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Author Topic: Sovaldi and GS-5816  (Read 11549 times)

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Offline omeco

  • Member
  • Posts: 21
Sovaldi and GS-5816
« on: November 13, 2014, 01:47:54 pm »
Today I was in Antwerp finally for the screening session to join a trial with this medicines.
They explained everything, one on six is gonna get a placebo, but if it's you, you get the real meds after the trial for free.
Only 600 persons on the world join this trial and I am one of them!!!!!
You only get the results from the lab after 12 weeks, but off course you can do lab tests yourself....
If my bloodresults from today are ok, the trial starts 8 December.

I'm genotype 4 with fybroses fase 3
I just can't wait!

Excellent Results Across Genotypes for Sovaldi and GS-5816

 

 Gilead Sciences’ Sovaldi (sofosbuvir) and GS-5816 cured about 95 percent of treatment-naive people with genotypes 1 through 6 of hepatitis C virus (HCV) who did not have cirrhosis in a recent trial. Aside from achieving excellent pan-genotypic results, the combination is also notable for successfully sidestepping the use of ribavirin. Results from the randomized Phase II GS-US-342-0102 study were presented at the 49th annual meeting of the European Association for the Study of the Liver (EASL) in London.

The 144 participants were randomized to receive the polymerase inhibitor Sovaldi plus either 25 milligrams or 100 mg of the pan-genotypic NS5A inhibitor GS-5816.

A total of 94.8 percent (73/77) of those participants taking the lower dose of GS-5816 achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). Meanwhile, 96 percent (74/77) of those who took the higher dose were cured.

“The results of this study of [Sovaldi] with a new pan-genotype NS5A inhibitor demonstrate the curative potential of this combination,” Gregory T. Everson, MD, a professor of medicine and director of the section of hepatology at the University of Colorado, Denver, and principal investigator of the study, said in a release. “The combination was not only effective across all genotypes and patient subgroups, but also was well tolerated. These results warrant additional study in future trials, with the hope of providing a potent, pan-genotypic combination with few side effects and a high chance for cure.”
The most common adverse side effects, occurring in more than 10 percent of the participants, were fatigue, headache and nausea. None of those enrolled in the study stopped taking therapy because of side effects. Plus, there was no evidence of laboratory abnormalities related to the treatment.

To read the press release, click here.   



Search: Sovaldi, sofosbuvir, GS-5816, Gilead Sciences, hepatitis C, HCV, hep C, virus, GS-US-342-0121, 49th annual meeting of the European Association for the Study of the Liver, EASL, Gregory Everson
on Sofosbuvir & GS-5816 trial since 8 dec '14
gen 4 fibr 3

Offline Bucky

  • Member
  • Posts: 341
Re: Sovaldi and GS-5816
« Reply #1 on: November 13, 2014, 02:06:50 pm »
I hope all goes well in the trial and you get the "real" meds.
Bucky
I HAVE SLAYED THE DRAGON.....CURED SVR24!

Offline BattleTheBeast

  • Member
  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Re: Sovaldi and GS-5816
« Reply #2 on: November 13, 2014, 03:06:47 pm »
Hi Omeco,

Wishing you the best and hope you are in the group that beats this beast 1st!

Congratulations for being one of the chosen 600!

~Mel~
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline omeco

  • Member
  • Posts: 21
Re: Sovaldi and GS-5816
« Reply #3 on: December 07, 2014, 12:23:41 pm »
Everything cool! Tomorrow I start with the medicines.
I'll keep you informed.
on Sofosbuvir & GS-5816 trial since 8 dec '14
gen 4 fibr 3

Offline omeco

  • Member
  • Posts: 21
Re: Sovaldi and GS-5816
« Reply #4 on: December 08, 2014, 07:04:30 am »
Just took my first pill
on Sofosbuvir & GS-5816 trial since 8 dec '14
gen 4 fibr 3

Offline BattleTheBeast

  • Member
  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Re: Sovaldi and GS-5816
« Reply #5 on: December 08, 2014, 08:00:15 am »
Congrats Omeco,

It's a crazy feeling isn't it? I had to do it with S/O and then with Harvoni. Keep the positive mindset and know we are all going to beat this beast!

Mel
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline zeena

  • Member
  • Posts: 114
Re: Sovaldi and GS-5816
« Reply #6 on: December 08, 2014, 09:50:59 am »
omeco
  drink plenty of water, get exercise, laugh and take care of yourself! we are all cheering you on!!

Offline omeco

  • Member
  • Posts: 21
Re: Sovaldi and GS-5816
« Reply #7 on: December 08, 2014, 10:36:26 am »
Until now, I only have a bit a strange feeling in my head
I really would like to have some side effects to be sure that I have the real pills
on Sofosbuvir & GS-5816 trial since 8 dec '14
gen 4 fibr 3

Offline Mike

  • Member
  • Posts: 999
Re: Sovaldi and GS-5816
« Reply #8 on: December 08, 2014, 05:52:49 pm »
Hi Omeco,

I'm glad you got approved for the trial. You have a bunch of friends here pulling for you!

Worse case scenario, and that's if you get the placebo, is that you have to wait 12 weeks for the real McCoy. In the scheme of things, if waiting 12 weeks for treatment is the only hurdle, bring it on!

Best, wishes, Mike
Genotype 1a
Treated 2001 with PEG and RIBV
Treated in 2014 SOL+PEG+RIBV
Cured July 2014

Offline omeco

  • Member
  • Posts: 21
Re: Sovaldi and GS-5816
« Reply #9 on: December 23, 2014, 01:03:47 pm »
Got 28
Got 33
Gamma gt 45
YES I have the real stuff!!!!
The best Christmas gift I could get!
9 weeks to go !
on Sofosbuvir & GS-5816 trial since 8 dec '14
gen 4 fibr 3

Offline omeco

  • Member
  • Posts: 21
Re: Sovaldi and GS-5816
« Reply #10 on: December 23, 2014, 01:04:43 pm »
Gpt =33
on Sofosbuvir & GS-5816 trial since 8 dec '14
gen 4 fibr 3

Offline BarbG

  • Member
  • Posts: 13
Re: Sovaldi and GS-5816
« Reply #11 on: December 23, 2014, 02:07:56 pm »
 ;D Glad you got the real stuff!

Offline zeena

  • Member
  • Posts: 114
Re: Sovaldi and GS-5816
« Reply #12 on: December 24, 2014, 07:39:30 pm »
HAPPY DANCE FOR OMECO AND HIS LIVER !!!!  LOVE ZEENA

Offline JillLynn

  • Member
  • Posts: 205
  • contracted 1973/ peg/rib 1999 & 2004/on harvoni
Re: Sovaldi and GS-5816
« Reply #13 on: December 25, 2014, 09:40:44 am »
Omeco......Congrats on getting the real meds!    That's great news!

Rock on around that Christmas tree friend!   
cheers!


Jill 


Offline BattleTheBeast

  • Member
  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Re: Sovaldi and GS-5816
« Reply #14 on: December 26, 2014, 12:49:10 am »
Hi Omeco,

That's just awesome news! See where all that positive thinking got you! I am so excited you for to be on the "real" stuff first time out! You are in the best position possible and you don't even have to deal with all this crazy insurance garbage we are!

Keep smiling, Happy Happy New Year to you!

Mel
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

 


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