In conclusion, based on the performance demonstrated in this study, the Procleix HEV assay on the fully automated Panther System may be useful for both blood screening and diagnosis of HEV infection. Disclosures: Alanna Janssen – Employment: Hologic Lisa Danzig – Employment: Grifols Jeffrey M. Linnen – Employment: Hologic, Inc.; Stock Shareholder: Hologic, Inc. The following people have nothing to disclose: Edgar Ong, Robin Cory, Maria Babizki, Tim Shin, Andre Lindquist,
Ngoc-Anh Hoang, Lee P. Vang INTRODUCTION: There is limited data about the safety and effectiveness of sofosbuvir (SOF)-based therapies in “real-life” patients with HCV recurrence after liver transplantation (LT). AIM: To evaluate the safety and effectiveness of
SOF-based therapies in patients with HCV recurrence after LT. METHODS: This is a retrospective, multi-center study of patients with post-transplant HCV recurrence who received pegylated interferon (IFN) + ribavirin find more (RBV) + SOF (group 1) ; simeprevir (SMV) + SOF (group 2); SMV + SOF + RBV (group 3); or SOF + RBV (group 4). Treatment response by HCV RNA, cell counts, and adverse events (AE) were compared between groups. selleck inhibitor RESULTS: 59 patients (88% genotype 1a /1b, 51% F3/F4 fibrosis, 71% previously treated) were included in the analysis. Median time from transplant was 1297d (56-6209). There were no statistical differences in demographics, genotype, weight, fibrosis or laboratory parameters between the groups. Analysis of undetectable HCV RNA (UD) is shown in Table 1. Overall, 76% had generalized AE including fatigue, musculoskeletal complaints, headache and nausea, but the frequency of AE was similar between groups (p = 0.74). Serious AE including 1 death were reported in 14 patients (6 anemia/ 上海皓元医药股份有限公司 cytopenia, 2 infection, 6 unrelated to therapy). Hgb decrease by >2 g and development of significant anemia (Hgb <10 g/ dL) was more frequent in patients receiving
RBV [85.7%(1), 10.5%(2), 80%(3), 73.1%(4) p=<0.0001] and [71.4%(1), 10.5%(2), 20%(3), 57.7%(4) p=0.003], respectively. Leukopenia and thrombocytopenia were more common in patients who received IFN. (p=<0.0001 and 0.002, respectively). The need for growth factors was higher in the IFN and RBV containing groups (p=0.005) and blood transfusions were more common in RBV containing groups (p=0.028). No changes in immuno-suppression doses were needed during treatment for any of the groups. SVR data will be presented. CONCLUSIONS: On treatment response using SOF based regimens in the treatment of HCV post-transplant appears promising. Treatment is well tolerated overall, but side effects are increased with RBV or IFN use. No immunosupression changes are needed when using SOF or SIM. Longer term data will help confirm safety and effectiveness in “real-life” patients. No significant difference between groups at week 2 and 4. Disclosures: Joseph Ahn – Advisory Committees or Review Panels: gilead; Grant/Research Support: bms Helen S.