The NDA included data from eight registrational studies as part of the glecaparevir/pibrentasvir clinical development program (n>2,300) in 27 countries across major HCV genotypes and special populations. Study patients included those with HCV genotypes (GT) 1–6, those who were treatment-naive and treatment-experienced, those with compensated cirrhosis and without cirrhosis, and patients with limited treatment options, including those with severe chronic kidney disease (CKD).
Data from Phase 3 studies showed that treatment with glecaprevir/pibrentasvir for 8 weeks led to high sustained virologic response (SVR) rates across all major genotypes GT1–6 in 97.5% of patients without cirrhosis; for patients with cirrhosis, high SVR rates were seen after 12 weeks of therapy. A primary intent-to-treat (ITT) analysis found that 98% of patients with severe CKD also achieved high SVR rates; a modified ITT analysis found that 100% of patients achieved SVR12. Difficult-to-treat populations—including those not cured with prior direct-acting antiviral (DAA) regimens—achieved high SVR rates as soon as 12 weeks.
The most commonly reported adverse events for HCV GT1–6 treatment-naive patients without cirrhosis were headache and fatigue.
Glecaprevir/pibrentasvir combines glecaprevir 300mg, an NS3/4A protease inhibitor, and pibrentasvir 120mg, an NS5A inhibitor. This investigational once-daily regimen was granted Breakthrough Therapy Designation by the Food and Drug Administration (FDA) in September 2016 for the treatment of patients with HCV who were not cured with prior DAA therapy in GT1, including therapy with an NS5A inhibitor and/or protease inhibitor.