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Hep C Discussion Forum -> General Discussion -> New Gilead non-Peg non-Riba study starting between 10/2013 - 11/2013 for Genotype 1's & 4's at NIH.
Post Info TOPIC: New Gilead non-Peg non-Riba study starting between 10/2013 - 11/2013 for Genotype 1's & 4's at NIH.
mehru


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RE: New Gilead non-Peg non-Riba study starting between 10/2013 - 11/2013 for Genotype 1's & 4's at NIH.
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Thanks Matt for outlining the details, my head is spinning over this opportunity.  The RN at NIH said I would probably qualify, but the screening is 5 hours of testing and my history is so borderline to their exclusion list. Then I'd have to commit to 8 an week study with additional housing expense during tx if I were approved. Well, they have my medical history paperwork (33 pages) sent to them electronically and just yesterday they emailed me saying they would get back if they needed additional info from me. It would be great if they had this study in other parts of the country as well. Although NIH seems very particular doing everything at their own facility.  



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Geno 1a, Stage 3-4 early cirrhosis (labs, recent biopsy, MRE elastography to confirm), 1999 rebetron trial with inf/riba *non/partial responder at 16 wks.  4/2013 started victrelis triple tx - had to discontinue after 2 weeks due to rash.

 
Matt Chris


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Hey Mehru

Thanks for posting this trial info. I checked it out and the study will have both cirrhotics and non-Cirrhotics in the study. They will also have treatment experineced and naive in its nine different arms. Gilead will be testing it's Sofosbuvir combined with it's other DAA's  

Here is there outlined Objectives: - To see whether GS-7977 with GS-5885 alone or in combination with either GS-9669 or 9451 can be used to treat HCV infection

GS-7977 =  Sofosbuvir - Nucleoside Polymerase Inhibitor

GS-5885 =  Ledipasvir  - NS5A  Inhibitor

GS- 9669 = Non-Nucleoside Polymerase

GS-9451 = Protease Inhibitor

Looks like they are trying to find the best combo for mostly Geno 1 , they are having one Geno 4 group as well.

So far they have listed only Maryland and the D.C. Area is the sites in the US 

This would be a good study to try to get into, but they have a long list of exclusion criteria which are clearly listed on the ClinicalTrials.Gov

Matt

 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
mehru


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You have to be in Washington, DC area during tx. I am considering doing this one but have to look in to cost of temporary housing.  Also, I would have to be approved.

Combination Therapy for Chronic Hepatitis C Infection

This study is currently recruiting participants.
Verified December 2012 by National Institutes of Health Clinical Center (CC)
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01805882
First received: March 5, 2013
Last updated: August 22, 2013
Last verified: December 2012
History of Changes
  Purpose

Background:

- GS-7977, GS-5885, GS-9669, and GS-9451 are new drugs for treating hepatitis C virus (HCV) infection. GS-7977 may help treat the infection when used with other treatments like interferon therapy. GS-5885, and GS-9669, and GS-9451 also lower the amount ofHCV in the body. Researchers want to see whether GS-7977 can be combined with any of the other three drugs to treat HCV infection. Some participants will take GS-7977 and GS-5885. Others will take GS-7977, GS-5885 and GS-9669 or GS-7977, GS-5885 and GS-9451.

Objectives:

- To see whether GS-7977 with GS-5885 alone or in combination with either GS-9669 or 9451 can be used to treat HCV infection.



__________________

Geno 1a, Stage 3-4 early cirrhosis (labs, recent biopsy, MRE elastography to confirm), 1999 rebetron trial with inf/riba *non/partial responder at 16 wks.  4/2013 started victrelis triple tx - had to discontinue after 2 weeks due to rash.

 
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Hep C Discussion Forum -> General Discussion -> New Gilead non-Peg non-Riba study starting between 10/2013 - 11/2013 for Genotype 1's & 4's at NIH.
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