Hep C Discussion Forum

Hey HR

I'm very upset to read of your 24 week outcome on S&L, I am 100% with you on your feeling about the cause or the reason why you have yet to achieve SVR.

I am sure of one thing, that Gilead is just as interested and likely have already have a hypothesis of why you have relapsed. I would press, insist and implore them in writing and phone.   I think your strategy to talk to Dr. Lawitz is a good one, you may have to press him a little but after meeting him and consulting with him on my own situation he seems very caring and highly motivated to get solid answers. I have forgotten how far along in fibrosis / Cirrhotic you are. Has Gilead ever talked about Sofosbuvirs Plasma saturation levels / or how much of drug is making it in your blood.

Also I would ask Eric his opinion of using Ribavirin with your next treatment because that's what he recommended for me with 24 weeks of S&L. 

The more I study about HCV treatments the more I see that it requires three phases of completion

Phase # 1 Clear HC virus /reach undetectable status from all blood circulating in body. Which will give you you early UND reading.

Phase # 2 Reach all parts of the LIVER / hepatocytes / Liver tissues and other organs that can store replication properties and inhibit all viral replication until it is no more.

Phase # 3  After all treatment drugs have been finished having your own body / immune system deal correctly with any residual weaken virus.

With those of that have had HCV for 30-40 or more years and have developed cirrhosis it takes a longer treatment to reach the areas of the liver that have been scarred with the current drugs that are being used.

Of course there is several variables in these phases that can alter the progression like developing RAVs or other drugs reactions during treatment.

The news of relapse is never easy to take, but RH you can take heart in the truth that scientists and the medical field is just starting to understand how these small molecules work in the body during treatment. So your future has not been written yet, there is a lot more to go.

matt 

        

-- Edited by Matt Chris on Thursday 21st of August 2014 07:10:18 PM

HR wrote:

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Tig56 wrote:

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Huey, 

I can't find any documentation anywhere that indicates a placebo was used in any arm of the ION 3 trial. 

Tig

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 It was an open label with no placebos. 3 arms  

1. 12 week Sof/ldv

2. 8 week Sof/ldv

3. 8 week Sof/ldv/RIBA 

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 ok I didn't know that! 

That was my understanding too. But I had to look after Huey mentioned it was a possibility. I'm sorry to hear you relapsed again HR. Such a disappointment I'm sure. Is Gilead going to perform any followup RAV testing to try and determine what happened?

Tig

Huey, 

I can't find any documentation that indicates a placebo was used in any arm of the ION  trial. 

Tig

Huey wrote:

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Can I point out that This is a Trial,  What if HR got a placebo,  You never know with those trials, I think though that at the end they will retreat because they are expecting to.

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 Are you serious?

I too am sorry to hear about your relapse. It sucks! The dreaded call, and the feeling like you've been kicked in the stomach by a horse.... It's been 4 months since I've got that call, and I'm feeling better Now about the situation. There are so many new treatments popping up, that it's just a matter of time before one of them works for us NONR... I've been exercising a LOT and that helps a lot. Makes me feel stronger... While I wait.... Patiently.... 

 

I hope this isn't indelicate but I'm trying to understand why this would happen.  You were tx with S/L for 12 weeks the first time and then for 24 weeks the second time.  You were tx naive, non-cirrhotic, and I don't know if you are a 1a or a 1b.   

It has to be attributable to RAVs.  Is Sovaldi created RAVs the most likely explanation?  I am wondering if they would have given you 24 weeks the first time if that would have made the difference.  I'm thinking that we may need a 3rd DAA or a different (non-Sovaldi) combo all together for retreatments.  

There needs to be some pre and post tx RAVs testing if we are to learn anything from these relapses.  I'd bet the farm (if I owned a farm) that Gilead knows more about these RAVs than they are saying. 

I'm interested to read Malcolm's opinion on this.  Very disconcerting.  

God! I'm so sorry to hear that, RH. I'd be so pissed if I was you. I congratulate you on your tenacity to just keep trying. Yes, I think they will have a lot more answers in the next year or two . Hang in there!

Misfis wrote:

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I feel great, but I never really felt bad with the Hep c, even before treatment.  I never would have found out I had it if my primary care doctor hadn't noticed that my liver enzymes were a little elevated.   But I've stayed undetected, and I agreed to continue letting them monitor me for their own research purposes.  Kind of a voluntary thing they ask you if you want to be a  volunteer for.   Gives me an excuse to go to San Francisco every 6 months and eat at one of my favorite restaurants down there.

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 Yeah, same here. Found Lund out because of alt/ast elevation. That's excellent news you are doing great. I keep up with Karen through PM's and she is doing great as well. Great talking to you.

