ABT-450: Phase II data

The open-label, international Phase II PEARL-I (M13-393) trial in 82 patients with HCV genotype 1b infection showed that 100% of 39 evaluable treatment-naïve patients and 87.9% of 33 evaluable null responders who received ABT-450 plus ritonavir and ABT-267 for 12 weeks achieved an SVR, defined as HCV RNA levels <25 IU/mL, 4 weeks after the end of treatment. The combination was generally well tolerated with headache, nausea, dry skin, fatigue, pruritus and diarrhea reported as the most common adverse events. One patient had grade 3 elevated alanine aminotransferase (ALT) levels and 2 patients had grade 3 elevated aspartate aminotransferase (AST) levels. The trial is enrolling 320 patients with HCV genotypes 1b or 4 infection. Patients received a once-daily regimen of 150 mg ABT-450 plus 100 mg ritonavir and 25 mg ABT-267. SVR12 data will be presented at the American Association for the Study of Liver Diseases meeting in Washington D.C. in November. ...