Incivek week 4 <43 (detected or not?)

[Cuda22]

I started my triple therapy with Incivek on 7/10/11  My week 4 and week 8  VL from Quest Lab was reported as <43 IU/mL (with no mention of detection or not)

But my week 12 and week 24 VL from Quest Lab was reported as <43 IU/mL (HCV RNA Not Detected)

I have since done a VL from Quest Lab 7 weeks post treatment and it was reported as <43 IU/mL (HCV RNA Not Detected)

My question is, why did Quest not report a Detected or Not Detected on my first 2 labs (Week 4 & 8) ?

My Doc had told me at that time that I was UND. So I only did 24 weeks total. But I just recently got the hard copies of my lab work (4 weeks after I stopped treatment)

Is there a chance that I was NOT UND at week 4? And if so, why would a doc report that as UND?
Any one know what your chances of SRV are if you only do 24 weeks total, but were DET at week 4?

Thanks!

[hrsepwrguy]

"<43 IU/mL (HCV RNA Not Detected)"

Means you are UND, congrats on the great news.

[willbb]

have since done a VL from Quest Lab 7 weeks post treatment and it was reported as <43 IU/mL (HCV RNA Not Detected)
---------------------------------------------
That is the important part of your post..as it pertains to you


Being UND..at Wk.4 post tx. is 96% definitive of SVR  and Wk.12 is 99.7%

.http://www.ihlpress.com/pdf%20files/hepdart09_presentations/oral_ii/12_martinotHEPDART%20PC.pdf

As far as your doctor giving you erroneous info.,  unfortunately this is happening all too often,as many doctors are not familiar with the lab reports as it pertains to being Det or not.. this is shameful and somewhat dangerous. Always best to ask for hard copies and have a thourogh discussion with the doctor on the results.

So looks like you are in good shape ..congrats!
Will

[stormy456]

We had the same thing week 4 <43  on Quest labs.  Our doctor (hepatologist at teaching hospital, worked with Vertex directly) called that UND.  However, week 8 and 12 it said <43 not detected.  I asked him specifically about this, and he reaffirmed that it was UND, and that we would treat for 24 weeks. I choose to believe him.

[stormy456]

Hmmm.  Our doctor shared husband's labs with Vertex (they were considering doing only 12 weeks of tx) and they also considered it UND.  Not sure why.

[willbb]

Hi  stormy.. The way I understand Quests lab reports that if it is <43IU/ML  and does not say UND. then it is considered DET.  as I know if it is UND. it will say that.

There still seems to be some confusion on this.  The lab can give proper direction to the ordering doctor on these if he makes a follow up call for clarity and hopfully that is what happened in your hubbys situation.

Best to you and hubby..
Will

[sharon413]

the important part of the viral load at 4 weeks is to be less than 1,000.  If you are not, then they discontinue treatment as it leads to building an immunity.  You were less than 1,000 so treatment conintued.  They test again at 6 months post treatment and if still undetectible than congrats !!

[pooh55811]

My understanding is that the 4 week VL is very important, not only to see if a person can continue, but also to determine how long the person treats.

In my case, I was <43 but detectable at 4 weeks. Therefore I have to treat for 48 weeks as opposed to 24 weeks. Had I been UND at 4 weeks I would only have to do 24 weeks.

I don't know why the docs are not more precise in following up with the testing lab to be sure the test results are very clear and that they have the correct conclusion as to the results. I also don't know why the testing labs don't spell it out. Lab reports should be clear, not questionable  (just my opinion, but I feel strongly about it).

[Cuda22]

Thank you for the reply Will!
I am new to this sight and I really wish I could have had this info before treatment.

Yes some doctors really need to get their act together.

BEFORE I had started my therapy, I had told my doctor about the importance of the week 4 VL (25 IU/mL and a limit of detection of 10 IU/mL)  and I told him that this was a response guided therapy.  But his answer to me was that my Insurance would not cover that test, and that I would have to use the one from Quest.

After my week 4 Quest labs (<43 with NO mention of detection)
I asked my doctor if I was DETECTED and he said that the odds of being DET <43 were very slim. And not to worry about it.

But when I noticed the difference in the 2 Quest lab reports: Week 4 <43 (NO MENTION of detected/undetected) & Week 12 <43 NOT DETECTED
I asked my doctor for clarification.
I was amazed when he said that he had never noticed (or Understood) the limit of detection on lab reports before.

