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AbbVie Demonstrates 96 percent SVR(12) in its Phase III Study of Treatment-Experienced Patients with Genotype 1 Hepatitis C
Date:12/10/2013

he 3D and placebo arms were headache, fatigue and nausea. Discontinuations due to adverse events were reported in three (1 percent) patients receiving the 3D regimen and no patients receiving placebo. Virologic relapse or breakthrough was noted in 2 percent of patients receiving the 3D regimen plus ribavirin.Additional information about AbbVie's phase III studies can be found on www.clinicaltrials.gov.

AbbVie's HCV Development ProgramThe clinical program supporting our 3D regimen includes more than 2,300 GT1 patients in more than 25 countries around the world. The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral 3D regimen with or without ribavirin with the goal of producing high SVR rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis. Results from the remaining four studies in AbbVie's phase III program will be available in the coming months, supporting regulatory submissions starting in the second quarter of 2014.

Overview of AbbVie's phase III clinical program is as follows:StudyPatients (N)Treatment RegimenTreatment DurationSAPPHIRE-I

GT1, treatment-naive

(631)

  • ABT-450/rb +ABT-267c
  • ABT-333
  • Ribavirin
  • 12 weeks

  • Placebo
  • 12 weeks, then active treatment for 12 weeksSAPPHIRE-II

    GT1, treatment-experienced

    (394)

  • ABT-450/r +ABT-267
  • ABT-333
  • Ribavirin
  • 12 weeks

  • Placebo
  • 12 weeks, then active treatment for 12 weeksPEARL-II

    GT1b, treatment-experienced

    (210 a)

  • ABT-450/r +ABT-267
  • ABT-333
  • Ribavirin
  • 12 weeks

  • ABT-450/r +ABT-267 '/>"/>

  • SOURCE AbbVie Inc.
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