ABSTRACTS 21ST ANNUAL CONFERENCE —2013

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distribution of genotype TT at allele rs 60 reported to havepoor HCV clearance rate and was found to be 1.34%. Atrs8099917 TT, another favourable IL28B host genotypewas found to be major variant (�70%) followed by TG(30%). Out of total 57 patients administered IFN therapy,40 of them showed IFN induced clearance were of CC geno-type, compared to only 6 patients who showed CT genotypeat rs 60. At rs 17, 31 individuals who had favorable TT geno-type showed IFN induced clearance, followed by 15 of themwho showed TG genotype.Conclusion: It could be concluded that CC, TT the two fa-vorable markers at SNP rs60 and rs17 respectively are moreprevalent amongst our study population. This informa-tion could aid clinicians to effectively advise patients topredict about the treatment regimen.

Corresponding author. Rushna Firdaus.E-mail: provash2000@gmail.com

ENTECAVIR+ADEFOVIR VERSUSLAMIVUDINE+ADEFOVIR OR ENTECAVIRALONE IN LAMIVUDINE-RESISTANTCHRONIC HEPATITIS B: 96-WEEK DATAFROM THE DEFINE STUDY

Jeong Heo,1 Sang Hoon Ahn,2 Young-Oh Kweon,3

Byung-Ho Kim,4 Sang Hoon Chan,5 Young-Oh Horban,6

Byung-Ho Wongcharatrawee,7 Sang Hoon Llamoso,8

Kwan Sik Lee,2 Rahul Bargaje9

1Pusan National University School of Medicine, Pusan, Republic ofKorea, 2Yonsei University College of Medicine, Seoul, Republic of Korea,3The Kyungpook National University Hospital, Daegu, Republic of Korea,4Kyung Hee University Hospital, Seoul, Republic of Korea, 5The ChineseUniversity of Hong Kong, Hong Kong, S.A.R, 6Hospital of InfectiousDiseases, Warsaw, Poland, 7Bristol-Myers Squibb, Shanghai, China,8Bristol-Myers Squibb, Wallingford, CT, USA, 9Bristol-Myers Squibb,India

Background:Unlike the combination of adefovir (ADV) andlamivudine (LVD), currently a recommended option fortreatment of LVD-resistant chronic hepatitis B, both compo-nents of an entecavir (ETV) +ADVcombinationhave antiviralactivity against LVD-resistantHBV. ETV+ADVmay thereforeprovide antiviral synergy in this challenging population.Methods: In this open-label, multicenter study, 416 HBeAg(+) CHB patients with LVD-resistant HBV were randomized1:1:1 to receive ETV+ADV (1.0 mg+10 mg), ETV (1.0 mg) orADV+LVD (10 mg+100 mg) once-daily for 100 weeks. Theoption to add tenofovir (TDF) to ETV monotherapy afterWeek 48 was allowed in countries where TDF was approvedfor CHB treatment. The primary efficacy endpoint was theproportion withHBVDNA <50 IU/mL atWeek 48; compar-ing ETV+ADV to ADV+LVD and ETV monotherapy usingthe 2-stage Hochberg procedure. At Week 96, the key effi-cacy endpoint was the difference in proportion <50 IU/ml

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for ETV+ADV vs ADV+LVD. Subjects who discontinuedprior to each analysis were considered failures (NC=F).Results: A total of 415 patients were dosed (94% Asian, 6%White, 67% male, mean age 44 years). Mean baseline HBV-DNA was 7.4 log10 IU/mL (86% Subtype C, 7% A, 4% B, 3%D, <1% H). At Week 48, proportions <50 IU/mL for ET-V+ADV (n=138), ETV (n=140) and ADV+LVD (n=137) were25.4%, 16.4% and 19.7%, respectively (P =NS). At Week 96,ETV+ADV vs ADV+LVD for <50 IU/mL was 43.5% vs28.5% (difference 15.0%; P =0.0095). Overall, there were nosignificant differences in safety or efficacy across treatmentarms.Conclusions:With 96Weeks of treatment, the antiviral ef-ficacy of ETV+ADV was superior to ADV+LVD. All treat-ments were well tolerated and had comparable safetyprofiles.

