Gilead study GS-US-248-0131 - phase 2 all oral

[OC]

I was screened today for the Gilead Protocol Number: GS-US-248-0131, Clinical Trials Identifier: NCT01435226

http://www.clinicaltrials.gov/ct2/show/NCT01435226?term=gilead&state1=NA%3AUS%3ACA&rank=13

“A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-
Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection”

This study also has a sub study (rescue therapy) that involves:

If the study doctor determines that you are not responding to the study drugs, you will be offered additional medications to treat HCV. If you decide to participate and receive the rescue therapy, you will receive GS-5885, GS-9451, PEG and RBV for up to 24 weeks, followed by up to 24 weeks with just PEG and RBV depending on your response to study drugs.

I will know shortly if I will be participating in this study.

What are your thoughts on this trial since this is a randomized, double blind, placebo-controlled study?

peace

[OC]

it's been 2 months since my last dose, i'm running again, hoping to get back into the gym soon...

mentally it was a long 51 weeks.

peace

[Dannyboi7]

Just read your thread OC.So sorry to hear it didn't work out for you,wishing you a good recovery and once you regroup I'm sure something will come along and you'll be ready for another round.Youre a top notch warrior and you will beat this dragon eventually.

All the best to you.

Dannyboi7

[OC]

:-)

[pooh55811]

I just read your post from Nov. 29th. I am very sorry to read that the virus is increasing again. Hopefully there will be something for you soon. Hang in there.

[OC]

thanks, i appreciate it...

i'm waiting for them to call me because i'm going to be in the registry follow up as well...

peace

[jsf52]

I just read your post from November 29 - I am so sorry to hear that the virus returned.  Keep faith, keep healthy and stay strong - God willing, there is a cure in the near future for us.  I enrolled in a Gilead Registry follow-up study after the trial failed me - I get monitored every 3 months with LFT tests and the researchers also check resistance loads and other blood data so that they can figure out why some of us are tougher to treat.  Try and get some r&r during the holidays.  Best, jsf52

[OC]

thanks, absolutely!!!

peace

[adamben101]

OC, keep the faith!  I'm so sorry to hear this.  Stay strong and you will get more chances to beat this soon!  

[OC]

thanks, it certainly is a bummer, hopefully, something will come up in the near future.

peace

[MRPH114]

really sorry to hear --- I also went on an all oral for 24 wks, then SOC for additional 24 wks----I know itz really hard for you right now but try and stay positive-- keep the faith

[Boobert]

That definitely SUX!!!! Sorry to hear

[Duttl48]

Sorry to hear this news. Hoping you the best!

[OC]

well, that didn't last long, first month followup, the virus is back.

need to figure out plan "b"

peace

[OC]

got a call from the study coordinator, undetected at 48 weeks, feeling pretty good!

peace

[adamben101]

OC, I got you beat.  I did 8 weeks on the all oral, then 48 weeks on the rescue.  Hope all is well!  :)

[OC]

thanks, yes, i made it, but it was a long 51 weeks total.

should get the last lab back this week.

peace

[jsf52]

Congrats - I just saw your post.  I needed to take a break from the dailiy reading of Medhelp.  If I read your last post correctly, then you are now done!  That is great news.  Looking forward to the SVR posting.  

[Diana66]

Awesome, you made it :) Five days, that's less than a week :)

[OC]

just finished shot 48 of 48 of the rescue study, plus 2 weeks of all oral study.

5 more days of ribavirin and that's it, go for my last blood test in 6 days.

if i never see interferon again it will be to soon.

peace

[jerialice]

best of results and SVR!

[OC]

that's great news, good luck!!!

[adamben101]

I just finished this trial.  56 weeks total.  8 weeks all oral failed so we added PEG.  Took 4 weeks, but been UND for the past 44 weeks.  Now waiting for all the good tests.

[OC]

week 40 update:

week 10 - <25
week 12 - <25
week 16 - undetected
week 20 - <25
week 24 - undetected
week 36 - <25
week 40 - <25

46 more days if all goes well.

peace

[OC]

:)