Hi, I tried Teleprevir last year and failed. The Institute called me last week to see if I wanted to be in this new study for Sofosbuvir GS 5885. I have not been able to get much info on the net except from the Drug Co.
They have one slot open and I need to be there tomorrow for my bloodwork and EKG. Is there anyone on Med Help that is in this trial or anyone with any info that would help me make this decision. I was so dis-hearted when I could not stay in the Teleprevir study. It is Phase 3, either 12 or 24 weeks and either with or w/o Riba. It starts next week. Thanks for any info. Reen
Excited we are both clear so far. You're a 1a and I'm a 1b, both clear at week 12 after ION2 trial 12 weeks with RIBA. I say so far because I will not feel completely convinced until at least week 24 results and definitely at week 52 results. If my energy level is any indication I am completely clear!
I agree with you....like I said before I'm not dancing in the streets yet!!
I too have much more energy. I do yoga 4 days a week though and I think that really helps a lot with energy and the release of toxins.
Good luck to you Latille...I am hoping for the very best outcome for all of us who participated in this trial.
I cut the dosage myself, coordinator said dr would not cut anymore. She also said you could have had 12 weeks also. I said I wish, I think she was saying 12 weeks does the job to me. I am taking cruise to Mexico in 4 weeks. She said they me take my meds and is okay if they do, she said I would be done then and okay--to have a good vacation and buy some bikinis and sit in sun. Was a 1b, had rvr at 3-4 weeks. Hope we all become svr for life! :)
I will definitely stay in touch..they actually are scheduling my eot 4 weeks lab to be around Oct 31 and then I see dr. too. If Mexico doesn't take my pills, which coordinator said they might maybe because pills say for investigational use only they wouldn't want that brought into their country???? and that would be in 4 weeks about!!! (but is okay, I would still be fine ) that my last pill is Oct 2....woo hoo..excited and can't wait!!!! So I definitely wouldn't be upset if they don't let the drugs into their country...then I am done!!! That would mean i did a 20 week treatment and end around September 9...that would make my vacation even sweeter!!!!
Keep posting how you are doing..i love hearing about all the energy every body gets..boy I could use some of that and better yet a good night's sleep!!
want to keep hearing your eot svr's also. this still seems like a dream..hard to believe it after having disease for so long.. But it just gives us all so much hope to keep hearing/reading all these posts about SVR..Finally cured Hep C it looks like.... take care, Renee..you have been a help here with all your posts.. i really enjoy reading them... :)
Thanks so much, this site has really helped me a lot too. So glad I found it. I feel a special bond with everyone that has gone on through this experience with me. I feel good about us all finally getting rid of this horrid disease. It weighs so heavy on the mind, even when we don't realize it. Such a gift to finally be released from it.
Also, I wanted to mention I had asked my trial nurse if once SVR when we get our bloodwork in the future will it show we no longer have hepc? She said that the anti-body will always be there. So I guess that means we will still test showing hepc and will have to tell them we only have the anti-body? Not sure, will have to research this more. If anyone else knows the answer , please share. It would nice to have it out of medical records...especially in the existing climate.
That definitely would be so informative to actually see nothing but the end results of the trials. I only know of one relapse on the Gilead trial and that was for a 12 week trial. I would love to know the results and what conclusions have been discovered by all these trials. I am still on the trial so I won't post..Will be done either in 3 1/2 weeks or 6 1/2...(trip to Mexico..coordinator said they might confiscate the drugs and IF they DO is ok! she said.)
I sure wish we would hear from Matt...Hope he is doing well!! :)
sofosbuvir + 5885+RBV 24 weeks trial
was that the LONESTAR tx-exp relapse quoted in a Gilead press release? (actually two relapses cited in their press release, one 12wk tx-exp no RBV and one 8wk tx-näive no RBV) (search terms gilead+lonestar+relapse)
I just got the call from my trial coordinator 8 week eot and still no sign of HCV. I can't express my happiness!!!! I am so grateful to Geilead fo letting me in this very small, limited trial. A special shout out to Hector ( probably the most informed non physician expert on HepC out there) who no doubt saved my life by sharing his trial info with me in 2012. Without this trial, I know I would not be very good now. My trial was 24 weeks, Sofo/Riba, for post transplants, cirrortic, and previous non responders. There were only 43 people in the world that participated in this trial.
To all who are on treatment please hang in there!!!!!
I can only hope and prey that soon this horrible disease will have a 100% cure rate.
SVR to all in treatment!
Thank you all so much. This forumn has been the very best thing that I have found for informing us inflicted with HepC. The support I have tendered from all of you has gotten me through many a dark day. You guys are the very best of the best, and my appreciation goes way beyond words.
Thank you all!!!!!!
So happy for you. I know the feeling.....
Wait until you start getting all your old energy back.....
That's what surprised me the most.
Happy, happy for you.
Let me know if you hear from Hector, I think about him a lot.
I love the Thoreau quote!!!! Well I got another call, my 12 week post trial blood work was also undectable!!!!! I could not be happier!!!!! 12 weeks post treatment and no sign of Hep C virus is as about as good as it gets from a old Hepper like myself..... I have had two strange experiences happen and wonder if anyone knows of anyone else who might have experienced what I did.
I have had 2 seizures in the last 60 days. Both seizures caused compression fractures in my vertabre. I was hospitalized both times for several days. No recall of anything that happen during the seizures. I understand this is normal in a seizure. The second one resulted in two old stress fractures being re-injured and 2 new fractures. This resulted in surgery to cement all 4 compression fractures with bone cement. A lot of pain. I was very fortunate to be taken to the Mayo both times it happen. I was blessed with the best of care and great Docs and nurses!!!!!! So blessed!!!!
