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.

[willbb]

I guess I could ..however it was a thread I posted 5 months ago. When I have time I will look to see where I found it...if you are interested.

[col135]

Thank-you very much for your helpful advice.All the best col135.

[pooh55811]

This an older thread with a headline about new drugs. You will get a much better response and some information that may be of help if you stat a new thread. Just go towards the top of the page to the orange box "post a question" and start your own thread. I think you will be more successful in having people see your question and give you some responses.

[col135]

Bit scary to be asked to participate in these trials/studys seems to be a lot of different drugs mentioned what to do for the best, had hep c genotype 1 since 1986 or they called it non- a /non- b hepatitis when had first liver biopsy at royal free hampstead in 86.Non-responder to first lot of treatment interferon/rib stopped after 12wks now platelets very low same with w/c/count wont treat me now at my local hospital because of the above been told it would be pointless.Usual problems with liver nodules/swollen/scar tissue and cirrioshis,going for a nap.Thanks col35.p.s any advice please.

[OdinLovesLife]

A twelve week treatment without Interferon would be a huge improvement! It will be interesting to see an update when more people have been tested 24 weeks post. Although a 90% hit rate from the first sample is hopeful. I must admit though, I would be much happier to see Ribivirin dropped from future treatments as well as IFN. RIBA is a teratogen and has it's own set of nasty SX that we could all do without.

[belle19]

very promising news!  best wishes...belle

[lynda607]

Very odd

[willbb]

odd isn"t it??

[hrsepwrguy]

"Head Spinning, have the names been changed to protect"


I know I thought I took a nap and woke up in a alternate universe

[can-do-man]

Head Spinning, have the names been changed to protect

[willbb]

nct01221298    says approx. 20 but there is 44 naives

[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]

no  naives  G1

[lynda607]

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

[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.  

[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."

[willbb]

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

[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.  

[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 :)

[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...

[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

[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!!

[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]

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.