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Post Info TOPIC: New trial for DAA failures


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RE: New trial for DAA failures
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It looks like this trial has two studys going at once.  The Polaris 1  (Nct02607735) is for  prior sof  exposer.

The Polaris II  (NCT 02607800) is for No prior sof exposer.

 

Two trials from Gilead with three DAA"s being used as treatment?  How could it get any better than that??

RC



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 M-61(3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18 https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep4.1280   

Tig


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I'm amazed at the size and scope of this study. I would definitely try to qualify for this if I was needing treatment. You're right Matt, it's Sovaldi/Velpatasvir and a new NS3/4A protease inhibitor, GS-9857. The last phases even tested using a 6 week protocol that was fairly successful for treatment naive individuals with genotype 1, but less so for Tx experienced. Longer protocols of 12 weeks looks to be the ticket for this study and the combo is pan genotypic (1-6) in nature. This is definitely one to keep our eyes open for as RC mentioned. Good information, thanks Robert! 

Here's some additional data on the earlier trials from EASL:

http://natap.org/2015/EASL/EASL_25.htm



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Tig

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Hey Robert

Thanks for posting info. on this new study. Like you have said this is a very large study.

Gilead is using their 2nd generation NS5A inhibitor (Velpatasvir) which has had very good SVR% on non DAA failures. I cannot imagine that there are that many patients out their for this study, maybe thats why their are so many sites.  

matt



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https://www.clinicaltrials.gov/ct2/show/study/NCT02607735?term=gilead+hcv+3&rank=27&show_locs=Y#locn 

Looks like folks who have been treated with DAA"s and failed could qualify for this trial. They may be looking for SOF failures.  The trial centers are all over the place so travel may be close for us.  This trial was just posted and recruiting has not started. This is one trial to keep an eye on. The only info it dosent mention is geno type?        RC



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 M-61(3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18 https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep4.1280   

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