Author Topic: FDA Grants Priority Review for New Hepatitis C Drugs (Read 25575 times)

lporterrn · « **on:** January 05, 2016, 05:33:12 pm »

Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection

-- Final FDA Decision Anticipated by June 28, 2016 --

FOSTER CITY, Calif. --(BUSINESS WIRE)--Jan. 4, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has granted priority review to the company’s New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013 , and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. Gilead filed the NDA for SOF/VEL on October 28, 2015 , and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016 .

The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for SOF/VEL is supported by data from four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. A marketing application for SOF/VEL is also under review in the European Union , and was validated by the European Medicines Agency (EMA) in December. The SOF/VEL fixed-dose combination is an investigational product and its safety and efficacy have not been established.

HHburme · « **Reply #1 on:** January 25, 2016, 10:52:41 am »

Lucinda, Believe this is the study that I am in. You can PM if you want to know more.
Hopefully this drug will work

Fight the Good Fight !!
John

lporterrn · « **Reply #2 on:** January 25, 2016, 11:54:08 am »

Hope you let us know how it goes. Info from clinical trial subjects is very helpful for those who are looking ahead to other treatments, Good luck.

HHburme · « **Reply #3 on:** January 25, 2016, 12:16:20 pm »

I will. Thursday is the start of meds, 12 weeks and follow ups. Really exciting stuff.

John

HHburme · « **Reply #4 on:** February 08, 2016, 11:36:35 pm »

I needed to have a Fibroscan before treatment with the study could begin. Everything is a go, waiting to get my meds. The study is SOF/VEL GS-9857. My understanding is that this will hopefully be the drug that gets the job done

lporterrn · « **Reply #5 on:** February 09, 2016, 04:36:24 pm »

So this study uses an additional drug, and isn't one of the ones under priority review. I assume this study has various arms with various combinations and durations of treatment? Let us know when you start what you are taking and for how long. Good luck!

HHburme · « **Reply #6 on:** February 10, 2016, 01:32:07 am »

Link for study https://clinicaltrials.gov/ct2/show/study/NCT02639247?term=hepatitis+c#locn

lporterrn · « **Reply #7 on:** February 10, 2016, 05:54:37 pm »

Are you in the 3 drug or 2 drug arm? When I did clinical trials, no one knew which arm they'd be in (including the nurse and doc) until the day the patient arrived to begin the drug. However, in this case, either arm is great.

HHburme · « **Reply #8 on:** February 11, 2016, 09:39:21 am »

LP, The study is the for Gileads latest trial drug with three medicines, SOF/VEL and a third drug GS-9857. This will treat all genotypes as well as RAV. I'm geno 1A so there is a 50% chance that initially I will receive a placebo. If I do, then after 12 weeks I will be given the real drug. This is only for geno type 1. All other geno in the study will given the drug at the the start. I was told this drug is believed to be the answer to all types of HCV. So, no matter what geno, whether you are resistant(RAV), treatment experienced or naïve, Cirrhotic or not, this drug will work. All are 12 week treatments. The anticipated approval date is next January. I am resistant, NS5A and one of the few that Harvoni did not work on and my Hepatologist is very, very confident this will work on me.

beto · « **Reply #9 on:** February 11, 2016, 01:28:58 pm »

so cool HH...congrats. Let's hope for the real McCoy. Either way, life is good. peace

lporterrn · « **Reply #10 on:** February 11, 2016, 03:52:16 pm »

You have such a good chance. In the ASTRAL-1 study, SVR rates for GT 1a were 99% with sof/vel, so even if you don't get the 3rd drug, you'd have to have very bad luck to not clear. Among those with RAVs, the SVR was 99%. Knock 'em dead!

FutureThinker · « **Reply #11 on:** February 11, 2016, 04:25:56 pm »

HHburme, keep us posted!! Prayers are with you........ FT

Else · « **Reply #12 on:** February 12, 2016, 04:04:07 pm »

That sounds really promising, HH! And it sounds like you have a hepatologist who stays very current in HCV treatments and breakthroughs. That is awesome!

Mike · « **Reply #13 on:** February 14, 2016, 01:58:47 pm »

Hi HHburme,

This is such great news! I'm glad you got in the trial and thanks for blazing the trial!

Best wishes, Mike

HHburme · « **Reply #14 on:** February 17, 2016, 12:12:17 pm »

Took my first pill yesterday. I will take for 84 days, every 24 hours, and hopefully this new three headed pill can slay the dragon. I go once a week for labs, exams, during the first month. Then monthly until finished. I will not know any lab results, as this is a double blinded study, until completion. This drug has tremendous potential to work, with little or no SE, much like Harvoni . It's really exciting, for me, to be involved with the Gilead researchers and the University medical team, to help find a cure for Hep C that will help everyone in the world be free from this disease. Worldwide there are only 320 people in this study. If all goes well, should be approved by as early January 2017. I feel truly blessed. I have always said "everything happens for a reason" and maybe that's why I failed Harvoni.

