telprivar relapse

[Debbie556]

I posted this morning about my husband being told at wk 24 he had not met the req. to continue in they study or he had e RVR. We know he was non detectable at week seven and have been told up to that point that he was doing "the best in the study" all his levels that they did give to his Dr were great. Monday we went in and was told he relapsed and was only going to do the follow up. I have read all the paperwork from Vertex and do understand that they can stop the treatment for two reasons : one you have relapsed or you have no dectable level in you system and they are just monitoring you for the next 48 wks.  They also say you will remain on treatment for the full 48wks either way unless you are clean.I am not sure if his Dr just said he relapsed at this time because we did get blood work done at 7 wks and told him he was clear by the outside testing. We are getting him tested asap either way. I just don't understand because this is a double blind study and his Dr does not have the actual results....

[Debbie556]

I sent you a note and hope you read it. To everyone else I am NOT trashing the study. I have been involved with it since day one. I know what the Dr said and How he said it. These studies are a wonderful thing and desperately needed. I am just upset with the handling of it. As far as breaking the terms of agreement you are wrong. I didn't sign anything and I am not trashing it. I was aking questions of people because the Dr could not answer mine. Do not assume you know my situation and where or not I am a Grandmother and where I need to be spending my time and with whom... I did say she was dying I did not say in three days. The three days came by finding out she is ill and getting the info exactly the way I first stated by his Dr. Two bad things in three days. My husband is also concerned as anyone in these groups about relapse. And I am not unblinding the blind study I am tring to get some information that is all

[portann]

Your mother is dying within the next two days.  Wouldn't it make more sense to put your boyfriend's situation on the back burner while you spend time with her?

He's a 1A, treating for the first time. The results are what they are, despite the confusion and trial secrecy.  Last minute emergency testing will not change the results. The cards are dealt and you've done your best. Pat yourself on the back for looking after him so well.

Front and center is that your mother is dying within the next two days. She needs you. Your boyfriend will understand if you set aside your perceived urgency of his situation to be with her instead. Sensitive testing can surely wait - it won't impact the outcome since the outcome is a fait accompli.

A mother only dies once.

[nygirl7]

I am sorry to be taking this out on you there is no excuse for this and I do apoligize. When we went into his appt. on Mon. his Dr. told him he had relapsed and was to stop all ************** meaning the rib. and the alpha inter. We went outside the test study at 7 wks and had his blood work done at that time we were told his was a 0--- no detection of the virus in his blood. this was told to his Dr. at one point "off" the record.  This was several weeks ago seeing he was told to stop treatment at the start of 25 wks. "

Two different things:

Deb, you have to find out the sensitivity of the test that you got OUTside of the test study - if perhaps say it was a test that tested to <615 but the trial test went to <50 - if he had a count of 400 then he would 'appear' to have been UND for the 615 test but not really be.........but by the <50 test he would come back positive.  This is a VERYimportant part of the equation that you need to find out.  You should be able to just call the outside folks and ask them what was the sensitivity of the test?

It happened to me which is why I know it is possible.....had my doctor not gotten me a sensitive test my 411 at week four would have appeared to be a true UND but it was not. so later if I had a higher sensitivity at say week 10 but the first test came back UND <615....I would have been shown to HAVE HAD BREAKTHROUGH when in reality I was never truly UND at all, so it's not a RELAPSE. Relapse is for AFTER treatment is over.

Unfortunately I doubt the doctor would say that he had RELAPSE/BREAKTRHOUGH if he had not, but I would want to retest that test just to make sure somehow it wasn't a false positive and that the scenario above is not what happened.

Good luck.....one way or the other find out what the sensitivity of that 7 week test was that should maybe give you a hint of what is going on? There is a big difference between breakthrough (meds stop working) and relapse (virus comes back after drugs are discontinued and the person was never TRULY UND at all)

Deb

[portann]

Debbie,

I'm sorry to hear about your mother's imminent death. Maybe this is contributing more than anything else to your flurry of emotions. Shouldn't you be spending time with her in her final three days instead of single-mindedly worrying about your boyfriend?

Since you imply you yourself are a grandmother, your consolation is that she's lived a long life and is a great-grandmother.

What does your boyfriend say about all this? I know you've been looking after him devotedly but was he there at the meeting when you say the doctor said he 'relapsed'? Does your boyfriend agree with you that this is exactly what the doctor said?

I find it puzzling because

1) the doctor was bound to say nothing at all and
2) he doesn't know, anyway and
3) he would have used the term,  'breakthrough',  not 'relapse'.

So maybe your boyfriend and you need to both confirm what he said because he was supposed to have said no such thing and frankly couldn't have known. It's either his mistake or yours, so first get to the bottom of that.

Does your boyfriend share the same anger and sense of grievance about the trial that you do? Is he equally willing to bad-mouth it publicly and break the terms of agreement? Did he sign the agreement or did you sign it together? Does he know you are disclosing personal information about him in a public forum that could unblind a blind study?

Personally, I think you are overstepping your rights unless he fully agrees with your point of view about trashing the trial. He should have taken the time to understand what he signed up for and maybe he did. I wish he would weigh in.

[copyman]

I was going by the consent form in my study which seems to be different. I'm in the "open label" study where everyone gets telaprevir for 12 weeks. The way I read my consent form is they will use week 4,12 & 24 week pcr;s to dertermine continuation. You can be randomized to 48 weeks even if you are RVR at 4 and still UNDE at 12 & 24 weeks. If you still have detectable virus anyrtime up to 24 weeks you continue to 48 weeks regardless. But "everyone" stops at 24 weeks if virus still present. They will not even consider a pcr from another lab, only their cettified contracted lab.

[Emilio44]

I'm still confused about the 7 week PCR and why it was done.  I did a trial this year PI and PCR'd every week for 4 and then fortnightly to week 8 and one at 12.  If UND at 4 or before (eRVR) then why was the week 7 necessary?  Bad doctoring, bloody disgraceful communication, but extremely common with busy research facilities.  Fingers crossed that tx was terminated due to RVR and only needing 24 weeks as per protocol.  He could roll over to SOC and do another 24 weeks??.  A PCR now is so crucial. Best of luck and hope everything turns out SVR. Emi