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.

[Boobert]

It could just be a glitch, get another PCR test. This has happened in other trials while treating only to go on to SVR.

[Advocate1955]

Hmmm...I'm not liking the sounds of those results or your lab's interpretation of them.  

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

To my knowledge, this one is clearly UND.

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

To my knowledge, this one is questionable.  <25 IU/mL is probably the limit of detection of this particular lab test, but since it does not say "Not Detected" or "Undetected", my concern is that it may be detected but not quantifiable as it is under the limit of detection of that particular test.

Since your trial team has never seen this result, if it were me, I would probably go to your hepatologist, primary care physician, or gastroenterologist, and ask for another PCR, just for peace of mind.

Maybe someone else on the forum is more familiar with that specific lab's PCR test and can answer this more clearly than I can.

Praying for good results for you.  Keep us posted.

Advocate1955