Very early & Small Study,but Encouraging Data

[willbb]

This from a financial piece,,that I don:t like to copy as I feel the financial reports are slanted every which way..depending on who the author,. however  early results on SVR"s in this very small trial are great to to see      all trial participants achieved eRVR and 9 so far of 10 have achieved SVR on this all oral regime.

The two Phase II trials of previously untreated patients combined the antiviral drug ritonavir with Abbott's ABT-450 -- a protease inhibitor from the same class as the Vertex and Merck drugs -- one of two Abbott polymerase inhibitors, ABT-333 or ABT-072, and ribavirin.

All patients who remained in the studies achieved an early virologic response at 12 weeks, meaning the virus was undetectable in the blood, Abbott said, with no virus rebounds occurring during therapy.

Of the 10 patients so far who were tested 24 weeks after completing the 12 weeks of therapy, nine had achieved a sustained virologic response, or SVR, the company said.

"In other words, these patients were cured with a 12-week course of therapy without interferon," Gonzalez said.

The regimen has been well tolerated to date, the company said, without discussing side effect details.

[UKgirl55]

This Abbott study is sure looking hopeful!

[beeblessed]

This IS encouraging news.  It is good to see that the approval and effectiveness of INC & VIC, have had a springboard effect in companies taking more stock in more tolerable cures.  And that they are cutting tx times dramatically -- even better!!  Thanks for sharing this.

[willbb]

Yes...the early going looks very good,keeping in mind there are only 44 total in this trial..   but positive results just the same....

[nygirl7]

That is extremely promising stuff and blows the doors off Inc/Boce. Amazing so much happening in such a short amount of time!

[Susan_1a_CC]

Wow, 12 weeks - and not a dream?  Gives a person hope ;).

[curiouslady1]

OK.  Let's keep a cool head here folks (much as Pharmasset shares went down 15% on this news).  It ain't over til the fat lady sings.  Here is what one commentary has to say about this news~~~

"Taking into consideration the ritronavir boosting ABT has a four drug offering. PSI-7977 may also be tested as monotherapy in late stage testing. Investors must consider not only the safety issue with ABT combining four drugs but the amount of testing the FDA will require. All the classes of HCV drugs that ABT is combining have demonstrated viral breakthrough in prior oral testing. There were a grand total of 44 patients in the results ABT released today. Someone please tell me what all the excitement is about?"~~~

I personally think this hullabulloo (sp) is something for all to very circumspect about esp. those looking to enter trials. Companies may be cutting corners in order to get to the finish line first, not just exaggerating the importance of preliminary data but trying to narrow the length of dosing (from 6 mo to 3 mon etc) and putting together multiple weak combos necessary to sustain the viral response.  Others have cautioned me and now, as I have become a little more educated about what is going on from back channel communication, I am asking others to take special care at this particular time.  We may see some marketable drugs in 3 rather than 5 years for those who can possibly wait it out and some of the trials are beginning to look very dicey.  The stakes are extremely high for these companies esp. now.  Please be cautious my friends.

[flcyclist]

This is promising news and give those delaying trt or possibly retreating an option for the future.  Of course the trials will continue and hope we'll see more data.

curiouslady: after all you've pushed Pharmasset's orals, I'm surprised to see you're so critical of another promising oral.  It may be a bit early to get excited, but defending and promoting your trial drug, while shooting another down?  I know virtually nothing about these new orals, but I'd keep an open mind to all as time goes on, regardless of finacial reports.  

[willbb]

This isn't a post derived from competitiveness ..rather just some positive exciting news....of which you are entilled to "not" be excited about
When there are 90 %(success rates posted(albeit a small group ) I for one  see the positive...... ..

[willbb]

To :All

I might add .. that I still feel that right now is an excellent time to treat .with approx. 80 % chance of success...this is not to encourage anyone to wait to treat...that is a personal desicion .between  someone and their doctor....this is just plain old solid good news IMO...90 % success with no INF...

