CONCISE (ChrONiC HepatitIS C and IL28B CC GenotypE) is a randomized, placebo-controlled, global, multi-center Phase 3b study designed to evaluate the efficacy of a 12-week regimen of INCIVEK™ (telaprevir) tablets in combination with pegylated-interferon and ribavirin in approximately 350 people with genotype 1 chronic hepatitis C who have the CC variation at the IL28B gene… All patients will receive INCIVEK in combination with pegylated-interferon and ribavirin for the first 12 weeks of treatment. After the first 12 weeks, patients who achieve a rapid viral response to treatment (measured as undetectable HCV RNA at week 4) will be randomized 2:1 to receive no further treatment or an additional 12 weeks of pegylated-interferon and ribavirin alone. Patients who do not achieve a rapid viral response will receive an additional 36 weeks of treatment with pegylated-interferon and ribavirin alone.
This trial will include both treatment-naïve and prior-relapse patients (but not prior non-responders). Incivek will be dosed BID (rather than TID), which will soon be the de facto standard for all patients who take Incivek.
Were you perhaps unduly skeptical of ABT’s HCV claims back in October? ABT does not have a habit of boasting unduly and we’re not talking about a small biotech company who needs to generate hype in order to raise capital on favorable terms. Regards, Dew