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!

[theskier]

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....

[Stronglady14]

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.

[jenn1958]

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.

[caz77777]

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!!!

[theskier]

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!!!

[jenn1958]

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!

[theskier]

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......

[Cindy815]

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.    

[theskier]

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.

[jenn1958]

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.

[theskier]

Hi stronglady, Its been some time since you completed your treatment. How are you doing now?

[theskier]

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.

[theskier]

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..

[patra_]

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

[jenn1958]

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.

[caz77777]

and these results from the triple phase 2...http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2039076

xox

[caz77777]

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

[caz77777]

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!

[JimmyMose]

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

[caz77777]

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! :)

[caz77777]

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

[Stronglady14]

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.

[alico222]

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

[caz77777]

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