title: Chronic hepatitis B treatment initiation and modification patterns in five European countries: a 2-year longitudinal, non-interventional study.
abstract: BACKGROUND
  Chronic hepatitis B (CHB) is an important health concern, but there are few studies describing its management in different countries. This prospective, longitudinal, non-interventional study aimed to assess differences in CHB management in five European countries (Germany, France, Poland, Romania and Turkey).
  
  
  METHODS
  Data were collected from CHB patients' records between 2008 and 2010. Patients were stratified by treatment status at baseline (treated or untreated). The primary objective was to estimate the probability of a CHB management modification (treatment initiation or change) among patients from each country during a 2-year follow-up.
  
  
  RESULTS
  A total of 1,267 patients were included (567 treated, 700 untreated). Baseline characteristics between countries and treatment status groups were broadly comparable. Most patients had an alanine aminotransferase measurement in the 12 months prior to baseline; proportions of patients with an HBV DNA assessment varied by country and treatment status. The Kaplan-Meier-estimated probability of any treatment modification ranged from 9.4% (Turkey) to 30.1% (Poland) at 12 months and 10.0% (Turkey) to 40.0% (Poland) at 24 months. Modifications were more common in treated than untreated patients. The most frequently reported reasons for modifying treatment were HBV-DNA-related. The majority of treated patients were treated with monotherapy; however, choice of therapy differed between countries.
  
  
  CONCLUSIONS
  This is the first longitudinal study describing CHB management in European countries. Differences were observed in treatment and monitoring between countries, but alanine aminotransferase and HBV DNA levels consistently emerged as key tests in the management of CHB in all five countries.
authors.affiliation: Service Hepato-Gastroenterology, Hopital Beaujon, Paris, France. patrick.marcellin@bjn.aphp.fr.
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
authors.forename: Victoria
authors.initials: V
authors.lastname: Arama
authors.forename: Hakan
authors.initials: H
authors.lastname: Leblebicioglu
authors.forename: Jean Pierre
authors.initials: JP
authors.lastname: Zarski
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
authors.forename: Stefan
authors.initials: S
authors.lastname: Mauss
authors.forename: Jerzy
authors.initials: J
authors.lastname: Sieklucki
authors.forename: Monica
authors.initials: M
authors.lastname: Acalovschi
authors.forename: Gaye
authors.initials: G
authors.lastname: Usluer
authors.forename: Isabelle
authors.initials: I
authors.lastname: Klauck
authors.forename: Edith
authors.initials: E
authors.lastname: Morais
authors.forename: Stefan
authors.initials: S
authors.lastname: Bjork
authors.forename: Benedicte
authors.initials: B
authors.lastname: Lescrauwaet
authors.forename: Driss
authors.initials: D
authors.lastname: Kamar
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Simon
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood / Q000187:drug effects*; D019468:Disease Management; D005060:Europe; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects* / Q000502:physiology; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D019259:Lamivudine / Q000627:therapeutic use; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D000068698:Tenofovir
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D063065:Organophosphonates; D011994:Recombinant Proteins; D019259:Lamivudine; D011092:Polyethylene Glycols; C413685:entecavir; D006147:Guanine; D000068698:Tenofovir; D000410:Alanine Transaminase; D000225:Adenine; C100416:peginterferon alfa-2a