Just curious if any one has heard of anything similar!!!
Thank you all as always and trying not to get to far off track!!!!!!!
You very nonchalantly referred to 2 seizures as "strange experiences". Are you kidding? I would consider these major events which may or may not be related to treatment and I'm so sorry to hear that you are going through this. Please feel better!
You are so right these were beyond strange and so very, very, dramatic events in my life!!!!!!! I was only trying not to get to far off our hep c topic. This being the site for the hep c related events. I agree with you 100% about major with a capital M........!!!!!! These were two events in my life that were certainly major and most defiantly unforgettable!!!
Thank you so much for your kind words!!!!!!!
We all were definitely in the right place at the right time. Saw clinic today for my 24 week draw..Next one will be the eot 4 on October 29. Dr said sofosbuvir will definitely be fda approved but not available for 2 more years because Gilead won't use another companies drugs and the 5885 isn't approved and they have since then found another drug more potent than the 5885 and the combo has to be gilead...People who need transplants and are in bad shape can do the trials though and get the drugs.
Dr also said treatments will be much shorter 8-12 weeks and NO RIBAVARIN. i just finished 23 1/2 weeks with RBV..but i am glad i skipped a couple of doses and lowered it after i had done 18 weeks..my blood levels are still too low..so i know i did the right thing. was surprised clinic admitted RBV is not needed..Coordinator said in 1 month i should start feeling better...
but for sure how lucky we were to get these particular drugs..Also no long term side effects dr said.. news was really good.. now looking forward to SVR... Take care all... :)
Glad you tapered off the Riba....I think most pp did. The low hemoglobin is hard to handle. Hang in there you will start feeling a "whole lot" better.
I go in for my 6 mo. check. Last one for awhile...hoping still UND.
I guess I will finally weigh in with some news from my trial experience.
I have held off deliberately partially because I was busy, both with work and investigating my issues. I also still feel rather torn about reporting them and I don't think they are a representative danger. They may be rare, but here they are.
I now have what I think is mild tinnitus and mild neuropathy on my feet, and in the course of treatment the neuropathy has traveled part way up my legs.
I do not have a clinical diagnosis on either issue.
I had some mild toe issues, maybe even foot issues prior to TX, but they were mild enough that I really could not tell what they were, and I figured that they also may be age related....or that they may resolve with successful treatment.
Essentially as the trial progressed the neuropathy increased, but I was working so much I really didn't notice it for what it was. I mentioned it a few times, but I thought it could be due to the work, the long long days, the physical nature of my work; whatever, it kind of escaped my notice.
My feet were more sensitive and might keep me from sleeping..... but I thought it was maybe the riba just keeping me awake.
About mid point through my riba was cut in half; 1200 to 600 mg.
And things improved as I became less anemic.
I started complaining more about the issue, and I could also dismiss it less.
At about week 19 I work up with tinnitus, something I could not dismiss or think; this is something different than what it is. I also thought, I seem to possibly have two nerve related issues going on right now.
I asked about both.... in my week 20 blood draw and I thought made it very clear I was worried that these were both TX related and I wanted to know that they would reverse. I got no answer....
over the weekend the neuropathy clearly was working up my legs.
I asked a few doctor friends/clients who seemed to think I was correct, both in my diagnosis if ailments and the cause.
I stopped the drugs Sept 10.
I still have both issues.
I have the general feeling that the drugs are leaving my system and of course, I feel better.
I do NOT have the feeling that my hearing has changed,
I do have the feeling that the ..... lets call it neuropathy has possibly improved. The feet are not keeping me awake anymore at night, I no longer have the sensation it is climbing my legs, but it could be that I merely have less sensation.
And less sensation isn't really the right word at all. I think some things I can't feel...... while other things feel more like a heightened and somewhat unpleasant sensation.
I report that I do not seem to have motor control damage. I still am running and have ramped that back up and in that sense I may be in better shape than I have been in a few years.
So in spite of the mild issues I am having part of me is doing well and I remain hopeful I may yet see improvement of my other issues.
I just finished my 23.5 weeks also. I got the tinnitus in my ears also. It came right after I started treatment. It would get louder after I took doses. I really notice it when I wake up. Coordinator said give it a month. This also happens to people in their 60's so I suppose it could be an aging thing, but I think cuz I am so sensitive to drugs. Time will tell and I will post everything. Eot next date is 29 . I will post if I find out results, but I heard they are blinded to us and clinic till week 12! Take care all!
I am going back for my first follow blood draw on the 28th. I was told yesterday I would receive all the results with the exception of viral load though out the follow up draws for the next four months.
That if I were to test positive on the blinded panel I would receive written notification immediately to return for retesting -
so as a practical matter I am comfortable I will know within a day or so if there is an issue.
I started with peripheral neuropathy in 1998. I thought it was caused by too many years in high heels (guess that thought never occurred to the guys!) I was diagnosed with hep c in 2005 or so. Neuropathy is a documented result of years of the hepatitis virus living in your body. It may have been accelerated by the trial drugs but probably not caused by them, though I have seen that association mentioned also. I am going to wait until I get the results from my 6 month blood draw, which is next week, and then, if clear I will start an in depth investigation as to how to alleviate the neuropathy. I suspect there is no "cure" but maybe I can halt the progression. Or maybe being rid of the hep c virus, if I am, will allow for some healing.
I am finding new awareness of my body everyday, I was diagnosed on 2000 and have always thought based on my life history I must have contracted it thirty years before that in my late teens.
