Journal of Viral Hepatitis
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
© 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.