I keep going round and round with my doc as to the sensitivity of the PCR's he is having run on me. The 4 week one was <50. I asked for him to run a more sensitive test (down to <5) and even mentioned the heptimax test. He still claims that the <50 test is fine and as long as my results are <50 I am UND.
Are there any articles on the web stating that a more sensitive test should be run that I can bring to the doc? I will be having my 12 week Pcr shortly.
FWIW, and I think it is worth something -- members here have reported being given sensitive tests like Heptimax by some very prominent doctors. That would include Dr. D. in NYC, Dr. J. in NYC, Dr. S. in Miami and Dr. G. in SF. I doubt if they would be using such sensitive testing if they didn't think it would provide value to the treatment.
Not all PCR's test to <50 copies.....Altough they have been testing me with that and I've been coming in at <50...They have used PCR,Roche AMPLICOR HCV MONITOR,The viral load quantitative test has a linear response between 2k copies to 500k copies of serum or plasma.
I guess they figure if I had anything at all it would show up weather it was 5 copies or 50...
Yes, other tests go down below 50 IU/ml as well, but you reported that your test only went to 50 IU/ml. "Heptimax" is just one example of a good, commonly available sensitive vl test. Quest also has an HCV RNA QL TMA that also goes down to 5 IU/ml and LabCorp has a couple of tests equally sensitive. There are other too.
If the virus is there, it will show up with the <50 test or the <5 test is what he is saying I think. My doc says the same thing, that the difference between the <5 or <50 is not worth worrying about nor is it worth paying thru the nose for. People make a big ta doo about the sensitivity when in reality the <50 test IS a "more sensitive" test. That test is fine. The test they used to use, the <615 test is the one that is outdated, but even that one is still a good test because the virus usually comes back in much higher numbers easily detected with a >615 test.
I wouldn't worry about it, if you are UND on the <50 test then you are UND. The virus replicates in the trillions PER DAY so if it was there, it would show up on the <50 test. Don't worry about it. Some still use the <615 test but even that one is sufficient in the eyes of most doctors, the patients want a more sensitive test but it isn't really medically necessary.
I disagree with your doctor. I had at least one positive viral load test per Heptimax under 50 IU/ml which would have been reported negative if I had only taken a PCR with a sensitivity of 50 IU/ml. I believe NYGirl had a similar experience. You should find articles to support a more sensitive testing on both the Clinical Care Options site as well as over at Projects In Knowledge. I believe 'Berg' also published a paper -- unfortun in German -- that also acknowledged the benefit of more sensitive testing, as best we could make out from the translation.
But there's also another point. Why shouldn't you take advantage of the most senstive test avaialble? With 'Heptimax' you will get the real-time PCR (sensitivity 50/ml) that your docor wants plus you will automatically get a more sensitive TMA if the PCR comes out negative. It's your liver, not your doctors, and I'd try and point that out to him in a nice way. Whether your doctor agrees on the importance of the TMA or not, asking for a more sensitive test is certainly a reasonable request based on current practice, and I can't see why a doctor should deny a patient that right.
Perhaps it's an issue with insurance and calling out a specific test by brand name. Maybe the labs your doc uses does not utilize Heptimax (believe it or not Quest Diag. is not the only game in town)? Try asking for a TMA test with the <5 sensitivity and point out your awareness of many false positives UND claims when the <50 threshold was used. I seem to recall that there is a studie somewhere where the rate of relapse was being researched that confirmed this, but do not have a link to it at hand.
Here is a PubMed article which might help explain why relapse rate is thought to be the result of insensitive PCR testing:
I said that mine came back<50........Thats what I began to show at 12 weeks...I actually don't know what test they used fro that....I'm just looking at what they used recently...I was merely stating it because I noticed it didn't go down that far....It caught my attention.
"I wouldn't worry about it, if you are UND on the <50 test then you are UND. The virus replicates in the trillions PER DAY so if it was there, it would show up on the <50 test."
I disagree with you on this though traveler may indeed could be clear. You make these kinds of statements as if they have been proven through unassailable studies and that what you say is absolutely true. If you have support for that absolutism I would like to see it. It is not as simple as you try to make it. I have tested in the teens before with blood tests. And, you may recall that my biopsy showed 30 IU/ml in my liver which is the primary site of replication. So the virus can be present in VLs <50 IU/ml and if it were I would want to know it. There are more sensitive tests available and I can see no reason not to use them. I am not saying that traveler should be worried about the PCR but that's not the same as saying that <50 IU/ml is absolutely undetectable. By definition <50 is not necessarily <5.
