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9648 tn?1290094807

Still <25 but not UND

My eight-week results came in (although they were actually 7 weeks and 2 days because they had me come in early to test Hgb) and I'm not UND yet. To recap:

Day 1  1320K
2 wk  940K
4 wk  629K
6 wk  <25 (Boceprevir/placebo added at 4 wk)
7.2 wk  <25

I'm somewhat bummed that it isn't UND because this takes me off the possibility of the 6 month arm of the trial (at least I think so), and also those are some lovely statistics for those who go UND at 8 wks on the Boceprevir. But, I am still close and at least I'm not going back up!

Still on Procrit. I wish I liked it as much as everybody seems to. It actually makes me feel not so good for a day or two afterwards. Nothing specific, just generally uncomfortable.  

Does anyone else find that they are cold all the time and have a hard time getting warm? I'm wondering if it isn't the interferon effect . . .
51 Responses
Avatar universal
What is the sensitivity of the test? It appears as if 25 IU/ml might be the lowest VL it can detect and therefore < 25 may be undetectable according to your test.
Mike
545538 tn?1295995617
Here's hoping that you are UND soon!
602261 tn?1252586758
I'm with Mike on this one ask your doctor about it that's soooo close!
9648 tn?1290094807
I did ask the nurse and she said that the sensitivity is 25 and that the virus is detectable but not quantifiable. So it's below 25. I am not seeing copies of the tests. I'm seeing her chart that she fills out.
Avatar universal
Not to say this is what is happening -- but this would not be the first time here that either the nurse (or doctor) misinterpreted the test results or that there was a problem of communication between nurse and patient. In addition to seeking clarification from your doctor -- why  don't you ask for your own copy of the test (you should make this a habit with all tests) and then post exactly what the test report says as well as the name of the test.
154668 tn?1290119595
Sweet!  My guess is that you are undetectable.  I asked my nurse about that “Detectable <25” and she shook here head and said they were having lab problems that have to be straightened out.  Is there anyone else on the trial that says "Undetectable <25"?
9648 tn?1290094807
jmjm530--I would love to get copies of the tests. I'll ask next time I go in. I've never met the trial doc. My nurse is *very* thorough and has been doing this for a while. I do think she knows what she's doing. Apparently the lab is COVANCE and when I googled it, several discussions (here) came up referencing a 30IU threshold and below that as "detected but not quantified" so I think that's really what it means.

Bill--My nurse hasn't said anything about lab problems. In fact, they seem to be willing to rush things through for her (for instance my Hgb tests on Fridays). I would be very curious to hear what everyone else is getting from the lab. I know it's all the same lab.

BTW, now my Hgb is UP (12.6) and I'm off Procrit for a week or two. I feel like a yo-yo. ;)
Avatar universal
On my lab report.

HCV RNA PCR TAQMAN 2.0
HCV RNA............... HCV RNA not detected
498948 tn?1253059441
My guess is also that you are UND and that <25 is the detection limit of the test.

So....... Congrats!

k
Avatar universal
i agree with the others. seems you are UNDE !!! This sounds like the same story we hear around here often....INCOMPETNENT nurses & doctors.

This is one of the main reasons to get copies of all your tests and see the results with your own eyes!  Personally I don't trust anyone when it comes to something as important as my life! I want to see the lab results with my own eyes!

Best of luck on being UNDETECTABLE
388154 tn?1306365291
My guess is that you are detectable.
Your on a study they must be very thorough with every result.

I my self got a four week result with a taqman <15 iuml  that was reading+<15iuml  ( if UND it would have read -<15iuml)  that means not measurarable but still detectable its a so called borderline result.

Here in sweden they always double check borderline results your result has most likely been tripple checked.

Anyway as you said your self, they are not going in up thats positiv!!
correct me if I´m wrong but you gonna continue on the blue pills for the rest of the treatment am i right?
If so thats also positiv I think.

And  again if so for how long are you gonna treat do you know that!!