Corresponding author.E-mail: balaji.ganesan@bms.com

RANDOMIZED, OBSERVATIONAL STUDY OFLONG-TERM ENTECAVIR TREATMENTVERSUS OTHER STANDARD OF CARENUCLEOS (T) IDE ANALOG THERAPY INNUCLEOS(T)IDE-NAÏVE PATIENTS WITHCHRONIC HEPATITIS B FROM A ‘REAL-WORLD’ CLINICAL PRACTICE SETTING INCHINA

Jin-Lin Hou,1 Ji-Dong Jia,2 Lai Wei,3 Hong Ren,4

Ji-Dong Xie,5 Lai Gao,6 Hong Zhao,7 Ji-Dong Wang,8

Guozhong Gong,9 Wukui Cao,10 MiaoYu11

1Hepatology Unit and Key Lab for Organ Failure Research, NanfangHospital, Southern Medical University, Guangzhou, China, 2LiverResearch Center, Beijing Friendship Hospital, Capital Medical University,Beijing China, 3Peking University People's Hospital, Peking UniversityHepatology Institute, 4Chongqing Medical University 2nd HospitalChongqing, China, 5Department of Infectious Diseases, Shanghai RuijinHospital, Jiao Tong University School of Medicine, 6Third AffiliatedHospital, Sun Yat-Sen University, Guangzhou, China, 7Nanjing SecondHospital Affiliated to Medical College, Southeast University, JiangsuProvince, China, 8Institute of Infectious Diseases, Southwest Hospital,the Third Military Medical University, Chongqing, China, 9Liver DiseasesCenter, Second Xiangya Hospital, Central South University, Changsha,China, 10Tianjin Infectious Disease Hospital, Tianjin, China, 11Researchand Development, Bristol-Myers Squibb Company, Wallingford, CT,USA

Background:This study presents the virologic efficacy andlimited safety data for up to 144 weeks of entecavir (ETV)therapy or other standard of care (oSOC) anti-HBV nucle-os(t)ide analog (NUC) therapy (lamivudine, telbivudine oradefovir) in NUC-naïve CHB patients from a ‘real-world’clinical practice setting in China.Methods: This prospective, observational cohort compriseda sub-group of 3546 NUC-naïve CHB patients enrolled in

© 2013, INASL

JOURNAL OF CLINICAL AND EXPERIMENTAL HEPATOLOGY

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the REALM study from 50 study sites in China. Patients wererandomized to ETV or oSOC, and were assessed for virologicresponses and limited safety parameters over 144 weeks.Results: Overall, 3528 patients were treated (ETV: 1768;oSOC: 1760). Baseline patient characteristics were well bal-anced across treatment groups: approximately 80% male,100% Asian, 64% HBeAg (+); mean HBV DNA z6.76log10 IU/mL in both arms. More patients in the oSOCarm than in the ETV arm discontinued study therapy(134/1773 [8%] versus 78/1773 [4%]); themost common rea-sons were subject request (ETV 30 [2%], oSOC 54 [3%]), lostto follow-up (ETV 21 [1%], oSOC 39 [2%]), death (ETV 13[<1%], oSOC 19 [1%]) and inadequate treatment response(ETV 1 [<1%], oSOC 10 [<1%]). At Week 144, 84% of ETV-treated patients had HBV DNA <50 IU/mL comparedwith 55% in the oSOC arm (non-completer=missing analy-sis). Serious treatment-related adverse events were infre-quent (<1%) and comparable between both treatmentarms. One patient (ETV arm) had increased alanine amino-transferase, 1 patient increased blood bilirubin (ETV arm),and 1 patient increased blood creatinine phosphokinase(oSOC arm). There were 13 deaths in the ETV arm and 21in the oSOC arm (on treatment or during follow up).Conclusions: In a real-world setting, nucleos(t)ide naïveChinese CHB patients treated with ETV achieved higherrates of virologic response compared with patients receiv-ing other standard of care over 3 years of therapy.