So I don't know is what is normal? that is rhetorical - I am 61 so 40 plus year of being positive for HVC.
My point is we will all be re exploring health going forward.
I have never been so excited - going to go for a bike ride this morning. Have been running everyday. I sleep well for the first time in years. Drinking tequila - partying with my wife - working with renewed creativity - all of life's little pleasures :)
Regarding my neuropathy....in some manners HCV may also affwect people as HIV does; increased inflammation to systems, and we see a percentage of us experiencing neuropathy, just as do a percentage of HIV patients.
Some "nukes" used for treating HIV are also associated with causing neuropathy. In this case, sofosbuvir is a nucleotide, whereas the HIV drugs in question are nucleosides.
I am still running and I remain hopeful that if the virus remains gone( and resultant inflammation), and since I am off the drugs, that I may get better, or at least no worse.
RE: my infection date...... I always assumed it may have been from in my 20's, but I really did not fall into any major risk groups, nor really connected to people who are infected. I later found proof my LFT's were normal in the early 90's even with moderate drinking.
By early 2000's the LFTs were climbing and in 2008 a biopsy showed stage 1 and 2012 showed stage 2.
I have a feeling I was infected later in life, but I have no proof and there is no way of proving it. I had several operations and was also exposed to a bleed on a guy who died young but it's all speculation. One never knows....
Was diagnosed in 1995 and I went the natural route, which has been good for me. But eventually the virus will win out; even in a healthy body. As I told everyone before, I almost did not do this trial because of my bad experience with teleprevir. But with my doc and a couple of people on this list, telling me I'd be a fool not to go for it. I decided to switch paths in the middle of my walk, put aside my fears and go for it. So far, the best decision I have made in a long time. But Willy, I have had this fear that it's going to come back or cause something else to happen. I lived with vertigo for the past few years. I would have occasional bouts with it and only one bad one "until" this trial. Towards the end of the trial I had a real prolonged bad experience with vertigo. I could not function normally and was sure the meds caused it, even though the trial nurse told me it did not. So I figured I must have a brain tumor or something caused from the meds. Logical way for the mind to go in our situation as lab rats right? Had an MRI, went to a specialist and all checked out good. The vertigo finally subsided and I have been back to normal for about 2 month. My trial doc, who also has vertigo did tell me that the meds "do" cause vertigo. And I think as latille said the meds accelerated it.
So maybe if we have conditions before the meds, the meds do make them worse by quickening the condition if only temporairly. I am sure vertigo will be with me, because there is no cure and it is not know what causes it. I think it's another one of those blasted aging things.
I'm just happy to have vertigo and not hepc.
I go for my 6 month blood draw this month too and hopefully will be able to shed a lot of the fear I have lived with for 17 years.
I posted a link in the post TX forum....my post prior before this that you might want to check, a utube link. I dunno if it is a connection or a cure.
You had a vertigo problem which the drugs may have worsened.
I did not have a tinnitus problem but it manifested during the trial.
I have been told that the two issues may be connected to the same nerve.
I also experienced an increased amount of damage in my nerves to my feet/legs. More coincidence?
This is not well established but it might interest you.
I too went the natural route when diagnosed. Found Dr Zhang in NYC and went on his herbal program for about five years all the conventional docs thought I was crazy - no doubt. Dr Zhang's theory is that the historical trend of the disease is a very long cycle and if one were to protect the immune system they might outlive the disease.
My liver enzymes went up & down over the years - the one constant - more stress higher enzymes.
eventually I went back to a more conventional diet and gave up herbs
during the entire time I never gave up red wine & my other herbs....
I believe my liver is getting healthier every day :)
I still believe in the natural route, especially in my everyday life. It's just who I am. But with something like hepc, you can live a healthy life with it but there is always that nagging thought that some day it will win. Age being the determining factor. As I mentioned to Willy my fear of doing this trial, besides the fact that it would not work "again", was that it may cause something worse to deal with down the road. The bout with the vertigo scared me but I know it did not "cause" it. I still eat healthy and take a lot of supplements. Most of them are antioxidants for the immune system. When I started taking supplements, I learned along the way which ones really help. I can tell you, besides the hepc I have not been sick in 10 years. I think it is all to do with my lifestyle and what goes in my bod. So doing this trial with this powerful drug was a leap for me. It was now or never. But with that said I am hopeful that it all works out for all of us.
Are you getting the flu shot this year? They are saying everyone needs to have it this year. Last year I got the whopping cough shot and got the worst cough ever after that for a really long time. So this year I'm not sure what I'm going to do. Take care! :)
Sorry about all the replies but one last thing concerning vitamin D. There are a couple of different studies out there on vitamin D and it's effectiveness on preventing the flu and colds. One by JAMA says it "appears" not to have any effect but others have said it does protect, so like anything else you have to decide for yourself. I have been taking it for a long time, along with other supplements and for me (personally) it seems to work. Here is another study:
I have been taking an extra 2000 dose of vitamin d3 for a year plus calcium with vitamin d for my osteopenia. I have heard the treatment lowers our vitamin d level. Am hoping it didn't lower mine or hurt my bones In any way. I don't want to o take flu shot this year I decided. I am 61 now. I will wait a couple more years to take it. I have been taking it for about 20 years maybe because of working in a hospital all that time it was almost mandatory. Thanks Renee! Have a great day. What other supplements do you suggest are good. Zinc for colds?
Hi I live in Canada and on Oct 10 I have tested + for Hepatitis C. I am blank. I don't smoke, drink, eating out, just home food made by me... I need advise as much as possible. I don't know anybody who has it.
