Week 12 - Not UND

[RobertBeWell]

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

[RobertBeWell]

Guess I should point out that I started with a VL of 3 million, so this is what, about a 10 log drop?

This is gonna be a tough call. I hate to waste the 12 weeks... and since I'm so close, I might at least go another 4 weeks till week 16. I already have the meds.

[spectda]

Hi Robert,
I am sorry that you didn't get the und yet. Of course we want to be und as early as possible, but I also think it's not as bad as you think. I was und at week 10, <25 at week 12, and und at week 14 and thereafter. My doc said that at <25 the margin of error is in question. Who knows the truth, but it would make me think about stopping yet if I was you.

Many of the studies and projections for svr were done with pcr tests that are not as sensitive as the one you are being monitored with. Many of the people on this forum who are svr who might have thought they were und at week 12 probably were at least <25
You are so close to und that I would personally keep going for at least another 2-4 weeks. Also the fact that your liver damage isn't bad increases your odds.

I know you are well aware of all this and I am no expert. I am sorry that you didn't get the response we all hope for each other. whatever you decide you have options and you will svr before long.

We all want to see you succeed as I am sure you are aware.

Take Care,
Dave

[RobertBeWell]

Yah, I'm kind of sitting here thinking the same thing Dave. Who knows, if I tested one day later, I may have been UND. Still, I did not achieve RVR at week 4, that's certain.

But perhaps you are right. I am very, very close. I guess it would be one thing if my sides were terrible, but they are very mild.

Ahh decisions, decisions. I hate to waste 12 weeks of treatment, but then at least now I know if I keep rolling, I'm going to have to go the full 48.

It's a tough call. Thanks for the input bro!

RBW

[copyman]

Tough call man. What lousy news for the holiday. Just plain stinks.

Can you get your own private PCR done right away? ask your primary doc for a lab slip? perhaps get the Quest test that measures down to <5 or Labcorps that measures down to <2.

Since you know you weren't UND at 4 and now at 12 you may want to consider stopping and wait for the new PI's. Especially if you have minimal fibrosis?

How often are they going to test? If not UND by 16 it is a no brainer you have to stop. Don't let them tell you that 24 week UND is the standard. That is old school and would mean you would have to treat 72 weeks!

hang in there and good luck

[RobertBeWell]

Something just occurred to me as I was reading some studies. All the IFN/Riba studies that I can find have defined UND as < 50 IU/ml. So, technically, by those standards, I am in fact UND. Plus, my earlier results are blinded. I have no way of knowing how long I've had this low a virus level. I may have been < 25 for weeks now.

Pretty much decided that I'd be stupid to stop at this point. I mean, who knows... my actual level might be a paltry 3 IU/ml.

At any rate, with my cEVR (UND at week 12, where UND < 50 IU/ml) is about a 65-70% predictor for SVR.

That's damn good odds - pretty close to what the PI's are going to offer.

Thanks Dave!

[pcds]

you are in the exact place I was.  Still detec at the first day of the 13th week. VL 348.  I had prepared myself with discussions with my doc.  He said any virus detec after 12 weeks I should stop,  odds are not in my favor, with possible relapse after 48 wks.  So I was sure I was going to stop if detec.  and I did.  More recently I went to Mayo just to chat with "an expert"  in prep for the new meds nex year.  Like a job interview, I decided I wanted to check out docs familiar with the new PI, the trials in AZ were done at Mayo.  This mayo doc, actually was a liver transplant guy, not the trial guy, but certainly a top notch doctor.   He told me he would have had me continue the medication.

I liked my doc who I was in tx with.  I'm OK with having stopped.  In fact I wish I stopped earlier.  With the old SOC, if not a RVR you might as well wait for the new stuff with a better chance of SVR.  I am enjoying life now.  I too feel like I wasted 13 weeks with no good payback.  But 13 weeks wasted is easier then 48 weeks with poor odds at SVR.

To All:  I am not advising anyone to do anything.  Just giving my thoughts how I feel about what happened to me.

[RobertBeWell]

Heh, the only trouble with a trial is - I won't actually know what my counts are from weeks 2-10.

I've made up my mind I'm going to 16 weeks at least. With almost zero sides, I'd be stupid to stop when I'm this close. I'll reevaluate at that point.

I knew going in there were no guarantees. Fortunately, I have time to wait if needed. But I'm still very hopeful I'll make it this time around.

Thanks!

[pcds]

If you have low or no sides, go for it.  My 2 cents.

[Trinity4]

Until today I might have tossed around the fact that I wasted 72 weeks.  However, consult with my doc today shows pathology from 12/2 biopsy at stage 2/3.  Diagnosis mild to moderate fibrosis.  Inflammation grade 1.   11/7 biopsy stage 3/4 -  Inflammation grade 3.  Enzymes and blood values all within normal range.  No supplements, no LDN IV's, no herbs, no hemopurifiers, no low voltage electricity, I eat red meat and I like sugar.
Even without an SVR, I like to think I bought myself some time while waiting for the PI's.  So whose to say what's good and bad in the big scheme of things.

Trinity  

[Bali05]

When I contemplated all the issues before starting tx it became clear
that the one of the toughest decisions would be knowing when to stop.

