All but out of new Telaprevir and VX22 study...

Well, I am heading towards plan B, although I don't have one yet.  I was supposed to start the study with SOC, Telaprevir and VX222.  All my screening blood work was done and I was just waiting. Then my doc called and said the genotype couldn't be derived from the test so come take it a second time.  Second test - same results.  So I went in a 3rd time and sent a sample to a 2nd independent lab and the original lab to make sure they were doing it right.  Both labs came back 'unidentifiable'.  Now I just had a VL done in June2010 - 225k.  And my geno was ID'd as 1a in Sep2009 when my VL was 800 (not 800k).  So now we're perplexed and not sure what to do.  Our next step is waiting another month and getting the geno test done again.

I have never done IV drugs or coke.  My exes are HCV-free.  Since the geno was ID'd last year I've been at zero risk of catching something else.  The only thing I've done was get HEP A and B vaccination shots (three of them).

Any ideas?  Anyone ever heard of this?

[nygirl7]

Wow this is such a bummer I don't know what to say - you still have the VL but now they can't figure out which geno when they previously had? I have never heard of this I don't think.....I had multiple geno strains and they could even tell that and my VL was only 568k (boy I think it's been that long I cant be sure of the exact number now) so it shouldn't be that hard to tell with your 225k when they could tell with the 800k.

I'm sorry I dont know anything about this except this *****.  Is there any chance they could use a different lab or something? It doesn't seem fair to me at all.

[adamben101]

Hi.  Just for clarification, my VL was eight hundred last September when they found the geno as 1a.  Not 800k.  And yes, it sux!

[RobertBeWell]

What is the technical reason they can't do it? Can they offer any information besides "can't be determined"? Which test did they use? Can they try a different one? Could there be more that one genotype present so they somehow throw the test off?

These are a million questions to ask. I wouldn't stand for "sorry, we just can't tell" without having it explained, in technical terms, WHAT went wrong, or WHY the result couldn't be read.

Of course, the lab may not be willing to provide that.

I'm thinking that all labs probably use a kit manufactured just for this purpose. So, it's not really surprising that they both got the same result. Perhaps there is more than one type of kit out there.

Until they tell you WHY, there isn't really much more that can be done as I see it.

[Diane12855]

Your viral load dropped from 225,000 to 800 in 3 months? And you're not doing tx yet? When were you exposed? Could it be that you had acute hep c and your body has dealt with it by itself? (Acute = first 6 months after being exposed)

Diane

[blondie717]

No punn intended. But if they let you do the treatment and you cleared. They could pat their self on the back and say it even cured unknow and named strains of hep. or hopefully diane is right. or Bill. maybe everybody at different places got a bad lot of test kits. What about your regular docs results? cant they just go off that. Yee gads.

[adamben101]

Hi everyone.  Thanks for the suggestions.  Just want to clear a few things up.  Sorry if I left out some info or wasn't making sense...

Infected with HCV Oct2008
Diagnosed Sep2009.  VL was 800.  Geno ID'd as 1a.
VL Feb2010 50,000
VL Jun2010 88,000
VL Sep2010 225,000

During screening for Vertex trial Sep2010 (this month), the geno was "unidentifiable" in four separate tests - 3 with lab A, and 1 test with lab B for confirmation.  The only info relayed from both labs was something to the effect of "not enough virus for identity".  I know, I know, it makes no sense.  The VL of 225k taken this month directly refutes that.  So the Doc is perplexed.  He and the study technicians have never seen this before.

We are going to retest in a month in the lab that was able to ID my geno a year ago and see what happens.  Since no study will accept someone with this status, my options are to treat with SOC or to wait for Telaprevir to be approved (whenver that will be).  My doc feels comfortable doing either since my disease is early stage and it was ID'd as 1a in the past.  Until we can find a lab to ID the geno, there really aren't any other options.  The whole thing is just a mystery.

The good news is that I feel great these days.  No symptoms of HCV.  Thanks again for the thoughts!

[RobertBeWell]

"The only info relayed from both labs was something to the effect of "not enough virus for identity".

I'm not sure why they would be perplexed... it seems pretty straightforward. You had a low viral load to start with, viral load fluctuates wildly, even day to day... there's probably some minimum amount that must be present for the test to be accurate, your VL is probably very low.

On the bright side, they say low VL is a positive for cure. ROCK ON!

[willing]

failure of the std. genotype tests because of an insufficient amount of virus is a fairly common problem. Since you are participating in a trial ask your Dr. about determining the genotype from a sequencing test - ie sequence relevant parts of the viral genome and then compare the results with known data to determine genotype. This is approach is not used in the commercial genotype tests but will provide an equivalent (actually more accurate) result. If this is not an option, just keep trying the standard test. As your numbers show, VL bounces a fair bit, eventually they should get enough to run the std test (and congrats on having such a low vl)

[adamben101]

Thanks for the suggestion.  Won;'t work for the study though.  More accurate or not, they require everyone to be tested the same way for consistency.  As for the VL, if they could ID the geno when the VL was 800 (eight hundred, NOT 800,000), why can't they get he geno when the VL is 225,000???

[spectda]

I am very sorry to hear that this could not be resolved. I imagine this is very tough to deal with after you had basically been accepted into the trial. Hopefully you will find something as good, or wait for one of the new PIs which makes a lot of sense for you.

I hope someone can straighten out the genotype issue though.

[pjhep80]

i was diagnosed about 6-7 years ago, i have had so many genotype type test i cant even count them, every single one came back undetermined... they let me on a trial back then and treated me as type one (tx failed it was for viramidine)  i tried to get on a Vertex trial recently and they denied me also because they cant determine my genotype

[willing]

of all the reasons to get excluded from a trial, this seems the silliest. HCV genotyping is basically pattern matching your dominant strain against a stretch of   sequence in the 5' non-coding region in which variability is known to cluster in  given groups (the genotypes). There's basically two reasons the tests could be failing : (1) not enough virus to make the comparison (2) a pattern that doesn't match the typical templates. Genotyping tests can vary quite a bit by manufacturer. Here's a free access comparison of three tests:
http://www.ncbi.nlm.nih.gov/pubmed/17021114
note low vl is a common cause, but also performance varies across tests. Probably worth digging up the manufacturer of the test that identified you as 1a at vl 800.
Excluding you from the trial because of the shortcomings of a particular manufacturer's assay seems good reason to get them to take a 2nd look.

[adamben101]

Thanks Willing.  I'm going to retest in a month with the lab that ID'd the geno at 800 a year ago.  Thanks for the tip!