Looks like the leak in the dam is starting to gush! :^)

I think 9 out of 9 SVR in previous non responders to Interferon probably answers the question about CC/CT/TT.
It doesn't seem to matter :^)

bump .. too good to get buried

Hallelujah! Thank you, bunny squirrel, you cutie-pie, you.

"... We are on track to submit the initial regulatory filing for sofosbuvir by mid-2013 and to file for approval of the fixed-dose combination of sofosbuvir and GS-5885 in 2014.

"...support a regulatory filing for the fixed-dose combination of sofosbuvir/GS-5885 by mid-2014." (so it's MID 2014 to file)

Okay, here's my question(s):

1. Any idea how long the FDA approval process takes? I realize there's no exact answer, but what has the "trend" been in the past? And this is only a question to the cosmos: WHY oh why does it take much time at all? People are out here DYING waiting for these drugs that are proving to be incredibly effective in trials. We'll take the risks of not knowing long-term effects. How long did the FDA take to approve the hellish Interferon that whacks some people hard for many years if not their lifetimes, ya know? Are politicians involved in this process (that's a joke)?

2. Will doctors be able to prescribe sofosbuvir alone once it's approved? I realize that the magic combo is sofosbuvir/5885 (and forget the riba), but for those of us who are cirrhotic, really can't wait, can't do or have failed triple, might this be an option since we need to treat NOW?

Any thoughts?

Great article!

Interestingly the are now starting (ION-2, phase III) trials with those who have failed SOC and triple. Someone from another forum just messaged me tonight. Don't know her but she failed triple and will be screening for this tomorrow...very exciting times, indeed!

nice!

havhope if you Google Sofosbuvir and Hepatits Genotype 2 you will see they are included in the trials

havhope read the last paragraph of the press release

Four ongoing Phase 3 studies will support Gileads initial regulatory filing in mid-2013 for an all-oral therapy with sofosbuvir plus RBV among genotype 2/3 treatment-nave, treatment-experienced and interferon-intolerant patients, and for sofosbuvir in combination with RBV and peg-IFN among treatment-nave patients with HCV genotypes 1, 4, 5 and 6. Topline results from the first Phase 3 study, POSITRON, were announced in November 2012, and results from the remaining three studies (FISSION, FUSION and NEUTRINO) are anticipated in Q1 2013. Results from ION-1, ION-2 and LONESTAR are intended to support a regulatory filing for the fixed-dose combination of sofosbuvir/GS-5885 by mid-2014.

Great news!!! bump!

@CC..... thanks for bringing the question about cirrhotics......I relaspsed just 1 month after 48 wks of triple with victrelis....I have cirrhosis as well....my Dr. hadn't had any body fail on vic, but he had on incivic.....best of luck to all.....beth

I just scanned this thread and got so excited. I'm going to slow down and digest all of this.

@ Kat - do you know where the other person is participating in their trial?
I investigated the trial in San Antonio but Gilead said it was filled. If I knew what site to call, I would do it.

I'm off work tomorrow and planned to touch base with the three sites I'm supposed to be signed up with and add a few more. If anyone has information on how they got their foot in the door - I would love to know.

This should be bumped. thanks

Bump Bump

After I failed Triple I talked to a couple of sites to see if I could get on a list for future trials. Ok heres what I learned today. Two of the sites I contacted today were in the ION-2 trial and were already full. They told me there were 60 sites and they only got 8 slots. One doctor actually called me to explain his method of selection was based on need and those with cirrhosis were offered up first. And he said all of them were selected. And I cant argue with this. I can stand aside for those in greater need. Kramer, Hank, and Bethann need this more now.

So anyway, once again.. the bridesmaid.

bump ..for those of us still keeping our "eye on the prize"

@kcaseytn - yeah, Arlington TX. I don't see this trial on clinicaltrials.gov; I saw one for cirrhotics and one for tx-naive.

There's contact information so I'd contact the Gilead reps listed. clinicaltrials is often not up to date and it's possible that by the time it's listed in might be unavailable. Anyway, that's my opinion.