Treatment with Telaprevir/PEG-IFN/RBV after 14-day Telaprevir exposure in phase I studies: Results from the phase IIIB C219 rollover study

Background and aims: C219 (NCT01054573) was an open-label, single-arm, rollover study that examined telaprevir (TVR)-based therapy in patients infected with chronic genotype 1 HCV who failed to achieve a sustained virologic response (SVR) following peginterferon/ribavirin (PR) alone in the REALIZE study, or with ≥1 dose of TVR (alone or in combination with PR) in Phase I studies (101 and 103). Here we present the primary endpoint, SVR24actual, for patients who had prior exposure to TVR only from the Phase I studies. Methods: In studies 101/103, all patients received 14 days TVR monotherapy. TVR-resistant variant…