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1797925 tn?1341099804
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!
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Comandries!!!
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Hi Alico, no Sovaldi is never used alone. 24 weeks with riba is the one for 3s, unless you can wait for Abbvie? Also they are beginning to use Harvoni for 3s too, and that should be approved here in June/July...in theory! Yes I think the wait in the UK for GS5816 will be a long one. A trial might be your best option?
Do you have experience of riba? It can be a rocky ride for some xx
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I did 24 weeks interferon and RIBA.. And failed in 2011.

No didn't mean SOF alone.. It would be with ribavirin .. But I meant SOF without another DAA ! Ie SOF and ribavirin for 24 weeks..

Yep harvoni coming... But not sure it does very well for geno 3.,,
It's great for geno 1!
Really don't know which would be the best.. Harvoni for 12 weeks or SOF and rib for 24 weeks.
Or wait..

Cheers
Alico.
When's your next blood test???
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Harvoni is good for 3s too, just not FDA approved yet for that...pretty sure it will be, not sure of the cure rate, will try to find out.

Next test in 8 weeks, D day!! Blind comes off.

xx
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http://www.hepmag.com/articles/Harvoni_3_6_2501_26447.shtml
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Thanks caz .. Will have a read...
2 months then!!!!
Blind off... Mid april then!!!!

And 12 week pcr too I suppose!!!!
Best of luck.
Love
Alico xxxx
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13th April...and yes, 12 weeks after that too....

Thanks....you're next!! xxxx
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Good luck !!!!
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Well I just spoke to my research nurse, it seems that I had it right, and the nurse I saw last week was confused, if we are placebo we get the real deal immediately!!! She had just had an email from Gilead about the roll over 'study' to say that their first patient would get the real deal on 6th April - she began on 20th October a week before me, and my 12 week post tx date is 13th April, so the day the double blind comes off is the day we begin the real drugs! (pending blood tests of course she said). Massive Phew! here!
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Fantastic news!  Although hopefully you won't need to be in another study!!
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Good for you caz!!!
So again.. Win /win!!!!
If not april 13 th then soon after!
Hurrah!

Any whispers on when gilead might put in for license.. Presume FDA first...
Then ema... What's the sort of time frame.. Or will they wait until all placebos treated???
Or put in ready ..early???

Anyway caz... Way to go !!!
Love
Alico x
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News release that NICE are recommending Harvoni, and Sovaldi has been approved but delayed till 31st July...it's nearly here!!!!! :) Soon be your turn Alico!! xx
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Re 5816, i do not know, as soon as the results are out I imagine they will go to the FDA, late summer, autumn?
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Ok figured its time for update. My blood work report for post 4 wk.
Total bili : 0.6  0.2-1.2 mg/dl
ALK Phos: 96  35-123 U/L
ALT (sgpt): 11  6-34 U/L
AST (sgot): 22  9-34 U/L
Creatine: 0.78  0.35-1.4mg/dl
Glucose: 90  10-100 mg/dl
ALB BCG: 4.2  3.3-4.9lg/dl
Sodium: 138  135-145mEg/L
Potassium: 3.8  3.4-5.4
Ck: 54  18-169U/L
Lipase:27  0-120U/L

SVR:4

Some of these I have no clue what they are for. To me none seem bad and to have SVR 4 is the one that counts. I'm pretty sure I beat the dragon. Now I have to wait for my liver to heal as much as it can and go from there.
Heres hoping everyone reaches there SVR too..
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Sl:  Way to go!  If I read those right, everything appears to be in the normal range - and you are still undetected at 4 weeks post Tx?  Only 8 more weeks to go to SVR12!!!

Keep on keeping on!

Blessings, Pat
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My trial nurse gave me a copy of the post treatment protocol for Astral 1.  I have uploaded a copy of it to my profile page.  She said she doesn't know why they are keeping the results so secret in this particular study.  Does anyone who started this trial in September or October have any results yet?  I started on November 24th.
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well I just found out I am the trial astral 2 and won't now what my viral load is till week 24. The one that took over for the trial for me after I finished meds didn't even know. well today makes 3 months since I finished meds so I guess I waited this long I can wait longer. she told me the reason they do this is because if they let people know the results right away , they don't come back to finish the trial. well heck I filled out a paper where they keep track of me and do more tests for 3 yrs I want all of that. They will be doing another fibroscan for me near the end of the 3yrs ,who would not want that.
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You should be told in a week or so if you a) need to go onto a follow up because you had the real drug but didn't clear, or b) need to go onto the rollover study as you were placebo, or c) you need to go in 12 weeks, cos you had the real deal and are UD, if your trial had a placebo arm.

