relapse at week 24 in telprivar study

[Debbie556]

Has anyone in this study been todl they had "NOT met the requirements at wk 24 and told to stop. We did go outside this study for blood wrk and was told 0 at week seven..Any ideas It ia a double blind study and his Dr does not have any blood work at this time..

[Debbie556]

I guess we will have to wait he had blood taken on Monday and hopefully we will hear from his Dr one way or another. Thanks to all for your input

[jacksonblue]

figuy is correct i was neg week 2 and already told if stay this way done week 24 i am not blinded

[FlGuy]

Or..on TVR and possible very successful through 24 weeks

"If you were in a telaprevir group and responded quickly and the virus stayed undetectable, you will have 24 weeks of treatment total"

The week 7 pcr would point in that direction, the way I read Andiamo's post.

[jmjm530]

from what is been posted, it appears that the reason you are stopped is because they found detectable virus at week 24. You should be able to confirm this with your doctor

Still, if you were truly non-detectable using a sensitive test at week seven< then I would still retest right away because viral relapses are not very common< so the possibility of a false positive may exist. should a retest come out negative in fact< if it's possible maybe your trial Dr. can have your blood retested especially if you show him your week seven results

[sandbash]

I was told to stop my meds after week 24.....but they did not tell me that requirements were not met or what my PCR status is.  I'm hoping I am in the 24 wk. arm and not a non-responder.  

[Isobella]

If he is in the tx naive trial-the one with 2 telaprevir arms and 1 placebo arm....this is from the consent form....page 18, I think.  I've had to re-read it myself...so I can relate I would suggest getting a PCR immediately and consider options.   I wish you the best of luck.  


At Week 24, you will be told by your study doctor whether your treatment duration is 24 or 48 weeks. This will be based on your treatment group and on virus levels during prior treatment decision points. Everyone in the group receiving placebo will have 48 weeks of treatment. If you were in a telaprevir group and responded quickly and the virus stayed undetectable, you will have 24 weeks of treatment total. If you were in a telaprevir group and responded less quickly or the virus did not stay undetectable through treatment, you will have 48 weeks of treatment total.
If you are to continue treatment for 48 weeks but the virus is detectable in your blood at Week 24 or at any study visit through Week 48, you are not responding to treatment any more, and the study doctor will stop treatment. This is a rule that is used in standard treatment, outside of research studies.

[Andiamo1]

According to Vertex:

At every study visit you will have tests done to assess your health and safety. Blood will be drawn to measure the levels of Hepatitis C virus in your blood. If the Hepatitis C virus remains above a certain level or becomes detectable at any time, you may not be responding to study treatment and changes will be made to your study treatment.
Depending on the level of Hepatitis C in your blood at different points in the study, decisions will be made about what the study treatment should be. The decision points are in place to make sure that subjects are responding to treatment. If it looks like your virus is becoming resistant to treatment you will stay on PEG and RBV treatment as you may still be able to respond to treatment.
For all subjects in the study, the levels of virus in your blood will be examined at Week 12 and Week 24. If this test shows that you are responding very slowly, or not responding to treatment, your treatment will be stopped. If you are responding very slowly, the chance of you responding to the whole treatment is very low, and is not worth the potential risks to you of continuing. This is a rule that is used in standard treatment, outside of research studies.
At week 4 and 12, additional reviews will be done for the subjects in the telaprevir groups.
• Based on the blood sample from Week 4, if the level of virus is above a certain cut-off level, you may be developing resistance to the telaprevir treatment. This means the virus may be developing genetic changes that will make it harder for the virus to respond to telaprevir and other similar drugs. The telaprevir will be stopped as soon as possible to keep the resistance from getting worse. Because you may still respond to treatment with PEG and RBV, you will stop taking telaprevir when you come back for your Week 6 visit, but continue taking PEG and RBV for as long as you continue to respond at the rest of the timepoints (up to 48 weeks total). Based on the prior studies, this is expected to happen in less than 5% of subjects in this study.
• Based on the blood sa mple from Week 12, if the level of virus is above a certain cut-off level, you may be developing resistance to the telaprevir treatment. Because you may still respond to treatment with PEG and RBV, you will stop taking telaprevir. You will continue taking PEG and RBV if your virus levels are below the necessary cut-off for week 12, and for long as you are continuing to respond at the rest of the time-points.

At Week 24, you will be told by your study doctor whether your treatment duration is 24 or 48 weeks. This will be based on your treatment group and on virus levels during prior treatment decision points. Everyone in the group receiving placebo will have 48 weeks of treatment. If you were in a telaprevir group and responded quickly and the virus stayed undetectable, you will have 24 weeks of treatment total. If you were in a telaprevir group and responded less quickly or the virus did not stay undetectable through treatment, you will have 48 weeks of treatment total.
If you are to continue treatment for 48 weeks but the virus is detectable in your blood at Week 24 or at any study visit through Week 48, you are not responding to treatment any more, and the study doctor will stop treatment. This is a rule that is used in standard treatment, outside of research studies.

