HCV 796 trials stopped

Wasn't there a poster here who was in a trial of HCV 796?  The trials have been discontinued due to elevated enzymes from a big portion of the lab rats.  Personally, teleprevir is farther along than most of the PI's and I am comforted by that, but I always hate to see a drug that seems promising turn out to need more work.  Teleprevir is farther along that HCV 796 was, so the issue of safety has been answered, now we are waiting for the results of success with SVR.  

Anway, just curious about the poster and if there was any further info.  I try to keep up with those drugs that may save my a**.

Willow

[susan400]

I, myself, am disappointed to hear this news.  Since I didn't get clear w/the Telaprevir.  I was/am keeping on the lookout for future trials.  The next Telaprevir trial in the fall is using naive patients, not non-responders.  My doctor did mention that depending on what comes out of the Halt-C studies at the Nov. conference, I may be looking at doing maintenance again.  Right now, it's a wait and see for me.

Susan

[Willy50]

Here's a bit of information.  The webcast is very good.  The stuff was working very well it appears.
The issue was safety.  Some 8% has elevations of 3 times the upper normal limit for liver enzymes.  About 1% (2 patients) had enzyme increases of about 10% the upper cut-off of normal.  They also reported that after several weeks off the new compound some of the high scores had not returned towards normal.  Lets hope that those on treatment recover; half still have elevated scores.  This may be the end of the compound or it may simply come back in reduced dosages or for shorter periods of time.  Stay tuned.

Willy
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http://webcastingplayer.corporate-ir.net/player/playerHOST.aspx?c=92320&EventId=
1624360&StreamId=959995&IndexId=&TIK={688a7901-c6fe-424b-b342-f0dbef3cf664}&RGS=3

(Teleconference, webcast)


http://phx.corporate-ir.net/phoenix.zhtml?c=92320&p=
irol-newsArticle_print&ID=1039323&highlight=
(current finding in study)


Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796  

[Willy50]

My sentance;
" About 1% (2 patients) had enzyme increases of about 10% the upper cut-off of normal. "

should have read 10 times the normal upper cut off.  (that means that they may have had ALT's around 400, around 40 generally being accepted as the highest "normal" score)

PS......they haven't spoken specifically about this and identified actual scores but the CEO indicated that it was a range of LFT's that were affected; not just one.

Sorry for my boo boo; that's a big one.

willy

[willows]

You seem to be in the same boat as I am, crossing your fingers that it doesn't sink before teleprevir comes out,  I am stage three and don't have a lot of time to wait, but I have a great doc and he asked me wait till 2009 so I'm taking a big ole leap of faith.  He's totally excited about teleprevir, especially for me, I had viral breathru at 30 weeks and he gives me about a 10% chance on traditional SOC.   So teleprevir with it's 24 weeks of interferon shortens my exposure to interferon, he says I have mutation virions to ifn.  Whatever.

I just know that it is harder than hell to wait, but everything I read and research tells me that by about 2009, I will have the teleprevir script and SOC, so I'm going with the flow.  I'm crossing my fingers for both of us, girl.  It's about time the odds were in our favor!

Willows

[Susie2007]

I am so sorry to hear that you didn't respond to Telaprevir. The Viropharma drug trial was stopped due to "untoward" side effects according to a Viropharma person I spoke with last week. They do not know if they are going to go on with the drug at this point. The reason I know this is I was scheduled to do a staff training for them about hep C and the advocacy community and they had to cancel it.

Unfortunately for people like you and me, repeated non-responders, the news about maintenance and HALT C is not good. I got to speak to one of the lead investigators and he said it is not working. He encouraged me to come off maintenance unless it consistently kept my viral load under 100,000 which is does not. These results will be published and discussed at AASLD. I will definitely let everyone know what I find out.

[mremeet]

You've heard about Schering Plough's SCH503034 haven't you? It's a protease inhibitor that's in a similar phase of development as Teleprevir (late phase 2). It seems they're keeping a pretty tight lid on the testing results (info is hard to come by on it), but as far as I know no glaring red flags have been raised yet. Anyway, something to look into if you haven't heard about it yet.  

[susan400]

Thanks, I'll keep it in mind for future watch.   Sort of hesitant to consider any more of the trials at this point, unless they are to the later stages and right before releasing it, i.e. broad scale-large amount of people, etc.  And I still may be doing the maintenance anyway, just don't know what I'll decide at this point.  Just not real thrilled w/the idea of doing the VX again because of the rash issues.

Susan

[dointime]

And without wanting to rain on anybody's parade (especially my own) there's still the problem of resistance to the VX.  Once you have it, like me, do you even have a chance at another bite of the apple with VX, or any other PI for that matter which targets the same protease?  

All I know is that once I developed resistance to the VX I might as well have been eating sugar pills for all the impact it had on my VL in the following 8 weeks that I was on it.  

If I don't get clear this time around I'm not pinning my hopes on the PI's 2nd time around.  I'll be watching for something which uses a whole different strategy.

dointime

      

[Terrylee8]

I'm in Schering Plough's SCH503034 trial but I'm in the control group which means I don't take the SCH503034 protease inhibitor.  My local group started with 7.  5 on the SOC+Protease and 2 control, SOC only.  One participant dropped out at 30 days when she started the protease, something about child care issues.  The remaining 6 of us are all clear with me being the last to clear at 8 weeks.  A man I've corresponded with who was in the trial, on the protease, was pulled from the trial by SP as he had a viral outbreak at week 6 and then more at week 8.  Is it working, I hear yes.  Is it the magic bullet, who knows.  I've heard that people are more prone to anemia on the SCH503034 as SP has started to pay for Procrit for those who need it.

[PSP-n-Me]

I have to say I question any Doc that tells someone that is a stage  to wait for clinical tiral drugs to hit the market..

[PSP-n-Me]

that should of read stage 3

[dogsledder]

Yes, that would be me. I am seeing the MD at the end of the month and do not have any current bloodwork results. If they share it with me, and it is significant, I will post. I am continuing with Int/Ribavirin. Thanks for the guidance. I'm still trying to figure out between the different forums and posts...I realize that stage 2 trials are a risk, but nothing ventured nothing gained.