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5079728 tn?1365549989

Sofosbuvir??

Good morning all,

Been on the forum for about two hours this morning now reading all the post that have the word Sofosbuvir in it. It is so much for my brain. I know I have to learn all the lingo but it just fills it up too quickly....(lil brain) LOL! needed that! anyway, I went to the Dr. yesterday for my second opinion on "treatment only" not my diagnosis (know that and understand) As I have stated in my other post, my GI doc hinted on waiting for this "S" pill to come out. The hepatologist also hinted on waiting and wants to see me in 3 months for a follow-up and suggested on doing a MRI in 3 months. I shared my concerns on waiting because I am stage 4 geno 1. He didn't seem concerned about it being that my liver is still compensated. I am trying to follow all the post but too much for me. Bottom line in what I am trying to figure out in simple words:

IS this new drug coming soon?
IS it for Geno 1 (do not know my subtype)
IF i start triple tx with interferon and the "S" pill comes out, can i stop that and start the pill?
  
I know I am looking for shortcuts to the answers I am seeking. Everyones time is priceless and I do so appreciate all the help and advice. This forum has helped me so much. I just can not grasp all the big words and medical terms.

Thank you everyone and DECLARE YOUR VICTORY TODAY!  
52 Responses
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Avatar universal
I think it has been said already and agreed upon that the decision to treat or wait should be made with the guidance of one's hepatologist and by weighing the individual pros and cons.
Helpful - 0
Avatar universal
"Probably because no one that tried interferon wants to repeat that LOL"
**********
If I had to do it all over again I would! I would rather take the INF again than have the Hep C.  You have to weigh the odds.
Helpful - 0
Avatar universal
As Jules said, Gilead has not yet applied for approval of sofosbuvir with treatment experienced or cirrhotics, so this drug will not be available to those populations in October of this year.
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Avatar universal
I am not really surprised but I am thrilled for you Willy.
Please keep us all informed. This is very exciting!
Helpful - 0
Avatar universal
Probably because no one that tried interferon wants to repeat that LOL
Helpful - 0
1747881 tn?1546175878
"Nice progress in one week"

I agree :)
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Avatar universal
Since it kind of pertains to the original poster's question, or may shed light on the power of the new drug combos...... or in other digressions within the thread....

I got my 1 week PCR results today
My screening date I was just under 3 million copies per.....
after one week of treating with Sofosbuvir, 5885 and RBV I am detected (or was a week ago) but under 25 copies.

In one week my ALT went from 130-43 (43 is the top of the normal range)
other blood work improved, but HGB dropped about 10%
Nice progress in one week.
===============================
FWIW

Doctors offices had Incivek within a few days of approval (overnighted).  Incivek was approved late May and there were people I know treating with it in early June.  

willy
Helpful - 0
Avatar universal
"Sofosbuvir is submitted for all genotypes.  GT 1,4,5,6 will have Triple, Sofosbuvir & Ribavirin + interferon.  GT 2 & 3 will only have all oral, Sofosbuvir + Ribavirin"
**************
GT 1,4,5,6 = treatment naive only
Helpful - 0
Avatar universal
Sofosbuvir is submitted for all genotypes.  GT 1,4,5,6 will have Triple, Sofosbuvir & Ribavirin + interferon.  GT 2 & 3 will only have all oral, Sofosbuvir + Ribavirin

http://www.gilead.com/news/press-releases/2013/4/gilead-submits-new-drug-application-to-us-fda-for-sofosbuvir-for-the-treatment-of-hepatitis-c
Helpful - 0
Avatar universal
I stand corrected then on the the approval date --> prescription date time line.  I can recall that my husband needed another treatment in 2007 and his previous hepatologist told him that Teleprevir would be out in a year.  It wasn't.  It's great that Gildead has the where-with-all to parallel process, and I hope that it's true that sofosbuvir will be available in October 2013 as you say, I hope that for my husband as he is currently out of treatment options and has Cirrhosis, and I hope that everyone else who is in a similar situation, because approval of sofosbuvir for g2s, g3s, and treatment naives of g1 and other genotypes means that there is hope for treatment experienced g1s somewhere down the road.  But to be quite frank, we will be happily surprised if that is indeed the case, and I will be the first to thank you for your inside scoop of information, even though it won't provide a treatment option for my hubby or others in his situation in October 2013.  Please remember that the application for approval is for treatment naive g1s, so if approved, it will not be one pill, it will be sofosbuvir, Interferon, and Ribavirin, and the application for approval does not currently include previously treated g1s.
Advocate1955
Helpful - 0
Avatar universal
Incivek was approved May 2011 and prescribed the same month.

Gilead has the where-with-all to parallel process "marketing, packaging, treatment guidelines"

I'm on a Gilead trial for Sofosbuvir & Ledipasvir and the drugs are in one pill, with a nice package.  The treatment guidelines will be part of the package submitted to the FDA from the data they collect, so they'll be ready.

