Hey can-do-man, what new drugs?

[cquest]

I just read your response to me from below. No, I haven't been keeping up on anything lately, what new drugs? there's new drugs out there? Wow...Just point me in the right direction and I'll do the digging.
Thanks!
Cin

[can-do-man]

If all keeps going well tx could be 12 weeks instead of 48 or more for geno 1's.

Go down here......i'm Genotype 3a...should i put off treatment to wait for VX-950? - niceguy2007 07/09/2006

And also go down to....... What are long lasting side effects of treatment? Pozzy 07/08/06.

Also schering-plough is also working on a new one.

Both of these have been FDA fastracked.

Should be a trial in your area PhaseII starting real soon.

[cquest]

So I got caught up in the back and forth sparring and lost the track...is there something other than VX950 going around? I don't know if I'd qualify for a trial...remember I tx'd for 5 days and quit which technically labels me as a non responder and limits my ability to partake in clinical trials...how stupid of me...but who knew? I had no idea it would screw me up...You know I still have that soft spot on my stomach from that shot? Isn't that strange?
Cin

[can-do-man]

The new trial is for people who had tx. prior. Besides schering-plough theres another one going on that alady that post in here is in.

[can-do-man]

Alady has a thread about three down. I ask her if she would come up here and tell you about the trial. Not sure if shes still online

[can-do-man]

This was just posted by cton.


couldn't think of a nickname
07/09/2006
C42  . I checked in, and thought I could help some in the drug development area.

1. VX-950 is being tested in Europe WITHOUT Riba. The company is not convinced riba adds much, as just 950 and IFN got 5.5 logs in 2 weeks anyway. In fact, and this is just my take, in the study they got 12 out of 12 neg. in 28 days, but 1 relapsed while on IFN/Riba maintenence, it would appear (to me anyway) that 950 was needed longer, and riba did not pick up the slack. Of course, patient 12 might have virus resistant to IFN for all we know.

2. Resistance: VX-950 does develop a resistant strain, the A156T strain. 950 does render it less fit. My guess is, it has not been a major problem, and A156T is sensitive to IFN anyway.

3. NM 283 could have a problem if it gets tested with riba. Both are nucleoside analogs, and Piper Jaffrey notes that they might have synergistic GI side effects. No one wants riba included, and even if the next gen of drugs are approved with it, I wonder if some might opt out of it anyway. I would.

4.ITMN has a PI that preclinically, is supposed to be much better than 950, and does not have that mutant strain issue of A156T. Maybe a poss. future combo? Way too early to speculate.
What happens in the clinic is an open question. IMHO any new therapy without IFN would right now need to be a combo of new drugs, not necessarily 1 alone.

5. VRTX has a second gen. compound that is 2 years behind 950.
Companies do this because the first to market is rarely the best over time. They can learn a lot from the first one, and improve on either liver concentrations, dosing, etc. Not much has been said about this, but they are working on it.They have since said this publicly, but I pretty much new it based on this exchange with the company I had a few months ago:
Me: "Is VRTX working on a next gen to 950?"
VRTX" "We have an active and productive drug development program". I saw that as a yes, having talked to various companies for many years, and knowing their language.

6. SGP has a PI, and they hoped to get into p3 later this year, but I doubt that will happen. They recently added a higher dose to their p2, and I don't believe preparations are in place for a p3 that soon anyway.

7. BMY has a PI. A privately held biotech has a PI in development. For what we do know about drugs in development, there is a lot we don't know. But, the next gen should certainly lead to much shorter tx times, which hopefully will lead to less long term side effects.

[jmjm530]

Thread got closed out but anyone closely following the Vertex trials, including the Webcasts, understands that Vertex intended from the start to test its drugs several ways including without riba and even by itself.

The faster route to U.S. FDA approval is to test it with both Peg and Riba. In the Europe Prove II trials it is being tested with peg but WITHOUT riba.

What is especially annoying about the incorrect characterization of my quote is that my whole point was that it DIDN'T matter how Vertex was going to be used -- with peg and riba, with just peg, or by itself -- the fact that the treatment time could potentially be shorter hopefully will result in less sides.

How this turned into a statment that I somehow said Vertex will hit the market without ribavirin and I'm therefore deceiving new people in the discussion group is totally beyond me. I posted relevant links in the post below, but again, go here: http://www.vrtx.com/Pressreleases2006/pr052306.html and then scroll down to PROVE II study.

CTON -- didn't get a chance to say "hello" below. Thanks for taking the time to visit and keeping us informed about how the newer treatments are going.

