Exploratory trial of ombitasvir and ABT-450/r with or without ribavirin for HCV genotype 1, 2, and 3 infection

- This phase 2 study enrolled treatment-naïve patients with HCV genotype 1, 2, or 3.
- Treatment-naïve, non-cirrhotics received 12 weeks of ombitasvir and ABT-450/r ± RBV.
- Ombitasvir and ABT-450/r ± RBV was well-tolerated with a low discontinuation rate.
- The RBV-containing regimen showed in vivo activity in patients of each genotype.
- 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