- The objectives of the 12-week, Phase 2 study were to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-450/r 150/100 mg QD and ABT-072 400 mg QD + ribavirin administered for 12 weeks.
- The study was conducted in 11 treatment-naive adults with host IL28B "CC" genotype from multiple ethnic backgrounds with non-cirrhotic HCV GT1 (8 GT 1a, 3 GT 1b). Ribavirin dose was weight-based (1,000-1,200 mg/day) and dosed twice daily.
- The primary endpoint was percentage of patients with HCV RNA <25 IU/mL from week 4 through 12. Other trial endpoints include early virologic response, RVR and SVR through 24 weeks.
- 100 percent of patients maintained HCV RNA levels <25 IU/mL from weeks 4 through 12 of treatment, and all had undetectable HCV RNA from week 5 to the end of treatment.
- 91 percent of patients (10 of 11) achieved SVR24.
- One relapse was observed 8 weeks post therapy and a second 36 weeks post therapy; overall, 82 percent of patients (9 of 11) achieved SVR36.
- No additional relapses were seen among the 10 patients with 48-week post-treatment data available / where SVR48 results were available.
- In the trial, the most common adverse events were headache (36%), fatigue (27%), nausea (27%) and dry skin (27%). Most adverse events were mild in severity and there were no discontinuations due to adverse events.
- Two bilirubin elevations, which consisted of indirect bilirubin with no associated transaminase elevations (i.e. no indication of liver damage), were reported during the study. The bilirubin elevations occurred one week after starting treatment and resolved with continued dosing.
Abbott Presents Positive Results From Phase 2 "Pilot" Study Of An Interferon-Free Combination Regimen For The Treatment Of Hepatitis C
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