I believe Gilead will put this on market soon after approval, if they get approved.
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Avatar universal
Here's the Sofosbuvir fast tracked link

http://newdrugapprovals.wordpress.com/2013/03/09/gileads-newly-acquired-sofosbuvir-gs-7977-shines-in-hepatitis-c-trial/
Helpful - 0
Avatar universal
I agree with Can-do, Hector, and others.  The OP is asking about Sofosbuvir (clear in the title).  The application for approval was April 8, and Gilead has requested a fast tracked decision.  The request for approval for G1s includes treatment with sofosbuvir, Interferon, and Ribavirin, not otherwise.  If approved in October 2013 for use as applied for, there will be some lag time for marketing, packaging, treatment guidelines, etc.  No way to know for sure, but "probably" 1st half of 2014.  Also agree with ID that the experience with the PIs was that the entire process from application for approval, to approval, to actual marketing, packaging, training for docs and NPs and actual availability for prescription was longer than the expedited time frame of 6 months.  
Given all of that, those with f-3/f-4 liver damage, have to make the best decision they can with the advice and guidance of an experienced hepatologist in a transplant center.  
From what my hubby's hepatologist has told us, people who have Cirrhosis, but are compensated, with careful monitoring from an experienced hepatologist, can stay compensated for a long time, but there is no way to predict the time frame from compensated to decompensated. However, as Hector said, the risk for liver cancer or decompensation increases as more time passes.
I won't comment on the black box warnings on the currently available treatment meds, because they are clear and available for every one to read, and each patient's and each doctor's responsibility to understand and decide if the potential benefits outweigh the potential risks.
Advocate1955
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Avatar universal
The last thing I'm reading tonight; bedtime in T-minus 5 minutes.

A good read from a good man.

I'm thinking of you each day and hoping for good news.

In the meantime, thank you for the wonderful read.  Whether we always agree or not we never doubt that the other parties deeply care.

~Willy
Helpful - 0
446474 tn?1446347682
The first thing you should do is find a knowledgeable and experienced hepatologist who treats cirrhotics on a daily basis. We are not doctors here and only they with all of your medical records can tell you the risks involved in treating or not treating. Also should you have adverse events from treatment, you will need a doctor to manage them.

Taking medical advice on the Internet when you have cirrhosis is very dangerous as improperly managed and treated cirrhosis can be fatal. Decisions you make should be based on your own medical history and status not general terms which is all we can talk about he.

Is this new drug coming soon?

Gilead has already submitted their treatment for genotypes 1, 4,5,6. If approved treatment will be available probably around 2014.

12 weeks of Sofosbuvir + peg-interferon + ribavirin in treatment naive compensated cirrhotics achieved 80 percent achieved SVR.
(17% of NEUTRENO trial patients had compensated cirrhosis.)

Side effects are minimal compared to current triple therapy especially in cirrhotics. Where anemia, dose reduction, Procrit and transfusion are not uncommon. Also there are issue of neutropenia and thrombocytopenia.

Only (2 percent) receiving sofosbuvir in combination with peg-IFN and RBV discontinued treatment due to adverse events.

Is it for Geno 1 (do not know my subtype).
Yes. subtype doesn't matter although 1b's are usually easier to cure.

If I start triple tx with interferon and the "S" pill comes out, can I stop that and start the pill?
No. The treatment is Sofosbuvir + peg-interferon + ribavirin all at once. Sofosbuvir is what drops viral load so quickly not peg-INF.

Realize the risk you are taking by waiting, know one can say when you will decompensate. As long as I had a top notch hepatologist I would take their advice and wait if possible. 12 weeks of the new treatment is more effective than 48 weeks of peg-IFN, Ribavirin and a PI.

--------------------------------------------------------------------------------------------------------
Willy50: I have been on 1,200 RBV and 400 Sofosbuvir for over 34 weeks. No anemia, no platelet drops or neutropenia. Some fatigue is about the only side effect. I couldn't even believe it was working because of no side effects until I saw viral load drop over 4.4 log by 2 weeks. UND since week 2.
-------------------------------------------------------------------------------------------------
Good luck to you.
Hector
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Avatar universal
That would be ironic getting in a wreck going to the trial center.  
The riba keeps me sharp. : )  

I get up at 2AM and drive 4+ hours to miss the morning traffic rush, get lost in the big city and make it in for my appointment, turn around and drive back. Kind of a long day.  Last week I got to see all kinds of Mississippi area flooding.  

This is better than when I was planning on living out of state for 6 months, 1200 miles from home.  I may only have about 12-13 more trips down.  After tomorrow I am on every 2 weeks til 12 week, then 16, 20 & 24, then the EOT draws.

Helpful - 0
Avatar universal
Careful Willy! Your driving on those "blackbox" warnings.
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Avatar universal
Thanks!  I am looking forward to ending this already. : )
First 1/12th was a snap we will see what the back end brings.  : )

willy
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1747881 tn?1546175878
Congrats on getting in the trial and starting treatment, wishing you all the best.
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Avatar universal
Cando, thanks for the well wishes.  I know and wholeheartedly believe that.

You've been there yourself.

Hrsepwrguy.  Thanks; I see it now. : )

willy
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Avatar universal
:-))))
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Avatar universal
Have a safe trip Willy!!! Wishing you the best really....
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1747881 tn?1546175878
The "S" drug is in the title of the thread

"Sofosbuvir??"
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Avatar universal
I * love* it when people agree with me, and in this case I also agree with you. : )  
On only that one specific point. :  )
......
.......

Of course.....I just ate 3 riba so I am still ready to rumble. : )

Hhahahahahahahahaah.

willy
Helpful - 0
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