? on CBC/HFP and VL during TX

[H20Lover]

Good Day all and Happy Friday!

Had 2 shots and 12 days worth of Riba at the time of my first blood work this past Tuesday.   Feeling pretty normal, but blood work came back (doc visit yesterday) with low levels of WBC and Neutrophils.  They were:

WBC 3.1 (4-10.5)
Absolute Neutrophils 1.5 (1.8-7.8)
Everything else normal range.

High end of low but dropped a lot from pre-tx test (WBC 8.5 & Neutros 5.7)

Doc says this is not unusual and will check again in 2 weeks when he does my first viral load during tx.  He also says it may recover, level off and be OK.  

As far as the liver panel goes ALT/AST were normal for the first time since June.  They were 34/31 respectively.  All other items on liver panel normal before and now.    I had a recorded high of 299/127.  2 years ago and always before that I know of I was in the 20's.

My questions are:
1.  What is the drug that you take for the WBC/Neutro situation?  Is there anything I can or need to do to aid in this problem.  How low is too low.  Neither the doc or I want to lower the dosage.  Is it the Interferon or Riba that does this?
2.  Concerning the RNA test.  I have an order for a "Hep C viral RNA/PCR Qualatative.   It is thru LabCorp.  Iam questioning because the test used to dx was the HCV QuantaSure Plus (non-graph) which sounds like Quantity not Quality.  What is the difference and is it the sensitivity?  Is Qualatative better?  Sounds better....My Quantasure read 6,120,000.  Looking for less than 61,200 right?
3.  That test leads to next question.  I understand there is a "better" time to do this 4 wk test.  Shot days are Thursday nights.  I am suppose to go for draw 12/10 which is 4 days after the 4th shot.  Does that sound OK?  Both doc and I are limited on what days we can have our pow wows and this works for both of us.  
4. Lastly.  I am hoping the normal ALT/AST is a good sign.  Any input on this result?   Doc seemed excited!

If you need more info, I have some posted on profile.  Ask though if you need more info.  

Thanks in advance!

[frijole]

2.  I think the QuantaSure Plus is sensitive to 10IU/mL.  It is kind of queer because the plain old QuantaSure is sensitive to 2 IU/mL.  My doc ordered that once, and I had to watch after that so that he didn't order it again.  I don't know why they ordered a Qualatative test at week 2.  I would have wanted a quantatative myself.   Qualatative will just give you a yes or no, down to the level of sensitivity of the test.  You might check with your doctor before you have the blood drawn just ot make sure and request a Quant.

1. Your ANC and WBC are good, but they are dropping rapidly from your outstanding pre treatment numbers.  Neupogen is the drug of choice to help manufacture some more white blood cells.  There has been a lot of discussion on this board how low you should/can go before boosting the whites (and congrats to your doctor for not wanting to drop doses).  Many doctors want to start the Neup when the ANC drops below 1000 or 800 (1 or .8).  My doctor insisted (I held off as long as I could) when it dropped to 400 (.4).  

3.  To get the best reading for the particular week, it should be the day before the shot.  Therefore the 4 week draw should be the day before shot 5. In your situation, I would go with the flow.  I don't think it is that big of a deal.

4. ALT/AST looks good but some folks enzymes actually go up and down on tx.  Mine did you higher than my normal which was in the 20s. So, I don't think it is a sign of much.

Overall, your bloodwork looks great.   Wtch the HGB (hemoglobin).  Draws every two weeks is good at first.  I think you are doing great.
frijole

[jmjm530]

A qualitative test will not give you a number. So you want a quantitative test at this point, like the LabCorp test you mentioned. Another good quantitative is "Heptimax" by Quest Diagnositics. You want to have the blood drawn for you week 4 viral load test, the day before you fifth injection.

It's nomal that WBC and neutrophils drop on treatment. Yours are still quite high. ANC (absolute Neutrophils) usually aren't a concern unless they drop below 500. Yours are 1500.

You didn't mention hemoglobin (hgb), either pre-treatment or now? Ironically, a good drop in hemoglobin isn't bad, because it may suggest the ribavirin is being absorbed efficiently. What is your genotype and weigh and how much ribavirin did they put you on?

The normalization of liver enzymes is always a good sign, but the bottom line is the viral load test. BTW you don't have to wait until week 4 if your doc will write the rx and the insurance company will pay. I had weekly viral load tests from week 1 until UND at week six.

All the best,

-- Jim

[jmjm530]

Just to reinterate, LabCorp's "Hep C viral RNA/PCR Qualatative" is the wrong test for you take as your first viral load test after starting to treat. Reason is because it will not give you a number if the virus is still detectible, and you need a number to quantify your viral drop.

