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!
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
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
Thanks I have forwarded all info. Hopefully he will do it.
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
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.
Do you think this is as promising as the sof/ldv combo?
oh, lol you beat me to the punch.
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!
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!!
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
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
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