Anyone else heard of this HCV-796?

[geosp724]

I'm new to this forum, I was diagnosed 3 years ago, genotype 1. My 1st treatment was nonresponsive, have gone almost a year now without teatment thinking all hope was lost. Talked to my Dr. about it and he sent me to Einstein medical center in Phila.
Man am I glad he did, for the first time since I was diagnosed I have some real hope. Seems there's a phase 2 study of this combined with peg-intron and rebetol that showed very positive results in phase 1, And he told me I was a perfect canidate for this study if I wanted to go for it. I've been reading anything I can find about this, and thought I'd ask if anyone else has heard of this or is going to be treated using this.
I haven't started it yet, as I haven't signed the consent forms yet, was hoping that some of you might have some insight on this, real people are much better to talk to then reading the medical terms (which I don't understand most of it anyway) I'm remembering how crappy I felt when I was on the first treatment which was useless for me.
I never told anyone what was wrong with me, (because of general ignorance to the disease) just went around feeling like **** all the time with no support. Hopefully I can find that here

[dmhrdh]

I have read great things about the HCV-796.  
If you have a chance to get into that trial I would take it!

[wyntre9]

Gee, CH.

I'm gonna change your name to research lady!

Will check out the links when I get a chance.  Thanks for the info.

[chcnme]

Hey there.  *IF* you happen to be one who wants to read read read read everything you can get your hands on :) (like me), I have collected some links on HCV 796 because I was offered the trial and so - I began reading all I could on it (the drug and phase I and opinions, etc).  I always pull this info back up when / if someone asks about HCV 796  IF they want to read it too.  

I've put the headings / titles of the articles above the link  (where you can find the whole article / abstract / opinion / trial info, etc.) Copy and paste that tinyurl into your browser, and it will take you to the full article).  

TITLE:
ViroPharma and Wyeth Initiate Dosing in Phase 2 Study of HCV-796 in Treatment Naive Patients and Non-Responders
EXTON, Pa., Oct. 24 /PRNewswire-FirstCall/

http://tinyurl.com/y9capn

==========================================

FROM VIROPHARMA / WYETH

EXCEPT:
Background
In December 1999, ViroPharma entered into an alliance with Wyeth, through its Wyeth Pharmaceuticals division, to discover, develop and commercialize additional novel inhibitors of Hepatitis C virus (HCV). Together with Wyeth, ViroPharma has discovered multiple, chemically distinct compound series that target the RNA replication process (RNA Polymerase) of HCV. The current focus of the companies' development efforts is on a compound called HCV-796, a non-nucleoside polymerase inhibitor.
Status
In October 2006, ViroPharma announced that dosing had commenced in a Phase 2 study of HCV-796.The objectives of this trial are to assess the safety, tolerability, pharmacokinetic profile, and antiviral activity of HCV-796, when used in combination with pegylated interferon alfa-2b plus ribavirin compared to the current standard of care in treatment-naïve subjects with HCV genotype 1 infection and in patients with HCV genotype 1 infection who were non-responders to prior HCV therapy.
(continued at link)

http://tinyurl.com/3ywowk

=========================================
TITLE:

ViroPharma Provides Financial Outlook for 2007
Monday January 8, 4:30 pm ET
- 2007 Net Product Sales Expected to Grow to $195 to $205 Million; Company to Increase Expenses to Advance Clinical Programs and Support Vancocin Growth -

(has some info on HCV 796 at url)

http://tinyurl.com/3brcxr

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TITLE:

HCV-796, new HCV non-nucleoside- 14 day study

"Antiviral Activity of the Non-Nucleoside Polymerase Inhibitor, HCV-796, in patients with chronic HCV: preliminary results from a randomized, double-blind, placebo-controlled, ascending multiple dose study"

Reported by Jules Levin
DDW, May 21-24, 2006, Los Angeles (Digestive Disease Week)

http://tinyurl.com/2dgbw6

===============================================

08 / 14 / 2006
ViroPharma and Wyeth Announce Achievement of Proof of Concept Milestone for HCV-796
- Companies Preparing to Initiate Phase 2 Clinical Evaluation

http://tinyurl.com/yy87rs

==================================================

Experimental Agent HCV-796 Shows Activity in Preclinical Studies
By Liz Highleyman

http://tinyurl.com/26otxj
===============================================

(THIS ONE - you will have to register to site, and then your can type in the search box "HCV 796" and read the literature that has HCV 796 in it (from the AASLD conference)

Clinical Care Options
Source: CCO Independent Conference Coverage of the 2006 Annual Meeting of the American Association for the Study of Liver Diseases*
By: Nezam H. Afdhal, MD, FRCPI, Karen L. Lindsay, MD, Mitchell L. Shiffman, MD
*CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.

http://tinyurl.com/2hqkxf
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Clinical trials dot org (Phase II trial info)

http://tinyurl.com/2ztkzp

======================

And this is some info Dr. Cecil (Hep C doc)  provided me when I asked him questions on his forum about the definition of the HCV 796 trial (what kind of trial, blinded, placebo, rescue drugs, etc.)  


