Adverse event (AE) and clinical laboratory assessment occurred at study visits during treatment and follow-up for all patients who received selleck screening library at least one dose of study drug. Results: In PEARL II, PEARL III, and PEARL IV, respectively, 186, 419, and 305 patients were randomized and received at least one dose of study drug. Collectively, 401 patients received 3D+RBV and 509 received 3D. Treatment-emergent AEs and laboratory values of note are in the Table. In both the 3D+RBV and 3D groups, the majority of AEs were mild. AEs occurring in >20% of

patients in both the 3D+RBV and 3D groups were fatigue (29.9% and 26.5%) and headache (24.4% and 25.3%). RBV dose modifications were made following an AE in 8.5% of patients MI-503 mouse receiving 3D+RBV, all of whom achieved SVR12. The rate of discontinuation due to AEs was 0.5% or less among patients treated with 3D+RBV or 3D. Conclusions: In the PEARL II, PEARL III, and PEARL IV trials, 3D was well tolerated either with or without RBV. Comparable low rates of discontinuation were observed in patients receiving 3D and 3D+RBV. Clinically significant hemoglobin reductions

and bilirubin elevations were infrequent and not treatment-limiting. *This patient received 3D with placebo. ULN=upper limit of normal Disclosures: Yan Luo – Employment: AbbVie; Stock Shareholder: AbbVie Richard J. Aspinall – Advisory Committees or Review Panels: Janssen Cilag, Norgine UK, Falk Pharma UK Giovanni B. Gaeta – Speaking and Teaching: BMS, Gilead, Roche, MSD, Jans-sen, Merck, Boheringer Ing Selim Gurel – Speaking Tyrosine-protein kinase BLK and Teaching: Glead, BMS, Roche, MSD, Glead, BMS, Roche,

MSD, Janssen Yiran Hu – Employment: AbbVie Inc. Jeffrey Enejosa – Employment: AbbVie; Stock Shareholder: AbbVie Daniel E. Cohen – Employment: AbbVie; Stock Shareholder: AbbVie Nancy Shulman – Employment: Abbvie Velimir A. Luketic – Grant/Research Support: Intercept, Merck, Idenix, Vertex, Gilead, BMS, Novartis, abbvie, Genfit, Takeda The following people have nothing to disclose: Jacob P. Lalezari, Ronald Pruitt, Iwona Olszok, William King Purpose: Patients with cirrhosis are at risk for declines in hepatic synthetic function over time. Antiviral therapy may lead to fibrosis regression and hepatic synthetic function improvement if a sustained virologic response (SVR) is attained. ABT-450 is an HCV NS3/4A protease inhibitor (dosed with ritonavir, ABT-450/r) identified by AbbVie and Enanta. Ombitasvir (ABT-333) is an NS5A inhibitor; dasabuvir (ABT-267) is an NS5B RNA polymerase inhibitor. The phase 3 TURQUOISE-II trial examined efficacy and safety of all-oral regimens of co-formulated ABT-450/r/ombitasvir+dasabuvir with ribavirin (3D+RBV) in treatment-naïve and treatment-experienced patients with HCV genotype 1 infection and compensated (Child-Pugh A) cirrhosis.