Hi Everyone,

RH, Congratulations on UND continuing at week 6. Finding out that you are still virus free is always such a huge relief. I have gotten UND at week 1,2, and 4. Probably won't get week 6 results until my EOT on Friday.

Socal and Sofi, So happy you guys are almost done. I am just a couple of days behind you. My EOT is on Friday and I am definitely looking forward to it. I got the mouth ulcers much better now with something called kenalog oral paste and saw improvement in less than a day  after using it. Had about a week of extreme exhaustion which confined me to bed and couch last week but has now improved. Also had dizziness but nothing like you have experienced Socal. I hope you see immediate improvement when you finish on Tuesday. I also had a flare up of occular migraines that cause temporary vision distortions that I am sure are triggered by all the medications. Anxiety has been a continuos problem and was causing me some heart issues but seems to be under control now. I can't wait to get off all these drugs including the ones I have had to take for the side effects. Since  you guys are going to finish earlier than me can you let us know how you feel the first and second days drug free? I made plans for both Saturday and Sunday assuming that I will feel good enough to do some fun activities. I know it can take a while to feel really good but I am hoping for the first day drug free to feel better. So keep us posted on your daily progress. Sofi, I sure hope your legs get better very soon and all your symptoms go away next week and you can get back to being your healthy self. You have been a real trouper sticking with this considering all the he!! You have gone through.

congratulations, RH!

Bravo RH...great news!  One more to add to the list of undetected...Yes!

Congrats RH!!! I really do want all of us to beat this thing!

And I am sorry, Socal. That is rough. I have dizzy spells and stay exhausted. My legs still swell daily but I have had a couple of days where the pain is much less. I returned to work on short shifts, and the pain intensifies on those days. But the fact that it has let up off and on has given me a little hope. My primary doc is keeping a closer eye on me now. Tuesday is my EOT, too. May the side effects wear off at blazing speed.

And where is Ckncali? I hope you are hanging in there, too.

Sofi

Thanks guys !!! Looks like Socal and Sofi are hanging tough and about to reach the first finish line..It will be interesting to see how long it will take yall to get to feeling normal again. Hoping for 100% SVR for everyone. Lets get it done.

Socal,  wishing the best for you.  I admire your tenacity!  I'm interested in hearing how long it takes for the effects of the Rib to wear off.   I think we will all be watching our own and each others EOT results, as much as we can get them, in the next months ahead!

Congrats RH on yer 6 week study results. Getting close to finished here i think, what 4 more days of treatment for me. Than i will be crossing my toes, fingers, rubbing my rabbits food and having a bowl of lucky charms for breakfast. Yes i will be glad to be getting off this RIBA all the same it has really taken a toll on me the past 2 weeks. I am really week and cant stand on my feet too long with out starting to feel dizzy and weak in the knees.  am sleeping about 12-14 hours a day as well. No energy. Well only 4 more to go, Tuesday will be the last day of medication. I heard it can take awhile until before you may get back to normal. We will see. Hope everyone else is hanging in there as well.

Hello Everyone,

 I got my 6 week VL back which is undetected. I am very happy about that.

 Has anyone else got any VL tests back? 

I asked the study nurse about the reasoning behind why they aren't giving us our test results after we finish meds. She said it is a tool to keep us coming back and to finish.( I'm sure if you ask 6 different study nurses you might get 6 different answers) Anyway that is what mine said. 

 So far this treatment has been a piece of cake. I was blessed not getting the arm with the RIBA. The people on that seem like they are going through hell. At least they are about done and can get to feeling better.

That's all I got for now.

Take care

Biggyb, if this was facebook then I would hit the "like" button.

I wish everyone the very best and hope all are cured.

Hey Sofi,

I hope you are feeling better. I sent you a private message.

Thought this was kinda true.

I'm not worried about reimbursement anyways--my clinic is affordable and I don't pay for the hospital tests. I just want people to know who may take this drug in the future that what happened to me can happen to them. And if all this goes away--then I will be ok. I am just scared right now.