Dr. sent me for an ultrasound and some blood tests. What is next.
Can you please give me some advise?
Hello and welcome to the forum. You were "just" diagnosed, wow must still be a shock to you, especially since most of us don't present any obvious symptoms, other than maybe high LFT's which can be a red flag for hep c.
You are in the right place to ask questions and get info. and get support.
I strongly suggest going to see a hepatologist versus a gastroinerologist, hep docs are much more knowledgable with it all including treatment options if that's something you will have to do or seeing if you can wait for newer better meds. Those are just a few things that you'll be able to discuss with your hep doc once you're evaluated.
Posting a new question like yours will get you more response if you start a new thread. If you go to the top of the page and click on post a question, you can start your own thread, that way more people will see this, it's just a suggestion..
Thank you for your advise. English is not my first language and I am so afraid to ask questions:).
This was first time when I am using a blog. I always avoid speaking being afraid people will misunderstand me.
My doctor (which by the way is my new family Dr. my previous doctor retired last year) was so indifferent and cold. He said he will send me after the results to a specialist.
I will keep in mind your advise. In the last two days I've read so many comments that I am completely confused. Should I or shouldn't I tell people at work? how about my friends. Questions, questions.
Thank you sincerely for your answer.
There are new meds about to be approved by the FDA very soon with few tolerable side effects, and a much shorter duration of treatment. You have probably read about the side effects from treatments that have already been on the market for quite a while, and yes that treatment is tougher to get through and has more serious sides effects. Once your fully evaluated by a knowledgable hep doc you'll know what's right for your situation.
Did you already have a PCR blood test with a viral load or just the blood test for + antibodies for hep c?
Don't worry about your English, it's very good and many come here to get info and to learn about hep c from all parts of the world, so you are not alone. English is my 4 th language and that is not a joke. I read write and speak other languages and English was the last and final one I had to learn, and it's the hardest and you'll probably agree.
I still suggest posting your own thread, you may get varying opinions and answers here from others who may have more knowledge than just me and give you support. Your title may begin with something "newly diagnosed"..
Go ahead and try it, your English is fine!
I had just a blood test and with the blood test the doctor gave another paper to go with the blood test.
My head was not there so I have no clue what tests he has requested.
Thank you again for encouragement.
I will take a deep breath and I will start a new thread.
You're welcome. Please come back and let us know what the results are of the next blood test.
Perhaps your doc only did an antibody hep c test so far and it came back positive, now your going to have the test that will tell if you have a viral load or not. It's called a PCR by RNA test, it will tell if the virus is still in your blood or if it's undetectable and your body was able to fight it off, which happens in about 20% of cases. That would mean you do not have Hep c and only the antibodies are present which means you were only exposed and you managed to fight off the virus on your own with out meds.
Good luck to you, and let us know how things turn out, you may be one of the lucky ones!
Thank you again Mag,
I wish all of us to be lucky and healthy.
We have a saying "if you are lucky you have everything"(Health, happiness etc).
I will definitely let you know my results.
I don't know you but I already feel close to you:)
I am sincerely,
We celebrate Thanksgiving in Canada this weekend.
I have no urge to cook but I have to
Congrats also on largest thread I've seen at Medhelp, also one of the most hopeful ones.
I may be contacting my center soon for another reason, but I may ask if my 4 week EOT PCR is back yet.
IF it is..... and I have not gotten the SX2BU letter I will have been UNDSVR4. : )
My EOT12 week PCR is in early December (I stopped at week 21) and so I think most 24 week cohorts will be done and SVR12 tested by New Years, or thereabouts. I am not aware of other Gilead trials or cohorts for DAA HCV therapy that extend past that.
(dunno about other specialty groups/approvals)
I usually post on still_above_dirt's post for Gilead trials status reports, but there are more people posting here...
I have my EOT 12 week blood tests tomorrow - results a couple of weeks later. I was on the ION-1 trial in the UK - 12 week sof+led + riba.
One thing I am trying to find out is whether anyone has had gastro issues that started during tx and have got much worse since end of tx. My liver specialist is dismissive, insisting my symptoms have nothing to do with tx, but nothing else has changed in my life - not diet and not lifestyle. I saw a gastro specialist last week (symptoms got bad a month post tx and have been going on constantly for two months) who thinks there's a connection - a friend who is a hematologist thinks there's a connection...
Scheduled for gastro tests but I'd really like to find out if anyone else has these symptoms post tx - stomach churning, gurgling, wind, flatulence, constipation etc etc.
Many thanks and so pleased that you're both SVR!
Will let you know what my 12 week results are in a couple of weeks...
Fantastic news and encouraging for the rest of us...
Willy50 - Here in the UK, the ION-1 trial 24 week arm ends about now (end Oct).
I had my EOT 12 week blood draw yesterday...so now a couple of weeks of nail-biting waiting...this thread makes me optimistic though.
FYI - some of Gilead's results and new treatment updates will apparently be published at the upcoming American Association for the Study of Liver Diseases meeting, to be held in Washington DC Nov 1 - 5 2013, with some info (not sure what) released to the public, via the press from Nov 2. Probably worth following.
It is all over the internet now and tv stations, Gilead cures with no sides, benefits far outweigh the risks and FDA said is safe! December 8 they will either approve it or not, but it looks like it will be approved.
I heard that from my doc before I started the trial. apparently it has to do with the trial protocol & not the effectiveness proven in the results. It seems such a shame that the process is so cumbersome.
with what we know about interferon - had I not been fortunate enough to be in this trial - I would opt to wait a year.
