Unblinded VL results - any opinions?

[lab-rat]

FOr those of you who have been following us vx trial participants, I thought I would share my unblinded vl results and ask your opinions on whether I should be concerned.  As it turns out, I'm in the placebo arm, so my results aren't nearly as interesting as most of the others.  It seems I'm not really much of a labrat after all, just a regular patient treating w/ standard meds.  I've been fortunate that I haven't experienced any dose reductions or debilitating side effects. In fact I feel pretty normal, which is great; however it appears I didn't quite meet the hallmark of a rapid responder. While I'm thrilled to be currently UND,I didn't really make it by week 4. Here are the numbers:

PreTreatment:
June '06 8,000,000+ (off-study)
07/28/06 3,070,000 TaqMan-RUO-CL
08/05/06 6,400,000 TaqMan-Exp-RUO-CL

PostTreatment:
Day 1 3,830,000 TaqMan-RUO-CL
Day 4 17500 TaqMan-RUO-CL
Day 8 16900 TaqMan-RUO-CL
Day 15 5348 TaqMan-RUO-CL
Day 22 1280 TaqMan-RUO-CL
Day 29 318 TaqMan-RUO-CL
Day 57 29 TaqMan-RUO-CL
Day 71 <30 IU/mL TaqMan-Exp-RUO-CL
Day 85(preDose) 29 TaqMan-RUO-CL
Day 85(post) <30 IU/mL TaqMan-RUO-CL
Week 16 29 TaqMan-RUO-CL
Week 20 <30 IU/mL TaqMan-RUO-CL

I need to go back and re-read all of the posts regarding the significance of the 29.  But there it is!

[jmjm530]

Another point is that the extended treatment studies (Tapias and Berg) were based on an 800 mg/day of fixed dose ribavirin. You're on weight-base dose.  That, along with your very low and bobbling detectible viral load, are another reason to temper your enthusiasm for 72 weeks unless your liver damage is signficant. NYGirl's doctor made a judgment call in her individual case and since he's one of the best it was no doubt the right decision for her.

[lab-rat]

Thanks so much for your very informative response.  I realize that my numbers were a little difficult to read since the white space(tabs) in my post were removed so I really appreciate you taking the time to look this over.  

I'm currently on 1000mg of riba (130lb.) and last week my hgb was 12.9, so it hasn't really bothered me too much.  The only side effect that I feel is "scatter-brained" but I'm pretty used to that now.  I think that as long as I remain <30, I'll continue through the 48 weeks of tx.  If it goes back to detectable, then I'm not sure if that makes me a candidate for the next vx-trial or not.  I guess I wouldn't really qualify as a non-responder in that scenario.  

As for liver damage, I'm a little confused as to my current status.  My biopsy 3 years ago showed grade 2 stage 1.  But my screening biopsy from August '06 was originally read by the pathologist as stage 3 w/ "evolving cirrhosis".  The doc disagreed and said it was more of a stage 2 w/some bridging fibrosis.  (They filed exclusionary paperwork to get me into the trial).  Thanks again for your informed opinion!

[nygirl7]

Jim said - Putting it all together, on one hand you start out as a rapid reponder but can't quite get rid of all the virus.



That is exactly what happened to me. And because I still had a couple rambunctious cooties left at week 12 I decided to do the 72 weeks.  Those tough guys worried me hanging on so very hard.

I think with you it's going to be a personal decision - and what you can do because of the trial constrictions maybe.

Jim explainned it so well above - I never could have done that :)

[jmjm530]

In looking over the numbers again, one might argue that since you were non-detectible at week 10, and only 29 between weeks 12 and 20, and then non-detectible at week 20, that you are still an EVR. Assuming of course, that you stay non-detectible <30 from here on out. That might argue to do 48 weeks of treatment being the compromise decision between stopping altogether and extending to 72 weeks. How well you're doing with side effects also should be factored in. As so often, no clear cut decisions, but since you've already done 20, maybe doing 48 makes sense.

Be well,

-- Jim

[jmjm530]

Lab: need to go back and re-read all of the posts regarding the significance of the 29.
--------------------------
Best to start with that. From what I understand, "29" means you're still detectible somwwhere between 10 IU/ml and 30 IU/ml. "<30" is the way they report if your non-detectible. If they do report "<30", you're actually non-detectible
<10 IU/ml but they just don't report the qualitativ part. We more or less deduced this from earlier posts and it it has lately been confirmed by APK's medical team. Why they make it so confusing, haven't a clue.
So briefly:
"29" = Detectible between 10 and 30 IU/ml
"<30" = Non detectible
================================================

Two week response was greater than 3 logs which according to a very recent study would suggest you have an excellent chance of SVR.

Four week reponse was greater than 4 logs which with some definitions would make you an RVR (rapid viral responder).

You were then non-detectible at week 10 which would still peg you as an EVR (early viral responder) at least.

But that's when things get more complicated.

If I read things correctly, even though you were non-detectible right after the shot, you were still detectible before the shot or in the "trough" as we say. I would then call this being detectible at week 12, although very slightly.

This seems borne out by your "29" at week 16 which also shows you're detectible.

It's not until week 20 that you become non-detectible again.
-------------------------------------------------------------

Putting it all together, on one hand you start out as a rapid reponder but can't quite get rid of all the virus. Being still detectible at week 12 and 16 makes and non detectible at week 20 puts you in that group of slower responders who are suggested to treat for 72 weeks for a better chance of SVR.

Assuming you stay non-detectible on what I assume will be your monthly tests, the question you and your doctors will have to deal with is do you stay the 48 week course based on an initial rapid viral response or do you do 72-weeks based on being detectible at week 24. In the case of "NYGirl", her doctor, one of the best, suggested the 72-week course where here stats I believe were somewhat similar.

If it were me, and I had significant liver damage (stage 3) like NY Girl, then I'd do 72 weeks like she did. However, if you don't have significant liver damage, then I think a reasonable choice would either to just do 48 weeks or stop treating altogether because of the diminishing odds. I just don't feel the risks of exposing yourself long term to these drugs is worth it for those with little or no liver damage. An opinion that many will disagree with but that is where I come out.

Your upcoming viral load tests will be very telling. If you revert back to "29" (detectible) again, then I'd probably just pull the plug unless, again you were stage 3 and even then something would probably have to be done -- dose increase maybe -- to keep things down.

Lastly, don't know how much ribavirin you're on, but if you're tolerating treatment fairly well, and you decide on the 48 week course, you might ask your doctor about increasing the ribavirin. I have heard anecdotally that this may help, although most of the U.S. studies seem to say the importance of ribavirin is more early-on in treatment.

Hope this helps some.

All the best,

-- Jim