Aa
Aa
A
A
A
Close
Avatar universal

Week 12 - Not UND

Well, got my VL results for week 12. Not UND, but < 25.

The nurse seems to think this is just Jim Dandy, but I'm seriously considering stopping the trial. Isn't the common knowledge nowadays if not UND at Week 12, then quit?

I suspect I'm probably in the SoC arm only, since over 85% of the people who got the real thing were RVR in Phase 1 trials. Of course, I could be in that 15%.

Oh well, sometimes we win, sometimes we lose. Guess I need to make a decision before my next shot, Wednesday.

Thanks

RBW

54 Responses
Sort by: Helpful Oldest Newest
1280753 tn?1367757932
I am so happy that you responded as well as you did. you are going to beat this thing. if it was me i would stay with it too...keep fighting.

...and if you see any BMS people, give them a kick in the nads for me....imagine, rejecting me for this trial....the nerve...bwahahaha...

you are doing great Robert...a wonderful Christmas present indeed....good luck

the dude
Helpful - 0
1431734 tn?1421011671
so sorry this is looking more complicated. i can only offer support for what ever you decide. i have not spent time in the research many of the heppers have. my 64 year old riba brain has to keep it simple. if your sx are minimal i see no reason not to stick by a bit longer. wishing u a comfortable resolution soon as the fence is uncomfortable. all the best, babs
Helpful - 0
Avatar universal
Heh, I'm a worrier by nature. I wish I could "bin them" but they just hanging around. Part of the problem is that I went into this trial with very, very high expectations. Heck, I was sure I would clear the virus by week 4 (which I had an 85% chance of doing if I were getting the real thing).

So even though by SoC standard my treatment is going really quite well, by my expectations, it is going poorly at best.

We'll see at week 16. Thanks for the encouragement brah!

Robert
Helpful - 0
1523804 tn?1316560909
Definitely right decision to continue. Very little to lose and so much to gain. Stick with your decision. Bin your doubts and and worries and that'll take care of whatever is left.

Good luck
Helpful - 0
408795 tn?1324935675
Well it sounds like you came to a decision with this unwelcome news to tx another 4wks.  Good for you and I hope it works out well.  good luck!    
Helpful - 0
Avatar universal
Oh, I did receive a lot of recommendations for a private PCR immediately. Not ignoring that advice, but I just can't afford to do that right now, especially at Christmas time. And by the time I had it done, it would be time for my Week 16 visit anyhow, when I can get one done without having to pay for it myself.

Thanks guys!
Helpful - 0
1391695 tn?1298139789
thank you, you know when you are going through this, I'm very positive about achieving SVR, but once in a while, you just freak a little, when you hear technicalities like this, and then I snap out of it. I will ask my doctor about a more sensitive test, just because.

Helpful - 0
Avatar universal
If they are using the taqman 2 as many clinical trials seem to these days and a person was und, the report from roche will merely sate  "HCV RNA not detected" without parameters.

This test was only recently approved by the fda but has been used in the clinical trials for a while. I don't have my printout before me but I believe that when I was under 25 it read: detected <25

If it is indeed the taqman 2 they either are unable to quantify or not approved to report a quantifiable number under 25 iu/ml. The lower limit of detection of the test is 10 iu/ml so <25 would mean RNA somewhere between 10-25 iu/ml. If it is above 25 iu/ml of course it will quantify it.

Robert-
There are at least a few people here who have SVRd and reported a blip at or after week 12 and you have no way of knowing if this is one or not. As you said it can't hurt to go another 4 weeks since you aren't feeling poorly. Good luck my friend!


Bree-
They used less sensitive test for you and it is reported differently. You can always ask for a more sensitive test if it would make you more comfortable.

All the odds are in your favor as everyone has mentioned. It's not over till it's over of course, and it's only natural to worry a bit, but I would be shocked if you are not und for real and if you don't svr.

Happy Holidays Everyone,
Dave

Helpful - 0
9648 tn?1290091207
Being on a trial has nothing to do with it, although being blinded for VL adds to the uncertainty. My trial wasn't blinded for VL so I had them all as I was going along and had tested UND from week 12 until I got the blip. Since that blip I've tested UND--up to and including the most recent 1 year post PCR.

Hang in there.
Helpful - 0
Avatar universal
"so some labs say undetected and some don't?
I went back to read mine and they all said the same thing, just the <43.
is there a test I can request that will actually says undetected? "

That's my understanding. You should talk to you doctor and the laboratory for the specifics. That's really the only way I would know to confirm an actual UND.

You have to remember that I'm in a drug trial, so every "i" is dotted, and every "t" has to be crossed. My tests are going to be very, very specific, and state that.

Talk to your doctor. But seriously, you have no reason to get worked up over this in my opinion.
Helpful - 0
Avatar universal
"You have no way of knowing if you have already tested UND and then got a blip. I had a blip at week 20-something (so soon we forget) and it turned out to be a big nothing, although it was rather concerning at the time."

Absolutely. Thats the peril of a trial :-)

RBW
Helpful - 0
1391695 tn?1298139789
so some labs say undetected and some don't?
I went back to read mine and they all said the same thing, just the <43.
is there a test I can request that will actually says undetected?

Thanks, and good luck to you Robert.
Helpful - 0
9648 tn?1290091207
You have no way of knowing if you have already tested UND and then got a blip. I had a blip at week 20-something (so soon we forget) and it turned out to be a big nothing, although it was rather concerning at the time.

