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24 week UND!!! Are PCR's unreliable?
Good Morning Vietnam!
I got 21 week PCR yesterday and called the dr. I read to me UND, but wasn't sure b/c of the language. Of course I am happy of this result, but it is so hard to understand.
The comments in parens are the 12 week PCR;
Hep C RNA >1.9 (8) (this said Not Qnt last time)/
<1.9 log IU (same as before)
*(8) Viral load is Result for HCV RNA is LESS Than 75 IU/ML
...Results below the limit of detection (1.9log IU/mL) will be reported as >1.9 log IU/mL. Results between 1.9 and 2.3 log IU/mL (75 to 200 IU/mL) will be reported as "HCV RNA detected below the limit of quantitation."
Would you say this means I am UND? Why the Not Qnt last time? Ultrasound says fatty liver versus cirrhosis, this is scary as he said it could be one or the other.
The GI told me that PCR's are SO unreliable that he doesn't put too much stake in them. Interesting! He says he was one of the first Dr's in the world to do PCR's and has done them by hand. Claims that the same blood sample can change from hour to hour as far as VL. If this is the case why do we put our lives in the reports of PCR's. I asked about getting a more sensitive test or TMA etc. He said they are all the same. He will do a Qualitative next time...I really thought this was something to discuss here. If PCR's are so unreliable and fluxuate, then why do we say someone that has a breakthough with a few copies stop tx?
I got 21 week PCR yesterday and called the dr. I read to me UND, but wasn't sure b/c of the language. Of course I am happy of this result, but it is so hard to understand.
The comments in parens are the 12 week PCR;
Hep C RNA >1.9 (8) (this said Not Qnt last time)/
<1.9 log IU (same as before)
*(8) Viral load is Result for HCV RNA is LESS Than 75 IU/ML
...Results below the limit of detection (1.9log IU/mL) will be reported as >1.9 log IU/mL. Results between 1.9 and 2.3 log IU/mL (75 to 200 IU/mL) will be reported as "HCV RNA detected below the limit of quantitation."
Would you say this means I am UND? Why the Not Qnt last time? Ultrasound says fatty liver versus cirrhosis, this is scary as he said it could be one or the other.
The GI told me that PCR's are SO unreliable that he doesn't put too much stake in them. Interesting! He says he was one of the first Dr's in the world to do PCR's and has done them by hand. Claims that the same blood sample can change from hour to hour as far as VL. If this is the case why do we put our lives in the reports of PCR's. I asked about getting a more sensitive test or TMA etc. He said they are all the same. He will do a Qualitative next time...I really thought this was something to discuss here. If PCR's are so unreliable and fluxuate, then why do we say someone that has a breakthough with a few copies stop tx?
I THINK what he means is that if you think of it this way...say you are UND to 75. All that means is that they can't count any LESS than that. So you COULD have 70 PER MIL left in your blood. Now if you times the amount of MLs of blood in your body...potentially you could have what trillions of virus's floating about BUT still be considered UND.
We all have to remember that.
When I tested at 4 weeks at 411...by the OLD testing down to 615 copies i WOULD have been told I was UND - but as you can see I was not at all.
Even with being tested down to 5...and coming up UND..that means if I had 2 per ml well - I don't know how many MLs of blood we have but there would certainly be enough to replicate and cause a relapse.
This is why I decided to treat for 72 weeks - hopefully it will knock the hiding ones out for Good.
Did that make sense? That was my take on why a doctor would say they are unreliable. But again...my guess you know?
We all have to remember that.
When I tested at 4 weeks at 411...by the OLD testing down to 615 copies i WOULD have been told I was UND - but as you can see I was not at all.
Even with being tested down to 5...and coming up UND..that means if I had 2 per ml well - I don't know how many MLs of blood we have but there would certainly be enough to replicate and cause a relapse.
This is why I decided to treat for 72 weeks - hopefully it will knock the hiding ones out for Good.
Did that make sense? That was my take on why a doctor would say they are unreliable. But again...my guess you know?
I wonder if they had tested your blood an hour later it would have said UND. That makes me wonder if some people are thinking they are UND at 12 weeks, not txing for 72 weeks as you are, because they think that they were UND at 12 weeks. Perhaps if they did several PCR's over a day they would be more accurate. I hate to think that people are getting false info and basing tx options on this. It is good (not really!) that you found out and are extending. Maybe others are basing their tx time based on false readings. A concern.
