Aa
New All Oral Phase II Trial Coming
PSI-7977 Polymerase Inhibitor PSI-938 Polymerase Inhibitor Pharmasset Aug 23, 2011
Comments:
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.
Comments:
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.
What about those of us that are already DAA resistant..as in failed teleprevir trial?
Just curious why I couldn't find this on cliniclatrials.gov. I was curious if my doctor was involved in this. Any ideas?
kat_rvk: It is not on clinicaltrials.gov yet. I looked on Pharmasset's web site and I think it said they were not as yet recruiting.
almawe: Trials at Phase II often want treatment naive patients. That is why those who have little or no fibrosis as of yet may want to "stay a virgin" in the event these opportunities come up. However, the DAAs on the market are from different classes of drugs than the ones which are being tried now. I was told that, if I failed my trial, I could go to the currently FDA approved triple and try that without a worry.
meakea: Me too. I smile also at how easy my younger sisters and brothers had it growing up compared to me.
MagTX: Keep clamoring. It's gotta happen.
Bill200: There are all oral trials which are in process already. This one hasn't begun yet. Let's hope for the best.
Dointime: You betcha!
almawe: Trials at Phase II often want treatment naive patients. That is why those who have little or no fibrosis as of yet may want to "stay a virgin" in the event these opportunities come up. However, the DAAs on the market are from different classes of drugs than the ones which are being tried now. I was told that, if I failed my trial, I could go to the currently FDA approved triple and try that without a worry.
meakea: Me too. I smile also at how easy my younger sisters and brothers had it growing up compared to me.
MagTX: Keep clamoring. It's gotta happen.
Bill200: There are all oral trials which are in process already. This one hasn't begun yet. Let's hope for the best.
Dointime: You betcha!
I was told that, if I failed my trial, I could go to the currently FDA approved triple and try that without a worry.
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Whoever told you this should have injected the word "possibly" as there still is no definitive prove that cross resistance is not an issue.
There is much reasearch going on presently but the full data is not clear yet...
Will
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Whoever told you this should have injected the word "possibly" as there still is no definitive prove that cross resistance is not an issue.
There is much reasearch going on presently but the full data is not clear yet...
Will
Will, both research doctors told me this at a reputable University research site. These are all different classes of drugs.
Also, here is the link for anyone interested in studying up more on interferon free regimens.
http://hepatitiscnewdrugresearch.com/interferon-free-combinations.html
Also, here is the link for anyone interested in studying up more on interferon free regimens.
http://hepatitiscnewdrugresearch.com/interferon-free-combinations.html
I understand fully these are different classes of drugs...however there is still no definitive clinical end point data that says there is no possibility of cross res.
If these folk presented you with studies,,that say the problem has been solved definitely....would you please posts these..
Will
If these folk presented you with studies,,that say the problem has been solved definitely....would you please posts these..
Will
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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. :)