Hep C Discussion Forum

Zlikster · Guru

RE: FDA Advisory Committee Supports Approval of Gilead’s Sofosbuvir for Chronic Hepatitis C Infection

suziq · Senior Member

Hi Zlikster,

They are recruiting at the study site where I am doing my study. I can talk to the coordinator about it when I go in Wednesday. She is at the Liver Conference until then.

For Gilead, I had to get ALL my recent (last three years) medical records to her, go in for blood work, then I needed a biopsy which Gilead paid for. Rejected because of cirrhosis. For Merck, she had all my records there already but I still had to go in for blood work(screening) before I was accepted.

Do you have telephone access to talk with her?? I will be there about 10 am on Wednesday, which is about this time of day--the time we have been exchanging these posts.

If it is truly a possibility for you, I will do all I can to help. My coordinator is one neat lady. She has her doctorate in medical research. If you can afford to do the trip and stay for the trial, then just maybe.

SuziQ

Zlikster · Guru

Gilead has one trial for GT3 (Sofosbuvir + GS518) in USA, NZ and AU. http://clinicaltrials.gov/ct2/show/NCT01909804

i have sent em email, no response :( (BMS on other hand responded straight away)

suziq · Senior Member

Any possibility of coming to US if you could find a clinical trial here?? Not that I know of any, but insurance companies and money would not be involved. Just curious.

SuziQ

Zlikster · Guru

in Bosnia, definetly not. My hepa is so desperate to get her hands on Boceprevir or Telaprevir (not yet available here!), so Sofosbuvir sounds like SciFi :( I presume it will eventually be available thru health insurance here, my estimate 10 years or more.

As for Sofosbuvir+Riba, really not that great SVR chance for GT3 (62%), which is similar to Interferon+Riba. But then again, no interferon nasty sx. GT2s folks are really lucky (in general) when it comes to Sof+Riba...

Yeah, using off the label Sofosbuvir + Daclatasvir (when it gets approved) will be perfect combo (for first of new DAA generations)...but imagine the cost? Sof 50-100k $ + Dacla 50-100k$? just for 2 x 90 pills? insane...

If you hear some GT3 Merck trial that is going on, please let me know! ;)

thanks!

suziq · Senior Member

Zlikster,

Any chance of getting sofosbuvir when it becomes available by prescription in January??? That is approved for geno 2 and 3 and does not require interferon. I'm sure some doctors here in US will use it "off-label" for geno 1 when daclavisir is approved.

SuziQ

Zlikster · Guru

Thanks SuziQ, but it's only for GT1s :(

suziq · Senior Member

Zlikster,

My Merck trial is NCT01717326. Go to clinicaltrials.gov and look it up. I think they are still recruiting in France--they were a few days ago. Genotype 1

France
MSD France	Recruiting
Paris, France
Contact: Dominique Blazy 33 147548990 Sofosbuvir by Gilead may be approved without interferon for genotypes 2 and 3 in January It could be prescribed by doctors once approved--at least in US. SuziQ

Zlikster · Guru

@SuziQ, can you point me to tha Merck trial? wondering do they accept GT3s treatment exp.

@Lisa, hows your present Hg/RBC situation? sorry about your husky :(

Loopy Lisa · Guru

Last check I as fine, but I am due for more blood works to keep a check on overall health. I don't predict any problems, but not looking forward to it lol!

Zorak will go to sleep today, it is not a good day , but he has earned the right to go with some dignity. Thank you x

-- Edited by Loopy Lisa on Monday 4th of November 2013 01:37:03 PM

Loopy Lisa · Guru

Zlikster wrote:
@Malcolm, BMS is now in phase III with it. 3 arms, double blind, PegLamb+Riba, Peg+Riba, PegLamb+Riba+Daclatasvir. As i mentioned, i would gladly appliy for it, if it were not double blind one. I would not want to go to Italy or Netherlands just to end up in Peg+Riba arm (again) :)

Seems Lambda is easier on bone marrow supression and body sx, which is my worst case with interferon and severe neutropenia i had, but also going thru blood brain barrier easier too, hence it means i would cry a bit more on documentaries and movies ;)

I am waiting for some clinical trial with DAA blocking NS5B + some DAA blocking NS5A (in Gilead's case Sofosbuvir + "old generation" Ledipasvir or new GS-5816), this one is perfect (http://clinicaltrials.gov/ct2/show/study/NCT01909804) but only USA, NZ, AU :/ Waiting is indeed annoying for me.