Corresponding author.E-mail: balaji.ganesan@bms.com

BUPRENORPHINE MAINTENANCEACHIEVES A HIGHER COMPLIANCE RATETHAN METHADONE IN PATIENTSCHRONICALLY INFECTED WITH HCVTREATED WITH PEGYLATED INTERFERONAND RIBAVIRIN COMBINATION

Dimitrios Dimitroulopoulos,1 Elefteria Petroulaki,2

Stavroula Kollia,2 Anastasios Tsantilas,2

Apostolos Malahias,1 Nikolaos Ziogas,1

Klisthenis Tsamakidis,1 Dimitrios Xinopoulos1

1Gastroenterology Dpt, “Agios Savvas” Hospital, Athens, Greece,2National Greek Organization Against Drugs (OKANA), Athens, Greece

Introduction: Chronic HCV infection (HCV) is the mostcommon infectious disease among intravenous drug users.Aims: To determine and compare compliance rates be-tween two groups of chronic HCV patients from the Na-tional Greek Organization Against Drugs (OKANA) insubstitution programs with buprnorphine or methadone,treated with pegylated interferon plus ribavirin during 24or 48 weeks of therapy and 24 weeks of follow up andalso to evaluate the efficacy of treatment in each group.

Journal of Clinical and Experimental Hepatology | March 2013 | Vol. 3 | No

Methods:Ninety seven consecutive chronic HCV infectedpatients, members of the OKANA program, were treatedwith pegylated interferon a-2a (180 mg/wk administeredsubcutaneous) in combination with oral ribavirin (1000or 1200 mg/day depending on baseline body weight #or > 85 Kg, respectively, divided in two doses), for 24 or48 weeks according to their genotype. Forty five were inbuprnorphine maintenance (Group A, 36 males, 9 fe-males) and 65 in methadone maintenance (Group B, 52males, 13 females). During the study, all patients were fol-lowed up periodically by hepatologists, internists and psy-chiatrists.Results: Baseline characteristics were similar between thetwo groups. Thirty four patients (75.6%) from group Aand 31/65 (47.7%) from group B completed therapy(P =0.006). Thirty-two (71.1%) patients from group A and27 (41.5%) from group B were followed up until the endof the follow-up period (P =0.004). At the end of the fol-low-up, sustained virologic response (SVR) was achievedin 23/45 (51.1%) patients from group A and 21/65(32.3%) from group B (P = 0.075).Conclusion: Buprenorphine maintenance achieves a sig-nificantly higher compliance rate than methadone in pa-tients with chronic HCV infection treated with pegylatedinterferon and ribavirin. After 24 weeks of follow-up, re-sponse rates were similar for patients who were compliantto treatment for both groups.

Corresponding author. Dimitrios Dimitroulopoulos.E-mail: dimdim@otenet.gr

ALCOHOL AND TOBACCO CONSUMPTIONBUT NOT METABOLIC SYNDROME OR ITSCOMPONENTS ARE ASSOCIATED WITHYOUNGER AGE AT THE DIAGNOSIS OFHEPATOCELLULAR CARCINOMA INCHRONIC HCV INFECTED PATIENTS

Dimitrios Dimitroulopoulos,1 Aikaterini Fotopoulou,2

Dimitrios Kypreos,1 Stefanos Basioukas,1

Aikaterini Katerinis,1 Dimitrios Tsamakidis,1

Stefanos Xinopoulos1

1Gastroenterology Dpt, “Agios Savvas” Hospital, Athens, Greece,2Radiology-Oncology Dpt, "Hygeia" Hospital, Athens, Greece

Background:HCV cirrhosis is a major risk factor for HCC.Other factors related to HCC are HBV cirrhosis, alcohol,tobacco consumption and metabolic disorders such as di-abet mellitus, dyslpidemia, obesity and arterial hyperten-sion. The association of several risk factors couldaccelerate the oncogenic process.Aim: The aim of the present study was to investigate theimpact of these factors in the occurence of HCC in chronicHCV infected patients.

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