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334A AASLD ABSTRACTS HEPATOLOGY, October, 2015<br />

Comparing two combination therapies, Arm A achieved higher<br />

rates of HBsAg loss (P=0.016) following flares than Arm B.<br />

This is partly driven by HBeAg-negative patients in Arm A who<br />

attained disproportionately increasing rates of HBsAg loss and<br />

HBsAg decline ≥ 1log 10<br />

IU/ml which was not observed in<br />

Arm B. Conclusion: Treatment-associated ALT flares, especially<br />

with TDF+PEG combination therapy, are associated with clinical<br />

endpoints related to HBV immune control. ALT flares were<br />

higher in the TDF+PEG x48w group and associated with the<br />

highest HBsAg loss.<br />

Table: Proportion of Patients who Achieved Clinical Endpoints by<br />

ALT flare status (N=679)<br />

*Includes subjects with baseline HBeAg-positive only.<br />

Disclosures:<br />

Henry Lik-Yuen Chan - Advisory Committees or Review Panels: Gilead, MSD,<br />

Bristol-Myers Squibb, Roche, Novartis Pharmaceutical, Abbvie; Speaking and<br />

Teaching: Echosens<br />

Wan-Long Chuang - Advisory Committees or Review Panels: Gilead, Abbvie;<br />

Speaking and Teaching: BMS, Roche, MSD<br />

Joerg Petersen - Advisory Committees or Review Panels: Bristol-Myers Squibb,<br />

Gilead, Novartis, Merck, Bristol-Myers Squibb, Gilead, Novartis, Merck; Grant/<br />

Research Support: Roche, GlaxoSmithKline, Roche, GlaxoSmithKline; Speaking<br />

and Teaching: Abbott, Tibotec, Merck, Abbott, Tibotec, Merck<br />

Phillip Dinh - Employment: Gilead Sciences; Stock Shareholder: Gilead Sciences<br />

Eduardo B. Martins - Employment: Gilead Sciences, Inc.; Stock Shareholder:<br />

Gilead Sciences, Inc.<br />

Leland J. Yee - Employment: Gilead Science<br />

Prista Charuworn - Stock Shareholder: Gilead Sciences<br />

Mani Subramanian - Employment: Gilead Sciences<br />

Harry L. Janssen - Consulting: AbbVie, Bristol Myers Squibb, GSK, Gilead Sciences,<br />

Innogenetics, Merck, Medtronic, Novartis, Roche, Janssen, Medimmune,<br />

ISIS Pharmaceuticals, Tekmira; Grant/Research Support: AbbVie, Bristol Myers<br />

Squibb, Gilead Sciences, Innogenetics, Merck, Medtronic, Novartis, Roche,<br />

Janssen, Medimmune<br />

Seng Gee Lim - Advisory Committees or Review Panels: Bristol-Myers Squibb,<br />

Novartis Pharmaceuticals, Merck Sharp and Dohme Pharmaceuticals, Gilead<br />

Pharmaceuticals, Roche Pharmaceuticals; Speaking and Teaching: Bristol-Myers<br />

Squibb, Novartis Pharmaceuticals, Merck Sharp and Dohme Pharmaceuticals,<br />

Gilead Pharmaceuticals<br />

Scott Fung - Advisory Committees or Review Panels: Gilead Sciences, Merck,<br />

Vertex, Roche; Speaking and Teaching: BMS, Gilead, AbbVie, Janssen, Merck<br />

Graham R. Foster - Advisory Committees or Review Panels: GlaxoSmithKline,<br />

Novartis, Boehringer Ingelheim, Tibotec, Chughai, Gilead, Janssen, Idenix,<br />

GlaxoSmithKline, Novartis, Roche, Tibotec, Chughai, Gilead, Merck, Janssen,<br />

Idenix, BMS; Board Membership: Boehringer Ingelheim; Grant/Research Support:<br />

Chughai, Roche, Chughai; Speaking and Teaching: Roche, Gilead, Tibotec,<br />

Merck, BMS, Boehringer Ingelheim, Gilead, Janssen<br />

Maria Buti - Advisory Committees or Review Panels: Gilead, Janssen, MSD;<br />

Grant/Research Support: Gilead, Janssen; Speaking and Teaching: Gilead,<br />

Janssen, BMS<br />

Giovanni B. Gaeta - Advisory Committees or Review Panels: Janssen, Merck,<br />

Abbvie, Roche; Speaking and Teaching: BMS, Gilead<br />

George V. Papatheodoridis - Advisory Committees or Review Panels: Merck<br />

Sharp & Dohme, Novartis, Abbvie, Boerhinger Ingelheim, Bristol-Meyer Squibb,<br />

