VL results question

[researchmonkey326]

I went in for my 8 week blood draw today (Gilead trial 9190/9256).  I had gotten my 4 week vl results as <25DET.  The Gilead rep had been in there today before me and they actually consider me UND at 4 weeks.  I know that there are different sensitivities to the tests but I'm not really grasping this - what was I - DET or UND? Or is this just manipulation of results to make the trial look more promising?  Granted, the results of the trial so far are excellent and there is no denying that.  Anyone else have experience with this?
BTW, the darn rash that so many people talk about has struck at the end of week 8 and almost doubled in body area covered since last night!

[researchmonkey326]

Thanks all, for questioning Neupogen intervention this early.  I have not met the parameters for the trial that requires the Neupogen but have for a dosage reduction of the peg- we'll see if that helps things.  This is such a better alternative to adding another drug.  Because of your support and questions, I made them read me the trial parameters today so I could play a role in what was happening.  It worked and I feel better about things now.
Debra

[willbb]

Hi Debra..the study would certainly have their parameters  in place when to bring in rescue drugs.  Normal ref. range for WBC is 4 -11  and neutrophils (ANC )
is 1.8  -7    so yes both are low. However mine went to  WBC- 1.8  and ANC to .57  and the docs said that they would not intervene at that level . And others here have said much the same. Most docs it seem don"t worry to much about the ANC until it gets down to about .5 or some apparently let it get to about .3 before intervening.

I just thought with the horrendous expense of it as well as possible sides ,are they being too aggressive,however they are the docs ,so there recommendations is what you should be doing ,by all means,however at least you might want to discuss with them how worried they are and if you have a choice in the matter.

Drop in white cells for the most part will have no bearing on how crummy you feel,however yes thyroid could be the culprit as well as Hgb. being low.

Hope it all goes ok for you ....
Will

[researchmonkey326]

Really?  that's not that low?  I need to do some research when I get home from work today.  Neupogen is allowed in this study - no Procrit.  Just got word that my peg dosage will be decreased this week instead to see how that goes.  Yes, the expense if awful - my cost $1100 for 8 shots. There is assistance available.  Maybe the study protocol has a certain level when they intervene.  This all happened so fast today between the jump in ALT up to 174 and the thought of all those $$$ - the way I have to look at the money though is that all of my other treatment is free.  Anyway, a rollercoaster day.  
Will - you said that this is not what is making me feel bad anyway, right?  I'm still thinking that maybe with the drop in WBC and the increase in ALT, that thyroid could be the culprit.
To top it all off, my insurance company denied the Neupogen anyway - guess they would rather pay a lot more later for transplant or cancer.  

[willbb]

Debra...I thought there was no rescue drugs allowed in that study....or am I thinking of another one ...?

Will

[willbb]

.  Neutrophils down to .67 and WBC 1.46.  


   Why  would your doc prescribe neupogen at these levels?  Raising your neutrophils will have no effect on how you feel, also it is horrendously expensive (if not covered) and there is  sometimes significant sides to Neupogen.

Will

[researchmonkey326]

Just responded to your new thread but you can always go to clinicaltrials.gov and search

[fredpacc]

Hi research monkey, hope you are feeling well. I was on Pegasys 5 years ago so I know how tough be. My doctor mentioned a possible up coming Gilead trial and I was wondering if you can tell me where I can learn about their trials; results, etc. I never even heard about it before today so anything you can tell me would be greatly appreciated. Thank you - Fred

[researchmonkey326]

Maybe because I had a jump in my ALT too?  This is all new to me because I'd been pretty much sailing along unscathed up until the past week.

[nygirl7]

Check if they have a patient assistance program? Also sometimes neuts go back up on their own.....mine did. I thought doctors didn't freak out until they were much lower than that?

[researchmonkey326]

Got updated lab results this morning - WBC and neutrophils took dive.  Neutrophils down to .67 and WBC 1.46.  Having problems getting Neupogen?  Doctor wants to get it in me no later than tomorrow so I can continue with shot #10 on Saturday but they are having to jump through hoops to get it prescribed that quickly.  I feel not very well and this is a major university hospital in a major city - I don't get it and am irritated at this point.  Plus, the cost is not included in the study - my cost is $1100 per month (I have $2500 out of pocket limit so at least there is that).  Overall, not a great day.

