Your PCR test looks good.
My only question would be why was the end of treatment PCR run before you actually finished treatment? If you have the PCR results already (so the test must have been run at least a week ago) and you still have 2 more weeks until you finish treatment, this PCR is not an end of treatment PCR. It is more like a 44 or 45 week PCR. Your doctor may not think this matters, but it could matter. If you are Undetectable in 6 months, then great, you attained SVR. However, if you come back Detectable (and with a viral count in 6 months), you will not know for sure if you would be classified as a relapser or as having had a viral breakthrough. If you come back DET and you need future treatment, it is important to know whether you were a relapser or if you had a viral breakthrough.
Hopefully, you will stay UND. However, a PCR done 3-4 weeks before end of treatment is not an end of treatment PCR. You really need to have a PCR done the day after you take your last pills. That would be your end of treatment PCR. Your doctor should know this but perhaps he does not. If it was mme, I would ask him for an order for an end of treatment PCR and have it done the day after taking the last pills.
Great that the test for autoimmune hep. came back negative.
So today I saw my GI for the last time until 6 months from now. I got the results of my EOT labwork today, even though I've got 2 weeks left of treatment. The results included my NGI HCV Quantasure PCR test, they are here;
http://www.medhelp.org/user_photos/show/387244?personal_page_id=2818410
5 copies or less so that's good right? I also got my cbc results my enzymes are still crazy, alt is 123, ast is 105, but I'm not going to freak out about it. I'm hoping to get another cbc test in two months, hopefully they'll start trending downward by then, who knows. I've been tested for Autoimmune Hepatitis and that came back negative so that's great.
As I mentioned before the NGI Quantative HCV PCRs only report
within range. A less than 40IU or 100 copies does not say anything
about what is going on below 40.
I was <43 @ wk6 your Dr. would have called it UND but I ran
the more sensitive TMA Qual at wk 8 and guess what it came back detected.
The only way to find out about your enzymes at this point is to wait
to see what happens when you stop the meds.
So this morning I went in to my gastro's office and again according to the results of the NGI HCV SuperQuant PCR test I am less than 40 IU/ml, no mention of detected or undetected on the report, but he calls it undetected. I also got other lab work that showed my liver enzymes as still high at Alt 133 and Ast 100. This was my week 40 visit with him. My gastro seems to feel confident that I have made good progress and will achieve SVR. He was also open to me getting the NGI HCV QuantaSure PCR next time. I asked him the best way to find out what the actual status of my liver is and he suggested I see a hepatologist that he recommended to find out whether I look into invasive testing like a biopsy or imaging. So I'm happy at this point, just wish my damn liver enzymes would come down. I know they flucuate during treatment for some people, lucky me.
This is how the NGI HCV QuantaSure reports UND result:
(the test can take up to 2 weeks to come back)
http://www.medhelp.org/user_photos/show/248299?personal_page_id=617047
This is how the Quest TMA Qual. reports UND result:
(I gotten this one back as early as 3-4days)
http://www.medhelp.org/user_photos/show/244704?personal_page_id=617047
Cheers
b
Okie dokie. Both Nulls & Prior partials treat 48 weeks according to Incivek Triple Therapy. I was a prior partial responder & did the whole 48 weeks.
Even though both my doctor and his NP explained the PCR test they were using (COBAS Taqman) would show if I was detected (and I actually really did trust them); my worry and anxiety did not subside until I had the NGI Quantasure.
Let us know how this works out :) :)
My GI told me that I would treat for 48 weeks because I was a twice prior null responder and I am a genotype 1a. I meet with him tomorrow and have a few questions. I definately want to get the NGI HCV QuantaSure lab test. I am not sure what the criteria is for the 24 week treatment. I thought it was treatment naive and/or genotype 2 or 3.
I think in many ways we are all saying the same thing: despite the detection limit of your HCV assay it would indicate detected if you were.
As I said in my earlier post. At week 40 I had the so be sure to ask for this test when you have your labs. It is LabCorp's NGI HCV QuantaSure, Lab test 140639 CPT Code 87522
http://www.medhelp.org/user_photos/show/302004?personal_page_id=414409
_________________________
One other thing, like others I was wondering why you are treating 48 weeks if you were UND at weeks 4 and 12 (eRVR). Is this your first time treating? I don't want to mislead you since eRVR, ethnicity, stage of fibrosis and prior treatment response are all determinants of treatment duration with triple therapy
I saw in your profile:
" I have not had a liver biopsy in 8 years, but the three I have had showed minimal fibrosis. Prior to treatment I was getting labwork done and the standard imaging of my liver every 6 months. "
The good news is that NGI HCV Quants.when under detection limit are always reported as " less than.....unable to calculate result ......." they don`t report detected or not so on your 40< IU you could have been truly UND.
