Medivir AB: HELIX-2, A Phase II All-Oral Combination Study Of Simeprevir, TMC647055 And Samatasvir (IDX719) For The Treatment Of Hepatitis C Has Been Initiated

Published: Dec 02, 2013

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STOCKHOLM--(BUSINESS WIRE)--Regulatory News:

Medivir AB (OMX: MVIR)(STO:MVIR-B), announces that IDENIX has initiated a phase II clinical trial (HELIX-2) evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of simeprevir, samatasvir and TMC647055 with a pharmacokinetic enhancer.

The HELIX-2 trial is a 12-week, randomized, open-label study evaluating the efficacy, safety and tolerability of simeprevir, TMC647055 and samatasvir. 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 75 mg of simeprevir, 50 mg samatasvir and 450 mg of TMC647055 plus a low dose of ritonavir as a pharmacokinetic enhancer, each once daily for 12 weeks, with or without the addition of ribavirin.

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