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.

[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