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....

[jmjm530]

moa: I think its important with doctors to cut them a bit of slack. Lets face it, many of them have spent most of their lives studying - instead of socializing like the rest of us. Additionally, they have to put up with sick people all the time.
-----------------
I don't know about this. I've had some good friends who were docs. Even dated several. And they seemed to socialize just fine. I suppose life would be easier for them if none of us were sick, but then how would they afford the big homes and fancy cars? I'm sure many going to the profession because it's helping profession, and honestly, that's not why most of my peers went into the profession, at least not the ones I got to know. It was very simple. They spend X. amount of time in school and they came out with a big fat salary for life. Nothing wrong with that, I'm just saying stand a little more time dealing with patients needs, you know earn that salary.

[zazza]

"Especially for the person that has just completed the drugs. Doing that alone is tough enough..."

This is so true. After I completed tx I needed a month or so just to feel the relief of being off the drugs. First after that was I ready to take a peek at what the results of my efforts on tx might be. Putting so much effort and time into a result unknown is scary, and I needed to rebuild some mental and physical strength first in case the result was not good.

I truly sympathize with you and your husband. But I also believe there will be a happy ending for you, and that is what is most important. You said he had a low baseline viral load, and the majority of these patients do get SVR as long as they get a proper treatment in accordance to their treatment response.

[Debbie556]

I must say somethiing in Jim's defense..... Dr's don't have to be the most soialized people in the world but  a little compasionate would help.. They are not in the feild because they hate what they do just a teacher picks teaching. They do it because they want to and it is not all work and books for them always they do believe it or not have wonderful social lives-- at least the Dr's I personnally know I again can't speak for every one but compassion is something some need to work on..

[moahunter]

"by jmjm530

Sometimes I really don't think medical professionals -- the doctors or nurses -- have any conception of how much their their communications can make in a person's life."

I think its important with doctors to cut them a bit of slack. Lets face it, many of them have spent most of their lives studying - instead of socializing like the rest of us. Additionally, they have to put up with sick people all the time. While in an ideal world we would have wonderful, well socialized individuals as doctors, if we had that, and they had spent all their time trying to become that, then they probably would have the knowledge to know what they are ****.

[Debbie556]

I agree with you totally. the Dr does not have info so for him to assume that the only reason he is stopping was because of a relapse was wrong. It was his interpretation of the letter but if you read the study it isn't much clearer. It could have been said that there are several reasons you are stopping , this is what they are and lets hope for the best.. That would at least give you hope and not take the wind out of your sails totally. Especially for the person that has just completed the drugs. Doing that alone is tough enough...

[jmjm530]

I didn't mean to leave the impression that the doctor should reveal anything that he was not authorized to. It's apparent from the lonely this thread, but from others, as well as my own personal experience, the doctor patient communication is often abysmal, not to mention the the written communication Debbie received from the trial. It could've been written in simple to understand English, which may have answered all the questions were not discussing. A doctor can still take the time to explain the situation clearly, even if he cannot divulge certain results.

Jim

[Willy50]

This thread takes too long to load.  : )  

Jim; I was rather impressed when Vertex announced way back that this entire trial was to remain blinded the entire time; even for the SOC component.  I don't know if current plans call for it remaining blind until SOC dosing ends or the ultimate end; 6 month PCR's for the SOC control group.  Please note..... I said that I was impressed.....not that I agreed with the decision. : )  I'll tell you....Wall Street was not impressed with that call; the stock promptly started dropping in value (about 16 months ago).  Why?  It seems that Wall Street doesn't just want to plunk down the investment dollar without some occasional feedback as to how the drug is doing.  The fact that Vertex decided to design the trial this way could be in some way to assure compliance in the strictest standards with what the FDA requires for approval.  Hey; they may be going over the top but they are trying to run a very tight trial.  It's one reason that no rescue drugs were allowed in Phase 2 where other companies DID allow them.  The intent is to get FDA approval ASAP and to minimize as many obstacles as possible to that goal.  I'm merely trying to point out that blinding of these trials is required and the more that they are unblinded the more that the trial is undermined.

I'm not sure exactly in what way a doctor can reveal some information if it runs counter to the trial design.  For the sake of argument if a doctor somehow did and that information made its way here it would probably not be a good thing.

I think that a certain level of discretion is required here.

I don't know exactly what was communicated .....and so it does not seem fair to judge a doctor or the trial process.  I think it does seem safe to suggest the PCR or further communication with the doctors but since none of us really knows what happened.....exactly.... it seems prudent to reserve judgement.

I also happen to believe that some discretion in leaving out information where one may be straddling the edge of compliance is a good policy.  I think it protects both parties more; both the doctor/facility and the treating trial participant.

Sorry, it's a touchy situation but I think actions (such as a private PCR) or further communications will bring it into focus relatively easily and quickly.  

best,
Willy

[jmjm530]

Sometimes I really don't think medical professionals -- the doctors or nurses -- have any conception of how much their their communications can make in a person's life. I'm sure all of us have been in a position at one time or another where a simple phone call -- maybe five minutes out of the doctors time -- would have been enough to clarify an important issue that has caused us significant stress. And why is it that it is so often so hard to get that phone call, to get that five minutes? They should understand that they went to medical school, we did not. So if you have to explain things twice, or even three times, or in a simpler manner, then that should be part of their job. And if they can't do it, they're not doing their job. What we see here are all too often or medical professionals not doing their jobs.

