When to get PCRs?

[WriteItDown]

My husband is considering participating in a clinical trial, in which he won't have access to his viral load info until 24 weeks.  I am thinking we're going to want this info -- when would you all recommend we get it?  And will any private place that does blood tests do?  Or how to go about finding a reputable one?  Thanks for your advice; we are new at this.

[WriteItDown]

Thank you again, HCA.  You have been extremely helpful.

Sunspot, could it be Heptimax?  

[sunspot]

Do you know the name of the test you have. I'm thinking of asking my GP to test me instead of my GI. My GP uses Quest.

[HCA]

A 2 log drop for geno 1 at week four on SOC would be a fair response.
There are no rules though!

[HCA]

A 2 log drop for geno 1 at week four on SOC would be a fair response.
There are no rules though!

[HCA]

A 2 log drop for geno 1 at week four on SOC would be a fair response.
There are no rules though!

[HCA]

A 2 log drop for geno 1 at week four on SOC would be a fair response.
There are no rules though!

[WriteItDown]

Thanks, copyman -- I am with you on wanting to know for those reasons.

And HCA, thanks for the clarification. The trial has two possible dosages of the PI: 75 mg and 150 mg.  This is because there were some problems with elevated bilirubin levels at the 200 mg dose, which didn't seem to have higher response rates anyway.

What is a good drop after 4 weeks if you get SOC?

[HCA]

The first published seven day data of triple therapy with TMC 435 is as followa



Mean reductions of HCV RNA from baseline to day seven with TMC435 alone and in triple therapy were 2.63 and 3.47 log10 IU/mL, respectively, in the 25 mg arm, and 3.43 and 4.55 log10 IU/mL in the 75 mg arm. In the 75 mg four-week triple therapy arm, no viral breakthrough was observed; 9/9 patients achieved HCV RNA below lower limit of quantification (<25 IU/mL) and 8/9 patients achieved undetectable HCV RNA (<10 IU/mL) at day 28 (RVR=89 percent).

I think they may now be dosing at 200mg-this will be in the trial documents.
All being well the virus will be knocked out very quickly-once you get an undetectable reading you don't need to test again except as a luxury.I would test after one week and four weeks.
Viral clearance at four weeks on SOC is quite rare in geno 1-something like 8%.

[copyman]

exactly WriteItDown. I agree with you 100% that knowing you are undetectable can help with the mental aspect. The private test can also help to make a decision to stop . For instance if you know you were undetectable at the most important points 4,12 & 24 weeks (especially 4 weeks) and sx became unbearable later in tx then you could stop knowing you have almost as good a chance at svr as continuing to 48 weeks. The 4 week test is becoming the most important test to make decisions and that is why I would want to know! Best of luck to your husband and you.

[WriteItDown]

I think the reason would be for encouragement, and to know, if the sx were really bad, that it was worth it. Or, conversely, to know earlier that it wasn't working.

[Bill1954]

If your husband intends to follow the trial protocol and complete the scheduled treatment regardless, I don’t see any need to go out of trial for viral assays; the only reason I can see to review these is if you intend to change treatment dose, meds, or duration.

These tests can cost >USD 500.00 each; you can easily spend 1000’s of dollars unnecessarily if you’re not careful—

Bill

[copyman]

I also was in the telaprevir trial and did my own PCR's at 4,8,12,16 & 24 weeks. My PCP wrote the prescriptions for me and my insurance paid for them. 4, 12 & 24 weeks are the most important tests. Once undetectable I used just the qualititive, Labcorps  "UltraQual" most sensitive test that measures down to <2.  If paying out of pocket this test is less expensive. Use this test "AFTER" becoming undetectable.

[WriteItDown]

Thank you for the info.

HCA, can you tell me what one looks for at one week?  Is it correct that this would tell you whether you were getting the protease inhibitor -- with PI you'd expect a very quick drop in week one, like 4 logs?  But not with SOC? I know that at week 4 you're looking for UND.  If you're not UND either you're a non-responder or you're in SOC -- and perhaps you could be a slower responder and then you'd maybe have to take a longer treatment?  

Tippyclubb, thanks for the detailed info.  In this trial there is no randomization about length of treatment -- if you are in one of the arms that gets the trial drug, the treatment is 24 weeks unless you don't have the appropriate response, in which case you stop.  If you get SOC (the control arm), you continue to 48 weeks if you have the appropriate response, just as you would if under a doctor's care and not in a trial.

Thanks again for all your helpful responses.

[Tippyclubb]

Yes you will need a prescription for a PCR.  You have to be very specific about how the doctor writes the prescription.  I used the Hepitimax pcr which detects less than 5.

I did not have insurance for the 4th week pcr and had to pay $450 out of pocket.  My 12th week pcr I had insurance and had a copay of $35 so yes insurance does pay for it.  

I was in the Vertex Telaprevir trial and its important to do your 4th week pcr to see if your a rapid responder.  If your not undetectable by week 4 you have no chance of getting randomized into the 6 month group and will have to continue tx for 5 more months.    

[HCA]

If the trial drug is introduced at week one get a test after one weeks treatment,then again at four weeks.
That should be all you need.
Getting the first test at four weeks is old hat and not appropriate for the latest inhibitors.
Similarly week 12 is not relevant unless he is on placebo.
He should clear early,week 1-4,and stay that way.
Quest Labs are fine-they require a prescription.

[WriteItDown]

Thanks, Joey and Mike.

Okay, this is really naive of me, but if you have it done at a private lab do you still need a prescription?  I was assuming we'd have to do it privately and pay?  Are you saying a PCP might prescribe the test for you knowing you were on a trial, and insurance would pay?  

We read the consent form carefully and I did not see any mention of blood work outside of the trial.

I would also be happy if others who have done trials will come along to advise....

[mikesimon]

I have used Quest Diagnostics for 8 years and I think they are top notch.
I, and most informed people, like a PCR at week 4. I would like another at week 8 if I was detectable at week 4. And then week 12 is the standard time to determine the likelihood of a successful outcome at the end of 48 weeks for type 1.
Trials don't always adhere to that and if they do they don't always tell you the results. You have to be careful because some trials forbid an individual from testing. You can do it but you might want to keep it to yourself and it would be a lot easier if your PCP wrote the script for your labs.
Read the trial information carefully before doing anything. There are a lot of people who know a lot more than I do about trials and their rules.
Hopefully someone will chime in.
Mike

[thegypsy9164]

I've been on the Vertex trial with Telapravir.  I was told that I'd get all of my lab results at week 24 (or maybe I just heard it wrong).  I started asking at week 24 and at week 26 was told that the trial will not give the lab results from throughout treatment until after totally completing the trial.  I was pissed and wished I'd had my VLC done through my GP at regular intervals.  I know that I started at almost 12,000,000 (12-million) but since then all I know is that I was told at week 28 that I am surely UND as the Vertex people would have called to let the people treating me know to take me off treatment as a non-responder if I hadn't by then.

I am suggesting that you get your GP to send you to the lab to be tested for VLC at beginning and about every 2-weeks thereafter until reaching UND.  I am not a doc, this is purely the opinion of a peer doing the treatment.
Joey