Gilead Trial with Sofosbuvir & GS-5816

[mdudley]

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!

[avandaly]

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.

[jerialice]

y'all be sure to keep us informed!
i am 2x tx - and relapser- waiting on breakthru!
no more INF/RIBA

Onward brave warriors!

[mauilady]

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.

[mdudley]

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

[rivll]

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

Praying for your SVR.
Love,
Riv

[BoceprevirGal]

  Great news, Margaret, proud of you!~  Katy