Fight the Good Fight
John

FutureThinker · « **Reply #15 on:** February 17, 2016, 12:54:21 pm »

HHburme -- I totally agree with you in that "everything happens for a reason" and that there truly is HOPE and a lot of it, for all with this disease! It is amazing how much new data has exploded over the past 18 months. Thank you for blazing the trail w/ this trial for those who relapse on Harvoni. It's my biggest fear now, since I've finally gotten the OK from IMR to start Harvoni -- pills should be here in the next 2-3 days. Excited and anxious at the same time. Best of luck to you on this trial and keep us posted -- The future is bright!! FT

HHburme · « **Reply #16 on:** February 23, 2016, 02:45:48 pm »

Finished first week with no side effects, had tests and labs today.

John

Else · « **Reply #17 on:** February 23, 2016, 03:31:08 pm »

Best to you, HH. Everyone here is cheering you on!!!

HHburme · « **Reply #18 on:** February 24, 2016, 09:49:57 am »

This is the correct info for the study that I'm participating with Gilead. The link is www.clinicaltrials.gov and enter the study number GS-US-367-1171 . It is the POLARIS 1 arm, studying relapsers of Harvoni.

John

northfork · « **Reply #19 on:** February 28, 2016, 11:31:23 am »

Lucinda, I am testing for the Polaris -1 trial also. Had initial labs and a fibrotest( f-2) but they want a fibroscan also. So I will have that and see. I checked on a Merk 3 drug trial, but it was phase2 and the side effects for just the first drug in that cocktail were pretty horrible, so I declined.

HH Burme is leading the way.

Best to all.

lporterrn · « **Reply #20 on:** February 28, 2016, 02:24:07 pm »

We need a "fingers-crossed" emoticon. Good luck!

HHburme · « **Reply #21 on:** March 01, 2016, 06:25:54 pm »

Northfork, I hope you get in !!!! Took my 15th pill today and no SE at all.

northfork · « **Reply #22 on:** March 01, 2016, 08:24:54 pm »

Starting next week, H.H. Hope this tames our frankenviruses.

I can't help but think there is a lot more to learn about this disease. If this doesn't do the trick, maybe technology will advance to where they can print me a new liver on a 3D printer if I need one. i guess they have done ears already.

Keep up the fight.

gnatcatcher · « **Reply #23 on:** March 01, 2016, 09:41:36 pm »

Quote from: northfork on March 01, 2016, 08:24:54 pm

… If this doesn't do the trick, maybe technology will advance to where they can print me a new liver on a 3D printer if I need one. i guess they have done ears already....

Ears -- and now ravioli, crackers, chicken nuggets, and more:
http://hosted.ap.org/dynamic/stories/E/EU_TEC_WIRELESS_SHOW_THE_QUIRKY?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2016-02-23-13-41-51
They'd better come up with a way to print a new liver, to deal with the astronomical gastronomical onslaught.

Best of luck to you guys!

Gnatty

Philadelphia · « **Reply #24 on:** March 05, 2016, 07:59:33 pm »

I'm pretty sure that one or one very like it was something my specialist had me tagged for if I had failed my DAA treatment. I know it was a Gilead study for people who had not cleared via the new DAAs. Good luck!

HHburme · « **Reply #25 on:** April 26, 2016, 11:41:00 pm »

Finished my 10th week of the study, 2 more to go. My liver enzyme tests have been in normal range. The VL labs are blind to me and my Dr., with a 50% chance of being on a placebo. Only other times my AST & ALT were normal was while taking Harvoni. So I think that I may be on the real drug. I will know in a few weeks.

HHburme · « **Reply #26 on:** April 26, 2016, 11:43:47 pm »

Check this out....
http://hepatitiscnewdrugs.blogspot.com/2016/04/ilc2016-sofosbuvirvelpatasvir-and.html

FutureThinker · « **Reply #27 on:** April 27, 2016, 12:37:25 pm »

So exciting, please keep us posted! Pleased to hear the SE have been so minimal. You and I are finishing our treatments very near the same day -- my last Harvoni pill will be on May 17th, which sounds close to your last date. You are making an extremely valuable contribution to the body of knowledge on this difficult-to-cure disease, for which we are all very grateful! The future is bright -- FT

morab · « **Reply #28 on:** May 14, 2016, 01:48:58 pm »

This is very exciting news.
I will continue to follow your progress!
Hang in there HH and keep us posted
Morab

HHburme · « **Reply #29 on:** May 14, 2016, 04:50:34 pm »

Finished 12 week clinical trial last Monday. Had labs drawn on Tuesday and going to see Dr in 4 weeks, hopefully get some answers then. Feeling good.

