Positive phase 3 for AbbVie’s hepatitis C regimen

AbbVie has presented positive phase three clinical trial results for its investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients chronically infected with genotype 1 (GT1) hepatitis C virus (HCV).

Over 630 patients took part in the trial, which was called SAPPHIRE-I. Results show that 96% of patients new to therapy who received 12 weeks of AbbVie's 3D regimen achieved a sustained virologic response at 12 weeks post-treatment.

"SAPPHIRE-I demonstrates that patients new to therapy with genotype 1 HCV achieved high rates of virologic response with AbbVie's interferon-free, all-oral 3D regimen plus ribavirin, and the SVR rate is consistent with results from our phase II studies. SAPPHIRE-I is the first of these studies to report results, and based on the progress of our clinical program to date, we are on track for major regulatory submissions in the second quarter of 2014."

Scott Brun, M.D., vice president, pharmaceutical development, AbbVie.

SAPPHIRE-I is the first of six phase three clinical trials supporting AbbVie's investigational 3D regimen for the treatment of GT1 hepatitis C patients. More than 2,300 GT1 patients in over 25 countries around the world are involved in AbbVie's clinical program supporting its 3D regimen. The aim of the AbbVie HCV clinical development program is to advance scientific knowledge and clinical care to as many patients as possible.

AbbVie has said it will disclose detailed SAPPHIRE-I results at future scientific congresses and in publications.