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Predictors Associated with Treatment Initiation and Switch in a Real-World Chronic Hepatitis B Population from Five European Countries

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dc.contributor.authorLeblebicioglu, H.
dc.contributor.authorArama, V.
dc.contributor.authorCausse, X.
dc.contributor.authorMarcellin, P.
dc.contributor.authorOzaras, R.
dc.contributor.authorPostawa-Klozinska, B.
dc.contributor.authorZarski, J. P.
dc.contributor.authorIDLeblebicioglu, Hakan/0000-0002-6033-8543
dc.contributor.authorIDSuceveanu, Andra Iulia/0000-0001-8669-4952
dc.contributor.authorIDSimon, Krzysztof/0000-0002-8040-0412
dc.date.accessioned2020-06-21T13:56:48Z
dc.date.available2020-06-21T13:56:48Z
dc.date.issued2014
dc.departmentOMÜen_US
dc.department-temp[Leblebicioglu, H.] Ondokuz Mayis Univ, Med Sch Samsun, Samsun, Turkey -- [Arama, V.] Carol Davila Univ Med & Pharm, Prof Dr Matei Bals Natl Inst Infect Dis, Bucharest, Romania -- [Causse, X.] Hop Source Orleans, Orleans, France -- [Marcellin, P.] Hop Beaujon, Paris, France -- [Ozaras, R.] Istanbul Univ, Cerrahpasa Med Fac, Istanbul, Turkey -- [Postawa-Klozinska, B.] Specjalist Szpital Zeromskiego, Krakow, Poland -- [Simon, K.] Univ Med, Wroclaw, Polanden_US
dc.description.abstractIn Europe, healthcare systems differ between countries and different factors may influence Chronic hepatitis B (CHB) treatment choices in different counties. This analysis from a prospective, longitudinal, non-interventional study in five EU countries aimed to explore determinants associated with treatment initiation or switch in patients with CHB. A total of 1267 adult patients with compensated CHB in Germany, France, Poland, Romania and Turkey were prospectively followed for up to 2years (March 2008-December 2010). Determinants of treatment initiation or switch were analysed using multivariate Cox proportional hazards regression. Median time since CHB diagnosis was 2.6 (0-37.7)years. Among 646 treatment-naive patients, the probability of treatment initiation during follow-up was higher: in Germany (P=0.0006), Poland (P<0.0001) and Romania (P=0.0004) compared with Turkey; in patients with alanine transaminase (ALT) 1-2xupper limit of normal (ULN) (P=0.0580) or >2xULN (P=0.0523) compared with ALT 1xULN; and in patients with hepatitis B virus (HBV) DNA 2000IU/mL (P<0.0001) compared with HBV DNA <2000IU/mL or undetectable. Among 567 treated patients, 87 switched treatment during follow-up. The probability of treatment switch was higher: in France (P=0.0029), Germany (P=0.0078) and Poland (P=0.0329) compared with Turkey; and in patients with HBV DNA <2000 (P<0.0001) or 2000IU/mL (P<0.0001), compared with undetectable. Viral load and ALT level were identified as the major drivers of treatment initiation. HBV DNA level was also a significant determinant of treatment switch. Results were statistically different across EU countries.en_US
dc.description.sponsorshipRocheRoche Holding; MSD; Bristol-Myers SquibbBristol-Myers Squibb; GileadGilead Sciences; Janssen-TibotecJohnson & Johnson USAJanssen Biotech Inc; Echosens; Dynavax; Idenixen_US
dc.description.sponsorshipVA has received research grants and speaker honoraria from Roche, MSD and Bristol-Myers Squibb. XC has received speaker honoraria from Bristol-Myers Squibb, Gilead, Janssen and Roche and been retained as an expert consultant by Gilead and MSD. PM has received research grants from Roche, Gilead, Janssen-Tibotec, MSD and Echosens, and acted as a study investigator for these and Bristol-Myers Squibb, Vertex, Novartis, Pharmasset, Boehringer, Abbott and Pfizer. He has received speaker honoraria from Roche, Gilead, Bristol-Myers Squibb, Novartis, Pharmasset, Jansssen-Tibotec and MSD, and been retained as an expert consultant to these plus Vertex and Abbott. KS has received research grants from Dynavax, Roche, Bristol-Myers Squibb, Idenix and has participated in lectures for MSD, Roche, Gilead, Alfa Wasserman and Hasco-Lek. AS has received speaker honoraria from Roche, MSD, Bristol-Myers Squibb, Astra-Zeneca, KRKA, Berlin-Chemie Menarini, Reedy's, Alvogen, Zentiva. SZ has participated as a consultant for Abbott, Achillion, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Idenix, Inhibitex, iTherX, Janssen, Merck, Novartis, Presidio, Roche, Santaris and Vertex. DK is currently consulting for Bristol-Myers Squibb. IK and EM are employees of Bristol-Myers Squibb. BL and SB were employees of Bristol-Myers Squibb at the time of the study conduct. SB and BL are currently consulting for international bio-pharmaceutical companies including Bristol-Myers Squibb. JPZ has participated as a consultant and speaker for Roche, Bristol-Myers Squibb, Gilead, MSD, Siemens and Janssen. HL, RO, BP-K and MW have no conflicts of interest to declare. This study was funded by Bristol-Myers Squibb. Editorial assistance was provided by ArticulateScience, funded by Bristol-Myers Squibb.en_US
dc.identifier.doi10.1111/jvh.12202
dc.identifier.endpage670en_US
dc.identifier.issn1352-0504
dc.identifier.issn1365-2893
dc.identifier.issue9en_US
dc.identifier.pmid24329883
dc.identifier.startpage662en_US
dc.identifier.urihttps://doi.org/10.1111/jvh.12202
dc.identifier.urihttps://hdl.handle.net/20.500.12712/15021
dc.identifier.volume21en_US
dc.identifier.wosWOS:000340391600010
dc.language.isoenen_US
dc.publisherWileyen_US
dc.relation.journalJournal of Viral Hepatitisen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectAdefoviren_US
dc.subjectAntiviral Treatmenten_US
dc.subjectChronic Hepatitis Ben_US
dc.subjectEntecaviren_US
dc.subjectLamivudineen_US
dc.subjectTenofoviren_US
dc.titlePredictors Associated with Treatment Initiation and Switch in a Real-World Chronic Hepatitis B Population from Five European Countriesen_US
dc.typeArticleen_US
dspace.entity.typePublication

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