Report suggests the possibility of "off label" treatment by Dr.s!

this is great Kramer - yet another option, and possibly available sooner than some others. Simeprevir is in phase 3...or have they already filed for approval? I only had time for a quick search, and found some conflicting reports...but either way, it's close to release, I think.

Here's another report on this with some good info:

http://www.marketwatch.com/story/medivir-first-interim-results-from-a-phase-iia-study-evaluating-an-all-oral-regimen-of-simeprevir-and-sofosbuvir-in-prior-null-responder-hepatitis-c-patients-2013-03-04

Okay, I'm sorry for posting three times in a row...BUT THIS MADE MY DAY!!!!

:) yeah I like the "off label" bit meaning a Dr. could Rx Sofosbuvir with Simeprevir or perhaps any other DAA target specific to their patient's clinical presentation.
Yes it is more good news, dribs and drabs everyday but it's all adding up!

I don't know, Kramer...this seems more than a drib and drab to me...this is really big news, in my mind. I couldn't totally get a grip on the exact success rate, but it seemed very high...and that's for genotype 1 (of course the patients had low-to-moderate damage). Combine that with the fact that Simeprevir seems to be on a similar release schedule to Sofosbuvir (I think) and, to my mind, this moves up the clock one year for some genotype 1 people in terms of the availability of effective treatment. I don't want to be in some fantasy cloud if I'm missing something, so if anyone can bring me down with facts, that's fine...but...I'm so happy about this right now.
Thanks for breaking the news.

If they're partnering with J&J, it's confusing then why they didn't remain partners with BMS. We all thought it was money but it may have been something else.

Very surprised by this info...

Let's keep are fingers and toes crossed, maybe even are eyes.
H
D

As I read the press release the test group were "hard to treat" that means high fibrosis and non responders. They had great success!
About partnering with Medvir (J&J) the statement about "off label" suggest to me that the two drugs would be available to be Rx independent of each Companies business relationship with each other.
Now why Gilead and BMS could not have done this a year ago is again infuriating.

You're right about the null-responders, Kramer, but I think the average damage was F0-F2. I think they said that further studies will come out on higher damage patients in the future (I'm citing the article I posted above).
But the success rate - just read this somewhere else - was 100%.
Oh, man...I hope this option will be available ASAP.

One more thing: my trial doc told me that Gilead put Sofosbuvir and 5885 into one pill to discourage off label treatment. I mentioned that Sofosbuvir alone would be prescribed for geno 2 & 3's. He said, "Yeah but that will be 2 or 3 years down the road."

Not saying he's right just repeating what he told me.

That's disappointing if it's true because if my trial doesn't work, I wanted to do Daclatasvir and Sofosbuvir off label. My trial nurse told me insurance companies might not approve both since they're both so expensive.

Not sure if these trial people have access to esoteric info but I find their comments interesting and wonder if they are in the know or are guessing like the rest of us.

Hepcat

Hey Hepcat...
When the Sofosbuvir-5885 combo finally comes out (2015???), it will make off-label mixing and matching harder, I suppose...and maybe unnecessary. But Sofosbuvir will be out early next year at latest...on it's own, as far as I can tell. Although it will be intended to be be taken with other drugs, I'm not sure how some off-label creativity can be stopped.
But I have no idea what politics will come into play with this...

According to the trial doc, lone Sofosbuvir will not be released before the combo drug. Dr. Nelson in Florida. Very famous guy. Is he right? I don't know but it's what i was told.

I expect Sofosbuvir + 5885 to be approved early 2014.

Sofosbuvir is being filed in with FDS in June of this year so I doubt they are going to just let it sit on the shelf. They are very anxious to start recouping the 11 billion dollars they paid for Pharmasset .
Yes it looks like early to mid 2014 but HCV drugs have been fast tracked in the past (Telap and Boce) so I remain optimistic it will be sooner than later.
Yes I see your article states Fibrosis 01 and 02 METAVIR (not to be confused with MEDIVIR) lol

Fast track means six month window for approval from submittal time.

Look up Dr. David Nelson in Gainesville. he's a shaker and mover in Hep C world.

Again, I'm just the messenger. I was told Gilead doesn't want people to take these off label -- that's why they're combing the meds into one pill.

It was disappointing to me too.

But time will tell what their intent is with this drug -- single or combo release.