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233616 tn?1312787196

AASLD 09...let's talk results, lead ins, inovio, etc

ASSLD in boston coming up...I don't know about anyone else but I've got a wish list for things I'd prefer my clinic's team to focus on,

add your wish list to mine.

mine includes

A, the Inovio vaccine that wipes out 99% of the virus of those infected (would make chemo a mop up by comparison, and lessen tx times.

B. a comprehensive redress on tylenol toxicity...too many docs had it drummed into them to be thinking this drug safe, which for liver patients it is not.

C.Why is no one getting excited about the boceprevir trial results. They are the only ones who tried the "LEAD IN" approach which improved SVR to 93% in EVR which is huge. I hope some docs pick up on this.

D. Comprehensive stategies to allow stage 1 and 2 people to treat. Currently many insurances are refusing to treat early stage patients. The chances of SVR go down significantly with each stage progression, plus as the endocrine system is affected other diseases emerge. The effect of refusal to treat early means many are being condemned to far less chance of SVR, not to mention other serious health issues. Here an ounce of cure could become pounds of productive years and better health.

add your wish list to mine



merrybe



































































29 Responses
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Avatar universal
my wish is that rocker wont post so may times in one thread :-)

I guess it is time to report him again, he just don't get the hint.
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475555 tn?1469304339
Here's my wish, Merry: That someone would finally come up with a fibrosis diagnostic that is reliable!
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29837 tn?1414534648
Your comment about Boceprevir reinforces my post a short while ago, that my doctor prefers that over Teleprevir, which is said to have about an 83% clearance record. So the more I hear about the results of Boceprevir, the more I'm convinced that it will be my 5th (and hopefully) last try. I don't know how much more my body can take, but I think it can take a lot since I really work out and do all the right things....

Magnum
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Avatar universal
opps...sorry....i meant to post the above post in the social side.
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Avatar universal
EXPANDED AUTHORITY- The Administrator shall have authority under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) to administratively detain and seize any food regulated under this Act that the Administrator has reason to believe is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of the food safety law.
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Avatar universal
BTW...in my first trial back in 2006 with SOC drugs only my VL drops were not as intense,they wnet from 24 million to 318,000 by week 4,and by week 12 it was still at 475.
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Avatar universal
you asked:has anyone seen non responders have a significant viral drop from the lead-in with a protease inhibitor

i went from 20 million to 6000 copies by week 4 with the SOC,then after 2 weeks of BOC it was < 15
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Avatar universal
You can also go to vertex web site and listen to the presentation from last night.  it was very interesting.
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897070 tn?1320652629
ok thanks for that.
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717272 tn?1277590780
On clinical care options, a site that provides continuing education for doctors but can be joined by anyone, they reviewed the current PI's and other drugs being tested.  They weren't sure if the lead-in was significantly important.  

I have downloaded the actual bocprevir slide presentations from AASLD before, think it was from the hiv/hcv advocacy site.  If you're pretty good at getting around the net, you can find just about anything.  The conference in progress now will generate tons of press and you will find places to read just about everything that is presented.  If not on the AASLD liver meeting site, then in popular press and investment sites.  Janis & friends is pretty good about posting everything and so is NATAP for popular articles.
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897070 tn?1320652629
Does anyone know whether the presentations will be available to read on line, will there be one on boceprevir ?
Is the general feeling that non response to  the SOC is now thought to be genetic in nature and if so will the new PI's go some way to removing this problem. In terms of lead-ins has anyone seen non responders have a significant viral drop from the lead-in with a protease inhibitor. In my mind this is what I think I may need as a non responder.
Cheers.
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Avatar universal
If im still clear in  Jan....losing my job will mean nothing to me....i have my life back...a good trade off id say.
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717272 tn?1277590780
That's what drives me nuts about reading (and quoting) results.  The percentages jump around according to what you are looking at.  It's good to read the actual data so you can get a hopeful look at the group you yourself fall into.  The popular press stories are nice but the real picture is in the data.
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Avatar universal
Importantly, for patients who received the boceprevir P/R lead-in regimen and had rapid virologic response (RVR), defined as undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment, SVR was 94 percent


http://www.medicalnewstoday.com/articles/130622.php
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Avatar universal
The ones who cleared between week 4 and 12 after taking the Boceprevir got 75% SVR

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Avatar universal
Schering-Plough's boceprevir, which is the closest competitor to telaprevir, has demonstrated a maximum cure rate of 75%, although that required 48 weeks of total treatment.

Not really true...the ones who cleared by week 4 after taking the Boceprevir,up to 95% got SVR
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Avatar universal
Here is a brief description of the difference in TX naives between Boceprevir and Telaprevir, although perhaps over the weekend Shering may have released new and better data.

The quote if from Adam Feurenstein in the article I posted in the recent Telaprevir thread in BID versus TID dosing which attained over 80% SVR rate;

--------------------------------------------------------
"Schering-Plough's boceprevir, which is the closest competitor to telaprevir, has demonstrated a maximum cure rate of 75%, although that required 48 weeks of total treatment.

Most of the patients in the study were treated for a total of 24 weeks, including 12 weeks of telaprevir. But 18% of the patients had their treatment extended to 48 weeks (still only 12 weeks of telaprevir) as part of the response-guided therapy. These patients didn't exhibit strong anti-viral response to telaprevir and standard of care early in the treatment cycle.

