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Vertex Pharmaceuticals Incorporated Message Board

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  • thirdmeinvestor thirdmeinvestor Jan 12, 2007 11:46 AM Flag

    Optimist's view of the Rash problem

    If the anecdotal event stated in the Forum holds true for other trial drop-outs, then some of 9% should be included in SVR percentage... this will raise the 88% end-of-trial SVR.

    Patients with severe rash may receive lower doses for shorter duration to achieve the same SVR as other patients get.

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    • incorrect
      the 88% refers to the % undetectable following 12 week dosing period of vx on an intention to treat basis. what this means is that any patient who started treatment for any period of time, even dropouts, are included in the calculation. the patient in question who only received 8 weeks of vx was therefore already lumped in with the 88% undetectable. stated another way, 12% of patients who were assigned to a 12 week treatment arm, irrespective of whether or not they dropped out, had detectable virus at week 12 of the study. now some of those patients may yet become undetectable beyond 12 weeks if they continue standard of care, but chance of svr for those patients is far lower. In addition, some patients who are undetectable at week 12 will inevitably relapse. so realistically, svr will be lower than 88%, and likely quite a bit lower than 88%, but bear in mind anything above 45% in genotype-1 patients represents an improvement in efficacy over standard of care

      • 1 Reply to thenextdna
      • thenextdna said:

        "the 88% refers to the % undetectable following 12 week dosing period of vx on an intention to treat basis. what this means is that any patient who started treatment for any period of time, even dropouts, are included in the calculation."

        I'm not quite sure that is correct. VRTX said:

        * In the telaprevir dosing arms, the incidence of treatment discontinuations due to adverse events was 9% and the incidence of serious adverse events was 3%.
        * At week 12, 65 of the 74 patients (88%) for whom data was available in the telaprevir groups demonstrated undetectable HCV RNA (less than 10 IU/mL; Roche Taqman).

        Certainly, at week 12 there was no data available for the 9% who dropped out. So when VRTX says "At week 12, 65 of the 74 patients (88%) for whom data was available in the telaprevir groups demonstrated undetectable HCV RNA" - what they mean is of those patients who didn't drop out. Therefore, on an intent to treat basis, the undetectable rate was 80% (if you run the back calculations to inlcude the dropouts).

        Still great numbers though if you ask me.

 
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