I asked about getting a more sensitive test, he said it wouldn't make a difference. Obviously, it did for you and would have for me, if I knew I had a small amt. of VL.
I didn't realize that the same blood sample can change so much in a PCR in an hour. Really makes me wonder! If my PCR at week 12 was detectable, I would have been taken off tx right then and there by the ins. co. Such important decisions are based on these tests.
I asked about getting a more sensitive test, he said it wouldn't make a difference. Obviously, it did for you and would have for me, if I knew I had a small amt. of VL.
I didn't realize that the same blood sample can change so much in a PCR in an hour. Really makes me wonder! If my PCR at week 12 was detectable, I would have been taken off tx right then and there by the ins. co. Such important decisions are based on these tests.
As the first excerpt form http://www.clevelandclinicmeded.com/hcv/lab.htm
shows PCR is simply one method of testing for the presence of the virus itself, not somply the presence of the antibodies.
It also goes on in the second excerpt to suggest that the quantitatice test is more sensitive than the qualitative test.
Other studies I've read suggest that the TMA is more sensitive than the PCR, and if I recall correctly significantly so.
1) "The HCV RNA test determines the presence of the virus itself rather than its antibodies. The HCV RNA test measures the amount of HCV RNA in the blood via target amplification with reverse transcriptase polymerase chain reaction (PCR), transcription-mediated amplification (TMA), or a signal amplification technique such as a branched DNA (b-DNA) assay. Amplification is necessary because the amount of virus in serum is generally very low. Regardless of the method of amplification, HCV RNA detection represents definitive proof that an infection exists.16
The sensitivity of the different types of amplification varies. The TMA is the newest of the HCV RNA assays, and it is also the most sensitive.It may have the potential to detect relapsed HCV infection earlier than PCR.16 Although qualitative HCV RNA assays are more sensitive, they do not provide a quantitative value for the viral load.
HCV RNA is customarily done at 12 and 24 weeks during the treatment course, at the end of treatment, and 6 months after treatment has been completed.11,16 In the past, comparison of viral levels between assays was impossible. Adoption of standardized units of measurement (IU/mL) has eliminated this problem.16,17,19 It should be borne in mind that differences in HCV viral load of 0.5 log or less are within the range of testing variability and may not have clinical significance."
2) "EIA is the most widely used initial test for HCV infection because of both its accuracy and its low cost.
A positive EIA is usually followed by an HCV RNA test to document active infection. Since HCV RNA levels in patients with chronic HCV infection are within the range of the quantitative assays, many experts evaluate EIA-positive patients with a quantitative HCV RNA assay. In unusual cases, the HCV RNA quantitative test may be negative, but the (more sensitive) HCV RNA qualitative assay will be positive."
shows PCR is simply one method of testing for the presence of the virus itself, not somply the presence of the antibodies.
It also goes on in the second excerpt to suggest that the quantitatice test is more sensitive than the qualitative test.
Other studies I've read suggest that the TMA is more sensitive than the PCR, and if I recall correctly significantly so.
1) "The HCV RNA test determines the presence of the virus itself rather than its antibodies. The HCV RNA test measures the amount of HCV RNA in the blood via target amplification with reverse transcriptase polymerase chain reaction (PCR), transcription-mediated amplification (TMA), or a signal amplification technique such as a branched DNA (b-DNA) assay. Amplification is necessary because the amount of virus in serum is generally very low. Regardless of the method of amplification, HCV RNA detection represents definitive proof that an infection exists.16
The sensitivity of the different types of amplification varies. The TMA is the newest of the HCV RNA assays, and it is also the most sensitive.It may have the potential to detect relapsed HCV infection earlier than PCR.16 Although qualitative HCV RNA assays are more sensitive, they do not provide a quantitative value for the viral load.
HCV RNA is customarily done at 12 and 24 weeks during the treatment course, at the end of treatment, and 6 months after treatment has been completed.11,16 In the past, comparison of viral levels between assays was impossible. Adoption of standardized units of measurement (IU/mL) has eliminated this problem.16,17,19 It should be borne in mind that differences in HCV viral load of 0.5 log or less are within the range of testing variability and may not have clinical significance."