I know. But that means my study doc would have to document it and say it is indeed from the study drugs. I don't trust them to do that. I have been to the doctor and hospital twice and the study people are not all concerned. I'm not mad at anyone on this forum. I am sorry I am being such a complainer. But my side effects are really bad and scary. I get vertigo and can't drive (the vertigo lasts all day long). I have shortness of breath and nodules on my lungs. I am 35 and walk like my 94 year old grandma. I have bruises, nodules, and a growth on my legs. My ankles, knees, and hips feel arthritic. I am also an emotional train wreck. I worry my body won't heal and the damage is permanent. A friend of mine is coming to get me today to take me to a potluck at a friend's house. I am hoping this boosts my spirits.

Gilead is a biopharmaceutical company so it means anything they do is all about the money. The not knowing at 3 months etc--It means they don't have to publish any results until they are ready.

Yes, I volunteered. However, the paperwork I signed says that it is the study doctors job to take care of me. There are twenty four hour numbers to call for medical assistance. So to be unable to walk without excruciating pain and to have nodules on my lungs and for the study doc to be so dismissive is unethical and goes against what I signed. Plus, it goes against what my study nurse verbally told me at the beginning. I am now having to miss work. I think it's unethical. I don't think it is about discovering better treatments out of altruism...it is to make money. Hopefully, the treatments work and we benefit off their greed. But they are not documenting my side effects. I probably have sarcoidosis because of the meds. I will know more tomorrow. This needs to be listed as a potential side effect and not dismissed. Other studies have documented sarcoidosis. Maybe, it is just my study doc that won't even record the side effects I am having.

Sorry, I am angry. My body is attacking itself. I am scared.

Misfis

Check your private messages. I went into detail how you get that audio.

Hey Socal

I am going to finish my study and probably sign up for the 3 year follow up. They explained everything that was going to take place on the consent form. I feel that as long as they stick with their part, I will do my part. I have been lucky with getting my results within 2 weeks. I understand you not being happy about not getting your results. That being said, I'm not on the RIBA and would be possibly singing a different tune if I were. 

Side effects for ME on this Sof/Led are so minimal it is just crazy. I can't explain it because they aren't there . Hopefully they will be able to treat everyone with a treatment like this one.

Take Care

 Karen, I think I really do understand all this. I just am trying to understand the research study's line of thinking. I'm not really trying to challenge it, just curious about how the research is structured.  I'm just curious by nature, I guess.

I dont see much use for the study after EOT myself since i plan to be going to my private doctor for follow in regards to the anemia i'm experiencing as well as some other side effects. I will have him check for the hep c as well. So what is the point of continuing with the trial study people. They have been awlful as far as giving me my results and if they do a blood draw at 12 weeks i can just imagine how long it would take me to get the results after 12 weeks. I would be more than happy to give them a copy of any blood work my doctor performs for me. As far as the 50 bucks for the visit, i am not being paid. My trial study is in Beverly Hills it cost mke over 10 bucks just to park for my visits, than there is gas and enough for a lunch. So i really dont feel i am being paid more reimbursed for my expenses.

Hi Karen

great post..It simplifies and puts things on the table as they actually are. I really never thought of it that way but that's the way it is.

take care

Not sure I can explain this in writing as easily as explaining it in person..Hope you do not take offensive- I will do my best.

We are not patients-we are in a trial.  We basically volunteered to be part of a study.  We are not paying but being paid (quickly, let me state-it is not about the money).  That is our role.  Where the study is conducted is also being paid to collect data from us volunteers, that is their role.  They than submit our information to the drug company. The drug company's hope, all goes well and they see their drugs come to market based on results.

This would be similar-if you agreed to test drive a car, cooking devise etc.  You give your feedback, get paid and go on your way.  If all goes well..down the road you see the product on the dealers car lot or the late night infomercial.

