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AbbVie's Investigational HCV Regimen Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration
Date:5/6/2013

. Leonard , M.D., senior vice president and chief scientific officer, AbbVie. "Our HCV program is one part of our advancing pipeline which is focused on delivering innovative therapies to address pressing areas of unmet clinical need."  

New results from Aviator were recently presented at the 2013 International Liver Congress® in Amsterdam. These results continued to demonstrate high SVR rates against GT1 HCV with the 12-week, triple-DAA regimen with ribavirin, across patient types. Specifically,

  • 99 percent of treatment-naive patients (n=79) achieved SVR12, 96 percent achieved SVR24 in an intent-to-treat analysis
  • 93 percent of prior null responders (n=45) achieved SVR12 and SVR24
  • A single relapse with this regimen occurred at post-treatment week two
  • Of the 247 patients treated for 12 and 24 weeks with triple DAA with ribavirin, four patients (1.6 percent) discontinued the study because of drug-related adverse events. Serious adverse events were noted in four patients (1.6 percent), with one (arthralgia) considered possibly drug-related. Other events reported in more than 10 percent of patients included headache, fatigue, nausea, insomnia, and diarrhea. Grade 3-4 laboratory abnormalities in total bilirubin (six patients) and ALT (one patient) were noted; all resolved with continued dosing.
  • AbbVie's all-oral, triple-DAA combination is currently being studied in Phase 3 clinical trials. The Phase 3 program includes more than 2,000 patients with HCV genotype 1, with trial sites in 29 countries. The DAAs in the studies include ABT-450/r (protease inhibitor and ritonavir), ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor). Treatment durations under investigation are 12 weeks in non-cirrhotic patients, and 12 or 24 weeks in cirrhotic patients. All patients will be followed for 48 weeks post-treatment. Co
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