I used to run the NGI HCV QuantaSure <2 IU and it always reported
the same way " less than .......unable to calculate"
The only unanswered question is could you have done only 24wks with
a more sensitive PCR being truly UND @ wk4 ?
I tx`d the old fashioned way with Peg/Rib and am not
100% on the requirements on triple but I am certain
there are many here that can tell you how that works.
Since you are running LabCorp I would make the NGI HCV QuantaSure
the next test because it is the most sensitive we have available and
it is also very reliable in terms of false positives ect....
If it comes back UND which I assume it will , it will again be reported
as " less than 5 copies or 2 IU/ml ....unable to calculate ...ect..)
but that result means UND as good as it gets...lol.
For psycological reasons if you want to read the words NOT DETECTED
I would switch labs and go to Quest and run their HCV TMA Qualitative.
The TMA has been used internationally in many studies so there is
good data on it and it is also very sensitive. Being UND by TMA @ EOT
has shown slightly better SVR rates (less relapse) than standard PCR for
example.
My SVR wishes go out to you
b
Thanks everyone, I came into this whole thing trying to be as informed as possible. I feel like it's the difference between getting an A on your research paper and getting a C. You guys all got the A and I got the C and now I feel kind of stupid. After 25 years of having hep C, the optimism I've felt over the last 40 weeks of treatment seems baseless or at least potentially baseless.
I read one of your other posts where you had all the wording on the lab test (and asked if it means you are UND)
Unable to calculate result since non-numeric result obtained for component test
I had similar phrasing on my labs but with a different assay and the way it was explained to me is if you were detected (under 40) it would say detected but not be able to provide the exact number due to the sensitivity of that particular test.
The example in Pooh's post is a good one. See how it says,
"DETECTED, but less than 43 IU/mL."
Said another way If you are Und with that test you will probably be UND with another assay but the only way to know and understand any of this for certain is to ask about this at your next appointment.
Since you are in the home stretch and (I am assuming) this is your insurance paying for all this anyway, ask for a Heptimax or NGI Quantasure.
I can completely relate to your feelings of frustration right now. I has similar concerns when I was at forty. I managed to have a PCR with a lower limit of detection. It took longer than a week but the result was still UND.
It was this one:
http://www.medhelp.org/user_photos/show/302004?personal_page_id=414409
Do you have any clinical centers that specialize ONLY in Hep C treatment/study in your area...or surrounding area? If so I would make contact with them. I'm lucky to have one of the larger Hep C centers (Alamo Medical Research Dr. Lawitz) 20 minutes from my house...but I believe there are quite a few throughout the US.
I just posted in the other thread, a response to your question, but I will post it here.
I had an excellent drop at week 4 but was still Detectable <43. I was Undetectable at weeks 8, 12, 16, 20, 24, 28, 32, 36, and 48. My week 48 test was able to detect down to 5 but it was Undetectable. Then I was Undetectable at 12 weeks post end of treatment. I am due for my 24 weeks post end of treatment VL and should have it in a few days. But, since I was UND at 12 weeks post end of treatment, I have a 99.7% chance for SVR.
Treatment Drugs: Interferon, Ribavirin, Incivek
Starting VL was 14,400,000 (Result in Log IU/mL= 7.16)
My tests read as follows (this is the exact format and wording). You can see that each test clearly states if I was Detected or Undetected. The 4 week test clearly states that I was Detected but less than 43:
Week 4 VL:
HCV RNA Detect/Quant
DETECTED
Reference Range: Undetected
Unit: IU/mL
(Note)
HCV RNA DETECTED, but less than 43 IU/mL (1.63 log IU/mL)
This assay cannot accurately quantify HCV RNA blow this level
Result in log IU/mL = <1.63
Quantification range of this assay is 43 IU/mL to 69,000,000 IU/mL (1.63 to 7.84 log IU/mL)
Week 8 VL:
HCV RNA Detect/Quant
UNDETECTED
Reference Range: Undetected
Unit: IU/mL
(Note)
Result in log IU/mL is UNDETECTED
Quantification range of this assay is 43 IU/mL to 69,000,000 IU/mL (1.63 to 7.84 log IU/mL)
Both of these tests were performed by the COBAS AmpliPrep/COBAS Taqman HCV Test (Roche Molecular Systems, Inc.)
Hope this helps. If your test does not have Detected or Undetected clearly written on it, you could call the lab directly and ask them (the lab supervisor) to explain the test to you . Ask the lab sup if your test means you are Detected but below 40 or if it means you are Undetected.
Best of luck.
Keep in mind that unless we really press for answers a lot of times a Doctor just figures we won't understand and just rushes thru things.
I don't believe it's to try and milk more money... Though I am curious what his reason was for you treating for 48 weeks sense your not cirrhotic and he was saying you were und at week 4..... Might be a lack of knowledge or some confusion on what he or the results from the lab really are.