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!
Hi...Caz and I are female...LOL its ok it happens. Please feel free to hook up with us on FB. Let us know who you are when you join. I also am very very thankful for this opportunity to cure. Has it been tough? Yes it sure has but it will be worth it. I was so alone for the most part of my treatment and I have even started threads on other forums at the beginning of mine and up until about a month ago I found only one person and now its nice to find others to share this journey with.
Thank you Cindy. Yes this is a very strong very potent antiviral but it has to be to kill this very resilient virus..especially for Geno3's. I have heard that all folks do get better over a period of time after they finish their meds. I am trusting that I will be the same and that my liver will be healing soon, as I was only Fibrosis stage 1-2.
C, re the Riba cough, I use plain, greek- style yogert morning and night for sure, then, a spoonful sometimes once or twice, during the day, to coat my throat, which does seem to help. I also use Chlortrimiton, 4 mg Tablets and part of my cough seems to come from - or be made worse by- sinus drainage. I checked with my doctor before I did that to make sure it would be okay. Also, at bedtime, sometimes, I use the 225 mg benedryl clear, no dyes added, capsules. Both help the cough, and help me get to sleep.
Now, having said that, I still cough, just not nearly as much, or as often. Also, tell him hydration helps. Drink that water.
Tell your husband to keep on using the yogurt morning and evening with the protein .
Good luck to you both. Hang in there. The time will pass more quickly than you realize. Pat
Hello LADIES! Sorry for the misunderstanding. :) I will check in with the FB Pages soon. Family in town for the weekend. More blood work news this week. (My really cool trial nurse emails them to me on off visit weeks) all criticals back in normal ranges for the first time in 20 years. ALT dropping fast from 209 to 61 to 38 now. I too am looking for numbers in the 20's but my normal base could be higher so I'll take what I have! OK, stay strong sisters!!!!!
LOL....its ok Woodeye...When I first heard her name I thought Caz was a male also. I am going to go to my GS trial coordinator appt tomorrow in Baltimore which is 3 hours away from me. Thats the closest I could find to get myself into this trial. I have some weird feelings again today. Feels like something is stuck in my gut...its like eating something large, not chewing it fully, and then swallowing and then getting that 'something is stuck there'...its weird. Oh my, I am so weary of it all. I will be glad when this is over thats for sure.
general...i hope you read this...were you on the GS 5816? You must have been in the phase 2 part. Did you take Riba or just the GS with sovaldi? Wow One year and still HepC free! You must be ecstatic! Thank you for sharing. That gives us newbies so much hope for us.
Guys, I found out something!!!!
GS/5816 is ASTRAL which is Sovaldi/Bocaprevir/Telaprevir. 1 horse pill per day. Maybe we could look these drugs up now? A friend who is on this trial dug into her own records and found this out. Will post in our FB page too.
Good day to all happy trialers. I started nov 25 2014 I am 1a .ast 196 alt 285 cirrohis 90000 viral load. I am convinced I am on the drug after reading all the threads. Wired is the key, nausea as usual. Question: Does anyone in this trial have cryoglobulinemia?
Hi all of you labrats! I am going to be half way tomorrow, everything is fine, same sides, wired and tired, some aches and fatigue, some days are better than others. I am still sure this is not placebo, I have more stamina, clearer skin, and don't get breathless like before. I seem to be more tolerant to yummy food. I will get enzyme results Monday, but given that mine began at 47 (ALT) and 44(AST) I cannot expect much change. Last time, at week 2, they were 48 and 39. If they are 25 I will know for sure, I can but hope!
Good luck all of you, it's great we have found each other, and a big welcome to this thread titussun!
We now have 4 placebo rats, let's hope we all have the real deal. Frannie is nearly done, we know she is UD already, this is a magic bullet!
