Schering-Plough's SCH 503034 Given FDA Fast Track Status!!!!!

[miked]

I posted the news release article earlier but it was deleted probably because I posted the entire article.  BTW a news release by a company is considered to be in  public domain.  Anyway here's the link to Schering's website and the release.

http://www.sch-plough.com/schering_plough/news/release.jsp?releaseID=809986

CTOAN:  What do you make of this news?  I think it's good to see a horse race between Vertex and Schering for the same dollars.  I was asked to join the SCH 503034 trial but declined because it is with INF and for twelve months (and my scarring is nil with no inflammation)....one of the big differences between the two trials is that Schering's is for non-responders and Vertex's is for tx naive (never been treated).

[layla]

Mike, How is your accident recovery coming! I hope well. It amazes me how much strengh we/actually you can have. I think of you and wish you well often. You have been a constant strength for many of us. I thank you so much for that. I always smile when I think of you or read your post.
Willing, Wow great to hear form you! I hope you are well. You were here when I first came and your scientific reseach was welcomed by me. I really needed it at the time as many of us did and many do so now. I hope all is well with you. Take care and thanks for posting.
Friole, The blip blip blip can be a reality. I hope it's yours next...
LL

[willing]

it's good to hear you're doing so well. As Mike said, I hope you drop by occasionally.

[can-do-man]

Hi there and welcome, inf. is interferon. Doctor Kwo is a very good hepatolgist there at iu. Please keep posting on the trial your in there. Im very interested in Schering-Plough new drug and would love too know what you think compared to current tx. Best of luck to you going forward.

[mikesimon]

Hi there Layla. I am thrilled that you're still clear. Stay well and drop in once in a while. Mike

[Hootie236]

Greetings All,
   Very thrilled to find a thread about this as I started the trial for SCH today at IU in Indy.
   A little hx: I am 50 y/o with 1a stage 1, good health and did tx 2 yrs ago. Went from 2 mil to 2000 in 24 weeks. Did most w/o ins so the looming issue of blood boosters became moot when Dr Kwo advised my then GI to have me drop tx.
   I need to read more threads as I have done little prep for this tx, unlike before but again SOoooo thrilled to find others talking about this.
  BTW what is INF?

TIA...will try and look in each day.

Hootie

[Forseegood]

nice to meet ya! yeah, watch out for that black cohosh! On the menopause sites there have been some warnings about it as well, in that it was making women's LFT's rise...it made me feel speedy, nearly everything does, ha ha! so I quit taking it right away...yes, we would love to know anything you'd like to share about these new trials, much appreciated, be well....

[friole]

Thank you for the inspiring news.  I started posting last May so didn't see many of your active posts, but had read an awful lot of them in the archives, especially about the thyroid.  That's got to be tough.  I am sorry yours did not return.  Thanks for the thought that this will someday all be a blip blip blip...

[vegas777]

will you do me one other favor please, once you get on that vertex trial see if you can pick the brains of the trial staff and get a ballpark of when they think phase III will begin...There are all kinds of speculation, not only among board viewers but the medical professional personnel as well...I was told last week by my hep doc that the new PI's were 5-7 years away from hitting the market and that phase III was 2 years down the road (they are going to be part of phase III) and then some people in here get a different synopsis and say it's 3-5 and 2-3 and so on...Would be nice to see if we can hear something directly from the staff that is involved in the trials...just a idea...

*dip*

[dancegirl54]

Yes PhaseII

[cuteus]

wow! 18 months! I think I am just about there now also. It does seem like a dream, this whole HCV thing, your reminder that it did happen is your struggle to stabilize your thyroid.  Someone came on not too long ago, chevy might remember because she asked about the thyroid issue and his/her problems resolved two yrs later.
I wish you a long healthy life. Enjoy that HCV life. You were part of the "graduating" class I was tracking, and I think most of us made it to SVR! Tnguy reported clear one yr post recently, another 1a bites the dust. That is three of us, recently.
take care

[vegas777]

the vertex trial you spoke of, is that phase II?