I got the shocking news (as I was so sure I had the meds) 2 days ago that I was placebo. I was so wired, my skin cleared, my digestion changed...I was gobsmacked!! I am still digesting the news. I wonder if the placebo has caffeine in it or something? I now have to rescreen, disappointed and also excited as this time I will know what I am getting, it's open label. I may feel better too as I still feel like dog poo. What a palava it has all been, my summer is now spoken for. Let's hope we all get cured at least! :) x
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Well I guess that is what they call the placebo effect!  It is good to know that you will now be treated with the meds.  Thanks for letting me know that you were informed about a week after your 12 week appointment.  I will expect the same timeframe.  Will be another month for me.  
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Well I guess that is what they call the placebo effect!  It is good to know that you will now be treated with the meds.  Thanks for letting me know that you were informed about a week after your 12 week appointment.  I will expect the same timeframe.  Will be another month for me.  
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The Astral 2 trial doesn't have placebo so you definitely have the real deal.  And they have already said that you were SVR4 so that is very good news for you!
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Hi caz,

What a bu..mer,
I really thought you had real thing..
The mind can be so strange and play tricks on us..
Placebo.. Cleared digestion..
Mind/ body..
Obviously your worry over hep c effected yor digestion, and once you thought you were tackling it.. Your digestion relaxed.

I know my blo..dy digestion is all over the place and gets worse when I get worked up and anxious.. It's a sort of repression of the fight/flight thing.. That we want to do.. But with hep c we feel powerless to flee it and without the drugs powerless to fight it. So we internalise our feelings and our gut suffers as a result.
So that's prob why your digestion and then your general energy levels were good on the placebo.
At last you thought I'm doing something to kill this bee virus, and getting on with it.
Now at least ... You can go forward and even though its another mountain to climb.. You can do it.. And do the tx in the summer!!! With good weather etc.. And hopefully come Xmas you'll be hep c free!!

All the very best to you.
Btw it just seems stupid putting people on nothing.. What does that really prove.. They've got a whole load of people on nothing.. Just trying to survive!
But that's the none sense of drug companies for you along with charging exorbitant prices.

I'm crossing fingers for dariop in uk...
No news yet..
Best of luck caz.. Keep updating .. I'm trying to keep an eye on this one as I hope it will be my saviour !!!
Probably misled!! But there has to be hope ! Otherwise were all lost!

Lots love
Alico
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Wow
With alt at 11,
Your liver is looking pretty good.. No imflamation!!!

Fingers crossed.. At mo.. No virus at work in your liver... Just hope its all gone from the rest of you.. Then home and dry.
4 week svr good.. Just need the 12 week .. Then your clear!!!

All best.. Great news
Alico x
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Maybe Jen..
To keep it from other drug companies????
As maybe they want to conquer th whole hep c market?

Love
Alico x
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That is along the lines of what I was thinking.....
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Hmmm, placebo effect, yes, I was looking out for that, but I think there was more to it than that. My skin cleared, my gut behaved, maybe if thee is really nothing at all in the placebo pills (I really do want to know what they are made of) then something I was leaving out affected me...I stopped taking various supplements. Nerves would explain the spaced, tired, wired, adrenalin thing, but not the clear skin, and hunger, and changed poo habits! All of which went back to baseline after I stopped the meds, within a week. Now given that i thought i was cured, the 'placebo' effect should have continued? It did not, and I was disappointed, assuming I was cured but my liver was still compromised, and all the chemo had affected me.
Stronglady you are done girl, well done to you! Jenn I am hanging on your results! Good luck!
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Thanks Alico, they are now trialling this 5816 with Harvoni, seeing if 6 weeks will cut the mustard! This is certainly the one to watch, hope you get your shot soon xxx
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Hi caz,

Humm!!! Don't know the answer... Maybe one of the supplements... Have you restarted any.. ?
Strange!!!
Re harvoni and GS 5816... Where have you heard of this.. Online or at your hospital???
If the latter... Are they recruiting in uk??? Then..
If so am have I missed the boat... Again!!!
Do you happen to know if its for geno 3 or just geno 1.
We spoke before I believe re your hospital and the trial you were on.. But I was too late and out of catchment I think... Although in the city they take from far and afield I believe!!!
Any news .. Let me know.. You can pm me on the uk forum if that's better...

