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Author Topic: Recruiting Clinical Trial for those with GT2 and GT3  (Read 8761 times)

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Offline BattleTheBeast

  • Member
  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Recruiting Clinical Trial for those with GT2 and GT3
« on: December 20, 2014, 02:07:10 pm »
Hi All,

I am always looking to see what's coming next and I know a few people have mentioned GT2 and 3 and what's the best for them. I can't say anything except that I found a clinical trial that's recruiting for that. If you are interested you can check it out, seems to be open across the US and it's in Phase 2.

https://clinicaltrials.gov/ct2/show/study/NCT02243293?term=%22HCV%22&recr=Open&rank=14#contacts

Mel
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline Luna7

  • Member
  • Posts: 179
Re: Recruiting Clinical Trial for those with GT2 and GT3
« Reply #1 on: December 21, 2014, 09:59:13 am »
Thanks for this info Mel, I am thinking about trying for this one though I haven't heard of these drugs.

I wonder though, is it true that all clinical trials require a biopsy, and if so I wonder why Fibrosure or Fibroscan wouldn't work.
I am reluctant to take tests that have a percentage of deaths as a result, however small, and especially when other tests are just as good or better.
Between F2 & F3
Alt & Ast nearly 100
Viral load over 8 million
Gt 3a

Treated 12 weeks with Sovaldi & Daklinza, start date mid-April 2016
Undetected at 4 weeks into treatment
Alt & Ast  normal
Treatment completed July 14
Most likely will be undetected at 12 weeks (mid October 2016) as symptoms are gone

Offline BattleTheBeast

  • Member
  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Re: Recruiting Clinical Trial for those with GT2 and GT3
« Reply #2 on: December 21, 2014, 12:55:17 pm »
Hi Luna,

My IDhero told me that if I was to go into one of the clinical trials at his office the biopsy is mandatory. Apparently the new tests aren't widely accepted and "proven" yet. He feels the new tests are valid and he actually prefers them because they are non-invasive.  I think it's the clinical guidelines for the trials. If you previously have on they may take it depending how long ago it was.

Let us know what you end up doing and how you are!

Mel
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline Maxlaw

  • Member
  • Posts: 20
Re: Recruiting Clinical Trial for those with GT2 and GT3
« Reply #3 on: January 10, 2015, 03:37:13 pm »
I am in this trial now, starting week 5. VL had a 4 log decrease within one week, and was undetectable at 4 weeks. The two drugs are the next generation NS3/4A protease inhibitor and the next gen NS5A inhibitor of two of the first gen AbbVie drugs contained in the Viekira pak (paritaprevir & ombitasvir) that was recently approved for GT 1. These next gen drugs have shown high potency against all genotypes, and a high barrier to resistance, particularly against GT 3a, in vitro. They were previously tested as 3-day monotherapy in a trial, followed by 12 weeks of the drugs that are in Viekira pak. The trial randomizes various dosages, and one arm adds ribavirin (I did not get ribavirin...yay! Altho my hepatoligist said sometimes ribavirin is "the glue that holds it all together").  Significantly, I have experienced no real side effects from these drugs! The first few days, a little dry mouth and very slight headache, but now...nothing at all! Everyone is different, though, but I would have no hesitation in recommending these drugs.

The trial required a liver biopsy and the cost to have it done in the clinic (Dr. office) under a local anesthetic would have her covered by the pharmaceutical company. However, I elected to have it done in the hospital under sedation, and I paid the co-insurance. I actually had already scheduled the biopsy anyway before they contacted me about the trial (my hepatoligist runs the trials and I had mentioned at first appointment that I was interested in getting in a trial, and he had already told me that I needed a biopsy, since it's the only accurate way to stage liver disease and I would need it for a trial anyway). This particular trial is for non-cirhhotics, so I had to wait until I got the biopsy results to see if I was eligible.  Very luckily, I was not cirhhotic, and I started the trial drugs in early December.  So far, so good...but, of course, we all know that the true test is post-treatment SVR.

 So here's to SVR 12 in 2015! For myself and everyone else fighting this dragon!!
GT 3a, dx 07/2014, baseline VL <400K, Fibrosis stage F2 prior to treatment; Completed AbbVie trial drugs ABT-493 & ABT-530 03/01/2015; achieved SVR 12 on 5/27/15...CURED!!

 


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