Honestly, everything I read nowadays depresses me. The DOJ, Iraq, Iran, Imus, border security, education, the disparity between the RICH and Poor, the cost of education and the lack thereof, flight of corporations and the exportation of jobs. I see it all as dismal Kalio - way too dismal. Mike
Be joyful, even though you've considered all the facts....
why not? we only get one trip on this planet, might as well make it as pleasant as possible, though of course that's hard sometimes...Course I've never been to Sambone's planet, maybe I'll try to go sometime:) Sorry for the wayward posting, realize it should be on the other side...
I agree with you completely on this issue. I just hope that this discussion doesn't cause Traveler any additional anxiety but that it does enable him to bring with him to his doctor some valid evidence regarding this subject. Mike
My doc is good about everything. Rescue drugs, frequent cbc's, PCR's, and visits. He is just real hung up on this PCR sensitivity. I even told him that I would pay for it myself and he told me I was just being foolish.
I looked at the studies for stopping treatment early and even all of those only talked about using <50 rather than <615.
I really would like to find an article showing that by not going to <5 that the virus could be hanging in there at low levels and come roaring back once the drugs are stopped. Basically that is my worry, that the meds are keeping it under 50, but once stopped it would come back. Of course, he could say "so the meds kept it under 5 untill you stop"
I will have another go at him before my next PCR.
Here is the specific study you are looking for, but as you say, your doc can say "that the meds kept it under ___, until you stopped.
Here's the study: http://www.hivandhepatitis.com/2006roberts/hcv/081106_c.html
Basically it says that a certain per cent of PCR negatives (detection limit 100 IU/ml) were indeed TMA positive (detection limit 9.6 IU/ml). ONE HUNDRED PER CENT OF THIS GROUP RELAPSED.
I do understand the predicatment you're in with a doctor who wants to do it his way and wish I could help you more. Maybe you can get a bit more assertive or try and get the more sensitive test through your PCP or another doctor.
The vast majority of doctors do not use the <5 test, maybe the case is different for transplant patients but most typical patients are using the tests the doctors have available and the difference between a <5 test and an <50 test is not significant.It is a rare patient who has the virus return in such tiny numbers. Testing in the teens is not the usual experience of nontransplant patients, normally if you relapse you will have more virus than <50. Being a transplant patient puts you in a different category than those without a transplant and the availability of tests that sensitive just isn't there for many people who don't have a team of transplant doctors nor is it needed. A <50 test is sensitive enough to satisfy the vast majority of doctors, it is rare for the virus to show up in such tiny numbers. I can see why a transplant doctor would use them and why they would be necessary but the average patient will show virus on a <50 test.
He seems overly worried about being detectable when his <50 test is clear and I think it is due to too much importance being put on the tiny difference between a <5 test and a <50 test. If it is readily available then sure, do the <5 test but if you can't get it, the <50 test is just fine. Im sure his doctor thinks it is a waste of money to test again trying to look for virus. Doctors can't just order tests willy nilly without having a good reason, being a transplant recipient would be a good reason, but just wanting the most sensitive test known to man even though you already are UND by <50 test would be rejected by my insurance company and Im sure most insurance companies. Doctors can't just test because a patient wants it, it has to be warranted by medical evidence and in this case there is none. He is UND <50 so what would suggest he needs a more sensitive test? Nothing, that is why his doc says he doesn't need it.
Being a transplant survivor puts you in a whole different category than the "average" Hep C patient.Most insurance companies won't even pay for <5 sensitivity tests and they aren't available for many patients unless they pay the hundreds of dollars for it out of pocket.