It took me awhile to gasp this.  I believe we are more sensitive to all of this because it is about our lives.  I was told early on by a friend-find or keep your current doctor you will need them...as you are not a patient of the study.

So..once the data is collected and the drug company knows the results.. we will not see it in on a car lot or an infomercial but hopefully as the new treatment for Hep C...

Please follow up with your doctor...that is who is really treating you...just not with these drugs.

I'm going to give that a shot after I come back from the gym.  Thanks!

Misfis

that was the one they did in May. It has some info on it about the trials and so forth. The one that comes out on Thursday will be the latest one. If you are able you should try to listen to the one from May.

take care

Hi RH,  oh, was that yesterday!?  I thought it was this Thursday.   I did register on Gilead's website the other day, but I would have been unavailable last night anyhow.  Did you listen to it?

I was thinking the same thing. I mean you will know after your 12 week visit one way or another. I go for my 8 week on Wednesday and I will ask the reasoning behind this. I can't think of any good reason for this but who knows. 

Misfis were you able to listen to that audio link yesterday ?

Take care

I'm curious..... What is the reasoning behind not letting the docs or the trial participants know whether there is any virus detected after EOT?  Especially considering that if the person is requested to come back for a double check, if they are found to have some virus in their blood, and this is a give away that they are not UND.  Help me understand this.  I know that there is some reasoning behind this, but it seems so paradoxical.  Love to hear other people's ideas about this.

Sofi

The consent form states that if you become sick or injured as a direct result of taking the study drugs the study site will provide you with medical attention. Gilead will reimburse them of the costs. 

I hope you get to feeling better.

Thank, RH, very kind of you.

Hi Misfis

You would go to the Gilead website. Then go to investor info and find 2nd qtr earnings 2013  audio webcast. You may have to wait late Thursday for it to post. I tried to get it live last time and didnt have any luck. if you have trouble I can send you the link .

Take care

RH, where would we go to find out what Gilead has to say this Thursday?

Also Gilead is going to have their second quarter earnings report and questions and answers coming up this Thursday. It will be interesting to see what they have to say.

Take care 

http://edge.media-server.com/m/p/aiaeaz5x/lan/en

This link kind of explains what Gileads plans are. However I believe what Malcom says about everyone holding their cards close to their chest. 

Take care everyone,we are getting close

I am glad my doctor is being thorough. I won't know the results from the CT scan until probably Monday. Acute sarcoidosis fits all my symptoms and can definitely be caused by the meds we are on. Acute sarcoidosis will clear up on its own. So I hope its that or something even less threatening.

On a side note...I am angry! I am so angry at the dismissive study doc. I am so angry for being told "mild" side effects and nothing severe. I am angry for being told my severe symptoms were not side effects and I felt crazy for being so worried and feeling so bad. I am very angry. However, I am grateful for this forum, for all of you who insisted that I make my doctor listen to me. Thank you.

Good to hear your Docs taking you seriously finally and hopefully getting a handle on it sofi. Good luck!

Hi Sofi,

It is good that your doctor seems to know what is going on and is figuring things out for you. I just said a prayer for you and asked that your lung nodules are nothing serious and that they will go away when you stop treatment or as soon as possible. Let us know how things go this afternoon at the hospital and I will be hoping for the best for you. Take care.

Ckncali and all,

I just reread the sheet my doctor gave me. He x-rayed my chest to check for sarcoidosis which can most definitely be caused by anti virals boosting the immune system and the sarcoidosis causes lung nodules and erythema nodosum.  So I think my doc is on top of it now. Finally. I am so happy he took me seriously and did all these tests. If that is it, it should clear up on its own as the meds leave my system. I will know for sure after my next round of tests this afternoon.