[Mary4now]

Hi researchmonkey, what is hgb level? and your bilirubin?  sounds like the riba is wreaking havoc,,,, getting all those little virons and making you feel like an extremely tired itchy person.
hope you are UND too.........   :}

[researchmonkey326]

Still confused but you know what?  It is what it is .  I'll have new results this week from yesterday's draw and fingers crossed that none of this rhetoric comes into play and I'm straight out UND.  Right now, my bigger concern is the rash and the increasing fatigue

[foofighter]

Hmmm. Sounds weird. You are either detected or not. I stayed "detectable <25" for six weeks in the Bocep Sprint 2 trial. There was still VL, just too few to quantify, I think. Sprint 2 used Taqman, sensitive to <10 if I recall.

Willing and Willy can 'splain better than me. Here is a Willing excerpt from this thread last year:

http://www.medhelp.org/posts/Hepatitis-C/PCR-sensitivity-range/show/1295609

"the results of CAP/CTM are reported in four different ways: undetectable (below or above the assays’ LOD), positive but below 15 IU/ml, positive above 15 IU/ml with an exact HCV RNA concentration, or positive and above 6.9 × 107 IU/ml (upper limit of quantification). The assay's linear quantification range is between 43 and 6.9 × 107 IU/ml, as indicated in the package insert. The assay's 95% detection rate is 12.6 IU/ml (package insert) and has ranged from 7.4 to 10.5 IU/ml in recently published studies"
http://www.ncbi.nlm.nih.gov/pubmed/18799708

So your w6 was in the category of detectable but below the limit of quantification. Whether to only start quantifying when VL reaches the linear range of 43IU and above or to report a number in the non-linear range of 15-43 seems to be up to the lab (may be worth asking Quest, as it would tell you whether you were more or less than 15),

Good luck.

[Mary4now]

I think you have to go with the results from the study..... >25 would be und.
AND you would have to be in the first arm for the 16 week cutoff, and you would have to win that lottery,  I did not either and I was und at week 1, ( I love saying that )
6 more weeks for me oooh I cant wait.

[researchmonkey326]

First - the results.  I am in a trial at Emory.  Whatever sensitivity of testing Emory does is over and above what is required by Gilead in the trial.  I think Emory considers UND at <10 (not absolutely sure).  Gilead standards for the trial are that  <25 is consider UND which I was at week 4.  Apparently, the Gilead trial supervisor (or whatever they are) was there this morning going over results or whatever they do and they are counting me as UND at week 4 based upon the <25.  So, when my research coordinator told me four weeks ago <25 DET it was because Emory was doing the reading of the labs (actually might be the CDC because they are all connected).  She did explain then that if it were at another clinic/hosp, I would probably be considered UND  Of course, when I was in the middle of the appt and talking about rashes and fatigue and other sx, these questions did not come into my head (which is fogged anyway and I was in one of my manic stages so brain was flying).  I'm still on track for 24 weeks of treatment either way - you had to be UND by week 2 for the 16 week regimen

Regarding rash - I had red cheeks for a few weeks but in the last two days, it has spread down my chin, neck onto chest and upper back, upper arms and abdomen. Nothing on my legs. It is not terribly itchy - more irritated than anything except for a random itch here and there.  It's blotchy redness, not raised or bumpy.  I'm trying OTC hydrocortisone for today.  If that doesn't work, we will have to move prescription.  Benadryl and Atarax are not allowed in the trial.  Heat (90's) seems to have made it worse but I've had to stay inside anyway because the heat and these meds do not play well together.

[nygirl7]

I'm confused as well because <25 would be considered UND, why would they want to credit it later, I mean it looks even more promising if you were UND at week 2 rather than 4?  Maybe they meant as per their trial some parameter is that you must be UND by week 4 to stop earlier or something?  Did it say anything else on the test?

Cover up that rash with the best lotion you can find several times a day it will help, if not get to the dermatologist and get something good.

[Jillybean65]

When you talk about body area covered...exactly how much are we talking about here?  I wasn't sure if people had it over their entire body, just the legs, etc.  

Sorry I can't comment on the lab results or offer any words of wisdom there.  I'm just learning here.