Dariop gets his news in may!!!
Take care...
Speak soon.
Alico xx
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Ok Its true there where no placebo's with my trial. The nurse tells me they do it this cause people don't come back after they find out and the trial is 24 wks for some. I signed an extra paper where they did a dna thing and they watch me for 3 yrs. I mean heck its all free why not. They said near the end of the 3yrs they do another fibroscan, my insurance won't pay for it so why not get one for free.
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Alico I am admin on a Hepatitis C Family and Friends Group, which is where I saw the trial. I will try to post the link, at my mums now and barely have time online, but will get back to you.

I have been reading about placebos!
http://www.sciencedaily.com/releases/2010/10/101018174335.htm
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Glad you got the real deal Stronglady, you will be fine! I am thinking I got an active placebo, no way were all my sides in my head...we will all get there I hope! :)
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Some people may be genetically programmed to feel better after taking placebo pills, while others may only heal with real drugs, suggests a new review of existing research.

Read more: http://www.businessinsider.com/r-is-the-placebo-effect-in-some-peoples-genes-2015-4
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Interesting, thanks for posting...doesn't feel right for me, I did not actually feel better, but wired and tired, and my skin cleared unexpectedly in the first week, and has stayed clear. This was the last thing I had anticipated, and the wired/spaced feeling I hadn't heard about till after I had reported it myself, I simply felt as if I had had too much coffee...Now I know that an active placebo exists I think this is quite likely, since Gilead make both the drug and the placebo. It is neither here not there really, it just made it more of a shock for everyone concerned. I still felt ill after treatment even though I thought I was cured. I am glad now as I have a chance to feel better maybe!
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Here you go: https://clinicaltrials.gov/ct2/show/NCT02378935?term=hepatitis+c&cond=%22Hepatitis+C+Virus%22&lup_s=03%2F18%2F2015&lup_d=30
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and these results from the triple phase 2...http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2039076

xox
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I found out today that I am SVR 12.  I started the Astral 1 trial on November 24th.  I am 57 and have had hep C since I was 17 so I am looking forward to seeing what life is like without the virus.  I have noticed some changes which I had never even associated with hep C.
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Congratulations!!  What a wonderful place to be!!

Now, step up the last step onto the dias and receiver your Dragon Slayer, Supreme Insignia!

Please don't forget to go to the SVR or Relapse threat that Nan535 started, so that there is a record!

Blessings, and enjoy your Hep C FREE life!  : -)

