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1797925 tn?1341096204

Gilead Trial with Sofosbuvir & GS-5816

Gilead Sciences:  Twelve week Phase 2 trial of sofosbuvir + GS-5816 (without ribavirin or interferon) for genotypes 1, 2, and 3 treatment-naïve.

The Protocol Number:  GS-US-342-0102
Clinical Trial Number:  NCT01858766

Anyone else in the Gilead 12-week trial with sofosbuvir & GS-5816 (without ribavirin or interferon)?  The initial enrollment was 140 patients and I would like to connect with or hear from anyone else who may be in these trials.  Thanks!
346 Responses
1797925 tn?1341096204
http://clinicaltrials.gov/ct2/show/NCT01858766?term=GS-5816+Sofosbuvir&rank=1

The above link is for this trial.
Avatar universal
I am in this trial but for 24 weeks..just am on week 12 now..plus i have the ribavirin..800 dose.  doing fine..minimum sides. undetected since week 3 or 4.  am going to cut down my RBV dose now.  i have noise in head from this medicine i believe...
Avatar universal
oops i am in the Sofosbuvir, RBV, and 5885 drug..sorry..
317787 tn?1473358451
Hi I just did a search and nothing came up,
317787 tn?1473358451
Hi Margarete here is a person who is starting but that is all I could find

http://www.medhelp.org/posts/Hepatitis-C/Biopsy-Results/show/1959539
Avatar universal
Hi Dee,

That's me but I did not get into the trial, it is closed. I am now waiting for the FDA decision on sofosbuvir and will most likely be doing the 12 week sofo/riba dual therapy for gen 2s in a few months (hopefully)
Avatar universal
Hi, I'm at about week 6 in the Sofosbuvir + GS-5816 12-week trial. Liver enzymes normal and HCV undetectable as of week 2. Platelets on the rise. No side effects to speak of. I hope it sticks, obviously. How are you doing? I'm GT-1A, btw.
131114 tn?1380083190
y'all be sure to keep us informed!
i am 2x tx - and relapser- waiting on breakthru!
no more INF/RIBA

Onward brave warriors!
163322 tn?1458676408
I am very interested in the results as I am 1A, did an unsuccessful 24 weeks with interferon/RIBA in 2007, and am waiting for this new one to be released. I would have liked to get on a trial, but missed the boat.  I don't think it was offered to people who live in Hawaii.

Wasn't there another all-oral trial going on two years ago or thereabouts?  Can anyone enlighten me about the results of that one?  I rarely come to this website,  so hopefully I'll get email notifications.
1797925 tn?1341096204
I am genotype 3a and my liver biopsy from Dec 2011 indicated Stage 2, Grade 3.  I started 12 week treatment with sofosbuvir & GS-5816 (no interferon or ribavirin) on May 22nd, in a Phase 2 trial.

My starting levels were VL: 6,500,000, AST 47, ALT 58.
After 1 week treatment:  VL: 567, AST 25, ALT 26
After 2 week treatment:  VL:   42, AST, 22, ALT 17
After 4 week treatment:  VL: <25, AST 20, ALT 13
After 6 week treatment:  VL:  UNDETECTED, AST, 22, ALT 15
After 8 week treatment:  UNDETECTED

The side effects have been absolutely minimal.  The first couple of weeks I had a few fleeting headaches and some nausea, but that has all subsided now.  I now have energy that I didn't expect to ever have again.  My thinking seems to be clearer, the depression has lifted and my spirit is soaring.  Before starting treatment I was constantly and utterly fatigued, bloated, nauseated, and just generally miserable.  My family and friends cannot believe the difference in the way I now look and feel in such a short time and neither can I.  

I have 18 more days of treatment (2 pills each day at 2:30pm), and if I remain UND until November 14th, I will be considered officially cured.  I have only been able to find one other person in this trial (besides you Avandaly) and he is UND as well with no side effects.  Hopefully, there will be others that will find their way here and we will be hearing UND from them all.

My prayer is that GS-5816 is truly Gilead's answer for Bristol's daclatasvir, and that soon all will have access to a cure that is safer, more effective, and with minimal side effects and is effective in ALL genotypes!  If the results from this phase 2 trial are as amazing as the sofosbuvir/daclatasvir trials were, then Gilead plans to initiate a phase 3 trial immediately from what was mentioned in their 2Q investor meeting.  And since both of these drugs are owned by Gilead, we won't experience what we went through in the Gilead/Bristol situation.

