Patience now there's an interesting word. One thing about hep c is you learn too have some. Peace

Good news indeed. I know there are lots of folks on this board waiting on the formal release.

I sure hope it proves successful in the real world without riba and interferon. Twelve weeks is much better than the current options, but it's still a ton of misery.

One question though: Is the twelve week period only for early responders? I haven't seen any treatment protocols listed like they have now, like going 24 weeks if you're undie at week 4, otherwise you go 48. Will there be a similar schedule with Sofosbuvir?

Reminder - Geno 2's will have Sofosbuvir & Riba whenever Sofos has FDA approval. Not sure about geno 3's - they were being found surprisingly "more difficult" to treat on that mix - however, I think they will be able to at least try the Sofos + Riba, with maybe less stellar results than the geno 2's. Geno 1's are stuck with Enter-Fear-On (AND Riba) if they want to do Sofos. when it is first approved - + Riba. Most of us geno 1's will say "no thanks" to that. Anyone who had "false hopes" about no Interferon in the first FDA approved tx off the block hasn't been paying attention. It's always been pretty clear in the various articles that Geno 1's were going to have to deal with the Interferon for a while - probably until 2015 - as far as FDA APPROVED tx. I get frustrated when I see posts here and on other forums that mislead people, i.e., don't state the entire facts - which is - geno 1 = Sofos. + Riba + Interferon ... until Ledispasvir is approved, both Sofos and Led being Gilead drugs. And yes, indeed, Gilead decided not to play ball with BMS even though their (Gilead) sofos and BMS' daclatasvir had ONE HUNDRED PERCENT efficacy in trials. Gilead hurt us bad! Of course it was about money. Gilead didn't want to split the profit with BMS - these pharmas don't care about us - and they never will. It's ALL about profit. As far as why so many trials STILL going on with Interferon, it has something to do with some kind of .... damn, I forget what it's called... but the pharma who has Interferon has some kind of contract or something in place until I think next year. ALL GAMES, POLITICS and GREED.

But HENRY has brought some real light into this picture for us geno 1's - yes, SIMEPREVIR! Sofos + Simi would be an off label tx, as Henry wrote, so let's hope our insurance will pay for it - I suspect they will want some sort of statement that it's rather urgent. Henry, am I right that this combo will be considered off label because FDA has not approved that SPECIFIC combo, that regimen - as in Sofos and Sime ONLY - for tx for geno 1's? This is an interesting article - a few months old now, but still interesting.

http://blogs.jwatch.org/hiv-id-observations/index.php/both-simeprevir-and-sofosbuvir-likely-approved-by-2014-clinicalethicalpharmacoeconomic-dilemmas-loom/2013/06/11/

Here's a blurb from it: "So if these two drugs are both approved as expected, one could easily make the case that the best treatment for HCV genotype 1 in terms of efficacy, safety, tolerability, pretty much everything except drug-drug interactions and cost will be the COSMOS regimen of simeprevir and sofosbuvir, with or without ribavirin. And emphatically without interferon.

And that, my dear friends, is off-label use."

Mr. O - I have not read anything specific about tx protocols with the "around the corner" tx with Sofosbuvir. In Gilead trials, and I follow only the ones for geno 1's, Sofosbuvir + Ledipasvir was being tested in 8 and 12 week arms, and everyone I know of - from reading another forum - who did either one of the arms was UD by week two. Some arms had Riba in them, but those folks didn't clear much faster than the ones who didn't have the Riba. Those trials were Phase III and are just wrapping up (I think). The BIG question is, will they achieve SVR - like SVR24? Let's hope so!

Reminder (and all) - just read over my (as usual) long post and want to clarify - when Sofosbuvir is FDA approved:

Geno 1's will be offered: Sofos + Interferon + Riba
Geno 2's will be offered: Sofos + Riba (no Interferon)
Geno 3's - same as 2's.

When I say "offer" I mean that it will be an FDA approved regimen, therefore, NOT off label, therefore, insurance SHOULD pay for it - but nothing is guaranteed in that regard. Each individual will just have to find out if and when they choose to treat with whatever regimen is approved for their genotype.

As always - thanks for the info Kramer :)

@catmagic wrote: "Gilead decided not to play ball with BMS even though their (Gilead) sofos and BMS' daclatasvir had ONE HUNDRED PERCENT efficacy in trials."

I don't believe they had a 100% cure rate regardless of the misinformation put out by Gilead's marketing dpt. My trial coordinator told me that not everyone cleared, and that was just at one location (only a handful of people) that I happen to know about.

