Wow, we all knew what they had done and therefore was getting a lot of negative press, but are they calling this at the last minute to try and make people forget?

I mean, Sofos was going to be one of the first, but are they trying to now claim the first coveted "all oral" now too? Seems sneaky.

THIS is a SUPER important article, and THANK YOU, Kramer. Indeed, my first question when I heard about this 24 weeks of Sovaldi + Riba for "Interferon intolerant" Geno 1 patients was - HUH? When was THAT part of a trial? I sure never saw one. And just HOW will that term be quantified for tx naive patients? Can I just say I am intolerant of it because I know I can't handle it and that's good enough? What a mess that will be - quantifying the "interferon intolerant" patients.

Gilead is trying to pull a fast one here, that's what I think. And... the FDA has bought into it? WTF?

And gee, "Gilead had provided no indication that data to support this particular labelling had been submitted to the FDA. Expectation instead was for sofosbuvir to only be approved in genotype 1 patients in combination with interferon and ribavirin." MY RED FLAG IS WAVING HERE, FOLKS!

I want NOTHING to do with this bogus tx - even IF my insurance would cover the bulk of the cost of it. Oh sure, pay for GILEAD's drug for 24 WEEKS - $168,000 (plus the Riba) instead of trying to get off-label Sovaldi + Olysio (yes, would cost as much for 12 weeks of those two BUT that combo has proven stellar in trials - this Sovaldi + Riba for Geno 1's is a bit lacking in that regard). Oh, or maybe wait for Abbvie's cocktail that should be FDA approved in the latter half of next year - with NO INTERFERON and has had great results in trials even with cirrhotic Geno 1a?

For me - forget this Gilead carrot dangling on a stick - for me, it's off-label Sovaldi/Olysio or wait for Abbvie. I won't fall for this ruse that Gilead is trying to pull off.

Something is really twisted about this, and this article laid it all out. wow

Interesting article Kramer - I'm looking forward to the "cheaper, fixed-dose combinations in late 2014/early 2015."

And this? Um, well, I don't know about other folks, but I am not eligible for the Gilead assistance program that has been posted somewhere here (because my healthcare is through federal govt/military retirement). And I'm okay with that; I get it.

So now what is THIS? "Gilead is reportedly offering a patient support programme that will ensure that most commercially insured patients will have no more than a $5 co-pay, which will include patients who are charged larger co-insurance amounts." What the hell is "most commercially insured patients..."? "most"?

And right now I'm listening to something on tv about how the AFA is going to mean... paying MORE for drugs - much higher co-pays in a lot of cases. omg omg

Before this U.S. healthcare mess gets even worse, I am going to grab the first reasonable tx that my insurance will cover - just NOT this 24 week attempt by Gilead to grab us Geno 1s with the lure of no interferon necessary. No thank you!

Well said Cat - I found this interesting.....

(brand names Sovaldi and Virunon)

http://www.meduweb.com/showthread.php?p=35110

Ganja, I may have to wait for that too - hope it isn't too long for me. But I will NOT do Sovaldi + Riba - not for 12 weeks, 24 weeks, 24 months - whatever - NO WAY am I buying that it would "work." Hell, Riba for 24 weeks would wipe me out! Just no way - for a late stage old lady who's had this shit for 44 years? No way....

Gilead is pissing me off!

that's $5 co-pay for UP to 20% of 12 weeks of tx costs... the way I am reading it is you can use the "coupon" with most insurance.

Gilead's been pissing me off since I started their damn trial.... 2 years ago. I think the LED/SOFO combo will be approved next year... but who can afford it?

omg - NINE people in first group of the study? NINE? Like, 1, 2, 3, 5, 6, 7, 8 NINE. god help us!

And - 68% or FORTY-EIGHT %, depending on riba dosage, of those in the second group (didn't say how many people - maybe 8?) achieved SVR 24? This is.... I mean, what kind of stats are these? Does this make me all excited about jumping into six MONTHS of Sovaldi and Riba? I think not.

"Following 24 weeks of treatment for all study participants, nine out of the 10 participants in the first group completed the trial and all of them (90 percent) achieved a sustained virologic response 24 weeks after completing therapy (SVR24, considered a cure). In the second group, 68 percent of those in the weight-based ribavirin subgroup achieved SVR24, while 48 percent were cured in the low-dose ribavirin arm, although this difference was not statistically significant, meaning it could have occurred by chance."

GOOD article! INFORMATION IS POWER! When I see my doc in Phoenix next month, I will ask him what he thinks about this ploy by Gilead to rope in Geno 1's NOW. He knows I will not do Interferon - no matter what. Can't wait to hear his response. If he suggests that I DO THIS - I may have to do an "about face."

GUAR-AN-TEE-YOU I can't use that coupon. The way it's written is very misleading. F them.

But Ganja, maybe you CAN use that coupon or whatever assistance is offered. I won't qualify, and I don't have a beef with that. I have incredible healthcare coverage with low low co-pays and really low deductible, so cannot complain (until the govt gets into that - and oh, I know they're looking at cutting military benefits). Although, it WOULD be nice to make this shit available at a reasonable cost to everyone.

I have a real sense of urgency because (1) I'm late stage and OLD and (2) I can feel the fed. govt. angling for a way to rip off military retiree benefits, and healthcare is a huge huge budgetary expense, and even pay - as it is, no cost of living adjustments of ANY value for YEARS now....

Gilead has Sofos/Led (okay SOVALDI/Led) in the hopper but .... not for a year FDA approved? Why not? I know why - they'd rather push 5816, in trials now for ALL genotypes. They don't care if some of us die off before it's FDA approved. There are lots of HCV victims out here and MANY who don't even know THEY ARE. MILLIONS and MILLIONS.

I need to take a chill pill.

(Love this thread, Kramer - it is really relevant for Geno 1s)

Now I DO need a chill pill and to get offline and listen to my cats purring or something. All those stats - the "study" with hardly any people in it - oh - now I see the second group had a whopping 50 people in it. Sure it did. BUT BUT BUT - it was a PHASE II! Yes, TWO. Not III. TWO. HOW did this label for Geno 1's with no interferon pass the FDA? I mean, WHAT is going on here? Hey, I'll see you guys tomorrow. My head is spinning. But still - lol - Kramer, this is truly revealing stuff. Please keep us posted on what this group posts about their questionnaire they were sending to physicians about this.

"The Phase II, open-label study had two parts. In the first, which was a proof-of-concept study, 10 people who had liver fibrosis that ranged from absent to moderate in severity received sofosbuvir plus weight-based ribavirin. In the second part, 50 participants who had all the various stages of liver disease were randomly and evenly divided into two groups. Both received sofosbuvir, while one received weight-based ribavirin and the other received a lower dose of 600 milligrams per day of ribavirin, irrespective of their weight."

Cat, the "up to a maximum of 20% of the catalog price of a 12-week regimen..." would leave a balance of $67,200.... and that's only 12 weeks of pills.....

Oh, well GREAT, eh? Not. People can maybe start FUND RAISERS on FaceBook or something? OMG

Cat they have been talking about cutting retiree and veteran benefits for years. Mostly talk remember there are tons of vets out here and vets are votes. I guarantee tricare is going to raise its rates Tricare for life is a very good deal. Tricare is my secondary ins it pays all my co pays or what ever my primary doesn't pay. I would like to see some hard numbers on this new drug. I personally don't think the svr is as high as they say. Peace