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Trials & Filings

Medivir Begins HCV Combo Trial

Combines protease inhibitor, polymerase inhibitor and NS5A replication inhibitor to test ribavirin-free regimen

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Medivir AB has begun a Phase IIa trial in patients infected with chronic genotype 1 hepatitis C to evaluate the efficacy, safety and tolerability of a 12-week combination therapy of simeprevir, TMC647055 and JNJ56914845, a NS5A replication complex inhibitor.

Approximately 40 patients will be enrolled in this open-label study to assess the efficacy, safety and tolerability of the combination regimen. The trial will evaluate genotype 1a and 1b HCV-infected patients who are either treatment-naïve or who have relapsed after prior treatment with interferon and ribavirin. Patients will receive 75 mg of simeprevir, 30 or 60 mg of JNJ56914845 and 450 mg of TMC647055 plus a low dose of ritonavir as a pharmacokinetic enhancer, each once daily for 12 weeks.

Simeprevir is an NS3/4A protease inhibitor jointly developed by Medivir and Janssen R&D Ireland for the treatment of chronic hepatitis C infection in combination with other antivirals in HCV genotype 1 & 4 infected patients with compensated liver disease, including cirrhosis.

TMC647055 is a potent non-nucleoside hepatitis C polymerase inhibitor with broad genotypic coverage. TMC647055 is in Phase II clinical development and is developed by Janssen R&D Ireland to treat chronic HCV infections. TMC647055 is being investigated in combination with other DAA agents in all oral interferon-free regimens.

JNJ56914845, is a potent NS5A replication complex inhibitor. Phase I and Phase II studies demonstrated that JNJ56914845 60 mg once daily is well tolerated and produces rapid, substantial decreases in HCV RNA in treatment-naïve CHC subjects when given alone as a single dose and for four weeks in combination with pegIFN and RBV.

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