Thanks! It will be interesting to read more details. Hope it won't include interferon and will include post-transplant patients.

Agenda: The committee will discuss new drug application (NDA) 204671, sofosbuvir (an NS5B polymerase inhibitor), manufactured by Gilead Sciences, Inc. (Nasdaq: GILD), with a proposed indication for the treatment of chronic hepatitis C infection, in combination with other agents in adult patients with genotypes 1 to 6 and/or adult patients awaiting liver transplantation. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

RIP.....Telepravir

First half week of December the pills will be on the market , as i am very certain it is already in production, packaged and warehoused somewhere.

I wish all of you a pleasant journey who had the luck , the time , or need to waited out..

And the best part next to the physical relief is the mental peace of mind. Calmness takes over inside and alters the mind from the constant anxiety..Depression was yesterday news.Happiness what fallows.

Unless I am mistaken, tx for Geno 1's will be Sofosbuvir + INTERFERON + Riba. Other genotypes, no Interferon. Geno 1's need the Ledipasvir (Gilead's) along with the Sofos in order not to have to take Inteferon. Gilead has this one pill combo in trials now, and it's proving to be very successful. Trial arms have been 8 and 12 weeks for genotype 1's with the Sofos/Ledispasvir combo - with and without Riba. Without Riba, results are almost as successful as with it. But this combo is not yet in the FDA hopper for approval. Geno 2's are "sitting pretty" when Sofosbuvir is approved - no Interferon for them.

So, although some who read this may think I'm being a downer, it's the TRUTH. I do think that it's best to know the whole story instead of thinking we genotype 1's are close to a non- Interferon tx. For us, it's gonna be maybe 2015 for that. We WILL have Interferon in the mix for now with the Sofosbuvir drug (and Riba) if we are going to do the FDA approved Sofosbuvir. Of course, if anyone can afford to go off label, or if their insurance will pay for off label, there are other pharmas' drugs that might be combined with Sofosbuvir.

I was in the trial of this & mine included interferon & riba but for only 12 wks. At my last apt (6 months post treatment) I was cleared!!! YES-hope it stays that way. The 12 wks were ROUGH but I survived. I am sleeping better now than I have in years. Still some rough nights but also having good ones.

I'm wondering with others that have cleared, did you get back any energy & how long did it take. I was told it may never get any better. Mine is only slightly better but I am thankful for any improvement.

phase 2 trials using only sofosbuvir and ribavirin for geno 1s are having great results, even for hard to treat patients.
I suspect the interferon will be dropped from the mix soon.
see:
http://media.jamanetwork.com/news-item/combination-drug-regimen-appears-beneficial-for-patients-with-hepatitis-c-and-unfavorable-treatment-characteristics/

if phase II trials are goin well....maybe some of us can get into the phase III????

"68 percent in the weight-based group and 48 percent in the low-dose group" This is considered good results??? Looks like pretty much a 50/50.

I think we're forgetting about what's going to be going through the samr scrutiny very soon after Sofosbuvir...

yeah, Simeprevir is going to be a close second in the approval process and when that happens then off-labeling can be done by your doctors once both are approved and without Interferon and/or Ribavirin!!!

so Catmagic honey! Don't worry about waiting to long because your ship is coming much sooner than you think!!!

Now as far as us post-transplanters are concerned, once the crack in the dam that is Sofosbuvir approval becomes a reality well, I'll use this analogy... That darn Dam will burst so fast and the waters that represent the rest of the new DAA's will soon be flooding the markets resulting in folks like ourselves as well as other HCV populations finally receiving the cure for this virus!!!

It'll be a Johnstown type of Dam bursting for sure!!! :>) ;>) ;>)

Respectfully,
Henry

Henry, I pray you are right.

Hi Marilyn!

Here's an open label study that your Doctor might want to look into for you...

http://www.clinicaltrials.gov/ct2/show/NCT01938625?term=post+liver+transplant+HCV&rank=24

There's currently 1 study that will soon be recruiting in Dallas or will be in Dallas very soon within this year to study Sofosbuvir, Ledipasvir & Riba for post transplanters, phase 2...

http://www.clinicaltrials.gov/ct2/show/study/NCT01938430?term=post+liver+transplant+HCV&rank=2&show_locs=Y#locn

Then there's this one form Abbvie also in Dallas:
Open-label, Single Arm, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adult Liver Transplant Recipients With Genotype 1 Hepatitis C Virus (HCV) Infection
Here's the link:

http://www.clinicaltrials.gov/ct2/show/NCT01782495?term=post+liver+transplant+HCV&rank=16

That's all I could find that may or may not help you currently so, if it's helpful for you Great, if not, oh well there's always next time!

Respectfully,
Henry

Henry, thanks. I'll check them out. I do need to do more studying about how trials work. My doctor told me months ago that if I was in a trial, I would have to go back and forth to that location. I need to find out how and if my own transplant team can take care of me if I'm in a trial in Dallas. That's at least a 7 hour drive for me. I'm already wondering how I'd get back and forth to Houston an hour away if I'm not well enough during treatments to drive myself.

RASS..I reword for you. Great results for Geno 1 and favorable results for hard to treat without Interferon.
I must be honest I log on to DS less and less these days and more and more onto other non HCV sites.
I am confident that there will be treatment for us all in the next few months to year.
I do not wish to spend any of my days fretting and worrying, being frustrated or angry. I have lived with HCV for over 40 years and I know I can hang on a few more months.
I choose to remain confident and have a little more patience.
As we all know a positive attitude can only facilitate better quality of life, it's the one I have adopted for these remaining few months.
I look around and see folks with much worse challenges in life than I and they somehow seem to get by. You and I and others will make it.

Folks..i am not clear on the new Tx approval for Gilead. If i am correct Gilead had the combo with BMS...the magic cure. With an outstanding cure rate. Now that idea was dropped over money, but now Gilead mixed their pill with Interferon and Riba? And they have already developed their own pill to replace Ribavirin and the dropped BMS made pill.

Are we getting in to a bunch of Pharma politics ? So people who are /were waiting for Interferon free regiments are had false hopes for the December to start the treatment? Everyone wants and waiting for the Interferon free meds, so this is the quickest way for now to take the money from Vertex? As both of the of the companion pills are already approved for many years? They are doing the same business model as Vertex did just to get a hold on the market for now?

And reading up on the new trials a while back i was shocked to learn how many Interferon combo trials STILL on the way..Just don't make sense why? Even as the all oral regiments are already showing great result...I guess to compare the results with the existing drugs? One verse the other?

thanks kramer. that is my overall attitude toward life: why worry? and, lots of people have a lot worse things. it's what got me through approx 40 years, too.

but since coming here to DS and doing one trial, now it seems i'm more anxiously watching all of this politicing and greed by the pharms...