strange news from nurse

just got a phone call from my study nurse that i was to stop taking my study med due to viral relapse but continue SOC. this confused me why keep me on SOC unless it is a mutated virus causing the increase ? I am in week 12 with just 7 more doses to take of the xv950/placebo . vl started at 3.8 mil they must have gone down then increased again as non responders would not have been notified till after week 12 . guess this make me the 1st and only ( i hope) failure of the 7 people on this board for the vx950 . dont quite no where I will go from here will continue SOC and see if I can get vl info friday . any thoughts would be appreciated as I begin to realign my ducks thanks chuck

[APKhaos]

That's rough news, Chuck. Can only imagine how that must feel. Sorry to hear it, brother.

On the dosing, you actually have the VX package still to be finished, right?  On the SOC, they automatically offer completion to 48 weeks of SOC if there is a breakthrough. Depending on how significant the breakthrough, it might make perfect sense to continue the SOC. Others here know much more about that than I do.

I'm sweating now. My starting VL was 27m.

[pln]

Chuck, Sorry to here this, maybe you were on placebo?? the study nurse told you to quit taking the vx or placebo at week 11, there is no reason they should keep you blined untill week 20, If you are in group A (placebo) and did not respond you have the first chance to do phase 3. and get the real vx. So I would demand to be unblinded now and go from there. Pam

[APKhaos]

See? Pam's so much smarter than me.

She said, "If you are in group A (placebo) and did not respond you have the first chance to do phase 3. and get the real vx. So I would demand to be unblinded now and go from there." This is right on the money, of course. Its worth checking that you can get early confirmation to Prove 3 non-responder trial next year.

[chcnme]

Chuck, I'm so sorry you got this phone call.  I totally agree with the others' suggestions. Wishing you the best.

[willows]

Wow, you must have felt very confused, I'm sorry that you didn't get better info.  All of you folks on VX, do you know if you were on placebo?  Could CR have been on placebo, 12 weeks would have been the right time to take off the placebo.  But then, would the nurse frame it in the context of vl breakthru?  I had viral breathru at 24 weeks and was taken SOC and now doc's don't want me to do any more current tx.  Just wait for something new.

cr, you may be a slow responder to IFN and riba, hang in there and keep taking the SOC as long as you can.  Please let us know if you find out anything further, so many of us rooting for you VX folks, I hang on every word.  Every one of you that reaches SVR, whether in 4 weeks or 12 weeks or 24 or 48 is a victory for all of us.

Willow

[APKhaos]

The only people who really know when and how the Arm A subjects [placebo + SOC] are unblinded are the subjects themselves, I guess. There was word that Arm A would be unblinded at the end of week 10, but its also possible that they decided to hold all unblinding until week 20.

On this basis, Chuck could have been in Arm A but that is pure conjecture. Sure worth asking the question. No reason they shouldn't give you all your results to data and confirm if you were VX or placebo. You've certainly done your part.

[crsrph]

thanks for all your support. I have been thinking about this (small wonder ) since i 1st wrote and if I was on placebo why bother to call me to stop taking 21 more sugar pills also why give a placebo tablet a bitter taste when no one would know if it had a taste or not (always took mine with milk to kill after taste after 1st day) so fairly sure I got vx950 . her phrase stoped due to viral relapse I would take to mean  in the strictest sense UND not non responder or partial responder I could be wrong here . but then why keep me on SOC for just another week or two unless i had shown a major response  I knew to start with that there were concerns with viral mutation (all bacteria and virius mutate)and I was required to decrease my pegasys dose to 90 ug in week 7 due to platelets at 40 then up to 135 ug for 3 more weeks then 180 again last week this may have allowed some mutants to get a foothold just a guess butI get the feeling that this may be the case due to the fact that they were doing extensive viral sequencing in this study . will see what info I get in a couple of days . APK saw you got a vl figure does this mean you got unblinded or did you have 1 done outside of the study your so close i'm sure you will make it best of luck

[cuteus]

why would she call it a relapse, I wonder?  that word is reserved for those whose virus return after stopping all meds.  That is not your case.  You had a viral breakthrough.  Are they using different terminology in this study?

