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.

[gsx1250fa]

You have me wondering also...seeing as we have the same trial pharma company in common. With that being said....if you tested again in a month or so and it was still <25...then I guess it would be about the same as UND as the virus hasn't replicated. But....I am not a doctor. Only wishing you...me...and the rest of us SVR.

[FaithforHealing]

Thanks for commenting. This is really ridiculous and as said, not acceptable. Either there is an explanation or there isn't, and they haven't come up with one that makes sense.

Does your study use Quintile Laboratories? I'm just curious if each study site has to use the same lab or testing protocols.

[gsx1250fa]

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

[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
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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?

[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.

[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.