I told my doctor that I wanted to know for sure what Quest meant by only reporting my week 4 labs as <43
Was I detected or not!!!

He later called Quest and then informed me that he was satisfied with the report. And once again, he said that the chances of being <43 DET were very slim.

So I stopped treatment (I actually did a total of 26 weeks)
I was planning on doing 30 weeks since I had the meds, but my doctor said that I was probably cured and once again he was satisfied with my week 4 labs.

But, since stopping my therapy I noticed a lot of people reporting a week 4 <43 DET
And after doing more research it seems that about 20% or more fall into that category.

So I called Quest Labs to get a strait answer and they informed me that the did not report DETECTED/UNDETECTED on lab reports until after 9/13/11
And that they do not know if I was DET OR UND at week 4.

I called my doctor and told him about this and he said I already STOPPED therapy,  so I cannot restart it.
He said the only way I will know for sure is with my week 24 post labs.

I am his first patient to do Incivek and he has since started many others on this treatment.
At least I know he is better informed now.

[fretboard]

There still seems to be some confusion on this.  The lab can give proper direction to the ordering doctor on these if he makes a follow up call for clarity and hopfully that is what happened in your hubbys situation.
-----------------------------------------------------------------------------------------------------------
This is not the first time this subject of <43 IU/mL and Quest Labs has come up and it will continue to come up until they do something about their results and how they are reported.  It shouldn't take a call from the Doctor to the lab tech for clarification, that's just ridiculous!!  Something needs to be done about this and I hope by writting about it someone will take this to a higher authority.  Maybe I'm missing something here but I don't think so.  If we didn't have people like willbb here explaining this nobody would understand!!!!!!!!!!!!!!!!!!!!!!!!!!  just had to vent!!.  carry on.

[willbb]

Nice to see you fret  :0)

[Cuda22]

Yes I agree!!!!

Has anyone ever had a Quest Lab HCV RNA PCR QUANT reported like this?

The limit of quantification for this RNA assay is 1.6 log IU/mL (43 IU/mL). If the assay DID NOT DETECT the virus, the test result will be reported as "<1.6 log IU/mL (<43 IU/mL)." If the assay DETECTED the presence of the virus but was not able to accurately quantify the number of copies, the test result will be reported as "Not Quantified."

I found this off of this link
http://www.aruplab.com/guides/ug/tests/0098268.jsp

[CoWriter]

Cocksparrow asked HR, who invented the most sensitive viral load test ...

"Do you know why with the Roche TAQMAN test some labs give the result as <43

While others give the result as <15. Is it as simple as some labs not
following the manufactures instructions?"

And HR answered.....

"The larger as sign refers to the cutoff point due to the inherent background of the test. It is indeed to be assumed that the manufacturer instructions are simply not followed in this case to give the impression of a higher sensitivity."

Co

[working dog]

my vl 4 weeks was <43..detectable..at 8 and 12 and 19 weeks of tx und ..then i had to stop tx...next vl 8 weeks post tx was und...12 weeks post tx alts are normal...i think chances are we will svr soon...you started tx a day before me...i'm wondering how your feeling...the first 6 weeks post tx i had some new symptoms but they went away..i had bad symptoms during tx but now i'm feeling good..some light stuff going on but not much.....billy

[crossroadsec]

I'm with you! A common standard or language is vital to those of us treating. I was relieved to hear the "resident experts" response. I'm not there yet, but thinking about the same thing. Haha. It sounds like you're in FINE shape. Truly happy for you. Karen :)

[his3707]

I had the same issue. have ended up doing 48 weeks.  I am at week 45 now so it is about over.  It was hard to take when I was told it was detected unquantifed on tagman at the study and private quest <43 no mention of det or und.   It shouldnt be this hard.  I thought I did my research and agonized over what test to take.  Now I think anyone should just do the labcorp quantisure or the heptamax.   This really is bull$

[Cuda22]

Hi Billy, how long were you on tx before you stopped?
I started July 10th and I stopped at 26 weeks. But I do not know if I was <43 det or und at week 4.

I am now 10 weeks and 4 days post treatment.
I was und at weeks 12, 24, and also 6 1/2 weeks post tx.

