PSI-7977 and PSI-938 Trial

[ipaqgps]

Hello,

Interesting news just came my way..  The Study has been pulled..  Seems the treatment is causing liver damage....  Just what it was so suppose to stop.... 

Now I could be wrong but my friend was on it and this is the latest.  Just hoping he knows what he was on. 

It was making him tired, nauseous and feeling sick.  But hey that didn't sound to bad to me I told him. 

Anyway, Gilead might want to rethink that takeover or are the pharmaceutical powers that be playing with trials to keep their company.?  Oh man I have watched way, Way to Much TV....

 

[greyrocker]

Yes, it was pulled. I posted it earlier in the News.

http://hcvsupport.org/forum/index.php/topic,4432.0.html

PSI - 938 was the problem it seems. So far it seems that PSI-7977 is still the wonder drug. That's the one Gilead paid the big $s for.

GR

[ipaqgps]

Thanks GR...  I haven't been keeping up here like I should...  My poor friend is disappointed and the trial doc is going to see what they can do.  That naive status is now over for him.  I have to read the article you posted..

See how behind I am....  The Gilead thing is done..  I better check my few little shares out and see how they are doing.  Might be time to cash out...

 

[greyrocker]

It shouldn't affect your shares. The Gilead deal was strictly for PSI 7977, not the one they stopped.

Read this:

http://news.businessweek.com/article.asp?documentKey=1376-LWASN36S972F01-7525TKVLM2A0MVP9KK0V4GOOOR

GR

[Justme]

I also have a friend who was apparently in the PSI 938 arm.  She was pulled and upset for the same reason as Ipaqgps friend.  But apparently they are cooking up some form of consolation prize. . . an open trial arm for early in 2012.  I went to the company's web site pharmasset.com and sent an email encouraging them to take care of the 235 people who this affected through offering another opportunity to them.  Otherwise, they have few options except to go to SOC which many probably wanted to avoid.  I said to them it looks bad for their image and makes them look like big Pharma insensitive bad guys. 

[greginky]

Yes, it was pulled. I posted it earlier in the News.

http://hcvsupport.org/forum/index.php/topic,4432.0.html

PSI - 938 was the problem it seems. So far it seems that PSI-7977 is still the wonder drug. That's the one Gilead paid the big $s for.

GR

I was following this closely too. In the beginning, they thought that PSI-938 was going to be a bigger star than the PSI-7977. But the merger is still going to take place, it wasn't a deal breaker I read.

[ipaqgps]

They are going to do something for them!  Right at the moment one thing is to put them on 7977 with riba...  Don't know when or for how long they expect them to treat.  One thing they are waiting on is to see if any of them stay UND.....makes sense huhh? 

My friend was a geno 1 and he was only going to treat for 12 weeks!  Can you imagine?  No Hellish drugs and only 12 weeks?!!   So we will wait and see how this unfolds.. 

Justme you are to cute!! You write lady and give 'em heck!

 

[ipaqgps]

My friend just called with some labs.  Crazy they only are showing ALT/AST and vl.

To start out his vl was 9 mill and alt/ast were 80/129 or along those lines...

He showed WNL for AST/ALT on week 2 with a vl of 25.... and week 3 the same.   Nothing for his last week since they haven't released the numbers yet.  It might be possible he went UND on the last week.... BUT was it enough..  Time will tell with all of this but looks like when they sort the mess out he will do 7977 & riba..... Man he is taking this so miuch better than I would have been..`

What we can all hope for is that no one was hurt by this trial....and they all can fight this again soon.
 

[ScaredyCat]

Yikes.
As for your friend taking this well, the shock of failure is numbing.  I don't think I ever cried. I felt very zombie-like for a couple of months about it. Now, it seems like something I never did.

That is so lucky if the pharm is going to retreat. Mine just said it didn't work and you cant retreat with interferon.  Why is everyone else doing tx 2, 3 & 4?

Cant wait to see how the 7977 goes.  Where did they get that 938 -the freeking gas station store? Same place they got Lambda  -everyone failed that tx that I know of.
yeesch.
We'll keep trying until this thing is off of the planet.
SC

[Justme]

Wow, the VRUS stock is up more than 3% today.  I guess the sale is still on.  Ipaqgps did you gt my pm? 

The latest I hear on this issue with the PSI 938 is that the peeps are going into a trial all their own called Reactor which is set to take place in April with 12 and 24 week arms, open trial and just PSI 7977 and Riba.  Not bad considering that preliminary trial info on a small group suggests that riba taken this way does not come with anemia.

Happy New Year to all you Pharmacites out there (and everyone else too!)

[DougV]

Have not been following these trials.  They are taken with Ribavirin too?  Did not realize that.  Personally I'd do daily infergen shots before taking Riba.

Good luck to those on this.

Doug

[ipaqgps]

He was UND by the first week from what I can tell without actually seeing the labs.. Love the guy but reading labs is not his forte....

He met with the Doctor last week and they are going to see how it goes right at the moment since he is UND...  But he did mention the riba/7977 treatment again as the back up. 

JustMe where did you see that about the riba not causing anemia?  Cuz it almost killed me.  Or could it be the combo of all 3 drugs together.   

Doug I did the interferon and it only wipped out the the white bc but which is much easier but than rbc but I wouldn't want that again either..

Oh and JustMe... I am going to have to call and find out some info on the stock since they sent me something in the mail that has to do with Gilead and I just don't want to even try to understand it.. 

I am going to call my friend right now and tell him that they have named the trial... Reaction is right!

Thanks for info!!  You gotta love this place!
 

[Justme]

Sorry for my tardiness.  I am trying to keep up with three forums.  Lessee,  the info on PSI 7977/riba is posted here.  The slide is about half way down the page under 7977 Electron where it shows a graph of the Hemoglobin level compared to trials where the interferon is included.

http://files.shareholder.com/downloads/VRUS/1405277499x6521170x515444/dce3c4f4-e7c8-4e56-8aeb-4a86cdc5f8da/VRUS%20AASLD%20IR%20deck_110611_FINAL2.pdf

Anybody who wants to find out more can go to the company's web site where a lot is posted.  Unfortunately, the fastest info which is quite accurate (otherwise they lose investors) is the info directed toward stockholders.  It is phamasset.com

You have to dig for the ribavirin info.  It is only one piece of a whole array of positive findings being put forth by the company.  Not too many subjects but you get the message. 

Also, from chatting with others who have been on this regimen in Australia and in US, it seems that people are generally tired but not anemic.  I believe that other all oral regimens that include ribaviron may yield more severe fatigue but that is just a hunch and of course, it depends on your condition.  I am tired and I don't even take ribavirin so a lot of it is individual.  Still, I haven't missed work and my business has improved since treatment started.  A power nap and a cup of coffee and I am good.

Doug, why would you take daily interfergen shots rather than ribavirin?  Just curious. 

[greyrocker]

Thanks for that link, Justme, it's very good. 

GR

[ipaqgps]

Thanks for the link JustMe...  Well you started it... I contacted Pharmasset and told them Thank you for curing me. I mentioned which trial, the dates and that at the end of one year post tx that my levels were still UND...

Not expecting really anything, I did receive an email back from them and that my email was sent on to others with my last name and email address being deleted.  How much they like hearing from us so they know that their work is working and making changes.   

Now if I could just kick this flu..... It will go away though....so no problem really.  Right?  Right!