New Findings for Novel Pan-Genotypic HCV Regimen in Phase 3 Study
The primary endpoint was the percentage of patients achieving sustained virologic response at 12 weeks post-treatment
AbbVie announced new findings from the EXPEDITION-1 study, a Phase 3 trial evaluating the efficacy and safety of glecaprevir/pibrentasvir (G/P) for the treatment of chronic hepatitis C virus (HCV) infection in patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A). Data will be presented at The International Liver Congress (ILC) 2017 in Amsterdam, The Netherlands.
EXPEDITION-1 is a single-arm, multicenter, open-label trial of 12 weeks treatment with G/P, without ribavirin, in 146 treatment-naïve and treatment-experienced adults with GT1, 2, 4, 5 or 6 chronic HCV infection and compensated cirrhosis. Patients with specific virus strains associated with resistance or with a high quantity of viral load at baseline were not excluded from the study. The primary endpoint was the percentage of patients achieving sustained virologic response at 12 weeks post-treatment (SVR12).
New findings from EXPEDITION-1 showed that 99% of HCV infected patients with GT 1, 2, 4, 5 or 6 and compensated cirrhosis achieved SVR12 after 12 weeks of G/P treatment. Only one patient with a GT1a infection experienced relapse. These high SVR12 rates were observed with G/P treatment without ribavirin. Additionally, G/P was found to be well-tolerated, with mild adverse events (AEs) and no drug-related discontinuations. Fatigue and headache were the most common AEs and no patients experienced ALT elevations ≥Grade 3.
Additional study data in specific populations with treatment challenges, including patients with chronic kidney disease, HIV-1 co-infection, post liver and renal transplant patients and in patients who did not achieve SVR12 with previous direct-acting antiviral (DAA) treatment, will also be presented.
G/P is an investigational, fixed-dose (300/120mg), once-daily, pan-genotypic regimen consisting of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, NS5A inhibitor. The FDA has recently granted Priority Review to its NDA in February 2017.
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