Thanks all,

Sofi

No one has said anemia but my primary doctor took a lot of blood today. So those will be in by the end of today and if anything shows up then I will receive a call. The pics online of erythema nodosum (which can be caused by ribavirin and a lot of medicines) look just like my legs and all the symptoms listed on the sheet my doctor gave me match all my symptoms. I am happy that it is something that will go away. Now I have to worry about lung nodules. No idea what they are or what it is from, but patients on other treatments which include ribavirin developed lung nodules. Guess I will find out soon.

Sofi have they mentioned to you at anything regarding anemia. they did tell me that i had developed it. Which is the reason for the aches in my legs for sure and the feeling of being a little wobbly at times. I havent heard you mention anything about anemia and that is one of the most common side effects of the riba.

I have gotten 3 copies of my blood work already but they always seem to be way behind on the results they have in their system for some reason. I have only been able to get baseline and weeks 1 and 2. But i made copies and dropped them off at my doctors office thou have not spoken directly with my doctor.

Anyhow we are almost finished, and should be feeling better soon. 

Hey,

I more than likely have erythema nodosum. It is probably from the ribavirin and will clear up as the meds leave my system. I googled it after my doc diagnosed it and the pics are just like my legs. My doc did blood work to check for muscle damage and tested for different infections that can cause erythema nodosum plus did a chest x ray. I have nodules on my lungs. There are reports of patients on interferon plus ribavirin developing lung nodules. I go to the hospital at 3 today for further testing. I smoked for eleven years and quit cold turkey May 5th of this year. My mom and grandma smoked for many many years (30-50 years roughly) heavily and so did my dad and no one has lung cancer so I am thinking it's the ribavirin but will know more later. If you pray, please pray for me.

Thank you,

Sofi

Lots of things can be caused by the hemolytic anemia Riba gives you. Some are considered short term some are considered long term but even then you and not even Doctors can predict what could happen with a given person with a given treatment it's just impossible to know. I had some leg and foot swelling when coming off Riba for just a short time so I know it is something I need to watch soon.

Good to be informed as much as you can about all given treatments and drugs and the best way we can is web searches. You do have to Doctor yourself somewhat these days. Big pharma or anyone else won't do it for you. 

Sofi,

Please google Autoimmune disorders. You may be having an autoimmune reaction to the medications where your body responds by attacking itself. I do not want to scare you but you need a rheumatologist to run some blood work on you including blood tests for rheumatoid factor, ANA, ESR sedimentation rate, CRP and numerous tests to figure out what is going on. You also absolutely should request and get copies of all the blood tests that were done from the clinical trial. Those blood tests are very important because they show your history of before taking the drugs and after. You can then give them to a doctor so that he or she can see the progression of your blood work prior to going on the trial drugs and up until now. Demand that they give you all copies of your blood tests from your baseline up until now. 

Sorry about your legs. My calves hurt, too, and that bulge is still on my right calf. My knees, ankles, and right below my hips hurt as well. I walk really slow now and with a limp. My knees and ankles swell and are covered in bruises which appear-disappear-reappear.  Is yours similar? Yesterday, my arms felt tired and achey and today it is worse.  Hopefully my doctor will listen to me tomorrow and take me seriously.

And I have some stupid lady I work with trying to find out what is wrong with me and what medical treatment I am undergoing. She isn't doing it out of concern. She's gossipy.

Sofi my legs hurt as well especially walking upstairs the back of my calves. I am not so worried thou. They did finally tell me i had anemia yesterday brought on the riba. i had already figured that out.

I will be doing follow with my doctor as well next month. Will have him do his own blood draw and i will get the results within 5 days. They still didnt have all my results in yesterday from week 4 only partial. I dont see what sense it does to go in after treatment for blood draws where i wont get results. Thinking of just going to my own doctor and have him do it so i can get results.

and another

http://www.aidsmeds.com/articles/sofosbuvir_ledipasvir_1667_23631.shtml

but this all for 12 weeks on the stuff not 8 weeks like us....but we can hope.

found this...

http://www.natap.org/2013/CROI/croi_07.htm

I hear ya, Socal. I want to know the results from the previous trial, too. Where are those people who did 8 weeks? I wish they were on this forum and could tell us.

