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Data from two pivotal Phase 3 studies examining telaprevir is to be presented at the upcoming 61st annual Liver Meeting hosted by the American Association for the Study of Liver Diseases (AASLD), October 29 to November 2 in Boston, MA.
The studies, ADVANCE and ILLUMINATE, examine the efficacy, safety and tolerability of telaprevir in treatment-naïve people living with hepatitis C virus (HCV). ADVANCE evaluated the potential for 24-week duration of therapy, whereas ILLUMINATE determined whether or not a 24-week telaprevir-based treatment regimen is non-inferior to a 48-week telaprevir-based regimen, both in previously untreated patients. Below is a snapshot of the top-line results:
Tibotec is co-developing telaprevir with Vertex Pharmaceuticals and will have the right to commercialize telaprevir in Europe, Latin America (except Mexico), the Middle East, Africa, India, Australia and New Zealand. Recent analyst reports from Piper Jaffray state that experts are “impressed by the drug’s overall efficacy,” with Phase 3 study data showing that telaprevir remains “safe and well tolerated” in trial patients.