I cannot argue with any of your points. I really don't know for sure how my transplant status translates into viral load so it could be that we are more apt to sustain low levels of virus than non-transplants. I will tell you that when I asked my surgeon what percentage of SVRs in the general population did he believe would show HCV on biopsy his response was 75%. That's just one man's opinion of moonlight but he has always seemed very on top of this stuff. I have to assume that you are more familiar with the protocols followed by the majority of practitioners because I have little experience in that area. I did not realize that getting the most sensitive test was such an uphill fight. And, I do believe that <50 IU/ml is highly suggestive of undetectable and I didn't mean to suggest otherwise or cause traveler any undue anxiety in that regard. My Niece is a brilliant attorney - far more intelligent that I - and I remember when she started law school we were discussing an area of law when she asked me what was the rule. I told her that in law there is no rule - it's all on a case by case basis and everything hinges in the particular facts. She was used to certainty and she had a lot of trouble accepting that reality. That may explain why I posted to you. I recoil whenever I see absolutisms because I am leery of them and I try never to state anything as a fact that I am not 100% certain of and there are few instances when I am that sure about something - anything. I am not a good poker player because I find it very hard to bluff - to present something that might not be true. I wish I were better but I don't think I ever will get passed that inability and win a lot of money. I have no hard feelings Kalio - I hope you don't either. Mike
If it were my dime and I had to spend it on either a week 12 TMA or an end of treatment TMA, I'd spend it on a week 12 TMA. That's because the chances are if you are non-detectible at week week 12 by sensitive TMA you will be non-detectible by sensitive TMA by end of treatment. The advantage of finding out now -- besides the anxiety issue -- is that it will give you and your medical team meaningful and more complete information right now to make future treatment decisions.
I certainly didn't intend to come off that way at all, my intent was to ease his fears, if he can get his hands on a <0 test power to him, but my doctor and all the docs basically don't see the value in spending all that money for a sensitivity difference between <5 and <50. He told me the same thing travelers doc did, "if it's hiding under <50, then it could hide <5 too, you are UND" plus he is on tx, the need for a maximum sensitivity test might be there after tx is over, maybe he can convince him when his tx ends. That is when I would spend the bucks for the most sensitive test, to ensure the virus is gone after tx. On tx he's got that "protective layer" of drugs suppressing the virus, the test is more to indicate tx progress than anything else.
I can see why a transplant patient is a different story and detecting virus popping up (even in very low numbers) would be prudent.
I had the same exact reaction from the doc regarding more sensitive tests as traveler has had, the doc basically didn't see the need on tx.
Are you having a field day reading all about issues with the DOJ? Man, what a MESS. Next week we should see some very interesting developments...
Mike: I really don't know for sure how my transplant status translates into viral load so it could be that we are more apt to sustain low levels of virus than non-transplants.
Mike, I really think that your transplant status is not of distinctive value here, and the points you made are valid for those treating, or finished treating, who have not had transplants.
As I mentioned earlier-on, I tested below 50 IU/ml early-on in treatment as well as NYGirl, just for two examples of folks we know. Both of us would have tested negative with a PCR of sensitivity 50 IU/ml, but not with a more sensitive TMA.
This study http://tinyurl.com/3dqutf suggests that 22% of PCR negatives at week 20 of treatment were actually TMA positive and therefore using a more sensitive TMA would have given the treatment doctors a better predictive value to base treatment on. http://tinyurl.com/3dqutf
And this study suggests that a percentage of EOT negative PCRs are actually TMA positive and 100% of that sub-group will relapse. Something someone would definitely want to know before stopping the treatment drugs, especially if the plan was to re-treat right away. www.hivandhepatitis.com/2006roberts/hcv/081106_c.html
And then there are members here who have reported being given either "Heptimax" or similar sensitvive tests by literally the 'Who's Who' of HCV treatment incluidng Dr. J and Dr. D. of NYC, Dr. S of Miami and Dr. G. of San Francisco. I doubt very much these esteemed doctors would admister more sensitive TMA tests unless they felt they offered useful data to improve treatment.
As to whether the vast majority of doctors use these more sensitive tests or not, I personally have no idea, but don't see that as the point. What we should be striving for is the best possible treatment scenario, not the most common scenario. Of course, insurance plays a role, but at least from my own experience, as well as many others here, getting a test like "Heptimax" through the insurance process has not been a problem, as long as the doctor writes an rx for the test. At the very least, the paitent owes it to themselves to contact the insurance company and confirm for themselves which test(s) are and are not covered.
I'll conclude by quoting Mike (hope that's OK, Mike) because, as stated, the value of these more sensitive tests is valuable to all of us, not just transplant patients. -- "There are more sensitive tests available and I can see no reason not to use them. I am not saying that traveler should be worried about the PCR but that's not the same as saying that <50 IU/ml is absolutely undetectable."
