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AbbVie's pan-genotypic regimen of glecaprevir/pibrentasvir shows 98% cure rate in late-stage study in HCV-positive patients with chronic kidney disease

Published 11/15/2016, 09:17 AM
AbbVie's pan-genotypic regimen of glecaprevir/pibrentasvir shows 98% cure rate in late-stage study in HCV-positive patients with chronic kidney disease
ABBV
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  • Results from a Phase 3 clinical trial, EXPEDITION-4, assessing AbbVie's (NYSE:ABBV) investigational pan-genotypic HCV regimen of glecaprevir/pibrentasvir (G/P) in patients with severe chronic kidney disease (CKD) chronically infected with the hepatitis C virus (HCV) showed a cure rate of 98%. The data will be presented today at The Liver Meeting in Boston.
  • EXPEDITION-4 enrolled 104 subjects including 85 who were receiving dialysis at enrollment, 20 with compensated cirrhosis and 44 who were not cured with sofosbuvir with ribavirin or interferon with ribavirin, with or without sofosbuvir.
  • The study showed treatment with G/P delivered a 98% (n=102/104) cure rate (SVR12) following 12 weeks of treatment. In a modified intent-to-treat analysis (excluding subjects who did not achieve SVR for reasons other than virologic failure), the cure rate was 100% (n=102/102).
  • HCV is common in CKD patients, with a prevalence of up to 80% in some regions of the world. As many as 500K Americans have both chronic HCV and CKD.
  • G/P is a once-daily fixed-dose combination of 300 mg of glecaprevir, an NS3/4A protease inhibitor and 120 mg of pibrentasvir, an NS5A inhibitor. Its development is ongoing.

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