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
http://www.dddmag.com/news-Two-New-Studies-Promote-Telaprevir-as-Hepatitis-C-Tre\
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atment-051809.aspx
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."