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.

[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]

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]

Yes, this is not just something I can accept without further testing, but I don't understand why the trial won't retest and are good with calling it UND and an SVR.  This is truly unacceptable information.
I'm going to have to pursue another test on my own since they don't feel the need to retest. I don't know how they can validate this as a SVR in their published results of the study. It sure makes me wonder how valid their stats on SVRs have been in reports from past years.

[gsx1250fa]

I would definetely get retested. From what I have learned at my clinic...<25 means the VL load is somewhere between 1-25, but the machine can't quantify the number...where no viral load is 'target not detected". I was <25 week 1 and 2 of my 12 week study (gilead) and "target not detected weeks 4,8 and 12. I had these same questions before I went UND. I hope and pray you retest UND. Good Luck

[FaithforHealing]

What do you think about the lab's explanation that "<25" means the same thing as "undetected" or "target not detected" and calling it another SVR in their study? As a subject in a trial I don't know if I can directly contact the lab myself, but I am going to find out.  

[FaithforHealing]

Thanks for the reply. It seems odd that a lab that uses both terms, "target not detected" and "<25" would say they are one and the same, then why have two terms for UND? Very disturbing to get this result at wk 24 post tx.

It's ridiculous that there is not a better explanation from the lab.