Gilead, Roche, Janssen, GlaxoSmith Kleine; Grant/Research Support: Roche,<br />

Gilead, Bristol-Meyer Squibb, Abbvie, Janssen; Speaking and Teaching: Merck<br />

Sharp & Dohme, Bristol-Meyer Squibb, Gilead, Roche, Janssen, Abbvie<br />

Robert Flisiak - Advisory Committees or Review Panels: Gilead, Bristol Myers<br />

Squibb, Janssen, Merck, Roche, Abbvie; Consulting: Janssen, Bristol Myers<br />

Squibb, Gilead, Merck, Abbvie; Grant/Research Support: Roche; Speaking and<br />

Teaching: Janssen, Roche, Bristol Myers Squibb, Gilead, Merck, Abbvie<br />

Patrick Marcellin - Consulting: Roche, Gilead, BMS, Vertex, Novartis, Janssen,<br />

MSD, Abbvie, Alios BioPharma, Idenix, Akron; Grant/Research Support: Roche,<br />

Gilead, BMS, Novartis, Janssen, MSD, Alios BioPharma; Speaking and Teaching:<br />

Roche, Gilead, BMS, Vertex, Novartis, Janssen, MSD, Boehringer, Pfizer,<br />

Abbvie<br />

The following authors have nothing to disclose: Sang Hoon Ahn, Fehmi Tabak,<br />

Rajiv Mehta, Kyungpil Kim, Aric Josun Hui<br />

242<br />

Nucleos(t)ide Analogues against Hepatitis B Virus<br />

Reduces the Risk of Various Major Malignancies: a<br />

Nationwide Cohort Study Based on the Health Insurance<br />

Review and Assessment Service Database.<br />

Donghyeon Lee 1 , Jeong-Hoon Lee 1 , Yuri Cho 1 , Jeong-Ju Yoo 1 ,<br />

Minjong Lee 1 , Young Youn Cho 1 , Hyeki Cho 1 , Hongkeun Ahn 1 ,<br />

June Sung Lee 2 , Eun Ju Cho 1 , Su Jong Yu 1 , Yoon Jun Kim 1 , Jung-<br />

Hwan Yoon 1 ; 1 Seoul national university hospital, Seoul, Korea (the<br />

Republic of); 2 Inje University, Ilsan Paik Hospital, Ilsan, Korea (the<br />

Republic of)<br />

Background: Preceding epidemiology <strong>studies</strong> reported that<br />

chronic hepatitis B virus (HBV) infection is a risk factor for various<br />

malignancies including hepatocellular carcinoma (HCC),<br />

cholangiocarcinoma, non-Hodgkin lymphoma, and stomach<br />

cancer. These associations have been partially explained by<br />

the HBV-inducing immune tolerance to malignant cells. It has<br />

been well proven that antiviral treatment in chronic hepatitis<br />

B (CHB) patients reduces the risk of HCC. However, it is still<br />

unclear whether nucleos(t)ide analogues (NAs) against HBV<br />

could reduce the risk of various malignancies except for HCC.<br />

In this study, we evaluated the association of anti-HBV treatment<br />

with NAs and the risk of various cancers in CHB patients.<br />

Methods: The National Claims Database from Health Insurance<br />

Review and Assessment Service (HIRA) was used. From<br />

this database, we included CHB patients who received anti-<br />

HBV NAs (i.e., lamivudine, telvibudine, clevudine, adefovir,<br />

entecavir, and tenofovir) for > 30 days between 2009 and<br />

2013 (the NA group) or no antiviral treatment (the control<br />

group). Date of data cutoff was December 31, 2014. The<br />

hazard ratio (HR) for NAs was calculated by Cox regression<br />

model. Results: A total of 299,740 patients with CHB were<br />

included and 39,900 patients (13.3%) were involved in the<br />

NA group. During the study period 14,186 patients developed<br />

any kind of malignancy. In multivariate analysis, the NA<br />

group showed significantly lower risk of developing new malignancies<br />

(vs the control group; HR=0.511, 95% confidence<br />

interval=0.466-0.561, P

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