Ledipasvir/Sofosbuvir combo

[Advocate1955]

Hi all,
This may have already been posted on this forum today, but in scrolling down, I didn't see it.

Gilead announced today that the FDA will do a Priority Review for Ledispavir/Sofosbuvir combo.  That means that the FDA will have a target action date on or around October 10, 2014.

Here is the link:

http://www.gilead.com/news/press-releases/2014/4/gilead-announces-us-fda-priority-review-designation-for-ledipasvirsofosbuvir-fixeddose-combination-tablet-for-chronic-hepatitis-c-genotype-1-infection

Advocate1955

[pooh55811]

Thanks for posting this. It is definitely good news for our forum members who failed triple and for many others, especially those with Cirrhosis. It will gladden my heart when your husband, Jules, 48, and so many others attain SVR.

[jules2551]

Hi Advocate!  Thanks for posting the links.  I havent been on much lately so Hrsepwrguy sent to me.  Cant come soon enough.  

Relapsed 6 mo post 3x therapy w/ Vic. Tx only 36 weeks.  

(Hi Can ******* and MZ)

[JimmyMose]

My opinion and guess if similar to Sovaldi and Ledipasvir wins approval, that will happen within a day of October 10.  The first will start treatment later October with more starting in Nov  many more in Dec Jan

Date filed + 2 months fast track + 6 months approval

-Jun. 7, 2013 Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C
Gilead filed the NDA for sofosbuvir on April 8, 2013, and FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of December 8, 2013.
Since 12-8 was a Sunday FDA announced approval on Fri 12-6 after stock market closed.  Gilead starts shipments to major distributors.
I believe a few started tx in late Dec. more in Jan etc.    

Apr. 7, 2014 Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection
Gilead filed the NDA for LDV/SOF on February 10, 2014, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014.(Friday so expect announcement either 9 or 10 after stock market closes.

For me GT2 5th day of SOV/RBV great so far. I'm wondering about when those GT2 who can't tolerate RBV will have another combination approved

The best of luck for all.  

[Advocate1955]

Great.  I am so happy for you, my husband, and other triple tx non-responders, especially those who have developed Cirrhosis and need to treat.
Advocate1955

[Advocate1955]

I think can-do was probably referring specifically to my husband's case, since he addressed it to me.  In my husband's case, because he has compensated Cirrhosis with a stable MELD score of 7, a couple of months won't make any difference for him.
Advocate1955

[48weeks]

I am gt 1a, w-IL28B of TT and I was a non responder to two bouts of int+rib in the early 2000's, and I relapsed after 48 weeks of triple therapy with Incivek so you can bet I've been watching everything that has anything to do with this combo. THANKS FOR POSTING!!

[Sarah1949]

Two months can make a hell of a difference!

[mzkity]

This is good news! Thanks for posting it!

[Advocate1955]

Yes, it's great news.  I'm trying to think of who our Triple Tx non-responders are, who have not yet started the off label Sofosbuvir'/Olysio combo, so we can let them know that this will be here soon (hopefully).
thanks,
Advocate1955

[can-do-man]

Great news, there's been nothing that has shown up to stop it. While October is possible I would guess December at the latest. Either way a couple months isn't going to matter... Fantastic news for people like your husband.