Yes thanks...Kramer did some clearing off site..The off label drugs are in the process of approval right now individually...how i understand the Dr will be able choose the combo from the approved drugs...

That being said we are hoping for "off label" access that will allow our Dr.s to start geno 1 with Sofosbuvir and Ribavirin or the addition of Simeprevir.
The Simeprevir/Sofosbuvir combo is excellent however it is from 2 different pharms.
Both are at the FDA. Both will be available in a few months.

I apologize for my "drama" here - not feeling very well - tired - worried about this damn virus that I've had for so very very long.

Hi all!!! I'm hoping & praying for the new TX
for you guys!!! Sometimes I feel bad that I
cleared when others have not or waiting. But
I wouldn't want any of you to go through what
I did. And I only did 24. Your all strong willed peeps!!!! And I'm proud of you!!!

Good luck,
Oz

CLEM! You hot mess tranny ho!

Did you see Kramer's new thread?

ALL ORAL TX for GENO 1's in 2014 - not 2015 anymore - NEXT YEAR - if all goes well.

Praise the LORD.

Yes Cat!!!! I read the post!!! Clemita
is so happy for you guys. She/he did
the splits this morning & silly little
back flips!!!! So excited!!! LOL.

Not only that, on the 24th of October the FDA is going to have an advisory committee meeting for Simeprevir!!!!

"The committee will discuss a new drug application (NDA) 205123, simeprevir (a hepatitis C virus protease inhibitor), manufactured by Janssen Pharmaceutical Co., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C), in adult patients with compensated liver disease (including cirrhosis) who are treatment-nave or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function."

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm368694.htm

So it looks like there's a really good possibility of having another DAA simultaneously or even a day before Sofosbuvir eventually gets approved!!!

The Floodgates are opening for sure!!!

Respectfully,
Henry

Great about Simeprevir!

HOWEVER, and I hate to keep ringing this bell but want everyone to be clear about it - for Geno 1's, Interferon is going to be in the mix for a while as far as FDA APPROVED tx. This goes with Sofos, and this goes with Sime. Unfortunate, but it is how it is for geno ONES at this point. 2's and 3's - when these DAA's are FDA approved, they will have their non-interferon tx. Geno 1's need TWO DAA's... or InterF*CKon.

From the "sime" post: " proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin ...:"
See it? PEGINTERFERON

Now - should we be able to get Sofos and Sime off label, we can get around that (interferon). Get each off label - I think I've seen pretty good results with that combo in trials (with riba, I think). But off-label will be iffy as far as insurance paying for any of the drugs. Our doctors will need to make a good case for us - so having a doctor who will do that is important for us geno 1's who NEED TO TREAT before the ALL ORALS for us come out - and we really don't know when that will be.

I hope I am not being seen as a Debbie Downer. I do hope so. Just that for me, it's important to be well informed - and so many seem to be thinking that genotype 1's are going to have a non-interferon tx as soon as Sofosbuvir is approved (and maybe same for Simeprevir). That is NOT the case! Nor is it the case that Riba is out of the mix for ALL genotypes when it comes to FDA APPROVED (as in, much better chance of insurance paying for it), treatment. I don't want to take Riba either - but when tx comes out for geno 1's with no interferon - but with Riba - I'll try it. I can always "forget" to take the Riba.

Henry - I do love ya - YES, when Sime is approved along with Sofos, I definitely will be pushing my hep doc to make a case for me with my pharma provider for off-label treatment AND payment for the meds. It IS awesome news to have TWO DAA's on the plate right now - in front of the FDA. Here's to off-label tx and cooperative insurance companies in that regard.

Yes Cat I think most of us know that but the good news is that both drugs will be in pharmacy dispensaries so now the task at hand is to get Dr.s to prescribe the two drugs together (which is a winning combo) without the added toxic drugs (Inf and Rib).
The BIG STEP here is the two drugs are going to be on market in a few months.
That is very good news!

I totally agree, Kramer - we finally have a reason to be very very hopeful that we will be able to treat very very soon --- if we can get the drugs off-label and paid for by our insurance companies. (or maybe some people can afford them - gulp - rock stars and the like) It is most definitely something genotype 1's should at least try to make happen. I sure will, and I know you will too.

It's GREAT news, yes. I think I'll stop trying to clarify about the "FDA approved" tx for geno 1's. As you say, most of you here know all that. I see a new hepatologist next month - I'll be taking copies of anything related to Sofos and Sime FDA approval just in case he doesn't know about it. I am more than willing to treat with those two agents - and NO Inf/Riba.

That's my point Cat!

When the two DAA's are approved regardless of what other drug is necessary to take with it, the prescribing physician can legally prescribe both with or without peg/ifn or riba for the patient as long as there's justification which can be argued easily if let's say the patient cannot tolerate Peg/ifn or riba and/or the patient has an IL28B type of either CT or TT, or the patient has previously treated and the treatment was unsuccessful and is either too weak to be on the combo of Peg/ifn & Riba, or has been on the combo previously more than once and has been waiting for Peg/Ifn/riba free treatment and is post transplant, or any other justifiable reason as to why their patient must be allowed to be treated with the 2 DAA's without SOC and have them approved for payment by the insurers, or for me especially, to have Medicare and/or the VA cover the costs of the DAA's for treatment...

No disrespect but, there are many ways for the doctors to skin this cat. ;>) 2014 is going to be the year CATMAGIC!!! NOT 2015!!!
We're almost home baby!! NEVER GIVE UP - NEVER GIVE IN!!!

Respectfully,
Henry

By golly, duh, I think I've finally got it! 66 years old, 108 thin pounds, IL28B of CT, some complement deficiencies that would make transfusions dangerous, and we all know what Riba can do, have had the virus for almost 44 years now, oh, some mental health issues .... um, yeah, plenty of reasons that my doc. will have to argue that I need two DAA's and NO Int/Riba. GOT IT!

BOOK IT! I BELIEVE! lol - many ways to "skin this cat" - you clever boy!

;)

My DR. wanted me on 1400 mg of Riba daily. Only problem was the Pegasys came pre boxed with one syringe of a daily dose of Interferon and only 6 X 200 mg tabs of Riba (1200 mg).
He and the pharmacist had quite a yelling match about the insurance company not covering an extra 200 mg pill daily for me.
My Drs response ( and I was there listening to his heated phone conversation) was in that case he would order two daily kits for me (2 syringes and 12 X 200 Riba) if that was the only way they would cover it.
My insurance company covers drugs how they are packaged and issued by the pharma, not the actual dosage.
Realizing they would be paying a hell of a lot more money, they finally conceded, saved themselves about $40,000 and covered the extra Riba pill ordered as a "side dish" lol
I suspect the same thing may happen with the pre packaged DAAs with Interferon.
Hoping that is the case!

Yes MWC my understanding is still December.