2) "EIA is the most widely used initial test for HCV infection because of both its accuracy and its low cost.
A positive EIA is usually followed by an HCV RNA test to document active infection. Since HCV RNA levels in patients with chronic HCV infection are within the range of the quantitative assays, many experts evaluate EIA-positive patients with a quantitative HCV RNA assay. In unusual cases, the HCV RNA quantitative test may be negative, but the (more sensitive) HCV RNA qualitative assay will be positive."
I've go to wonder about your doctor's expertise when I read:
"I asked about getting a more sensitive test, he said it wouldn't make a difference."
This is just wrong. I'd watch that guy closely if he was treating me.
Mike
"I asked about getting a more sensitive test, he said it wouldn't make a difference."
This is just wrong. I'd watch that guy closely if he was treating me.
Mike
Believe me I am watching this guy!! I asked about a TMA, he also said it would not make a difference. Not sure why! If I had a more sensitive test and had a small VL, like NY, at 12 weeks I would most likely extend. Given the fact that my test said NOT QNT, the ins. co approved me for a year of tx, whereas I would have had to stop if my 12 week showed detectable. Gotta wonder which would be better, having to stop or continue not knowing you had a small VL.
I have been thinking a lot about the PCR also-what does it really mean. Undetected to <5iu which is about less than 10 copies per mil. This is very good but even if there is only 1 copy per mil there still can be a lot there. In a pint of blood there is about 500 mil so if only 1 virus per mil is in the blood that that
i guesse if it was 70 copies you would still have to tx for 48 weeks so it is irrelevant???
i recommend 4 week pcr to all to really get an idea of progress. a large percent at 4 wks clear.
bobby
i recommend 4 week pcr to all to really get an idea of progress. a large percent at 4 wks clear.
bobby
Despite not having the most sensitive test available an undetectable result is cause for celebration. We've got to keep things in perspective which isn't always easy and it is clear that you are responding. I would probably research and bring copies of articles discussing the benefits of sensitive testing as well as the potential pitfalls with less sensitive testing. The guy might just learn something and you might end up getting a better test next time. But by all means do not dispair or agonize over what's been done. It's still great news. Congratulations again! Mike
I think I could beat you in being a pain in the neck, girl! LOL This stuff is a pain in the neck and worrying about everything just exasperates it. Sometimes I wish I were really stupid (no comments about that please!!) and just could cruise on through, but my head does double time thinking about all this stuff. As does yours!! LOL
Thanks for the congrats! It does feel good to be UND. I was worried and now I am more worried...LOL The dr. says he was the first to do PCR's. Well maybe they are more reliable now. He worked in NYC with HIV patients back in the day. While I do think the sensitive tests are more reliable, it is interesting that the same sample can change in an hour! The what if's are driving me nutz!
I can't wait until you start tx and become a REAL pain in the neck! I am gonna get you then! LOL
Thanks for the congrats! It does feel good to be UND. I was worried and now I am more worried...LOL The dr. says he was the first to do PCR's. Well maybe they are more reliable now. He worked in NYC with HIV patients back in the day. While I do think the sensitive tests are more reliable, it is interesting that the same sample can change in an hour! The what if's are driving me nutz!
I can't wait until you start tx and become a REAL pain in the neck! I am gonna get you then! LOL
i had it 37 years and knew it ...they kept saying i had CRONIC hep before they knew about hep c. married 32 yrs and she is neg and i am sure will stay that way. it does't hide they just did not understand it. good theory though...keep thinking.
she just was refused to give blood again.
she just was refused to give blood again.
I am really one of the hard core 4 week PCR people. It is CRUCIAL to my overly obsessive HCV mind.
I was 411 at 4 weeks. 3 log drop. Yippee right?
But at week 12 I was 419. 3 log drop. Yippee?
If I had not had the 4 week PCR I would have mistakenly thought I'd been going down, down down the entire time but as it was...
Of course in the end it really made no difference because I extend anyway due to the positive at week 12. But I really believe that having more frequent PCRs gives you a clearer indication of what is going on.
I asked Dr. J about this and he said that they always do monthly PCRs during treatment but it was more to satisfy curiosity than anything.
