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Vertex Pharmaceuticals Incorporated Message Board

  • justrpaul justrpaul Apr 26, 2008 11:00 AM Flag

    Schering Boceprevir EASl release

    7:55 am pst

    Has the data from the treatment naive boceprevir trial been released yet? I know the abstract has been up, but I haven't seen anything new yet. The paper isn't due to be presented for another hour at 5:45 pm Milan time, which is I believe 8:45 am here on the west coast.

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    • the 86% number is similar to the 91% that vrtx got, from the AASLD press release:

      "For those patients that achieved RVR, completed 24 weeks of telaprevir-based therapy, and had data available for SVR analysis, 91% achieved an SVR 24 or SVR 12. This finding demonstrates a correlation between RVR and SVR in a 24-week telaprevir-based treatment regimen. "

      I'll bet there will be confusion with analysts citing an "SVR" rate of 86% for boceprevir

    • Lucky, I have been away from the computer. It was not clearly stated there, but only 60% or 39% of patients in the two arms had achieved RVR(rapid viral response at week 4)because only 62 out of 103 (= 60%) and 42 out of 107 (= 39%) had UND at the end of 4 week of Boce. (In comparison, in PROVE 1 79% of patients achieved RVR. RVR is a positive indicator for final outcome.) Out of these 62(or 42) patients only 53(or 31) later achieved SVR.

    • <During a late-breaker oral presentation at EASL, Dr. Kwo presented interim results for the two 28-week boceprevir arms of the study. For patients receiving 4 weeks of PEGINTRON and REBETOL therapy prior to the addition of boceprevir, SVR 12 was 57 percent (59/103), compared to 55 percent (59/107) for patients in the boceprevir triple combination arm. For patients in these two boceprevir arms who had undetectable virus (HCV-RNA) after 4 weeks of boceprevir treatment (RVR), the SVR 12 rates were 86 percent (53/62) and 74 percent (31/42), respectively. SVR 12 rates are not yet available for patients in the 48-week boceprevir arms or the 48-week control arm, as treatment of these patients is ongoing.>

      note the difference in the population
      numbers..."for patients in these two
      boceprevir arms"....
      after 28 weeks...
      arm 1: P+R then B SVR 12... 57%
      population 59/103
      arm 2: triple comb SVR 12...55%
      population 59/107

      now for the same arms after 4 weeks of boceprevir...SVR 12 was 86 & 74%...
      arm 1: population is 53/62
      arm 2: population is 31/42

      how can the population denominators be different???
      regards

    • The discontinuation rates for PROVE 1/2 included both the rates for AEs and for breakthoughs. If you do the same for SPRINT, you get the rates of 15% and 23% for dropouts. Odd thing is that by inserting priming doses you decrease the dropout rate. This is difficult to believe, but is some thing new.

    • Nope, doesn't work.

      But thanks third. Was there anything in the link that wasn't in the Schering PR?

    • Paul, the dropout rates and RVRs for B have been released along with some updates, but SVRs have not been.

 
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