If you go with LabCorp, the test of choice at this point would be their Hepatitis C Virus (HCV), QuantaSure™ Plus, Quantitative, TaqMan™ PCR Number 550027 because it has a dynamic range of 10 IU/ml to 100 million IU/ml.

Their other test, the Hepatitis C Virus (HCV), NGI QuantaSure™, Quantitative, PCR
could be probamatic since it only goes up to 2 million IU/ml and would not as accurately reflect a smaller drop as the first test mentioned. Once you test either below 2 million IU/ml or UND, then you could switch to this test because it has a sensitivity of 2 IU/ml.

Alternatively, you could just test with "Heptimax" by Quest Diagnostics. A lot simpler to order for both doctors and patients. Just have your doc write "Heptimax" on the "rx" along with your diagnosis code. BTW not surprising your doc may confused. Looking a Labcorp's Hepatitis test menu (Quest's as well) is enough to give you a headache.

All the best,

-- Jim

[H20Lover]

Thanks for your answers.  That cleared up pretty much everything, but still need to understand the quant vs qual thing better.  Ae both of you saying the Quantity one is better.  Will they not both show if a have the desired 2 log drop?  Are you saying no numbers at all, only pos or neg on the one he ordered?  Glad I questioned why the PCP ordered the Quanta and the Gastro the qual one.  

I don't want to question him of course but I know the "young girl" in the office jotted it down after it came out of his mouth.  I myself did not hear it right then because I did not yet know there was a difference.  I noticed it when I compared the first VL to this order to see if it told anything.

Jim....funny you metion Quest because during the middle of this h*ll my insurance changed.  I have to use LabCorp if I want insurance to pay.  

Red blood cells.  After reading your post Jim, I pulled those labs out again and they have dropped from the base.  Still in normal range, but lower.  Scary to me because I hate the thought of slowing down.

Current Hemoglobin is 12.8.  Started with 14.2.  

I am about 10 lbs overweight according to the BMI test that we all hate.  I am taking 1000 riba a day (3+2).  I am a lucky geno 2 (lucky?)  24 weeks standard go at it.  No other medical problems at all,  but I understand my viral load (7mil) and age (52) are not exaclty my friends.

Oh....the test dates.  I'm Ok with every 4 weeks and I think that is what he is looking at.  Just want to do the right test.  I am not a fan of the vampires but are you saying whenever he wants to pull blood for the counts, to ask for the viral load to be run to.  What advantage is there in knowing so often versus every 4 weeks?

Thanks to both!

[H20Lover]

Just dawned on me....I saw some recent posts referring to Positive vs negative with no mention of numbers.  Is that what you mean by a qualatative test?  

Assuming my assumption is correct (ugh) and someone gets a "negative".  How sensitive is that?  If it is negative does the number matter?  

Am I getting this at all??????  

[Hepatitis Researcher]

The test you want at this point in time is the NGI quantasure Labcorp#140639. It will give you quantitative information AND the highest sensitivity that currently exists (2iU). If you are NEG by this test you are as UND as you can possibly get by testing. Other UNDs are not as meaningful , because the sensitivity cutoff is critical. What does UND mean: It means that the test ordered has not found any virus using ITS sensitivity limit. Therefore the most sensitive test is the best.

If you are still  in the positivbe range, you still get a quantitative number with that test , not just the answer "positive", so you know WHERE YOU CURRENTLY STAND with your VL..

The reeason why some docotors/insurances will not order this test is, that it is the best, but also more expensive than other PCR/TMA tests for HCV. The second reason is, that they simply do not know.

And, because of its extreme sensitivity, it has an UPPER limit of 2 million iU. That is its only drawback for patients with a very high VL. Clinically it does not make a big difference .

[jmjm530]

The reason I suggested Quantasure Plus, and thereby sacrificing 8 IU/ml,  is because it had a wider dynamic range with a high end of 100 million IU/ml while Quatasure only goes up to 2 million. Since this would be H20's first test, my reasoning is that Quantasure might not be able to quantify his response if his viral load turned out to be over 2 million.

-- Jim

[jmjm530]

OK. I re-read your post, and see your reasoning that clinically no different if over 2 million, and probably that's true in the vast majority of cases. Still, Quantasure would make plotting a slow viral decline easier and what if he has some sort of autoimmune reaction and his viral load actually goes up beyond his 6 million pre-tx vira load? Quantasure would not flag that, yet it might warrant pulling someone off treatment.

