Prove 3 trial - Appointment #4 - question about unblinding

Had appointment #4 today.  Nothing big to report; just weighed me, drew blood and sent me back for another two hour drive home.

I do have a question about unblinding....Vertex has been very vague about Arm A (palcebo arm) but if you're not getting a response (which they don't really define what that is) then you'll be rolled over at week 4 or week 12.

My gut tells me I'm not in the placebo arm because I just feel different and feel like puking if I don't eat after taking the VX950.  Just mu instincts talking.

I know that I'm not in Arm C because I'm taking Ribaviren so therefore I'm in Arm B which is 24 weeks of VX950 + RBV + INF or Arm D which is 12 weeks of RBV + VX950 + INF followed by 12 weeks of SOC.

For you other Prove 3'rs; how do you understand the unblinding process to happen?  Like if I'm in Arm B at 24 weeks do they tell me, "We have a pleasant surprise for you of another 24 weeks of VX950+RBV+INF?  Or if in Arm D do they tell me at 24 weeks, "Congrats; you just did 12 weeks of vx950 and 12 weeks of placebo, wer'll lt you know your results"?

Any ideas or comments?

Also, knock on wood but I don't seem to have the VX950 rash (yet).  I have the itchy's but that could be the Ribaviren and hot tub time.

Mike

[andiamo]

Mike, the consent from says that we will be told at week 24 if we are 24 or 48 weeks.

I am not sure when we will be given all the results.  The consent from says that if we are in a 24 week program, the blind will be lifted at 24 weeks.  The research coordinator says that the blind will be lifted for everyome at 24 weeks and that makes more sense to me.

I am not sure how I would feel about completing 48 weeks without the knowledge of  RVR or not during the early part of the treatment.

[dmhrdh]

My understanding is that we'll find out at week 24.

[Cheesegrater]

I think the tests will show by week 8 who is responding and who is not. It is my understanding that this info might be made known to the researchers (I can not say WILL because I am not sure) before week 8.
Personally I am looking forward to finding out if I am responding.

Cheese

[andiamo]

I don't have the form in front of me, but I remember it saying that at week 24 people that are in group a or b will be told to continue unless they were in group a and did not respond.

I am feeling very week; lost 15 pounds so far (I could afford to do that).  We will go sailing this weekend for the first time.  We have been working on the boat full time.  I am not accomplishing much, since I move very slowley.

If you get to the New York/Connecticut area, I will be happy to take you sailing.

[miked]

So, 24 weeks is the magical date unless one is in the the placebo arm and not responding.

I read the consent form again and it says that at week 26 patients in Groups B, C and D will be asked to return to the clinic to determine what's next.  So if I'm in Group B which gets another 24 weeks of SOC, do I take a two week break between 24 and 26?  That doesn't make sense.

Just trying to get the whole picture.  Thanks for your help.

How you feeling?  Have you raised the mainsail yet?

[andiamo]

I don't envy you having to work while you go through this.  I feel awful just doing nothing!!!

We have a 44 foot sloop built in Finland.  We have taken it to the Caribbean; it is a great ocean boat.

I might post the log of the ocean trip on the other board.  It was one of the great experiences of my life and one of the only times I did not think about HepC for 10 days.

[Tallahassee]

I don't know about Vertex, but during my Interfero/ Riba trial I did not know until week 24 that I was schedulled to treat for 48 weeks.

I wish all of you all the very best!!

[andiamo]

How are you feeling these days?  Has your Hgb come back up now that you are off Riba?

My wife and I would  be happy to take you sailing as well if you get to the NY area.  Sailing is a good treatment for SX!!!

Do you know anything about the dreaded rash?  When, on average, does it occur?

[Cheesegrater]

My copy of the consent for indicates that on weeks 6, 14 and 26 my response to treatment and my continued participation will be discussed.
While this is not really unblinding the study, it does offer great insight for patients who failed to respond at all to standard therapy.

cheese

[miked]

dmhrh; the Provigil has really made a difference for me, especially in the morning after I take it I feel energized but the brain fog is still there.  By 4:00 in the afternoon I'm wiped out.  Right now I'm on a two days business trip and would just as soon order room service than go to dinner with 5 customers and co-workers.  Note that not all insurance providers will pay for Provigil but a letter from your doc should make it happen.

Today I went through airport security for the first time with 8-10 VCX-9050 pills and INF in a notebook-type cooler.  TSA asked what this was about, I said chemo tx and they ran me right through.

Adiamo; thanks for the sailing invitation.  What type of boat do you have?  I', an old Hobie Cat sailor and actually had the priveldge of teaching my 12 year old daughter how to sail last year ( I long ago sold my boat)....what a blast.

[dmhrdh]

I think you'll stay on whatever you were on.  They say week 26 because that's when they expect to have your 24 week lab results.  Are you still feeling better?

[APKhaos]

Sounds like week 24 unblinding is the design for Prove 3. It was 20 weeks for Prove 1. If you are anything like me, you'll be expecting to get your VL results when you go in for your week 25 visit. Doesn't happen that way.

The way it worked for Prove 1 was that the week 20 results [week 24 results for Prove 3] needed to be available before the full set of results was released. This finally happened in week 22 for me.

Only reason I mention this is because my whole family was on edge for two weeks. We expected to see the VL data immediately after week 20, but that was an unrealistic expectation. I suspect that the Prove 3 clinics will know this now, and should be letting you know ahead of time. Prove 1 had a 'voyage of discovery' feel about it every now and then, and this was a good example of that.