Femme et Homme
- | Pays : -
- | Organes : -
- | Spécialités : -
Extrait
● To show the non-inferiority of the SVR12 rates among mono-infected HCV GT1 DAA-naïve subjects (the percentage of subjects achieving a 12-week sustained virologic response, SVR12, [HCV RNA < LLOQ 12 weeks following therapy]) of 12 weeks of treatment with the combination regimen ABT 493/ABT-530 to the historical SVR rate established by current approved standard of care regimens for mono-infected HCV GT1 DAA-naïve subjects (ombitasvir/paritaprevir/ritonavir + dasabuvir ± RBV or SOF/LDV for 12 weeks); ● To show the non-inferiority in SVR12 rates among mono-infected HCV GT1 DAA-naïve subjects of the ABT-493/ABT-530 regimen for 8 weeks versus 12 weeks of treatment; and ● To assess the safety of 8 and 12 weeks of treatment with the combination regimen ABT-493/ABT-530.
Critère d'inclusion
- HCV Genotype 1 and HCV Genotype 1/HIV-1 co-infected subjects