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530A AASLD ABSTRACTS HEPATOLOGY, October, 2015 644 Long-Term Safety of OCA in Patients with PBC Yvette Peters, Roya Hooshmand-Rad, Richard Pencek, Janet Owens-Grillo, Tonya Marmon, Leigh MacConell, David Shapiro; Intercept Pharmaceuticals, San Diego, CA Background: Obeticholic Acid (OCA) is a potent and selective FXR agonist developed for treatment of primary biliary cirrhosis (PBC). 216 patients with PBC were treated in a randomized, doubleblind (DB), placebo (PBO)controlled Phase 3 clinical study to evaluate the efficacy and safety of OCA. 198 patients completed the DB phase of the study and 193 enrolled in a longterm extension (LTSE) phase. Exposure to OCA during the DB phase resulted in statistically significant liver biochemistry improvements and was safe. Methods: All patients enrolled in the LTSE first met the inclusion criteria for the DB study, which included PBC diagnosis, ALP ≥1.67x ULN and/or total bilirubin >ULN to
HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 531A 646 Significant non–adherence to DAA HCV therapy in decompensated patients - a tertiary hepatology centre assessment Aisling B. Considine 1,2 , Suman Verma 3 , Kath Oakes 3 , Kate E. Childs 3 , Sarah Knighton 1,2 , Andrew Ayers 3 , Abid Suddle 3 , Kosh Agarwal 3 ; 1 Pharmacy, Kings College Hospital, London, United Kingdom; 2 Kings College London, Institute of Pharmaceutical Sciences, London, United Kingdom; 3 Kings College Hospital, Institute of Liver Studies, London, United Kingdom Background: The advent of directly acting anti-virals (DAA) has led to simplified HCV regimens with increased efficacy rates and better tolerability. The high adherence seen in clinical trials may not translate to real life populations. Optimal adherence is critical to protect patients from treatment failure and resistance. Aim: To identify potential factors which may contribute to sub-optimal adherence in a population with decompensated cirrhosis. Methods: HCV patients eligible for access to a 12 week treatment regimen under a UK NHSE mandated access scheme were consented to complete a baseline questionnaire capturing data on sociodemographics, clinical status and perceptions of illness.Adherence assessments at treatment weeks 4, 8 and 12 with pill counts and a Morisky Medication Adherence Scale were undertaken. Suboptimal adherence (SA) was defined as any report or pill count which indicated a delayed (>2hrs) or missed dose of anti-viral. Descriptive statistic and multivariate regression methods were utilised for analysis. Results: 80% (n=47) of the cohort had reached SVR 12 and are included in the adherence analysis.85% received sofosbuvir/ledipasvir and 15% sofosbuvir with daclatasvir. All patients received ribavirin and had been attending specialist hepatology services for >12 months.43% (n=20) of patients demonstrated SA during their treatment. Multivariate analysis demonstrated that any non-attendance during treatment and a ‘limited support network’ predicted higher rates of SA (p3 medications (vs 74% in adherent group). The average MELD score was 15 in the SA group (vs 13 in adherent group). 80% of SA was associated with symptoms secondary to disease stage not reflected by the MELD. SA secondary to side effects of therapy was not identified. 85% of the SA group achieved SVR12.Failure to achieve SVR was seen in those with SA adherence at all assessment points (weeks 4, 8 and 12). Conclusions: Our initial results demonstrate that despite an intensive adherence focused multi-disciplinary approach, SA occurs in decompensated HCV cirrhotic patients. Acceptable SVR rates were achieved in this population. Further research is warranted to develop strategies which maximise adherence in all HCV populations. Disclosures: Kosh Agarwal - Advisory Committees or Review Panels: Gilead, BMS, Novartis, Janssen, AbbVie, Gilead; Consulting: MSD, Janssen; Grant/Research Support: Roche, Gilead, BMS, BMS; Speaking and Teaching: Astellas The following authors have nothing to disclose: Aisling B. Considine, Suman Verma, Kath Oakes, Kate E. Childs, Sarah Knighton, Andrew Ayers, Abid Suddle 647 Hepatology nursing in Canada: Current practices and future challenges Colina Yim 1 , Cheryl Dale 2 , Geri Hirsch 3 , Jo-Ann E. Ford 4 , Carolyn Klassen 4 ; 1 University Health Network, Toronto, ON, Canada; 2 London Health Sciences Centre, London, ON, Canada; 3 Halifax Capital District Health Authority, Halifax, NS, Canada; 4 Vancouver General Hospital, Vancouver, BC, Canada Background: Hepatitis C treatment landscape is changing. The rapid therapeutic advancements may impact the roles and responsibilities of some of the hepatology nurses whose practice focused solely on hepatitis C. This study aims to describe the current practices of hepatology nurses in Canada and to gain insights into nurses’ perceptions and concerns about their future roles and values. Methods: An 18-item survey was designed. Survey was sent in November 2014 to all active members of the Canadian Association of Hepatology Nurses (CAHN) via email for their voluntary participation. A second email was sent 8 weeks later as a reminder to complete survey. Demographics collected include age, length of practice, practice settings and focuses. CAHN Members were asked to rate their levels of concerns in regards to job security, sustainability of current positions, change of role and the future of hepatology nursing. Results: Of a total of 136 active CAHN members, 94 (69%) completed the survey. Eighty-one percent were employed full time, 78% age > 40 years, 64% have at least 6 years or more work experience in hepatology. Hepatitis C treatment was the sole practice focus in 52% while 38% of them managed more than 50 hepatitis C patients on treatment in last 6 months. A majority of CAHN members (78%) work in academic institutions and community settings. Salary support varies with 35% being paid from industry grants and the remainder either by government (health authority, provinces, academic centres and community agencies) or by research grants. Up to 85% expressed satisfaction with their current positions and the support they received from their physician partners but at least 60% are concerned about their job security, job description change and current position sustainability. A lack of funding for hepatology nurse positions remain the major challenge, 69% of members predict a positive hepatology nursing future. Conclusions: Hepatology nurses in Canada are experienced professionals in the field. A majority have a focused practice on hepatitis C treatment management. We are satisfied with our current roles and responsibilities and feel most supported by our physician colleagues. Hepatology nurses acknowledge challenges exist for role sustainability but remain optimistic about our values in future. Disclosures: Colina Yim - Advisory Committees or Review Panels: Janssen; Consulting: Gilead; Speaking and Teaching: Abbvie Jo-Ann E. Ford - Advisory Committees or Review Panels: Gilead, Roche, Janssen, Merck Canada, Vertex; Speaking and Teaching: Gilead, Roche, Janssen, Merck Canada, Vertex The following authors have nothing to disclose: Cheryl Dale, Geri Hirsch, Carolyn Klassen 648 Pharmacists mitigate effect of simeprevir on blood pressure in patients with hepatitis C infection receiving concurrent calcium channel blocker therapy Heather Johnson 1,2 , Emily Graham 2 , Michael A. Dunn 1 , Kapil B. Chopra 1 ; 1 University of Pittsburgh, PIttsburgh, PA; 2 UPMC Presbyterian, Pittsburgh, PA Simeprevir (SMV) an NS3/4A inhibitor for the treatment of Hepatitis C infection (HCV), has a number of drug-drug inter-
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1000A AASLD ABSTRACTS HEPATOLOGY, O
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1312A AUTHOR INDEX HEPATOLOGY, Octo
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1366A CATEGORY INDEX HEPATOLOGY, Oc
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