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Hep C Discussion Forum -> General Discussion -> Alisporvir resistance issues
Post Info TOPIC: Alisporvir resistance issues
Roadwarrior


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RE: Alisporvir resistance issues
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Hi Malcolm

Yes, I'm trying to focus more on Gilead right now, we'll see, are you clear now? how are you doing?

 

Nick



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mallani


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Hi Nick,

AbbVie will not accept anyone who has had a previous DAA for their trials. As DEB025 is not a DAA I can understand why you are not impressed by their attitude. One of our Forum members had failed Incivek Rx, but was accepted onto a Gilead/BMS trial, and achieved SVR. AbbVie are probably worried about resistant mutations affecting ABT-267, their NS-5b polymerase inhibitor. They did 2 Phase2 trials using this drug with Riba. but did not publish results. This makes me think there were high levels of resistant mutations. Also, the Phase 2 trials using all 3 of their drugs, showed much better SVR rates for Geno1b (compared to 1a). Again, this suggests that resistant mutations were a problem. Have you tried to get on a Gilead Trial ?   Cheers



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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
Roadwarrior


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Hi Malcolm

 

Thanks for you reply, you confirmed what I know, that there a litlle or no resistance problems regarding Alisporvir.  Seemed to have backed into a corner thro getting involved with that trial. As you are probably aware the FDA stopped it on danger grounds.  As you say Abbvie may be being over cautious.

 

How are you doing?

 

Nick



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mallani


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Hi Nicolas,

You asked the same question in your previous post of 3rd May. Bills and I responded to your question, but you did not reply.

AbbVie are concerned about resistant mutations. DEB025 (Alisporvir) acts on the hepatocyte cytoplasm, and indirectly on the HCV site NS-5a. If you read the link I have posted (below), you will see that there is a 'lack of cross-resistance between DEB025 and DAA's of other classes', and that 'there is a high genetic barrier to resistance to DEB025'. AbbVie are obviously being very cautious.

 

 

http://www.plosone.org/article/info:doi/10.1371/journal.pone.0013687



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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
Roadwarrior


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Hi everyone

 

has anyone any information regarding drug resistance issues surrounding Alisporvir debio025 cyclophin inhibitor, Abbvie have told me they cannot consider me for their interferon free studies.

good energy to all

 

Nick



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