Post Hep C Clinical Study

[chino1969]

It's been awhile since I posted so I'll bring everyone up to speed.  I finished a 24 week course of therapy of Harvoni on 8/9/2015.  The HCV was non detectable the whole time I was on therapy, SVR @4,12,16 & 34 weeks EOT.  I am now enrolled in a 5 year clinical research study, funded by Gilliad, to study cirrhosis in those who have cleared HEP C.  The pre requisites involved an endoscopy within 6 months prior to the beginning of the study.  On Tuesday, I received my very first Fibro Scan which is one of the tools used in the study.  My score was 18.4.  Blood was drawn as it will be drawn every 6 months as part of the study.  The Fibro Scan will be performed yearly.  Before the 5 years is up, I will receive another endoscopy.  These costs are all covered by the study.  In addition to the above I am also involved in another study which is to evaluate the usefulness of new markers found in blood that might help to diagnose HCC early among people with cirrhosis.  Hope this is informational to some.

[lporterrn]

Fabulous study and I am so glad you posted. This will be very interesting and valuable data. Did you happen to have a Fibrotest before your treatment?

[FutureThinker]

Thank you, Chino1969, for being a trial participant and posting! FT

[Lynn K]

Hi Chino

Would you know the study number? I would like to get involved with something like that as well. I have upper endoscopies every year because I previously had varicies

Thanks

[chino1969]

Hi Chino

Would you know the study number? I would like to get involved with something like that as well. I have upper endoscopies every year because I previously had varicies

Thanks

Hi Lynn.
Looking at my consent form I see the following in the lower right hand corner:
Gillead Sciences, Inc.
GS-US-337-1431

Hope that helps.

Additional info.  Type in Gillead clinical trial GS-US-337-1431 should get you to clinicaltrials.gov website.  The identifier for this trial is NCT02292706.  The site should tell you everything you need to know.  Good luck.

[chino1969]

Fabulous study and I am so glad you posted. This will be very interesting and valuable data. Did you happen to have a Fibrotest before your treatment?

Hi Lucinda.
No I did not have a Fibro Scan before treatment.  When I relapsed after 12 weeks on Solvadi/Olysio in Oct. 2014 my blood work skyrocketed; AST 268, ALT 231, AFP 477. The whole time I was on Solv./Oly, my HCV was not detectable and my liver chemistries were normal.  My Dr. appealed for a 24 week course of Harvoni which was initially denied and then approved.  I started Harvoni 2/23/15 and finished 8/9/15.  I was undetected the whole time.  My most recent blood work (34 weeks EOT) is: AST 28, ALT 31, AFP 3.4.  As you can see the Harvoni worked. 

I will post as time goes on but that's all I have for now. 

[Lynn K]

Thanks took me straight to it

https://clinicaltrials.gov/ct2/show/study/NCT02292706?show_locs=Y#locn

A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

Apparently it is by invitation only. They have 2 locations in Seattle but I was at Swedish Liver not Harborview Medical (UW) or Virginia Mason.

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

    Proportion of participants maintaining sustained virologic response (SVR) at Week 240 [ Time Frame: Week 240 ] [ Designated as safety issue: No ]
    Proportion of participants who develop liver disease progression or regression, as assessed by clinical and laboratory parameters [ Time Frame: Up to 240 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 240 [ Time Frame: Up to 240 weeks ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

    Proportion of participants with detectable HCV RNA due to re-emergence of pre-existing virus through Week 240 [ Time Frame: Up to 240 weeks ] [ Designated as safety issue: No ]
    Proportion of participants with detectable HCV resistance mutations through Week 240 [ Time Frame: Up to 240 weeks ] [ Designated as safety issue: No ]
    Proportion of participants with detectable HCV RNA due to re-infection through Week 240 [ Time Frame: Up to 240 weeks ] [ Designated as safety issue: No ]

[chino1969]

Lynn,
This study is being run out of The Perlman Center For Advanced Disease of The Hospital Of The University of Pennsylvania.  This is a crack team of professionals led by one of the top Hepatologists in the country, if not the world.  I am fortunate to have found them and been accepted as a patient.  When I relapsed in 2014 on Solvadi/Olysio my GI wanted to send me to another hospital and Dr..  I decided to take the reins myself and found the Dr. I wanted through research.  It was the right decision. 

[Lynn K]

Here are 3 of the 123 locations for the study I referenced

United States, Pennsylvania

Thomas Jefferson University Hospital    
Philadelphia, Pennsylvania, United States

University of Pennsylvania Health System    
Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center    
Pittsburgh, Pennsylvania, United States

I guess one of those is your location.

Our primary study location in Washington state is also on the list

United States, Washington

Harborview Medical Center    
Seattle, Washington, United States

One of the doctors there is Kris Kowdley you likely will have seen his name in much of the hep c literature. He is at both UW Harborview and at Swedish.

I had been seen there at University of Washington a couple of times but was recommend to go to Swedish for treatment. I guess I am out of the loop as far as being known to the researchers as a multiple treatment failure with established cirrhosis.

I also made a decision to change doctors. I was seeing a gastro in a smaller town. We had a falling out when he said was concerned about the possibility I could develop HE "maybe tomorrow, maybe in a year, maybe 5 years, or maybe never" and he wanted to clip my wings on the basis of a "maybe" so I changed doctors to a higher level of specialist to get a better diagnosis of my situation.

Wish I could get this follow up like you will be but I guess time will tell for all of us anyway

Good luck

[chino1969]

Lynn,
It is important to take the reins and manage this disease on your own.  Doctors are an important element you have to be comfortable and have faith in the ones treating you.

[Lynn K]

I couldn't agree more