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Hep C Discussion Forum -> Clinical Trial Participants -> New Gilead Clinical Trial With Sofosbuvir/Ledipasvir For Those With Advanced Liver Disease Or Post-Liver Transplant
Post Info TOPIC: New Gilead Clinical Trial With Sofosbuvir/Ledipasvir For Those With Advanced Liver Disease Or Post-Liver Transplant
lauralou57


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RE: New Gilead Clinical Trial With Sofosbuvir/Ledipasvir For Those With Advanced Liver Disease Or Post-Liver Transplant
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I completely agree about being careful about the clinical trials - I don't decide but let my Hep C doc decide.

Also I am aware of NCT01805882 at clinicaltrials.gov.

Thanks for the information.



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mallani


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Hi all,

I urge anyone who is considering a Trial to look carefully at all the arms, if you are to be randomly assigned. Some Phase 3 Trial results should be available shortly, and this will give a clearer idea of what period of treatment is acceptable. I notice some Trials have arms with short treatment duration, eg 6, 8 or 12 weeks total treatment length.  Remember, you will only get one chance with most of these new drugs, due to the emergence of resistant mutations. Gilead require patients to have pre-Trial testing for the S282T mutation (against Sofosbuvir).  I would be very concerned to have only 6 weeks of treatment, if I was cirrhotic. I accept cirrhotics may need fairly urgent treatment, but if the cirrhosis-specific lab. values are OK, I'd wait until I could get 24 weeks of treatment at least, no matter what the drug combo is. I don't want to put anyone off Trials, but it would be a real shame to relapse after a short Rx and not be allowed to use these drugs again.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
lauralou57


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I am so glad that both of you found this.

I am a 1a but have very little damage to my liver. I have had 5 biopsies since 1999 and my doc says there is no change in them.

I am lucky enough to have a good friend who is an M. D. and Ph. D. and does medical research. He helps me translate all of the scientific information. But I am a mathematician and completely understand the mathematical statistics in clinical trials.

I failed interferon/ribaviran treatment in 1999 (my viral count actually went up!).

I know several people who are 1a's and either have had a liver transplant, are waiting for a liver transplant or are just really sick with the side effects of cirrhosis. So I look for clincial trials for them when I search...

My doc has me waiting for Gilead's sofosbuvir/ledipasvir or perhaps sofosbuvir with daclatasvir off label. But I check clinicaltrials.gov, Gilead, other internet sites everyday.

My wish and prayers are 100% SVR for everyone!!!!!smilesmilesmilesmile



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mehru


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I as well was in a study at Johns Hopkins in 1999 ..had interferon 3xweek with rbv daily for 12 weeks and was also a null responder. Over the years I started having them monitor my lab work every 6 mo's from the two GI liver specialists at kaiser as they do not have hepatologists at kaiser. The first specialist did not carefully monitor my labs very well and I switched to the other specialist. Once the new doctor came on board he started looking at my labs, looking at changes over the years and seeing trends. I had not had a biopsy for several years at this point. He started showing me past AFP blood test and grouping them together and pointing out the changes in range then normal then high again. He kept emailing me and sending notes of concern about what he was seeing in the labs. Then he called me one day to tell me he thought I had early cirrhosis. I could not believe it, I did not have a recent biopsy or any significant change in how I felt in several years, what was he seeing in the labs. I told him to go ahead and schedule a liver biopsy, he did and confirmed cirrhosis.  I was really shocked that it happened so fast. Now I wish I'd seen a hepatologist occasionally but it was so expensive to pay out of pocket.

Did you know the National Institutes of Health in Bethesda, MD is starting a study for specifically for geno type 1s and 4s?  I don't know where you live, but if you have any hcv at all you should not wait at all as hcv can sneak up on you really fast.  It gets harder to treat the longer you wait.  They are offering Sofosbuvir/Ledipasvir in a fixed dose along with another DAA GS9669 with no inf/rbv for 8-12 weeks for

gt 1s.  ClinicalTrials.gov Identifier:  NCT01805882.  Good luck and many thanks!!!               

 
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-- Edited by mehru on Saturday 28th of September 2013 08:53:50 PM

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Geno 1a, Stage 3-4 early cirrhosis (labs, recent biopsy, MRE elastography to confirm), 1999 rebetron trial with inf/riba *non/partial responder at 16 wks.  4/2013 started victrelis triple tx - had to discontinue after 2 weeks due to rash.

 
suziq


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Hi Laura,

Thank you, thank you.  I have a friend in Portland who has been on a transplant list for about 4 years, but her MELD score is not real high.  I just called her and sent her the info.  I am on week three of a Merck trial in Texas.  I so love her and when I got on a trial at age 79 I wanted for her to find something. She is the age of my daughter.  Again, thanks for the posting!!!!

SuziQ



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR
mehru


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Hi Laura,

Just wanted to thank you for posting this latest round of Gilead studies.biggrinbiggrinawwawwawwawwbiggrin

How you ever found it....many thanks!!  I am enrolled in a Gilead study that will be starting in a month or two at NIH. I had hoped I would not have to travel so far to participate for I live in Calif. IT looks like this one might be a match for me. I emailed the contact person to see when the San Francisco study will start.  Are you thinking about doing a study?

 



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Geno 1a, Stage 3-4 early cirrhosis (labs, recent biopsy, MRE elastography to confirm), 1999 rebetron trial with inf/riba *non/partial responder at 16 wks.  4/2013 started victrelis triple tx - had to discontinue after 2 weeks due to rash.

 
lauralou57


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I just noticed this clinical trial in clinicaltrials.gov and I had not seen it before.

It is using Gilead's sofosbuvir/ledipasvir and is for those with advanced liver disease or post-liver transplant.

I thought I would post this as others might be interested.

The link is below:

http://clinicaltrials.gov/ct2/show/NCT01938430

 



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