Prove 3 VL's revealed

As those familiar with Prove 3 testing the Viral Loads are revealed at week 26. Mine are interesting and similar to others before with one anomaly that even the researchers decided was a 'fluke' - you decide:
Screen was about 1 million
Week1 was 63
Week2 was <30 IU/ml HCV RNA detected
Week3 was
Week4 was
Week8 was
Week12 was
Week16 was
Week20 was
Week24 was

The week 12 is the anomaly and of course I was allowed to continue but it's a bit unsettling in an otherwise stellar report card. Remember I am stage 4 with some cirrohosis so anyone's guess to why week 12 did what it did is possible. They told me it just happens sometime and is a problem with the testing procedures? Glad that it doesn't happen more often.

But anyway, I very grateful that it appears to be working and I'm guessing that I am in ARM B due to RVR but it's still possible that I'm in ARM A (control arm). On SOC it took me 28 weeks to clear with a relapse 3 months out. I was less than 30 IU/ml by 2nd week this go... enjoy! Thanks for your encouragment collectively and onward to 'mop up' and finish the 48 if I can muster the strength to do so.

Warmly

[sallyo]

Which drug trial are you in? Vertex?  I hope the very best for you

[FullOfHope77]

not sure why that didn't come through but here they are again:

Week2 was <30 IU/ml HCV RNA detected
Week3 was <30 IU/ml NO HCV RNA detected
Week4 was <30 IU/ml NO HCV RNA detected
Week5 was <30 IU/ml NO HCV RNA detected
Week6 was <30 IU/ml NO HCV RNA detected
Week7 was <30 IU/ml NO HCV RNA detected
Week8 was <30 IU/ml NO HCV RNA detected
Week12 was <30 IU/ML HCV RNA detected
Week16 was <30 IU/ml NO HCV RNA detected
Week20 was <30 IU/ml NO HCV RNA detected
Week24 was <30 IU/ml NO HCV RNA detected

[mremeet]

Looks like you're doing good, congrats. So apparently you tested a low detectable at week 12 is that right? In prove 1 and 2 they would report a "29" if you were under 30 IU/ml but were still detecable. There was a lot of confusion over that for both patients, doctors and nurses alike, O si supoose they wised up and changed it to "<30 IU/ML HCV RNA detected" instead. What it means is that you 're testing positive somewhere between 10 IU/ml and 29 IU/ml. It can't be quanitifed within this range, so a qualitative score is given instead.

Anyway, was your week 12 blood sampling a "PK" (multiple blood draws in one day as occurred on day 1)? In prove 1 it was and I think it was also that way for prove 2. Charlotte ('prettydamscared") tested a weak positive on one of her week 12 blood draws too (there were 4 of them that day). It was almost certainly a fluke because she was UND by week 2 or 3 and had remained that way all the way up until week 12. She also remained negative throughout the remainder of her tx (lasting 41 weeks and for 6 weeks afterward). On our 12 week PK, they would draw blood for a baseline and then we would take our shot and gulp down our pills. Then the blood was drawn three more times afterwards (at intervals approximating an hour each). Her first two draws were UND, and her third blood draw was the one that tested "29" (i.e. a weak positive just like you have above). But then her 4th draw that day was again UND just like every other test since week 2/3. So according to her tests, she was UND for months prior, she was UND again on that day, then she gulped a bunch of the pills and took an IFN shot, and was UND again about an hour later, and then was detectable about an hour after that (i.e. right when the drug's antiviral effects are being pharmacologically "refreshed"), and then was UND again an hour after that. She also remained UND throughout the remainder of her treatment (and up until she was killed about 2 months post tx).

So I think it was fairly obvious that her weak positive (just like yours) was a fluke and was a test error. I remember a lot of people referring to their own "29's" somewhere midstream in treatment. Hard to say which ones were flukes and which ones were accurate. But at least in Charlotte's case I'd say it was a fluke for the reasons described.

[Andiamo1]

Sounds like you are doing well.  Here is hoping for SVR!!!

[spcecst2]

As long as I've been doing treatment I should know this, but if the test (Week12 was <30 IU/ML HCV RNA detected) only goes to <30 then shouldn't a positive (detected) have a corresponding VL amount detected, like 30,31,32 etc... (example week one had 63)? I have never had a test they had a positive (detected) that did not have an amount, maybe I never had one that was that close?? Which would make me think it was a typo that left off the "NO",,,, I vote typo!!!!! Good luck with your treatment and SVR, and Merry Christmas!!!!!!!!!!!!

[mremeet]

The test they use in this trial will give you an actual number IF the viral load is 30 IU/ml or higher. If the virus is detected, but is below 30 IU/ml and above 10 IU/ml, it will only say "<30 IU/ML HCV RNA detected" (used to simply say "29"). If the result is below 10 IU/ml then it says "<30 IU/ml NO HCV RNA detected", which means UND.

Clear as mud, ehh?

[dmhrdh]

Congratulations!!!!!!!!
It took quite a while for the Telaprevir to leave my system....weeks in fact.  But, you are about to feel better soon :-)  The fatigue is less.  I'm much stronger physically and the itching and rash are totally gone.
Just think how great we're going to be feeling when we're SVR!

[jmjm530]

"Mud" is what they should throw at the fellows who designed, implemented and notated this particular test protocol.

[FullOfHope77]

Thanks for all your kind words of encouragement! You know what it means too and something that we all need, so again thank you very much! I think the research nurse is corrrect when she indicated that week 12 was a fluke and likely the folks behind the study did as well as otherwise it would be considered a break through and disqualify me from continuing. But, I'm going to assume the best and go forward with hopefully a better attitude. I've been so beaten down that I had to take a 6 week sabbatical that I've earned at my work instead of using it at the end to go celebrate. But glad to hear that the Telaprevir takes a while to clear out and the terrible rashes to subside. I do think I'm feeling a little bit better after 2weeks off but it is slow in coming.

Here's to everyone! May we all SVR!!!!!!!!!!!!!!!!!!!!