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Enanta Announces Positive Phase 2 Results From Interferon-Free Combination Studies with ABT-450 for Hepatitis C Treatment to be Presented at EASL
Date:4/4/2012

30 CET / 9:30-11:30 am EDT.
12-Week Interferon-Free Regimen of ABT-450/r+ABT-333+Ribavirin Achieved SVR12 in More Than 90% of Treatment-Naive HCV Genotype-1-Infected Subjects and 47% of Previous Non-Responders

  • The objectives of this phase 2 study were to assess safety and tolerability 12-week interferon-free regimens in HCV GT1 patients who were either treatment naive or previous non-responders. The trial had three arms with three primary end points – rapid virological response (RVR) at week 4 and SVR at weeks 4 and 12.
  • Enrollment was open to GT1-infected patients regardless of IL28B host genotype and ribavirin dosing was weight-based.
  • 95 percent (18 of 19) of treatment-naive patients infected with HCV GT1
    (17 GT 1a, 2 GT 1b) achieved SVR12 with ABT 450/r 250/100 mg dosed once daily (QD) + ABT-333 400 mg dosed twice daily (BID) + ribavirin (Arm 1).  
  • 93 percent (13 of 14) of treatment- naive patients infected with HCV GT1
    (11 GT 1a, 3 GT1b) achieved SVR12 with ABT 450/r 150/100 mg QD + ABT-333 400 mg BID + ribavirin (Arm 2).  
  • 47 percent (8 of 17) of patients with HCV GT1 (16 GT1a, 1 GT1b) who had previously not responded to other HCV treatments achieved SVR12 with ABT 450/r  150/100 mg QD + ABT-333 400 mg BID + ribavirin (Arm 3).
  • One patient in Arm 1 discontinued due to asymptomatic isolated ALT/AST elevations at week 2. One patient in Arm 2 discontinued due to noncompliance in week 1. All remaining patients in Arms 1 and 2 completed treatment and achieved SVR12. In Arm 3, six patients experienced viral breakthrough while on treatment and three patients relapsed after treatment stopped.
  • In the trial the most common adverse events were fatigue (42 percent), nausea (22 percent) and headache (20 percent).

Abbott is developing ABT-450 with low dose ritonavir (ABT-450/r) which enh
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SOURCE Enanta Pharmaceuticals, Inc.
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