Yep...This coming Friday is my last pill...UD since week 2. I have to go for my last pill appt friday. then back in Jan for a VL then in March that will be their scientific VL which will prove that I am SVR. It does sound like all you Placebo peeps have the drug. I hope so but even so, if not, you will get it later. But with the SX that you all talk about I can say that its exactly what I felt and I am not on a placebo. Mine was a efficacy trial. And please excuse my latest post..our drug is NOT Sovaldi/Bocaprevir/Telaprevir. The lady who posted that was mistaken and Caz helped to find out about it and its actually incivek which has been taken off the shelves. So we are still without a clue what this GS 5816 is. Im super duper tired today...a couple flippy heart thingies but only one more week to go! My trial coordinator said that I will probably have sx for 4 weeks or so even after my last pill. But each day should be better and I will feel less and less as time goes by. I am trusting so! Talk you to all later! God bless!
Ed, gives me/us much hope for the future...Thank you! I hope you are enjoying your new found freedom on life. Thank God. I am only one week away from being finished on my 12 week regimen. I am looking forward to being where you are in 7 months. :-)
well the 11th will be 6 wks for me. I noticed my hair is like straw now and my nails kinda crappy too. But well worth the cure.
I am gonna have to call my trial worker and tell her I can't make this next appt cause my hubby has the flu and can't find anyone else to take me. I hope this doesn't make them ditch me. I have been to every other apt loyally. Not much else to say, i'll have to wait a bit longer to find out if I'm still undetected. ***** I can't drive due to foot and spine problems. And we have no mass transportation where I live.
I really hope you can get to your appt!! I have just turned 6 weeks 2 days ago so we are almost neck a neck. I have noticed my skin is very dry, especially on my stomach, it's peeling. I am still very wired, it's like one long adrenalin rush, exhausting! Let us know what she dais, my research nurse told me yesterday there is a 3 day window either way for bloods. Good luck.
i started the trial of Sovaldi and GS-5816 yesterday
i'm gen 4
fibrose fase 3
i hope i get the real pills and no placebo's
i don't really have any sides, probably a bit a strange feeling in my head
Hi all! I am on week 10 of the Sofosbuvir / GS5618 Gilead trial in Philadelphia. I am not sure if I received the real pill or the placebo. The day after I took my first dose, I was extremely ill. Had a headache, dry heaves, and felt dizzy. That did not last very long. I then had cramping in my feet & calves and a metallic taste in my mouth up until about 6 weeks. Havent had a lot of side effects the last few weeks. My ALT and AST have not changed much....but they were almost in the normal range to begin with? I am around 37-47.
Hi Gail and Anne!!! Good to have more of us labrats in here!!
Feeling pretty rubbish today, funny drugs these, it's like a constant adrenalin buzz that leaves me aching and exhausted...a state of tension that never lets up. Some people like Frannie have muscle spasms and tremors on this treatment so I consider myself lucky the 'buzz' is all I get. Not pleasant but worth it, hope it's not all in my head!!
Gail it really does not sound as if you have placebo, and my enzymes are behaving exactly like yours. I was told very clearly that if they were in normal range to begin with then I should not expect much change!
Thanks Caz! I feel so much better! I had no idea about the cramping.....and I had spasms horribly in my feet & calves initially. It went away eventually. Like you had written.....we must have active imaginations if we do not have the real deal?
well my tiral nurse is really being a jerk. I know things need to be done at a certain time but my hubby is stage 3 empyhesema and he is running a fever and not well at all. I have absolutely no one else to take me. I'll be damned if I'm gonna take a chance on my hubby getting real sick and ending up in the hospital. What ***** is my apt is thurs. I told them theres no way I can even come fri cause I have to get a procedure on my spine and will be sedated for it. This place is local or I wouldn't be doing that either. I can't afford a cab for a 2 hr drive to the trial place. I'm going nuts don't know what to do. I have been practicaly bed ridden since they did last spinal procedure. This time they are putting something to deaden the nerve.. hopefully I'll be able to walk again without horrid pain. Why do these things happen to me ,ahhhhhhhhh
Oh Stronglady this is not what you need. I am so sorry you have this stress and your husband is so poorly. The protocol os 3 days either side research nurse told me that, so it's not her fault, it's Gilead's rules, but what a dilemma for you! Could you by any chance get the bloods done on Friday at that hospital and sent on? I have a scan 3 days before my next clinic appt and my nurse is going to ask the doctor to do my bloods as she isn't there that day...maybe it could be arranged like that? You're doing so well, you must find a way to do this...wishing you a way through x
where just gonna go hubby don't wanna take a chance on me getting kicked. don't even wanna discuss it anymore. on top of it I will be probably be sick to now. everytime I get blood drawn I get sick., and the next day I will be sedated for procedure. just don't care anymore. nothing ever goes easy for me, ever.
