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Avatar universal

VL results, does <25 = UND??

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.
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Avatar universal
It was a false positive and the retest reads target not detected = UND.  Thanks all for your support!
Helpful - 0
Avatar universal
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!
Helpful - 0
Avatar universal
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.
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1815939 tn?1377991799
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.
Helpful - 0
Avatar universal
Hi hepcat, faith was in a gilead trial that included a SOC arm, not uncommon
Helpful - 0
Avatar universal
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.
Helpful - 0
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