Aa
telprivar relapse
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....
I do know what you are saying but all I have been through since Monday and the total inhability of the Dr to give any answer beyond you relapsed, has been a hard thing to take..
I do consider myself to be a reasonably intellegent person but that comment coming out of left field so to speak was mind blowing to say the least.
You can put so many "twist" on things to have it come out the way you want it can blow your mind. I do understand that he may be one of the " LUCKY" ones that achieved a rapid response and maintained a undetectable viral load. That is what not only vertex wants but as a patient you also want that. The options as to what you are left with if you did in fact receive the real drug are not something that I would wish on anyone. But then again what choice are people left with.. I have gone through a gambit of emotions from wanting to die for him to feeling like I have lost my mind to anger, to wanting to fight like no one has ever thought of.
At this point I don't care if by me saying where he received treatment is a big deal--- no one should have to go through this and if it means me bringing this to peoples attention and them changing the wording then so be it. My hope for him and anyone else going through this or any other type of treatment for this is that they get the type of treament they deserve and not just be treated like like some type of lab rat.
I do consider myself to be a reasonably intellegent person but that comment coming out of left field so to speak was mind blowing to say the least.
You can put so many "twist" on things to have it come out the way you want it can blow your mind. I do understand that he may be one of the " LUCKY" ones that achieved a rapid response and maintained a undetectable viral load. That is what not only vertex wants but as a patient you also want that. The options as to what you are left with if you did in fact receive the real drug are not something that I would wish on anyone. But then again what choice are people left with.. I have gone through a gambit of emotions from wanting to die for him to feeling like I have lost my mind to anger, to wanting to fight like no one has ever thought of.
At this point I don't care if by me saying where he received treatment is a big deal--- no one should have to go through this and if it means me bringing this to peoples attention and them changing the wording then so be it. My hope for him and anyone else going through this or any other type of treatment for this is that they get the type of treament they deserve and not just be treated like like some type of lab rat.
In the first naive trial the 2 triple therapy courses of treatment were to be a total of 24 weeks. IF the patient were a slow responder then the doctor could continue treatment (it would be SOC; not any form of triple therapy) for up to another 24 weeks. the doctors could stop TX during that period for reasons either medical need or simply because the patient wasn't responding.
It was the SECOND phase 3 naives trial in which patients were randomized into 24 and 48 week groups (not the this one).
So....in this trial all successful triple therapy participants would stop at week 24.
Only placebo arms and slow responders would continue beyond 24 weeks.
It may be an uncommon use of the words and wording but......
If you don't "meet the criteria to continue" that might mean that you cleared and have stayed clear; since only SOC arms and the triple therapy slow responders can continue beyond the 24 week mark.
Does that make sense to you? I don't know what they said but this is one more spin on it....just different wording of what has been suggested earlier.
best,
willy
It was the SECOND phase 3 naives trial in which patients were randomized into 24 and 48 week groups (not the this one).
So....in this trial all successful triple therapy participants would stop at week 24.
Only placebo arms and slow responders would continue beyond 24 weeks.
It may be an uncommon use of the words and wording but......
If you don't "meet the criteria to continue" that might mean that you cleared and have stayed clear; since only SOC arms and the triple therapy slow responders can continue beyond the 24 week mark.
Does that make sense to you? I don't know what they said but this is one more spin on it....just different wording of what has been suggested earlier.
best,
willy
well I understand your reasoning here but I did not sign the agreement and actually to be honest-- whether or not I say where the treatment took place is not even on my mind. It is my and only my opinion that the way in which it was handled---- it was WRONG... I know that by going outside the trial was not what they wanted but then again what they subject you to in reguards to what you go through during the treament is not at all what they tell you to expect. The actual percentage and what you as an individuale go through are not what is on paper. I know that as the "caretaker" for lack of a better word go through is just as hard as what the patient is going through without the actual symptoms.
I guess for lack of a better way of putting it I have been put through hell for the last few days and I think that there is a better way of putting it to patients without Ripping their guts out to say they failed. Especially when you have nothing to base it on.. And you want me to be careful as to where I say he was treated. Please let them come to me and say I did something wrong then we will see....
you seem to know enough to know that the next round of treatment for people who fail the protease inhibitor is not what you want to look forward to....
I guess for lack of a better way of putting it I have been put through hell for the last few days and I think that there is a better way of putting it to patients without Ripping their guts out to say they failed. Especially when you have nothing to base it on.. And you want me to be careful as to where I say he was treated. Please let them come to me and say I did something wrong then we will see....
you seem to know enough to know that the next round of treatment for people who fail the protease inhibitor is not what you want to look forward to....
My 2 cents.
The doctor cannot tell you the viral loads. They can only run the trial as Vertex contracted for them to do and your hubby agreed to do when he signed the consent form.
I think a lot of this has come from fuzzy communication. The first thread said relapse and suggested that the trial end was due to the relapse. I think it was suggested at the end of that thread of the POSSIBILITY that the trial ended simply because the hubby was done dosing and in an arm which only went 24 weeks; not a failure at all.