[friole]

I am so sorry you got this news -- but I can't imagine that you are on the placebo.  What would the use be to stop the placebo trial when all it is used for is to compare the results to the real thing. (Isn't that right?)  THerefore, I would assume you were on VX.

I hope youa re able to get the viral load results soon.  Although you are guaranteed the SOC, it might be that you will need to extend.  Do you have cirrhosis?  I wonder becasue of how low your platelets are.

[APKhaos]

Chuck said,"APK saw you got a vl figure does this mean you got unblinded or did you have 1 done outside of the study?"

My pre-trial VL was over 27 million. I have not had an off-the-reservation PCR since starting the trial, so all my VL numbers are still blinded for another week or so. It's hard to believe, but next week is my week 20. All will soon be revealed.

Chuck, you are probably on to this already but you should insist on a meeting with the investigator running your trial group. You need someone who has all the information, can answer your questions, and can give you solid treatment advise. That may well include participating in the non-responder trial if that is appropriate. The nurse is nice, but right now you need the senior Dr leading your trial group. Accept no substitutes!

[NYgirl]

I think they want you to know that although you still do have the virus - it wasn't wiped out early by the vertex (or placebo) but you should STILL do STANDARD treatment for 48 weeks to try and kill it.

Probably the nurse just said the wrong thing (breakthrough vs. relapse) not thinking her verbiage really mattered (most of them think we are stupid and how would we know hahahhaa).

If I was you I'd continue doing regular treatment and if I cleared by 24...continue on towards 48 or 72 (more likely 72 depending, since you are pos at 12).

What a bummer. BUT...you didn't fail treatment or anything so you still have good hope of a cure.  :)

[prettydamscared]

Thanks for answering.  It does seem, based on my conversations with Pam anyway, that our two studies are managed somewhat differently.  Perhaps my study coordinator is just handling the "unblinding" differently.  I would really like to know that though because if you, for instance, are able to get vl results at week 20, I don't know why my study couldn't put that together as well.  My doctor was pretty firm about his wording with the viral breakthrough info though.  He used today's bloodwork as an example.  If I should have viral breakthrough in test results today, there is no guarantee that we'd be notified of that in any particular time frame.  

I did read the thread regarding Chuck's slow response or breakthrough.  I'm not sure exactly which it was but it was consistent with my understanding of what happens if one is not UD at week 10.  I hope we find out soon if he's on placebo or vx, placebo being my guess.  This is the downside of a study, the not knowing.  It is killing me too!  Please let us know asap when you find out about your unblinding.

Talk to you soon, Char

[APKhaos]

Pam said'"APK, Hey I am getting a little nervous!! what about you?"

Nervous? Hell no! I'm just antsy for confirmation that those little buggers are dead, gone, and history. All 27 million of them. Somehow I've got a good feeling about this. Not so sure how good I'd feel about being in Arm B. I'd do a deal with the devil to be in Arm C.

C'mon Pam, you know they're done, right? If they weren't, I think you would have been informed by now.

[pln]

LOL, Deal w/ the devil, I know what know mean though. You are always very positive and I thank you for that. We will have alot of info VERY soon, your right it is all down hill from here. PDS is at the DR today, so I am going to leave her a message to post if she finds out any new news. Pam

[prettydamscared]

Hi, I haven't talked with you in a while but I do follow your posts.  Sounds like you're holding up fairly well.  I hope your sleep issues are resolving as well as the residual rash.

As Pam posted, I met with my doc today for my 16 week visit.  I got two pieces of information that were a bit surprising.  I asked doc directly if he would have been informed by third party coordinator if I'd experienced viral breakthrough after the 10th week.  Everyone knows that if we didn't clear by 10 weeks or experienced viral breakhrough, we would have been pulled from the initial study, however what happens after the 10 weeks was never really clear to me.  Since I was on prednisone for that rash for a time and was not consistent with meds, again because of the rash, I just wanted to confirm that I'd be notified in the event of viral breakthrough.  (Just a reminder, I did get the off the reservation pcr at 3 weeks and was UD.)  Doc said that he couldn't "promise" that he or I would be informed of viral breakthrough.  Several of us here did get those off study pcrs. I thought I was home free but didn't know that we wouldn't be infomed of viral breakthrough, at least not in any kind of timely way.....

