005). Liver transplantation was required in 12.9% of other HDS-related cases and 2.3% died of liver failure, compared Epigenetics Compound Library to only 3.4% transplanted and 3.1% dying who had conventional DILI. Conclusions: HDS products have accounted for an increasing

percent of cases of hepatotoxicity in the USA during the last 10 years. Bodybuilding products are the most common cause for HILI, producing a cholestatic syndrome that is rarely, if ever, fatal. Overall, death or transplantation occurred twice as commonly with HILI as with DILI agents, underscoring the hepatotoxic potential of some HDS products. The specific ingredients responsible for injury need further study. PERIOD DRUG BODYBUILDING HDS OTHER HDS Trend, all HDS: P<. 001 Trend, Paclitaxel price bodybuilding HDS: P=0.01 Trend, other HDS: P=0.05 Disclosures: Herbert L. Bonkovsky – Advisory Committees or Review Panels: Amer Porphyria Foundation, Iron Disorders Institute, Amer Porphyria Foundation, Iron Disorders Institute; Board Membership: Iron Disorders Institute, Iron Disorders Institute; Consulting: Recordati Rare Disease, Clinuvel, Inc, Alnylam Pharmaceuticals, Best Doctors, Inc; Grant/Research Support: Merck, Clinuvel, Inc, Vertex, Recordati Rare Disease, Clinuvel, Inc, Clinuvel, Inc; Speaking and Teaching: Recordati Rare Diseases, Recordati Rare Disease Robert J. Fontana – Consulting: GlaxoSmithKline, tibotec; Grant/Research Support: Gilead, vertex,

Ocera K. Rajender Reddy – Advisory Committees or Review Panels: Genentech-Roche, Merck, Janssen, Vertex, Gilead, BMS, Novartis, Idenix; Grant/Research Support: Genentech-Roche, Merck, BMS, Ikaria, Gilead, Hyperion, Janssen, AbbVie Jayant A. 上海皓元医药股份有限公司 Talwalkar – Consulting: Lumena; Grant/Research Support: Intercept, Salix, Gilead The following people have nothing to disclose: Victor J. Navarro, Huiman X. Barnhart, Timothy J. Davern, Lafaine Grant, Jay H. Hoofnagle, Leonard B. Seeff, Jose Serrano, Averell H. Sherker, Andrew Stolz, Maricruz Vega, Raj Vuppalanchi Background: Cross-sectional studies have shown an association

between steatohepatitis and the serum levels of keratin 18 fragments (CK18) in pediatric NAFLD; it remains to be determined if serum CK18 levels predict changes in liver histology. Aim: To examine if changes in serum CK18 correlate with changes in liver histology in children with NAFLD. Methods: Serum CK18 levels were measured at baseline and weeks 24, 48 and 96 in 127 out of 147 children who had both baseline and week 96 liver biopsies as part of the TONIC trial (JAMA 2011; 305; 1659-1668). Changes in serum CK18 across treatment groups as well as the relationship between changes in serum CK18 and liver histology over the 96 week trial duration were assessed. Results: Baseline mean serum CK18 levels as well as their mean changes at weeks 24, 48 and 96 across 3 treatment groups were similar. However, there was a strong relationship between changes in serum CK18 and changes in liver histology, irrespective of the treatment assignment.