Cirrhosis of the Liver Community
Clinical Trial for those with HVC, cirrhosis, HCC awaiting tranplant
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Cirrhosis is the end result of chronic liver damage caused by chronic liver diseases. The purpose of the community is to share support and information with Cirrhosis of the Liver patients and their loved ones. Topics in the community include: causes, clinical trials, complications, family issues, living with Cirrhosis of the Liver, prognosis, research, surgery, treatments

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Clinical Trial for those with HVC, cirrhosis, HCC awaiting tranplant

There will only be 40 people world-wide (US, Europe and New Zealand) in this study you you have  HVC, cirrhosis, HCC and awaiting transplant within the next 6 months this may be the best way to cure yourself of hepatitis C for good. Two oral drugs NO interferon. GS-7977 + Ribavirin. Currently recruiting.

"An Open-Label Study to Explore the Clinical Efficacy of GS 7977 With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant"
This study is currently recruiting participants.
Verified April 2012 by Gilead Sciences
Study NCT01559844   Information provided by Gilead Sciences

http://clinicaltrials.gov/ct2/show/NCT01559844?term=gilead+gs-7977&rank=4

Current Primary Outcome Measures - To determine if the administration of a combination of GS 7977 and ribavirin to HCV-infected subjects with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation for up to 24 weeks can prevent post-transplant re-infection as determined by a sustained post-transplant virological response (HCV RNA  10e4 IU/mL at Screening
Patients meeting the MILAN criteria undergoing liver transplant for HCC secondary to HCV with a MELD of  10 mg/day) in the Pre-transplant treatment period.
History of previous solid organ transplantation
Evidence of renal impairment (CrCl < 60 mL/min) calculated by the Cockroft-Gault equation.
History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, porphyria, or poorly controlled diabetes, cancer other than HCC, or a history of malignancy that in the opinion of the investigator makes the patient unsuitable for the study. Patients with clinical signs or symptoms of acute pancreatitis with elevated lipase (at Screening or during the Screening period)
Known hypersensitivity to RBV, the study investigational medicinal product, the metabolites, or formulation excipients.
History of having received any systemic antineoplastic (including sorafenib) or immunomodulatory treatment (including radiation) within 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study (excluding a local regional therapy such as TACE).
Treatment with Transcatheter arterial chemoembolization (TACE) or radio frequency ablation (RFA) within 30 days prior to the first dose.
Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to first dose administration at the Baseline/Day 1 Visit.

Cheers!
Hector
26 Comments Post a Comment
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1654058_tn?1407162666
Cheers to YOU Buckaroo! What an amazing opportunity you've been given. No one deserves it better. That's not to put anyone down, but if they have limited the scope of the people who get this chance, you should be in it!
Do you have a start date? How long does treatment last? Will they stop and then continue it if you get transplant in the middle. lol. I'm sure all these questions have gone through your mind also.
And Hector gets the gold!
Karen:)
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446474_tn?1404424777
I completed the trial evaluation this Monday. Blood, urine, EKG and signing all the paper work. I was patient #2 at UCSF. My doctor helped me to get the chance at this study. I am grateful for that. I am waiting to hear back from the trial administrator to see if I was excepted or not. I should hear anytime now.

Treatment lasts up to 24 weeks. During that time it is expected that you will be transplanted. So you will be on treatment right up to your transplant. The idea is to be on treatment with an undetectable viral load when you have your transplant. (There is no reason to continue treatment post transplant). Then they will follow up testing to see if the hepatitis C virus reoccurs in the donor liver. The goal of the study is to prevent recurrent hepatitis C in the donor liver. This is something that is still a major issue for all transplant patients with hepatitis C.

My problem is that all patients with a history of cancer other than liver cancer are excluded. I had cancer in my foot in 2009. So my doctor is trying to get an exception for me so I can be in the trial. That is the only issue that may prevent me from being in this trial.

As this point it is out of my hands. So I can only hope for the best and will know either way very soon. I'll post either way when I hear Gilead's decision.

Thanks for your support!

Cheers!
H
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3097131_tn?1357088481
My prayers go out to you Hector! I hope all goes well for you,you deserve it.I havent been on this forum long ,but I read a lot of your comments to others and I look up to you for you have came a long way..God will Bless you for all the help you have given on this Forum.

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1475202_tn?1388955435
Hector thank you so much for all that you contribute. You are very strong minded and strong willed. We all know you have certainly taken it upon yourself to go above and beyond to arm yourself with all of the required knowledge needed in order to be prepared and successful. I will be praying for your speedy recovery and a successful outcome! The medical break-through could be so terrific and help so many others. Thanks again for all that you do. Please keep us posted :)

Randy
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H, I am so very very happy to hear this wonderful news.  You give us your best,
You deserve all the best

WOO!!! HOO!!!
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446474_tn?1404424777
I got a call from my doctor's NP saying to keep taking my Rifampin for my tuberculosis (TB) (which is a good sign that I am still in the race). My blood, urine and EKG were good. I was a little worried about my bilirubin being higher than 3.0 but it wasn't on Monday anyway. I will have to stop my TB treatment 28 days before starting the GS 7977 with Ribavirin because the trial protocol says I can be taking a drug in the same family as Rifampin while in the trial.

