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]

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"
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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