PCR details prove 3

[Andiamo1]

I had a visit today with the Capo Grande to discuss my PCR results and options.  Four PCRs were done on the first day 1 hour apart.  Just to give you an idea of the power of this new drug: my initial viral load was 8,290,000 IU/ml; after 4 hours it was 3,030,000 IU/ml !!!

The advice about RVR with a PI is that it means the same thing and is just as good an indicator of SVR for people without special circumstances.  In my case, he felt that my age was a major negative indicator for SVR and that I need to stay on ifn/ribe for the additional 48 weeks.  He also said that if I was about to enter SOC he would have recommend 72 weeks because of my age weakened immune system.

All in all, he felt age was more of a negative predictor than my prior treatment failures, but felt that I had a very high probability of SVR if I toughed it out for the full 48 weeks, especially with my RVR.

Since I am never going to treat again, regardless of the outcome of this treatment, I have decided that it is a no brainer for me to choose to continue for the full treatment.

This from one of the top Hepatologists in the country and a great guy as well!

[Andiamo1]

Thank you both for your support

[Tallahassee]

Indeed great news! It should give you enough energy and motivation to continue ... All the way to SVR!!

[pln]

The rest of your tx should be alot easier knowing you long you have been UND!! Good luck.

[Andiamo1]

In what capacity do you meet with them?

[viaduk]

That is great news!  It gives me great hope to read that this has worked so well for you.  Congratulations, and thanks for sharing.

I agree with you that Vertex should do something for those who went through the treatment with no riba.  Now that the data seems pretty conclusive, I think that giving these folks the option to roll over into a triple therapy arm is the honorable thing to do.

[Susie2007]

We've been meeting with Vertex for the last few years and will meet again at AASLD. I'll let you all know if we find out anything we don't already know.

[Andiamo1]

I've done plenty of complaining about the way Vertex runs the trial, but now it seems all worth it.  I only hope they come up with something for the people that ended up in the no riba arm.  I think the right thing for them to do is roll them over into a triple therapy.

I never expected results this strong and now for the first time in 20 years, I am hopeful that I will get rid of the beast - finally!

I do believe that we can influence Vertex with our posts on this forum, so chime in if you think Vertex should do something for Amanda and Susan and all the others that I don't know.  I tthink dointime might also be in that group.

[mremeet]

Yes in Prove 1 they took multiple blood samples within 1/2 hour(?) and then every 1.5 hours (or something like that)  right after you down the first handful of VX/placebo/riba pills and take your first IFN shot. When you came in for your 12 week visit the same process was repeated. And if they couldn't get the heplock in, they'd stick you over and over again until you looked like a junkie for several days thereafter. ;-)

[Willy50]

"it was at increasing intervals throughout the day."

I'm glad to hear that.  They must have a good database of responses and therfore must have some decent data to support theory.  We may see some of this at AASLD.
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"Interesting how your guy thinks age makes such a difference"

What encourages me is that the age and past failures seem to have made very little difference.  Eric had a great antiviral response.  This bodes well for all of us; treatment failures or the over 50 set.  Presumably younger and (treatment) naive types might even do better.  ; )

Willy

[dointime]

Willy - for Prove2 blood tests were done at intervals on the first day of dosing, but I seem to remember it was not every hour, it was at increasing intervals throughout the day.  

Andiamo - I'm still rooting for you whatever the he!! RVR means.  Interesting how your guy thinks age makes such a difference - not what I wanted to hear but better to know anyway, thanks for posting.
dt.

[Willy50]

With all the interest in the "RVR" thread it is also quite interesting to see that the folks at Vertex are dropping money for PCR's at one per hour.  What would the reason be for that?  One guess is that they might like to be able to chart response rates and be able to seperate the UBER-responders from the Rapid Responders (RVR).  They may be able to prove or disprove the theorum that faster responses mean a better shot at an SVR.

If indeed the rate of viral reduction is a good predictor of response to treatment or for treatment success then charting out the early responders or super responders could provide a means of triaging out people into different treatment arm lengths.  If they can develop a means of predicting success they may make the treatment more attractive (even less than 24 weeks) than it already may be.  They mentioned in one of the teleconferences (and a few articles have backed this up) that in theory SOME people who treat with triple therapy may be able to do shorter treatments than the standard "12&12".  

The viral load reduction is so fast that they may need to look at smaller increments of time to isolate who these super responders are.  This could provide the data that the RVR thread seems to be yearning for.  I don't remember if they did these hourly tests for the Prove 1's and Prove 2's; anyone remember?

We won't expect them to talk about Prove 3 too much at the conference but if they did the hourly PCR's during Prove 1 and 2 we may see some collected data on those responses at the AASLD.

Anyway......amazing and encouraging.

Best,
Willy

[Andiamo1]

Thanks all.  I am heartened by this and if I could 7 other 48 week stints, I can do one more.  It is more difficult now that I am in my 60s, but now that I have a goal, I am going to go for it!

Deb: I am so sorry you are suffering like this.  I sure hope you feel better soon.  In any case you don't have much more to go and you will feel much better when the drugs stop.

Eric

[glucklich]

Go Andiamo!

[debnevada]

i think that's just marvelous. I really do and the drop in the four hour test was phenomenal.  Can you believe it?

I think the fact that he thinks a PI RVR is no different than a SOC RVR is also good news...I'm not sure why, I just do.

That being said, I'm not sure I can make it further than 36, Eric. This **** is just killing me. Not to hijack your thread, but last night i was sure i had to quit, between the pneumonia, the antibiotic effects (diarrhea and yeast), the resurgence of that "boil" post injection and some kidney pain.

I also found his statement about "age weakened immune system" an interesting one. I have been told and have long thought that my immune system was probably spot on and strong as heck prior to my surgery and infection with Hep C last year and I think it is still fighting even with the IFN.  Most of my problems are more about the "war" going on in my body than typical side effects. I had a drop in blood counts but am now back to normal. So I think I was very strong immune wise prior to this and that's the war that's happening that is bringing me to my knees now.  Does that make any sense. I very nearly cleared this on my own. Lowest pre tx VL was 192.

but the long and short of it, eric is that you sound very heartened by this.  For that I'm glad. And I'm glad that he was a good guy.

Cheers, buddy I love it
deb