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AbbVie's next-generation pan-genotypic HCV regimen shows cure rates as high as 99% after eight weeks

Published 11/11/2016, 10:13 AM
AbbVie's next-generation pan-genotypic HCV regimen shows cure rates as high as 99% after eight weeks
ABBV
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  • Top-line data from three pivotal studies released by AbbVie (ABBV -1%) today on its pan-genotypic HCV regimen of glecaprevir/pibrentasvir (G/P) showed cure rates of 95 - 99% after eight weeks of therapy. Complete results will be presented at The Liver Meeting in Boston, November 11 - 15.
  • In ENDURANCE-1, the cure rate (SVR12) was 99% (n=348/351) in HCV genotype 1 patients without cirrhosis who were new to treatment or did not respond to previous treatment with peginterferon or sofosbuvir with or without ribavirin. The patient population included patients co-infected with HIV-1.
  • ENDURANCE-3 showed a cure rate of 95% (n=149/157) in treatment-naive HCV genotype 3 patients without cirrhosis.
  • SURVEYOR-2 showed a cure rate of 97% (n=196/203) in HCV genotype 2,4,5 and 6 patients without cirrhosis who were new to treatment or were not cured with previous interferon-based treatments (peginterferon, sofosbuvir with ribavirin, sofosbuvir with peginterferon).
  • The company plans to file its regulatory application in the U.S. this quarter and in Europe and Japan in Q1.
  • 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.

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