Alternate HCV Combination Therapy in Phase 4 Study
December 12, 2006
Valeant Pharmaceuticals International (NYSE:VRX) today announced its plans to initiate a phase 4 study of Infergen(R) (Consensus Interferon), which is in development for daily use in combination with ribavirin in the treatment of hepatitis C in patients who were non-responsive to previous pegylated interferon and ribavirin therapy. The study will evaluate the use of Infergen 15 ug/day plus ribavirin (1.0-1.2 g/day) in patients who did not have an optimal response at week 12 of treatment with pegylated interferon and ribavirin.
“Approximately 50 percent of patients do not respond to initial pegylated interferon and ribavirin therapy. Week 12 has been shown to be a pivotal time point in determining the likelihood of responding to therapy. Patients who still have detectable virus at week 12 have less chance of sustaining an SVR than those who are undetectable at week 12. These patients are in need of a new treatment regimen to improve their chance at achieving a sustained response,” commented Mitchell L. Shiffman, the study’s principal investigator and Chief of Hepatology at Virginia Commonwealth University Medical Center.
The multi-center, randomized U.S. study will enroll patients who received initial treatment with pegylated interferon and ribavirin and achieve a greater than 2log10 decline in HCV RNA at week 12 but still have detectable virus. The patients will be immediately randomized to receive Infergen 15 ug/day plus ribavirin (1.0-1.2 g/day) for 36 or 48 weeks or continue on their pegylated interferon and ribavirin regimen for an additional 36 weeks of therapy. All treatment groups will have a 24 week follow up period to measure sustained virologic response.
“Based on interim results from the DIRECT trial, a shorter washout period from previous pegylated interferon and ribavirin therapy and the degree of fibrosis, may affect response to daily Infergen and ribavirin. This study is the next step in the development of Infergen in patients who exhibit a poor response to initial treatment with pegylated interferon and ribavirin,” said Wesley P. Wheeler, Valeant’s President of North America and Global Product Development.
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