Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
6123112 | Journal of Infection | 2015 | 9 Pages |
â¢This phase 2 study enrolled treatment-naïve patients with HCV genotype 1, 2, or 3.â¢Treatment-naïve, non-cirrhotics received 12 weeks of ombitasvir and ABT-450/r ± RBV.â¢Ombitasvir and ABT-450/r ± RBV was well-tolerated with a low discontinuation rate.â¢The RBV-containing regimen showed in vivo activity in patients of each genotype.â¢The RBV-free regimen showed in vivo activity in patients with HCV genotype 1 or 2.
SummaryObjectivesTo examine the safety and efficacy of ombitasvir and ABT-450 with ritonavir (ABT-450/r) ± ribavirin (RBV) in treatment-naïve, non-cirrhotic adults with chronic HCV genotype 1-3 infection.MethodsPatients in this open-label, exploratory, phase 2, multicenter study received ombitasvir (25 mg QD) and ABT-450/r (200/100 mg QD) ± RBV for 12 weeks. Primary efficacy endpoint was HCV RNA < lower limit of quantitation (LLOQ) from week 4 through 12. Sustained virologic response 12 weeks post-treatment (SVR12) was a secondary endpoint.ResultsSixty-one patients were enrolled. Among genotype 1-, 2-, and 3-infected patients, respectively, HCV RNA was