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Collaborations & Alliances, Trials & Filings

Idenix Begins HCV Trial

Continues collaboration with Janssen

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Idenix Pharmaceuticals has begun patient enrollment in a Phase II trial evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of samatasvir (Idenix’s once-daily pan-genotypic NS5A inhibitor), simeprevir (a once-daily NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB), and TMC647055 (a once-daily NS5B non-nucleoside polymerase inhibitor boosted with low-dose ritonavir developed by Janssen).

The trial is a 12-week, randomized, open-label study evaluating the efficacy, safety and tolerability of samatasvir, simeprevir, and TMC647055. The trial will evaluate genotype 1 HCV-infected patients who are either treatment-naïve or who have relapsed after prior treatment with interferon and ribavirin. Patients will receive 50 mg samatasvir, 75 mg of simeprevir and 450 mg of TMC647055/ritonavir (30 mg), each once daily for 12 weeks, with or without ribavirin.

The trial is the second study in HCV-infected patients to commence under a non-exclusive collaboration agreement signed with Janssen in January 2013. The previous trial of samatasvir in combination with simeprevir was initiated in May 2013 and is ongoing.

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