AbbVie initiates Phase 3 studies for pan-genotypic HCV regimen
Posted: 11 January 2016 | | No comments yet
AbbVie’s investigational HCV regimen, combining ABT-493 and ABT-530, will be evaluated in patients with genotypes 1-6 chronic HCV infection…
AbbVie has announced the initiation of six global Phase 3 clinical studies evaluating the safety and efficacy of its 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 AbbVie’s Phase 3 HCV pipeline programme and will recruit approximately 1,600 patients globally. 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 AbbVie’s investigational HCV 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 AbbVie’s investigational HCV regimen versus placebo in GT2 chronic HCV infected patients. ENDURANCE-3 compares AbbVie’s investigational regimen with sofosbuvir/daclatasvir in treatment-naïve patients with GT3 chronic HCV infection. ENDURANCE-4 evaluates GT4-6 chronic HCV infected patients.
Meeting the needs of a broader range of patients with HCV infection
The EXPEDITION trials evaluate AbbVie’s investigational regimen for 12 weeks in difficult to treat patient populations with chronic HCV infection. EXPEDITION-1 evaluates AbbVie’s investigational HCV 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.
Commenting on the announcement, Michael Severino, M. D., executive vice president, research and development and chief scientific officer, AbbVie, said, “We believe AbbVie’s work in hepatitis C has contributed to the transformation of HCV care over the last few years. Our journey continues with the initiation of these Phase 3 studies, which we hope will help us meet the needs of an even broader range of patients living with hepatitis C.”