Hey,Sl: So sorry you have been having all the complications! But, hang in there, you are not done yet!
I don't know if y'all have religious ties in your community, but if either you or your Husband do, then call your Pastor Rabbi, Priest or whoever, and ask if there is a congregation member who is willing to drive you.
Another possibility, depending on your state or county, is a Seniors Volunteer Driving service. If you call your local TPO (Transportaton Planning Organization) or senior outreach organization, they can tell you what special, lowcost, transportation might be available.
Having said that, you do what you must for your hubby and yourself, and don't stress any more over this! It will work out. I agree w/caz. Ask your trial nurse if they can get scripts to the hospital where you are going to have your procedure.
Whatever happens, we are all praying for you and hoping for a positive outcome in all things, and SVR!!
Saying prayers for you Stronglady. Stay the course.....keep your eye on the prize. Once the HCV is gone......you will be living a different life. I like what Pat said in calling your congregation and asking for support. Maybe someone can drive you? Meanwhile......praying for your strength through this.
I'm beginning to get discouraged with this trial place. She told me I was 15 / und last time , and then today said 15/ detected, I said what did it come back again and she said no it stayed the same , looked and she had 15/und last time checked paperwork and she told me wrong. Insisted I had to go today EVEN WITH ALL GOING WITH MY HUBBY CAUSE I HAD TO SEE A DOCTOR well guess what never saw one.
Now she is telling me they have to check to see if I can get the procedure for my spine , suppose to go tomorrow ,how can I give 24 prior cancellation. before she said was ok. Just getting so fed up.
So now I'm 15/detected ,never saw a Dr. and have no clue what to do about procedure. My life is crazy enough I don't need them screwing it up even more. She is suppose to call me about procedure today ,if she doesn't I'm gonna get it and go from there. Gotta go my head is spinning from everything.
Caz I feel exhausted and yet I cannot sleep. Yes....it is tiring. I kinda feel achy and fluish? I have 16 pills to go and I am done (unless I got the placebo). I pray I do not have to go through this again.....but I will.
Only 16 to go Gail!! I am finding the tiredness is cranking up, and I have a shoulder injury that has really flared up too, so feeling quite sorry for myself the last 2 days, pretty much house bound. I really hope you got the real deal, I am sure I have this is not in my head!! My head is racing with a too many thoughts at once, tape loops of songs, and my body feels wired but tired...5 weeks to go for me....
We will get there!!
Hello Caz, I am on my 19th day of 12 weeks. I have a fluish feeling in my muscles. I did have fatigue and a metalic taste in my mouth for the first week. Otherwise I'm doing well. I also have muscle knots in my upper back/neck area which I am prone to.
Hi Jenn! I get a funny cold/acidy feeling in my tum an hour or two after the pill too. I have definitely got more tired as the weeks have gone on. Do you feel spaced too? I have a shoulder injury and I am sure it has cranked up because of the pill...12 weeks is not long though! Frannie finished yesterday!!
As of tomorrow.....I am down to 12......appt on Monday. Then...I go back the end of December to get end blood results. I won't know them though. One month out, tests.....then 2 more months out I think? Caz I so agree, I am getting more tired by the day, I have lost weight and do not seem to have much of an appetite?
I lost a kilo in the first week...not sure now as they don't weigh me any more!
I had the worst sides ever last night, shaky, bubbly tum, couldn't eat, wired, spaced, like caffeine overdose or bad speed if anyone has ever had that! It went on for hours and hours till I slept eventually. Was told today I have a frozen shoulder, great, not!
