Starting Sofosbuvir GS 5885

[Renee543]

Hi, I tried Teleprevir last year and failed. The Institute called me last week to see if I wanted to be in this new study for Sofosbuvir GS 5885. I have not been able to get much info on the net except from the Drug Co.
They have one slot open and I need to be there tomorrow for my bloodwork and EKG. Is there anyone on Med Help that is in this trial or anyone with any info that would help me make this decision. I was so dis-hearted when I could not stay in the Teleprevir study. It is Phase 3, either 12 or 24 weeks and either with or w/o Riba.  It starts next week. Thanks for any info. Reen

[gerard11]

I am 3 days away from completing my 24 weeks of Sofosbuvir and RIBA Gilead trial!!! Most of my friends and family think I am cured. They see the way I look ( compared to 6 months ago) and the weight gain, energy levels and think I am ok. When I explain that clearing the virus while on meds, and keeping the virus from coming back, after I stop the meds, is really the purpose of the trial they get perplexed. I try to explain that this virus can come back and often does to do its damage. I fall into that very hard to cure group of post liver  tranx, cirrhosis, non responder many times, taking  immune supressent's  ect..., I really do feel like I will have a complete recovery.:)  Taking the meds, along with getting the great news (und. ) made my time in trial Very tolerable.  Lots of improvement keep my dark days at bay!!!! Now the hard part for me is here. I really believe if I can make it a month, I think that I will be ok. No scientific proof, just my gut feeling. There are only 40 of us in this trial worldwide ( post liver transplant with cirrhosis). If we can get to SVR 12 I feel the rest of Hep C patients stand a great chance of becoming free of this horrible affliction. Good luck to all !!!! Will keep posting.

[nobodyone]

I am thinking it was submitted this way due to fact that for some types of hep c the dose with RBV works the best.  I think that is why i am on the RBV included and got the 24 weeks since I am 1B.  That gives me the best chance of SVR forever.  There was a special last night on the Brian Williams show Rock Center about FDA approval for some liver damaged babiesthat desperately needed this new drug in order to even survive and the FDA needs to see different arms of the drugs before they will give them their approval...very interesting show.  

With the Sofosbuvir one way must be the best way for SVR forever I figure and that must be the reason they are submitting it this way.

I have accepted that I am on the RBV and just keep on taking them.  I feel totally fine except a slight noise in my head, which it bearable I suppose and I know it will go away when i finally get done with the meds.  After I reach 14 weeks though I am hoping for a reduction but if I can't I will accept that too because then I am past the half way point.  I just don't ever want to go through any of this ever again..hopefully the drug will get fda approval and as time goes on we will learn more about the results.  I know just the Sofosbuvir worked for some for 12 weeks eot.and the sofosbuvir plus RBV worked for over 6 months eot for another and he is still  undetected and I am betting his is for life.  Probably the girl's is too who has reached the 12 week eot.  We need to see all the results, simple as that.

[can-do-man]

So you know this is what has been submitted for approval.

On April 8, Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sofosbuvir for the treatment of HCV infection. The data submitted in the NDA support the use of sofosbuvir and RBV as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and peg-IFN for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.

[nobodyone]

Why does it say with Interferon???  December 8 is the target date too so that is great to hear!!

[nobodyone]

Gilead’s Hepatitis C Drug to Get Priority Review by FDA
By Andrew Pollack - Jun 7, 2013 4:48 PM CT
  

Gilead Sciences Inc. (GILD), the world’s largest maker of HIV medicines, said its experimental hepatitis C pill, sofosbuvir, will receive a priority marketing review by U.S. regulators.

Gilead applied to gain approval of the drug in combination with ribavirin, a current treatment, as an oral therapy for patients with two types of the virus and with ribavirin and interferon for patients with other types of the infection who have never received treatment. The Food and Drug Administration has set a target review date of Dec. 8, Foster City, California-based Gilead said today in a statement.

Gilead is competing with drugmakers including Bristol-Myers Squibb Co. (BMY) and AbbVie Inc. (ABBV) to gain approval for oral hepatitis C treatments that don’t involve injections of interferon, which can cause flu-like symptoms. Hepatitis C attacks the liver and can lead to liver cancer. The virus affects about 150 million people worldwide and the market for new pills is estimated at $20 billion.

A priority review, granted to drugs that may provide major advances in treatment, speeds FDA evaluation to eight months, rather than usual 12.

Gilead gained 3 percent to $52.89 at the close in New York before the announcement. The stock has more than doubled in the past 12 months.

[nobodyone]

Just wanted to mention a 75 year old female started the 8 week course a week ago and is feeling great with no sides..so that helps prove there are no safety issues with the Sofosbuvir..What comes 10 years from now we don't know but so far is looking great!!