So I guess I haven't been ruled out as of yet because of my "eccrine syringomatous carcinoma" in my foot. So that is good news. I have been nervous about hearing that I have been turned down because of my cancer.

Thank you all for your well wishes!
Hector
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1840891_tn?1383280315
So far, so good, and I hope it all continues going your way. The study sounds like an extremely good idea – almost a no-brainer!. I hope the results live up to the hopes and expectations, and I especially hope that you DO end up included. Good luck!
-Saelon
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I am praying for you.  You deserve the biggest break of everyone here
It will happen
Dee
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Man my fingers are crossed for you (I know that you know that I know that such metaphors have about as much to do with you getting into the study as the weather but I'll still keep them crossed). d
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Avatar_m_tn
You are in my prayers.  You deserve this chance more than anyone else.  Good luck.  
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Avatar_m_tn
It is fate/karma/etc. that you will be enrolled into this trial and get the golden HCV.    You deserve a big break, and I hope that this one does it for you. I'm glad that you followed up on this study,  Sounds perfect for you!

Be well!
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Just saw this thread.  I wish you the best because you deserve it.
I know how exhausting this all is and yet you find the time to GIVE to others.
I understand you...all will go well.

Nan
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446474_tn?1404424777
Fanfreakentastic!!!

I am happy to report that today (8-8-2012) I got accepted into the "An Open-Label Study to Explore the Clinical Efficacy of GS 7977 With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant".

I will be 1 of only 40 people in the U.S., Europe and New Zealand in this trial.

I am planning on receiving a liver transplant in 5-6 months due to my HCC (liver cancer). My hepatologist will be leading the trial here at UCSF. I am a previous null-responder to treatment so the chance to try an all oral treatment is my best chance of curing my hepatitis C. This could free me from having to worry that my hepatitis will destroy my donor liver too in 5-10 years. This could increase my longevity to be on par with others post transplant that don't have hep C.

The approach of this study is to make the viral load undetectable while treating up to 24 and at some point before 24 weeks have a transplant. We will then be followed post transplant to see if the virus reoccurs.

Cheers!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Hector
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Avatar_f_tn
It is so fitting that you will lead the charge with this new study  in trying to slay that dragon!

May you have success in doing that and getting that new liver soon.

Know that many on this forum are cheering you on and want only the best possible outcome for you.

Nan
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1475202_tn?1388955435
Congratulations Hector!  You very much deserve a rare opportunity like this. I hope you will keep us updated when possible concerning how you are doing. I have no doubts you will have all the support you will ever need to make terrific recovery and to be a successful candidate! I wish you the best my friend :)
Randy
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Yea, man that is great!!!  You could not hope for a better procedure ;-). What an honor and I know it will payoff for you with those magic words CCS (Cured Cancer Survivor) along with SVR ;-).
Told you you were one of the best candidates of FUP (F--ked up people) lol.
When will you start?
What a trip. you got to be sick, have cancer , cerious, hep C and yet here you are all of that, yet your a cherry pick, because you are in such great? shape.
Keep us informed. Ginger  ps. So happy you are improving your odds and the sx's.
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Avatar_m_tn
Congratulations on getting into the trial.  Looking forward to seeing that you get SVR.  Keeping you in thoughts and prayers.
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Congratulations! It's your time to be UND, get a new liver, and then SVR!
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1691407_tn?1332716147
Congratulations HectorSF!!!  It is exciting after working so hard fighting for your life that you know you have a chance.  It is a great feeling for sure!!!! Cheers and woot woot!!! lol

PEACE~HOPE
Allison
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Congratulations!!!! I am SO happy for you and wish you the very best.  You seem like an amazing person who has helped many people go through  very difficult situations.  
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The trials With Gileads GS-7977 was first used with a anti viral from Bristol Myer,they had some of the most significant resultson record,100% success rate riding 100patients of hepatitis C,but for political and greed,they found they could not work together,and we have to suffer because of this stupid,race for control,their is a petiotion I've signrd and if you google it you
can find it I'm sure please if anyone can sign it It will ulyimately save thousands and get Gileads GS7977 and Bristol Myers anti viral working together again thanks
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I'm so jelous I wish I had the chance to takeGS-7977 Your a very lucky man but much deserved,just tell them we all need it.
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1116669_tn?1269146866
Hey there Hector. How are you doing with your hopeful therapy? You ok relative to the circumstances? Hope so. d
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Congratulations Hector....all my best wishes and good thoughts are going your way...you are inspirational in showing what a positive attitude can accomplish.  
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All the best Hector. Keeping my fingers crossed.
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Thanks for signing Marco.  Over 8400 have signed thus far and we are still waging the battle against Gilead Sciences for this cure combining GS-7977 (now called sofosbuvir) and daclatasvir.

Others can join our effort at www.HepC-Cured.org

And all the best to you Hector!
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