Telaprevir trial Exclusions

[copyman]

This question is for any EX trial participant or anyone else that may know. Can someone on meds for cholesterol and/or blood pressure meds be in the trial? I'm kind of stuck between a rock and a hard place, my PCP wants me to start a statin & i have taken BP meds on and off over the last few years. I don't want to start anything until i know what the telaprevir criteria is. But on the other hand don't know how healthly you have to be to get in trial. Will they take someone with "boarderline" high BP? If not then I will start back on my BP meds before screening. I looked at the Vertex info about the trial and also clinical.gov and nothing is said about if you are on any meds.  Just curious in case I try and get into a trial. Thanks

[dmhrdh]

I am in the Prove 3 trial.  I was taking BP meds when I was accepted into the trial.
Good luck!!!!!!!!!!!

[fretboard]

I rec'd a telephone call from my connection over at the trial center here in California and I was told that it would still be another 2 to 4 months until a trial with telaprevir comes along that I would qualify for, with my prescription situation.  Kind of a drag, as I thought I was good to go and I been checking the mail, waiting for that return call and I get the news that it will still be another few months before I'm even considered.  Oh well, everything happens for a reason, maybe I will just skip the teleprevir all together and maybe I won't.  At this point I just don't know, I know this still doesn't help you with your situation, but I just thought I would let you know.  I don't really think I could give you a helpful answer anyways as I am not on high blood pressure meds.  Maybe someone else will chime in with some info., good luck with your meds and tx.  later

[mremeet]

Not sure what you mean by borderline high BP? Like around 130/80 or so? When I was screened they measured BP but didn't say anything about it being an excluding factor. The main things were not having cirrhosis or any other serious confounding health issues (like HIV, cancer etc). We were also allowed to take all sorts of drugs during the trial to deal with side effects (except no rescue drugs during the telaprevir dosing period). As far as I know someone with borderline high BP would not be excluded during screening, and as far as I know the medication that would be prescribed to deal with borderline high BP is pretty "milquetoast", pharmacologically speaking. In other words, I seriously doubt it would inhibit or otherwise obstruct the antiviral efficacy of the telaprevir (i.e. I doubt it would be contraindicated). But of course that's just a layman's guess. Also, this is a final phase III trial (prior to FDA approval) and to my knowledge they usually loosen earlier restrictions in order to see how the drug will perform under more "real world" conditions (like for an otherwise healthy person with a perfectly ordinary "extracurricular" managed health condition like borderline high BP).

Also, FYI - I sometimes have borderline high BP, but I've noticed a strange phenomenon concerning my measured BP. Everytime a nurse manually measures my BP using a stethoscope and inflatable arm cuff, it's normal and looks great. Like 112/70 or 115/72, or 120/75 etc. But everytime I have my BP measured by a machine, it measures higher. Like 130/78, or 140/82, or even 145/85 sometimes. I've had my BP measured on those machines at pharmacies, which probably aren't that accurate, but they almost always read that high. And during the VX950 trial, my BP was measured during my checkups using a machine, and again it measured these higher numbers. And during the trial, my blood pressure started to elevate, probably caused by the drugs and my horribly unhealthy state - the machine measured even higher numbers. My last BP machine reading before exiting the trial was about 150/85. So if you have borderline high BP now, if the drugs and tx lifestyle hits you like it hit me, prepare to have your BP elevate even further. You will almost certainly need to continue taking your BP meds, if my experience is any indication.

Now, I just saw a doctor for a flu I had a few weeks ago (been off tx for about a year now). And the nurse came in and gave me a manual BP reading. Once again (according to her), the pressure was like 115/70 - normal. So I dunno what my BP really is. One thing I do notice is that when nurses manually measure my BP, they're almost always hurried and don't seem to take their time measuring it. So I'm a bit suspicious they're numbers are off, but on the other hand of course I'd like to believe they're numbers are more accurate than the machine's numbers (and machines can certainly be inaccurate as well). Also, I do have my own inflatable cuff and stethoscope and I use it to measure my BP once in a while. I always seem to measure around 130/80 or so. Sometimes a little lower, but generally around there. But I've never been trained on how to use it (like nurses are), so I dunno maybe I'm reading it wrong somehow. I guess my point to you is that I've learned that BP is something that's not really that easy or straightforward to nail down. And it also naturally varies throughout the day and from day to day in all of us. It isn't just some static number that's the same all the time. You probably already know this, but just thought I'd point that out so you can keep an eye on any possible differences between manually measured BP and machine measured, especially if you get into the vertex trial.  Good luck...

[fretboard]

A couple of months ago when I went to the trial center in my area they said that the trials that they've had so far I would not have been allowed to get into.  I am on a couple different prescriptions, the nurse told me that they would be allowing it at some time or they would find something else for me to get into.  Here's the reasoning they gave me;  History of, or any current medical condition which could impact the safety of the subject in participation in the study.  I just talked to the nurse a couple of weeks ago and it sounded to me like they're are gonna let me in.  She asked me a couple of questions about my prescriptions and she said that consent forms are going out in mid-May.  I been checking my mail every day and I even called and left a message on Monday.  Good Luck.