@Lisa, low platelets? (thrombocytopenia?), i think you will do good on Riba+Sofosbuvir :) don't worry...try to find some high altitude place, tho i bet it's hard to find some in .nl. I had no rbc anemia almost at all from Riba while i was on mountain (1680m alt). Also beet juice helps a bit.

I don't know. I do remember having disgusting medicine that tasted like metal and very dizzy a lot and generally weak. Hahaha I will go stand on the rubbish tip :P

Zlikster · Guru

@Malcolm, BMS is now in phase III with it. 3 arms, double blind, PegLamb+Riba, Peg+Riba, PegLamb+Riba+Daclatasvir. As i mentioned, i would gladly appliy for it, if it were not double blind one. I would not want to go to Italy or Netherlands just to end up in Peg+Riba arm (again) :)

Seems Lambda is easier on bone marrow supression and body sx, which is my worst case with interferon and severe neutropenia i had, but also going thru blood brain barrier easier too, hence it means i would cry a bit more on documentaries and movies ;)

I am waiting for some clinical trial with DAA blocking NS5B + some DAA blocking NS5A (in Gilead's case Sofosbuvir + "old generation" Ledipasvir or new GS-5816), this one is perfect (http://clinicaltrials.gov/ct2/show/study/NCT01909804) but only USA, NZ, AU :/ Waiting is indeed annoying for me.

@Lisa, low platelets? (thrombocytopenia?), i think you will do good on Riba+Sofosbuvir :) don't worry...try to find some high altitude place, tho i bet it's hard to find some in .nl. I had no rbc anemia almost at all from Riba while i was on mountain (1680m alt). Also beet juice helps a bit.

Loopy Lisa · Guru

I had anemia as a kid, I had so bad nose bleeds I used to lose a lot of blood and had my nose vessels sealed a few times. I hated anemia, was horrible. I dread it lol! :)

suziq · Senior Member

Check out the just released data from Merck. 100% in 2 arms of the trial--for geno 1's. Best results I've seen since the Gilead/BMS debacle.

http://finance.yahoo.com/news/merck-announces-presentation-interim-data-130000587.html?soc_src=mediacontentsharebuttons

I am in week 8 of the new Merck trial (same meds). I am 79, have cirrhosis, geno 1a, was treatment naïve. I was <25 weeks 1 and 2. UND week 4. Week 8 blood work next Wednesday. Merck has been given Breakthrough Status for it--whatever that means

I realize nothing is guaranteed, but I sure am hopeful--especially after seeing this result data published the first time yesterday Nov 2nd. Gilead may be the fastest show in town--but it is not the only show in town. Merck is still recruiting for this trial in France.

SuziQ

-- Edited by suziq on Sunday 3rd of November 2013 04:23:24 PM

mallani · Guru

Hi Zlikster,

Peg Interferon lambda-1a is still a bit of a mystery to me. The EMERGE Trial showed similar SVR rates for Geno 3's using Pegasys or PegINF-lambda, but it appears the anaemia and neutropenia was much less using the lambda.

http://www.hepmag.com/articles/hepatitis_interferon_lambda_2501_22275.shtml

BMS are conducting Trials in Italy, but only for Tx- naives. You could contact them and see whether they would take you. If it was me, I'd want to see the results for the Phase 3 Trials. I know you're impatient, but I would wait for a while. Who knows what will happen in the next 6 months. If India ignores the patent on Sofosbuvir, maybe you could pick some up there- just joking buddy! Cheers.

Zlikster · Guru

@Lisa, belive me Riba is kiddies game compared to Interferon. Problem with Riba is it accumulates with time, makes u anemic, mood swings, uv sensitive, etc. But compared to Interferon shots and how miserable it makes you, i would take Riba anytime :) Thats my at least case. As for Lambda, i am also curious was anyone on any trial with it?

@Bills, Daclatasavir+Sofosbuvir is history...we were all excited with phase II results (95% SVR all gts, no sx,etc), but Gilead obviously wants whole pie for itself. I wonder when Daclatasvir gets approved too...does that means that ultrarich folks now can buy both on their own (i presume up to 150-200k $) and cure themself with nice SVR chance? I doubt doctors will have free hands to propose that expensive all oral combo? how i hate this profit game :(

I am preparing myself psychologically for next round of Peg+Riba. I will know sometimes in January will they approve me another round. If not, i am off to search clinical trials around the world. I can't sit still and wait 10 years or even more (triple therapy is still not available here!) for new DAAs to arrive here while hcv is slowly munching my liver and making it fatty too.

best

Loopy Lisa · Guru

I am curious to know about this Lambda as well. I haven't heard anyone take it yet?

