Off label simply means the medicine is being used in a manner not specified by the FDA. It is actually used very often for other drugs.

In this sense, the Sovaldi/Olysio combo has not been officially approved by the FDA, but has shown great promise in trials.

The challenge may be getting your insurance to pay for it, some may balk at a hefty price tag for an "unproven" combo.

Hope that makes sense.

Bob

In other words...both Sovalsi and Olysio are each FDA approved but the combo of the two together WITHOUT riba is called off-label use. the study shows excellent results for those who are Geno 1.

Not all insurance cos will approve payment for off-label usage. Some docs get around this via appeal. there is a post you can search for here about off label approval.

Google "Cosmos HCV study" - you might want to print it out and take it to your doctor to discuss this treatment *IF* you are Geno 1.

I have been on this treatment for one week. I am experiencing NO side effects. It's a 12-week all oral treatment.

Thanks for the info!!! I wonder if this can also be used for geno 2? I know geno 1 is harder to treat, so I wonder if it would work just as well for geno2? Thanks so much for clearing this all up for me. Im new to all this and really find you guys to be so helpful!

I am GT 2 also and was required to take the Riba but am not sure why the olysio wouldn't work for us... The Riba isn't all that bad but it takes a while to kick in. Good luck !

I would think your knowledgeable doc will recommend treating for 12 wks w/Gilead's Sovaldi & ribavirin tx for geno 2. The cure rate is 97% in patients that are tx naive according to trial data. It doesn't get any better than that at present. A virtual cure!

Olysio is only for genotype 1 patients & the FDA approved it combined with IFN/ribavirin for 24 or 48 wks. This FDA combo is not as effective for geno 1a patients who have the NS3 Q80K polymorphism which you might also be reading about. Some docs are prescribing both Solvadi/Olysio to fight the virus on multiple fronts for geno 1a. The Cosmos study was very promising as others have stated & I presented my GI with that data when discussing my next tx option with him.

Wishing you a side-free & successful tx!

I'm g2 was prescribed sovaldi and olysio. Just waiting to hear back from pharmacy. I also relapsed a few years ago.

Dragonars...just curious but is your doc prescribing this combo to avoid riba & also because you relapsed so you are considered a difficult to tx geno 2?

Allabout he never really said. We talked about sovaldi and ribb before all these where approved. But last visit he hit me with this combo he's said he was sure it would Work. If I ever state ill do a journal. Peace

Dragonars - not to burst any bubbles but I share Allabouts concerns. I have done a pretty fair amt of research on Sovaldi & Olysio because I am on it, and it is recommended for genos 1s based on the Cosmos study.

Sovalsi & declastivir (sp) works on genos 1,2 and 3 but I don't know the status of fad approval of that one.

Olysio is only for Geno 1's.
And in trials with Interferon and Riba, which is the FDA approved use (label) of it, it didn't work so great.

It DID work well in Geno 1's along with Sovaldi.

oops -- I see "allabout..." answered that one (about Olysio and geno 2's).

p.s. OT a bit here - but my specialty pharmacy called today - my first month's Sovaldi/Olysio arrives at my house on THURSDAY! :) Geno 1a, 12 weeks of tx (NO RIBA). Need to have a "phone" class with my nurse before I start taking them - and I just today got put on an antibiotic for a pretty bad bronchial "infection" - so that may push my start date out until I'm done with the 10 days of antibiotic. Fine with me - I'll be watching road on Th. for the UPS truck. IT'S HAPPENING.

Daclatasvir is not yet FDA approved, but when it is, we can BET it will be prescribed off-label with Sovaldi for Geno's 1, 2 and 3. No Q80K issues with Daclatasvir (although my doc says that for us 1a's who might have the Q80k issue, Sovaldi is SO good that Q80K is not an issue). Ledipasvir along with Sovaldi, KILLED IT in HUGE trials.

So far, from all I've read, SOVALDI is the SERIOUS dragon killer - but it can't be used alone - not effectively, anyway.

Gilead's Ledipasvir and Sovaldi is THE one to watch for. Ledipasvir is supposed to be put in for FDA approval this quarter. Being from the same pharma, those two will be out in ONE pill, ONCE a day, and will be "label" tx, meaning it will be easier to get FDA approval for. This "one pill wonder combo" will be for all genotypes from what I understand.

sorry - I was cutting and pasting there and made rather a mess. This part should not have been where it was, "Ledipasvir along with Sovaldi, KILLED IT in HUGE trials."

Dragonars, I didn't read all of the replies but I'm a little concerned about GT 2 being treated with sovaldi and olysio. I haven't seen any trial info on this at all. I'm not saying there isn't any, just that I haven't found any.

Maybe you should mention this to your doctor. Either he is trying something extremely experimental or he is ill informed. Maybe I'm the one who's ill informed but why could I find nothing this combo being tried on gt 2?

Please be careful and do your research before treating. I want you next treatment to be a success.