Tibotec HCV drug gets EC nod

The earlier studies, which included previously untreated genotype-1 chronic HCV patients and the patients who failed previous treatment, showed improvements in cure rates when treated with telaprevir in combination with peginterferon alfa and ribavirin as compared to standard treatment with peginterferon alfa and ribavirin alone.

The EC’s decision was based on results of three Phase 3 studies, Advance, Realize and Illuminate.1,2,3 Advance and Realize which investigated the efficacy and safety of telaprevir in combination with peginterferon alfa and ribavirin compared with the previous standard treatment (peginterferon alfa and ribavirin alone).

The results of the trials demonstrated that treatment with a telaprevir based regimen increased cure rates for genotype-1 chronic HCV compared to the previous standard treatment in previously untreated patients and patients who relapsed during previous treatment.