More all-oral research .including genotypes 1,2 and 3.

[willbb]

Pharmasett anounces three new Inf. free Phase III trials for all geno types:

http://investor.pharmasset.com/releasedetail.cfm?ReleaseID=619564

[Juttutin]

When I mentioned to the PI on our trial that our cohort had been discussing buying $VRUS shares together, based on the results we were having / seeing, he quite literally retreated backwards a few steps with a look of fear/horror on his face at having been party to such a conversation - although his only input came a moment later, when he explained that there was no way he could offer any opinion whatsoever etc etc.  

I think he was (momentarily) literally freaked out by me bringing it up.

Sorry Doc.  :-)    I crossed a line, one very clear in his mind, that hadn't occurred to me.

Like your PI, ours was humble (for a senior doctor, anyhow) and clearly committed to his work - healing us and our co-infectees.  He will be presenting at AASLD, and I dunno if the clinical community follow these forums, but my feelings are very much as follows:

"You go Doc!  Your thanking us for partaking is appreciated, but doesn't compare with our thanks to you for giving us the opportunity to be part of your (and their) experiment. Don't forget to souvenir a few of the socks you knock off"

[curiouslady1]

I was very happy to hear today that my PI is getting a lifetime achievement award from AASLD.  She is very modest but she has been doing a lot of good work with HepB and C.   It is very comforting to know I am in good hands.  I am learning a lot about these trials.  For example, many of the sites pick and choose the trials carefully because they don't want to run two competitive ones from two different companies at the same time and because there is so much involved that the potential for mistakes is high.  Apparently they have lists of hundreds of potential research subjects from which they eventually end up with only a few subjects.  Much of what they know is confidential, not just with regard to the subjects but regarding the overall study and findings.  None of PI etc can invest in the market because they are considered true insiders and there is a significant amount of information they withhold.  You kind of have to guess from the way the research project is designed and how they add to, subtract from or change the trial as they go along as to whether or not it is worthwhile to get involved.    I recall I had heard some bad news about a trial (not PSI) and I checked the posting on Clinicaltrials.gov to see what trial and what arms.  I came back days later and the trial arms had significantly changed.  I believe there is a lot we don't know.  Heck, what we do know is scary enough sometimes.

But yes, I am optimistic too.  Well, I have to be.  I am only 3 months in!

[Juttutin]

"So, you are saying that the 10 all orals are all SVR?"

No, I don't know this - I'm very confident that if it's not 10, it will be close to 10.  I won't be at all surprised, given the doc's comments 12 weeks ago, and the general success rates I saw around us at the clinic, if they do announce it was 10 out of 10 on the 6th.

We will just have to see, but I'm extremely optimistic.  I really got the feeling that the faith in 7977 is well placed, at least for GT 2 and  GT 3. I truly truly hope the results hold up similarly for GT1 (and GT 4 etc for that matter, mustn't forget our middle-eastern etc friends)

[curiouslady1]

I think Aaron has already posted this elsewhere but for anyone following this thread it might be helpful to repeat it.  I also have the URL in my journals page.  This is a Guide to Clinical Trials for Hepatitis C

http://www.treatmentactiongroup.org/hcv/publications/2011/hcv-clinical-trials-guide?id=4606&utm_content=ecamhi%2540generes.com&utm_source=VerticalResponse&utm_medium=Email&utm_term=HERE&utm_campaign=Guide%2520to%2520Clinical%2520Trials%2520for%2520People%2520with%2520Hepatitis%2520C%2520-%2520English%2520%2526%2520Spanish

[curiouslady1]

So, you are saying that the 10 all orals are all SVR?  Did you see that they just opened another arm for monotherapy in NZ for 7977 alone for 3 months?  I would be interested in seeing how that turns out.  They certainly have a lot of faith in that drug to put it out there like that.  

[Juttutin]

Better actually answer I guess...

I was GT 3.

I can't track down the interim results from ELECTRON Phase I.  But as I said, there were only 10 of us 'oral only'.  But three days to go until the good stuff comes out:

"We look forward to reporting SVR12 results from Part 1 and interim data from the PSI-7977 monotherapy arm of ELECTRON on Sunday, November 6th, 2011 at the upcoming 2011 American Association for the Study of Liver Diseases (AASLD) annual meeting.  The preliminary results to be discussed at AASLD led us to expand the study to add an arm of PSI-7977 monotherapy for HCV GT1,"

Worth repeating.  >>> PSI-7977 monotherapy for HCV GT1

In the context that they're going to trial monotherapy, I'd have no hesitation recommending trying to get on a 7977+RBV all-oral trial if qualified.

Cheers,
  --J