Additional endpoints included rates of rapid virologic response (RVR; HCV RNA <25 IU/mL
at week 4), end-of-treatment response (EOTR; HCV RNA <25 IU/mL at week 12), and SVR at 4 and 24 weeks after end of treatment (SVR4 and SVR24). Safety and tolerability were assessed throughout the study. Results: 44 TN patients received ombitasvir and ABT-450/r, and 42 TN and 49 TE patients received ombitasvir Small molecule library and ABT-450/r with RBV. The majority of patients were white (89%) and male (65%). Most patients (93%) had F0-F2 stage fibrosis. All TN and TE patients who received ombitasvir and ABT-450/r with RBV achieved SVR12 (Figure). Three TN patients who received ombitasvir and ABT-450/r (without RBV) had virologic failure; 1 had rebound at Decitabine research buy treatment week 8, and 2 patients had post-treatment relapse before posttreatment week 12. Common treatment-emergent adverse events (AEs; >15% in any group) were headache (27-33%), asthenia (24-33%), fatigue (7-18%), and nausea (9-17%). Most were mild in severity. One patient experienced a serious
AE (contusion due to traffic accident) and 1 patient had a grade 3 liver function test elevation (AST >5× ULN). The AST elevation was asymptomatic and resolved during continued dosing. No patients in any group interrupted or discontinued the study due to AEs. Conclusion: Interferon-free regimens of ombitasvir and ABT-450/r with/ without RBV achieved high rates of RVR, EOTR, and SVR, and were generally well tolerated in TN and TE patients with HCV GT4 infection. Disclosure/Acknowledgements: Oxalosuccinic acid The authors and AbbVie
scientists designed the study, and analyzed and interpreted the data. All authors contributed to the development of the content; all authors and AbbVie reviewed and approved the presentation; the authors maintained control over the final content. Medical writing support was provided by Mariana Ovnic, PhD, of Complete Publication Solutions, LLC, Horsham, PA. AbbVie funded the research and medical writing support. Disclosures: Stanislas Pol – Board Membership: Sanofi, Bristol-Myers-Squibb, Boehringer Ingel-heim, Tibotec Janssen Cilag, Gilead, Glaxo Smith Kline, Roche, MSD, Novartis; Grant/Research Support: Glaxo Smith Kline, Gilead, Roche, MSD; Speaking and Teaching: Sanofi, Bristol-Myers-Squibb, Boehringer Ingelheim, Tibotec Janssen Cilag, Gilead, Glaxo Smith Kline, Roche, MSD, Novartis K.