Sofosbuvir Is Waiting for Green Light
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Regulators Await Gilead’s Hep C Candidate
Feb 21 2013
Gilead Sciences’ (GILD) sofosbuvir has passed all its preliminary examinations, and now is looking like a good bet for regulatory submissions in the coming months. The last of four phase III trials in combination with one or both of the mainstays of current hepatitis C treatment has met its primary endpoint, likely providing sufficient data to support approval in combination therapy in the six major genotypes of the virus.
The pivotal data leave the California company tantalisingly close to reaching the holy grail of hep C treatment: an all-oral treatment that removes interferon and ribavirin – and their associated side effects – from the treatment regimen. With filing of the fixed-dose combination with GS-5885 not expected until next year, a limited approval of sofosbuvir should help Gilead begin to earn back the $11bn it spent to acquire the candidate.
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28 Comments
I participated in the Phase II trial of sofosbuvir + daclatasvir Plus Riba. Just got the news I am cured at 24 weeks SVR. I was a relapser on a previous 48 week trial with telaprevir+interferon+riba in 2007. The sofosbuvir + daclatasvir was all oral and only 24 weeks! Few if any side effects. (The riba seemed to cause breathing difficulties at about 20-24 weeks.
I pray that Gilead and Bristol Myers Squibb will work out their silly problems so that others can use this awesome cure, which appears to cure the vast majority of those in the trial so far. It will be quite sad if they don’t release these two drugs to be used as a combo. I suppose docs will be able to prescribe them together. Wanted you all to know so you’ll have hope.
Hi, I am very glad to hear you achieved a cure! Congrats! I am wondering what genotype you are? I am 1b and have been through treatment twice, the last being almost 10 years ago, I was a non-responder the first time and a re-lapser after the second (at 6 weeks post treatment). I am waiting on approval for a newer treatment that should be made available soon (I hope). Thanks for your help!
I was genotype 1b. The all oral combos are so promising. Good luck.
I think that Ginsing from ur local dollar store helps, also mixing applecider vinegar with water 1 tbl.spoon pr.10 ounces, may help if nothing else it cleans out ur systems.
After years (off and on) of considerable research, and experience, I’ve determined that milk thistle is by far the best alternative to toxic pharmaceuticals. Actual studies have now been done on milk thistle…and you can bet that big pharma fought the results tooth & nail!…and it has been proven to help those with liver disorders.
The drug mfg justify their denial of the effectiveness of milk thistle by saying that it doesn’t bring your viral load down. Ok…it probably doesn’t…but that’s a moot point in the scheme of things. I have a viral load of over 5 million. Just how far over I don’t need to know because I’m not a candidate for treatment following 2 failed interferon-based toxic treatments. That being said…I’ve been taking milk thistle for years and during 90% of that time my enzymes have been almost normal… AND I feel great. I have never been actually sick from HVC but once it was discovered via random blood screening, doctors rushed in with their interferon. And it didn’t work…at all. In fact, the 2nd treatment came very close to killing me.
Anyway… back to milk thistle… I go for a CBC every 6 months and a sonogram every year. Even though my viral load is so high, all of my other lab (with the exception of slightly elevated enzymes) are normal. My former doctor told me that your viral load could be a billion and you could go through live and not even know you have HVC.
There are a few other vitamins & supplements I take as well daily but I’m convinced that it’s the milk thistle that is the most effective. After all, it’s been used in China for thousands of years for liver disorders. Doctors would have us believe that it’s dangerous to take supplements. In fact, the drug mfg have a HUGE campaign going on to try to make supplements, etc. ILLEGAL! Of course! They aren’t making any money off of them…
Sorry for going on for so long! It’s a VERY touch subject with me and many others as well…
Good luck!!
“earn back the $11bn” Don’t you mean steal back the $11bn, and profit dramatically, off the backs of those whose misfortunes include getting Hep C. Gilead Sciences didn’t create this drug or protocol, all Gilead did was to buy another company so they could profit off of others work and misfortunes. The scientists, doctors, and others that put their hard work and lives into developing drugs deserve to be remunerated in kind, but what Gilead is doing is pure avarice at the expense of those with a deadly illness.
Having been diagnosed with Hep-C (Genotype1a), I finished up the Phase III trial in October ’12 using Sofosbuvir (GS-7977) with ribavirin and peginterferon. I was declared cured at 12 weeks. Side effects were minimal — I was tired, but functional and experienced hairloss which started 6 weeks following the completion of medication and lasting about 8 weeks. Although my hair is on the thin side and will take a few years to completely fill in again, it is a small price to pay for the gift of hearing “CURED! Praise God! There is hope for everyone infected!!
I live in South Africa and battling with same condition,What has the treatment cost you as in SA its out of reach Regards Andrea Martini
Hi Andre, I was involved in a Clinical Trial and therefore, there was no cost. What a gift!
Usually you are also paid to be in a trial isn’t that correct?
Yes…clinical trials are at no cost to the recipients… after all…they’re taking their life in their hands on an unproven and unapproved medication.
BUT..you can bet that when and if it DOES come out…it will cost thousands and thousands of dollars per month! It’s been 10 yrs since I was on treatments and they were over $2,000.00 per month. Outrageous! First of all, they didn’t work. Secondly, they made me very, very, very sick. I ended up in the hospital…almost dead!!
