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1871Entecavir Safety and Effectiveness in a National Cohort of Chronic Hepatitis B Patients in the United States - the ENUMERATE studyJoseph Ahn1, Hannah Lee2, Joseph K. Lim3, Calvin Q. Pan4, Mindie H. Nguyen5, W. Ray Kim5, Huy N. Trinh6, Tram T. Tran7, Danny Chu8, Albert Min9, Son T. Do10, Jocelyn Woog11, Ajitha Mannalithara5, Anna S. Lok12;1OHSU, Portland, OR; 2Tufts Medical Center, Boston, MA; 3Yale University, New Haven, CT; 4NYU Langone, New York City, NY; 5Stanford University, Stanford, CA; 6San Jose Gastroenterology, San Jose, CA; 7Cedars-Sinai, Los Angeles, CA; 8Albert Einstein College of Medicine, New York City, NY; 9Mount Sinai Beth Israel, New York City, NY; 10Digestive Health Associates of Texas, Plano, TX; 11Asian Health Foundation, Rochester, MN; 12University of Michigan, Ann Arbor, MIBackground- Entecavir (ETV) has been shown to be safe and efficacious in randomized controlled trials in highly selected patients infected with hepatitis B virus (HBV). There are limited data about the safety and effectiveness of ETV in “real-life” patients in the US. Aim- To determine the safety and effectiveness of ETV in “real-life” patients with HBV infection in the US. Methods- The ENUMERATE study was conducted in a national network of 26 academic and private liver centers in the US, in partnership with the AHF. Treatment-naTve HBV patients ≥ 18 years old who received ETV for ≥ 12 months between 2005 and 2013 were included. Exclusion criteria included co-infection with HIV, hepatitis C or D, a history of hepatocellular carcinoma (HCC) or solid organ transplantation. Outcome measures included cumulative rates of ALT normalization, unde-tectable HBV DNA level, HBeAg and HBsAg loss/seroconversion, estimated glomerular filtration rate (GFR) based on the MDRD formula, and adverse events (AE) leading to ETV dose reduction or discontinuation. Results- Of 841 patients, 745 [63% male, 83% Asian; median age 47 (18-83) years] met the inclusion criteria. At baseline, 195 (26%) were HBeAg+ and 69 (9.3%) had cirrhosis. Abnormal ALT (ALT ≥ 30 U/L for men, ≥ 19 U/L for women) was observed in 89% of patients, with a median of 58 (6-3286) U/L. Baseline median HBV DNA was 5.7 log 10 (1.9-10.2) IU/ml. Median duration of ETV treatment was 4 (1-8.3) years. Among all patients tested for ALT, 42.1% (308/731) had normal ALT at year 1, 46.8% (251/536) at year 3, and 53.3% (169/317) at year 5. At year 1, 63% (308/489) had undetectable HBV DNA, 76.3% (222/291) at year 3, and 82.4% (126/153) at year 5. At 5 years, cumulative probability of HBeAg loss and HBeAg seroconversion was 38.5% and 29.7%, respectively and of HBsAg l oss was 4.4%. Median GFR was 92.6 (IQR 79, 107.2) ml/min at baseline and 91.9 (IQR 79.9, 106.4) mL/min at 5 years. ETV dose reduction was required in 2 patients due to renal insufficiency. ETV discontinuation was required in 7 patients due to AEs with two for nonfatal lactic acidosis. Hepatic decompensation occurred in 10 patients (1.3%) and HCC in 26 (3.5%) patients. Seven patients died (3 liver related). Conclusion- In a large “real-life” US cohort of HBV-infected patients, ETV treatment was well tolerated. Rates of ALT normalization, HBV DNA suppression, and HBeAg seroconversion were lower than those previously reported in randomized clinical trials.
Disclosures:
Joseph Ahn - Advisory Committees or Review Panels: gilead; Grant/Research Support: bms
Hannah Lee - Grant/Research Support: BMS
Joseph K. Lim - Consulting: Merck, Vertex, Gilead, Bristol Myers Squibb, Boeh-ringer-Ingelheim; Grant/Research Support: Abbott, Boehringer-Ingelheim, Bristol Myers Squibb, Genentech, Gilead, Janssen/Tibotec, Vertex, Achillion
Calvin Q. Pan - Advisory Committees or Review Panels: BMS, Gilead; Consulting: BMS, Gilead, Merck, Abbvie, Janssen ; Grant/Research Support: BMS, Gilead, Genentech, Merck; Speaking and Teaching: BMS, Gilead, Onyx
Mindie H. Nguyen - Advisory Committees or Review Panels: Bristol-Myers Squibb, Bayer AG, Gilead, Novartis, Onyx; Consulting: Gilead Sciences, Inc.; Grant/Research Support: Gilead Sciences, Inc., Bristol-Myers Squibb, Novartis Pharmaceuticals, Roche Pharma AG, Idenix, Hologic, ISIS
W. Ray Kim - Consulting: Bristol Myers Squibb, Gilead Sciences
Huy N. Trinh - Advisory Committees or Review Panels: BMS, Gilead; Grant/ Research Support: BMS, Gilead; Speaking and Teaching: BMS, Gilead, vertex; Stock Shareholder: Gilead
Tram T. Tran - Advisory Committees or Review Panels: Gilead, Bristol Myers Squibb; Consulting: Gilead, AbbVie, Janssen; Grant/Research Support: Bristol Myers Squibb; Speaking and Teaching: Bristol Myers Squibb, Gilead
Danny Chu - Consulting: Gilead, Gilead, Gilead, Gilead; Speaking and Teaching: Gilead, Gilead, Gilead, Gilead
Albert Min - Consulting: Bristol Myers Squibb, Gilead, Janssen; Grant/Research Support: Bristol Myers Squibb, Gilead; Speaking and Teaching: Bristol Myers Squibb, Gilead
Son T. Do - Advisory Committees or Review Panels: gilead, Asian Health Foundation, gilead, Asian Health Foundation, gilead, Asian Health Foundation, gilead, Asian Health Foundation; Speaking and Teaching: bms, gilead, Asian Health Foundation, bms, gilead, Asian Health Foundation, bms, gilead, Asian Health Foundation, bms, gilead, Asian Health Foundation
Anna S. Lok - Advisory Committees or Review Panels: Gilead, Immune Targeting System, MedImmune, Arrowhead, Bayer, GSK, Janssen, Novartis, ISIS, Tekmira; Grant/Research Support: Abbott, BMS, Gilead, Merck, Roche, Boehringer
The following people have nothing to disclose: Jocelyn Woog, Ajitha Manna-lithara
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