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Vertex Pharmaceuticals Incorporated Message Board

  • thirdmeinvestor thirdmeinvestor Nov 1, 2009 5:57 PM Flag

    Boc in PR

    The following direct quotes summarize its efficacy and safety.

    ... Based on an intent-to-treat analysis (ITT), the 28-week and 48-week lead-in boceprevir arms had SVR rates of 56 percent (58/103) and 75 percent (77/103), respectively, and the no lead-in boceprevir arms had SVR rates of 54 percent (58/107) and 67 percent (69/103), respectively, compared to 38 percent SVR for the control group.(3-5)...
    ... Treatment discontinuations due to adverse events were between 9 and 19 percent for patients in the boceprevir arms, compared to 8 percent for the control arm. Treatment discontinuations in the boceprevir arms due to viral breakthrough were fewer in the 28- and 48-week lead-in arms (4 and 5 percent, respectively) compared to the no lead-in arms (7 and 12 percent, respectively). ...

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    • The raw data in the PR are not new. The data I quoted came from their new analysis of old data (SPRINT 1). The trial patients were entirely treatment-naive. Nevertheless, the PR uses the term null-responders for those patients who achieved less than one log drop in HCV counts after 4 wks of SOC. A null-responder was normally reserved for treatment-experienced patients who did not achieve 2 log drop at 12 wk treatment point.

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