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

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week 28 results, everything is about the same. no viral load test until week 36.

peace
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2035311 tn?1332683577
Fantastic!  Don't know why the back and forth under 25 and und. What does Dr. say.  How long are you on SOC 48 weeks?  Good luck!!!
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doc says no problem if i'm <25.

failed study (all oral) after 2 weeks

then 2 DAA's & SOC for 24 weeks, then SOC for 24 weeks for total of 48 weeks

thanks!
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1835200 tn?1427463838
OC glad to see you are still UND. I know SOC is no fun and hoping you have many comfortable days ahead. Stay in the fight. God bless.
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thanks, only 19 more weeks!

peace
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Glad to see that you are UND.  Keep slaying the dragon!  Will keep you in thoughts and prayers.
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thanks, i appreciate it!!!

peace
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week 32 blood tests today.

they told me 2 weeks ago that the rescue study protocol is like SOC protocol, meaning they only test PCR at weeks 24, 36, 48.

my HGB is slightly above 10 and platelets are in the 60's, so i don't have much stamina these days.

is this the normal protocol, especially if someone is run down like i am?

peace
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Glad that you are still slaying the dragon.  Try and get some rest - what did the trial team say about the HGB and platelets?  Hope that you have a good 4th.  God bless.
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163305 tn?1333672171
I just did 24 weeks of SOC with viral loads at 4, 12 and 24 weeks.  But I think 24, 36 and 48 sounds right.
I think if you do a separate post about your situation you might get more replies.
Hang in there~
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1835200 tn?1427463838
OC- glad to hear you are still in the battle, keep up the fight. I believe the PCR test are correct for this trial. I don't have my info. with me but I will look at it when I get home and let you know if different. I know that the trail protocol is to reduce the riba if HGB goes below 10. If your HGB is "slightly above 10" I know you don't feel that great. Just praying that some comfortable days are ahead. Stay in the fight.
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1835200 tn?1427463838
OC...also please keep us posted. Thanks.
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got a call from the study coordinator yesterday:

they're dropping the PEG to 135mcg because my absolute neutrophils are at .68, if I go down to .50 i'm off the PEG...Riba still at 800

HGB 10.6
Platelets 67

107 more days to go

peace
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Glad that the trial coordinator connected with you.  You are almost there.  Keep drinking lots of water.  Keeping you in prayers.  Best, Jeff
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thanks, i appreciate it!

can't forget to keep drinking lots of water.

peace
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just received week 32 results, i'm fading:

super anemic: ribavirin still at 800 mg, interferon now at 135

HGB - 10.6
WBC - 1.49 - (G3)
RBC - 3.1
Platelets - 66
Absolute Neutrophils - .68 - (G3)

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1835200 tn?1427463838
OC....so sorry you are having a hard time. I can only imagine how you must feel. All your numbers are within range to continue tx., easy for me to say. You may already know this but the protocol calls for interf. reduction if your neutrophils are <.75 and discontinue interf. if <.50. Also there is a interf. reduction if platelets are <.50. HGB at 10.6 is good, again easy for me to say. Wow 16 more weeks to go. Try to take it day by day. Keep moving some and maybe try to schedule small fun events to keep your mind off how bad you feel. Keep that UND thought in your mind. Heck I failed tx. and still have this bug. Praying you have some comfortable days. Keep fighting. We are pulling for you.
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thanks, great advice, i need a fun day!!!

peace
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Just checking in to see how you are feeling.  Sorry that you are struggling with the counts and energy level.  Keep going for UND and SVR.  I know that both times I treated, even though they were only 12 weeks each, family and friend time kept me going during rough days.  Hope that you have family and friends that can help you out during these times.  Favorite tv shows, music, whatever you can do to relax and get your mind off tx helps.  Good luck - keeping you in thoughts and prayers.
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thanks, yes, family is a lifesaver.

feeling a little better, can certainly feel the difference between 180 mcg vs 135 mcg of interferon.

99 more days if all goes well.

peace
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just received week 36 results, feeling slightly better now that the last 4 shots of interferon have been at 135 mcg. i'm concerned about whether the doc should give me helper drugs so they can raise the interferon back to 180 mcg. i have 12 more weeks to go.

doc says he isn't concerned with my latest test being <25

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

80 more days if all goes well.

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You are in the home stretch.  Will keep the prayers going for you. Try to beat the heat - stay indoors with the a/c and drink lots of water.
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i was just moved from the office to the field and it was hot today.

70 more days if all goes well.

peace
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131114 tn?1380086790
i just found your post- but hoping you make the finish line and success as SVR!
prayers for us all,
ja
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thanks, i appreciate it!

peace
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Good luck with being in the field.  Hopefully this heat wave won't last long.  Keep counting down!  Best to you - keeping you in thoughts and prayers.
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:)
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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
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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.
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that's great news, good luck!!!
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131114 tn?1380086790
best of results and SVR!
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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
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3093770 tn?1389742726
Awesome, you made it :) Five days, that's less than a week :)
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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.  
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thanks, yes, i made it, but it was a long 51 weeks total.

should get the last lab back this week.

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OC, I got you beat.  I did 8 weeks on the all oral, then 48 weeks on the rescue.  Hope all is well!  :)
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got a call from the study coordinator, undetected at 48 weeks, feeling pretty good!

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

need to figure out plan "b"

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Sorry to hear this news. Hoping you the best!
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901131 tn?1293748153
That definitely SUX!!!! Sorry to hear
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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
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thanks, it certainly is a bummer, hopefully, something will come up in the near future.

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

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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
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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
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1815939 tn?1377995399
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.
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:-)
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3230925 tn?1397619565
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
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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.

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