Pat
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Your story is really interesting. Let us know when you get the real deal because it for sure will wire you up and grab your stomach from time to time but other than that the war begins and c will lose. I completed treatment Jan 12.There are a lot of strange phases during the war;sleep  fatigue inspite of the wirey drug. I was called this thursday and told I had the real pill. August is next appt. The body aches have diminished  tremendously but the last week liver region is on fire 24/7 very weak. F4 is a bad place to be so eliminating all fun food. No medicine, no marijuana as I recently see that it can contribute to fibrosing.. Hope you are being treated by now  drink lots of water..
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Jenn congrats on the healing proccess. How do you feel now. We started the trial similar  time and I  completed in  jan. 12. I began with liver at stage f4. How was your liver prior and now. About 2 weeks ago my liver region turned into a flame and I do not feel well . I do not take any medicine /alcohol and eat well so I am curious whats going on. I was called Thurs  by trial group and told I had the real deal which was obvious as alt 257 , ast 191 on 10/31/2014.  As of 12/11 2014,  alt 26, ast 27. Hope you are doing well.
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Hi stronglady, Its been some time since you completed your treatment. How are you doing now?
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Hi Skier, we were right on the same schedule as I started a day before you. I had a F1-F2 fibroscan score the year before I started the trial.  I must say that I did not feel tired and wired while on the drugs.  I did feel a little "off" for the first week and I had a metallic taste in my mouth for the first few days.  I felt really tired and I slept a lot during the first two weeks post treatment and I started to feel all kinds of sensations around the liver region, don't know if I would describe it as burning but it was really worrying.  Over the years I have attributed a lot of "symptoms" that I have had to hep C but one thing that has changed without a doubt is something I had never associated with my liver.  Since I was about 19 I noticed that I couldn't lie flat on my back for long periods of time without getting pain in my right shoulder and down my arm.  About a month ago I noticed that I was lying on my back with no pain and I have tested it almost everyday since then and I have no pain at all when lying on my back.  Other than that I do seem to have more stamina.
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That is really encouraging you are feeling better Jenn. Interesting you have had to pick sleep position in the past. Mine demands to lie on stomach or right side. My liver flame is tuning down a bit today but still total weak and fatigue . Last night soaked sheets and pillow from internal heat. I had these feelings several years ago but not at all lately. I can only conclude that my liver is still trying to detox the medicine. Did you originally ever get really sick when you were 17? Did you have symptoms most of your life. Did you drink during your life? My doc warned me in 1972 no drink, no tylenol if you want to live long. I obeyed but I did enjoy pie cookies ice cream etc.... which was like adding to the fatty liver problem while hep c was pacmaning. I am being really careful now more than ever as I would like to feel better. I am frustrated that we can not find the rest of the 600 from our trial as well as the trial 1 and 2 patients to hear how they are doing. That would be so helpful. Take care and wishing you continued improvement.
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My husband was in a phase 3 trial with Sofosbuvir/GS5816 for patients with cirrhosis.  He just received his 12 week post treatment results - Undetected.  This is an amazing treatment.  I hope it is FDA approved soon.    
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Cindy, that is great news. How is your husband feeling now that we are 6 months down the road? Yes I agree that this 1 pill program is phenomonal but my liver is on overload now more than ever. I am just hoping it is just working on getting rid of the gnarly power pill and it just takes longer when the liver is compensated......
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Skier, I did not originally get sick when I was 17 and I only got tested when I was 40 because a friend told me she had been diagnosed with it and we had engaged in the same risky behaviour.  Luckily I had completely given up alcohol in 1988 and I still don't drink.  I have never had an abnormal liver function test and I did not seem to be less healthy than anyone else I know.  I guess that my perceived improvement in stamina could just be from the relief of knowing that I'm hep c free. I have a read a few clinical trials done after the earlier treatments used in the 90's where they followed patients to gauge liver improvements after treatment and it seems like it takes many months to see the difference. So, I think you will get steady improvements over the next year or two.  Probably a very good idea to avoid the fatty foods, I am also trying to eat well. It is so strange that there aren't more of us on here.  I really hope that you continue to heal and enjoy a better quality of life after hep c!
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Jenn, thanks for responding and answering all my direct questions and encouragment. I think you are correct about time will heal. I think this cryoglobulinemia might be part of my ill feeling. I figure be nice to the liver is easy and doable. The fuzzey brain and irritable is really frustrating because it takes the happy down . I am encouraged by everything I have read about trial results but do not understand all the trialers not posting somewhere gleeful reports or any kind of reports. I guess they must feel fine and have moved on..... and I say Hooray to all. Wishing you well for the next 30 or so years!!!
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Hi everyone...I am back on the pills, the real deal this time for sure, day 4 now. The most bizarre thing is that my screening enzymes (ALT and AST) were 28 and 29 - so had dropped in the 3 months post placebo from tehir usual 40-50 levels.
I have not had many side effects so far, but I have a cough/cold which is making me feel rubbish anyway so it's hard to tell. I did just have an attack of the liquid tum out of nowhere after I had had pasta and salad for lunch, hoping it was a one off.
So glad you're cleared Jenn and Skier, wishing you both a safe passage back to good health. Stronglady too if you're about, and anyone else who has had these drugs and cleared, well done...go forth and have fun!!!
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Caz, fantastic news!  It will be nice to see the results of your blood tests as they come in and not have to wait for 12 weeks!  I'm sure that at the end of week one or two you will have enzymes in the teens.
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Sorry haven't been on but not much to put right now. I go for my 6 months post treatment test in July. Very hard for me to differentiate between symptoms of hep c and all the other health issues I have. My spine is in pretty bad shape . Cervical and lumbar. In the past 9 months I have had 24 procedures done on lumbar area. I can actually walk again, hardly use scooters at all in stores anymore, but I will never be pain free. I would be amazed to find out ithat myliver has started to heal itself. I have always pretty much watched my diet I can thank my Mom for that she had her masters in nursing, she would've made an awesome Dr. Taught me whats bad for liver .
Feels good to actually be tired from doing stuff, been so busy in rl. Did a lot of container gardening this year. Finally getting to do more around the house too. Still have to be careful tho if I over do I suffer dearly. I have so much to catch up on sometimes wonder if I ever will. I feel like I'm getting somewhere and then realize by time I do this that has to be done again,ugh. I love my home but sometimes wonder why we got such a large one. Oh well maybe somewhere in the future a reason might show up.
Glad to here that so far everyone is doing well. Hang in there guys.Hope everyove reaches svr.
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Hi Caz, glad to hear you are finally being treated. I do not know about cleared until august. Body aches diminished ratically which is marvelous. I swear I am still peeing out those drugs. My last pill was Jan 12. Your enzyme levels are so weird . You must have a powerful belief system . Nonetheless, this combo pill  is a winner . I feel overall much better. You will be amazed....
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