{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T07:23:20Z","timestamp":1790061800251,"version":"4.0.1"},"reference-count":34,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2019,7,10]],"date-time":"2019-07-10T00:00:00Z","timestamp":1562716800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background &amp; Aims<\/jats:title><jats:p>Tenofovir disoproxil fumarate (TDF) is a first\u2010line treatment for chronic hepatitis B (CHB). We aimed to describe the efficacy and safety profiles of TDF treatment for up to 10\u00a0years in a well\u2010described cohort of CHB patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Hepatitis B e antigen (HBeAg)\u2010negative and HBeAg\u2010positive patients from two randomised, double\u2010blind trials (ClinicalTrials.gov: NCT00117676 and NCT00116805) completed 48\u00a0weeks of randomised treatment with TDF or adefovir dipivoxil. A subset of these patients was then eligible to receive open\u2010label TDF treatment for up to 10\u00a0years. At Year 10, patients were assessed for virological suppression, alanine aminotransferase (ALT) normalisation, serological response, safety and tolerability.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 641 randomised and treated patients, 585 (91%) entered the open\u2010label extension phase with 203 (32%) patients completing Year 10 of the study. At Year 10, 118\/118 (100%) of HBeAg\u2010negative patients and 78\/80 (98%) of HBeAg\u2010positive patients with available data achieved hepatitis B virus (HBV) DNA\u00a0&lt;\u00a069\u00a0IU\/mL, while 88\/106 (83%) and 60\/77 (78%) patients achieved ALT normalisation, respectively. Of the 23 patients with HBeAg status available at Year 10, 12 (52%) and six (27%) experienced HBeAg loss and seroconversion, respectively. No resistance to TDF was documented up to Year 10. In the period between Year 8 and Year 10, the safety profile of TDF was similar to previous reports, with few patients experiencing renal\u2010 or bone\u2010related adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Over 10\u00a0years, TDF had a favourable safety profile, was well tolerated, and resulted in continued maintenance of virological suppression with no documented resistance.<\/jats:p><\/jats:sec>","DOI":"10.1111\/liv.14155","type":"journal-article","created":{"date-parts":[[2019,5,28]],"date-time":"2019-05-28T14:34:09Z","timestamp":1559054049000},"page":"1868-1875","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":142,"title":["Ten\u2010year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection"],"prefix":"10.1111","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8950-0287","authenticated-orcid":false,"given":"Patrick","family":"Marcellin","sequence":"first","affiliation":[{"name":"Viral Hepatitis Research Unit H\u00f4pital Beaujon Clichy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David K","family":"Wong","sequence":"additional","affiliation":[{"name":"Toronto Centre for Liver Disease University Health Network, University of Toronto Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Sievert","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Unit Monash Health and Monash University Melbourne Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Buggisch","sequence":"additional","affiliation":[{"name":"Liver Unit, IFI\u2010Institute for Interdisciplinary Medicine Asklepios Klinik St Georg Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg","family":"Petersen","sequence":"additional","affiliation":[{"name":"Liver Unit, IFI\u2010Institute for Interdisciplinary Medicine Asklepios Klinik St Georg Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Flisiak","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Hepatology Medical University Bialystok Bialystok Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Manns","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology, and Endocrinology Hannover Medical School Hannover Germany"},{"name":"Helmholtz Center for Infection Research (HZI) Hannover Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly","family":"Kaita","sequence":"additional","affiliation":[{"name":"Viral Hepatitis Investigative Unit University of Manitoba Winnipeg Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zahari","family":"Krastev","sequence":"additional","affiliation":[{"name":"Clinic of Gastroenterology St Ivan Rilsky University Hospital, Medical University Sofia Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel S","family":"Lee","sequence":"additional","affiliation":[{"name":"Liver Unit University of Calgary Calgary Alberta Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea L","family":"Cathcart","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc Foster City California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerald","family":"Crans","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc Foster City California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marjoleine","family":"Op den Brouw","sequence":"additional","affiliation":[{"name":"Gilead Sciences Europe Ltd Uxbridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Belinda","family":"Jump","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc Foster City California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anuj","family":"Gaggar","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc Foster City California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Flaherty","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc Foster City California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Buti","sequence":"additional","affiliation":[{"name":"Liver Unit Hospital Universitario Vall d\u2019Hebron and CIBEREHD del Instituto Carlos III Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,7,10]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"World Health Organization.Guidelines on hepatitis B and C testing 2017.http:\/\/apps.who.int\/iris\/bitstream\/10665\/254621\/1\/9789241549981-eng.pdf?ua=1. 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