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."
Date: April 29, 2009
Source: New England Journal of Medicine