I heard a really interesting feature on NPR that I posted about a while back. Pharma can do multiple studies and if, let's say, only 25% of the trials have promising results they can and do disregard all the disappointing studies and will publicize the promising results from the few good studies and hide all the other studies from the public and medical community.

Well, okay - maybe not 100% - I did read that though - however, I think the results were pretty darn good. If not, then we geno 1's lost nothing in the power play made by Gilead, and it was all hype. That could be the case. Who knows. I certainly wouldn't put it past any pharma to pick and choose the information they make public from trials.

I think I'll just sit back on these discussions from now on and wish everyone the best who still has this virus and is hoping for tx that is effective and not so harsh. And also - forever SVR for those who have treated, be it trial or "regular" tx.

FDA process to begin Oct 25 and financial news is predicting Dec 8 for approval.

Predictions, predictions, predictions = estimate = guess = treatment because of making their best educated guess and the results are once again are a product of predictions!

I personally hope it's sooner than the 8th of December... Still, no one really knows for sure when exactly it will be approved so let's not get ahead of ourselves with that date although, it sure does read as not too long from now and that's very positive and promising IMHO!!!

Respectfully,
Henry

Too many "are in that sentence!!! Fat fingered virus has now altered my sense of sentence structure... Ohhhh Noooo!!!!! Mr. Bill!!!

@catmagic...what did confused me really badly is Gilead Interferon free trials. Included Kat so i the the combination she did the one what will get the approval as was so successful.I was 100% clueless as even Kramer was writing the new stuff is coming out in Dec, and everyone is shelved and waiting for that.

That case people who cant take Interferon got to wait 2 more years? What is a shame as the new pills are proven working NOW. What is the wait for? So all it happened now we got 3 different pills for the time being, one will take over for sure immediate and rule the roost.

In the same time peoples liver keep on deteriorating, oh this is not real.If those Interferon free meds are so successful, why don't they getting the approval for that?Many folks did the trial , prior non responders, so as people who failed a couple times. What's going on here? They have approved Telepravir and the drugs works even better went on the sidelines?

Bika,

The treatment FAILED US!!! we didn't fail the treatment at all because we took it just like everyone else who's treatment was successful for them!!!

So let's get that straight because I'm really tired of some folks in here whether it be consciously or being unaware that when someone says that the person failed when they write this or something similar: "so as people who failed a couple times."
Why is this not only wrong but also insulting??? Because of this:

They are basically saying that we did something wrong or we're not good enough because we weren't successful with the treatment when in reality, the treatment failed us instead of the other way around!!! We didn't fail anything at all!!!

So to those of you that are unaware that when you write:
"They failed treatment" or something similar where you are inferring that the person failed treatment, please be aware that you are insulting all of us who had the treatment fail them! Because that is what really did happen.

Respectfully,
Henry

All I can say is simply this - I, as a Geno 1, will not have an FDA approved treatment until there is a DAA added to the mix along with Sofosbuvir. As it looks now, what will be hopefully FDA approved in December is this:

Geno 2's: Sofosbuvir + Riba
Geno 3's - same as above
Geno 1's - Sofos + Interferon + RIba

I cannot answer as to the "why" of it - the unfairness and injustice - beyond the fact that Big Pharma cares about money and NOTHING ELSE. Geno 1's need a second DAA to go along with the Sofos (and to leave out Interferon) in order to have a decent chance at viral clearance. Right now, no such beast is in the FDA hopper - trials HAVE cleared MANY without Interferon. Trials and FDA approved meds are two very different beasts.

GENO 2 and 3 WILL HAVE ALL-ORAL TX maybe in December - whenever Sofosbuvir is FDA approved.

GENO 1 - still has Interferon in the mix for a while.

Again, trials and FDA approved tx are two very different things - I cannot get into a trial, and I have to wait for FDA approved TX - doubtful my insurance would pay for "off label" treatment - as in, combining drugs from different pharmas that are not an FDA approved treatment.

GENO 2 and 3 WILL NOT HAVE TO TAKE INTERFERON WHEN SOFOS IS APPROVED.

I'm getting sick of this. The more I try to explain, the more angry I'm getting - and that's really not good for me at all. I don't KNOW why it's taking so f@cking long for FDA approval for things. You are mixing up trials with FDA approval, maybe? Okay, I have to stop. I'm tired and just not in the mood to try to explain stuff anymore on here or anywhere else. I am seen as a "bearer of bad news" when I simply write the facts as I've read them - and hell, maybe it's ALL BULLSHIT.

Maybe someone else can try to answer Reminder. I just can't do this anymore.