[jmjm530]

Yes, a "Qualitative" basically gives you a "yes" or "no", or as stated on my qualitative -- either "Virus detected" or "Virus not detected". Different qualitatives have different sensitivities but mine went down to 5 IU/ml. This is a very good test to take after you're UND, but its limitation prior to being UND is that you will not get a number. As to test frequency, the advantage to doing weekly viral load tests is that they give the treatment doc more of a heads-up how things are working, allowing him the opportunity to tweak meds, if that is his practice.

-- Jim

[jmjm530]

Thinking it over, probably not much significance  between a reading of 2.1 million and and 6 million, given his pre-tx viral load of 6 million -- but I still think a larger dyamic range would have certain "alert" benefits should viral load actually increase with tx, rather than decrease.

[jmjm530]

Thinking it over, probably not much significance  between a reading of 2.1 million and and 6 million, given his pre-tx viral load of 6 million -- but I still think a larger dyamic range would have certain "alert" benefits should viral load actually increase with tx, rather than decrease.

[Hepatitis Researcher]

Since I know the true technology behind both tests, i can tell you that the false positive issue and the true true sensitivity limit are in favor of the Ngi quantasure, which in reality is a double test - it starts with a quant PCR, using 100ul of serum, then, if neg, it continues with a full 1ml of serum, fully worked up to completion to catch every little virion in existence in this ml, often being even more sensitive than the nominal 5copies/ml. Please note :copies, that is individual virions.
The TMA test is a bit more prone to false positives in the lowest numbers because of the contamination issue that exists and other issues.

As I stated before , the whole iu issue is a shameful development, because it uses an absurd unit for something that can be counted. Next time you see 25 people in a room and are asked how many do you see, you would have to answer: "Ten manunits".  Now many forget that their true virus number/mlis actually 2.5 times higher than their "viral load"?  So "my VL is 1million" is understood by most patients and docs to mean that they have 1 million viruses /milliliter of " blood".  Quite misleading. You might note that I painstakinkly attach the iU sign after every mentioning of a number, but I am sure that does not help in many cases.

[H20Lover]

Good morning!

Thank you both for your responses.  I feel very special that you took your time to help me.   Sorry for just now replying, but I was away from the computer all weekend trying to enjoy life!  But I could not wait to hear your answers.

So....I will call about making a change.  

I understnad HR's reasoning for the "better" test.  I do not know if it is covered by insurance or not at this point.  With it's limit I agree, if I am still over the 2mil IU, then I did not have a 2 log drop and I suppose the exact number is a mute issue.  But could it actually go up????

I will check with UHC and if it is covered I will ask for that one.  If not, I may have to go with the Quantasure Plus because I know that one is covered.  

This discusion though prompted a couple of questions of other questions?  The ceiling seems mute, but can that sensitivity area between 2 IU's and 10 be the diference betwen SVR and relapse?  That concerns me.  Any statistics on that.  Any possibility people were really not undetected because of a high threshold or poor testing methods?

Gentleman, I do have a small issue with "telling the doc what to do".  I can't be sure if it was the nurses mistake or his.  As I said in the original post my first test was the Quantasure plus (10-100 IU/ml) that my PCP ordered.  He had to call the lab though and ask.  He was honest about that and told me he wanted to be sure.  That is the test Lab corp told him to run, but it was for diagnosis not for treatment response.

Either way, I have to call the doc and tell him I am questioning his orders.  But it's my body....right guys?  Nothing personal, I will tell him I questioned it and called LabCorp.  I have already told him about this website and he told me to not believe everything I read.  

By the way Jim, unless your reference to "him" is a clinical reference, I am a womanunit.  


Thanks so much, if there is anything else you can add, feel free!

Have a stellar day!

[H20Lover]

Forgot to ask you.....did my small drop in Hemoglobin mean anything?  I suspect I should watch that too?  Was that enough drop to indicate good absorbtion of the riba?  

Also, while we are on the subject.  I asked doc about Procrit and the (nupra something) one for the neutrophils.  He said if I needed those he would probably turn me over to a hematologist.  Is that normal practice for a gastro?  Is this an issue I can push with him to avoid yet another doctor?

Thanks!

[jmjm530]

Hgb drop seems about normal. Ideally, you should be on weight-based ribavirin, even though you're a geno 2, but perhaps you already are.

As to the hematologist, yes, many gastro's do not treat anemia in house and refer to hematologists. The problem sometimes comes that the hematologist is not as familiar with SOC induced blood disorders as they should be. Best to monitor blood as frequently as possible and stay on top of things.

Back to the tests, yes, a qualitative just gives you a "yes" or "no" and it's not what you want for your first viral load test. Apparently HR and I disagree on which LabCorp Quantitative to take, for reasons we both have given.