I waited 13 for a non interferon trial - this is really troubling to me
Yep, I also waited for ten years for an interferon-free regimen...
But Gilead trial results have shown that Sof without Led in G1 patients have not proved to be nearly as effective as sof+led.
The trials without interferon but with sof with or without riba they're doing at the moment are only on G2 + 3 people. This is because sof alone is not totally efficaceous on G1 patients - that's why they developed ledispavir as an alternative to BMS's dataclasvir (not sure I've spelled it correctly) because they knew they needed an extra agent for G1s. So sofosbuvir alone would not work on many of us without ledispavir...
I am going Tuesday for my 4 week eot. Feeling much better now and sleeping very well. Still having mild noise in ears-tinnitus- I hope that ends soon, I didn't have that before treatment, not sure if related or not. Sad that we don't get results till after 12 weeks, but I will stay positive about the whole thing. I was very lucky to get on this trial, even though I did double the time needed.
Take care all. :). Still would like to hear from Matt !
...but readers do need to remember that since they're following this thread, that this is different than the sofosbuvir/ledipasvir combo (aka sofosbuvir/GS-5885) which was the original topic of this thread.
Thanks for that mention. Yes, different treatments. : )
I just thought is was worth mentioning. This is some of the biggest news since I have been on boards. As big or bigger than the Victrellis/incivek launches.
By the way.....
I talked to my center and asked if since I had not heard from them after my EOT 4 week PCR, that I didn't get the SUX2BU call...if I could infer I was still clear. I was told I would have to fail both my EOT 4 and 12 week PCR to get that call. I have not checked my trial agreement, but I'd bet she was right.... there was no hesitation in her voice. She seemed very certain of that, no wondering involved.
Yeah, the informed consent documents were never really very clear on that, at least in my mind, they weren't. But that's kinda what I figured, though. That's part of the reason why I did my own independent viral load tests at EOT+6 and EOT+18.
I dunno when I'll make time to look at mine. My next draw is a 12 week EOT in about 4 weeks. If I fail that I'll get notified.
I kinda doubt I will, as I have yet to meet a 12 week w/ riba tx failure, and I treated 21 weeks. There may be more data released at the Gilead 3rd quarter meeting Oct 29, or at the AASLD early November.
Most of us 24 week treaters should have their 12 week EOT by around New Years and the 24 week PCR 12 weeks later. The efficacy rates and safety will have long been established by then, so I don't know why Gilead cannot apply for an NDA by that date. If they are only applying for 12 week treatments I also wonder if the 24 week TX is even relevant/required. : )
And don't forget there are a few on these threads who are doing the 8 week tx.
I was told by my trial nurse that some data would be released at AASLD, with more to follow at the European biggie liver meeting in April.
In the UK, I will have my 12 week EOT results in around a week's time (12 week tx w riba - ION-1 trial for tx naive). Re the 4 week blood draw, one small indication, though not definitive is the liver function tests - my ALT was still low at 16.
I was told the treatment would be 8 to 12 weeks -- there's no more 24 weeks. I had my treatment at Northwestern Memorial Hospital in Chicago by the way. Did 23.5 weeks with RBV! I go for my four week end of treatment on this Tuesday. I guess I won't know for another 3 months then!
(nobody wrote) "I was told the treatment would be 8 to 12 weeks -- there's no more 24 weeks."
Yeah, I think that's a given. If so, I kinda wonder why any 24 week data might be needed for a treatment they will not go with? As long as some serious safety issue does not crop up. Looking at it backwards.... if they only had started with 8 and 12 week treatments..... no 24 week TX...... couldn't they still apply for an NDA?
If that is all they are applying for, either 8 or 12 week, do the need the 24 week SVR-12 or 24 week to apply?
Understand also.... there is a humanitarian use aspect to this.
The sooner the drug treatment gets approved, the sooner many lives will be saved.
Is it possible that an NDA could be applied for early?
I am looking for a disclosure of interesting news at the Oct 29 Gilead quarterly meeting.
Willy - I don't think they can rush the NDA but not sure. They had to try the 24 weeks first as they really didn't know if 12 or 8 weeks would be enough. In the UK and Europe, they still don't know - as I said we're still on ION-1 with everyone finishing 24 wk tx about now. I guess they'll do ION-2 soon and maybe they won't do 24 weeks, but I think they will until they have definitive, long-term evidence.
These are small trials in each center and there is still no long-term data. Who knows if 12 week tx people will still be clear after 1 year, 2 years, 3 years? We don't know, and neither do they, yet. Maybe (I hope I'm wrong) only the 24 weeks treatment will be sustainable over a few years...that's what they still need to check. These drugs are still so new.
Re the humanitarian aspect - it's the same for all trials for all illnesses - cancer etc. There's a pace and protocols they have to follow, not just for protocols' sake, but to ensure safety etc.
I wouldn't hold your breath re Oct 29 - I doubt if they'll release any info that we don't already know. I may be wrong.
I also don't know.... but I've heard of earlier 2014 approval; no longer 2015.
We will see.
I was also under the impression that they have been treating a SVR12 w/ DAA's as the same as SVR 24's, although there may be a difference so far as FDA NDA approval.
Regarding the ION 24 week ...... I don't know the approval requirements if they will not be NDA filing using a using 24 week dosing regimen. (who knows; maybe they will for some group )
All I know is that if they could apply 12 weeks earlier it will mean a huge opportunity to treat more people sooner. I think we won't have long to wait for that info.