-- Jim

[Kalio1]

The thread where you asked about 3a's was closed, hope you see this. The other person Mister Beagle referred to, FlGuy, is 3a also and did 24 weeks and relapsed also but I think he is on vacation so he might have missed your post. I know how difficult it is to make these decisions, and I know the feeling of not wanting to ingest these drugs. No matter what you decide there are risks as you know so that makes it tough. A real "pick your poison" situation. I know other 3s HAVE cleared the virus in 24 weeks, I do not know any that cleared it on less weeks but that doesn't mean it doesn't occur. We have a few members who are 2 and cleared the virus on less weeks treating, one ( Rifleman) cleared it in 12 weeks I think. There are others but I can't remember their names, but they were 2's. I don't think 2's have as high a relapse rate as 3's.
I agree with you it is a shi**y choice all the way around.
I am 3a and had a VL of 400 at week 4 and was UND by week 12, I did 24 weeks on 800 riba and full dose IFN never missed a dose and relapsed. I did not get a biopsy, my doctor didnt feel it was warranted Ultrasound was clear. My enzymes were never over 100 and normalized by week 4. I am now on the second round of tx, this time for a year. 72 weeks in all.
This round I was UND at week 4 and so far am still UND.

[Alady1620]

I'm in a trial with NM283 (Valopicitibine) and pegasys interferon.  I cleared the virus by week 12 and I have been undectable since.  I *think* I'm in week 32 of treatment.  I get confused easily these days.  :lol

I started on 800 mg of nm283 and the prefilled pegasys syringe.  I agree with the person he made the statements about gastro problems bc I had them bad until my dose of NM283 was cut to 400mg.  I can't imagine what it's going to be like in the new trial with ribavin/nm283/pegasys.  If you don't have insurance and you are in a hurry to treat, you might try it.  My nurse said they're paying $1000 for that trial.

[couldn't think of a nickname]

I got your drift on your post, and I agree. Nothing out there says that 950 can't work by itself, at least for some. However, it is in everyone's best interest to get it to market ASAP, and that is at least with IFN, if not both.

I hope you start to get rid of those sides soon. When I do check in, I like to see how you, and everyone else are feeling, and everyday I pray for those I have come to know in here for a cure, and recovery from it.

Funny thing is, my post below was probably better done in this thread, and even though this thread is at the top of the page, I just scrolled down and the thread on long term side effects caught my eye, as that is a concern to me, and I prefer to read real experiences.
But, it was cut-and pasted anyway, so it's all good LOL

[Alady1620]

I should add that everybody in the study I'm in at my doctor's office has cleared except 2 people.  They have around 15 patients in my trial.  So, I have confidence that a person joining the newer study would have a good chance to clear the virus with that combination of drugs.  It wouldn't be a waste of of time.  Just stock up on Immodium and bottled water. LOL

[friole]

foresee - my husband heard about that last week so I googled it this weekend.  Perhaps using statins will give us some hope that we can give up the ribavirin.  Here is a ling to a short article

http://www.eurekalert.org/pub_releases/2006-07/jws-ssh070606.php

[Forseegood]

ctoan: hey really great to see you here! youre so kind to post this info for us, thanks so much for keeping an eagle eye and compling all this, hope life finds you well, good thing on the horizon huh?

Alady: thanks to you too for posting your experiences here, I'm sure we are all curious about the new drugs, and it's very good of you to tell us what's going on with you, be well!

[couldn't think of a nickname]

Thank you, hope you are well also.
These next several months, and this first part of the p2B trial for 950 are very important. Good 3 month results could help move the process along. If not, it still looks like it is under 3 years for that.
I was pleased they chose J&J to partner with outside of N. Amer. J&J's subsid. also has a compound in development that would be considered second gen, but it is actually behind VRTX'S. The efforts are certainly being made by the drug companies. Let's hope they bear fruit ASAP.

[Forseegood]

hi! what do you think of this new statin finding in Japan? Wouldn't that be a kick if that bore fruit! Don't see you enough around here!

[niceguy2007]

foreseegoodman,

statin find? whats that? im in Japan and i never heard of that!

[couldn't think of a nickname]

It is interesting, but I would like to see more studies on it. It would be better than riba. I do find it a little ironic, in that statins can actually raise enzymes in healthy people. And, I wonder if people with low cholesterol would be able to take it IF it were deemed a good alternative. My cholesterol avg's around a 120, and has been like that for many years. Was actually below 100 once. I wouldn't want mine to go lower.

[Forseegood]

oh and thanks for that Friole! hope youre doing well!!!!

[FlGuy]

Do you or your doc think low ldl is a result of hcv?  Mine, over the course of last 20 years or so has been around 65. During tx went to 105. Post tx back in the 60's.  Didn't clear. I've read somewhere that low ldl is sometimes a companion to hcv.  Over the years, docs and other medicos have remarked about the low level but never connected any dots to hcv.  I wonder if we all missed something.

[Forseegood]

Well, that's some questionable validation for you! I've had more than one poster suggest I think like a dude, but just for starters Nice Guy, that's Forseegood! not Forseegoodman! ha ha ha! Only joking with you!

And I haven't forseen a good man in awhile! Ha ha ha! Couldn't resist that one, hope you have a good day Nice Guy, as another poster Jim and I will attest, a diet of Japanese food is some of the most healthiest cuisine on the planet...as long as you don't include Fugu, the pufferfish, but maybe Jim is a little more intrepid than I am...ha ha! wow, am I silly this morning! I think I better go drink some green tea or something, hope we all have a good week!!!!

Here is the link talking about statins and hep c....


http://tinyurl.com/mh2a6