I hope everyone is improving as we go down this road. Wanted to wish you all the best of the holidays and also provide a little more hope if I can, so, Merry Christmas, Happy Holidays and best for the new year.
As a personal update, after 35 days of treatment (42% elapsed) I just received my latest numbers:
Starting ALT 209. New ALT 21
Starting AST 166. New AST 23
Very exciting! Keep the faith. We're all going to be cured!
That is fantastic news Woodeye, very happy for you! Can I ask what sort of back pain you had early on? I had some upper back pain which now seems to be improving as I'm just reaching week 4. Merry Christmas to all!
Amazing news Woodeye!! I am at week 8 now and my enzymes are still hanging around 30-40, was so hoping to have a drop! They have dropped a tiny bit, but they were normal in the beginning... They have told me if I am on the drug and it's not working they would have stopped tx by now, and I know I am not on placebo, too many changes for that...so...let's all get well for 2015!! Happy Solstice everyone..keep on keeping on x
Hi, I am on the double blind Astral 1 trial in Scotland. Started on 15th Sep so I only have 2 weeks left. I am pretty certain that I am on the treatment though and not the placebo. I had mild sore heads every day for the first month or so but they have become less frequent. I did have one today however. I am taking bit longer to get off to sleep at night even though I am really tired. The tiredness has been the main side effect but it is manageable compared to my previous treatment attempts. This is attempt number 3.
Hi Kerso, good to meet you! I seem to be getting increasingly tired too, just beginning week 9 here in Devon, started 29th September in Plymouth. My main side effect is being wired and spaced, as if my head is rushing with too much coffee/adrenalin. It's exhausting. A few fleeting headaches but nothing too bad. I am on the double blind too.
Does anyone else feel as if their whole body is in a constant state of tension, like a sustained adrenalin rush? I feel as if my eyes are on stalks and I am wired as if I am off to an exam or something? It's exhausting, I think this is similar to what Frannie felt with the muscle flickers, it's like hyper motor tension...anyone else?
Thanks Jen and Caz. Jen, I had minor lower back pain and some "indigestion" for about a week. That was the extent of the sides. So Caz, you must be on the drug and it appears to be working. Happy for you. Keep posting all. Merry Christmas to all!
I got the best gift I could get found out today I am undetectable, no virus in my system. Between that and my spinal procedure working I am one happy camper. Happy holidays to all. Wish everyone could reach svr, just never give up.
Just wanted to wish everyone a Blessed Christmas and happy as well healthy New Year! I have 2 more pills to take (Sovaldi & GS5816) then I get my blood tested in 1 month, then 2 months out. I am sure I am on a placebo....but I am thrilled to be ending this part of the experiment for Gilead. Glad we are taking a 3 month break, wiill be happy to start the REAL drug in March hopefully. Prayers to all for good health and to beat this draining disease!
Headaches every day now. Feeling exhausted every now and then, specifically at the end of the day. But the first four weeks are almost done and I 'm still very happy to know that I have the real stuff.
I just read on forum that weaning off the med can be tougher then taking it. I hope that isn't the case with this trial medicine. I have 24 days to go and have noticed hair loss and my skin getting really dry now. Also my nails are pretty much shot. I would do this again if I had to the side effects to me a not bad. My goal for this year is to keep a healthy diet and please hope to quit smoking. I will not take the medicine to quit I already take enough meds . Have severe spinal issues due to a very bad accident so I live on some heavy pain meds. I'm hoping I can somehow help heal my liver while still on these meds. Unfortunatly I will never be without severe pain. Also hoping that pain Dr. will be able to at least make it so I can drive again, at least local driving. I hope everyone has a good year just remember your body is your temple and you only get one. If you abuse it in any form it tends to get even.
How is everyone doing? I have 12 pills left. I feel very rough today after a trip to the clinic yesterday, it's a long day out. No news, my enzymes have dropped a tiny bit to 42 (ALT from 47) and 32 (AST from 44). They keep saying this is no big deal as they were in the normal range already but I was so hoping for them to be in the 20s. I will just have to wait. I am sure I have the real drug, far too many good and bad effects...better digestion but feel spaced and exhausted, it's different from the hep C exhaustion though. I had hives come up on my wrist last night and today...weird...
