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.
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
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