He invents tests, of course he feels that way. He recommends his test too as I recall, wouldn't you if you had a wall full of patents for inventing tests? I sure would.
The average patient does not need to obcess over the diff between a <5 sensitivity test and a <50 sensitivity test on treatment. PCR testing on tx is by and large to gauge your progress.Some here seem to get all up in arms over it and act as if it is a medical necessity when it isn't. Maybe it's worth the trouble after tx is done and you are verifying you have SVRed, but it isn't worth worrying about on tx. Tx is hard enough without having to bust your tail trying to obtain a test that can only detect 45 more virii and isn't readily available for all.
Traveler,
If it were my dime and I had to spend it on either a week 12 TMA or an end of treatment TMA, I'd spend it on a week 12 TMA. That's because the chances are if you are non-detectible at week week 12 by sensitive TMA you will be non-detectible by sensitive TMA by end of treatment. The advantage of finding out now -- besides the anxiety issue -- is that it will give you and your medical team meaningful and more complete information right now to make future treatment decisions.
All the best,
-- Jim
First off, I'm assuming you're in treatment now, right? Your 4 week PCR is not post treatment? If so I'd go for the most sensitive test you can get if I were you. I got a test that went down to 2 IU/ml from LabCorp, which is the same sensitivity as the Heptimax test (in fact I'm starting to wonder if they're really the same test). I got the test ordered through my primary care doctor, it was no big deal. He originally diagnosed me with HCV so he knew I had it. I told him I wanted to see if the virus was in "remission". Since he knew very little about HCV or the specific test I wanted, he simply agreed to it and signed off on it. His secretary filled out the Labcorp paperwork and I provided her with the name and number of the test (available at labcorp.com). Done deal after that. And although I suspect the higher sensitivity test is more expensive, my insurance paid for nearly all of it. Also, I noticed on my copay bill (which was like $3 or something) that my insurance co only paid like $30 for the test! (normal "retail" is several hundred) I don't know whatever mechanism the insurance co uses to negotiate lower prices with labs/doctors etc, but as you can see it won't necessarily cost your insurance company a lot of dough. And therefore it shouldn't be too much fuss over its approval without you having to pay through the nose for it (assuming you have decent insurance).
As far as whether it's worthwhile to test down to 2 IU/ml, there's no question I'd want that level of sensitivity (although I'd also settle for 10 IU/ml if push came to shove). The reason I believe it's necessary and desirable is because during our time in the Vertex trial I've seen many people score "29's" during the trial. A 29 means that the patient is detectable somewhere between 10 and 29 IU/ml. And we've seen several patients report these 29's multiple times throughout their treatment, so they can't all be flukes. Also, nygirl just scored a 65 or 69(?) 1 month post, which obviously is less than only 20 IU's above a 50 IU/ml threshold. If I were detectable at a very low level in the early phase of treatment, given a choice, I'd certainly want to know it. This knowledge could play an important role in determining how I managed the remaining portion of my treatment (vis-a-vis early termination of treatment, extending treatment or increasing standard doses of IFN and/or riba). Depending on what that knowledge told you, it could conceivably even make the difference between getting your SVR, or not.
Also, I think a <50 IU/ml would be fine for someone who had completed/stopped treatment and were not planning to restart even in the event they relapsed. Or if they were getting a 1 year or longer post treatment follow up test to simply verify their SVR was still intact. Under these circumstances a 50 IU/ml would be fine in my opinion. It wouldn't matter if you were detectable at a lower level because you're not planning on restarting anyway. Plus, as I think Kalio was alluding to, if a relapse did occur after stopping treatment, the VL will nearly always soar well above a mere 50 IU/ml. It may take more than a month or two to fully break out, but to my knowledge in the vast majority of cases it will show itself in much greater numbers than 50 IU/ml. So I think the post treatment follow up tests would be ok at 50 IU/ml, although for my earliest post treatment tests I'd still want the most sensitive test, especially if I had the intention of restarting the drugs in the event I became detectable.
Lastly, if I were you I would print out a copy of the study jim referenced and hand it over to your doctor. I would also tell him that you wish to have the most sensitive test used for your remaining tests, especially for the tests near the end of treatment. You want to know to the best of your ability if you are truly negative, the virus can at times sit there at very low levels well below 50 and yet above 2 IU/ml for a prolonged time. I'd want to have the closest look possible before stopping the meds. If your doctor can't see the wisdom in this and firmly declines your request, then there is absolutely no question (if it were me), new doctor shopping would be my first priority the very next day. But remember if you do have to do this, your PCP might be able to take care of you in the interim by ordering the test required.
Good luck
I agree with you completely on this issue. I just hope that this discussion doesn't cause Traveler any additional anxiety but that it does enable him to bring with him to his doctor some valid evidence regarding this subject. Mike
HR thinks most sensitive testing is important, the latest Berg study said it is most important, and me (a nobody) thinks it is very important.
Ina
Once again thanks to all.
You are right that it is the comfort level I am looking for. With this disease you don't even know if it is ever gone, even if you do get to SVR. I have read many times that some think it can come roaring back later if you don't keep a real healthy lifestyle (no drinking, good diet).
I will bring the articles with me and try to get the <5 test. If not at 12 weeks I will get one before tx ends if I have to pay myself. I guess the most important time to get it is before stopping the meds so I will no whether to quit or continue longer treatment.
Of course my original plan was to quit after 12 weeks if not UND. I might have to take a UND<50 as to keep on going.