Does NOt detected necessarily mean UNDetected (4 Week Labs)

[Idyllic]

HCV RT-PCR, Quant (Non-Graph)
Hepatitis C Quantitation   HCV Not Detected IU/mL   
HCV log10        
Unable to calculate result since non-numeric result obtained for component test.


The quantitative range for this assay is 25 IU/mL to 69 Million IU/mL using a combination of Taqman real-time PCR (LLOQ 43 IU/mL) plus reflex to another Taqman assay (LLOQ 25 IU/mL) for low viral load samples that were detectable by the original Taqman real-time PCR assay but not quantifiable. The limit of detection of the assay is 7.1 IU/mL for HCV Genotype 1.

Question: Does this mean my VL is lower than 25 IU/mL or 7.1 IU/mL & I am technically not UND yet, right?

[nygirl7]

"for low viral load samples that were detectable by the original Taqman real-time PCR assay but not quantifiable." As stated above, the sample was detectable, but not quantifiable.  That is my understanding. "

I am not sure what tweedle means by undetectible when the verbiage clearly does not say you are not detectible, except over the sensitivity of 25. However; with even one virus present it opens the door to possible reinfection and you must eradicate them all - not just the ones in your bloodwork but others that might be present outside it.

The good news is that you can continue on with the protocol and have an excellent shot at the CURE.  In the end that is the goal you must remember is the most important.

[pooh55811]

Okay, just to compare that detectable test to my undetectable tests, I will include this one which clearly states I am undetectable:

Test: Hepatitis C 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)

Test was performed by the COBAS AmpliPrep/COBAS TaqMan HCV Test (Roche Molecular Systems Inc.).

You can see it is pretty clear that the result of my 4 week test (in the last post) was Detected and the results in the following tests have all been Undetected.

[pooh55811]

You mentioned you wanted to see the results of other people's 4 week tests. I looked at my hard copy of my 4 week VL test and here are the results (word for word).

Test: Hepatitis C RNA Detect/Quant
Detected
Reference Range: Undetected
Unit: IU/ml
HCV RNA detected but less than 43 IU/ml (1.63 log IU?ml)
This assay cannot accurately quantify HCV RNA below 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)

Test was performed by the COBAS AmpliPrep/COBAS TaqMan HCV Test (Roche Molecular Systems Inc.).

[pooh55811]

"So at this point I think it only matters that my HCV-RNA levles were LESS than 1000 IU/mL "
----------------------------------------------------------------------------------------------------
I am not going to comment on the interpretation of the test. I leave that to the experts on the forum.

I will, however, comment on your statement above.

For the purpose of continuing treatment, you are correct. Your levels were under 1000 so you can continue treatment.

However, if you are/were truly detectable at 4 weeks on Incivek and SOC, you will need to treat for 48 weeks instead of 24. To me (who has to treat for 48 weeks because of detectable virus at 4 weeks) that is a big difference. I was very happy at 4 weeks that I could continue treatment because I was so afraid I might be 1000 or above and have to stop. I am now at 21 weeks and have been undetectable since week 8. I am happy I am undetectable, but I really, really wish I had been undetectable at 4 weeks. So to me it does make a difference in the long run.

If I were you, I would get this test result clarified by your doctor or your lab or both. Hopefully your doc can interpret the test accurately.

I wish you the best.

[Idyllic]

The Incivek page elaborates a little more. It says:

Treatment futility rules in all patients:

Patients with inadequate viral response are unlikely to achieve SVR. Futility rules are therefore in place at key time points during treatment. Discontinuation of therapy is recommended in patients meeting these rules.



Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions. Discontinuation of therapy is recommended in all patients with

(1) HCV-RNA levels of greater than or equal to 1000 IU/mL at Treatment Week 4 or 12; or

(2) confirmed detectable HCV-RNA levels at Treatment Week 24 (see Table 2).

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm

So at this point I think it only matters that my HCV-RNA levles were LESS than 1000 IU/mL


There is a chart about 3/4th way down.
http://www.incivek.com/hcp/treatment-duration-treatment-history

[suezeeque]

I'm terribly confused.

I've seen similar results posted many times.  This one says "HCV Not Detected IU/mL".  Then the standard blurb that seem to follow all of these things.

I can tell you, mine said "DETECTED" and under 25.  It did not say "NOT DETECTED".