I think you are making the right decision. Good luck!
Helpful - 0
Avatar universal
"After reading posts on Robert's thread:
Now I'm a bit confused. I'm G3, My 2 week VL test was 55, My 4 week and 12 week VL tests both say HCV RNA PCR QUANT  <43  <1.63 Isn't that UND? Is there another test I should be taking? "

Well, by most all published studies, it meets the criteria for UND (< 50). It just depends on how the lab reports it. With the exact information you state above, it doesn't technically say "undectected".  But again, it just depends on how the lab reports it.

With G3, and such an impressive 2 and 4 week result, you have nothing to worry about. The odds are very, very, VERY  strongly in your favor.

Rest easy, all is well ;-)
Helpful - 0
1477908 tn?1349567710
You've put alot of time and thought into this trial and I wish you the best going forward. You've really got nothing to lose staying in the game with minimal sx and the meds there for the taking. And if you indeed get a reassigment, so much the better.

Hang in there!

Pam
Helpful - 0
Avatar universal
Thanks guys for the kind words. That's what this site is all about, sharing the info. Perhaps the information contained in this little self-centered thread of mine will help another faced with the same decision in the future.

I'm still very hopeful at this point. My odds are at least as good as with the new PI's, though I will admit they start dropping dramatically with each passing week that I still have detectable virus.

Week 16 will be the tipping point for me.

Merry Christmas to all!

Robert
Helpful - 0
979080 tn?1323433639
From what I am told most people that are UND <43 or 50 are UND even with a more
sensitive test. I would want to make sure I am not somehow stuck <25.
Also as with any important test result it is a good idea to confirm it
with a second test.Samples do get cross contaminated at the labs sometimes.


Helpful - 0
1391695 tn?1298139789
sorry meant to start a new thread
Helpful - 0
1391695 tn?1298139789
After reading posts on Robert's thread:
Now I'm a bit confused. I'm G3, My 2 week VL test was 55, My 4 week and 12 week VL tests both say
HCV RNA PCR QUANT  <43  <1.63
Isn't that UND? Is there another test I should be taking?
Helpful - 0
Avatar universal
I admire the approach you've used to reach your decision.  Being one of those coming up behind you, you've set an excellent example and I want to say thank you for sharing your information and getting the multiple feedbacks.  I'm pretty certain that with your odds I would also continue to roll the dice.  Keeping positive thoughts for your next 4 weeks.
Helpful - 0
1391695 tn?1298139789
<For what it's worth (G3 here), I needed the UND at week 4 and came back with "

Now I'm a bit confused. I'm g3 too, My 2 week VL test was 55, My 4 week and 12 week VL tests both say
HCV RNA PCR QUANT  <43  <1.63
Isn't that UND? Is there another test I should be taking?
Helpful - 0
Avatar universal
This thread makes my heart smile...not because you had a difficult choice to deal with...but because you have (and continue to) educated yourself about Hep C and all the issues surrounding treatment outcomes and because there are so many knowledgeable people here that help in the decision making.  All of that made your decision making "easier" and it sounds like a very solid and wise decision.

We see so many people who get into Hep C treatment not knowing anything about it and then when a difficult decision arises they don't know anything about it other than what their doctor tell them (and we all know that the docs aren't always as up on Hep C as they should be).  

Kudos to you Robert for being on top of things; along with the others here who know more than the average joe.  

There's no doubt in my mind that you will get where you want to be with this!!  Go get em!!
Helpful - 0
179856 tn?1333547362
As someone who was not und until after 12 but before 24 I can sympathize - it totally *****. Of course I had to extend to get  to SVR (I was a stage 3) but if I were stage 1 I am not sure I would go for it. Of course whether you  got the real deal or not is a big part of the equation. What a crap shoot it all really is at the end of the day.

I'm sorry I know how much you want to post I'm UND...took me forever to get that post in!
Helpful - 0
Avatar universal
Thanks all for the food for thought. That's one of the invaluable things about this board, so many different perspectives. After some research late into the evening, and sleeping on it, I've come to the decision that I'm too close now to just stop. I have to continue for at least another 4 weeks.

All the published studies I've read define UND as < 50 IU/mL. I have beaten that. Who knows, my viral load at this point may be 3, but the point is, it's far, far less than 50. As Dave (spectda) pointed out, many who have achieved SVR and were measured at week 12 as UND may have, in fact, still had detectable virus had a more sensitive test been used. My response, while not exactly what I wanted, has in fact been EXCELLENT, especially in light of the fact that I have almost no sides.

So, I'm going to continue to Week 16. My reasoning is as follows:

1. By all the published studies on PEG/Riba treatment I could find, I have achieved complete early viral response (UND at w12, where UND < 50). With this response, I have a 70-80% chance of achieving SVR.

2. I may have just received a drug re-assignment (I have no way to know for sure) but I may be getting the real thing now. Waiting four weeks will allow this to take effect.

3. I have no side effects to speak of. My blood work is rock solid. Even the auto-immune stuff is all normal.

4. I already have all the meds on hand to continue until week 16,

5. My study blood work from now on includes viral load counts. So at my next visit (week 16) I'll have another VL test to base my final decision on. It won't cost me anything.

I'm thinking I have absolutely nothing to lose by going another 4 weeks. It might be a different story if I was beaten down, unable to work, tons of sides, and being pumped full of rescue drugs. But I'm not. My life, besides little odds and ends, has not changed during treatment. I still work full time, and do all the things I used to do.

Thanks again for all the ideas. It has really spurred me on to gather the data I need to make this tough call. I hope this information is useful to those in the future who face a similar dilemma.

Be Well!

Robert
Helpful - 0
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.