[Debbie556]

Thank you and everyone for thier well wishes in ALL of this. I didn't mean to come off bitter or angey---upset yes. but I am still hopeful for my husband and also for my mother. It is just alot to take in in such a short time and the not having educated answers are the worst- I understand the Dr's position and I do after beating my brain and reading over and over everything for the study and talking to people here and others that it very well can be a good thing and his Dr may be wrong or just misinformed at this time. It just is what it is and only time will tell. Again Thank you all

[jmjm530]

To put an optimistic spin on things, if someone from the trial, or from Vertex is reading this -- and I hope they are -- perhaps they will put more of an emphasis on clearer communications not only between doctors and patients, but between the trial organizers and the doctors who actually run the trials.

This is not the first time we've seen massive confusion in and trials run by Vertex. And the confusion, as often as not, has been with the doctors and their staff, not just the patients. It's one thing when a patient here posted on understand this or that blood result. It's quite another thing when the NP who runs a study also doesn't appear to understand.

These trials use some very powerful drugs, and while we as patients potentially benefit from the drugs being tested, we are also offering ourselves up as guinea pigs for the drug companies. But the fact is we're not guinea pigs, we're real human beings with children and families, and we should be treated that way, especially in a drug trial setting.

-- Jim

[comeagain]

debbie i just wanna suport you in this stress youve been in, theres is no exuse for the doc to say your husband has relapsed in that unclear way which he probably hasn`t (relapsed that is) anyway.

I my self know what it is to recive such a message "you have relapsed" .

Chock and stress noone who hasn´t been there not even can imagen.

And about if you should have unblinded any studie I think its very unsensetiv to even mention this to you in this stressful time.

If somebody wants to warn educate others about it they cold very well open a thread about not to  unblind studies in a couple of days  when this have calmed down a little for you.

I don´t know what i would have done if it was me how have been treated the way you have been.

Slapping is the least for that doc in my opinion, and about what you have said here on forum you have nothing to apologise for, some others owe you instead in my opinion.

ca

[jacksonblue]

i agree with portan well said god bless hope you can find peace

[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

[Willy50]

And don't worry..... I took no offense.  I understand that this is a tough period for you.

I am also very sorry to hear about your mom.  I just lost a friend my age a few months ago to cancer.

No worries...there is nothing to apologise for.

Willy

[Willy50]

You wrote;
"the total inability of the Dr to give any answer beyond you relapsed"
---------------------------------------------------------------------------

If that is what they said then I don't think there is much room for many interpretations.

Get the PCR and prove it yourself.  If there is a viral breakthrough there are several possibilities

12 weeks of triple therapy  followed by 12 weeks of SOC yields about a 70% SVR rate.  that means about 30% fail.

In all likelihood 8 week triple therapy arm may have a lower success rate..... but we don't know that.  8 weeks may be as effective as 12 but could see a lower drop out rate.  We don't know yet.  Assume a 30% failure rate here too just for ease.  Any of the failures may be have less success with treating with PI's in the future; we don't really now about that yet.
The third group could be SOC null responders or breakthroughs that they decide not to treat into the extended arm.  He may be a part of that group as well.  In his case if he is in the SOC arm you have proven that he is a responder and in all likelihood if he had been on a triple therapy arm he may have had success.  That means if he were to treat with PI's the next time he may be fine.

I am very interested.... trying to explain things.  If he failed it is of course a tough thing, a scary thing but it in all likelihood is not the end.  

These trials are tough.  The blinding process makes them very tough and this one has a VERY long blind period.  I hope that you are not in the dark much longer.  I will float out the possibility that once you know more you will feel better.  Not knowing is very hard.

I've got to turn in; work tomorrow but just wanted to see if I could make some things more clear.  I may not be able to make them better.  If I could.....

best.....

Willy

[Debbie556]

Thankyou for the concern but I started this before work and now I think after all you might be right.... I think I need some sleep it has been a long 4 days......Thanks

[Debbie556]

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.

It is stressful and as a parent and grandparent my heart goes out to you I know what it is like to wait I had to wait 5 day for cancer results and I do know what that can do to you..

I know they can not tell him much in order to keep this a blind study but I also know there are better ways of dealing with these types of things..

Again I do apoligise for my total lack of patience with you but this and finding out my Mom is dying in less than three days is a bit much for anyone to take.. Please forgive me...

[jacksonblue]

you have been at this all day and  nite  get some rest no worries best wishes good nite

[Willy50]

Part of what I'm saying is that I don't want you stressing without need.

The vast majority of success cases in the Vertex trials will all have to stop at week 24; only the slow responders and SOC patients can continue beyond....at  least as I understand it.

I guess my question is if you are sure they said he failed....or you are interpreting that?  I can kind of imagine the state that you are in.  I've been in a similar frame of mind when I was DX'ed or while waiting for results of my kids PCR's.  A week is a long time to wait; an eternity.

All that I am suggesting is the possibility that this could be good news and not bad news.  All I am asking is that he get back with the doctor and make sure of which it is.  I have a feeling that only the successes will be shut down at week 24.  IF a person "failed" I don't even know if they will tell them that at the time.  For that reason I am wondering if he was actually told that he failed TX.  

If he was a slow responder he would continue treating.

If he has experienced a breakthrough they may not tell you but you can determine it via outside testing.  If he experienced a breakthough I'd guess that he is done treating no matter what.

Does this help or is it making you feel worse?  I feel as though what I have communicated may mean some hope..... but if they flat out says he failed TX then I haven't much more to add.

I'm sorry that this is stressful but it is not yet clear to me that he "failed".

best,
Willy