FutureThinker · « **Reply #30 on:** May 15, 2016, 05:51:43 pm »

Please keep us posted! FT

HHburme · « **Reply #31 on:** June 08, 2016, 10:13:49 am »

Going today for 4 week post treatment clinical trial follow up. Should get the news if I was taking real drug SOF/VEL GS-9857 or placebo. Hoping for the best !

John

Rosie13 · « **Reply #32 on:** June 08, 2016, 05:13:35 pm »

HH, you are so inspiring! I get the goosies reading your posts. I know this will cure you ...feelin' it in Florida!

HHburme · « **Reply #33 on:** June 20, 2016, 11:17:13 am »

Hi Everyone !! 4 week post treatment labs came in. I was on the REAL drug, not placebo. I am NEGATIVE 4 weeks after stopping treatment!!!!!

John

lporterrn · « **Reply #34 on:** June 20, 2016, 11:55:46 am »

Fantastic!!!!

KimInTheForest · « **Reply #35 on:** June 20, 2016, 03:43:10 pm »

Wonderful news, John! Congrats!

kim

Rosie13 · « **Reply #36 on:** June 20, 2016, 04:51:04 pm »

HH, seems a conga line is forming for our newest freedom fighter! Congrats on testing what will be another breathtaking advance for this disease. So Exciting!

morab · « **Reply #37 on:** June 20, 2016, 05:03:19 pm »

HH
This is some of the most awesome news I have heard in a long time.
Thank you so much for being so brave for those that come behind you for tx.
Congratulations!
Morab

kimlav · « **Reply #38 on:** June 21, 2016, 09:44:56 am »

Wow John that is fantastic news! That is the drug I was planning on should Harvoni have failed me which thankfully is not the case.

Yay for you!

Kim

brie41 · « **Reply #39 on:** June 22, 2016, 08:39:07 pm »

Hi John,

Great news, so happy for you!!! Brie

HHburme · « **Reply #40 on:** June 25, 2016, 10:13:46 am »

Thanks everyone!! It's been a hell of a rollercoaster ride !!! Feel so fortunate to have been asked to participate in this clinical study and hope that this may be a cure for everybody with hcv. I am scheduled for my 12 week post treatment labs in six weeks. Feel great!!

Fight the good fight!!!

John

Rosie13 · « **Reply #41 on:** June 25, 2016, 11:32:58 am »

Hey John, 6 wks. left to confirm what we feel! You got it done & now thousands will take this next step & it is just amazing! The Harvoni commercials have been modified to say " over a quarter of a million" have been treated with success...now that number should sky rocket. I still get a surreal feeling when I remember we were untreatable just a short time ago. So happy for you!

FutureThinker · « **Reply #42 on:** June 25, 2016, 12:14:02 pm »

Excellent news, John and yes -- we are all fighting the good fight!!!! Keep us posted on this very important issue, FT

HHburme · « **Reply #43 on:** August 16, 2016, 12:10:37 pm »

Just got the call. UNDETECTED !!!! SVR 12. Na Na Na....Na Na Na....Hey Hey Hey.......GOODBYE !!!! Feels so great to finally join the winning team and post that I made it !! Thanks to Gilead and my team of Doctors for helping me. I believe this drug will end HCV. Feel so blessed to have participated in this clinical trial study. To everyone that relapsed or still waiting for treatment, THIS is the drug !!

Fight the Good Fight !
John

KimInTheForest · « **Reply #44 on:** August 16, 2016, 12:24:19 pm »

CONGRATS JOHN !!! You made it!

kim

HHburme · « **Reply #45 on:** August 16, 2016, 12:29:47 pm »

Thank You Kim !!!!! I feel GREAT !!

FutureThinker · « **Reply #46 on:** August 16, 2016, 02:40:51 pm »

HHburme -- WAY TO GO!!!!!!! You must feel on cloud 9!!!! I will find out if I have reached SVR12 on Monday, so I will hopefully be able to post news as great as yours.
Enjoy!!! The future is very bright, FT

Rosie13 · « **Reply #47 on:** August 16, 2016, 04:29:51 pm »

JoHN!Your exciting post gave me the chills.the good kind!So happy for you..

HHburme · « **Reply #48 on:** August 16, 2016, 05:38:08 pm »

FT, confident you're joining me in the SVR12 club with the others. Rosey....thank you for all your support!! So Happy !!!

FutureThinker · « **Reply #49 on:** August 16, 2016, 07:32:14 pm »

HH, I have to tell you that your trial and your results certainly ease some of the stress for those of us who are in the final days of reaching or not reaching SVR12. And for that I am very grateful. Be proud that you've contributed some very valuable data towards the eradication of this beast. FT

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Author Topic: FDA Grants Priority Review for New Hepatitis C Drugs (Read 25575 times)