O165 SIMEPREVIR PLUS SOFOSBUVIR WITH/WITHOUT RIBAVIRIN IN HCV GENOTYPE 1 PRIOR NULL-RESPONDER/TREATMENT-NAIVE PATIENTS (COSMOS STUDY): PRIMARY ENDPOINT (SVR12) RESULTS IN PATIENTS WITH METAVIR F3–4 (COHORT 2)

treatment, discontinued therapy due to an AE. No AE leading to discontinuation occurred in >1 patient. Hemoglobin <10g/dL occurred in 8% of patients taking SOF/LDV+RBV and no patients taking SOF/LDV. No other significant laboratory abnormalities were observed. Conclusions: A single tablet regimen of sofosbuvir/ledipasvir administered once daily for 12 weeks is highly effective and well tolerated in treatment-naive, genotype 1, HCV-infected patients, including those with cirrhosis. The addition of RBV did not enhance the SVR rate.