Hep C Discussion Forum

Members Login
Username 
 
Password 
    Remember Me  
Chatbox
Please log in to join the chat!
Hep C Discussion Forum -> Hep C News -> Idenix Announces Phase II All-Oral Combination Study of Samatasvir and Simeprevir
Post Info TOPIC: Idenix Announces Phase II All-Oral Combination Study of Samatasvir and Simeprevir
rundout


Member

Status: Offline
Posts: 20
Date:
RE: Idenix Announces Phase II All-Oral Combination Study of Samatasvir and Simeprevir
Permalink  
 

Helix -2 is now open for enrollment 

 

http://ir.idenix.com/releasedetail.cfm?ReleaseID=810564



__________________

GT1a /1b  IDX719/Olysio/Tmc647055/Noravir/Ribavirian ..ST1/27/14..  EOT 4/21/2014 UND EOT+4 SVR
Cinnamon Girl


Guru

Status: Offline
Posts: 5629
Date:
Permalink  
 

Idenix Pharmaceuticals Announces Initiation of Phase II All-Oral Combination Study of Samatasvir (IDX719) and Simeprevir (TMC435) for the Treatment of Hepatitis C Virus (HCV) Infection

Idenix Pharmaceuticals, Inc...today announced the initiation of the phase II HELIX-1 clinical trial evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of samatasvir (IDX719), Idenix's once-daily pan-genotypic NS5A inhibitor, and simeprevir (TMC435), a once-daily protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB.

The HELIX-1 trial is a 12-week, randomized, double-blind, parallel group study evaluating the safety and tolerability of samatasvir and simeprevir in addition to antiviral activity endpoints, with a target enrollment of 90 treatment-naļve, non-cirrhotic, genotype 1b or 4 HCV-infected patients. Patients will be randomized equally across three treatment arms, receiving either 50, 100, or 150 mg samatasvir once-daily for 12 weeks in combination with simeprevir plus ribavirin. The HELIX-1 trial is the first study in HCV-infected patients to commence under a non-exclusive collaboration agreement signed with Janssen in January 2013. A second trial (HELIX-2) of samatasvir, simeprevir and TMC647055, a once-daily non-nucleoside polymerase inhibitor boosted with low-dose ritonavir being developed by Janssen, is expected to initiate in the second half of 2013.

Full article...

http://hcvadvocate.blogspot.ca/2013/05/idenix-pharmaceuticals-announces.html



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
Page 1 of 1  sorted by
 
Quick Reply

Please log in to post quick replies.
Hep C Discussion Forum -> Hep C News -> Idenix Announces Phase II All-Oral Combination Study of Samatasvir and Simeprevir
Legal Disclaimer:

THIS FORUM, IT'S OWNERS, ADMINISTRATORS, MODERATORS AND MEMBERS DO NOT AT ANY TIME GIVE MEDICAL ADVICE AND IN ALL CASES REFER ANYONE HERE TO SEEK APPROPRIATE MEDICAL ADVICE FROM THEIR DOCTOR.