EASL presentation on HCV-796

For those following or interested in HCV-796  (polymerase inhibitor)  here's what they presented at the EASL.

ViroPharma Announces Presentation of Additional HCV-796 Data at Meeting of The European Association for the Study of the Liver      

(continued next post)

[chcnme]

ViroPharma Announces Presentation of Additional HCV-796 Data at Meeting of The European Association for the Study of the Liver

13 Apr 2007 Phase 1b Combination Data Highlight Favorable Tolerability and Additive Antiviral Activity of HCV-796


EXTON, PA, USA | Apr 13, 2007 | ViroPharma Incorporated (Nasdaq: VPHM) today announced additional data from a Phase 1b study of HCV- 796, a unique, orally dosed hepatitis C virus (HCV) polymerase inhibitor at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL). This meeting is being held in Barcelona, Spain. These data on the antiviral activity and tolerability of twice daily HCV-796 in combination with pegylated interferon alfa-2b (peg-IFN) elaborate on previously presented data. HCV-796 is currently undergoing Phase 2 evaluation and is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).

These Phase 1b combination data demonstrate the additive antiviral effects of HCV-796 across multiple genotypes of hepatitis C virus, in treatment-na

[chcnme]

For those interested in the trials with HCV 796 see:

SOURCE:  
http://clinicaltrials.gov/ct/show/NCT00367887?order=1

A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects

This study is currently recruiting patients.

Verified by Wyeth April 2007

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00367887


Purpose

This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype

1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).


Hepatitis C
Drug: HCV 796
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase 2, Randomized, Open-Label Study of the Safety, Antiviral Activity, and Pharmacokinetics of HCV-796 Administered in Combination With Peginterferon Alfa 2B (Peg-Intron) Plus Ribavirin (Rebetol) Versus Peg-Intron Plus Rebetol in Subjects With Hepatitis C Virus Genotype 1 Infection

Further study details as provided by Wyeth:
Primary Outcomes: Hepatitis C Virus (HCV) RNA concentrations in the blood.
Expected Total Enrollment:  267
Study start: September 2006;  Expected completion: October 2008


Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both
Criteria
Major Criteria for Inclusion:

Infection with HCV genotype 1
HCV- infected subjects naive to treatment
HCV-infected non-responder subjects
Major Criteria for Exclusion:

Women who are pregnant or breastfeeding
ALT > or = 3X the upper limit of normal
AST > or = 5X the upper limit of normal
Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00367887

Trial Manager       ***@****


United States, Alabama
      Birmingham,  Alabama,  35235,  United States; Recruiting

United States, California
      San Diego,  California,  92123,  United States; Recruiting

      San Francisco,  California,  94115,  United States; Recruiting

      San Diego,  California,  92161,  United States; Recruiting

      Los Angeles,  California,  90033,  United States; Recruiting

      Long Beach,  California,  90882,  United States; Recruiting

      La Jolla,  California,  92037,  United States; Recruiting

      Los Angeles,  California,  90048,  United States; Not yet recruiting

      Pasadena,  California,  91105,  United States; Recruiting

      San Francisco,  California,  94121,  United States; Recruiting

      Anaheim,  California,  92801,  United States; Recruiting

United States, Colorado
      Denver,  Colorado,  80262,  United States; Recruiting

United States, District of Columbia
      Washington,  District of Columbia,  20010,  United States; Recruiting

United States, Florida
      Gainesville,  Florida,  32610,  United States; Recruiting

      Miami,  Florida,  33136,  United States; Recruiting

United States, Georgia
      Atlanta,  Georgia,  30309,  United States; Recruiting

United States, Illinois
      Chicago,  Illinois,  60637,  United States; Recruiting

United States, Kentucky
      Louisville,  Kentucky,  40202,  United States; Recruiting

United States, Louisiana
      New Orleans,  Louisiana,  70115,  United States; Recruiting

United States, Maryland
      Baltimore,  Maryland,  21287,  United States; Not yet recruiting

United States, Massachusetts
      Boston,  Massachusetts,  02215,  United States; Recruiting

      Worcester,  Massachusetts,  01655,  United States; Recruiting

United States, Michigan
      Detroit,  Michigan,  48202,  United States; Recruiting

United States, Minnesota
      Plymouth,  Minnesota,  55446,  United States; Recruiting

United States, Missouri
      St. Louis,  Missouri,  63104,  United States; Recruiting

United States, New Mexico
      Albuquerque,  New Mexico,  87131,  United States; Recruiting

United States, New York
      Bronx,  New York,  10468,  United States; Recruiting

      New York,  New York,  10032,  United States; Recruiting

      New York,  New York,  10021,  United States; Recruiting

      New York,  New York,  10029,  United States; Recruiting

      Bronx,  New York,  10461,  United States; Recruiting

United States, North Carolina
      Chapel Hill,  North Carolina,  27514,  United States; Recruiting

      Durham,  North Carolina,  27710,  United States; Recruiting

United States, Ohio
      Cleveland,  Ohio,  44195,  United States; Recruiting

      Cincinnati,  Ohio,  45219,  United States; Recruiting

United States, Pennsylvania
      Philadelphia,  Pennsylvania,  19141,  United States; Recruiting

