Interferon-Free Therapy Demonstrates Efficacy in GT1 HCV Infection Trials

Interferon-Free Therapy Demonstrates Efficacy in GT1 HCV Infection Trials
Interferon-Free Therapy Demonstrates Efficacy in GT1 HCV Infection Trials

AbbVie announced results for four studies from its Phase 3 clinical program designed to assess the investigational oral, interferon-free therapy with or without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The investigational regimen consists a fixed-dose combination of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333 with or without ribavirin.

RELATED: Infectious Disease Resource Center

The results were as follows:

PEARL-II Study (12 weeks):

  • GT1b treatment-experienced patients (N=179) randomized to the AbbVie regimen + RBV (n=88) achieved a SVR12 of 97% (85/88)
  • GT1b treatment-experienced patients (N=179) randomized to the AbbVie regimen only (n=91) achieved a SVR12 of 100% (91/91)

PEARL-III Study (12 weeks):

  • GT1b treatment-naive patients (N=419) randomized to the AbbVie regimen + RBV (n=210) achieved a SVR12 of 99% (209/210) 
  • GT1b treatment-naive patients (N=419) randomized to the AbbVie regimen only (n=209) achieved a SVR12 of 99% (207/209)

PEARL-IV Study (12 weeks):

  • GT1a treatment-naive patients (N=305) randomized to the AbbVie regimen + RBV (n=100) achieved a SVR12 of 97% (97/100) 
  • GT1a treatment-naive patients (N=305) randomized to the AbbVie regimen only (n=205) achieved a SVR12 of 90% (185/205)

TURQUOISE-II Study (12 & 24 weeks):

  • GT1b treatment-naive and treatment-experienced with compensated cirrhosis patients (N=380) randomized to the AbbVie regimen + RBV (n=208) for 12 weeks achieved a SVR12 of 92% (191/208) 
  • GT1b treatment-naive treatment-experienced with compensated cirrhosis patients (N=380) randomized to the AbbVie regimen + RBV (n=172) for 24 weeks achieved a SVR12 of 96% (165/172)

SAPPHIRE-I Study (12 weeks):

  • GT1 treatment-naive patients (N=631) randomized to the AbbVie regimen + RBV (n=473) achieved a SVR12 of 96% (455/473) SAPPHIRE-11 Study (12 weeks):
  • GT1 treatment-experienced patients (N=394) randomized to the AbbVie regimen + RBV (n=297) achieved a SVR12 of 96% (286/297)

Previously in May 2013, AbbVie's regimen with and without ribavirin for HCV GT1 was designated as a Breakthrough Therapy by the FDA.

For more information call (800) 255-5162 or visit AbbVie.com.

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