Serious adverse events forcing patients to drop out of the study occurred in 5% of patients, and were mainly related to rash (3%) and anemia (2%)."
-----------------------------------

Keep in mind.... this is still discussing 2 compounds in phase 2 trials.  The percentages could change.

best,
Willy

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Avatar universal
Boceprevir Rocks....no rash either....i cleared after 2 weeks taking it....still clear 12 weeks post TX....my 6 month PCR  in first week in Jan 10.
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Avatar universal
Who knows if Shering's data is accurate. After all with the amount of money at stake I wouldn't put anything past these companies. I feel both PI's are good and very similar in acheiving SVR.
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233616 tn?1312787196
thanks, that helps allieviate some fears for sure...of course if I had good numbers and a trial a year and a half old, AND a competitor with lead-in numbers, I'd be rushing to get mine out there...if they were better that is.

I agree, and that was one of my points, that we aren't able to compare apples yet.

That they didn't get the math wrong is not entirely comforting,
I mean, well,
why would anybody in their right mind unblind their own study....
especially when the drug that gets the final NOD will undoubtedly make an extra billion or two worldwide, assuming the drugs work as advertised.

mb
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Avatar universal
(you wrote) "..the other issue of course is that Vertex skewed the numbers on their first study and never tried lead-ins, so theres no real way to be even comparing apples to apples, as the  techniques study don't match up nor can we know that this years Vertex numbers are accurate this time."
____________________________________________

The numbers that Vertex "skewed" was merely waiting to present the data (as required by the FDA) at a large liver conference. (the AASLD)  Investors claimed that Vertex "withheld" the data to inflate the stock value.  In actuality, if Vertex had prematurely released data such as in an investment stock presentation, that might have been considered "unblinding" of the study.  That's my understanding of the so called skewed numbers.

Vertex has indeed tried lead ins (predosing with SOC).  They have not released the data yet, although I believe that about 18 months has gone by and we may soon see that.

I don't always think that the companies want people to easily compare their drugs.  It seems like it took years to get a clear handle on comparisons to Peg-intron and Pegasys.  Since there was not clear proof each was entitled to claim the title of "best".  ; )
I think you can count on their data being solid, however.  The data is gathered by a 3rd party during the trials.  The data is presented to Vertex by that 3rd party (part of theFDA  blinding process) and so they don't even know everything at all times.  That at least, is my understanding.  

I believe that Boceprevir is a good compound and *could* even bet better than Telaprevir in some areas but I don't think we'll see that until they are compared on a level playing field with lead ins and use of rescue drugs.

best,
Willy
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233616 tn?1312787196
Yes, I remember when Magnum finally got some relief...wonder how he's doing.

Well I'm glad to see some docs looking at the stats...the other issue of course is that Vertex skewed the numbers on their first study and never tried lead-ins, so theres no real way to be even comparing apples to apples, as the  techniques study don't match up nor can we know that this years Vertex numbers are accurate this time
. Somehow I find it incredulous that microbiologists wouldn't know how to do the mat
h in a double blind, since it's drummed into them add nausem.... and that calls all their trials into question in my mind.

Susan,

you break my heart, so much effort for so little reward....but you are a real trooper...hang in there, some real hope is on the horizon.
Yes, that's that same kick to curb that stage 1 and 2er's are getting.

I'm also trying the natural approach now, the long chemo pushed me into  type 1 as well as type 2 IR, diebetic territory so I'm really having to regroup on all of this.
I'm still waiting to hear if Inovio will be offering their vaccines soon...hopefully the Boston retrovirus conference will get news.
It would be so good to get the virus 99% ddead and then treat wih the 3 drugs for only 6 months
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717272 tn?1277590780
I suspect that Teleprevir and Boceprevir are giving very similar results.  I think the reason that Teleprevir gets so much attention is because they do a LOT of press releases.  They are a smallish biotech company that needs investors.  Schering Plough is a huge international pharma which is about to be bought by an even bigger one, Merck.  SP does not put out press releases, their info mostly just comes out as conference presentations and papers.  Buzz does not indicate anything, but it does cause people to favor one over the other just because they read more about one.  I think patients would be well served by either PI added to SOC.  Anxious to read the info coming from the AASLD meeting next week.
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Avatar universal
I just want them to come out of there with some way to help those of us who are considered "Telaprevir failures"...., I am tired of hitting a roadblock.  All they want to do is kick us to the curb, let us get worse....       I, fortunately, have been fighting back with doing everything in my power to stay healthy since, the doctors quite frankly aren't helping me right now.  I've been exercising like crazy, even when I really don't want to.  It's paid off for me, too.  I've lost weight and my blood sugar is in the normal range and my A1C has remained perfect for the past year..., not that I was ever termed a diabetic anyway, because I wasn't.  My blood pressure is perfect.  The ONLY thing that is wrong with my body is Hepatitis C and the fact that all the treatments have left me with a chronic, no-treatment for, skin condition..., where I cannot get in direct sunlight without being totally covered up i.e. long sleeves and long pants.   I just really want to be done with Hep C.  I want to kick it to the curb..., I want to post, I am SVR!!    Susan400
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