So I guess really ... its very subjective and depends on how much you want to know or not. Some people unlike us in here just treat and never ask ONE question - don't know what geno they are except "the bad one" etc.
of course..........we need to know EVERYTHING ;)
I was 411 at 4 weeks. 3 log drop. Yippee right?
But at week 12 I was 419. 3 log drop. Yippee?
If I had not had the 4 week PCR I would have mistakenly thought I'd been going down, down down the entire time but as it was...
Of course in the end it really made no difference because I extend anyway due to the positive at week 12. But I really believe that having more frequent PCRs gives you a clearer indication of what is going on.
I asked Dr. J about this and he said that they always do monthly PCRs during treatment but it was more to satisfy curiosity than anything.
So I guess really ... its very subjective and depends on how much you want to know or not. Some people unlike us in here just treat and never ask ONE question - don't know what geno they are except "the bad one" etc.
of course..........we need to know EVERYTHING ;)
I know I am responding and am very happy about that. I really feel for those that don't even respond to the drugs. This has to be heartbreaking! So yeah, I won't look back, but as NY says, who knows if I was REALLY UND at 12 weeks, since my test was to 75IU. As an obsessive treater that obsesses about all of it, it's hard not to think about all of this!
You know, I go through the I wish I'd had a 4 week PCR, I wish I had a biopsy, I wish I had txed 5 years ago etc, etc. Just a real worry wart I am!
In the end it is the luck of the draw. Some of us will relapse, that is just the fact of it all, especially us 1's. We all know we are against the odds going in. Those that are Geno 2 and 3, now have to worry about txing time with all the relapses.
You know, I go through the I wish I'd had a 4 week PCR, I wish I had a biopsy, I wish I had txed 5 years ago etc, etc. Just a real worry wart I am!
In the end it is the luck of the draw. Some of us will relapse, that is just the fact of it all, especially us 1's. We all know we are against the odds going in. Those that are Geno 2 and 3, now have to worry about txing time with all the relapses.
Congrats! Sounds good to me!
Your doctor may just have a different perspective about this, but doesn't mean he is correct. None of the doctors have it all, because this disease is still a mystery in many ways.
Plus, he didn't really want to push for cat scan either?? I know insurance reasons and stuff, but i don't know,,,,,,
Don't let anything the doc said discourage you...you are on the road to SVR!!!!! Congrats!
Another subject....one thing I have been thinking of is...they say alot of us have been carrying this 35 years,as I was told to be carrying 35 years,,, how come there are people who are in their 20's who are getting it and some even saying they know they contracted it 5 years ago, such as niceguy (I think he said that)
Why doesn't it stay dormant for 35 years in their system? And if it does stay dormant 35 years, maybe our spouses have it and it is undectable until 35 years after being exposed. If you know your spouse only 10 years and he is negative..maybe in 25 years it will be positive? God forbid.
Whose to say that it doesn't hide when first exposed ...occult beginning, test neg, then replication begins,,detectable in blood,,,,tx,,,UND,,,but possible occult,,,,then relapse.
Just possible theory running through my head. But it comes down to this....we have to hope for the best....You are a very upbeat, positive person, continue to be that way, don't let a doctor who may be completely wrong discourage you.. Not saying you shouldn't have posted this and asked this.
There are many knowing people on board that help in sorting things out, I'm not in that position yet, but we all have a role in helping, whatever mine may be,besides being a pain in the neck lol
But anyhow, congrats SFBaygirl!!!
Your doctor may just have a different perspective about this, but doesn't mean he is correct. None of the doctors have it all, because this disease is still a mystery in many ways.
Plus, he didn't really want to push for cat scan either?? I know insurance reasons and stuff, but i don't know,,,,,,
Don't let anything the doc said discourage you...you are on the road to SVR!!!!! Congrats!
Another subject....one thing I have been thinking of is...they say alot of us have been carrying this 35 years,as I was told to be carrying 35 years,,, how come there are people who are in their 20's who are getting it and some even saying they know they contracted it 5 years ago, such as niceguy (I think he said that)
Why doesn't it stay dormant for 35 years in their system? And if it does stay dormant 35 years, maybe our spouses have it and it is undectable until 35 years after being exposed. If you know your spouse only 10 years and he is negative..maybe in 25 years it will be positive? God forbid.
Whose to say that it doesn't hide when first exposed ...occult beginning, test neg, then replication begins,,detectable in blood,,,,tx,,,UND,,,but possible occult,,,,then relapse.