United States, Texas
      Houston,  Texas,  77030,  United States; Not yet recruiting

      Houston,  Texas,  77030,  United States; Recruiting

United States, Virginia
      Richmond,  Virginia,  23249,  United States; Recruiting

      Fairfax,  Virginia,  22031,  United States; Recruiting

      Annandale,  Virginia,  22003,  United States; Recruiting

United States, Washington
      Seattle,  Washington,  98195,  United States; Terminated

United States, West Virginia
      Morgantown,  West Virginia,  26506,  United States; Not yet recruiting

Puerto Rico
      Santurce,  00909,  Puerto Rico; Recruiting


Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research    
More Information

Study ID Numbers:  3173A1-200
Last Updated:  April 11, 2007
Record first received:  August 21, 2006
ClinicalTrials.gov Identifier:  NCT00367887
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on April 13, 2007
=================================

SOURCE:  

http://clinicaltrials.gov/ct/show/NCT00367887?order=1

[foofighter]

Does this info have anyone else interested in participating in the trial?

I go for my trial screening exam tomorrow.  I somehow missed that Phase 1 didn't include Riba (or didn't remember). And adding the Riba might really kick it into high gear. Or cause problems, I guess.

So, even though it was a small group it looks pretty good, right? What do you think Jim? Of the three that dropped out on the combination therapy, the side effects didn't seem too scary (except for the methadone guy). Scary enough if it happens to you I know.

[chcnme]

Hi foo.  I have heard from some (or read notes) where some are interested, though I don't think the word is out as much about 796 as VX  (understandably), and VX is what everyone has been eyeing.  Personally, based on what I've read - I think the 796 looks like a great trial for someone to shoot for if they want to be treated with "newer drugs".   Doc said that unlike VX-950 it would allow people such as myself who had just had a few weeks of prior treatment to get in.   He said it would be given with SOC  (PegIntron and Riba) for 48 weeks.  

I recall reading  (can't tell you where from what source I read it)   that one day HCV treatment will most likely consist of a protease inhibitor and a polymerase inhibitor  (and I recall it was thought the two might be VX-950 and HCV 796).  That sparked my interest even moreso in the 796.  

It's got pretty good looking data, don't you think?  If I weren't so concerned about the fact that no rescue drugs will be allowed  (probably)  I'd be real excited about the chance.  For someone who's never treated or who's had only a few weeks and doesn't have concerns about neutropenia, reduction of dose, or other health issues, or for nonresponders, I think it's a great chance if someone can get in it.  If my doc at Duke thinks it's the next best "newer drug" as far as a trial,  then it's a good one,  I think.   My hepatologist locally is concerned about the rescue drug issue  (trials usually don't allow them.)  Doc at Duke said that was to be seen and that I would be told about whether they're allowed or not and when they're allowed when they (the research coordinator)  calls me.   THe clinical trials site has just recently updated many of the sites to "now recruiting" (they had mostly been listed as "not recruiting yet" -- for months).  And so...it looks like they're starting up and getting into gear.  Ask your doc if you're interested!  Best of luck.  

[coeric]

for what it's worth,  Dr. E at the university of colorado characterized this drug as "very promising."  and is currently enrolling subjects. two weeks ago my alt was 400 so i  don't  qualify.  

[chcnme]

DA**!  I am so sorry about the 400 something enzymes :(  Hang in there.  Let us know how you're doing.  

[willing]

thanks for posting - if anyone has a link to Wyeth's '05 monotheraphy results it would be interesting to compare those with the combo ones. The combined polymerase/protease inhibitor strategy is one I'm betting on as well. The escape mutations required for the virus to survive each inhibitor are independent so the effects should multiply: if 10 % of the virus can evolve to the C316F/Y or S365T/A mutations required to replicate in the presence of 796 and 10% can evolve to the corresponding 750 escape mutations combo tx should only leave 1% to ifn's general purpose antiviral effect. I assume it won't be too much longer before some specialist/research-lab that has access to both drugs can post results.

[jmjm530]

http://www.hivandhepatitis.com/2006icr/ddw/docs/053006_c.html

[chcnme]

Good question, Willie  (thanks for the link on that).  I think a poly and prot inhib will be the treatment one day, for sure - hopefully without INF (probably for sure, too.)  I wonder which two it'll be (another wait and see, definitely for sure :)

And thanks, Willing  - great observation.  

[Willy50]

http://www.marketwatch.com/News/Story/Story.aspx?guid=%7b26632261-E630-4A66-9A16-371F06B1B3E5%7d&siteid=yhoo&dist=yhoo

SGP's (PI) + a polymerase inhibitor= possible new TX

TVR (PI) VX-950 is also expected to be combined with another polymerase inhibitor at some point in the future.  IF they are in partnership with SGP could that prevent combining these 2 compounds? (TVR and HCV-796 )

Some folks think the new inhibitirs will be the wave of the future; no more shots.  No more interferon.

best,
Willy

[Forseegood]

Just wanted to say, it's always good to see you here, I'd be interested in hearing your observations, once all this data comes in on a few of these new meds...hope youre well and thriving...