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....

[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