Hope everyone is ok!
Still undetected, liver enzymes in the teens. I have 17 more pills to take. And right now I am suffering from a horrible sore throat. Went to a clinic today to test for strep throat and don't have it. Already had scarlet fever as a child don't want it again. I pretty much had every childhood disease , my Mom was a nurse.
Wanted for that test that takes a month is gonna seem awfully long.
Just so everyone understands the sore throat is not from the meds ,its just something I picked up. Seems everyone around here where I am has sore throat or strep throat. That's why I went for test. I have had my hair thin out a lot, and my fingernails went to heck that's about it. I'm pretty sure when the meds get out of my system that's will all go back to normal.
Finished treatment on Monday, but I have been very fatigued all week. Not what I expected. My ALT has dropped from over 100 at start of tx to 42 at week 10 so heading in right direction. Does anyone have a skin condition called Lichen Planus (apparently it is common in HCV). Mines started on my lower legs during first treatment attempt in 1995 and has never went away and it spread into my mouth a few years ago. Well it has completely disappeared in my mouth and my legs are almost clear for the first time in all those years. I'm hoping this is another indicator that I received the real treatment.
Kerso this sounds brilliant (the enzyme drop) also encouraging for me as mine dropped to 43 and 38 and I wasn't sure if that was enough, they were only 50 to begin with though. Your big drop is very positive. Great your
skin has cleared, mine has on my face but is very dry and peeling on my trunk. 7 pills left...and counting! Some days have been harder than others, the agitation and wired brain along with the fatigue and some indigestion are the main sides I have had. Of course it could still be placebo...but I don't think so. Enough of the negative sides...positive sides I have noticed are:- no more fibromyalgia type muscle aches; greater tolerance to 'taboo' foods such as onions, spices, meat and late night snacking; clearer skin; no gastric upsets or heartburn; less breathlessness up hills; a clearer (but racing) mind; more stamina; occasional bursts of 'wellness'; a building excitement that 22 years of being ill may be coming to an end. If this is placebo I will still eat my hat and my coat.
In 5 days I take my last pill been undetected for quite awhile. Next comes the dreaded wait to see if its gone for good. I hope I won't go thru much Of a withdrawal when I stop taking theses pills. Looking forward to my hair coming back to where it was it did thin out quite a bit, my nails got pretty bad too. Been going thru a lot of stuff with spinal issues already had 2 rfa 's with 3 more to go, and that's just the lumbar area. I have very severe chronic pain from a very bad car accident. Hoping maybe by spring I'll actually be able to walk more then I can now. I'm hoping this year will be my year for improving a lot of my health issues unfortunately I have many. One can hope and must never give up.
Wishing everyone out there luck with reaching svr.
Bloodwork drawn today. Recieved my labs from a month ago. ALT & AST levels up to 109 & 107.......I am rounding up my time with this plcebo. I have an appt in 2 months......will not be long till I get the real meds!
Thank you Stronglady. I am having one of the most sick Winter's ever. I m so tired that all I want to do is lay in bed. The new study has been approved and all the paper work has gone through.....I just need to be released and re-screened. I cannot wait........it is so hard feeling sick & depressed and getting up everyday. The higher my counts go, the more tired I get and my body is in so much pain. At least there is a rainbow in sight. I pray for your SVR!
This is my second attempt to post. Tired and wired seem consistent complaints . I too experience the same. I started nov 25 2014. alt 257, ast 191 .On Dec 9, 2014 alt 26 ast 27. Those are serious changes so either I am on the real deal or I have turned into a faith healer! I have cihorris f4 and cryoglobulimemia ( a mystery cold clotting protein in blood) a result of 43 years of hepc. I take medical marijuana for the side effects . It works very well and I am fortunate to be in a state where that is possible. I don't take any other medications. Sure hope this wonder pill sustains all of our virus and we don't have unusual late occuring side effects...