[curiouslady1]

Fly, I am also suspicious about the drugs I am taking esp. since they are cutting dosage to three months in the next research project.  I like to think that they have early data suggesting that it is safe to do but I am also aware that the stakes are high for these companies.  I still worry about the black cat crossing my path and throw salt over my left shoulder when I spill it.  Believe me, the fact that willbb took one of "my" drugs and did not treat successfully is on my mind and will continue to be that way for many months to come.  Yes, this is encouraging news.  But my note of caution is for those seeking to enter trials at this time -- it is an exciting time but also a dangerous time.  

[UKgirl55]

I just heard from a trial nurse (via someone else) yesterday that Abbott was having this type of success and the patients that were on the trial were still SVR 8 weeks post treatment. I think the Danoprevir, boosted with Ritonivir seems to be a game changer, added to the Polymerase and Riba. I also heard that the sx were very mild. I really think it's a possibility that there'll be more than one way to skin this cat....because of such fierce competition right now the pharma's have been working overtime to get to the finish line. I do think curiouslady has a point. We can be excited and hopeful, but tread carefully with our decision making right now. Or at least in the near future when more trials will be available.

[curiouslady1]

Yes, I realize that I am tempering my initial enthusiasm.  I do feel good about my particular trial but, then again, what else do I have?  I see that the cautions I was given initially by others (willbb among them) does hold a substantial amount of water.  This is esp so after seeing what happened to Sue and Adam and getting some other back channels. Don't mean to throw a wet blanket but just asking for caution in those who want to do a trial and yep it may be critical (what happened to the other 34 of the original 44?).  I do think the competitiveness is good willbb.  It causes everybody to work harder and accomplish the goal sooner ~~as long as cutting corners does not compromise safety :) Hmmm. I think I am beginning to sound like YOU!!

[willbb]

Well........ I and many others in trials have had less than stellar results..that is why the data to date shows approx. 75% and not 100%. and the exact reason I posted one with 90 %...but ones trial experience has nothing to do with anothers.

.Also   I may have only been on placebo..   As I have said many times here my particular trial will not be unblinded until Mar 2012.

It is interesting (to say the least)  to hear you say that a trial can be dangerous.....something most of us here have been stating consistently

Trials are data collecting experiments for the drug companies....however lately the results have been very impressive as we hope yours are.....
Best
Will

[willbb]

patients that were on the trial were still SVR 8 weeks post treatment.
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SVR ..is only UND at 24 weeks post treament ..which 9 of 10 were in this particular trial small trial.

My take on developments that in the years to come there will be many ways to skin this cat..as you say...but it is going to take time.....possibly in 3 to 5 years is what quesstimates are...

[beeblessed]

Hey, hey, hey now!!  What did the cat ever do to you??  There will be no promoting of skinning of cats. (Heeheehee)  Sorry, couldn't resist :)

[flcyclist]

"I am also suspicious about the drugs I am taking esp. since they are cutting dosage to three months in the next research project."
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
I'm a relative newbie to these trials, but its obvious that it's not about what's best for and curing the patient. It's about collecting data on the drugs by controlling variables such as dosage, length of trt, various combinations, etc. to determine what works and what doesn't.  After several trials and hundreds of patients, they will have the data necessary to support minimum trt times at the proper doses that are statistically significant.   Until then they have to cut dosage times to determine what the lowest threshold of trt will be.    

I do hope this works out for you.  

[willbb]

I guess a bad choice of words..being more of a dog person  :O )

[curiouslady1]

Sorry.  I read this in Business Week as SVR12 not 24 and I didn't see the piece of RVR or what occurred for the other 34.  Well, it will all be clear in a couple weeks at the meeting anyway.



"Abbott released early results of its trial, dubbed PILOT, at the conference. The study found the hepatitis C virus was reduced to undetectable levels in 41 of 42 patients after they were treated with Abbott’s drug combination for three months. At six months, nine of the 10 patients still being monitored showed no sign of the virus."

[curiouslady1]

willbb - is this the one?

NCT01306617

Fly - I know what the companies are interested in but I am a research participant and my goals are different.  I want to be cured.  

[lynda607]

Too lazy to look but is this across the board for all genotypes?

[willbb]

no  naives  G1

[curiouslady1]

If its the one I think it is.  GT 1 only.  

I need a hot fudge sundae (in lieu of a beer).  I'm outta heah.

[willbb]

nct01221298    says approx. 20 but there is 44 naives

[can-do-man]

Head Spinning, have the names been changed to protect