[nygirl7]

I think you really do need to get a PCR so you can see what is going on - if you haven't had a breakthrough perhaps you could get another doctor to extend you onto SOC and if it's a matter of hemoglobin or something maybe a non-trial doc would be willing to give you rescue drugs to fix whatever the issue might be (something that perhaps the trial doc is not allowed to).

I would not just let it lie though - if that doctor is not willing to tell you why he is terminating treatment.....get the bloodwork done elsewhere and find out if there is any chance you can stay on.  Call some GI's today and explain that you NEED to have this done ASAP, even if they can't squeeze you in to an appt maybe they will figure out a way to just write the tests?

Good luck.

[Willy50]

It's merely a guess but based on what you wrote and only that...... a rebound is one guess.  If he cleared, broke through and has not cleared in subsequent weeks while on full dose Vertex might figure that continued dosing is likely to be unfruitful.

I'm not saying that this is what happened but it is one scenario.  Generally speaking they can extend treatment if it turns out that the participant is a slow responder.  If one is a non-responder they can end treatment.

One does not know exactly when he may have relapsed but generally speaking they make their decisions at week 12 and 24. (based on viral loads, not medical type emergencies like dropping WBC or WBC, rash etc.)

I may be wrong but I believe that this study is to remain blinded until it is completed and so if there is any action to be taken (such as extending TX) you will have to go it alone.

Once again; speculation but if one was on SOC on full dose and had broken through I don't think the odds of some other course of treatment are very good right now.  I'm not sure what form of treatment that you could extend and continue onto that might reverse the rebound.

Once again..... I'm only speculating and limiting this to discussion about viral load as it pertains to staying in the trial.  You don't mention any other factors such as blood work, compliance, or other serious sides which would explain ending of TX.

As mentioned; this remains blinded until the SOC arms finish, I think.  I wonder if that means all medical records or just the viral load aspect?  You may be able to get some of the other basic information; just not the viral loads.  Even though the doctors are also shielded from the data in the double blinding process I think that they could comment on what this MAY mean.  Perhaps there is a possibility that we have missed or advice that they can offer.

I also think that even though he may be done treating you might also ask for sure what follow up type visits are required and if the results of those also would remain blinded.  I don't believe that there is any "rollover" in any phase 3 trials but I would also ask the doctors if there would be any way to determine if your hubby got triple therapy.  It appears that he was in the first Phase 3 trial for naives (correct me if I'm wrong).  If this is the case I believe he has a 1 in 3 chance of having gotten onto the placebo arm.  I think that it's possible that you won't be told of that until the control arms are done dosing and even perhaps until their 6 month PCR's.

I'm sorry, this is just one scenario.  Since the study is blinded we don't really know.
It makes sense to me to retest and get a PCR.  If he has a positive count I think that would explain it.  If it negative then some real thought must go into his next step.

best,
Willy

[jacksonblue]

hello deb could be any number of reasons all your blood work is rated with codes toxicity   grade g1  g2 g3 then letters t is telephone  p panic exclusion rx possible exclusion i have copies in front of me i received yesterday i had 3 g1 2 g2  i am still good to go you could very well still be viris free or relapse your doctor should have this paperwork from covance cls lab they may have called him if it was a panic code and paperwork to follow none of these codes have anything to do with viral loads so you see could be any number of reasons these codes our for hematology and chemistry  and each item is rated your doctor will be able to let you no shortly wishing you all the best regards

[portann]

I'm confused. Has your husband already been told he relapsed and will be pulled from the study?

According to you, the doctor hasn't received the bloodwork, so how could he have made a decision one way or the other?

Since he was treatment-naive, could he be on a 24 week arm, if there is one in this trial?

[susan400]

You have one plus that I can think of and that is that you at least tested as undetected at the beginning.  If you hurry, maybe you can get your regular G.I. doctor to roll you into SOC and then, extend it out to 72 weeks..., if your GI will do that.  I would have him retest it first though.  

I was on Prove 3, Telaprevir trial but, I got placed in Group C, the no Riba group so, I didn't clear it by week 4 and was bumped out of the trial.  Now, the various other trials that use P.I.'s won't allow me into their trials.  I wanted to get into Boceprevir's trial and Schering told me no because of my having been exposed to the Telaprevir.  So, I'm sort of bummed out about that.  

I'll hold out good thoughts for you!

Susan400

[FlGuy]

I'm not sure about the protocols of your trial.  But, is there criteria for discontinuance other than viral load? For example, hemoglobin or other lab value hitting a threshold? Where you 'unblinded' when you were discontinued?

[jmjm530]

if you are undetectable in week seven, and your undetectable now (you could get tested privately) then one option is to continue treatment with a private doctor. But first, you should try to do some quick research why they dropped you. regardless of the studies double blind, the doctor should have an understanding of the criteria being used. You might also mention that you are UND week seven, and see what he says. Nothing to lose at this point.

[copyman]

I have not heard of anyone in my study group. It is my understanding even if you meet the "requirerments" (UNDE) at 24 weeks you still could be randomized to the 48 week arm.

why not just get another PCR on your own to see where you are at?