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Gilead Trial with Sofosbuvir & GS-5816
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This forum is for questions about medical issues and research aspects of Hepatitis C such as, questions about being newly diagnosed, questions about current treatments, information and participation in discussions about research studies and clinical trials related to Hepatitis. If you would like to communicate with other people who have been touched by Hepatitis, please visit our new Hepatitis Social/Living with Hepatitis forum

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274 Comments Post a Comment
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Avatar_f_tn
I was a strawberry blonde up until about 30 then it got more brown then red. I now dye my hair...LOL to keep it with a reddish tone. I have also always been very sensitive to everything. I goggled it once...Hyper Sensitive People..and I took a 22 question test just out of curiosity and I think I posted 18 of the 22 as a 'yes'. It was pretty interesting. I hate it though...a small little cut on my finger feels like I cut the top of my finger off! Geesh!
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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.
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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.
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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
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Cindy:  On the Benedryl, I only take a TWENTY-FIVE  (25) mg capsule.  Can't believe I didn't catch that typo before I posted it!  Sorry!

Again, Don't give your husband more that the 25 mg capsules!

OMG, scares me that someone might see that and fo it!  Again, 25 mg caps.

Pat
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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!!!!!
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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.
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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.  
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Hang in there Frannie. The day is coming!
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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.
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Avatar_m_tn
We started the same day I believe I can feel the medicine. I am in calif
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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?
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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!
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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!
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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. :-)
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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.
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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.
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Avatar_m_tn
i started the trial of Sovaldi and GS-5816 yesterday
i'm gen 4
fibrose fase 3
male, 55
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
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Avatar_n_tn
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.
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By the way, I am Gail. Hi Anne & Caz!
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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!!
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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!
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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?
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I have already said I want the Gold medal for imagination if this is placebo!!
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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

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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
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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.
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Good luck then....things will get easier when the hep C is gone...stay strong x
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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!!

Pat
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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.
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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.
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Hope it all resolves stronglady! Let us know how it all went.

I am struggling more with these meds daily, so wired, and spaced, as if my whole body is in tension, my mind too. Like a non-stop adrenalin rush..anyone else like this? It makes my body ache...
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Avatar_m_tn
5 days on drugs now. Thirsty all day. And strange feeling in my head. Bit nausea. Think I must have the real stud. I'm blessed to get this medicines for free.
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Real stuff is what I wanted to say
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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.
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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!!
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Anne sounds as if you have the spaced feeling too?
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Yes i have a strange spaced feeling. I'm not gonna wait 12 weeks before I know if I get the real stuff, gonna do a bloodcheck next week to be sure before Christmas
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Ah we can't do that here in the UK, not with the NHS anyway. Good luck with that.
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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.
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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!!
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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?
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You are nearly there Gail!!! That must feel amazing! You're a month ahead of me then :) Paving the way for us all x
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HI, I just took my last pill on this past Friday. Yes, the spacy feeling is definitly one of the sx I had and I was not on a placebo trial. What other ways are you feeling?
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MIchahblue, that is exactly what I felt like when I took my first pill...and I am not on a placebo trial....you sound like me. I took my last pill this past friday.
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Maybe I have the placebo then because I actually feel pretty normal this past few days.  No side effects at all.
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Avatar_m_tn
Does anyone of you lose wait? I've lost almost 2,5 kilo in a week!
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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!
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Some people have no side effects...wait and see and keep the faith!!
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Yes, you're right, I will just have to wait until the middle of February!
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I lost an extreme amount of weight. I am now trying to gain some weight back.
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Avatar_m_tn
Greetings all!

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!

Best to all!
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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!
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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
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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.
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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.
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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?
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Avatar_m_tn
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!
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Avatar_m_tn
Got 28
Gpt 33
Gamma gt 45
YES!!!!!! I've got the real stuff!!
This is the best Christmas gift I could get!
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9 weeks to go
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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.
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That is amazing news, Stronglady!!! Merry Midwinter and a happy new year!
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Fantastic!! I am so pleased for you!
I wish my enzymes would drop a bit more but I am still sure I am on it, we will all be well!!!
Happy New Year to all of us!
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Avatar_n_tn
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!
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Avatar_m_tn
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.
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Probably I just have the flu. All my muscles and joins hurt more then usually
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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.
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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!
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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.
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I am at six weeks and I haven't had any side effects since the end of the second week.
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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.
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Avatar_n_tn
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.
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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.
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Anyone problems with short memory? I really forget everything directly. Very annoying
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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.
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