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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.
I'm not against interferon, however, it no longer works against the virus in my body, as of this trial that I just ended, it turned out I was on SOC alone because I got the placebo and I only got it for 10 wks. At my last appt., it was unblinded because the trial was cancelled and I got the first 8 wks of viral loads and I barely responded to the SOC alone, I had like a 1 log drop (barely) by 8 wks, which is considered VERY poor in term of viral response, i.e. null responder. Susan400
I cant write well with a needle up my arm but got released to come home for a bit. I am 14 days in and my VL went down to 53 in 6 doses of one oral drug alone (from 13 mill in mid August). In Phase 2 they are more careful about participants than in Phase 3, that is correct. And in Phase 3 they get more trials stopped in the middle because the people in Phase 3 are not the healthiest and Adverse Reactions can bring a drug down. I am 64 and have diabetes, overweight and FLD and LP and Graves disease and arthrities. I am hardly a perfect specimen. But I don't have any conditions which are deal breakers. My BMI is under 35 and my heart and eyes and liver are ok. I could withstand SOC if I had to and if it came to that in rescue. They are getting good results Upbeat and that is what you and everyone who is waiting want because in Phase 3 you have a better chance and in general you have a better chance to have it get to market sooner. If they put out that we all GT 1a's went UND by 1 month, imagine the publicity and the pressure to move forward. Phase 2 is a good time to tweak but not if people are too sick. Investors do need some assurance for their money. Millions of dollars for each drug I am told and so many fall by the wayside. All you need is for a couple old geezers to drop dead for an unknown reason and that is the end.
hey Bill.. I remember those days...when I was first diagnosed 11 years ago...like many here...there was only mono INF. and the doc said you got about a 20% chance...I passed. :)
Things have really changed...and thankfully folks now have some real hope and things are just going to get better and better IMO.
Best to you..
..
Will
Things have really changed...and thankfully folks now have some real hope and things are just going to get better and better IMO.
Best to you..
..
Will
BTW, I don't why you guys are so against interferon. Of course some of you will have bad effects but with the triple therapy and a near 70% I'd jump all over that before trying new stuff. When I first started there was around a 15% chance of cure with straight interferon. I worked my regular job through all three attempts. You should try the well-known SOC first, I think, at least until there's more data back. Those studies they posted only had about 45 patients. Very promising but it is a brand new thing. I'd wait until they had a few more trials under the belt. I only wish the standard triple therapy had been around a few years ago.
I'm in a PI trial (BI 20133) and there are 6 spots at my hospital for participants. They have only 5. Korea was also supposed to have a number of participants that they didn't reach, giving more spots to North America.
I guess there are just lots of trials going on now and people are being smart about what they choose to participate in. I don't know why my hospital didn't reach its number except that it was only available to treatment naive patients...
I just chose the first darned thing I was offered. ;)
I guess there are just lots of trials going on now and people are being smart about what they choose to participate in. I don't know why my hospital didn't reach its number except that it was only available to treatment naive patients...
I just chose the first darned thing I was offered. ;)
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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. :)