I do know some doctors actually run two tests at times. Depending on your doctor and insurance, this is one possiblity. Using the same blood draw, run the test HR mentions for low end sensitivity and the one I mention for a wider dynamic range.
My concern again -- and statistically the chance is very low -- is that if you run the Quantasure, you won't know if you have an autoimmune reaction to the drugs, i..e. where your viral load actually goes up. Using both tests simultaneously (for the initial test) will cover you both way.

-- Jim

[copyman]

you have every right to request the "best" test for the ever important 4 week draw. this is perhaps the most important bloodtest during tx. i would not say anything to the insurance company, just get the best test done and they most likely will pay for it. once you call them it will be put on record and they will be looking to not pay it.  personally for the 4 week test i would want the best test even if i had to pay for it. best of luck

[H20Lover]

Morning!

I assume it is weight based.  I weigh 159 and am 5'5'' doing 1000 a day.  Need to get down to 149 but with my new taste buds, probably will be the easiest weight loss program on the planet.

As for the VL tests I am doing the research right now and have printed off the 2 tests thru lab corp.  At worst may be a small co-pay for the NGI Quantasure.  I think I now understand the subject a little better.

I can't possibly think of it being over 2.5 IU's BUT your caution in the area of possibilites is understood as well.  What if I do the Quantsure plus (10 IU/ml) for now and then once undetectable (assuming of course) then go the the more sensitive to be sure from there on out?  

Back again to my question (post above this second one this am).  Is there some correlation to being less than 10 IU/ml vs 2 when it comes to SVR and relapse?    Will that small difference actually be the reason for relapse or is that (as is everything about HCV) going to vary from person to person.   It all goes back to our individual immune systems I suppose.

It worries me that people may be getting false hope if they are getting tests that are less than desired to get the true picture.

Thanks HR and JIM and all who come here your input makes me better able to cope with this disease.  Knowledge truly is power!

[H20Lover]

If you knew me you would know how naive I am.  You are right!  If I had called them I would have alerted them!  Go Big D!

I understand you too then to believe that the "best" test is the one I need.  The one drawback though is the ceiling.  Is that though less of a concern then the floor so to speak?  

I guess the only sure way is to do what Jim said and ask for both tests.

I made copies of both.  I am going to fax them to the doc and tell him the pros and cons of both and see if he will order both.  What do ya think?  

Also copyman and all.....why is the 4 week so important?  I know a early response is good, but is the difference between the 2 and 10 UL/ml gonna make that big a difference at that point?  Am I missing something?

Gotta get ready for the office......will be back later.....

[jmjm530]

H20: What if I do the Quantsure plus (10 IU/ml) for now and then once undetectable (assuming of course) then go the the more sensitive to be sure from there on out?  
------------------------------------------
Good thinking, but actually you might try the opposite. Do the test "HR" recommends first, and then ask the lab if they would "reflex" the test into the one I recommended should the viral load be over the 2 million IU/ml limit. If they can't do it automatically, ask if some xtra blood can be drawn and then held for that purpose if needed. I would make the calls to LabCorp myself and see if this is feasible. If they won't speak to you, maybe someone in your doctor's office might speak to them. The concept here is to do the most senstive test but to cover yourself if you don't have the expected drop. Sort of like doing the two tests, but you only pay for one if the first gives you a result below 2 million. Hope this makes sense.

As to the difference between 2 and 10 IU/ml, I've never seen one of the major "rule" studies  that used anything less than 10 IU/ml, but I would presume that the more sensitive the test used, the more certainty you might have in projected SVR rates if you show UND. On the other hand, if you show 4 IU/ml, not sure how you should
react:)  FWIW Heptimax by Quest is sort of in the middle with 5 IU/ml and has a very wide dynamic range. That's why it's a good "one test for all" type of test.

Good luck and do let us know how it all works out.

-- Jim

[jmjm530]

After a little quick research -- there is no "reflex" test that will accomplish what was suggested, however, it's still easy enough.

Each of the two tests requires a single tube that will be frozen and sent to the lab. What you want your doctor to specify is that they draw enough blood for TWO frozen tubes. LabCorp will then keep those tubes and your doctor then has the option to ADD the second test, should the first come in over its limit of 2 million IU/ml. Apparently, LabCorp will hold the second tube automatically, but if it were me, I'd have the doctor add a little note saying to hold the second tube as a second test might be added.

-- Jim

[nygirl7]

Either way, I have to call the doc and tell him I am questioning his orders.  But it's my body....right guys?