I am disgruntled because I was told mild side effects and now I am barely able to get around. I have bruises that appear and disappear within hours. I have no clue what is going on with my legs. My mom is going with me tomorrow to my regular doctor. I am super emotional and my mom is going to make sure the doc understands that I want my legs examined to make sure the damage is not permanent. I really want my strong legs back, I miss them, I won't take them for granted anymore. And I feel guilty for reducing hours at work--I was just promoted and given a raise back in May. I hope we all heal after treatment.

Back in early May i believe it was Gilead released info on the phase ll of the study with included 60 partipants. At the time of that press release partipants had reached svr 4or svr 8 with 58 of the 60 partipants. It has not been at least 8 weeks since that release. Has anybody heard of any addional info from Gilead. Partipants should have reached svr 12 by now or lets hope they have. Just wondering if anyone has heard anything more...

Hi guys,

I haven't seen the pdf. file, but the meaning is obvious.

If you are Detected at 12 weeks post EOT, and still Det. at the retest 2 weeks later, you will be asked to participate in a followup which is for the purpose of detecting RAV's, and how long it takes the wild-type virus to emerge. There is no option of further treatment, and they do not expect you to have any.

If you are Undet. at 12 weeks, it is interesting they still want to do a 24 week VL test. Up until now, the Trials accepted an Undet. 12 weeks after EOT as SVR. They will still want to follow you, to ensure you remain Undet. (which >99% will) and to check for any persistent RAV's that are not able to be detected on routine VL PCR tests.

Wouldnt it be real simple and practical just to let you know that you have been detected with the virus again. Maybe that makes too much sense...geeesh

Well i guess what i was told was somewhat correct from what i was reading from others feedback. Still doesnt make a lot of sense to me, afterall it concerns our health and to hold on to the info just doesnt seem right, more wrong. Anyhow nothing stopping anybody from going to their own private doctor and getting your own updates which is what i will plan on doing.

Sofi  sorry to hear you just seem to be suffering  way too much hope your doctor does something for your situation. it is funny how they finally told me as well yesterday that i had anemia due to the riba. They had been so reluctant to do so on previous weeks.

i have an appt already scheduled with my doctor for mid August i believe it is and i will have a long talk with him regarding this whole i process ive gone through and lack of information to questions i have been given and have him do his own assessment of what condition i am in . I asked yesterday how long the riba will have an effect on my body and really didnt get an answer to that question as well.

Really do just feel like a lab rat at times where their concerns are just about the numbers and results from medication. 

I got this copied from a friend who was able copy the pdf  Hope it helps.  I imagine you could have your own test done.

"For 3 months after you stop taking any study drug(s), you and your study doctor will NOT be allowed to know if you still have HCV in your blood. Instead, if HCV is not found in your blood after the 12 week (3 month) follow-up visit, you will be asked by your study doctor to return for the 24 week (6 month) follow-up visit. Alternatively, if HCV IS found in your blood after the 12 week follow-up visit, then a return visit within 1 to 2 weeks to confirm this test result may be necessary and you will then be told that you are still infected with HCV.

After all the follow-up visits and procedures are completed, you are done with this study.

If you do not clear the hepatitis C virus from your blood, the Sponsor is interested in following your HCV viral sequence (how the virus is structured) for up to 3 years. You will be asked to sign a separate consent form for a different study to take part in long-term follow-up visits if this applies to you.

If you clear the hepatitis C virus from your blood by the end of the study (24 week follow-up visit), the Sponsor is interested in following your HCV status for up to 3 years after you stop taking study drug. You will be asked to sign a separate consent form for a different study to take part in long-term follow-up visits if this applies to you."

Thanks RH.

The swelling and pain is really scaring me. I hope my doctor takes me seriously, especially when I hobble into his office.