Just possible theory running through my head. But it comes down to this....we have to hope for the best....You are a very upbeat, positive person, continue to be that way, don't let a doctor who may be completely wrong discourage you.. Not saying you shouldn't have posted this and asked this.
There are many knowing people on board that help in sorting things out, I'm not in that position yet, but we all have a role in helping, whatever mine may be,besides being a pain in the neck lol
But anyhow, congrats SFBaygirl!!!
I have been thinking a lot about the PCR also-what does it really mean. Undetected to <5iu which is about less than 10 copies per mil. This is very good but even if there is only 1 copy per mil there still can be a lot there. In a pint of blood there is about 500 mil so if only 1 virus per mil is in the blood that that
Hi bobby,
when you say 37 years ago,,,,did they "test" you 37 years ago and find hep or are they assuming it was from 37 years ago without test? I know they didn't call it hep c, just wanted to clarify, don't know if I misunderstood you.
also you said...
"she just was refused to give blood again." How come they are refusing her to give blood if she is neg? That would lean towards my theory of the occult beginning stage....or was it a typo and you meant to say your wife doesn't give blood, just to play it safe, so to speak?
Where are you as far as stats? are you tx or finished? Hope all is well with you.
when you say 37 years ago,,,,did they "test" you 37 years ago and find hep or are they assuming it was from 37 years ago without test? I know they didn't call it hep c, just wanted to clarify, don't know if I misunderstood you.
also you said...
"she just was refused to give blood again." How come they are refusing her to give blood if she is neg? That would lean towards my theory of the occult beginning stage....or was it a typo and you meant to say your wife doesn't give blood, just to play it safe, so to speak?
Where are you as far as stats? are you tx or finished? Hope all is well with you.
I developed acute hep symptoms around 30 years ago. Was diagnosed and treated for Hep A. At the time, there were only two hep types identified - A [infectious], and B [serum]. A little later, a third type called non-A, non-B was identified but it was some years before hep C was described and classified. In any case, the symptoms subsided and I was declared cured.
Clock forward 30+ years, and a positive diagnosis of HCV with an initial VL of 27.5 million IU/ml. Antibody and surface antigen tests for hep A and B were negative, meaning I had never had hep A. The diagnosis was the result of a terrific [and rare] Dr who saw elevated ALTs and was determined to prove why they were high. My ALTs had been elevated for 20+ years, but ignored by every Dr who had seen them over that time!!
No question that I was symptomatic, particularly over the last 10 years - reduced energy, v low tolerance for alcohol, etc. My wife was not infected.
Clock forward 30+ years, and a positive diagnosis of HCV with an initial VL of 27.5 million IU/ml. Antibody and surface antigen tests for hep A and B were negative, meaning I had never had hep A. The diagnosis was the result of a terrific [and rare] Dr who saw elevated ALTs and was determined to prove why they were high. My ALTs had been elevated for 20+ years, but ignored by every Dr who had seen them over that time!!
No question that I was symptomatic, particularly over the last 10 years - reduced energy, v low tolerance for alcohol, etc. My wife was not infected.
lol yeah you guys will have your hands full when I start tx. Please be kind and gentle, I'm sensitive.lol
I was going to ask for volunteers to man the forum on the graveyard shift, just to make sure there was always someone on forum in the middle of the night to hold my hand.lol
a new symptom today,,,feels like the virus is walking around in my head lol,,,but really does. Oh so tired of feeling like my body is not my own anymore, like some alien has invaded.
Everyday some new weird feeling in our bodies,,,,can really get on your last nerve...
see ya later......... again ..............CONGRATS!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
------------------------------------------------------------------
Paris, where are you??? are you okay?
I was going to ask for volunteers to man the forum on the graveyard shift, just to make sure there was always someone on forum in the middle of the night to hold my hand.lol
a new symptom today,,,feels like the virus is walking around in my head lol,,,but really does. Oh so tired of feeling like my body is not my own anymore, like some alien has invaded.
Everyday some new weird feeling in our bodies,,,,can really get on your last nerve...
see ya later......... again ..............CONGRATS!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
------------------------------------------------------------------
Paris, where are you??? are you okay?
Wow, that is some story. Well, discounts my theory.
