Test results

[brianmo]

After nurse told about my blood results I called her back and had her fax me a copy. This is what it says..
WBC 2.3
RBC 3.8
Hemoglobin  11.8
Neutrophils  .99
Hematocrit. 34 percent
Hep c quant results. Less than 12 iu/ml
HCv RNA not calculated
very low positive. The quantity of virus is below limit of detection.

Am I undetectable ?    She was unable to give me information and I don.t want to wait until Monday





Am I considered undetectable? ???

[lynda607]

Labcorp has now revised the RT-PCR to 25 IU/mL which is in line with Vertex and Merck specifications.  Actually, the LOD is a bit lower than what they used in the trials.  If someone is looking for the lowest LOD then QuantaSure would be it.  Either way, as long as LOD is below 100 with Vic and 1000 with Inci they continue with treatment.  How many had detectable levels below the LOD in the trials?  We don't know but the response guided rules applied in the trials as long the PCR said HCV RNA not detected down to the lowest sensitivity of the assay which was 10 IU/mL. That was considered UND.  I'm comfortable with the 7.1 IU/mL.   2 IU/mL and 7.1 IU/mL to me just doesn't make that much difference when your taking the PI daily and pretty much assured it's killing the virus.  With Inci at 12 weeks your done with the PI so you have time to wait on the QuantaSure  -  same thing with Vic at 24 weeks.

[hrsepwrguy]

I would like to add that the detectable limit on my labcorp was still 7.1 - 43 IU/ml and in my mind left to much room for guess work.

[hrsepwrguy]

"a person must do what they feel comfortable with"

I totally agree, in my case the LOD of 7.1 turned into to a topic of debate with trial investigators as vertex calls for 10-15 IU/ml and I showed detectable at 4 and 6 weeks. I made the choice to treat for 48 wks due to the results of my biopsy "heavy bridging fibrosis, no obvious cirrosis" Batts grade 3 act 2 and the fact that if I fail I will have resistance issue's for at least 3 yrs which I believe if I had to go 3 more years I would have cirrosis by the time I could even think of retreating.

[lynda607]

Actually scoleman, the LabCorp RT PCR has an LOQ of 25 IU/mL and an LOD of 7.1 IU/mL and it takes 3 days for results.  Quantasure results take 3 weeks to return so if the results were above the futility stopping rule at 4 weeks the patient would be exposed to an additional 3 weeks of triple unnecessarily.  If they have a two week PCR done and it shows the response is such that UND is almost certain at 4 weeks and feel more comfortable with a PCR that has an LOD down to 2 IU/mL like Quantasure than it would be reasonable to have the Quantasure done.

Just my opinion, a person must do what they feel comfortable with.

[hrsepwrguy]

It says 10-15 IU/ml so IMO 12 IU/ml should have you covered as UND.

[scoleman]

Your viral load is less than 12 IU/ml which is the limit of detection for this test making the result UND.  12 IU/ml is so close to 10 IU/ml that I think you would qualify for shortened treatment if your results continue to be this good.  

Of course, the best thing would be to have one of the PCR tests that can measure 10 IU/ml or less such as Heptimax or NGI Quantasure.

Sherry

[hrsepwrguy]

Laboratory Tests
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA
levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU/mL and a limit of
HCV-RNA detection of approximately 10-15 IU/mL. For the purpose of assessing response-guided therapy eligibility, an

[desrt]

I'm not sure about "For triple therapy, under 10 IU/ml is considered UND." but 'undetected' and 'detected - below level of quantification' are two very different things. Sorry.

[brianmo]

Thanks, I panicked after I read it. When she said UNDET I thought just that!

[scoleman]

For triple therapy, under 10 IU/ml is considered UND.  From what I read in your post, I would assume you're UND.

Congrats, Sherry