Stay away from interferon-based treatments!!
You’re right Pam. I was told by my technician to consider this a $30K gift. I’m so sorry to hear of your horrible encounter and I hope your cure comes soon.
you cannot be declared completely SVR until 6 most post treatment…
My 6 month blood work will be next month. In my mind, I will not believe it completely until I am released from the study – which will not be for another 2 1/2 years. The only indicator I have is when I pee – the yellowish color is back and not the orange/rusty color. But I still look forward to the blood work.
HOW did you get into the trials!!! I am sooo happy for you that you are cured!! I am getting ready to get treatments soon, I am 3A and have very mild fibrosis. I am scared till death of interferon and just have a really nasty gut feeling that I would suffer tremendously from taking it. I am keeping an eye out for trials but have found none…can you help. Gods blessings of Peace!
btw something interesting (Grace?) happened to me. I have tried an incredible number of natural remedies, some very expensive, to heal this disease…about 5 months ago I had my 3rd or 4th Viral load test and it was 10 million. A month ago I had another one and for some reason it ended up at 155000…..in 5 months it declined 10 million???!!!! I have no idea why, but I am planning on another test before I go for the inteferon treatment. Thanks a lot for sharing your story!
How to register for participation in trail
My Primary Care Physician sent me to an Infectious Disease Physician who runs multiple Clinical Trials. You should check with your Doctor.
Get a good expert doc at a hospital that runs trials. My doc actually ran an arm of the sofosbuvir + daclatasvir (and a telaprevir one before that as well as others). It is only because I put myself in the right place at the right time that I was able to be in these cures. There is also a resource online that lists trials (google “clinical research trials”) but it’s better to be a patient at a top-notch research hospital.
Might there be hope for those of us, who live in Brazil? They spend fortunes on “standard” Inter-Riba treatments (which to my knowledge wrecked me, and killed 2 friends, rather than cure.
I have taken MT (Ultimate MT) for 10+ years. The only time I didn’t was during the two trials I participated in, as the docs wanted to let the substances do their work. I will continue to take MT forever. I feel it is a magic substance for health.
I really needed to hear your story thank you! I just decided to try milk thistle. I have type 2b and won’t be able to try treatment for another year or so. I have an occasional drink so I want to keep my liver as healthy as I can, hoping I respond well to whatever treatment they have available then. Thanks 🙂
Hello all,
I have been trying to get into a clinical trial for hep-c either through Abbot’s 3 drug trial or the Gilead Sciences’ (GILD) sofosbuvir trials for months now. I have applied to everyone I can find with no luck. I’m in a bad way and my recent Hospital stay last week for 4 days intailed the removal of over 20 :Liters of fluid.. Diuretics don’t work and my Doctor said I was down to weeks of life left. I SAY BS I WILL NOT DIE YET! Can anyone help me get into a treatment protocol other than the Alpha Interferon Hep-C treatment THEY OFFER HERE. I think we all Know about that drug and the side effects. I live in WA. State and for some reason there are no trials anywhere close to my State. PLEASE CAN ANYONE HELP ME? You can reach me directly at tnm711@live.com
Thanks and God Bless,
Tim Matthews
Snohomish,WA. 98290
Thank you for sharing. I was diagnosed with HCV about 10 years ago via my annual check up. I also use milk thistle, selenium and alpha libroic acid. My enzyme levels are a bit elevated but that’s it. I had a CAT scan done last year and my liver has no sign of scarring, tumours or thickening of the arteries. It is like a new born babies.
Healthy eating, no smoking or drinking and exercise.
My specialist actually strong armed me to go in for treatment. I resisted and follow homeopathic and alternative methods. I will not poison my body.
The people that I know that have done the treatment (notably only a dozen or so) wish that they had never done so. They are not cured and many never completely recovered from the side effects.
There is no magic pill.
Hi,
I was diagnosed with hep C in 2000 ,The dr’s wanted me to start interferon treatments Which I did not do! ( I read all the horror stories and decided to go it on my own). I took milk thistle (still do) tried so-saki-do and several other herbs . I had bi annual cat scans and blood work
They always looked good and my numbers were high but not crazy.
Feb 11,2010 after a cat scan the dr called and said I had a tumor on my liver and needed a transplant right away.3 weeks later I had a transplant.
and so far hep C is stable and low.!
My point is cat scans and blood work may not tell the correct story, After my transplant they biopsied my old liver and the dr said it was almost totally shot. very cirrhotic ,..And I felt fine ..
Please let me know if I can be a trial patient. The Inferferon would kill me. I am a type 1 and have over 8,000,000,00 viral load. Sofosbuvir will not be available where I live until another 16-18 months. I really would like to be a trial patiient. I have requested this before and got not answer. I don’t want to die. Please inform me on the best way to be a participant in this trial. Thank you for your time and concern in this matter.
Sincerely,
Vonnie
Thanks droitduseigneur your post is a really BIG RAY of HOPE for me & all others who were POISNED with that DREADED interFEARon!
I am going to try sofosbuvir/riba Jan 2014! did peg/interferon/riba in03-04, after 9wks had to stop because I went blind. The tx was worse than the disease, I now have chronic degenrative spine issues, fibromyalgia, cryglob, I am praying this will work for me, i am 54!