The pattern I have recently seen is that Gilead usually throws the shareholders some delicious tidbits. Last year we went through EASL, but a few weeks later we were told about prelim data on Lonestar and the new expanded 8 and 12 week Ion trial. Some of it timing, but check it out, it's always a good listen/read.
In the shareholders meeting we may hear where Gilead is going, in the liver conferences we hear where they have been. : )
Forgot to mention along with my 24 EOT they noticed I had not had an ultra sound for awhile, so they sent me to get that. Results are good and one bonus, they did my entire abdomen area, including spleen. My spleen was a little enlarged last ultra and now it has also shrank back to normal size. So good all the way around. I also signed up for the 3 year checks, which is optional. I figure why not? It's a blood draw once a year for three years by the trial doctors.
1st follow up draw after EOT four weeks ago
blood work looks great enzymes low end of normal - hemo back to 15.1
I feel great!
next draw is in 60 days
no one in the UM studies has relapsed, got to spend some time hanging with the techs who I have gotten to know. They have been working in Center for may years going back to Interferon trials and they are very excited -
Just had a phone call from Trial nurse that there is a slot for a teleprevar fail person to go on a 12 week Sofosbuvi rplus one other unnamed drug with or without riba. I am a 1a and have had hep c for over 30 years, my last biopsy was f2. I am concerned that if I fail this I will ruin other chances in the future. WAs only on the telepravir trial for 4 weeks before I was bumped..
Just read the trial info.. these are the arms. I am in Melbourne Australia.
1) SOF 400 mg + GS-5816 25 mg once daily for 12 weeks, or
2) SOF 400 mg + GS-5816 25 mg + RBV (1000 or 1200 mg/day in a divided daily dose) for
12 weeks, or
3) SOF 400 mg + GS-5816 100 mg once daily for 12 weeks, or
4) SOF 400 mg + GS-5816 100 mg+ RBV (1000 or 1200 mg/day in a divided daily dose) for 12
I would grab the chance with both arms - there are several people on these posts who are telapravir failed - Gilead's drugs are said to be far superior and are proving to be the way forward.
Do you know the name of GS5816 or will you let us know when you do? I had heard from my hepatologist that Gilead has developed a drug better than ledipasvir so I am guessing this is it. If it is superior, then just maybe they will go for FDA and other countries' approval with this instead than ledipasvir?
Willy - For some reason, senior management at Gilead have been dumping stocks these past few months - more than six senior board members have sold shares - usually this means something's wrong with the company, but in this case, it kinda contradicts clinical evidence with their hep C drugs anyway. But when senior people sell shares, they do know something we don't know, which may only be apparent months or a year later. If one person sells, it could mean they are paying for a divorce or their kids' college fees, but six selling?
Watching out for news from AASLD...
Renee - good news about the spleen. I too am going for an ultrasound (from my gastro guy) soon, to see what's going on with my gut - supposed to have colonoscopy too, but dreading that one.
Yes, that Telapravir experience was a bad one. It almost stopped me from doing this one.
The colonoscopy is a piece of cake. I had my first one not too long ago. When I woke up, I said are we ready to go? LoL didn't even know it was over!
I also, noticed the stock going down. We the little people are always the last to know. Let me know what you find out.
(geshmit wrote) "Willy - For some reason, senior management at Gilead have been dumping stocks these past few months - more than six senior board members have sold shares."
They have to report insider selling, so we tend to see what has happened in our rear view mirror. There was an article reporting it..... at the end of September. Are we worried that the insiders know more than we do? The stock just hit 70 a few days ago..... that is fact. OTOH...... if you go back 30 days before the article which I provide was written....the subject being insider trading, the stock was at 59 dollars. I dunno..... that's a lot of money to leave on the table.
Here is the article..... but be sure to read the comments below the article. I have no opinion, except that these people are smart, and have good advisors. Some of it is that they are given stocks as pay and may need to sell or divest to keep assets safe.
(hahhahahah; maybe I am in denial. : ) )
I followed these insider trading deals real time, I'm subscribed to Google alerts for all things Gilead - (they happened when Gilead was still optimistic about trials) but still don't know exactly why they took place....I can't see the end of this article unless I register for future emails and not sure if I want more junk in my inbox.
I don't think they sold cos the stock was going down - it's been up and down for a while - 70 is the all time high I believe - but it will continue to go up as long as the trials produce good results. Gilead stands to make a killing with Hep C, but they also have other new drugs for cancer and HIV. I think their scientists are the best.
Let's see what comes out of the AASLD meeting...
I just saw another forum on another website where people are doing the latest 5816 trials, so definitely the next generation from ledipasvir.
I would also invest in Gilead stock if I could at the moment. Yes, HCV is only part of their biz, but a prominent part especially as their drugs do mark a revolution in hep C which was neglected for years as a disease.
A reset is exactly what I need at the moment - a gut and full system reboot! Back to the gym, I guess.
Going to share some of the letter my trial doctor sent to my Gastro with a cy to me. It basically says that the HCV RNA was undetectable from week 6 to the end of treatment. A sustained viral response (SVR) with no HCV RNA detected at 24 weeks after discontinuation of meds. With an SVR there is 1% chance of return of the virus. The fibrotest on 1/4/13 indicated a likelihood of stage 4 fibrosis. My most recent liver biopsy was in 2010 with stage 2 fibrosis. These fibrotic changes may improve now that there is no HCV attacking the liver. Further monitoring of my liver status can be done annually for a couple of years by testing the viral count not the HCV antibody as it will usually remain positive for life. In addition, I should receive hepatocellular carcinoma screening every 6 months with a liver scan and AFP tumor marker blood test. Also, I had the option to enroll in a follow up study that will monitor the live serum tests and HCV RNA for 3 years. (I did enroll).
