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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....
not sure how these things work, but now that your husband has been dismissed from the trial, shouldn't his blood results be available to him immediately? might want to double check on this. also, do you have this week seven results printed out? was a sensitivity of the test? it's fairly uncommon for someone to be UND with a very sensitive test and then have a viral breakthrough during treatment. I certainly don't want to get your hope up, but the best result would be if the test you take now shows him to be UND which may suggest a false positive for some other mixup with the trial blood tests. In that case, if I read this study correctly, he would only have treated 24 weeks anyway, which is already completed. But really just a lot of speculation, what you really want for all of his blood tests from the trial, and a current viral load test. Two tests I'd recommend from quest labs are either : (1) Heptimax; or
(2) HCV RNA QUAL TMA. Both tests are sensitive down to 5 IU/ml. good luck.
(2) HCV RNA QUAL TMA. Both tests are sensitive down to 5 IU/ml. good luck.
He was not dismissed he was told he didn't meet the requirements to contine on the drugs which are the standard treament for hep c. He still has to go in to have follow ups and be monitored. His Dr said they are not releasing the test results for him until the end of the trial. Like I said we are going to have his blood drawn outside the group and we did the HCV RNA tests at 7 wks and he was undetectable at that time. I just am haveing a hard time trying to understand how his Dr could say he relapsed with out knowing the blood results or wondering if he is one of the lucky ones that did clear early and has remained clear and that would also explain him being taken off the rest of the standard treatment. Telprivar is supposed to be a 24 week total treament when it finally approved so I am just very confused at this time
Since it was hubby who was given the information, are you sure about how they phrased it? As you point out, the doc might not have the information to determine relapse. If it was phrased more like 'hubby did not meet the criteria to continue' that could mean something different entirely. It does sound like a confusing mystery.
now I'm getting a bit confused. Are you saying that your husband was told not to take any more drugs because either (1) he was RVR and therefore only needs to treat 24 weeks, or (2) he didn't meet the requisite viral load drop and therefore is being discontinued because more drugs aren't doing many good. And not because the doctors are blinded, they don't know which of the above categories your husband falls into.
OR are you saying that they are telling you that he simply didn't get the requisite viral response and therefore more drugs aren't doing any good?
OR are you saying that they are telling you that he simply didn't get the requisite viral response and therefore more drugs aren't doing any good?
our posts crossed, but FLGuy and myself are saying the same thing. You really should have a talk with Dr. directly and find out exactly what's going on.
"it's fairly uncommon for someone to be UND with a very sensitive test and then have a viral breakthrough during treatment."
This is true when treating with SOC, but it might not be true when treating with a PI. Say you respond well to the PI, but not to the pegylated interferon and the ribavirin. You might reach UND at first and then when the PI resistant mutations develop, you might have a breakthrough, since you were a null responder to SOC.
Debbie, I sure hope this is not the case with your husband. Just trying to be realistic about the possibility of breakthrough. Sending prayers your way that it all will work out.
Za
This is true when treating with SOC, but it might not be true when treating with a PI. Say you respond well to the PI, but not to the pegylated interferon and the ribavirin. You might reach UND at first and then when the PI resistant mutations develop, you might have a breakthrough, since you were a null responder to SOC.
Debbie, I sure hope this is not the case with your husband. Just trying to be realistic about the possibility of breakthrough. Sending prayers your way that it all will work out.
Za
The paper we got on Monday stated:
This subject did not meet the necessary Week 24 criteria to continue study treatment or had an eRVR. This subject should discontinue all study treatment and continue per protocol.
His Dr was told by us that he was undectable at week 7, this was after we went outside to his personnel Dr. We were also told several times by his study Dr that he was doing the best as far as side effects and maintaing good levels in the blood work that were given to his Dr.I know this a double blind study but at this point there is something that is not right.
This subject did not meet the necessary Week 24 criteria to continue study treatment or had an eRVR. This subject should discontinue all study treatment and continue per protocol.
His Dr was told by us that he was undectable at week 7, this was after we went outside to his personnel Dr. We were also told several times by his study Dr that he was doing the best as far as side effects and maintaing good levels in the blood work that were given to his Dr.I know this a double blind study but at this point there is something that is not right.
you could be correct, but I'm unaware of any data to support (or not to support) what you're saying, and yes, I was referring to SOC data which we do have. the more important issue seems to be what exactly is the Dr. trying to communicate. As Florida Guy and I suggest, it may well be better husband was taken off the drugs because he was RVR and therefore doesn't need to treat beyond 24 weeks. That still seems unclear.
the test drug is given for the fist 8 to 12 weeks along with the standard drugs peg.-rib. He continued with the standard for the 12 weeks after the telprivar. He passed at week 12 to continue but at week 24 was stopped from taking anything else with his Dr saying he Relapsed. I don't understand that because he was basing it on the letter I posted earlier..