Well being a Geno 3 I'm glad the pills are coming soon. I'm a bit gutted it still might be 24 weeks of Ribaviren, this drug sucks as much as interferon! But don't want to wait any longer, the party has to end for Hep C, the viruses had far too much fun for far too long. I'll have to charge rent soon!

Zlikster · Guru

cheers Malcolm

seems there are no clinical trials in Croatia, Slovenia and Bosnia (neighbouring countries). I am still waiting for my hepa to return from Gilead's seminar. Maybe she got some information first hand. As i am "only" F0/1 A1, i doubt i will be on any priority list whereever and if i apply...and of course i would feel guilty if i took someone's place who has far worse liver condition than me.

Whats your opinion on interferon lambda? There is one trial in Netherlands, but it's double blind 3 arms and i would hate to end into Peg+Riba arm (instead PegLambda+Riba+DAA one).

This clinical trial also sounds interesting to me (tho it's tad early phase II), espec since there are locations in NYC where i could maybe go (they got locations in Australia too):

http://www.clinicaltrials.gov/ct2/show/study/NCT01909804?term=hepatitis+c+genotype+3&rank=17&show_locs=Y#locn

i am thinking if they offer me retratment (SoC 24w Peg+Riba) that i will ride it again. I will stock my self with Neupogena this time and i wont let my hepa reduce my Riba if i fall below with Hg 110 (100 as u said should be lower limit for reduction). Full dose interferon, full dose riba full 24w (RVR or not). Would be cool to try Pegasys this time, instead Pegintron, if Pegasys is indeed 2-3% better in SVR chance than PegIntron, i need every tiny % on my side ;)

thanks!

Bills · Guru

I'm with you Zlikster,

What happened to BMS and Gileads equal dual therapy? I still can't believe how close they were and got shut down for Gilead to steel the show and as you say the $$$ I think I'm understanding here this is like a tease for us Relapse Cirrhotics with Geno for me and only for me I want a higher SVR %

Don't get me wrong I'm very excited for the G2's and G3's. We all suffered in treatment together up till now. If I was naive G1 and was just starting I'd be on line today.

I'll need a lot of convincing to do Intf / riba again. The Hep tenant in my liver seem to have laughed at Intf & riba at the end 3 times. But could be worse so.

I'm gonna sit back and watch for now and celebrate everyone who gets a shot at SVR the easy way.

SVR to all of you.

Bill S

Oh and I agree with 24 weeks hell I'd do 36-48 cant be worse than 74 consecutive weeks Intf & Riba w/ incivek and a trial. bring it on

-- Edited by Bills on Thursday 31st of October 2013 10:03:58 PM

Caryn · Senior Member

Thanks for the response Malcolm. So with the 60% results at 12 weeks, I'd be very curious to get results for a 24 week run?? Maybe that looks a little better. I am just starting to get a little concerned as I am not sure I am willing to play the lottery with my health. i emailed my nurse today to see what testing I will need to have done before my December appointment, but no response. I also asked about a fibro scan in lieu of an mri.

mallani · Guru

Hi Zlikster,

I had a call from my doc today. He was checking up on me, but I think he wanted to play golf at my Club. We're playing next Sunday.

I asked him how the Trials were going. To his surprise, Gilead have been generous, and he has access to enough Sofosbuvir to treat ~20 of his Geno 3's. He has over a hundred who failed Peg/Riba, and is choosing to treat those with the most advanced fibrosis (mostly cirrhotics). He is contacting them to see if they are willing to have a go. Treatment will start in January, and he intends to use Sofos./Riba for 24 weeks. Treatment will stop if not Undet. by week 8. Ask around, to see if Gilead have offered Sofos. anywhere else . This may be part of the Valence Trial, which is worldwide. They are even doing a Trial in Estonia!

Hi Caryn,

My doc did a small trial of Sofos/Peg/Riba late in 2012. It was for Geno 1 (Rx-experienced) and was only for a 12 week Rx duration. From memory, the SVR rate was only ~60%. He was then made Abbvie Trial Co-ordinator, so that is why he is surprised that Gilead have given him another chance with Sofos. Cheers.

