Biotech Values

[DewDiligence]

VRTX starts HCV trial to test a 12-week duration for all therapy in genotype-1 patients with ‘CC’ variant of IL28B biomarker:

http://finance.yahoo.com/news/Vertex-Starts-Global-Phase-3b-bw-3041214939.html?x=0&.v=1

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.