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Trials & Filings

AbbVie Regimen Wallops Hep C

Sustained virologic response in 96% of patients

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

AbbVie has posted Phase III results for the investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients with chronic, genotype 1 (GT1) hepatitis C virus (HCV) infection. In the 394-patient study, 96% of patients who previously failed pegylated interferon and ribavirin treatment, including approximately 49% who were prior null responders, achieved sustained virologic response at 12 weeks (SVR12) with the regimen. The majority of patients were GT1a, considered a difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 96% and 97%, respectively. Virologic relapse or breakthrough was noted in 2% of patients receiving the 3D regimen plus ribavirin. The discontinuation rate due to adverse events was 1%.

This was the second placebo-controlled trial and the second of six Phase III trials supporting AbbVie’s investigational 3D regimen for the treatment of GT1 hepatitis C patients. AbbVie will disclose detailed results from the trial at future scientific congresses and in publications.

The trial was a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with ABT-333 (250mg), ribavirin (weight-based), both dosed twice daily, and the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg) and dosed once daily in non-cirrhotic, GT1a and GT1b HCV-infected, treatment-experienced adult patients who previously failed treatment with pegylated interferon and ribavirin.

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