"While Gilead is unlikely to pursue a partnership with Medivir and J&J since the company is developing a combination of its own therapies, doctors may prescribe the pair reported in the study off-label, Brian Abrahams, an analyst with Wells Fargo Securities in New York, said in a note today."
I hope Brian knows something!
http://www.bloomberg.com/news/2013-03-04/gilead-medivir-hepatitis-c-drug-clears-virus-in-patients.html

Yeah...and if further studies keep rolling out 100% results, why would insurance companies have a problem approving the off-label course? They'd love it, it seems to me - they only want to pay one time (if that) so they'll go with what works.
The reason this news is so exciting to me, apart from the great success rate with geno 1, is because I get the impression that Simeprevir is further along towards approval than other off-label candidates (for instance Daclatasvir). Maybe I'm wrong though...I looked into it briefly, but didn't find a definite answer on that.

The trial folks have regular communication with trial sponsor -- in my case that's Gilead. I don't know where they get their info, just repeating what they told me.

Correct or not, it's what I heard from those close to Gilead, at least in terms of trial.

As far as insurance not approving off label drug combos: if it's true, my bet is that it's financially based. It's just a business to them.

One other thing: the Sofosbuvir + 5885 trial has 800 patients enrolled. That's huge and seems like pre-FDA submittal actions, at least to me.

Anybody have data on the size of Sofobuvir (alone) trials? I do not know that; and are those trials for geno 2 & 3 only? Not sure on that point either.

Any info would be appreciated...

Hepcat

Does anyone know when it will be FDA approved? I can't get into one of these trials for anything! I am a relapser; is that the same thing as null? Thanks guys.

Linda we are just speculating on that. It goes to the FDA for approval in a couple of months and the FDA can take up to two years to approve but it could get fast tracked to 6 months as Boceprevir and Telaprevir were. That means with luck we could see it to market end of this year or early 2014.
Relapser is not as tough as null/non responder.
As a relapser you got a good viral response, either two log drop or became undetectable but then relapsed.
A null/non responder never got a 2 log viral drop in less than 12 weeks.... That's me!!! :^)

No, Sofosbuvir with the 5885 will be out with the Geno-2 and 3s in 2013, at the latest 2014 and that would be Jan.!

Hepcat--one pill or two combo --who gives a *uck when it come to off labeling. That has nothing to do with it. Daclastasvit is out--gone.

Geno I's--old your fuc'n seats--it is coming and fast. You won't need off labeling b/c your TP will be ble to treat soon.

Interferon is already being used for melanoma--need I say more--they have a diff. group of pts.

Heppers--it is a New Day!

Daclatasvir is in Phase III trials. It's not dead.

Gemo 2 & 3's, in trials, do not receive combo drugs. They receive Sofosbuvir alone or with Riba.

Off labeling is when the doc prescribes a med for you that's not intended for your ailment. Sofosbuvir alone would be intended for Geno 2 & 3's. My GI doc (not trial doc) suggested off labeling when the two drugs were approved (Sofosbuvir & Daclatasvir) but my trial doc said the combo pill discourages that. (I was disappointed too.)

However, if Sofosbuvir is released solo, that moots that point. Then the only obstacle would be whether your insurance company approves Sofosbuvir paired with another HCV drug. They might approve one and not the other or approve neither. Remember, the Rx is going to cost between $60,000 & $100,000.

Again, I'm relaying what I've learned. Don't get upset... I'm just the messenger.

Hepcat

Hey Hepcat - I'm sure nobody's upset with you. In fact, taken as whole, I'd PREFER your scenario, because you also see an early 2014 launch of the combo (if I read one of your posts right). If that was true, I wouldn't bother to quibble over combo or solo distinctions. I'd be too busy whooping it up!
But here's how I understand it - the late 2013-early 2014 launch isn't for the combo. It's just for Sofosbuvir, which will usually be used with Ribavirin to treat Genos 2 and 3.
The combo - Sofosbuvir AND Ledipasvir (5885) - won't be out til 2015 (ok, maybe late 2014). That will be effective for geno 1 - hopefully all genos and hopefully without Ribavirin - and that will REALLY be a new day.
I think your right that daclatasvir will still have an important place in this somewhere...in combo with SOMEBODY'S drugs. It's just too good to ignore. But the reason this thread that Kramer started here got me excited is that simeprevir seemed to work just as well with Sofosbuvir, and I was under the impression that it would be out before daclatasvir...opening up the off-label options much earlier.
I'm not sure if that's true...some confusing things on the net...but I'm still happy about this study. 100% is a great number to see.
Anyway...all the best to you! All the best to you, too, Renee! Sorry to disagree with you, but as with Hepcat, I HOPE YOU'RE RIGHT!