[layla]

Thank all of you for your good wishes and I also hope the best or each of you.
Cuteus, I did try to wean of the thyroid drug but unfortunately that will never happen now for me. I just could not accept losing my thyroid. I also saw 2 people who regained thyroid function and optomistically decided that was going to happen to me. Well it didn't. That does happen but it is very rare and I felt it was worth a shot. Oh well I have SVR!
Kalio, I hope you are doing 24 weeks and will soon be done. It's hard for me to even think of how I felt on tx. Keep in mind after all is said and done it is worth it.
Tallblond. I do hope your HCV stays in check and if you ever decide to tx I wish you the best. All these decisions are very tough and as you know very personal. Thanks for the well wishes.
Strator. It is not a pipedream. Hang in there. I does seem a long journey but when SVR it eventually becomes a past memory. Forseegood, Thanks for the well wishes. Take care.

Glad to see this forum is still a great place for support. LL

[dancegirl54]

Been traveling for work but I read this almost every day, I don't understand the problem with the posts- sometimes there are no new threads, other times there are a few new ones.
Going to have blood work redone next week since I have been off the herbal supplements for 2 months now - should be interesting to see if my levels have come down after the spike that doc said was primarily due to the black cohosh. These tests are part of the Fibroscan study I am in.  They plan to still screen me for the VX 950 trial that is probably not going to actually happen until April or most likely May. So I am working on improving my diet and trying to get more exercise. Cant lose weight, I'm skinny, but I really want to eat healthy
Daughter says she is just going to eat whatever she wants- what can I say, she's in college, at least she is not drinking

[jmjm530]

Can-Do-Man summed up the pro's and con's of treating very well.

As you may already know, another protease inhibitor, Vertex, has already been fast-tracked, and should the trials work out could be available in as little as 2-3 years. Preliminary SVR data for Vertex 950 is projected for very late 2006.

For now, you must carefully weigh the rewards of treating now (age, viral load, good health?) against the risks of the treatment drugs themselves given about a 40-50% success rate as a geno 1.

I don't know how much time you've already put into this decision, but you can't spend enough time educating yourself. In addition to researching here and elsewhere on the net, you also might want to speak to a couple of more doctors -- preferably hepatologists.

There's something you can't get anywhere other than sitting down face to face with an experienced doctor. Just keep in mind that like folks here, doctors have their own treatment bias and that's why I recommend more than one consult.

Good luck in however you decide. No right or wrong as long as you do the homework and you're comfortable with the decision.


-- Jim

[can-do-man]

After reading your post, I see two reasons to treat. Age 50 and low vl.

Also see two reasons not to treat. Little damage and geno1.

You seem to be leaning towards tx. So maybe thats the tie breaker? Whatever you decide heres hoping you the best of luck.

[antman]

hi,
just to reiterate mt stats. i'm M 50 yo, VL 750,000, 1/2 , 1a.
i am glad Schering is fast tracking the new PI drugs, but i don't think i will wait for them. i really don't think it's gonna be available 'till i'm in my mid 50's or later. then, will age negate the benefits? who knows, but it's also encouraging they are testing non-responders. if, and i don't want to poisen my chances, i didn't respond, it would be nice to know there was an alternative down the road. since, i'm only st.1 it's tempting to wait. but, let's face it the clock is ticking.i would like your opinions, as this is a very subjective call. eveyone has a different take, i like them all.
antman

[strator]

I love seeing posts like yours. Sometimes I catch myself thinking it's just a pipedream. Then I meet someone or read a post from someone SVR that's nice enough to stop by and spread the hope. Thank you, may your life be filled with joy,
Don

[friscosue13]

Excuse me for breaking into the thread.  Saw my gasto today and told him about the Penlac Nail Lacquer that my internist rx'd for my nail infection (we discussed this in an earlier thread).  He said that while it's not as harmful to the liver as oral meds for the condition, it's probably a good idea to wait until after tx to use it.  I'll probably be starting tx by the middle of February after a bx sometime next week.  It took me two years to make the decision to treat, but my doctors advised me that I'm playing Russian roulet, so here I go.