Misfis wrote:

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Hey HR!  Good to hear from you.  I was wondering when the treatment would be over.  Good luck on these next months.  Keep all of us posted on how it goes.  It's good to know that the treatment had no crummy side effects for you.

 

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 Hey Misfis

How have you been doing? Feeling good all back to normal? I'm interested in knowing how you are doing now that's it's been about a year since you were on meds. Take care and it was great to hear from you.

Isis, Thanks for the hope, 100% sounds good to me:)

Hi HR:  

Congrats on finishing your tx.  

There is always that lingering doubt that creeps up on us but when that doubt comes remember that in the clinical trials 24 weeks of S/L resulted in 100% SVR.  I just love those odds for you.

Enjoy the rest of your summer.  Come Fall you will be SVR. 

Thank you, Jill and thank you, Isiscat.  I went to therapy but it was through school and she was super young and super sweet but not very good.  My doctor at the clinic has referred me to someone else and I need to make that call. I wrote a short piece about the treatment and in it also told the story of my friend who died from it. She and I were the same age but she drank heavily and it exacerbated it and shut down her liver. So I definitely know there is a silver lining but on days when the pain in my joints is great, I do tend to get down. A friend of mine recently said to me "you're too young to be old" and she is right. But thank you both for your kind words. It's nice to just be heard.

 

Sofi

Hi Sofi:

I have read your story from the inception of your clinical trial until now and it really got to me.   You have been through hell, both physically and mentally, and I'm sure you never thought this could happen on an all oral regime.  

I question the ethics of placing an asymptomatic young woman, who has no evidence of liver damage, on drugs that are experimental--combined with a drug that has proven safety risks.  Your anger is justified.  

I went through a similar experience and it takes some time to get through it.  I believe an experience such as this can cause PSTD; it is serious stuff.  Add to that there are few people who can even remotely relate to what you are going through.  I had numerous post-treatment problems but  I didn't realize how much I had been impacted emotionally until I talked with a therapist.  Within 5 minutes I was crying almost uncontrollably (and I'm not a big cryer most of the time).  A box of kleenex later and I felt like a weight had been lifted.  

In the end all we can do is make the best of whatever cards we are dealt.  For me that meant moving forward by taking care of my health and focusing on the beautiful things in life that I had not always fully appreciated.  I noticed that you are a writer.  That ability can help you work through this and how much do you want to bet this experience improves your writing skills?    There is always a silver lining, Sofi.   Look for yours and you will find it. 

 

I am being sent to a rheumatologist because I probably have rheumatoid arthritis. All my health issues are because of the medicine and not just the ribavirin. My doctor says hypothyroidism and RA are common sides of sofosbuvir. Would have been nice to know but everyone called it the miracle cure, including the study nurse. My quality of life has declined since treatment. I was not sick or in any pain before treatment. Now I am an old woman at thirty six.

Congrats Lil Eddie.....

I just finished watching Dallas Buyers Club and couldnt help but think of many peoples struggle with the FDA with their HepC issues as well. So glad to have won the fight, myself.

Thanks RH, you must be a ways into your treatment at this point. Hope you're feeling well!

Excellent news Misfis!! Congrats

Congrats Eddie! I never thought of it that way Matt, "When I used to have Hep C". What a pleasant thought!

Tig

Great news Eddie....dance, dance, dance!!!

Congrats Eddie.. Great job Buddy

Hey RH

Way to go, great to hear your back on treatment. This time will be the ticket to SVR. 24 weeks will take care of all the extra needs that your body requires.

Come July and August you will be free and clean of HCV

matt

Hey Guys,

 I started treatment again today. Sofosbuvir /Ledipasvir  for 24 weeks. So far , so good.

Just a little update. I hope everyone is hanging in there.

Take Care

Congrats to Sofi, Rick and Carla

It's quite amazing that 8 weeks was enough time to clear the HCV and then keep it gone forever.

Remembering that 48 weeks of Interferon & Riba were and still is SOC for a lot of the world.

We have come a long way, I can imagine that in ten years it will be down to 1 or 2 shots and your done.  The whole health care and latest cancer devolpments have been looking at the part the viruses play in disease with HIV and HCV leading the way into the investigation.

Hoping the best for your long term progress.

matt 

Well no longer did I finish writing my last post when I call a call from my trial nurse. My 24 week results had come back and I am virus free as well. Yay Yay Yay...

They did ask me to join another group which just wants to follow up on me for three years and I told them I would.

Carla regarding my ankle issue I have found that I cant seem to stand or walk for any lengthy period of time as well or they will really start aching, which was never a problem for me in the past. I still have my hair thinning out as well but I have read the the Ribavarin can take months for the side effects to subdue. I still get some itching scalp but very s;light to what it once was a few months back.

Good Luck All

Rick