title: Efficacy and safety of tenofovir in chronic hepatitis B: Australian real world experience.
abstract: OBJECTIVE
  To evaluate the long-term treatment outcomes of tenofovir therapy in patients in a real world Australian tertiary care setting.
  
  
  METHODS
  We performed a retrospective analysis of treatment outcomes among treatment-naïve and treatment-experienced patients receiving a minimum 3 mo tenofovir therapy through St Vincent's Hospital Melbourne, Australia. We included patients receiving tenofovir [tenofovir disoproxil fumarate (TDF)] monotherapy, as well as patients treated with TDF in combination with a second antiviral agent. Patients were excluded if they demonstrated human immune-deficiency virus/hepatitis C virus/hepatitis delta virus coinfection or were less than 18 years of age. We considered virological and biochemical response, as well as safety outcomes. Virological response was determined by measurement of hepatitis B virus (HBV) DNA using sensitive assays; biochemical response was determinedviaserum liver function tests; histological response was determined from liver biopsy and fibroscan; safety analysis focused on glomerular renal function and bone mineral density. The primary efficacy endpoint was complete virological suppression over time, defined by HBV DNA < 20 IU/mL. Secondary efficacy endpoints included rates of biochemical response, and HB e antigen (HBeAg)/HB surface antigen loss and seroconversion over time.
  
  
  RESULTS
  Ninety-two patients were identified who fulfilled the enrolment criteria. Median follow-up was 26 mo (range 3-114). Mean age was 46 (24-78) years, 64 (70%) were male and 77 (84%) were of Asian origin. 55 (60%) patients were treatment-naïve and 62 patients (67%) were HBeAg-negative. Complete virological suppression was achieved by 45/65 (71%) patients at 12 mo, 37/46 (80%) at 24 mo and 25/28 (89%) at 36 mo. Partial virological response (HBV DNA 20-2000 IU/mL) was achieved by 89/92 (96.7%) of patients. Multivariate analysis showed a significant relationship between virological suppression at end of follow-up and baseline HBV DNA level (OR = 0.897, 95%CI: 0.833-0.967,P= 0.0046) and HBeAg positive status (OR = 0.373, 95%CI: 0.183-0.762,P= 0.0069). There was no difference in response comparing treatment-naïve and treatment-experienced patients. Three episodes of virological breakthrough occurred in the setting of non-compliance. Tenofovir therapy was well tolerated.
  
  
  CONCLUSIONS
  Tenofovir is an efficacious, safe and well-tolerated treatment in an Australian real-world tertiary care setting. Our data are similar to the reported experience from registration trials.
authors.affiliation: Grace C Lovett, Tin Nguyen, David M Iser, Jacinta A Holmes, Robert Chen, Barbara Demediuk, Gideon Shaw, Sally J Bell, Paul V Desmond, Alexander J Thompson, Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy 3065, Australia.
authors.forename: Grace C
authors.initials: GC
authors.lastname: Lovett
authors.affiliation: Grace C Lovett, Tin Nguyen, David M Iser, Jacinta A Holmes, Robert Chen, Barbara Demediuk, Gideon Shaw, Sally J Bell, Paul V Desmond, Alexander J Thompson, Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy 3065, Australia.
authors.forename: Tin
authors.initials: T
authors.lastname: Nguyen
authors.affiliation: Grace C Lovett, Tin Nguyen, David M Iser, Jacinta A Holmes, Robert Chen, Barbara Demediuk, Gideon Shaw, Sally J Bell, Paul V Desmond, Alexander J Thompson, Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy 3065, Australia.
authors.forename: David M
authors.initials: DM
authors.lastname: Iser
authors.affiliation: Grace C Lovett, Tin Nguyen, David M Iser, Jacinta A Holmes, Robert Chen, Barbara Demediuk, Gideon Shaw, Sally J Bell, Paul V Desmond, Alexander J Thompson, Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy 3065, Australia.
authors.forename: Jacinta A
authors.initials: JA
authors.lastname: Holmes
authors.affiliation: Grace C Lovett, Tin Nguyen, David M Iser, Jacinta A Holmes, Robert Chen, Barbara Demediuk, Gideon Shaw, Sally J Bell, Paul V Desmond, Alexander J Thompson, Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy 3065, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Chen
authors.affiliation: Grace C Lovett, Tin Nguyen, David M Iser, Jacinta A Holmes, Robert Chen, Barbara Demediuk, Gideon Shaw, Sally J Bell, Paul V Desmond, Alexander J Thompson, Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy 3065, Australia.
authors.forename: Barbara
authors.initials: B
authors.lastname: Demediuk
authors.affiliation: Grace C Lovett, Tin Nguyen, David M Iser, Jacinta A Holmes, Robert Chen, Barbara Demediuk, Gideon Shaw, Sally J Bell, Paul V Desmond, Alexander J Thompson, Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy 3065, Australia.
authors.forename: Gideon
authors.initials: G
authors.lastname: Shaw
authors.affiliation: Grace C Lovett, Tin Nguyen, David M Iser, Jacinta A Holmes, Robert Chen, Barbara Demediuk, Gideon Shaw, Sally J Bell, Paul V Desmond, Alexander J Thompson, Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy 3065, Australia.
authors.forename: Sally J
authors.initials: SJ
authors.lastname: Bell
authors.affiliation: Grace C Lovett, Tin Nguyen, David M Iser, Jacinta A Holmes, Robert Chen, Barbara Demediuk, Gideon Shaw, Sally J Bell, Paul V Desmond, Alexander J Thompson, Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy 3065, Australia.
authors.forename: Paul V
authors.initials: PV
authors.lastname: Desmond
authors.affiliation: Grace C Lovett, Tin Nguyen, David M Iser, Jacinta A Holmes, Robert Chen, Barbara Demediuk, Gideon Shaw, Sally J Bell, Paul V Desmond, Alexander J Thompson, Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy 3065, Australia.
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Thompson
keywords: Australia; Chronic hepatitis B; Hepatitis B virus; Real-life; Tenofovir; Virological suppression