[can-do-man]

The new trials that Schering-Plough is having is for non-responders. Good luck to you, and hope some day you can beat this.

http://biz.yahoo.com/prnews/060130/nym083.html?.v=31

[susan400]

It's exciting for a lot of people to have a chance at these newer drugs coming out.  However, I will probably not be able to have access to any of these new drugs for years to come.  I don't qualify for any of the trials.  My insurance won't approve any of these expensive new drugs either.  I am currently trying to appeal a denial for Zelnorm and it's been around a heck of a lot longer and is a lot cheaper than the new Hep C drugs will be.  They decided not to approve the 8 Riba's (fortunately I had a surplus), either.  The weird thing is that they did approve the 7 Riba's (after many headaches)and it's as off label as the 8.  Somebody asked me on an earlier post as to why I'm taking so much Riba.  The answer is because: this is my 8th time treating and I've never gone undetected and my doctor heard about this study in Europe where there was a 90% clearance rate with people using high dose Riba with their interferon.  And before somebody asks me...  no, I have not had any improvement in my liver.  Each biopsy shows more fibrosis, not less, and I've had 3 biopsies. Anyway, I wish everybody well.

Susan

[Dale_Ray]

Hello Everyone:
My Neutrophil are up to 4365 as of Friday. The doctor tells me that is good so I am really not smart enough to know. I know when they were below 500 it was bad for a several days. My Nupogen injection has been cut in half fro 300 to 150 each Saturday night. I hope to feel better with this reduction. Valentine's Day is the date I will find out if I am a responder to the Pegasus treatement. What I am being told is that the viral load should have dropped 4 times or that I should show as non detectable. Big day I suppose. Several of you had told me about the water intake and how crucial it was. Life's been better with that little piece of information too. Hope everyone is doing well. Dale

[Forseegood]

the above post was meant for you didnt come out in the title...

[Forseegood]

Ha, funny title to my post I know, sounds like I'm talking about Eric Clapton, ha ha! Anyway, Layla, just wanted to thank you for your inspiring post, always nice to see people get their lives back from this strange world...and yes, one thing I have cultivated from this experience is a lot more empathy for people...which is a good thing and will serve me well for the rest of my life...

As far as the new drugs - I know there is a lot of controversy surrounding them, and many people are afraid that with the news of them being in the pipeline, that many will wait for them which might not be a good thing for everyone of course...I can sympathize with these fears...but I also think that if a person wants to find out what their own personal situation is, they can get plenty of info as to what to do in thier own case and ultimately make their own decision based on what their own doctors say, etc....

I'm just old enough to remember HIV and what a scourge that disease was (and still is for many people around the world.) I had many, many friends who were horribly ill with the disease (I work in the movie and television business, and there are many gay people, etc.)I had friends who hardly had any t-cells left and they were on their deathbeds, none of us were very hopeful about their futures because so many friends and collegues had already died. When they discovered the protease inhibitors for HIV they were fast-tracked and seemed to go into huge trials (where most people I knew were able to avail themselves of them) and they seemed to hit the market really fast after they were fast-tracked.

I wish I had the stats for this (I might go try to look them up) but they did this in order to stave off an epidemic of huge proportions. Well, the same type of situation goes for HCV (to a certain extent) and I just can't  believe that these new drugs are not going to be available for 5 to 7 years (with how well they are doing in present trials) my own doctor doesn't belive this, and I don't either. The government knows it has to do something because HCV infected people are on the verge of bankrupting the various governmental medical allotments....I respect other opinions on this, but this is just my own and my own docs....CTON hasn't chimed in on this shering drug, I remember him preferring the Vertex...and please, if you do want to argue this (to you know who) we can argue this intellently and civilly....hopefully...

[can-do-man]

WOW, after 2:00 pm eastern time and still opening threads.......Hmmmmmmmm