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:
- Results from ADVANCE confirm that a significantly greater proportion of previously untreated patients with chronic genotype 1 HCV achieved sustained viral response (SVR) with both 12-week and 8-week telaprevir-based combination regimens (75% and 69%, respectively), compared to patients treated for 48 weeks with pegylated-interferon and ribavirin alone (44%).
- Results from ILLUMINATE confirm that a 24-week telaprevir-based treatment regimen is non-inferior to a 48-week telaprevir-based regimen in previously untreated patients with hepatitis C virus (HCV) who achieved undetectable HCV RNA as early as week 4 (known as rapid viral response, or RVR) and week 12 of treatment. Ninety-two percent of patients in the 24-week group and 88% of patients in the 48-week group achieved SVR.
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.