Second thing, at 20 weeks, we'll be unblinded in terms of which group we're in but NOT as to viral load information, etc.  My study nurse said that information won't be forthcoming for another 4 weeks, which would put it at week 24.  She did say I could call her at 22 weeks and she'd give me info verbally but won't "officially" get it until 24 weeks.  Mremeet was told the same thing but we're in the same study.  I'll be really interested to find out if you get viral load information at 20 weeks.  Have you heard anything similiar?

As always, thanks for your help.

Char

[APKhaos]

Will check tomorrow on just exactly what we get in our eagerly awaited week 20 info packet.

Will post back here as soon as I know, so pls keep an eye on this thread tomorrow.

[APKhaos]

Hey Char - good to hear your going well. Its gettign close, but maybe not as close as I thought!!

On the viral breakthrough case, my study coordinator specifically said that the sites were being informed if any of their subjects failed UND on any of the followup VL tests. That's very different to what you heard, so I guess I can ask the question again.

There's a thread this week from Chuck describing how he was advised to stop trial drug dosing and switch to SOC after a breakthrough. He was in the middle of week 12, so the breakthrough most likely turned up on his week 10 labs [not 100% sure, but its likely].

The 20 week unblinding for Arms, but no VL data is again inconsistent with what our study coordinator has said. We have talked several times about getting the VL results in week 20. Its entirely possible that this was an assumption that ALL the blinded info would be release in week 20. Once again, I'll try to confirm on that too.

Would't it be nice if we did not have to speculate about such basic things. How hard can it be to give the subjects the simple facts of what information they will be given, and when.
This is my only criticism of the trial management. In all other respects, it has been extremely well done.

[pln]

Hello, I was told at week 10 blood work that if I (we) were not responding we would be notify soon after to stop meds.Maybe 10 weeks of placebo is enough for study?  My study did confirm that group A (placebe) would be able to do phase 3 vx-950. I am hoping he is in group A. If so stop now ,take a rest, and wait. My study site is getting ready to do phase 3. Richmond VA. We will see soon, I am at week 18, two more weeks then unblinded.                                                                                                                                                                                           APK, Hey I am getting a little nervous!! what about you?

[pln]

((((CHUCK)))), Big hug to you, How are you? did you talk to your DR? I hope you get this matter cleared up fast so you can take all the right steps to kill this virus!! Pam

[prettydamscared]

Will do.  Talk to you tomorrow.

Thanks, Char

[crsrph]

thanks to all of you for your support it has helped to calm my mind. they did blood draws today should get vl's and rest of info next wed from there doc will decide on course of treatment unless my vl's took a huge jump up I will continue treatment untill they pry the drugs out of my cold rigormortised hands and that may take a while since I just got 4 months worth of SOC

[APKhaos]

Just received confirmation that the Week 20 unblinding packet will include the Arm we are in AND the VL results. This seems to be at odds with what PDS was told, so I guess we wait and see.

I did make a point of asking the straight question about VL results, and got an equally straight answer.

[APKhaos]

That's much better news, C. Sounds like they plan to look after you and give you all you need for SOC. From what I've seen, they treat their subjects really well. YMMV, of course :-)

Did they mention the non-responder trial that's starting up early 07?? Thought you would have been a certainty for that IF you want it.

[crsrph]

yes they they did bring it up in my week 10 appt (premination on their part dont know how ast alt were good they dont have vl's ) or experience 1 other person in our group was pulled maybe had a similar senerio on the decreased pegasys dose . then np said same on wed and fri (week 12 ) I ask what if i wasnt in group a or it was a relapse she seemed to think that there still maybe a spot for me but doc would talk to me wed orwhen he had more results vl's to go on so it sounds like they maybe expanding phase 3 to include some rvr's and not just nonresponders  which may help some people out . i agree with you the care has been very good the confusion on the final draft for the study changed so many times i still dont think all involved in this study know what is going on