None of us know; only the doctor or NP can tell you in the special way that they must that hubby is done for one reason or another. Either hubby or both of you needs to get the message clearly....as clearly as they are able to tell you. You understand that they are NOT permitted to tell you certain things, as it would unblind the study. You need to be very careful to understand what they tell you and not misinterpret it.
Rebounding in the middle of a study may mean no continuation of treatment.
Being in the 12 or 8 week triple therapy arm and being randomised into a 24 week total treatment time means the same thing; no continued treatment after 24 weeks. You see....the end result is the same but there is a hell of a difference isn't there? Complete failure versus a likelihood of success probably on par with 90-95% (if one eRVR'ed).
One other thing that I'd warn you about is that the reason that these trials are blinded is that they don't want people unblinding the trials.
That means..... you should probably not be posting such information if and when you get it. That is part of the agreement that hubby signed.
Lastly, I would also suggest not naming names or hospital locations for obvious reasons. These trials can be a wonderful thing but one has to take care of them.
Everybody has had good input but I think that some of this may have been avoided with a little more clarity about what was actually communicated. (and having said that I don't know what was communicated)
By the way..... this didn't happen in other trials since the blinding process is longer and more complete in this trial.....or so I believe I understood. Other trials were unblinded as people went along; not immediately but maybe in 12 week increments. This one is to remain (or the origional intent was) blinded until the SOC arm ends (that's about either 12 or 18 months if they figure waiting for 6 month PCR's) which will place a lot more stress upon the participants (and I'd also guess the doctors as well).
Sorry if this sounds like scolding a little bit but you have to be careful what to reveal/post here. I have a feeling that you will be able to deduce where he sits fairly soon.
A private PVR will show if he is positive or not.
If he was clear at 7 weeks but experienced viral breakthru (as proven by the PCR)..... there probably isn't much that can be done except stop TX.
IF he was clear at 7 weeks and is clear at 24 weeks I'd venture a guess that you are in good shape, eh?
How many more options are there?
best,
Willy
The doctor cannot tell you the viral loads. They can only run the trial as Vertex contracted for them to do and your hubby agreed to do when he signed the consent form.
I think a lot of this has come from fuzzy communication. The first thread said relapse and suggested that the trial end was due to the relapse. I think it was suggested at the end of that thread of the POSSIBILITY that the trial ended simply because the hubby was done dosing and in an arm which only went 24 weeks; not a failure at all.
None of us know; only the doctor or NP can tell you in the special way that they must that hubby is done for one reason or another. Either hubby or both of you needs to get the message clearly....as clearly as they are able to tell you. You understand that they are NOT permitted to tell you certain things, as it would unblind the study. You need to be very careful to understand what they tell you and not misinterpret it.
Rebounding in the middle of a study may mean no continuation of treatment.
Being in the 12 or 8 week triple therapy arm and being randomised into a 24 week total treatment time means the same thing; no continued treatment after 24 weeks. You see....the end result is the same but there is a hell of a difference isn't there? Complete failure versus a likelihood of success probably on par with 90-95% (if one eRVR'ed).
One other thing that I'd warn you about is that the reason that these trials are blinded is that they don't want people unblinding the trials.
That means..... you should probably not be posting such information if and when you get it. That is part of the agreement that hubby signed.
Lastly, I would also suggest not naming names or hospital locations for obvious reasons. These trials can be a wonderful thing but one has to take care of them.
Everybody has had good input but I think that some of this may have been avoided with a little more clarity about what was actually communicated. (and having said that I don't know what was communicated)
By the way..... this didn't happen in other trials since the blinding process is longer and more complete in this trial.....or so I believe I understood. Other trials were unblinded as people went along; not immediately but maybe in 12 week increments. This one is to remain (or the origional intent was) blinded until the SOC arm ends (that's about either 12 or 18 months if they figure waiting for 6 month PCR's) which will place a lot more stress upon the participants (and I'd also guess the doctors as well).
Sorry if this sounds like scolding a little bit but you have to be careful what to reveal/post here. I have a feeling that you will be able to deduce where he sits fairly soon.
A private PVR will show if he is positive or not.
If he was clear at 7 weeks but experienced viral breakthru (as proven by the PCR)..... there probably isn't much that can be done except stop TX.
IF he was clear at 7 weeks and is clear at 24 weeks I'd venture a guess that you are in good shape, eh?
How many more options are there?
best,
Willy
thanks so much for you well wishes I just wish you really had a chrystal ball cuz I have alot of questions
Seems very probable to me that the dude was stopped because he's UND and did enough. Not to put too fine a point on it, but a VL recorded while on the drugs is a breathrough, not a relapse.
Breakthroughs on PI's alone are common. That's why the poison was added back into the cocktail. Debbie - my crystal ball sees Crystal... Crystal champagne for you and your dude when you get the good news. Good luck.
Breakthroughs on PI's alone are common. That's why the poison was added back into the cocktail. Debbie - my crystal ball sees Crystal... Crystal champagne for you and your dude when you get the good news. Good luck.
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