Can't get over your story....How are you now? That was a long time to have elevated enzymes. Are you doing okay? Have you tx?
Can't get over your story....How are you now? That was a long time to have elevated enzymes. Are you doing okay? Have you tx?
Its a saga, that's for sure:-)
BX showed S3 fibrosis, so I was getting close to cirrosis. The little buggers had been munching away at my liver and doing some serious damage.
Timing is a wonderful thing. I'm at week 9 of the VX950 clinical trial. ALT and AST returned to low normal within 4 weeks of starting tx. HGB is down to 10.4 and both WBC and PLT are marginal at around 1/2 of my basline levels. SX are almost tolerable, but I'm in awe of anyone who stands up for a second or third round of soc!! Still, the enzymes are suggesting that something good is happening. We will know for sure at week 20.
BX showed S3 fibrosis, so I was getting close to cirrosis. The little buggers had been munching away at my liver and doing some serious damage.
Timing is a wonderful thing. I'm at week 9 of the VX950 clinical trial. ALT and AST returned to low normal within 4 weeks of starting tx. HGB is down to 10.4 and both WBC and PLT are marginal at around 1/2 of my basline levels. SX are almost tolerable, but I'm in awe of anyone who stands up for a second or third round of soc!! Still, the enzymes are suggesting that something good is happening. We will know for sure at week 20.
Well, good to hear you are tx and doing well.
Please keep us all informed as you continue. Good talking to you. And.....I will be starting tx hopefully real soon, next month some time...please jump in any of my posts to offer advice....don't be shy lol I need all the help i can get.
wishing you the best!!!!
Please keep us all informed as you continue. Good talking to you. And.....I will be starting tx hopefully real soon, next month some time...please jump in any of my posts to offer advice....don't be shy lol I need all the help i can get.
wishing you the best!!!!
There are other VX'ers who post here. I though that thy 'unblind' you at week 12 and give you some viral load info. No?
The VX950 trial protocol comprises four arms. Of these, arm D is dosed for 12 weeks with the combined SOC + VX-950. It is my understanding that the Arm D subjects will be unblinded at week 10, and that Arm A, B, & C subects will be unblinded at week 20.
Welcome to the forum. You aren't alone - there are plenty of us in here who had no idea we had this disease for 25 years or more. Personally I'm a stage 3 too - never had any symptoms that I am aware of.
I consider it lucky that we finally found out we had it so we could smash it into oblivion with meds. :)
I'm on week 53 of 72 so I'll be around here still for quite a while. The guys in here are the best and are always willing to hand hold.
It's great so see another VXer in here so we can see how it goes! It's exciting stuff!
(I am on regular old Peg/Riba just so I dont make it sound like I am another VXer by mistake).
Great luck to you!
I consider it lucky that we finally found out we had it so we could smash it into oblivion with meds. :)
I'm on week 53 of 72 so I'll be around here still for quite a while. The guys in here are the best and are always willing to hand hold.
It's great so see another VXer in here so we can see how it goes! It's exciting stuff!
(I am on regular old Peg/Riba just so I dont make it sound like I am another VXer by mistake).
Great luck to you!
"Why doesn't it stay dormant for 35 years in their system? And if it does stay dormant 35 years, maybe our spouses have it and it is undectable until 35 years after being exposed. If you know your spouse only 10 years and he is negative..maybe in 25 years it will be positive? God forbid."
the way it works so far, is that those that just found out at age 20, that they are positive, just lucked out that the drs are now testing for hep c. it has nothing to do with 'dormancy' since there is no such thing with hep c. The infection is chronic, your body is reacting to it, whether you notice it or not, whether your enzymes are normal or not. Those that say they had it for 35 yrs and now know about it, it is just that they recently were tested. If they would have had a hep c test 35 yrs ago, it would have been positive. It is about testing, not dormancy.
the way it works so far, is that those that just found out at age 20, that they are positive, just lucked out that the drs are now testing for hep c. it has nothing to do with 'dormancy' since there is no such thing with hep c. The infection is chronic, your body is reacting to it, whether you notice it or not, whether your enzymes are normal or not. Those that say they had it for 35 yrs and now know about it, it is just that they recently were tested. If they would have had a hep c test 35 yrs ago, it would have been positive. It is about testing, not dormancy.
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