Vertex Proves tials placebo

[Bill200]

Hi, for those that have done the PROVE trials with teleprevir, is there anyway at all to tell if you have the placebo or not?  I think on the PROVE III non-responder trials, you can be fairly certain inf+riba+placebo isn't going to work, especially if you've been through multiple treatments.  I would think if one fits that profile, got into a trial, and could tell it was a placebo there'd be no point in putting oneself through that.  It's just a matter of figuring out which group you're in.

[Bill200]

All three legs contain Riba and inf.  One leg no teleprevir, one leg teleprevir day 1, and one leg teleprevir 4 weeks in.  

Miked, great news.  I hope one day I can say the same thing.  I can't even imagine how great that must feel.  Actually I can but I don't let myself think about it too much.  I'm still far from out of the woods.

[mremeet]

The placebos were sweetish to neutral tasting.That's how all placebo people interpreted their pills. Nearly everyone who was later actually proven to be getting VX950 described it as a gagging bitter taste. But Vertex has been monitoring our chats here all along (including placebo detection), so they may have wised up by now and bittered their placebos. However, I can't believe they're still testing a group that does not get ribavirin? I'd look into that carefully, I seriously doubt they are dumb enough to keep doing that. That would be a waste of money and also be horribly unethical based on what happened to the others here already. But against all odds, if they are including a ribaless group - I wouldn't enroll in the trial if I were you.

[miked]

Hi Bill,

I was in Prove 3.  Previous non-responder and now UND around post-tx week 39.

When I started Prove 3 there was one arm that didn't have Ribivirin which from research I knew was critical.  If they didn't give me pink pills (Ribivirin) I was going to drop out Day 1 because I didn't want to put up with 6 months of INF for nothing.  I got pink pills Day 1.  I don't know if Vertex still has an arm without Ribivirin.

On Prove 3, there was a distinct taste between VX950 and placebo.  For the first 12 weeks I got VX950 which was bitter.  Weeks 12y-24 were placebo which tasted like sugar.  They may have changed that...I would.

One biggie is around week 8 I got the rash from hell.  Although it has to be treated with steroids, I knew then that I was on the real deal.

Susan's comments about an off-study PCR is correct.  I went UND between week 1-2 which would be picked up.  Most people go UND by week 8 if they are responding.

miked

[Bill200]

Well, I'm not in the trial yet.  I'm marginal on some of the blood readings such as platelets.  Still, I'll try and then try to figure out whether I'm getting the teleprevir.  No need to go through even 12 weeks of treatment if not.  It'd just be severely reducing my quality of life for three months with slim-to-no-chance of clearing.  I've already done two trials (interferon infusion and int + riba) and one SOC (peg + riba).  The third time SOC was not pleasant!  If I recall the viral load test costs about $250.   I think it's good advice to get checked after two weeks.  OTOH one arm of the the trial doensn't start Teleprevir until 4 weeks in.  I wonder if they'll give those in that leg a placebo starting on day 1.  Decisions decisions...

[dmhrdh]

I am in the Prove 3 trial.  I was still UD 3 months post treatment and will go in for my 6 month labs in Sept.  I was a former non-responder.
When do you become unblinded?  The only way to know if you are receiving the Telaprevir and not the placebo is by looking at your VL.  It's up to you whether you wait for Vertex to inform you or you go off site for a VL.
I used Peg-Intron the first time I treated and a different brand of Riba last time so I can't be sure whether new or magnified sides were from the Telaprevir or not.  Most of the differences I noticed with this treatment took time to develop.  I had much more nausea this time. My stomach made a lot of strange rumbling sounds with this treatment.  I also became severely anemic very early on...but I did the last time I treated also.  I had the typical Riba rash off and on throughout this treatment and didn't get what they thought might be some of the Telaprevir rash until very late, around week 20.
I would not put any stock in the taste test.  When I first started treatment I decided to try the taste test and let one of the pills dissolve on my tongue.  It had a very mild taste.  I was convinced I was receiving the placebo.  Many months later one of my pills got stuck on my tongue and started to dissolve.  It tasted horrible!!!!
Remember, as someone who has treated before, you know that your sense of taste changes on treatment.  
Best of luck to you and congrats on getting into the trial!

[susan400]

One couild conceivably get a viral load outside of the trial, (at their own cost), at about the 2 week mark and see if their viral load had gone just about undetected (if not undetected) and be able to tell in that way.  A previous non-responder is not going to clear the virus on standard SOC in 2 weeks time.  

I did not go outside of my trial because I knew right from the beginning that I was actually getting Telaprevir, because Group C was the only group in Prove 3, that did not receive RIBA...., Group C got Telaprevir and Pegasys,  Period,   end of story, no placebo for Group C.   This was the group I got randomized into.  At week 5, after my week 4 blood draw results came back, they called me up and told me that I would not be allowed to continue because I had rebound on my virus.  But, because I was double-blinded, they would not release my viral loads reports.  I had to wait until 24 weeks had passed until I was able to get all of my past viral loads from screening through week 5.  

So, my advice would be that if you choose to go into a Telaprevir trial, plan on going to outside of the trial for a viral load at week 2 and that would be a good indicator.  I am not worried about getting into trouble with the Vertex people since they have already told me that I'm not allowed to participate in any more Telaprevir trials.   Jerks!    They wouldn't even give us Group C people a chance to retreat w/all 3 drugs!!!   I know because I wrote them a letter and begged for the chance and was told by the VX rep, NOPE.

So, that is my opinion for what it's worth!  

Good luck to you all.

Susan400

[dointime]

I did Prove2.  At that time the VX tasted bitter as to make you gag but the placebo tasted like nothing much.  But they may have changed that by now.

Probably the best way to tell if you are getting the VX is if you have sides that are different than you had before.  VX added will make you feel appreciably worse than SOC alone.  Also rash and nausea are more common.  But if you don't get any different sides then can you deduce that you are not getting the VX?  I would not like to make that call.  Hope this helps.

Good luck,
dointime  

[FlGuy]

A couple of years ago there was an ongoing discussion about this among a handful of people who were in Prove 1.  I don't think that any deducing, or experimenting, lead to a clear answer.  At the time, apparently the placebos were made to be bitter tasting to disguise any connecting of the dots.  Therefore, the clear knowledge that a person is getting placebo might be a little evasive.  As I recall, the discussion at the time veered off into a ethical discussion as well.

[Bill200]

Yes, the risk of Teleprevir is something to take note of but what I'm saying is if you get in a trial as a former non-responder and find  out you're getting a placebo, then I think it'd be advisable to drop out at the beginning.  I'm interested in knowing if it's possible to tell the placebo from the real thing.

[FlGuy]

Even if you have TVR and the if trial includes placebo in pace of riba, there is still a risk for non-responders.  Ask Susan400