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new treatments coming along question
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new treatments coming along question

I am confused about the new treatments.  Can anyone tell me more about the Sofosbuvir, Ledipasvir Combo Therapy?   The alternate  and off label names are  hard to keep straight.  Is there a trial anywhere without the riba and interferon?   Trying to find out for a friend  that is a 1a. I almost have convinced him it is time to treat!  Any help would be appreciated.   Unfortunately my friend has no insurance and poor as a church mouse.  He will not treat with interferon.  Im trying to make him understand he needs to find out his liver status.  last biopsy was in 04 and he had some scaring but he couldnt tell me what stage he was.   He also had a bad experience with the biopsy.  Just a bunch of bad luck for him.  He also has horrible guilt because he use to donate blood a lot not knowing he had it.  When one day they sent him a letter that he tested positive when the test first was used to test the blood supply.  
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1747881_tn?1358189534
Looks like maybe spots available, 3 site's in VA not yet recruiting


UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects

United States, Virginia

Mt Vernon Endoscopy Center Recruiting
Alexandria, Virginia, United States, 22306
Contact: Jonathan Mccone, Site 0042    703-780-0994      

Local Institution Not yet recruiting
Falls Church, Virginia, United States, 22042
Contact: Site 0050        

Local Institution Not yet recruiting
Newport News, Virginia, United States, 23602
Contact: Site 0027        

Local Institution Not yet recruiting
Norfolk, Virginia, United States, 23502
Contact: Site 0049        

http://clinicaltrials.gov/ct2/show/study/NCT01979939?term=hepatitis+c+AND+virginia&recr=Open&rank=6&show_locs=Y#locn
13 Comments Post a Comment
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1747881_tn?1358189534
Sofosbuvir, Ledipasvir Combo Therapy?

It is up for approval at this time

here is a non inf trial that look good in tx

http://clinicaltrials.gov/ct2/show/NCT01979939?term=hepatitis+c+AND+texas&recr=Open&rank=10

It is the only one I see for geno 1's in TX, follow the link for all open trials in that state

http://clinicaltrials.gov/ct2/results?term=hepatitis+c+AND+texas&recr=Open&pg=1
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180992_tn?1383377657
BMS triple non interferon trial started in January and Gilead 's for Cirrhotic  was also January and all if filled at my local labs.  I know of no others at the moment. The BMS that Hrsepwrguy mentions above in Texas is all filled in Calif. where I am.  I have a friend in the trial and on 4th week. Has been UND since week 2.  Doing really well !

Gilead filed for approval for combo of SOF/LDV recently
http://www.gilead.com/news/press-releases/2014/2/gilead-files-for-us-approval-of-ledipasvirsofosbuvir-fixeddose-combination-tablet-for-genotype-1-hepatitis-c

They filed April 2013 for Sofosbuvir alone and it was approved in December, so this combo pill should be approved by late fall?

Best Wishes
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789911_tn?1368640383
Thanks for your replies! My friend lives in VA and I have sent him all I could find on research centers there. Will this combo pill be for 1a's. with no interferon or riba?  How will people pay for it with no insurance??  I was hoping to help him find a phase 3 trial.   Oh I see the link purplecat. I will go look at it.  Thanks!!
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1747881_tn?1358189534
Looks like maybe spots available, 3 site's in VA not yet recruiting


UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects

United States, Virginia

Mt Vernon Endoscopy Center Recruiting
Alexandria, Virginia, United States, 22306
Contact: Jonathan Mccone, Site 0042    703-780-0994      

Local Institution Not yet recruiting
Falls Church, Virginia, United States, 22042
Contact: Site 0050        

Local Institution Not yet recruiting
Newport News, Virginia, United States, 23602
Contact: Site 0027        

Local Institution Not yet recruiting
Norfolk, Virginia, United States, 23502
Contact: Site 0049        

http://clinicaltrials.gov/ct2/show/study/NCT01979939?term=hepatitis+c+AND+virginia&recr=Open&rank=6&show_locs=Y#locn
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789911_tn?1368640383
The NCT01979939 , I did look into this trial and it looks very promising for my friend.  He needs to get into a trial due to finances.  They are not yet recruiting where he lives in VA near newport news, but they are in mt. vernon Va  which is drivable.  It is also great that the bristol myer drug daclatsvir is the one which was paired up with Gileads Sofosbuvir  where all the stink was raised about them not working together.    So thank you also for that info!
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789911_tn?1368640383
oh, lol you beat me to the punch.  
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789911_tn?1368640383
Do you think this is as promising as the sof/ldv combo?
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1747881_tn?1358189534
Investigational Triple DAA Regimen of Daclatasvir, Asunaprevir and BMS-791325 Achieved SVR12 of 94% in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C Infection in Phase II Trial

http://news.bms.com/press-release/rd-news/investigational-triple-daa-regimen-daclatasvir-asunaprevir-and-bms-791325-achi

I would do it.
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1747881_tn?1358189534
Abbvie has a new combo as well, I think it is up for approval also, lots of good stuff coming but the trick is getting treated with no ins, maybe could get some kind of compassionate care.

(Reuters) - AbbVie Inc's all-oral hepatitis C therapy cured 96 percent of difficult-to-treat patients in a late-stage clinical trial after 12 weeks, keeping the company well placed in a highly competitive race to deliver new treatments for the serious liver disease.

http://www.reuters.com/article/2013/12/10/us-abbvie-study-hepatitisc-idUSBRE9B90KL20131210

AbbVie’s trial for an unnamed multidrug therapy is in the last of three stages typically required for U.S. approval and is moving quickly, Scott Brun, the company’s head of drug development, told investors today at a conference in New York. Gilead is seeking to bring its own multidrug regimen with its therapies sofosbuvir and ledipasvir to market next year.

“We’ve got a very good shot at being first,” Brun said at the conference hosted by Goldman Sachs Group Inc. “It is a very tight race.”

http://www.bloomberg.com/news/2013-06-13/abbvie-says-it-can-be-first-with-new-hepatitis-c-drugs.html
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789911_tn?1368640383
Thanks I have forwarded all info.  Hopefully he will do it.
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408795_tn?1324939275
Glad you brought up the question about Ledipasvir/Sofosbuvir Combo.  My doctor wants me to tx with this combination at the end of 2015 as he expects it to be approved by then.  According to his numbers the percentage cured or SVR were 95% for genotype 1's, that's dang good.  I haven't been on this forum for quite awhile but I had to say something when I read your post.  If you can get your friend hooked up with a clinical trial site then they'll do the rest.  Good luck to you and a big shout out to all my friends here on this forum.  More info at the below link.  


http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/antiviraldrugsadvisorycommittee/ucm375286.pdf
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317787_tn?1373214989
Hey there lady, it is so nice of you to help your friend.  I wish you both lots of luck.
You are a great friend.
Dee
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789911_tn?1368640383
medhelp sent me a note to pick out a best answer.  I did for the one hrspower sent me about the NCT01979939 trial info. but all of these answers I needed and are the best.  Thank you all for your awesome time that you would take to get me the info I am looking for.  and your thoughts my friends!  
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