I think that the 'or had eRVR' part is an important part of that notice and reason to be optimistic.
This subject did not meet the necessary Week 24 criteria to continue study treatment or had an eRVR.
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if this is the language they sent you, the writer should be shot, especially if it was not accompanied by a conversation with your doctor. At face value it seems to suggest that your husband has a 50-50 chance of being RVR and therefore is not continuing because the hope is for him to become SVR with only 24 weeks of treatment. Again, you should confirm this with your doctor. Sounds like things may be looking up, hopefully.
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if this is the language they sent you, the writer should be shot, especially if it was not accompanied by a conversation with your doctor. At face value it seems to suggest that your husband has a 50-50 chance of being RVR and therefore is not continuing because the hope is for him to become SVR with only 24 weeks of treatment. Again, you should confirm this with your doctor. Sounds like things may be looking up, hopefully.
I interpret that as either your husband was UND at week 4 and therefore only has to do 24 weeks OR he was detectable at week 24. Since you know your husband was UND at week 7, I would say the chance is great that he also was UND at week 4 and therefore only needs 24 weeks of tx. Looking good in my opinion!
If I deciphered correctly, this is how it should have been written:
You should stop all drugs at week 24 because you fell into one of two following groups. unfortunately, because the trial is blinded, we cannot let you know at this point which group you are in.
Group 1: You had a eRVR and therefore we do not believe that you need more than 24 weeks of treatment to be cured.
Group 2: Your viral response did not meet the trial requirements and therefore we are stopping treatment because we do not believe the drugs can cure you.
You should stop all drugs at week 24 because you fell into one of two following groups. unfortunately, because the trial is blinded, we cannot let you know at this point which group you are in.
Group 1: You had a eRVR and therefore we do not believe that you need more than 24 weeks of treatment to be cured.
Group 2: Your viral response did not meet the trial requirements and therefore we are stopping treatment because we do not believe the drugs can cure you.
No matter how it turns out please pull up one of these threads and let us know how it turns out. I, for one, am really curious about this. Good luck to you and hubby!
THANK YOU ALL for the in put. I just needed to hear from others that I am not losing my mind and that this might not be as bad as it was put.. The letter from the Dr was exactly as we got . I have the copy. My only defense to his Dr being so for lack of a better word heartless was he did know that he was neg at 7 wks and just assumed that he must have relapsed. I think it has taken a couple of yrs off after Monday for the both of us but I am trying to look on the bright side and I do believe that he is clear and we will fine. Again thanks to all here you are Mind and Life savers.....
eRVR must mean early RVR. Could this be RVR even before week 4? I know here in Sweden the hepatitis doctors use the term vRVR, which means "very rapid viral response", and is used for having less than 1000 IU/ml at week 1 (day 7).
I have also heard the term 'super-responder', but don't know the duration for which that applies.
like a true editor using voice recognition software that won't let me go back and edit LOL at least you get the point. as to eRVR, yes, these trials usually test viral load well before week 4. I can only assume from the letter, that eRVR is required to stop at 24 weeks as opposed to simply RVR, although I'm sure it's all written down in the trial protocol.
reread trial protocol this is a naive trial so i dont have it i know on prove 3 trial wich was also double blinded all viral loads were released to me at 6 months i had to request them they were not offered that is when i realized i was on placebo arm i think you need to speak to doctor again
If your doctor had spoken as clearly to you as Jim did in his suggested letter above, a lot would have been won. It seems to me your doctor was very careless in his interpretation of the letter.
I am thinking chances are good that your husband is SVR already.
I am thinking chances are good that your husband is SVR already.
You should be given all pcr results from this point on....so the mystery will be over soon. If it comes back UND....he must have been in one of the Telaprevir arms and is done. No one in the placebo group has an option to tx for 24 weeks-they all go the full 48-unless there is a viral breakthrough then they are stopped.
If the pcr comes back with a detectable level then you will know at some point he had a breakthrough. If it were me.....I'd get that pcr as soon as you can....but I'm impatient.
I agree with Jim.....whoever worded that letter needs to be smacked. Preferably by a bunch of us in the study.
I'm wishing the best for you and your hubby =)
If the pcr comes back with a detectable level then you will know at some point he had a breakthrough. If it were me.....I'd get that pcr as soon as you can....but I'm impatient.
I agree with Jim.....whoever worded that letter needs to be smacked. Preferably by a bunch of us in the study.
I'm wishing the best for you and your hubby =)
the really frightening thing is that her doctor may not actually understand the letter. We've seen similar here before haven't we :(
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