VL results, does <25 = UND??

[FaithforHealing]

Well, this is rather anti-climatic. I started SOC for genotype 2 a year ago on a Gilead trial which uses Quintiles Laboritories.  At WK 8 on tx VL was reported as <25. At WK 12 on tx VL was reported as "target not detected" and remained so for the following 12 weeks on treatment AND then for 20 weeks after treatment.

But Lo and Behold, my last test (post wk 24) comes back like WK 8: <25!!

The exact wording of lab work is as follows:

WK 8 tx             HCV RNA QUANTITATIVE PCR below limit of quantitative   RESULT  <25  IU/ml

WK 12- WK 20 Post      HCV RNA QUANTITATIVE PCR   RESULT    Target not detected   IU/ml

WK 24 Post      HCV RNA QUANTITATIVE PCR below limit of quantitative   RESULT  <25  IU/ml

The tx team had never seen this happen before at post wk 24 (given UND for previous 32 weeks). At wk 8 on tx they, the team, did not consider <25 as UND so they contacted the lab thinking a re-test was needed, and were told it was as good as UND. This was new information for them, but they accepted it and told me that had I relapsed (or whatever it's called) my AST and ALT would have spiked, but they remained low and unchanged so this was considered a SVR.

I might understand this if they had changed labs and the reporting was different, but this is the same lab. I would certainly like a better explanation for this, so who do I contact? The lab or Gilead?

If anyone has any thoughts or clarification on this topic I would appreciate hearing it.

Thanks.

[ceanothus]

Hooray, what a wonderful relief! Congratulations, you've done it!

[pooh55811]

That is great news!

[Advocate1955]

Woo hoo! So glad to hear this faith.
Advocate1955

[can-do-man]

Wow scarey that was my thoughts, congrats to you..........

[jules2551]

Congrats Faith!  Excellent news

[rivll]

Wonderful news!
You must be so relieved, very happy for you, Faith.

[FaithforHealing]

It was a false positive and the retest reads target not detected = UND.  Thanks all for your support!

[hepcat1954]

Yes, I've been in a trial for 4 weeks with Gilead's Sofosbuvir & Ledipasvir (GS-7977 & GS-5885).  

I went UND in 14 days.  Yay!  No interferon!  No sides!

[FaithforHealing]

Just as one does not know much about HCV until they get it and learn about it on this site, one generally does not know much about trials until they seriously look for one or start one.

Both have many misconceptions. HCV has the stigma that it is most likely from recreational drug use, and trials have the stigma that they are all crap shoots and one might get a placebo and not even know if they are being treated.

There are different types of trials and can be phase 1, 2, 3 etc. As pointed out by others, my trial was comparing the new drugs with the FDA approved. As it turns out we probably won't see many people treating with interferon in 2014 as the all oral with 7977 is more effective and with less side effects. Yay!!...for those who can wait.

[pooh55811]

If you go to Faith's profile you will see that she was in a study and was in the SOC arm of the study.

[can-do-man]

Hi hepcat, faith was in a gilead trial that included a SOC arm, not uncommon

[hepcat1954]

Why are they doing a trial on FDA approved drugs?  Trials are used for collecting data to submit to FDA for approval.  I'm throughly confused.

[can-do-man]

Good luck Faith, though I really believe you will be und. Something similar happenend to me. Being you was und at 12 weeks post a relapse would have came back much higher......... Only the best

[FaithforHealing]

I found out today that the trial sponsor is questioning my labs (as we all were) and I go in tomorrow for a retest. My faith is restored in clinical trials; I could not believe they were just going to call it good for SVR given the results of that last test.

[hepcat1954]

Sorry I thought you were in a study with the new meds.  Duh, I reread your post and it specifically states you were on SOC.

With that, retesting is exactly what you should do. You need to know if your VL is going up.

Best
HC

[FaithforHealing]

I did not use experimental drugs. As I said in my post, I had the FDA  approved SOC (interferon/riba). I did not say anything about expecting them to care about a cure so I'm not sure how that is relevant to my post.