First off, I'm assuming you're in treatment now, right? Your 4 week PCR is not post treatment? If so I'd go for the most sensitive test you can get if I were you. I got a test that went down to 2 IU/ml from LabCorp, which is the same sensitivity as the Heptimax test (in fact I'm starting to wonder if they're really the same test). I got the test ordered through my primary care doctor, it was no big deal. He originally diagnosed me with HCV so he knew I had it. I told him I wanted to see if the virus was in "remission". Since he knew very little about HCV or the specific test I wanted, he simply agreed to it and signed off on it. His secretary filled out the Labcorp paperwork and I provided her with the name and number of the test (available at labcorp.com). Done deal after that. And although I suspect the higher sensitivity test is more expensive, my insurance paid for nearly all of it. Also, I noticed on my copay bill (which was like $3 or something) that my insurance co only paid like $30 for the test! (normal "retail" is several hundred) I don't know whatever mechanism the insurance co uses to negotiate lower prices with labs/doctors etc, but as you can see it won't necessarily cost your insurance company a lot of dough. And therefore it shouldn't be too much fuss over its approval without you having to pay through the nose for it (assuming you have decent insurance).
As far as whether it's worthwhile to test down to 2 IU/ml, there's no question I'd want that level of sensitivity (although I'd also settle for 10 IU/ml if push came to shove). The reason I believe it's necessary and desirable is because during our time in the Vertex trial I've seen many people score "29's" during the trial. A 29 means that the patient is detectable somewhere between 10 and 29 IU/ml. And we've seen several patients report these 29's multiple times throughout their treatment, so they can't all be flukes. Also, nygirl just scored a 65 or 69(?) 1 month post, which obviously is less than only 20 IU's above a 50 IU/ml threshold. If I were detectable at a very low level in the early phase of treatment, given a choice, I'd certainly want to know it. This knowledge could play an important role in determining how I managed the remaining portion of my treatment (vis-a-vis early termination of treatment, extending treatment or increasing standard doses of IFN and/or riba). Depending on what that knowledge told you, it could conceivably even make the difference between getting your SVR, or not.
Also, I think a <50 IU/ml would be fine for someone who had completed/stopped treatment and were not planning to restart even in the event they relapsed. Or if they were getting a 1 year or longer post treatment follow up test to simply verify their SVR was still intact. Under these circumstances a 50 IU/ml would be fine in my opinion. It wouldn't matter if you were detectable at a lower level because you're not planning on restarting anyway. Plus, as I think Kalio was alluding to, if a relapse did occur after stopping treatment, the VL will nearly always soar well above a mere 50 IU/ml. It may take more than a month or two to fully break out, but to my knowledge in the vast majority of cases it will show itself in much greater numbers than 50 IU/ml. So I think the post treatment follow up tests would be ok at 50 IU/ml, although for my earliest post treatment tests I'd still want the most sensitive test, especially if I had the intention of restarting the drugs in the event I became detectable.
Lastly, if I were you I would print out a copy of the study jim referenced and hand it over to your doctor. I would also tell him that you wish to have the most sensitive test used for your remaining tests, especially for the tests near the end of treatment. You want to know to the best of your ability if you are truly negative, the virus can at times sit there at very low levels well below 50 and yet above 2 IU/ml for a prolonged time. I'd want to have the closest look possible before stopping the meds. If your doctor can't see the wisdom in this and firmly declines your request, then there is absolutely no question (if it were me), new doctor shopping would be my first priority the very next day. But remember if you do have to do this, your PCP might be able to take care of you in the interim by ordering the test required.
Once again thanks to all.
You are right that it is the comfort level I am looking for. With this disease you don't even know if it is ever gone, even if you do get to SVR. I have read many times that some think it can come roaring back later if you don't keep a real healthy lifestyle (no drinking, good diet).
I will bring the articles with me and try to get the <5 test. If not at 12 weeks I will get one before tx ends if I have to pay myself. I guess the most important time to get it is before stopping the meds so I will no whether to quit or continue longer treatment.
Of course my original plan was to quit after 12 weeks if not UND. I might have to take a UND<50 as to keep on going.
