PROVE 2 - Some personal observations

I was one of 9 participants in one of the European PROVE2 groups.  Recently there have been some very good discussions about the value and limitations of telaprevir or VX-950, and I just wanted to kick in my 5 cents worth.

There were nine of us in my trial group.  Four were in the placebo arm and got peg-inf and riba only.  Three got telaprevir and peg-inf but no riba.  The other two got the triple therapy.  At the 12 week unblinding the results were as follows.  3 of the 4 patients in the placebo group failed to clear and failed also to achieve a 2 log drop. In the no-riba group, one managed to clear by week 3 but had viral breakout in week 4, another managed to clear by week 8 but then relapsed in week 16 (or thereabouts) and the third cleared quickly and stayed clear (to my best knowledge).  Finally, in the triple therapy group, both patients cleared quickly (less than 3 weeks) although one subsequently fell victim to the telaprevir rash and had to stop all medications around week 8.  

I was one of the two patients in the triple therapy arm.  I was a 59 year old, genotype 1b, initial viral load of over 13 million, with stage 2 fibrosis (on a scale of 0:4) and grade 2 inflammation (on a scale of 1:3).  I dosed for 12 weeks and achieved RVR in 3 weeks.  I had to reduce peginf dose to 135mg/wk and riba to 800mg/day because of anemia and neutropenia since no rescue drugs were permitted.  I nevertheless maintained the full dose of telaprevir for the 12 weeks and (with the help of some great advice from mremeet and others on this site) managed to steer clear of the rash.

I agree with just about everything mremeet said in his wise and comprehensive recent post about the value of telaprevir.  http://www.medhelp.org/forums/hepatitis/messages/46936.htm There seems to be little doubt that it is of enormous value in increasing the chances of geno 1 folks (and perhaps non-responders) to quickly reduce their viral load and greatly improve their ultimate chances of SVR.  It may well turn out that telaprevir gives geno 1s more or less the same chances of treatment success as SOC does for geno 2s and 3s.  This is a huge accomplishment, and a significant advance in HCV treatment and I for one feel very grateful for having been able to use telaprevir in my treatment.

Having said this, however, I believe that there are a number of points that are crucial to those going through telaprevir medical trials which can get lost in the general enthusiasm for a better solution.   Going through a medical trial is not an equal or fair proposition. The company wants to test all the potential (but as yet unknown) benefits of the drug.  The patient wants just to get well. In order to get access to the drug, the patient has to follow the trial rules and these can sometimes work against his or her best interests.  Of course, every patient has an absolute and unequivocal right to leave a medical trial at any point, for whatever reason.  But the reality is that there is a lot of pressure to stay with a trial even when it may not be in your interest to do so.  This includes financial pressure (since you lose the free meds and monitoring) as well as emotional or

[GrandmaA]

Thanks for your candid, open and honest posting about the clinical trial you were in. It's very interesting.

[Upbeat]

Darn I was really hoping for better results with the no riba arm.  The thought of forgoing the riba would have swung me to the treatment side.

                                                                                                      Ron

[mremeet]

Thanks for the kind words, and what a perfectly stated assessment of what it's like to be in a trial like this. Especially the points on how those in the riba-less arm were (mis)treated, and also on the manipulation (and withholding) of trial info that should have been made available to us when it was available (and not just at an investor's conference). Hoping you and dointime are hanging in there, in the meantime keep at it - better times are ahead.

[dointime]

VXman you are funny.  No, we were actually standing in a circle saying our prayers for whoever happened to be on the floor that day with an adverse reaction.  It got intimate pretty quick.  I see that Vertex learned their lesson and are conducting a rather more sanitized version with you guys.  It doesn't do to let the participants see what might happen to them.  Tends to put the wind up and sometimes even makes them think.  I mean, look at the state of hungry there. (tongue firmly in cheek hungry).

dointime.    

[Happyhungry]

Cannot seem to view your comments on my post.  Some kind of tech problem I guess.  Maybe people could re-post them in a new thread.

[VXman]

Very informative summary from your trial. What really interests me is how you were able to obtain all the observations that you made. Was this information made available to you prior to it becomming public? I'm not inclined to think that they had you in a group circle singing, "Kumbaya Lord."

I'm in the 8th week of the Prove 3 trial. The patient appointments are staggered so that you barely have time to make eye contact with each other.

I cannot fault you for deciding to pay for meds after the 12-weeks to better your chances of a SVR. The way I look at is: Their question was - "Let's see if the patient maintains their SVR even though we cold turkeyed her after 12-weeks", Your question was - "Can I better my personal chances of maintaining a SVR by continuing with SOC for a period after the telaprevir portion of the treatment was stopped."

You are obviously a very intelligent person and did what was best for you.

Best Wishes to you!

[miked]

HappyHungry; I'm week 7/8 in the Prove 3 trial.

"after the unblinding, I decided against continuing with the trial (which would have meant stopping treatment right then) and decided to continue with SOC rather than jeopardize my three week RVR and the potential of subsequent SVR. Of course I then had to start paying for my meds, but I just didn