Zlikster · Guru

now i can wait for 10 yeras for Sofosbuvir to be available in Bosnia and voila, or even worse, pay 50k $ for 90-120 pills of Sofosbuvir and get Riba for free here and bam 62% chance of SVR :/ I wonder does GT3 patients have more chance if interferon is included in?

still waiting for dual or tripe DAA combo to "explain" my liver subtenat that he must leave :) (c'mon Merck, BMS...don't let Gilead take all the glory aka money)

Caryn · Senior Member

I read that too, only treatment naive geno 1's. Interesting that I was told it would be sofosbuvir with interferon, and not even riba for me once this was approved. Unfortunately, I am just going to have to wait for my appointment to see what is going on. I am getting close to the appointment date and it is driving me crazy not knowing anything! I have had a hard time finding results for the above combo anyway. Malcom, you had mentioned a while back that your Dr knew about or had held a trial and the results were not that great. I am not sure I am willing to take the chance right now. If there are other drugs on the horizon that would be a better combo in a year, that may be what I will have to do.

Cinnamon Girl · Guru

Thanks Malcolm. Yes, I must say I was quite surprised to read that for genotype 1`s sofosbuvir will only be approved for tx naive patients. But maybe that will change at some point further down the line. Let`s hope so anyway.

mallani · Guru

Hi all,

For the Geno 1's, the recommendation is that Sofosbuvir will only be approved with Peg/Riba for the treatment naives. If you had to stop triple Rx due to severe Sx from eg Incivek, this is a bit of a blow. I can understand not giving permission for non-responders or relapsers. These patients are obviously not Interferon sensitive.

Great news for the Geno 2 and 3 relapsers, Rx failures and cirrhotics. All these will probably get 24 weeks of Sofosbuvir/Riba.

Loopy Lisa · Guru

I'm afraid the approval is for only Genotype 2 and 3 offically without interferon. It will probably be another year for drugs aimed specifically at 1s. That is not to say that Doctors may or may not perscribe this to other genotypes over an extended period.

tonib · Senior Member

But this is only for geno 2 & 3??? thats what the article said? I also read this for interferon free for geno 1?
www.marke****ch.com/story/merck-receives-breakthrough-therapy-designation-for-mk-5172mk-8742-an-investigational-oral-combination-regimen-for-the-treatment-of-chronic-hepatitis-c-virus-hcv-infection-2013-10-22

What does this link say exactly? I am a non responder and I don't think I can take interferon....my doc told me I may need interferon free therapy,

lauralou57 · Senior Member

The FDA Advisory Committee met in Silver Spring, Md which is close to where I live and the meeting was open to the public so I attended.

This is fantastic news!!

Loopy Lisa · Guru

That is fantatic news! I believe for genotype 2 it will be 12 weeks, Genotype 3 they are considering 16 as minimum as SVR rose with a longer duration up to 24 weeks for slow responders. For 1's and 4s was expected to be 12 weeks til 24. :D

Shaun · Senior Member

This is wonderful news. It is only a 24 week treatment and NO interferon except in the most stubborn cases.

Cinnamon Girl · Guru

Hi Shaun, good to hear from you again! smile

We don`t know yet exactly how long the treatment duration will be but it`s likely that many people will only need to do 12 weeks, which is even better! People with genotype 1 will still need to include interferon along with sofosbuvir and ribavirin, but that won`t apply to genotypes 2 and 3. Yes, definitely good news, things are looking up!

Cinnamon Girl · Guru

Oct. 25, 2013. Gilead Sciences today announced that the Antiviral Drugs Advisory Committee of the US FDA has voted unanimously (15-0) that the available data support approval of the once-daily nucleotide analogue sofosbuvir in combination with ribavirin for the treatment of chronic hepatitis C in adult patients with genotype 2 and 3 infection. Committee members also voted unanimously (15-0) that the available data support approval of sofosbuvir in combination with pegylated interferon and ribavirin for the treatment of chronic hepatitis C in treatment-naïve adult patients with genotype 1 and 4 infection.

Final FDA decision on Sofosbuvir is anticipated by 8^th December.

Full press release...

http://www.gilead.com/news/press-releases/2013/10/fda-advisory-committee-supports-approval-of-gileads-sofosbuvir-for-chronic-hepatitis-c-infection

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