Vertex Pharmaceuticals announced that the FDA has approved Incivek (telaprevir) tablets for the treatment of patients with genotype 1 chronic hepatitis C with compensated liver disease. Incivek is indicated for use in treatment-naïve patients and for previously treated patients who did not achieve a viral cure (relapsers, partial responders and null responders). The approval of Incivek was based on data from three Phase 3 studies, which showed that patients who received Incivek, in combination with pegylated-interferon and ribavirin, achieved significantly higher rates of sustained viral response compared with those who received pegylated-interferon and ribavirin alone, regardless of their prior treatment experience. Sustained viral response was observed in 79% of treatment-naïve patients, 86% of relapsers, 59% of partial responders, and 32% of null responders compared with 46%, 22% 15%, and 5%, respectively, of patients who received pegylated-interferon and ribavirin alone.

Incivek will be available this week in a 375mg dosage strength tablet.

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