title: Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year Prospective Field Practice Study in Germany.
abstract: Multiple clinical trials have demonstrated the efficacy and safety of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB). However, long-term efficacy and safety data for TDF in real-life clinical practice are limited.
  
  
  
  Prospective German field practice study in CHB-mono-infected patients. Patients were TDF-naïve but could have been treated previously with other HBV antivirals.
  
  
  
  Efficacy analysis included 400 patients; 301 (75 %) completed 36 months of TDF treatment. Both treatment-naïve and treatment-experienced patients showed a rapid decline in HBV DNA within 3 months of TDF initiation. After 36 months, HBV DNA < 69 IU/mL was achieved by 91 % of treatment-naïve patients (90 and 92 % in hepatitis B "e" antigen [HBeAg]-positive and [HBeAg]-negative, respectively) and 96 % of treatment-experienced patients (93 and 97 %, respectively). Three patients experienced virologic breakthrough, all with reported non-compliance. Overall, 5.7 % HBeAg-positive and 2.2 % HBeAg-negative patients lost hepatitis B surface antigen. Safety data were consistent with the known TDF safety profile; the most commonly reported adverse events possibly related to TDF were fatigue (2.0 %) and headache (2.0 %). Few patients (1.3 %) experienced renal-related adverse reactions. Creatinine clearance remained relatively stable over time; patients responded favorably where TDF was dose adjusted per label for decreased creatinine clearance.
  
  
  
  TDF showed a favorable tolerability profile and induced rapid and sustained suppression of HBV DNA in patients with CHB treated for up to 3 years in routine clinical practice, irrespective of treatment history. Efficacy and safety in this heterogeneous patient population were consistent with data from clinical trials.
authors.affiliation: IFI Institut für Interdisziplinäre Medizin an der Asklepios Klinik St. Georg Haus L, University of Hamburg, Lohmühlenstr 5, 20099, Hamburg, Germany. petersen@ifi-medizin.de.
authors.forename: Jörg
authors.initials: J
authors.lastname: Petersen
authors.affiliation: Leberzentrum Checkpoint, Berlin, Germany.
authors.forename: Renate
authors.initials: R
authors.lastname: Heyne
authors.affiliation: Zentrum für HIV und Hepatogastroenterologie, Düsseldorf, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Mauss
authors.affiliation: Universitätsklinikum, Essen, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Schlaak
authors.affiliation: Gastroenterologische Schwerpunktpraxis, Augsburg, Germany.
authors.forename: Willibald
authors.initials: W
authors.lastname: Schiffelholz
authors.affiliation: Universitätsklinikum, Heidelberg, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Eisenbach
authors.affiliation: Gastroenterologische Gemeinschaftspraxis, Herne, Germany.
authors.forename: Heinz
authors.initials: H
authors.lastname: Hartmann
authors.affiliation: Gastroenterologische Gemeinschaftspraxis, Leipzig, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Wiese
authors.affiliation: Leberpraxis, Hannover, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Boeker
authors.affiliation: Facharztpraxis für Innere Medizin, Wiesbaden, Germany.
authors.forename: Hanns-Friedrich
authors.initials: HF
authors.lastname: Loehr
authors.affiliation: Facharztpraxis für Innere Medizin, Berlin, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: John
authors.affiliation: Hepatologische Schwerpunktpraxis, Offenbach, Germany.
authors.forename: Maria
authors.initials: M
authors.lastname: Leuschner
authors.affiliation: Universitätsklinikum, Aachen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Trautwein
authors.affiliation: Gastroenterologische Gemeinschaftspraxis, Herne, Germany.
authors.forename: Gisela
authors.initials: G
authors.lastname: Felten
authors.affiliation: Gemeinschaftspraxis, Stuttgart, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Trein
authors.affiliation: Praxis Dr. Krause, Bayreuth, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Krause
authors.affiliation: Gilead Sciences, Martinsried, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Ruppert
authors.affiliation: Gilead Sciences, Martinsried, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Warger
authors.affiliation: Gastroenterologische Gemeinschaftspraxis, Herne, Germany.
authors.forename: Dietrich
authors.initials: D
authors.lastname: Hueppe
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D003404:Creatinine / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D054459:Elasticity Imaging Techniques; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005858:Germany; D006261:Headache / Q000139:chemically induced; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000097:blood / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D006801:Humans; D007674:Kidney Diseases / Q000097:blood / Q000139:chemically induced; D008099:Liver / Q000000981:diagnostic imaging; D008103:Liver Cirrhosis / Q000000981:diagnostic imaging / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000068698:Tenofovir / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D000068698:Tenofovir; D003404:Creatinine
keywords: Chronic hepatitis B; Clinical practice; Real world; Tenofovir disoproxil fumarate