telaprevir anemia prove 3

Any advice would be appreciated i am currently 14.5 weeks into treatment last does of study drug was dec 30 blood draw from that day hemoglobin 9.9 got call yesterday wanting me to reduce ribavirin from 1200 to 600 cut off for trial is 10 i was to reduce meds last nite at this time i have not i really do not want to i have relapsed 3 times in past ounce from 72 weeks i have had my fill of interferon i have been neg between week one and two it looks like there is 10 percent chance relapse betwwen week 12 and 24 if make that far then there is 90 percent chance of this working considering both drugs cause anemia and one stopped dec 30 hoping will rise next appointment jan27 hope do not get the boot for non compliance am i in dangerous territory hear in 98 treated no rescue drugs was like this 6 months any thing i can do to help levels i was thinking of waiting to end of week going to my family doctor get tested if over 10 could fax to hospital tel would out of system just over 2 weeks at this time next shot is this tuesday thanking you in advance regards

[copyman]

Hi, First sorry to hear your HGB has dropped. I have interest in this as well. I'm also in the telaprevir trial and just finished my 12 weeks of Telap. My last 2 weeks HGB have been 10.2. The study nurse then there is a good chance it may rise now that the telap is over. Keeping my fingers crossed.
Seeing your family doc for a CBC sounds like a plan before reducing. if #'s look better then no worries, if still low reduce meds and go to your study ctr for blood draw a week or so later. I would not send them the blood test results from your family doc, good or bad. I don't think they can accept blood test results except from their own lab, but not sure about this. Best of luck

[charm27]

Just wanted to wish you the best of luck. I am too sorry to hear about the HGB drop.
I treated with SOC, so I cant voice an opinion on this just wanted to wish you well.

[dmhrdh]

I was in Prove 3 and was SVR in Sept. '08 :-)
I was rarely on full dose Riba throughout the trial.  In fact, I they had to discontinue my Riba totally several times during the trial.  This all started at week 2!!
I understand why you're nervous but I doubt you have anything to worry about with a dose reduction....especially this far into the trial and knowing you have been UD since week one or two.
Good luck!
Denise

[Andiamo1]

I also dose reduced Riba during the Telaprevir trial and I am SVR.  My Hgb improved with the dose reduction and I completed the trial.

[Deb_c430]

I dose reduced riba as well,   it helped,    

[fretboard]

I think you've been given some sound advice, my belief is the study won't allow rescue drugs and sponsor protocol dictates what has to happen.  Hopefully after you drop to 600 Riba your HGB will raise immediatly and maybe you can jump right back up to a higher dose.  You have gone thru the "beat down and conquer" period required in the first 12 wks., I think your smartest option is to stay with the trial and the guidelines in force.  You've relapsed in the past, but I'm sure you've never been on telaprevir until now.  Good Luck  

[Trish77]

If I recall from reading other posts from those who are also in your trial, they don't allow you rescue drugs, such as procrit to bring up your hgb. However, if there is even a small chance they will allow it, I would suggest you fight for it to start bringing up your hgb so that you can get off  and prevent any dosage reductions ongoing.

A 600mg dosage reduction seems like quite a bit.  Is there any room for negotiation there?  Maybe you can convince them to reduce by 200mg?  That would put you in the 80% range of your current dose of riba.

I would also go get the test from your doc, nothing to lose there.  You can share the results with your trial team...or not.  

Barring all that....the difficult thing about being in a trial is that it's either compliance or getting off the trial once you've exhausted any other options.  It's a very difficult place to be in, to be dealing with this when it has gone so well so far.  The upside is that you've gone UND very early and that is in your favour.  I wish you good luck with all of this.

Trish
Trish

[copyman]

there is NO chance in hell you will be offered rescue drugs in the Telaprevir trials. They never have allowed them, the FDA wants to see how much more telaprevir lowers HGB and does not want skewed results from rescue drugs.

[jacksonblue]

thankyou for all the responses hope things our going well for you copyman you our correct no chance of rescue drugs would not entertain anything less then reduce by 600 rib i guess will try to get test done on monday and if results not better reduce cannot chance being droped

[mkp13]

Here's my experience on a Telaprevir trial:  My hemoglobin went below 10 at about week 8.  Knowing there's a fairly large error range in the test, I convinced my doc to retest the following week before reducing my Riba dose.  When they retested it had gone just barely above 10, so I was OK.  Note that the test assumes a fixed blood volume, so if you go in dehydrated, it may increase the result a little bit.  I went in as dehydrated as I thought I safely could.  Also note that because of the interferon, your levels may fluctuate during the week.  I always tried to test the morning of my interferon shot.