I inadvertently posted this to you. I meant to leave the space blank but I must have copied and pasted while paying the IRS for 2006 and that always puts me in a different state of mind. I didn't mean to single you out - I was cornfused by the drudgery of my tax liability. I apologize that it seemed like I did single you out. Mike
My accountant did do it. All I had to do was write the checks and that was enough. I think you know how I feel about this thread. I must be changing a bit because I am not as eager to engage in conflict as I formerly was. I suspect that ribavirin might be at play here because as I said I don't think any of us really disagree. I am at a loss to figure out how we got here so I'm going to blame it on ribavirin until it is crystal clear that's not the driving factor. Mike
He invents tests, of course he feels that way. He recommends his test too as I recall, wouldn't you if you had a wall full of patents for inventing tests? I sure would.
The average patient does not need to obcess over the diff between a <5 sensitivity test and a <50 sensitivity test on treatment. PCR testing on tx is by and large to gauge your progress.Some here seem to get all up in arms over it and act as if it is a medical necessity when it isn't. Maybe it's worth the trouble after tx is done and you are verifying you have SVRed, but it isn't worth worrying about on tx. Tx is hard enough without having to bust your tail trying to obtain a test that can only detect 45 more virii and isn't readily available for all.
I posted above, but what's the deal between your hemo and liver doctor? A two doctor approach works with some but they are supposed to agree or delegate responsibilities I would imagine. You say your hemo will go with transfusion at a certain point but your doc will reduce dose. So who do you go with? What's the plan here :)
Had another thought but since this thread has more or less gone to pot anyway, thought I'd post here rather than above. Since your hematologist and hepo don't seem to see eye-to-eye anyway, maybe bring some of the studies over to the hemo and see if he'll give you that sensitive test. If I were thinking of reducing riba, or if the possibity was looming as it might be with rapidly declining hgb levels, then knowing I was non-detectible to 5 IU/ml, might make the decision to cut back a little on the riba easier, but keep in mind I'm kind of belt and suspenders when it comes to treatment.
Sorry about airing the dirty laundry but feelings often run high, especially when different doctors treat under use different approaches. We all like to think that our doctors are giving us the best care -- and like you say, compared to other countries we really are. As mentioned, you're half way through anyway, so a lot of this is academic unless your plan was to treat immediately upon relapse, which isn't necessarily the best thing to do anyway -- but why get into another controversial topic :) Do wish you the very best with what looks like an SVR in the making, and if you do end up showing the doctor some of the study papers, do let us know if it made any difference.
To try to construe an argument that I am somehow anti sensitive testing is ridiculous, please, gimme a break. That is not what is being said at all. A <50 test IS a sensitive test for heavens sake.
I know HR personally and have tons of respect for him, to insinuate I don't is really rude. As rude as trying to create some argument that I am anti sensitive testing. I AM anti overblow everything and over exaggerate every detail about Hep C however. There seems to be a number of people here that make a mountain out of a molehill at everey turn. A federal case doesnt need to be made about the diff. between one VERY SENSItiVE test <50 and another VERY SENSITIVE test, <5
There are much more important things to concern yourself with. He is on tx and UND, his <50 test is MORE than sufficient.
Detecting 45 more virii is making a mountain out of a molehill. The man's <50 test is fine, like his DOCTOR told him it was.
If the virus is there, it will show up with the <50 test or the <5 test is what he is saying I think."
The statement stands for itself, it's simply wrong.
You called me out in a previous thread that I was being "passive agressive" because I made subtle references to you without addressing them to you directly.
Yet, you have done, and are doing the same thing here when you say, "...There seems to be a number of people here that make a mountain out of a molehill at everey turn. A federal case doesnt need to be made about the diff. between one VERY SENSItiVE test <50 and another VERY SENSITIVE test, <5"
I personally don't mind if you use my name or not but please don't be a hypocrite and make a big deal if I don't use yours in the future. I didn't do it because I was being passive/agressive but just that I thought it would be less confrontational, as I assume that is why you did it as well. Let's just play ball fair with the same rules for both, eh.
