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Hep C Discussion Forum -> Post Treatment -> Alisporvir(Debio 025) Clinical trial FDA stopped April 2012
Post Info TOPIC: Alisporvir(Debio 025) Clinical trial FDA stopped April 2012
Bills


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RE: Alisporvir(Debio 025) Clinical trial FDA stopped April 2012
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Nicolas

 

This is the link to the article  I mentioned

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0013687

 

I'm sorry if this a very technical document It's also from 2010 I did the trial in 2011 I can't understand it

I think it was the title that drew me in but I couldn't find final outcome of the whole DEB 025 trial and over all findings  I only know it was caned  due to a death in Asia and a few close calls all involved the pancreas.   

I'm thinking the trial was stopped in April 2012 leaving me with like 2-3 months to complete It was a blind-blind trial so I didn't even know if I was UND  Having Novartis open the case and reveal the blood test etc would mean immediate dismissal and releasing Novartis from liability  cause I walked  We had another doctor do a viral load and I was UND so I continued Peg and Riba till another blood test revealed the virus was coming back at 45 weeks ( that hurt )  not knowing what to do I did the last 3 shots Peg & ribaviran   and shifted to right into Incivek  triple drug  I went another 26 weeks till that also broke through  Now I wait for the Gilead Science (soboisevier?)   and the Bristol Myers drug  

That's pretty much it. 74 weeks of poison. Maybe I'm lucky that I don't seem to have any reactions to that much drugs except  brain fog lol.  

If you find and dirt on that trial please let me know

Good luck with your fight Nicholas

Bill   



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.

Roadwarrior


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Hi Bill

 

How is it going? have u any more news regarding Alisporvir triple therapy trial?

 

Nick

 



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Roadwarrior


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Hi Bill

How are you going? like you I have many, many unanswered questions regarding the DEBIO 025 trial, I am just about to email the research nurse because on top of everything I am having hassles getting my travel expenses from Novartis.  I was stopped in May 2012, one month after the FDA stopped the trial.  I was experiencing adverse effects at  week 24,  shortly after relapsed.

 

let us know your experience

 

Nick



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Roadwarrior


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Hi Bill Great hear from you! I'm in a cyber cafe at the moment and will message when I get to my laptop. Nick

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Bills


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Heres a link to a publication was sent to me last year about what happend to the trial I was on

I'd be happy to discuss this I have a lot of questions as well  You can message me if you want

Bill S

http://uk.reuters.com/article/2012/04/19/novartis-idUKWEA852020120419

 

(Reuters) - Swiss drugmaker Novartis said on Thursday that U.S. health regulators had put is development programme for a treatment of hepatitus C on hold after one patient's death was reported in a clinical trial.

The company said a small number of patients being treated with DEB025 (alisporivir) in combination with pegylated interferon and ribavirin were diagnosed with pancreatitis. One case resulted in a patient's death, although the cause of death is still being dertermined.

 

"As a result, Novartis has been notified by the FDA that the development program of DEB025 being studied for the treatment of Hepatitis C, will be placed on full clinical hold," the company said in a statement.

 

Novartis said it was working closely with the FDA to assess the implications of the clinical hold on the DEB025 program.



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.

Bills


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Hi,

I'm Bill I don't have time to do this just yet but I did a blind blind DEB 025 trial  I beleive it was Alisporvir study last year and relapsed  in I'm not sure If this is the same thing. Ill look and see when I get home

 The study I was in DEB 025 with Peg and ribv  was August 2011 by Novartis the study was withdrawn ? about 7-8 months in due to saftey and I continued Peg & Ribv till 45 weeks then relapsed  I thought it was removed from testing after that

I'll look back later

  So far I'm OK   

Bill S



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.

mallani


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Hi Nicolas,

I forgot to ask whether you had been refused admission to the Abbott trial because you had been on the Alisporivir Trial. If so, that's nonsense as Alis. does not even target the virus, but is a cyclophilin blocker acting on the cytoplasm of hepatocytes. Very confusing.



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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
mallani


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Hi Nicolas,

The Abbott triple regime contains an Antiprotease (ABT-450/r). As both Victrelis and Incivek were both Antiproteases ( at the same site, NS-3/4), they reason that treament failures or relapsers who used these drugs, will have RAV's (resistant mutations) to these drugs. In patients with Geno 1a in particular, these RAV's persist for an unknown period (perhaps years). Abbott do not want to compromise their regime by including patients who probably have Antiprotease RAVs.

Gilead do not use an Antiprotease. Their drugs target NS-5a and NS-5b. We have a member who failed Incivek, but was accepted on a Gilead trial, and has achieved SVR.

It''s unfortunate, but all Drug Companies have the same policy at the moment.



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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
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Hi Everyone

Need to communicate whith others who were on this trial, I am very aware of Abbott and Gilead developments.

This incredibly difficult jouney is getting more mystifying as I emailed Abbott and they maintain that their protocol will not allow anyone who has been on a tripple therapy trial to participate in their interferon free studies, Turquoise ect.

I'm fairly clued up about resistance and it would be really good to hear from others, especially those who have been on other trials who were not previously on SOC??? in other words on a  direct acting anti viral who went on and did a further clinical study.

 

I went clear at week 8, virus returned later.



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