Be well !!! rooting for you.

ca
Avatar universal
I agree with Comeagain that you most likely are detectable. I had borderline results at week 12, detectable but not quantifiable at <15 IU/ml. The test result said "repeatable borderline value".
9648 tn?1290094807
comeagain--it depends on what arm of the trial i'm on and whether i'm undetectable at week 24. i could end up with a placebo after that, or with the boceprevir. it's not likely that i'll make the arm that quits at 28 weeks because i'm still detectable at week 8. (although the blood test was early--i don't know how they'd establish when i went UND if I am on my blood draw which was at slightly over 9 weeks).

zazza--that's what I think too. I will ask to see the tests and get a copy, though.
Avatar universal
well, the good news is that there's not much left. Given  your limited response to ifn/rbv, the blue pills are likely supplying most of the firepower. The next few weeks of vl tests seem critical - if significant resistance to the pi crops up it might be accompanied by an increase. Else, if it simmers for a bit more and drops below und this would leave it to the ifn to mop up whatever's left. In light of your first measurements, you might not want to cut off the ifn too quickly if you're  given the choice.  Overall looks pretty darned good - best luck!
Avatar universal
HI- IM ALSO ON THE TRIAL AND AT WEEK 6 I WAS <25 AND MY NURSE TOLD ME I WAS UND --SHE MADE IT A BIG DEAL WHICH MADE ME FEEL GOOD !

IM NOT SURE ABOUT THIS BUT---- I WENT FOR THE 12 WEEK BLOOD DRAW AND SHE TOLD ME THIS WAS DECISION WEEK BUT SHE THOUGHT I WOULD BE OKAY BECAUSE I AM UND----- I DONT THINK THEY COUNT THE 4 WEEK LEAD IN I THINK ITS 8 WEEKS ON THE BOCEPREVIR ????

I AM ALSO COLD ALL THE TIME LOL   AMY
Avatar universal
HI- IM ALSO ON THE TRIAL AND AT WEEK 6 I WAS <25 AND MY NURSE TOLD ME I WAS UND --SHE MADE IT A BIG DEAL WHICH MADE ME FEEL GOOD !
---------------
Somebody's nurse doesn't know what she's talking about. Surpise, surprise :)
Avatar universal
are you saying < 25 is detectable ?  
Avatar universal
No, what I'm saying is that "GreatBird's" medical team says its detectable Isee first post in the thread) but your medical team says it's undectectable, therefore one of them has to be wrong. Hopefully, your medical team is correct and that would be my guess.

-- Jim
Avatar universal
Jim couldn't have meant that. Quite the opposite. I'm sure he'll explain as soon as he tears himself away from the Oscars but in the meantime, you're UND, just as your medical team said.
Avatar universal
They actually gave me the "official" lab results in addition to the little chart they keep in our notebook.

I guess we need is to reach <10 to get the undetectable report like Can-Do.

My lab report reads:

HCV RNA PCR  Taqman 2.0
HCV RNA: <25 IU/mL HCV RNA detected  (Clinically significant: YES)

At weeks 6, 8 & 10 I have been detectable at that damn <25. I just can't clear. I had my week 12 labs drawn on Thursday and will get those results on Friday. Talking with my doc about what will happen was interesting.

I am in the naive trial. If I don't clear and I am in Arm A I would be offered the rollover after week 24. Absolutely no info whether a PI will work added this late. If I clear at 12, I will end up just doing SOC.  I am either in Arm A or I am not responding to the PI, which I cannot imagine could lead to anything but mutation soon. Arrrrgggh.

All my stupid research, two years of planning and working to get into this study and things have gone completely different than I ever imagined. The chance you take knowing you could end up with placebo is one variable I was prepared for, but I just thought I would be lucky.

I am done no matter what my week 12 results are, as I cannot tolerate the sides.

Good luck to you GreatBird! If you can stay warm and deal with the "uncomfortable" you can keep going!
601210 tn?1302660252
My sons 4 week viral check showed HCV RNA detected at less than 10, but they were unable to count the virus accurately below a certain level.

At the 12 week viral check it was undetected at less than 10.

Our copy of the 4 week test states:  This assay cannot determine an accurate titer below a certain level (ours was 10 IU/mL), so it is possible to go below the stated count and still be detected.
748940 tn?1233341048
"Detectable but no quantifiable" sounds fishy to me.

My four week pcr came back 18 iu/ml detectable to <5. .. that's easily understood. A friend pointed out that I was probably undie less than 24 hours after the blood was drawn.

I expect that's the case here. I would certainly ask someone with greater knowledge to explain the results.

good luck always,

Max
Avatar universal
Whatever happened with your rollover? You were going to have to wait until April 28th last I recall. The stop and restart... which others thought might be a good thing based on jmjm's study about controlled stop/starts.

Or did they make a change and offer the immediate start with boceprevir? Any news?
Avatar universal
<25 IU/ml detected
<25 IU/ml undetected

What's so difficult to understand about this? It is two completely different test results. Just like kciav says above: "This assay cannot determine an accurate titer below a certain level (...), so it is possible to go below the stated count and still be detected."

GreatBird is detected, and miracle05 is undetected.
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