I try to believe that we're all driven by the same motivation - a search for the truth. Admittedly, ego can insinuate itself into just about everything we do or say but once we pause and dispassionately consider the situation we should be able to put ego aside and focus on the real picture. I am surprised and disappointed that this thread has come this far and generated passive, if not overt, animosity when it would seem that we all agree - the more sensitive test is better than the less sensitive test. And, it seems well established that there are instances, though they may be rare, when the less sensitive tests haven't detected low levels of the virus and as a result incorrect treatment decisions have been made and people have suffered. The mere possibility of error compels using the best and most sensitive test we can get. Mike
Sometimes you have to try and straighten out the past so that the future will work better.
I was called a name in the past, and I thought this was the appropriate time and place to resolve the issue so it would not crop up in the future. I'm a little surprised at your comments, because you of all people have always stood up both for yourself and others you felt wronged in these types of situations. That's all I'm doing.
Unfortuntaly, "rare" is not an accurate characterization of viremia hiding between the covers of PCR and TMA. If you check out the studies posted above on SOC, or read Mremeet's post regarding trial data. Unfortunatly, trial data is often slow to trickle down to the average GI, and the reason TMA technology is not used as often. Same thing with the 4-week PCR, and individualized treatment (either shorter course or extended). Takes awhile for the average GI to catch on/up.
My hearfelt sympathy regarding the whole tax thing. Personally, I'm just going to pick up the phone and tell my accountant to file an extension. Don't really want to deal with all that right now. Hope this finds you otherwise well.
You said in "C8" above to Kalio in regard to her comments "...You make these kinds of statements as if they have been proven through unassailable studies and that what you say is absolutely true. If you have support for that absolutism I would like to see it. It is not as simple as you try to make it..."
That was the most forceful statement in this entire thread regarding the issue, and I personally would not have phrased/expanded it as you did, but I do happen to agree.
As far as I'm concerned, and based on the studies presented, I see no reason to change that statement based on the argument that your case is special because you've had a transplant. These tests are important for all of us, as has already been discussed.
So again, I'm surprised that you're taking such issue with some of my statments and possibly others. Yes, we all want the same thing, but it's important as you have said in the past, to acknowledge the facts as they are, so other reading will not be swayed in the wrong direction.
I don't want to pick a fight with you because I have too much respect and admiration, and hopefully you won't see this as such. But once the can of worms is opened, it's sometimes better to see it through. Well, I've seen it through on my end as much as I care to, so please have the last word if you wish and if you have the time considering all the tax stuff.
That's the way I felt and feel. I thought Kalio tempered her statement following that post or backed away, if you will, but then she seemed to get testy or defensive and I want to attribute that to ribavirin because I believe that at the root she is a good person and wants what is best for us all. She and I have had major differences before and both of us got a little nasty and I would prefer not to get to that place again. So I am looking for the best in everyone but I can get very mean easily and I'm trying hard not to let that happen. And, I believe that anyone reading this thread dispassionately will see the truth regarding testing and allow the truth to guide their treatment insofar as they can and that's really the important thing. Mike
Sorry if I opened a can of worms. Just shows that folks have different opinions. If I new before starting tx that my doc would not do the most sensitive tests available I would have gone to another doc. I thought I covered all the bases: 4week PCR, Rescue drugs, weight based riba. weekly cbc.
I am at the point now that there is no turning back. Next week will be 1/2 way so it is what it is. I will try the study letter out on my doc and see what he says. My PCP does not want to get involved. His words were "It's up to your hep doc".
I am still lucky as in other countries a lot don't get a pcr until 12 weeks or until they finish.
Why it is important to test as sensitive as possible has already been said above, no need to repeat it.
And no, I don't think HR is pushing sensitive tests because he invented them, that thought never crossed my mind, I think much too highly of him.
National Genetics makes their money testing the national blood supply, testing individuals is small fry, did squat doodley nothing to them.
The reimbursement under my plan for their Quant or Qual is around $100, same as for one of those antiquated "down to 615 I/U" ones.
The Berg study had no ax to grind.
I tried to translate it into English. Anybody interested, it's under "Tallblonde", in the community forum, quite a few weeks ago.
Now it can't be spelled out more clearly why sensitive testing is important.
Actually I cant believe that somebody as seasoned as you is defending a position that is clearly outdated.
I can only be offended by people that mean something to me.
I care less about you, your posts, your thoughts about PCR testing, or anything else for that matter.
I wish you health and SVR, I wish that for everybody, otherwise you can go where the sun does not shine.
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