]

Welcome to the world of the VX trials.  If you are waiting for Vertex to change their stated trial protocol then you could have a long wait.

The only way that I can see for you to get the information that would enable you to make an informed decision at week 24 is to get a sequence of off-study PCR's starting right away.  As far as I know, there's nothing in the trial rules that prohibits you from doing that.

dointime    

[pln]

Yes, welcome to the world of the VX trials, I was (am)  in prove 1, never did tx before. I learned so much from this site. I was blinded untill week 20. At week 11 I had an off campus pcr, which was und. I wish I would have had one at week 1 or week 2. when I was unblinded at week 20 I found out I had been UND since day 4. Then I was told I was in the 24 week group. I cried, I was so scared to stop at week 24, being a stage 3 and knowing the meds were working. But I did.
I go monday for my 24 week post. I guess what I am getting at is you can have all the off campus pcr's you want. Good luck.
Pam

[Andiamo1]

I can't speak for anon, but I think it is too late for me.  I am in week 11, so a  pcr is likely to show me undectable no matter what Arm I am in.  I would have needed to do it by week 4.

I always respond and then relapse.  I was treated before the importance of rapid response was known, so I tried pegasys and peg-intron each for 48 weeks.  Both times was undetectable at week  12 and relapsed.  This is the 8th time in total that I have been treated with various flavors of interferon and other drugs and I have definitely had enough!!!!

[dointime]

I sympathize Andiamo.  I did not have off-study pcr's when I did the trial.    But after the unblinding and finding out that I had had breakthrough for the last 10 weeks, boy was I kicking myself for not having had those off-study pcrs.  Ain't hindsight a wonderful thing.

Dointime    

[Terrylee8]

A lady who dropped out of the trial because the VX-950 made her sick posted the following at another location.  She knew she had the real deal because when she threw them up they came back yellow.  Might be worth a try:-)

[cruelworld]

i wasnt really aware of the of some of these nastier details of trials.
seems like off campus tests are some of the answer. i personally agree with the
more selfish approach that others here have espoused. when the trial goes against you, jump out. preplan for all eventualities. do whatever you know you need
to do for your own SVR. as a lab rat, cruel torture is your expectation.
some of it can be avoided.