Tomorrow is World Hepatitis Day and I pray that by World Hepatitis Day 2014, the whole world will have something to truly celebrate - life without Hep C!

Avandaly- Please keep us posted as to your progress and I will do the same.

Warmest regards to all!
mdudley



Avatar universal
So happy to read your good news! Thanks for informing us and please keep us updated.

Praying for your SVR.
Love,
Riv
Avatar universal
  Great news, Margaret, proud of you!~  Katy
Avatar universal
I'm happy to hear of your good news.  I relapsed after 48 weeks of interferon/ribavirin combo and wanted to do the Gilead trials but it does not appear available for relapsers.  

If phase III comes available, I'm wondering if there will be any arms for relapsers.  

sljl
Avatar universal
I feel so encouraged from your current results.  I've had HepC 2b since 1995.  I've been blessed that my symptoms have, for the most part, been kept at bay and my ALT/AST within range.  There have been a few times, and most likely now, that my VL has been considerably high.  I'm very excited about this drug and the "minimal" side-effects.  If it weren't for the side-effects of current treatments and the multiple horrific stories I've read from others having gone thru the treatment "hell" I might have been more brave to reconsider but I'm thankful I'm in good health for the most part and that I've gone this long without any health issues from this disease.  Awesome, thank you for being a testament to those of us who are waiting in the wings to make a bold step forward to the treatment for a cure!  MRC
Avatar universal
I just signed up for the sofosbuvir gs5816 12 wk trial. I completed 48 wks
Interferon/ RIBA combo and relapsed ov a year ago. I'm 62 yr old male
Stage 1, geno3a. I start the treatment on Thursday. Good luck to you.
Your results are encouraging to me
Thanks,
Avatar universal
@mdudey my experience is Identical!!     september 4th will be my first 30 day test after finishing the pill regimen.. fingers crossed..  
same 3A genotype
789911 tn?1368636783
congrats mdudley.  I know you have put a lot of time and effort into getting a better cure out there faster for everyone!  Best wishes to you
Avatar universal
I started today gileads 12 wk trial. I'm in the sofo and gs 5816 100 dose group
And no RIBA or interferon. Glad to be in this study.
Hope your progressing well.


Avatar universal
I too am in this trial.  Now at wk 5.    Geno 3a, stage 2-3, Grade 2.   Also relapsed after 24 wks of standard tx in 2011.
Age 69.  I'm in the arm with Sofo + 25 mg of GS-5816.  Wk 1 and 2 viral load were both <25.  I should get the wk 4 viral load in about a week.  Baseline AST 55, wk1 24, wk2 21, wk4 48.   Baseline ALT 52, wk1 25, wk2 16, wk 4 25.
My best wishes that you reach SVR.  Let us know of your progress.  Regards,  zandra666
Avatar universal
I'll keep posting as my blood work comes back
Good luck to you
Avatar universal
I just started the 12 week trial yesterday.  I am taking the Sofosbuvir with Ribavirin AND 5816.  I have previously been treated with interferon and ribavirin after 12 weeks as the treatment seemed to be working but the the viral load climbed back up to where it was when i started.  Very discouraging i am hopin this will work.  I am taking 1,000 mg RBV, 400 Sofosbuvir and 100mg 5816.  Anyone else in this same trial?
Avatar universal
Ion 2 study
Naive stage 2
geno1a
24 weeks with RIBA
Completing week 18
6 weeks to go
UDL at week 4
Hemo went to a low of 12 and has rebounded
enzymes low range of normal
Feel better with more energy than in recent yrs - just finished in gym :)

Skin rashes
Aggressive behavior
Insomnia
Lack of energy in the beginning

There you have it :)
Avatar universal
I am in this Gilead trial, also.   Previously relapsed after 24 wks of standard tx.   Geno 3a.  I am in the arm with Sofo + 25 mg GS-5816 and no riba.
I am at wk 6 and just got back the viral load for wk 4 -  UNDET.    No sides.  I am hopeful.  You should do well.  Let us know how you are progressing.
Avatar universal
I did a long post a few hours ago but I don't think it went through.

I, too, am in the 12 week study with only 5 days of pills left.

Dianne
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