My brain is sludge today. ill come back to this later. Sure sounds like a benevolent offer. Wow.

I started a clinical trial for those very drugs. was undetected withing 9 days. The drugs were easy to take and had no side effects. some of us took riba with it, as I did, and some did not. Either way all were cured. I go back next month for my final blood test, It is over a year since I have been in the trial, started last April. I am so happy. These drugs are it!!!!

Best of luck CC!

I think the study was the old one.

They might be talking about off label treatments since Gilead & BMS are not doing further studies.

after hearing about this trial i would not reduce myself to consider doing anything having less than these desirable results

Just know hepcme that you would have to wait for Daclatasvir to be approved (it's not yet submitted) and even once both drugs are approved, the insurance might possibly do battle with you about paying for an off label treatment. They may or may not pay.

Sad but worth considering when choosing a Tx program next year or soon thereafter.

this is true, i was thinking about that. in my logical mind i say to myself, 'how can i do something less than what has been proven to be effective' plus a person - i think gets only one shot, if not successful he/she will be in a place worse than prior to trial treatment.

This trial has been discontinued quite a while ago and i'd bet good money on it never going to phase III. These were my trial drugs btw...

Hi Hepcat,

Daclatasvir is currently in phase III trials and their other HCV drugs... Studied in more than 4100 patients to date...

Asunaprevir is an oral, NS3 protease inhibitor in Phase III development with Daclatasvir... Also studied in more than 2000 patients to date...

BMS-791325 is a non-nucleoside inhibitor of the NS5B polymerase, currently in Phase II development for hepatitis C as a component of daclatasvir-based treatment regimens that has been studied in more than 300 patients to date as well... And then there's this recent news:

"Bristol-Myers gains FDA's 'breakthrough' track in race for hep C drug approval" April 25, 2013 | By John Carroll

"Bristol-Myers Squibb ($BMY) just gained an inside regulatory track in the frantic race to get new interferon-free hepatitis C drugs to the FDA. The big biotech reported in its quarterly statement that the agency has provided the coveted "breakthrough" status for a combination of daclatasvir with two other direct-acting antivirals, asunaprevir, an NS3 protease inhibitor and BMS-791325, an NS5B non-nucleoside polymerase inhibitor." The rest of the article is here:

http://www.fiercebiotech.com/story/bristol-myers-gains-fdas-breakthrough-track-race-hep-c-drug-approval/2013-04-25

Now BMS hasn't submitted their NDA's (New Drug Applications) yet for the above mentioned drugs, but are very close in doing so and since they have been given IND ( Investigational New Drug) status in order to proceed with trials... BMS has just about all they need to submit an NDA for Daclatasvir & Asunaprevir, they may do so in a matter of a couple of months, or in a few weeks for all we know!

So I wouldn't count out a Daclatasvir based combo being submitted and approved in the very near future just yet! ;>)

Yep! BMS is starting to look more and more like the "comeback kid" in this race for the cure! And the fact that they have years of experience in dealing with the FDA to approve new drugs, they may not come first in being approved but, they'll have an easier time going through the process of having an NDA ultimately approved by the FDA...

P.S... BMS has also formed a strategic alliance with Santaris Pharma, the folks who are developing Miravirsen, the first microRNA-targeted drug to enter human clinical trials, which is designed to recognize and sequester miR-122, a liver specific microRNA that the Hepatitis C virus requires for replication...

Miravirsen (SPC3649): a novel treatment for Hepatitis C Virus is a specific inhibitor of miR-122, a liver specific microRNA that the Hepatitis C virus requires for replication. Thus, unlike many other Hepatitis C therapies that directly target the virus, miravirsen works by removing a "helper" molecule (miR-122) that the virus needs in order to make new copies.

As a result, miravirsen is expected to provide a very high barrier to the generation of viral resistance - a significant problem with direct acting drugs due to the very high mutation rate of the virus...

They're still in a phase II b? trial, but the date from a completed phase IIa trial gave some very promising results which I won't get into because it will take too much space in this post for folks to read and take notice of this news... I will instead, include a link to the Santaris webpage that describes the data from the IIa trial in further detail. ;>)

http://www.santaris.com/product-pipeline/drug-candidates/infectious-diseases

I also read somewhere that BMS is partnering with Vertex, the makers of "Insanevik" lol to develop another drug combo with their newer drug : VX135... They're also partnering with Janssen - the makers of Simeprevir to test a combo with daclatasvir in a phase II or III clinical trial... I'm getting tired & sleepy so I apologize if I don't get everything perfectly precise as far as the data goes:>)

Then they're partnering with Merck, who was or still is conducting a phase II trial of a once-daily dose of BMSs NS5A replication complex inhibitor daclatasvir, and Mercks NS3/4A protease inhibitor MK-5172... What happens after that has yet to be decided, the companies admit. ;>)

http://www.pharmafile.com/news/179002/hcv-agreement-merck-and-bms

Bottom line is this... Don't count out BMS even if they're slightly behind Gilead because they're gaining on them! ;>)

Respectfully,
HANK

Hank, I didn't say Daclatasvir wouldn't be approved. I said there will be a wait since it's not been submitted yet. And to take it with Sofosbuvir would be off label which might be a fight with insurance co to pay for the tx.

Hepcat
The Study is 2012
The proposal is EASL 2013
Of course they are talking "off label" clearly.

Reference

Sulkowski MS et al. Phase 3 randomized controlled trial of all-oral treatment with sofosbuvir+ribavirin for 12 weeks compared to 24 weeks of peg+ribavirin in treatment-naive GT2/3 HCV-infected patients (FISSION). 48th International Liver Congress (EASL 2013), abstract 1417, Amsterdam, 2013.

to sum it up, the right combo is a reality100% cure with gilead and bms who are in development of the equivalent partner drug, and so far the trials have seen less than the desired 100% cure rate. very disappointing, but hopeful indeed. side effects long and short term are a concern worth considering

@Kramer, yes, I can read that.

Again, I was advised (i.e., warned) by my trial nurse that off an off label, expensive HCV TX might not be approved by the insurance co. It was why I went to the ION-2 study rather than wait for Sofosbuvir/Daclatasvir to take off label (which was my plan months ago).

Will insurance cos pay for Sofosbuvir + Daclatasvir once Daclatasvir is approved (and Sofosbuvir)? I don't know but I didn't want the potential battle.

Maybe we'll all get lucky and they'll be approved relatively close together and insurance will gladly pay for the off label TX.

Being a Canadian, you don't have to worry about insurance, right? We do down here in the US. And the insurance companies might squawk at this off label TX. Just saying it's something for US citizens under private insurance to think about.

That's all... HC

I posted some info on off label tx discussed at the forum. The way I read it (and I could be wrong) is since this combo only went through 2 phases so it might not have enough evidence as a treatment.

The result, Dusheiko said, is that "we don't have a large body of phase III data and that may restrict physicians from prescribing this particular combination."


http://www.dailystrength.org/c/Hepatitis_C/forum/16331626-blurb-off-label

uhm ..it's rescue therapy .holy cow!