Yes, I am a data point and the relevance of that is if they are going to record me as a SVR I'd like to know why the term "target not detected" was used on the 32 previous results and the final post 24th week  is written as "<25" and not "target not detected" (obviously creating questions....even for the tx team). Why the two different results? Does it imply that <25 = UND?  Does SVR mean sustaining one's initial response of a 4 log drop, but not exactly undetected? I thought SVR meant a sustained UND. All I am expecting is to know the study's protocols for declaring UND and SVR, and not their concern for me achieving a cure. Early on in treatment when I still had a viral load and it was reported as <25, it was not considered UND by the team and all of a sudden it is? Or SVR does not require "target not detected"?

They may not care about cure or SVR rates in terms of the subjects, but they certainly do (or should) care about documenting and maintaining accurate cure or SVR rates in terms of the validity of the study's conclusions. Or at least we and the FDA should care about the accuracy of records and what those terms mean.

As previously said, "There is no doubt I will be pursuing an independent PCR..."  

[hepcat1954]

Of course Gilead would like to see you maintain SVR.  However, the purpose of the study is not to cure you -- it's to see whether you can be cured or not using their experimental drugs.  You're a data point, no more no less.  They most likely will test you at the next scheduled post TX week (if there is one).  They have their protocol and will stick to it.

Wait a couple of weeks and retest on your own through your GP.  That should tell you if you have relapsed or if this is a false alarm.  Unfortunately, if it is a relapse, your options may be limited.  Nobody wants to use interferon.  You may have to wait for another trial.

I wish you good luck,
Hepcat

[FaithforHealing]

I haven't gone over the top yet, but I'm teetering. :)  There are a couple of phone numbers/contacts on my study disclosure if one has questions about the study and subjects' rights, etc. I'll have to start on that tomorrow. We shall see. There is no doubt I will be pursuing an independent PCR, but it's not right that they are saying <25 is the same as "target not detected" without a valid explanation and I'm going to pursue that as well. Thanks

[gerard11]

I agree , have another test ordered by your primary care. This would really put me over the top if I were in your shoes!! I completely understand where you are coming from! Way too much work on your behalf to be this close and get this very weak expiation. As we all learn it in our best interest to be our own advocate. Good luck.

[Boobert]

What do you think about the lab's explanation that "<25" means the same thing as "undetected

From what I'm told the test is finding bits of the virus or dead virus. If I were you I would have another PCR done from where ever possible just to rule out relapse.

[FaithforHealing]

Thanks all for your comments. I think we are all in agreement that there is something amiss with what I am being told.  I only found out on Friday and will have to make some calls on Monday.

[ceanothus]

This is really disappointing, and looks like these doctors need a refresher course on what makes good science. They seem to be allowing the lab personnel to gloss over a questionable report without making an effort to really get to the bottom of it. My husband regularly publishes papers in scientific journals, and if medical journals have peer reviews that are as strict as other science journals, these doctors are going to be nailed when they try to publish these results. Unless they maybe do have a better answer but just haven't articulated it clearly to you. I'd try to be more demanding of a satisfying answer (if you have another person with you it might help), and if that doesn't work just get your PCP to order another PCR test for you and pay out-of- pocket if necessary. I'm crossing my fingers for you, hoping you are still truly UND.

[Idyllic]

I am not sure how much this will help but as far as terminology goes but with Triple therapy with Incivek, "target not detected" pretty much means UND.

For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA (Target Not Detected) result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCV-RNA result (reported as "Target Not Detected" or "HCV RNA Not Detected").

On the chart it says, "Undetectable (Target Not Detected) at Weeks 4 and 12" http://www.drugs.com/dosage/incivek.html
http://www.drugs.com/pro/incivek.html#S5.6
____________________

below limit of quantitative   RESULT  <25  IU/ml

The way this term was explained to me ´★¸¸.☆ with the assay that I used´★¸¸.☆ (which is clearly not the same as yours so there is that huge caveat)  is the expression means detected but the way that assay is designed cannot produce the actual number but it detects presence of the virus.

This is the way my doctor explained it to me when I said I wanted to test with a lower detection limit (other than the Taqman). He told m e if I was detected the test would say I am but it would be unable to calculate the actual amount of the virus. Plus, it would not say Not Detected if I were detected.

But you have two different examples from what is what? The same assay? I think even if at this point you hear an acceptable explanation you might always wonder. Is there a way you can have the Heptimax of the Quant at LabCorp?

[gsx1250fa]

My lab work is done right there at the clinic. Unsure of what machine they use.