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Two New Studies Promote Telaprevir as Hepatitis C Treatment

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  • scarletpaolicchi
    This looks to me like great news if it all goes well in its approval. Two New Studies Promote Telaprevir as Hepatitis C Treatment Drug Discovery & Development
    Message 1 of 1 , May 20, 2009
      This looks to me like great news if it all goes well in its approval.

      Two New Studies Promote Telaprevir as Hepatitis C Treatment
      Drug Discovery & Development - May 18, 2009

      Two clinical studies published the New England Journal of Medicine demonstrate
      that treatment with the investigational oral hepatitis C virus (HCV) protease
      inhibitor telaprevir dosed in combination with pegylated-interferon (peg-IFN)
      and ribavirin (RBV) as part of a 24-week treatment regimen resulted in a
      significant improvement in the rate of sustained viral response (SVR),
      considered a cure of the viral infection, in treatment-naïve genotype 1 HCV
      patients, as compared with the SVR rate for standard therapy dosed for 48 weeks.
      The data are from two Phase 2b (mid-stage) clinical trials of telaprevir known
      as PROVE 1 and PROVE 2. In these trials, patients who received a 24-week
      telaprevir-based treatment regimen achieved SVR rates of up to 69 percent, as
      compared to SVR rates of up to 46 percent in patients in the control arms of
      these trials who received peg-IFN and RBV for a standard duration of 48 weeks.
      Telaprevir is being developed by Vertex Pharmaceuticals Incorporated in
      collaboration with Tibotec and Mitsubishi Tanabe Pharma. Telaprevir is currently
      in Phase 3 (late-stage) clinical development.

      HCV is the most common blood-borne infection in the U.S., four times more common
      than HIV infection, and is the leading cause of liver transplantations and liver
      cancer in the US.

      "Currently available therapies for patients infected with HCV can be difficult
      to tolerate and less than half the patients who start the yearlong treatment
      regimen achieve the ultimate goal of having an undetectable level of virus in
      their bodies," said John McHutchison, M.D., Lead Investigator for the PROVE 1
      trial and Associate Director of the Duke Clinical Research Institute. "In these
      Phase 2 clinical trials, up to 69 percent of patients in the 24-week
      telaprevir-based treatment arm had undetectable virus levels after 24 weeks, and
      even though telaprevir does produce side effects of its own, its addition to
      standard therapy allowed us to shorten the duration of treatment. This 24-week
      regimen was half the duration of currently approved therapies and, if confirmed
      to be this effective in larger Phase 3 studies, could one day become a very
      important treatment option for hepatitis C patients."

      "In the PROVE 1 and PROVE 2 trials, telaprevir significantly improved the
      proportion of patients who were cured of their disease and also shortened the
      duration of HCV therapy from 48 to 24 weeks for the majority of treatment-naïve
      patients - an exciting achievement and a potentially meaningful advance in the
      treatment of this disease," said Robert Kauffman, M.D., Ph.D., Senior Vice
      President of Clinical Development for Vertex. "Based on data from these trials,
      as well as from the PROVE 3 trial in patients who failed prior HCV therapy,
      telaprevir is being evaluated in a comprehensive Phase 3 registration program in
      more than 2,200 treatment-naïve and treatment-failure patients. Assuming
      successful completion of this program, we expect to file an application for
      approval of telaprevir with the U.S. FDA in the second half of 2010."
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