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AbbVie Inc. Message Board

  • ibexx ibexx Feb 11, 2014 12:17 AM Flag

    Gilead Sciences files 2 drug combo for treatment of HCV GT1 patients

    All oral, once daily, no interferon, no ribavirin
    8 weeks for drug naive patients
    12 weeks for drug experienced patients

    When is ABBV gonna file its 3 drug combo plus ribaviron?

    Wake up guys!

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    • just some weeks away from filing. ABBVs filing will include an exclusive phase 3 data set for for cirhhotic patients where it achieved a proven cure rate of 96%. GILD has no data available and filed for cirrhotic patients, so the usage of its drug regimen in this patient group will be flawed and docs will prefere a drug with clinical data of cure reates for this population. But anyway, ABBV has a cure rate of 99%/100% in GT1b (treatment naive / treatment experienced) patients as single regimen and without ribavarin/interferon. Thats superior compared to the GILD data in the GT1b patients. And concerning the 8 week treatment regimen it is very unlikely that they will get this approved because their own dataset demonstrated that treatment with 8 weeks instead of 12 weeks generates about 4 relapser per 100 patients which have - subsequent to failed treatment - a treatment resistant HCV strain which may be the source for the establishment of more treatment resistent mutant HCV strains in the general population - and thats a public threat and for sure not accepted by FDA.
      hofno

      Sentiment: Strong Buy

 
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