Vertex Shareholders Stay Vexed

Stock quotes in this article: VRTX  

What's the SVR12 result for Arm D of the study? Using the most generous analysis, the SVR12 would be a robust 81% (13/16 patients). But using a stricter calculus, the SVR12 would be a less rosy 65% (13/20 patients).

For this reason, pay attention to both the numerator and the denominator used to analyze the upcoming telaprevir data. There are pros and cons for using either calculation, which go a long way toward explaining why there's so much uncertainty about the upcoming presentation. (And I did warn you that this column would get wonky.)

Other things to keep in mind about the upcoming data:

  • Pay attention to the side-effect profile of telaprevir and the reporting of any toxicities or adverse events that might have caused patients to discontinue treatment.

  • The SVR12 data will be a good measure of telaprevir's efficacy, but it's not enough. For a hepatitis C drug to receive FDA approval, patients must have undetectable virus for 24 weeks, or six months, following the end of treatment. Generally speaking, about 50% of treatment-naive hepatitis C patients are cured (achieve SVR24) on the currently marketed drugs.

  • If Vertex doesn't succeed with its home-run strategy of treating patients for only three months, the game is far from over. As I said above, the majority of patients in the Prove 1 study are being treated with three months of telaprevir in combination with either 24 or 48 weeks of interferon and ribavirin.
    • Loading Comments...
    •  
    1 2 3 4
    Next >

    SHARE:

    • email
    • print
    • comment
    • digg
    • delicious
    • linkedin
  • Adam Feuerstein writes regularly for RealMoney.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.




    Connect with TheStreet

    Dow Jones S&P 500 NASDAQ 10-Year Note
    10,270.47 1,093.48 2,167.88 34.29
    Oil *
    75.55
    UP
    73.00
    UP
    6.24
    UP
    18.86
    DOWN
    0.17
    10 Yr
    3.43%
    SPDR Gold
    109.74
    +0.72%
    +0.57%
    +0.88%
    -0.49%
    Data delayed 20 minutes

    Brokerage Partners

    TheStreet Premium Services

    All Services