At week 1 post tx I started to feel better. At week 2 post tx I felt great!
But at week 3-4 post tx, I was sure that the virus had come back. I was getting that sickening feeling back. The one I always have when the virus is present.
(I have been on treatments and the relapsed 3 times prior to this, I know how I feel with and without the virus)

I tried to persuade my liver doc to do labs since this was driving me crazy and I needed to know,  But he refused and said to wait for the 24 weeks. So I had my primary Doc do labs at 6 1/2 weeks post tx, and it came back und.

Since then I have been up and down. I will feel great for half a day and then it hits me and I feel like crap and I am 100% sure the virus is back.
Or I will go 2 days feeling incredible like I am 30 years younger and then I will feel bad the next day, convinced that I have relapsed.

But the last few days have been good!
And I will keep you posted

[Cuda22]

Yes this is bull!!!!

I thought I did my home work too.  But my doc had no idea of what he was talking about when he told me that my chances of being <43 DET were slim, and not to worry about it.

So I stopped at 26 weeks!!!

Sorry, I needed to vent......

[Cuda22]

Did you do the lab test with the study after you first got results from Quest lab week 4 <43 (with no mention of DET or UND)

And that was how you found out that you were indeed week 4 <43 DET?

[fretboard]

That's a terrible shame that some people are undergoing more tx than necessary due to a test result that is not fully understood.  Tx is hard enough without the added stress of a test result that is not understood by all concerned.  I wonder how many people have been told by their doctors to continue txing b/c the <43 IU/mL result was mis-understood?  That's just insane!  If one person goes through tx for any amount of time, it's too much in my book!!  I wonder who can be contacted to correct and enforce better and easier to understand test results?  

Would it be that hard to just make a test result detectable or not detectable?  Are the numbers always needed?  Reminds me of the saying about being a little bit pregnant.  You're either pregnant or you're not.  It seems to me that you would either be HepC positive or not.  Viral load or no viral load.  Detected or not detected!!  Argh!!!  I'm just sayin'!

[Sentinel13]

Cuba: Like you, I am familiar with what it feels like when the virus is ravaging my body. Whenever that happened, I would either go on the full treatment or go on pegylated interferon liver maintenance therapy to stabilize myself.

I recall reading that riba can stay in the body for 6 months. Maybe the bad days you are experiencing is your body trying to deal with the residual toxins from all the nasty drugs you were taking during treatment. Cheers, GB

[Cuda22]

I hear ya brother!!!

I did 1 1/2 years of maintenance therapy but had to stop (I got mersa from low w/count) that was 3 years ago.

I feel much better being on interferon with a 0 VL, than having that nasty virus in me.

What has me so upset with my doc is, I already did the heavy lifting with the incivek. I could have done an xtra 24 weeks without a problem had I known there was a good chance that my week 4 <43 might have been DET.  

But the Doc talked me out of it.
I had not done enough home work to now what the odds of being <43 DET might be.
But by the time I found the data (20% chance or more)  I had already stopped!!!

Thank you for the info on Riba! ....makes me feel better.

Cheers to you too, RP

[Sentinel13]

Hi Cuda:

I found a link suggesting riba can stay in the body for 6 months after treatment is ended.

http://www.spfiles.com/mgrebetol.pdf

Page 1 of the link states, "Do Not become Pregnant within 6 months after discontinuing REBETOL therapy."

I'd say that's a good indication that it takes up to 6 months to detoxify. During my last treatment, I was still itching 3-6 months after stopping riba, which convinced me the riba sticks around a long time -- occasionally making my life miserable.

Cheers, GB

[his3707]

The incivek dosing study I am in keeps the actual test numbers blinded until the study is over.   I could not wait and had my own private tests done.  I was shocked when the study's test (tagman) came back detected but they would only tell me it was under 1000 so I could stay in the study.  the same day at week 4 and 8 I had tests done privately. My quest came back <43 with no mention of det or und.  I also had my 8 week test done the heptamax and it came back <5 but also did not say det or und.   Also My study 8 week test also still came back det but they could not give me a number only that it was under 1000.  My 12 week study test came back und. At week 45 I have so far remained und.   I have not had any more private tests done as it only matters what the study result is.  I can only say now that I have whacked this virus in the head with a sledgehammer.  

[Cuda22]

You had a heptamax at week 8 that reported <5 (I think that is below detection)
But your week 8 study labs reported you detected?

I would say that you were undetected at week 8

You only have a few more weeks, your kicking ***!