After that second test, my levels went down to 9.8.  I could tell when I was going to get a bad result from how I felt.  Those weeks I'd deliberate "forget" to ping my doc's office for the test results, so I could stay on higher meds longer.  The net result of all this gaming was that I was only at half-dose Riba for week 12, followed by the next week at 80%.  By then the Telaprevir was pretty much out of my system and my hemoglobin level went back above 10 and has stayed there.

If you really want to avoid Riba dose reduction, consider asking to drop out of the trial.  While it's really awkward with the doc (who has strong incentive to keep folks in the trial), if you quit, you can probably get rescue drugs.  In my case, the Telaprevir ended at week 12 for everybody who'd been on it at all, so quitting after week 12 loses you nothing (from then on, everybody's in SOC).  My doc said that since we would never know for sure if I'd been on Telaprevir (instead of the placebo), that he'd have to keep me in treatment for the full 48 weeks.  But I was *sure* I had been in the 12-week Telaprevir arm, so I might not have gone along with that anyway.  The interesting thing was that by talking seriously about quitting at week 12, my doc called Vertex and got a special dispensation to put me back up on my Riba dose even though my hemoglobin didn't exactly meet their criteria for that.

My belief is that it's the job of the companies running trials to make sure that SOC really *is* SOC.  In this case, with prohibitions on rescue drugs, it just isn't.  When I discovered this bind I felt I'd been lied to by Vertex, because I had no idea rescue drugs were important and were prohibited.  Their "informed consent" docs did nothing to enlighten me.  Fortunately, Vertex seemed to understand the problem and was willing to have a little flexibility.

Bottom line: these things are more negotiable than you might think.  Go talk to your doc about it and be willing to quit the trial if that makes the most sense for your own health.  Most docs deeply care about their patients' success, so hopefully you can explain the bind and get them to help you out.  Even so, though, you may need to dose-reduce for a little bit.  But don't forget that if you're now off Telaprevir, this could correct itself pretty quickly.

Good luck!

[Andiamo1]

My own experience is that they are not negotiable while you are taking their drug.  Once you pass the point where you are on SOC only, they might look the other way if you took procrit.

[can-do-man]

mkp........Bottom line: these things are more negotiable than you might think.  Go talk to your doc about it and be willing to quit the trial if that makes the most sense for your own health.  Most docs deeply care about their patients' success
------------------------

That is so true, while they can't give you rescue  drugs doctors do have lead way in these trials. I'm in a trial and i know this first hand........ Best to you

[can-do-man]

All i can base it on is my own experenice, when the trial i'm in first came open i read the critria, i did not quite meet all of them. I called a very pleasant rep with the drug company and was told they did allow a certain lead way. well my platelet levels even with their 10% lead way was still going to be cutting it close. I was told the final call would be my doctors with-in reason. I have just finished 8 weeks and my doctor has had to make a few phone calls on my behalf.

So if you have a doctor thats willing to go the extra mile for you there is some things he can get done. As for telaprevir i don't have a clue but maybe they need to lighten up just a bit.

[copyman]

this strict protocol by telaprevir is helping to get FDA approval much faster.

as for withdrawing consent and dropping out of study I would'nt do it. now that you are done the telaprevir that may work since you are going to be on SOC drugs anyway Keep in mind that now you or your insurance company is going to have to pay for the SOC drugs & rescue drugs! could be $20,000 just for the SOC drugs alone, then add on $600 a shot for the procrit !!!

[Trish77]

That is also my experience on my trial, that if you have a doctor who is willing to push the limits, some things can be done.  My NP told me that more things were tried with me than with anyone else on the trial and that the only reason I got the procrit was because I went after it.  If you are no longer on the telaprevir and are considered to be on the SOC portion, there is no harm in asking for the procrit and even pushing for it particularly if they know how disturbed you are by the dosage reductions.  It helped my case to be able to pull stats with the doc that 100% of the dosage 100% of the time is most preferable and he agreed with that and was willing to then introduce the rescue drugs to help keep me there.  (He also happened to be a firm believer in the power of riba as am I, so that didn't hurt either!) There may be leeway that you don't know about unless you ask...or even push for.    

Good luck.

Trish