Hepatitis C Therapy in Community Practice (OPTIMAL): An Educational Partnership Program between Academic and Community Practices: 408

Purpose: Hepatology Centers of Educational Expertise (HCEE) are a network of academic centers dedicated to educating health professionals about management of chronic liver disease. These sites have experienced clinicians who participated in clinical trials with the first hepatitis C direct acting antiviral (DAA) therapies approved in 2011. Historically, WIN-R and other HCV trials demonstrated that response rates in the community setting were lower than academic centers, in part due to higher discontinuation rates. The OPTIMAL study is a phase IV trial evaluating the effectiveness of an HCEE-led educational program in improving community site (CS) HCV therapeutic management and patient outcomes. This abstract focuses on design and implementation of the program. Methods: Primary endpoint is treatment compliance rate for patients treated at CS vs. HCEEs. Each CS was required to have experience treating HCV, but no experience using DAAs. Educational program was administered by the HCEE to the CS through four standardized educational sequence visits (SV). SV1 (live): Review of protocol and safety/efficacy data with first-generation DAAs, strategies for patient evaluation/management. SV2 (live): Completed prior to patient enrollment with the goal of formulation of education plan for the practice. SV3 (live): Review records on OPTIMAL patients and provide feedback. SV4 (telecon within 60 days of SV3): Review OPTIMAL patient labs/treatment response and provide feedback on side effect management. In addition to structured visits, the HCEE offered ad hoc support to CS via email and phone consultations with the CS and their staff. Results: Prior to study start, SV1 and SV2 were combined into one live visit at each CS. 35 CS were asked to participate from December, 2011 to July, 2012. 33 sites agreed to participate, and completed SV1/2. Four sites discontinued due to opting out/no enrollment following SV1/2 (One each from four different HCEE sites). Of 29 CS who enrolled patients, the average time from SV1/2 to first patient enrolled was 75 days (range: 0-257). All sites completed SV3 and SV4. The average time from first patient enrolled to SV3=45 days (range: -12 to 145). SV4 telecon took place on average 69 days from SV3, with 66% of the telecons taking place within the 60-day protocol-defined window. Efficacy results will be reported separately. Conclusion: An educational bridging program between HCEE and CS is warranted for complex treatment regimens. This will increase the pool of knowledgeable HCV providers by linking them to experienced mentors in anticipation of more broadly applied future HCV therapies. Modifications of the program based on regional differences will be explored. Disclosure - K. Brown: Ad boards: Vertex, Merck, Genentech, Jannsen, Novartis, Gilead CME speaking: Gilead Boards: AST, CLDF Consulting: Blue Cross Research: Vertex, Gilead, BMS, Mass Biologics, Merck, CDC Foundation, Hyperion, Exelenz F. Poordad has received consultancy fees from Merck, Vertex, Abbott, Gilead, Achillion, Boehringer Ingelheim, Genentech, Novartis, and Janssen/Tibotec; has grants/grants pending from Merck; and has received payment for development of educational presentations and speaker fees from Merck, Abbott, Achillion, Genentech, Vertex, Salix and Gilead. R. Brown declares grant/research support from Gilead, Janssen, Novartis, Salix, Schering/Merck, and Vertex; and speaking and teaching for Salix Pharmaceuticals, Roche/Genentech, Gilead, and Schering/Merck. L. Balart reports having received grant support and support for travel to meetings for the study or other purposes from Merck; and payment for lecture fees including service on speaker's bureaus from Merck, Genentech, and Bristol Myers Squibb. R. Reddy: Advisory Board: Genentech-Roche, Merck, Gilead, Vertex, Janssen, Idenix, BMS Research Support: Genentech-Roche, Merck, Gilead, Vertex, Janssen, BMS, AbbVie. This research was supported by an industry grant from Merck.