Hi Caz, I entered some time ago under titus sun and lost all my set up info so am back under the skier so all know I am the same. I sure wonder how the remainder 587 astral 1 trial group are doing. It is hard to believe more have not stumbled on to this site to check up.I am so curious and only counted 13 in this group. Oh well wishing you and all the rest success and many better days ahead!!!
My treatment was the 400 sofosbuvir and 100 GS5816. The 22 nd of this month will be exactly one month since my last pill. I go in the 2oth for blood work , then go back in 3 month, 6 months then I think a yr. When I go back in year I think they said that's when they do another fibroscan to see if my liver improved. I'm hoping I get good news with that and all the other bloodwork. The place I am going to said they don't consider being cured unless I stay cleared 6 months after last med.
Hi to you too!
I have just come back from my 4 week post tx check...enzymes are still at 40 something, normal but not much different from baseline. I have a question, I was told before that they take the double blind off at 12 weeks post tx, and the meds begin straight away if we are placebo rats. Well, today the nurse told me she thinks it's 24 weeks post tx they give the real deal??? What?? I need to ring to check on Monday as the main research nurse is on leave. Any input please?
Also at 4 weeks she says the drugs should be out of my system but I do not feel quite normal yet, I seem to have the paced feeling and erratic digestion, some days are great and then the next I am trashed...anyone feel like this? My cognitive function still seems to be a bit out.
Hope everyone is doing ok!!
Caz, my study nurse told me that we won't be getting the real deal until August. And I won't be finding out if I'm on placebo or not until 12 weeks from today. Today was my last pill! Before I started this trial I asked when we would get real meds if we were placebo and she said it would just be "weeks" but this will clearly be months. However, your case could be completely different. Good to know about that 4 weeks to get drugs out of my system (if I have them)
Oh Jenn that's a long wait, so it is looking as if the double blind comes off at 12 weeks then the real drugs begin at 24 weeks. Sigh, I need to be well in September, it was one of the reasons I signed up to this trial, they were not sure at first if it would roll straight on from my 12 week mark or if I would have to wait till the whole study ended internationally, then the doctor running the trial assured me I would be done and dusted by September. Let's keep updating here as we learn more! Congratulations on taking your last pill, how do you feel?
Hey caz.. Alico here from uk..
Think we spoke on uk forum..
Hoping you will be clear and done and dusted as you say by sept!!!
If not... You will be in good place to do meds for real!!! Ahead of the game...
Wish I was in either of your shoes... It's win win either way!
Either win today.. If you svr and have been on real deal or win tomorrow.. Sometime next year if get the real drugs later... So alot to be optimistic about!!!
Everyone else in uk will prob have to wait several more years to access this on nhs!!!!
With love and take care,
I don't think they will do much till these phase 3s are finished? They are already talking about offering the patent for generics to India for developing countries, they say it would cure 54% of the worlds hep C like that...so they must be very confident.
I had my 12 week appointment today and was told that my ALT & AST which were both in the mid 20's are now in the mid teens. The doctor said that he was "hopeful" that I have been on the real meds. Now I just have to wait for 12 weeks to see!
Oh good for you Jenn!!! Those are amazing enzyme levels, I wish mine were like that, I keep a record and mine have dropped a little from around 50 to around 35-40 but it's not enough to make a good guess.
I feel so much better though, after 4 weeks off the pills, my digestion and muscle pain is much better.
Alico yes, this IS the bees knees!! I so hope you can get your mitts on it soon xox
My consultant hasn't heard of it..Which is a little worrying!!!to say the least..
Thinking of maybe.. 24 week SOF and rib ?
What do you think???
Not really sure SOF alone good enough for the job.?
But the wait for gs5816.. Unless other trials come up.. Is likely to be a long one!!!
Take care.. Keep truckin.. Glad you've found some command rise here.. Where's dariop got too???
Hi dariop if your looking in..
Any thoughts your end?
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
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!
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
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..
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.
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.
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
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.
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.
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..
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!
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!
Humm!!! Don't know the answer... Maybe one of the supplements... Have you restarted any.. ?
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!!!
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.
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!
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.
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..
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.
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.
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.
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.
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......
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!
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!!!
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!!!
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.
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.
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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