I decided upfront that I would want to be UND by a very sensitive test
by wk12 , if not stop.

Before making a final decision I would want to rerun immediately one of the tests
that copyman mentioned (btw they can take longer for result up to 2 wks)
and I would want to know my viral load at week 4 and if they did one
wk8.
Propably even add the IL28 test to get as much info you can to make
this tough call.

You are stage 1 from what I see and geno 1a. Many hepatologists would
propably tell you to wait for Tela. even without these trial results.

I am currently going into wk33 and I would not want to do this if the odds were
not in my favor and I had a better options in the near future.

[Trinity4]

11/07 biopsy stage 3/4

[willbb]

Bali o5

"You are stage 1 from what I see and geno 1a. Many hepatologists would
propably tell you to wait for Tela. even without these trial results."

That would make sense,however their is now an 80% chance that in this study he is taking Tela (or Tela like PI).

That has to enter the equation,does it not and also is their a resistance issue here?

WILL

[Bali05]

I was assuming he got SOC only arm.
Is there anyway to find ?

[willbb]

none unfortunately

[RobertBeWell]

Unfortunately, there is no way to know what you are getting until the study is complete. That's one of the drawbacks of a trial. The manufacturer sets the rules.

On the bright side, all my blood work is excellent. Also as part of week 12, they do all the obscure tests that they do on Day 1 as well, all the thyroid stuff, etc. My blood work, except for my lower HgB and WBC counts, is as robust as Day 1.

It's just my feeling that I am getting placebo. The initial results of this drug we so impressive that on'y 15% of the patients failed to achieve RVR, and only ONE patient failed to become UND at week 12. It was a small study however.

[RobertBeWell]

This drug, like all the current crop of DAA drugs, absolutely has a resistance profile. The good part is, the study we're in is an NS5A inhibitor - which will have absolutely no cross resistance with Telaprevir/Boceprevir (which works on the NS3 viral unit (or NS4, don't remember exactly).

As a matter of fact, that's the only reason I took a chance with this study - because I knew that the 2011 PI's would be an option to me should this trial not work out.

At the very least, I found out that I respond very well to SoC, which is gonna be around for quite a while longer. If I am getting SoC, a 10+ log drop at week 12 is DEFINETELY an impressive result. Not the best, but I'm certainly not a non-responder in any sense of the word.

[willbb]

That is the way that I understood the resistance issue also however glad that you confirmed it for me.

Given all you know right now, it is still my feeling that it is best to plunge ahead till at least 16  and revisit then.

All the best friend

WILL

[RobertBeWell]

And to correct a misstatement, I keep tossing around a 10 log drop, but that's not correct. My starting viral load was 2.95 million, and just for grins, if I assume that I am currently 24, then my drop was:

log(2.95 million) - log (24) = 6.47 - 1.38 = 5.09 log drop.

Heh, to get a 10 log drop, you'd have to have a starting counting up there in the jigga-watt range or whatever they used in Back to the Future

RBW

[James10500]

Hi,

When I get a PCR it says <43, when I got my heptamax test it was <5, meaning the lowest detectable level was 43, and 5.  A VL was not detected above those levels,thus undetected.  If your test result was <25 doesn't that mean not detectable greater than 25, there for UND given the parameters of the test ?

[willbb]

Was kinda wondering about that 10 log thing, didn"t think you started at 3 billion?  :)

[willing]

bummer - but knowing you're a responder is definitely a big plus. It's a hard call. I think Bali makes a very good point about making these cut point decisions before starting. Once you're invested it's emotionally harder to pull the plug.

I suspect you're right about the placebo given the very strong results for bms790052. Not having any interim data makes it impossible to know if this is an insignificant  one time spike. Pushing on based on the information available  has more of a 'I'm feeling lucky'  feel than I would opt for. Did they say anything about w12VL being a discontinuation criterion?

Best wishes!

[copyman]

I agree with James if the test read <25 then you are UND by their test. If you were not UND they would have given you a specific viral load #.

You should still do your own  "sensitive" PCR. Having this information will allow you to make informed decisions moving forward.

I did my own PCR's during the Telaprevir study I was in. It was an open label study where everyone got the real drug. But the PCR's were blinded. I decided before study started I would have my primary order all the important tests, 4,8,12,16,24 weeks. I felt I needed to know this to make decisions regarding "my health". Sure enough at 24 weeks I was randomized to the 48 week group and because of my private PCR's knew I was UND from 4 weeks on. So I made a decision to stop around 30 weeks. Just did my 1 yr PCR a few months ago and still UND.
My tests were all the Labcorp Quantasure <2. Also had the UltraQual done at the same time.

[RobertBeWell]

We had a brief thread about what UND actually was a while back. The < 25 thing just means that's the lower COUNTABLE limit from the test. The actual wording from my lab result is:

"TAQ/PCR < 25 IU/ml. Virus detected but unable to quantitate."

Means the test found some virus, but the amount was too small to be counted by this particular test.

[RobertBeWell]

I can see your point about getting my own tests, but what purpose would it serve at this point in time? If I had gotten them from Day 1, I could put this current result in perspective, but without weeks 2-10 there's not much information to be gained from it.

In other words, would it make any difference if my count was 24 vs 12 at this point in time?