24%, P = 0.001). Almost all (99%) experienced at least one AE, and 17.5% were hospitalized. Both TVR and BOC cohorts had high rates of treatment discontinuation (43.4% vs. 47.1%, P = 0.60). However, more patients treated with TVR adhered to the “80/80/80 rule” than those treated with BOC (56.4% vs. 26.7%, P Palbociclib in vitro < 0.001). Overall, SVR by intention-to-treat was low in both cohorts, especially the BOC cohort (Figure 1). On the multivariate logistic regression, adherence to the “80/80/80
rule” was a significant independent predictor for SVR12 or SVR24 following adjustment for cirrhosis, choice of DAA, baseline HCV RNA, prior treatment, and use of EPO (OR = 4.43, 95% CI: 2.8-6.06, P < 0.001). Conclusion: SVR was much lower in routine practice than in pivotal trials (53% for TVR and 40% for BOC vs. ∼70-75%). Disclosures: Marina Roytman - Advisory Committees or Review Panels: Selleckchem NVP-AUY922 Gilead; Speaking and Teaching: Gilead Ramsey Cheung – Grant/Research Support: Gilead Sciences Naoky Tsai – Advisory
Committees or Review Panels: Gilead, Vertex; Consulting: BMS, Gilead, Merck; Grant/Research Support: BMS, Gilead, Genentech, Vertex, Novartis, GSK, Bayer, Abbvie, Janssen, beckman; Speaking and Teaching: BMS, Gilead, Genentech, Vertex, Merck, Salix, Bayer, Janssen Mindie H. Nguyen – Advisory Committees or Review Panels: Bristol-Myers Squibb, Bayer AG, Gilead, Novartis, Onyx; Consulting: Gilead Sciences,
Inc.; Grant/Research Montelukast Sodium Support: Gilead Sciences, Inc., Bristol-Myers Squibb, Novartis Pharmaceuticals, Roche Pharma AG, Idenix, Hologic, ISIS The following people have nothing to disclose: Kevin P. Vo, Philip Vutien, Matthew J. Akiyama, Vinh D. Vu, Joy I. Piotrowski, Nghiem B. Ha, James M. Wan-tuck, Jiayi Li Introduction: In Australia, and many other countries, the standard treatment for HCV genotype 1 is triple therapy with Pegylated interferon-α-2a/2b, ribavirin (PR) and a first generation direct-acting antiviral (DAA), such as boceprevir (BOC). Uncertainty over the timing of regulatory approval and reimbursement for newer DAAs has led to increasing impetus to treat now to reduce disease progression, especially in advanced liver disease. Current BOC treatment experience data to date is mostly from the northern hemisphere. Thus, we aimed to evaluate the efficacy and safety of BOC based triple therapy in a large Australian cohort reflective of real-world clinical practice. Methods: A retrospective, observational analysis was conducted in 1026 patients enrolled in an early access program in 65 hepatitis treatment centres. Patients received a PR 4 week lead in followed by either response-guided or fixed-dose duration of BOC for 44 weeks according to standard guidelines. Demographic, clinical and virological data were entered into a central database.