title: Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year, Prospective, Real-World Study in France.
abstract: Tenofovir disoproxil fumarate (TDF) demonstrated potent and sustainable antiviral efficacy and a good safety profile in patients with chronic hepatitis B (CHB) in controlled clinical trials. Real-world data are important to confirm effectiveness and safety data in patient populations encountered in routine clinical practice.
  
  
  
  This non-interventional, prospective, 36-month study included treatment-naïve and treatment-experienced patients with CHB initiating their first TDF regimen (monotherapy or combination therapy) in routine clinical practice in France. Clinical, virologic, biochemical, compliance, and safety data were collected.
  
  
  
  Data from 440 consecutive patients from 58 centers were analyzed. The majority of the cohort was male (71 %), hepatitis B "e" antigen-negative (HBeAg-) (74 %), and treatment-experienced (56 %); 11 % were aged ≥65 years; and comorbidities were reported in 39 %. After 12 months, 92 % of the overall cohort achieved virologic response (HBV DNA <69 IU/mL) which was maintained to 36 months (96 %); virologic response was achieved by >90 % of patients irrespective of HBeAg status, age, or prior treatment history. At 36 months, 77 % of patients had normal alanine aminotransferase levels. Fourteen patients lost hepatis B surface (HBs) antigen, and seven seroconverted to anti-HBs. TDF was well tolerated over the 36-month study, including in 14 women who became pregnant during the study. Median estimated glomerular filtration rate did not change markedly from baseline irrespective of prior treatment history.
  
  
  
  TDF demonstrated potent virologic and biochemical responses across a broad range of patients reflective of routine clinical practice. The safety profile was consistent with results from pivotal trials.
authors.affiliation: Service d'Hépatologie, Hôpital Beaujon, 100 Bv du Gal Leclerc, Pavillion Abrami, 92110, Clichy, France. patrick.marcellin@bjn.aphp.fr.
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
authors.affiliation: Hôpital de la Croix Rousse, Lyon, France.
authors.forename: Fabien
authors.initials: F
authors.lastname: Zoulim
authors.affiliation: Hôpital Henri Mondor, AP-HP, INSERM U955, Universite Paris-Est, Créteil, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Hézode
authors.affiliation: Centre Hospitalier Régional, Orléans, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Causse
authors.affiliation: Hôpital Paul Brousse, Villejuif, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Roche
authors.affiliation: Hôpital de l'Archet, Nice, France.
authors.forename: Régine
authors.initials: R
authors.lastname: Truchi
authors.affiliation: Centre Hospitalier, Gonesse, France.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Pauwels
authors.affiliation: Institut Arnault Tzanck, Saint Laurent Du Var, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Ouzan
authors.affiliation: Hôpital Edouard Hériot, Lyon, France.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Dumortier
authors.affiliation: Hôpital Saint Eloi, Montpellier, France.
authors.forename: Georges-Philippe
authors.initials: GP
authors.lastname: Pageaux
authors.affiliation: Hôpital Saint Joseph, Marseille, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Bourlière
authors.affiliation: Hôpital Charles Nicolle, Rouen, France.
authors.forename: Ghassan
authors.initials: G
authors.lastname: Riachi
authors.affiliation: Hôpital de la Tronche, Grenoble, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Zarski
authors.affiliation: Centre Hospitalier Laennec, Creil, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Cadranel
authors.affiliation: Gilead Sciences, Boulogne-Billancourt, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Tilliet
authors.affiliation: Gilead Sciences, Boulogne-Billancourt, France.
authors.forename: Christiane
authors.initials: C
authors.lastname: Stern
authors.affiliation: Gilead Sciences, Boulogne-Billancourt, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Pétour
authors.affiliation: Gilead Sciences, Boulogne-Billancourt, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Libert
authors.affiliation: Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Silla M
authors.initials: SM
authors.lastname: Consoli
authors.affiliation: Hôpital Saint Eloi, Montpellier, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Larrey
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D001247:Asthenia / Q000139:chemically induced; D004279:DNA, Viral / Q000097:blood; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D005602:France; 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 / Q000188:drug therapy*; D006801:Humans; D017674:Hypophosphatemia / Q000139:chemically induced; D007674:Kidney Diseases / Q000139:chemically induced; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011446:Prospective Studies; D000069078:Seroconversion; D000068698:Tenofovir / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D000068698:Tenofovir
keywords: HBV; Real-world; Routine practice; Tenofovir
references.citation: Hepatology. 2009 May;49(5 Suppl):S185-95
references.pmid: 19399802
references.citation: J Hepatol. 2008 Feb;48(2):200-7
references.pmid: 18086507
references.citation: Presse Med. 2001 Jun 16-23;30(21):1044-8
references.pmid: 11471275
references.citation: Lancet. 2013 Feb 9;381(9865):468-75
references.pmid: 23234725
references.citation: Clin Gastroenterol Hepatol. 2007 Aug;5(8):921-31
references.pmid: 17678844
references.citation: Toxicol Sci. 2010 Jul;116(1):1-4
references.pmid: 20558414
references.citation: Clin Infect Dis. 2013 Dec;57(12):1773-81
references.pmid: 24046310
references.citation: Hepatology. 2009 Sep;50(3):661-2
references.pmid: 19714720
references.citation: N Engl J Med. 2004 Oct 7;351(15):1521-31
references.pmid: 15470215
references.citation: Hepatology. 2010 Jan;51(1):73-80
references.pmid: 19998272
references.citation: Presse Med. 2006 Feb;35(2 Pt 2):304-7
references.pmid: 16493334
references.citation: Gastroenterology. 2010 Oct;139(4):1207-17
references.pmid: 20600025
references.citation: J Hepatol. 2012 Jul;57(1):167-85
references.pmid: 22436845
references.citation: Eur J Public Health. 2013 Aug;23 (4):642-7
references.pmid: 23132874
references.citation: Gastroenterology. 2011 Jan;140(1):132-43
references.pmid: 20955704
references.citation: JAMA. 2006 Jan 4;295(1):65-73
references.pmid: 16391218
references.citation: Am J Gastroenterol. 2006 Aug;101(8):1797-803
references.pmid: 16817842
references.citation: Gastroenterology. 2006 Mar;130(3):678-86
references.pmid: 16530509
references.citation: N Engl J Med. 2008 Dec 4;359(23):2442-55
references.pmid: 19052126