December 16, 2013

Predictors associated with treatment initiation and switch in a real-world chronic hepatitis B population from five European countries

Journal of Viral Hepatitis

Early View (Online Version of Record published before inclusion in an issue)

Original Article

H. Leblebicioglu1,*, V. Arama2, X. Causse3, P. Marcellin4, R. Ozaras5, B. Postawa-Klozinska6, K. Simon7, A. I. Suceveanu8, M. Wiese9, S. Zeuzem10, I. Klauck11, E. Morais11, S. Bjork12,†, B. Lescrauwaet13,†,  D. Kamar14,  J. P. Zarski15, for The AI463-121 European Longitudinal Chronic Hepatitis B Study Group

Article first published online: 15 DEC 2013
DOI: 10.1111/jvh.12202
© 2013 John Wiley & Sons Ltd


Keywords: adefovir;  antiviral treatment;  chronic hepatitis B;  entecavir;  lamivudine;   tenofovir


In 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 2 years (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-naïve 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) 1–2 × upper limit of normal (ULN) (P = 0.0580) or >2 × ULN (P = 0.0523) compared with ALT ≤1 × ULN; and in patients with hepatitis B virus (HBV) DNA ≥2000 IU/mL (P < 0.0001) compared with HBV DNA <2000 IU/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 ≥2000 IU/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.


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