Retrospective Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Jan 8, 2017; 9(1): 48-56
Published online Jan 8, 2017. doi: 10.4254/wjh.v9.i1.48
Efficacy and safety of tenofovir in chronic hepatitis B: Australian real world experience
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
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
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, Faculty of Medicine, University of Melbourne, Parkville 3010, Australia
Author contributions: Lovett GC data collection, data analysis and manuscript composition; Nguyen T, Iser DM, Chen R, Demediuk B, Shaw G and Bell SJ data collection; Holmes JA data collection and manuscript reviewing; Desmond PV planned study, supervised data collection and analysis and revised manuscript; Thompson AJ planned study, supervised data collection and analysis and revised manuscript.
Institutional review board statement: This study was reviewed and approved by the St Vincent’s Hospital Melbourne Review Board.
Informed consent statement: Informed consent was not required for this study as only a retrospective audit was undertaken. The confidentiality of participant records has been maintained at all times, with patient information remaining deidentified.
Conflict-of-interest statement: Thompson AJ is an advisor/consultant to Gilead Sciences; has received research funding and acted as a speaker for Gilead Sciences; NHMRC fellowship Translational studies into viral hepatitis.
Data sharing statement: No data were created so no data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Alexander J Thompson, MBBS, FRACP, PhD, Department of Gastroenterology, St Vincent’s Hospital Melbourne, Level 4 Daly Wing, 35 Victoria Parade, Fitzroy 3065, Victoria, Australia. alexander.thompson@svha.org.au
Telephone: +61-3-92883581
Received: May 8, 2016
Peer-review started: May 10, 2016
First decision: June 18, 2016
Revised: July 29, 2016
Accepted: September 21, 2016
Article in press: September 22, 2016
Published online: January 8, 2017
Processing time: 243 Days and 16.2 Hours
Abstract
AIM

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 determined via serum 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.

CONCLUSION

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.

Keywords: Tenofovir; Hepatitis B virus; Australia; Real-life; Virological suppression; Chronic hepatitis B

Core tip: Clinical trials have demonstrated that tenofovir is a safe and efficacious treatment for patients with chronic hepatitis B, with high rates of sustained virological suppression. There are limited data evaluating the safety and efficacy of tenofovir in real-world settings. The aim of this study was to evaluate the long-term treatment outcomes of tenofovir therapy in patients in an Australian tertiary care setting. We performed a retrospective analysis of treatment outcomes among treatment-naïve and treatment-experienced patients.