Right now, they're studying the drug combo, Sofosbuvir + 5885, in 3 trials: 600+ patients (ION-1, ION-2 and Lonestar). That sounds like they're getting ready for an FDA approval. These studies are massive.

I don't hear about similar Sofosbuvir (alone) huge studies. Maybe they're being conducted and I just haven't heard. All I know is Dr. Nelson told me that Sofosbuvir alone was 2 to 3 years out to discourage off label prescribing (which was my plan until recently).

Do these investigators have inside info? I don't know. I'm just glad I'm geno 1a, targeted for the combo therapy and don't have to worry about it. But I let you all know what I hear for general purposes. Believe it or not... it's what I heard but I have no way of verifying their info. Just repeating it. (I have verified the three studies and the numbers.)

Best to you,
HC

Sorry Hepcat if I came across hard. It is just that a lot of folks have been following these drugs for a while.

AND my family is slowly letting come out of the garage following my tx. :) Trust me, I have said a lot of 'sorries!' Sorry Hepcat for my forwardness.

But I have been following Sofosbuvir since Pharma. owned it. I saw the collapse of 7997 with Daclastasvir. If there is anyway that it could be marketed off label with the two together, Gilead would have moved forward with BMS. Plain and simple.

I have heard that Sofosbuvir could be offered off label with the interferon for genotype I in a shorter duration till the all oral comes out for all genetypes. But since THAT is right around the corner, why do it.

Another thing, these docs are just reporting info. to the drug companies. I don't think it is a two way street where they are letting the docs know what their plans are. I just think the docs see the data and are forming their own opinion.

I was part of the 200 in the beginning of the 800 in 11/12. My group did not even make it to the West Coast. Now the rest of the 600 have started.

Here is the link to the tax write off for BMS. I have heard that they could possibly hit Japan before the other drug Co. but not so here in the US.

www.fiercebiotech.com/tags/daclatasvir. ( you might remember the young man that died or the nurse on the heart transplant list???) homasjhenrylaw.com/practice-areas/drug-recalls-and-pharmaceutical-litigation/daclatasvir-and-bms-986094

The above is when they split and BMS had their own 986094 polymetase inhibitor.

Oh yes, Sofosbuvir only for geno types II and III with riba and later the 5885 with the genotypes 1-6 and hopefully no one will need the riba.

Tired of being banished to the garage :)

I see it this way. This is twice now Gilead is holding out for "The Whole Pie" but they spent $11,000,000,000.00 for Pharmasset over a year ago and are very anxious to start getting some return.
In the playing field Gilead's Sofosbuvir with Ledipasvir still needs Ribavirin to get the scores that have come in when they pair with another drug co. Last year is was BMS and now it's J&J.
I ssupect they will either really get their own single pill with Ribavirin very fast tract (you know how BIG money makes things happen here), or it will allow off label and start generating income from Sofosbuvir.
The competition is nipping a their heels and they are taking a gamble.
In the meantime we are dying. Could you imagine the public cry if this was a cure for cancer and this shit was going on?
Nobody cares about HCV ..feck most people don't even know what it is! Get it from salads you say? grrrrrrrrrrrrrr

BTW deaths from HCV now are higher than HIV annually.

I hear you Kramer. I have felt quilty, but also feel good and I did all that I could for these drugs to hit the market. I have come close to my fellow heppers.

My first experience in getting help was from a GI and was told "Oh no, we will call you, you don't call us." I did not go back, instead went to a University Hosp.

Round II--a doc I have been seeing for 18 years was told I needed some meds from the clinic during treatment, it was like pulling teeth. Currently trying to find another doc. .

Assholes. All about the $.

and pre-judgement.