New All Oral Phase II Trial Coming

curiouslady1

PSI-7977 Polymerase Inhibitor PSI-938 Polymerase Inhibitor Pharmasset Aug 23, 2011
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Phase 1 combination study to evaluate once daily doses of PSI-7977 and PSI-938 (both dosed QD) in 30 patients with HCV who have not been treated previously. The antiviral properties of the drugs (alone and in combination) will be observed for 14 days.

EASL 2011: In the patients who received the PSI-7977 and PSI-938—92% were HCV RNA negative at day 14. The side effects were considered mild with no treatment discontinuations in the PSI containing arms.

A new study (QUANTUM) with PSI-938 and PSI-7977 (without interferon) is expected to begin in the third quarter of 2011.

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Bill200

curiouslady1 - I wholeheartedly agree with your thoughts about giving hope.  You know, that's what keeps me going.  Whenever hope starts to slip that's the worst thing for one's mental outlook.  We all pretty much know the our own situation and condition, it's the promise of kicking this thing that really is the light at the end of a long dark tunnel.  It seems like a lot of doctors don't really get this.  It's like they are afraid of getting sued I think.

Upbest - Very big obstacle these days.  In the 90's they didn't even run arms without medication, at least those I participated in (high dose, Inf "infusion", and the first riba trials).  None worked for me nor did the current SOC.  Would have loved to get in the teleprefvir or bocephavir trials but by the mid 2000s they began all this blind study stuff and threw a bunch of criteria on participating.  Vertex really did cherry pick, basically you had to be in great health with good numbers and treatment-naive to participate.  I understand they have investors with $100s millions at stake.  Any bad result and poof! the investment is gone.  It's just one of those things.  I think once they demonstrate safety, they should allow and make available to the patient the drugs at our own risk of course.  I think Teleprefvir could have easily been on the market or at least available for critical time-sensitive case two years earlier than it was.

Willb - you do make a good point, I hope it wasn't lost in all the words.  :)

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curiouslady1

If you treated with a NS5A Will then, no, it would not be true for you. It would be true for me. I am treatment naive and the two drugs that are in my trial are an NS5b (first, this particular drug has a very low tendency to create resistant mutations) and an NS5a (added later to "mop up" the several hundred per ml virons left). If I fail then I would go to the SOC plus the protease inhibitor if I so chose . . . which I wouldn't because I have no intention of using interferon. I will give more information on my trial later. I am sorry you think my doctors are "irresponsible". They are not the ones who hurt you.

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curiouslady1

Kate I believe I read that 2 and 3 are getting 100% with interferon added. I don't know the rest. I would just check the web site or the Pharmasset web site or google Quantum over the next few weeks.

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willbb

You aren"t treatment naive now.....you are treating with 2 polys...and again. for the fourth time..there is no conclusive data that there is not cross. They are still working on this aspect of Daa treatment..

I never mentioned anything about anyone hurting anyone....No one has hurt me in the least. I do know tho,,,in order to treat again(like anyone in a failed trial with a Daa..regardless of the mechanism) the resistance profiles will need more clarification to be able to treat again...that includes you also if you happen to fail (very much hoping you don"t)... also no-one said your doctors were irresponsible...I said ..that any doctor that states categorically " if you fail in this experiment ..you can just swith to a Protease.. ...without the word "possibly inserted when the data is not yet finished .."is irresponsible" and it is....if he showed you any studies on cross on polys please post them for others to look over

Best to you...
Will
Will

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willbb

You aren"t treatment naive now.....you are treating with 2 polys...

meant to say you are now treating with a poly and an NS5A

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appleboy

I have had Hep C for 28 years. The last few years have been a rough time for me not b/c of the disease (I am very lucky and it seems to never want to be an every-day issue with my liver) but because of PIs coming and going when they get to near the line where they have to cross before they can be released.This last one sounds like a miracle with no Tx side effects (although none they mention). Maybe we do get favours from God now and again.

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willbb

The PSi 7977 / BMS 790052 combo looks very promising ... hopefully they will be on the market as an INF.free therapy sooner rather than later. Most in the field believe it could still be from 3 to 5 years away .
best to you.

Will

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