You will get VERY used to doing this as the course of time and treatment go by.  Unfortunately, some doctors treat as if they are using an old dial up line and don't realize they can use cable...most of the time they just don't know it exists.

My doctor while at first irked by my constant questioning and pointing things out at the end was learning LITERALLY from me and although most docs don't have the ego to do so...I was lucky and he was wonderful and thanked me (not sarcastically either).  It worked out well for his next patients TOO.

I would NOT worry about the "ceiling" of th "best" test at all...if you are still over 2 million it won't matter one whit.  Week 4 is crucial because the earlier you respond to UND the better your chances of SVR should be.  

One example my 4 week test was 411.  Great! Woo hoo!  So it appeared I had everything going on ... then my 12 week test was 419 - I hit the draed plateau that sometimes exists.  Had I not had the 4 week test I would have falsely believed I was on a steady decline.  I wasn't. In the end it lead me to do tye 72 weeks of treatment that now have me SVR.  Had I not known I could have falsely done 48 and perhaps not gotten in.

[jmjm530]

The discussion has been detoured a little into a "battle of the tests :) " , but I think the single most important thing to carry away is that you do not want a Qualitative test (as your doctor suggested) at this point in treatment. What you want is a sensitive Quantitative test that will give you a viral load number. Once you finally become UND, then Qualitative tests can be given. It's possible your doctor or nurse simply made a mistake because they did order a pretty good test the first time.

-- Jim

[nygirl7]

I can't even imagine having a  test and not getting a number back - what in the world would there be to obsess endlessly about?  Why, that would have ruinned treatment for me!!!!!  ;)

[jmjm530]

Nothing wrong with a qualitative AFTER you're UND. In fact, I most of my post treatment tests have been qualitatives. They just say "virus detected" or "virus not detected" and at this point that's all I need to know. But yeah, getting a qualitative for your first test on treatment is just wrong :)

[H20Lover]

Thanks again for your interests.  The knowledge here is amazing.  Unfortuantely experience is the best teacher.

As for the test I am glad I asked.  I will ask for the one HR recommended and ask for the 2nd vial in case I am over the 2 mil as Jim suggested.   Makes sense to me.  I don't expect grief from the doc.  I will go down there and take him the copies of the tests that I got from labcorps web site.  So far he has taken my need to learn quite well.

Jim.....if and when I do become undetectable, then you say the qualatative is OK.  How low does that one have to be to be undetected?  Just curious.  Is that only undect POST TX?  does it have a lower threshold than the quantatative or is it simply you don't need the numbers anymore?

Thanks again....you all are great.  It is like having a consulting firm!

[jmjm530]

H20: How low does that one (the Qualitative) have to be to be undetected?
----------------------------------------------------
First, what is UND anyway?

Up until recently, 50 IU/ml was considered UND in the sense that this was the sensitivity of mosts tests used in treatment. In fact, you will see 50 IU/ml as the UND threshold in most European trials.

More lately, a number of trials are using 10 IU/ml as the threshold. I believe that is what Telaprevir uses, not sure.

Many of us here use 5 IU/ml, as in "Heptimax" by Quest Diagnostics.

The test you're taking has the lowest threshold of any of these tests at 2 IU/ml.

So as you see, there is no uniformity in what is considered UND, and I should also add that there are no doubt other factors that go into evaluating a test besides just it's sensitivity such as reliability, etc.

-------
As to the Qualitative, the only one I'm familiar with is Quest's HCV RNA QUAL TMA.
That test has a sensitivity of 5 IU/ml and is the one I now take post treatment (previously I took "Heptimax" by Quest, also with a sensitivty of 5 IU/ml)  

In your case, for future testing, you would have to find out the sensitivity of whatever qualitative you might want to take, but in general, qualtiatives are pretty sensitive. Alternatively, you could continue on with the quantitative test you plan on taking since it goes down to 2 IU/ml.

-- Jim

[jmjm530]

But again, the key thing to impress upon your doctor at the visit is that you want a sensitive QUANTITAVE, and not a QUALITATIVE for your next test. That's because you want to know the number of virons left, not just whether they are still there or not.

Since he already ordered that test once, I really don't see any problem, and I'm sort of guessing that someone in his office may have made a simple mistake in ordering the qualitative.

Good luck and do let us know how this bloody saga plays out :)

-- Jim

[H20Lover]

By gosh I think she's got it!  It makes perfect sense.  By the way, the whole reason I questioned this was because I compared the order to the first test.  My PCP, not the gastro ordered the right test the first time, but had to ask the lab tech which one to run.  They did quantasure plus so naturally I wondered why.  Knew you all would know.

So.....here I am better equipped to deal with this nasty virus thanks to this forum!