HE SAID:

"This is a small preliminary trial and will guide the doses for the large phase 3 trial to come later. As a previously untreated patient, you would have a 50-50 chance of getting all 3 drugs and 50-50 chance of getting only pegylated interferon plus ribavirin. They are comparing standard 2 drug treatment that is the current FDA approved treatment to their 3 drug treatment that they hope is better. There is no placebo group who gets nothing.

It is open label meaning that you and the doctors would know what drugs you are getting.

The viral levels might be blinded to patients and doctors until the trial is completed. This helps prevent patients who are not responding from withdrawing from the trial since they do not know how they did until it is all over. Otherwise patients who are not responding tend to quit after a few months.

Some patients in each group will be sustained viral responders and presumably the ones who received all 3 drugs will have a higher percentage. Hopefully, there will not be any severe side effects from the new drug. This is a safety study to see look for serious adverse effects like death or liver failure from the new drug.

You will be given a copy of the complete protocol to study before you sign. Everything is spelled out in the protocol. You will see if you are allowed to have Procrit, Neupogen etc if needed. You can also see if the doses of ribavirin and pegylated interferon must be reduced if the hemoglobin or wbc are low.

The protocol will state if patients who were not given HCV 796 originally will be able to get it as a rescue therapy at a later time.
===================================

Hope this helps some. I am awaiting for the call myself to be told about the trial, and then I will be able to ask questions, and..go from there  (make my decision).  

For me personally, I am not too sure anymore  (even after getting real excited about this "opportunity"  with HCV 796, and even though my doc has said it's looking good)  that I am all too eager to attempt this trial with HCV 796 at this time (especially with the VX-950 data looking as GOOD as it is, and especially since VX-950 has been shown to have much greater potency in knocking the virus down - MUCH more potency, and  more data is coming out soon on VX-950, too - and that info is going to be very important for anyone "waiting" right now, and - since I've been told I'm in no "trouble"  and can wait.)  But then again, I'm torn  on the decision  (treat now or wait.)   If they call, I have to make a decision.  I was told I'd get the call in mid Jan and be in the trial by mid Feb.  (Yeah right! ) lol  sorry for the sarcasm - just tired of waiting :)  

Best of luck!  Stick around.  Have you seen the main forum, too?   This is a great place for info and support - there are a lot of people concentrated here who know a lot about Hep C and treatment.  

[geosp724]

Thanks a bunch, some of those I have read, some of them I didn't until today. Thanks again. It sounds very promising to me, I will contact the Doc tomorrow and ask him to put me on the list.
will update progress if accepted in trial.

[geosp724]

after posting last reply, I looked up that vx-950. Now I have a few questions for the Doc tomorrow, since it seems if I go for the hcv-796 trial I would then be ineligible for the vx-950 trial, which he didn't mention to me, so I need to ask questions about this.
Thanks a bunch for mentioning that, I did see it while reading about hcv-796 but didn't read about it.
Hey, during the first treatment, I asked no questions assuming that whatever the Doc said to do was the right thing, didn't research, didn't do nothing but what I was told to do.  And none of it helped me.
I was wrong the first time for not asking questions, not getting involved in the treatment just doing the treatment. I won't make the same miststake twice. I want to be rid of this disease!
It has opened my eyes some reading through the forums, Nice to know there are many others out there with this disease helping others. I wish I'd known about this site 3 years ago when first diagnosed.

[chcnme]

Hey there!  Been so busy today, and when I sit down at the computer I can't keep up with everything - lol (I just saw this post - your post back to me) and so since it's late, I'll catch you sometime tomorrow and will chat some more.  It's very nice to meet you.  I was diagnosed about 4 years ago, and it's been an eye opener.  Stick around! This is a great forum.  Today has been.. a little .. crazy, but we all get that way at times (guess we have to vent and express somehow - lol - and occasionally talk about something other than HCV.  

See in the funnies : )  btw - there are a lot of people here very very smart on the VX-950 stuff.  We have quite a few here in the VX-950 trial.  

Gosh I could talk all nite if I get going - I better go to bed :)  See ya soon.