So, I have a 1% chance of relapsing....hopefully my liver will repair damage done (I am taking a lot of supplements to help it) and just keep an eye on everything yearly...with the tumor marker tests added. Remember the antibody will always be with us.
So this is pretty much the end of the chapter, I wanted to share with all of those coming up behind me, so you can get an idea of what to expect.
Going to make the most of my renewed life...the glass is half full.
Renee going into these trials we had only hope and prayers. Now we have a Hepititas C free body, with a tiny chance that it might come back. I think we are some of the most four ate people who walk the earth!!!! Congrats to you! When Hector and I answerd this thread ( I think we were one and two) if memory serves me, I think we told you to run and get into the trial!!!! Who mould have ever thought ths thread would have continued this long. I have seen nothing but great information, kindness, compassion and a general sense of we will all get through this somehow ith everybody's adding their 2cents!!!!
I can only hope that Hector health improves quickly. He was such a tremendous help to so many including me. As I have said many times I really believed he was instrumental in getting me on the Gilead trial that has basically saved my life!!!! Hector if you read this my and many of us thoughts and prayers are with you.
Rene and all others who have achieved SVR good luck lead healthily and productive life's. Peace to all!
I hope all is well and I wanted to start by wishing you a Happy New Year.
First off let me start by apologizing for the delay in my response. The months have been busy and it took awhile for the results to make their way to me. The downside to this was, that my family physician wasn't the one who relayed the information to me, even though the information came in, Dr.Cold didn't contact me. I, just today, found out that I was exposed to Hepatitis C (the virus is inactive within me). Which is wonderful news!
The journey was not an easy one, the funny thing about how all this came to be was that the Doctor that tested me initially (let's call him Dr.Awesome) was the one that asked for my results, and not Dr.Cold who is my family Doctor (which was shocking to me, and I felt very offended for his lack of interest in his patient).
With all the good that came to be, I am not one to complain or even let it get to me. I feel very fortunate and to be honest I owe a lot of my strength to you MagTX. You gave me the courage to speak out and ask questions and also the willpower to further see into my case. I will be tested again in one year.
Today was the day I told my family and since I had good news, it was of course well received. I felt that it wasn't good to keep the information away from them, but better to not have them worry until I found the final result myself.
With the scare, my family is in line to get tested as well.
We will see the results.
I hope I can do for someone on this blog what you have done for me, this way I will remain as active as I possibly can be on the forum.
Hi lost, very happy to hear your great news! Also, thank you for coming back to let us know your turn of events and for wanting to help others on the forum, that's so kind. :)
So basically what I'm reading is that you only have the antibodies present and no viral load for HCV, wonderful! You were one of the lucky ones, only about 20% are able to fight off the virus after exposure and never have any problems except that your antibodies will always remain positive. There is no problem at all with having pos. antibodies, as long as your second test showed no viral load, the PCR by RNA test... I'm confused as to why you will get retested in one year, there's no need since you already have these results and nothing will change. Did someone in the health care community ask you to repeat this in one year? If so, I would question this advise. Hep C is not like Hep B, and there's nothing inactive about the hep c virus, you either have a viral load or you don't, and your own body fought it off naturally and it can't return unless someone infects with hep c again in the future,it's gone and dead. You don't have any thing to worry about, and go ahead with testing your family just for a piece of mind knowing they are ok, but hep c is very hard to transmit unlike the hep b virus which is easier to contract. Also, if you and your family have never been exposed to hep b it is wise to get immunized for it. There is no immunization for hep c.
I'm glad we can all make a difference here for you and that you followed through with the advise, it's great to hear your story, and thanks again for posting! Happy New Year!
I hope that all of us that went through this journey together are having a Happy New Year. I know I will never forget 2013. The year my life changed for the better. I decided to go for the year follow up because why not? That way I can stay on top of my blood work and if anything else is wrong it would show up. I'm not so much worrying about the 1% chance of return.
The nurse told me it is offered as a way to just have follow up results on people who cleared. She said they especially want to monitor people who had cirrhotic liver. I was a stage 4 fibrosis but that is close enough for me.
Anyway so far, so good. I go next week for my first yearly follow up exam.
Would like to hear from some of the people who cleared about the time I did, I think about you guys often.
Very happy new year to everyone.
Thank you again for your advise. I will ask Mr.Cold why I have to repeat in one year.
I will also let you know about my family results.
My husband when he was a child (3 years old) had peritonitis and after the surgery he got Hepatitis B. I know the doctor told me yesterday that there is no cure for Hepatitis B but there is treatment for Hepatitis C. I know just my husband liver tests were always perfect. They never saw on his blood that he had Hepatitis B. How is this possible? He was tested before for A and B ( like me also, when they told me that I had hepatitis A some time in my life -which I have no clue when) but they said that he never had A or B how is this possible? and he should get the vaccine.
My in-laws kept him on a strict diet for 14 years. I have the book for that diet but unfortunately is not in English. It is a guide how to eat and cook the food for chronic liver disease. The book was printed in 1954. You might say it is old and not up to date but what I learned from this book it seems for me that it is a healthy way of eating and more special how to cook the food on liver diseases. Really hard for people who don't have the time.
I don't know if it is important but my in laws told me that the food that they give to my husband when he was sick was never refrigerated nor re-heated. His grand mother was cooking from scratch every meal following the recipes in this book I told you about. They gave him just organic meat and vegetables.
