AbbVie announced the initiation of six global Phase 3 clinical studies evaluating the safety and efficacy of its all-oral, once-daily, ribavirin-free investigational hepatitis C virus (HCV) regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, in patients with genotypes 1-6 (GT1-6) chronic HCV infection. The ENDURANCE and EXPEDITION studies are part of the company's Phase 3 HCV pipeline program and will recruit approximately 1,600 patients globally, from over 250 study sites and in 27 countries. The primary efficacy endpoint of all six studies is rate of sustained virologic response at 12 weeks post-treatment (SVR12).

The four ENDURANCE studies evaluate the company's investigational regimen in patients without cirrhosis for up to 12 weeks. ENDURANCE-1 compares SVR in GT1 chronic HCV infected patients who received ABT-493/ABT-530 treatment durations of 12 weeks and as short as eight weeks. ENDURANCE-2 evaluates the company's investigational regimen versus placebo in GT2 chronic HCV infected patients.

ENDURANCE-3 compares the company's investigational regimen with sofosbuvir/daclatasvir in treatment-na ve patients with GT3 chronic HCV infection. ENDURANCE-4 evaluates GT4-6 chronic HCV infected patients. The EXPEDITION trials evaluate the company's investigational regimen for 12 weeks in difficult to treat patient populations with chronic HCV infection.

EXPEDITION-1 evaluates the company's investigational regimen in GT1, 2, 4-6 chronic HCV infected patients with compensated cirrhosis (Child-Pugh A). EXPEDITION-4 evaluates GT1-6 chronic HCV infected patients with severe renal impairment and end-stage renal disease, with or without compensated cirrhosis.