This was what I was trying to do for me(as much as I could) from the time I found out about Hepatitis C . I didn't do it exactly the way they have done it (no time) but I tried my best. The hardest was no salt at all. Instead of salt I was using fresh organic lemon juice -just a little bit. It is the hardest diet I have ever tried to follow on my life. You get used to it but really hard.
Thank you again Mag.
Hi, I can try to answer your question, though there may never really be a good explanation about your husbands hep b status on his lab findings. If he was indeed exposed to hep b then he would still have those antibodies present, they will remain positive for life. It's hard to answer why he doesn't have these antibodies present now with testing as they are neg. Maybe there was a lab error, which sometimes can and does happen through contamination or by getting another patients results as your own results, in error. Somewhere there was a mistake, that's all i can think of. If it were me I would retest and if these results show neg, antibodies to both hep A and hep B then I would start scheduling for immunizations for both A and B. Also, since you tested neg. for hep b maybe you both can start the immunizations together and get them out of the way. Hep b is a series of 3 injections , it will take 6 months to achieve full immunity, but some immunity begins to show up after the first injection, so that is good. :) you won't need to have the hep a vaccine, you have natural immunity for that one too! You're very lucky, you have nothing to worry about as long as you didn't have a viral load on the hep c PCR by RNA test and only showed pos. antibodies, you're good to go, congratulations!
I have no idea what Dr. Cold was talking about in wanting to re check your HCV status again in one year.... Let us know what he says if you don't mind. All I can think of is that sometimes doctors make mistakes or they are just not knowledgable enough about HCV. Thanks:)
Re diets - I think there are newer schools of thought than 1950s ones about keeping the liver healthy. Our general diet has deteriorated since those years with the advent of processed foods, junk food and corn syrup. I've tried different diets to keep my liver and gut reasonably healthy - macrobiotic, not mixing protein and carbs, no fried foods etc, but I never heard of not eating refrigerated foods. But then again, refrigerators were not as commonplace in the 50s..these days I don't do anything extreme.
In this millennium, I think that cutting out processed and junk foods, eating whole grains and fresh fruit and veg with not much red meat is pretty good for keeping healthy. Milk thistle is also a good supplement for the liver.
Hep B antibodies always show if you've had the disease and cleared it - I don't know if you can have a vaccine if you've already had it? And if you're not travelling to exotic places or having promiscuous, unprotected sex there's no reason to contract Hep B, but different countries have different policies regarding the vaccine. People with Hep C should have the Hep A vaccine - this I know, because if you get Hep A while you have Hep C, it can kill you.
Great news about the 24 week SVR, Renee. I have my 24 week EOT test in a couple of weeks. I'm not sure if they do the follow up observations in the UK, but if they do, I too will take part (that is, as long as I am SVR!).
You will be :)). I think supplementing is the reason I am healthy. I keep my immune system built up and eat healthy too. Milk Thistle is good to keep the liver healthy and there are other supplements too that really help the liver. I think resolutions have to turn into habits to work.
Let me know how it goes.
Hi Mag ,
I will let know for sure.
Thank you again for all your support.
I would also be here all the time following all the postings.
You guys are my best friends(I don't know to use another word here because I feel you all so close), advisor and a place where I could be opened at the time that I couldn't tell anybody how I was.
I even didn't tell my sister,nor my brother because I didn't want to spoil anybodies holidays.
You are my close friends:)
I will let you know when I will have any news
Hi all. I have a dumb question. Unless I dreamed it, it seems like when I was on here a couple of days ago, somewhere on the Medhelp site, that I read a link to some foundation that helped with high medication co-pays? Someone posted it, but I can't seem to find it. Did anybody else see the link that I'm talking about and if so, can you either send it to me by PM or repost it? I seriously don't think I dreamed it?
thank you. I'm sure you will be fine too. As far as I can make out, relapses are occurring at an earlier stage - 4 week EOT, so it's looking good for you and 95.4% or so of everyone else!.
Yes, we were so lucky, especially now that sofosbuvir alone will cost $1 a pill. In the UK, it is available now if you have a spare $55k to pay privately for a 3 month course of treatment. The health service and various authorities (our system is different to yours - public health services free because we pay taxes for that) will probably fast track it for use in cases where it's life or death. It certainly won't be available for everyone for some time. And given the silent nature of hep C patients here, I doubt if they will fight for it. Very much a stigma here and for every ten diagnosed hep C sufferers, there is an estimated 5 who are still undiagnosed.
I'm not feeling a massive difference yet in well-being but I guess that will happen over time. After living with a virus for 30 years, it seems to be taking time to recover fully. I had expected to feel like a new woman, but that hasn't happened - yet.
Just want to say I was the same. I did not immediately feel like a new woman either and I was clear of the virus but my numbers were not normal at the end of treatment. My enzymes were still a bit high but way lower than when I had hepc and my platelets were still a bit low also. But each check up they are better and better. So you are right, it is not an immediate noticeable effect. But to feel better I eat healthy, take supplements for my liver and immune system and exercise (yoga and walking do it for me.)
So glad to hear everyone is doing so well and we are lucky to have been able to participate in this trial. May you all have a healthy, happy life after hepc.
What supplements do you take for the liver? Glad to see everyone doing so well here now and that we are done and moving forward. Sometimes I drink warm lemon water too for my liver, although it is supposed to be first thing in the morning, I don't do it that way, I need my coffee first thing!
Hi all, I just received my 'undetected' at 12 weeks post treatment email. so happy. I am a 1a, stage 2. I was in the SOF 400 mg + GS-5816 25 mg + RBV (1000 or 1200 mg/day in a divided daily dose) trial.