{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T11:03:29Z","timestamp":1792839809771,"version":"4.5.0"},"reference-count":33,"publisher":"Wiley","issue":"11-12","license":[{"start":{"date-parts":[[2024,9,27]],"date-time":"2024-09-27T00:00:00Z","timestamp":1727395200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"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":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In two phase 3 studies, tenofovir alafenamide (TAF) showed non\u2010inferior efficacy versus tenofovir disoproxil fumarate (TDF), with more favourable renal and bone safety in patients with chronic hepatitis B (CHB).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Here, we report the studies' final 8\u2010year results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>CHB patients (hepatitis B e antigen [HBeAg]\u2010negative and HBeAg\u2010positive) were randomised (2:1) to double\u2010blind TAF 25\u2009mg\/day or TDF 300\u2009mg\/day for up to 3\u2009years, followed by open\u2010label (OL) TAF through year 8. Virological, biochemical, serological and fibrosis responses, and safety, including bone and renal parameters, were evaluated. Resistance to TAF was assessed annually by deep sequencing of polymerase\/reverse transcriptase and by phenotyping.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 1298 patients randomised to double\u2010blind TAF (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009866) or double\u2010blind TDF (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009432), 775 in the TAF group and 382 in the TDF group received OL TAF, including 180 and 202 who switched from TDF to TAF at year 2 (TDF2y\u2009\u2192\u2009TAF6y) or year 3 (TDF3y\u2009\u2192\u2009TAF5y), respectively. At year 8, among patients in the TAF8y, TDF2y\u2009\u2192\u2009TAF6y and TDF3y\u2009\u2192\u2009TAF5y groups, 69%, 66% and 73% (missing\u2010equals\u2010failure analysis) and 95%, 94% and 97% (missing\u2010equals\u2010excluded) of patients, respectively, achieved HBV DNA &lt;29\u2009IU\/mL. Estimated glomerular filtration rate (Cockcroft\u2010Gault method; eGFR\n                      <jats:sub>CG<\/jats:sub>\n                      ) and hip\/spine bone mineral density (BMD) remained stable in patients receiving double\u2010blind\/OL TAF, with only small declines at year 8. Decreases in eGFR\n                      <jats:sub>CG<\/jats:sub>\n                      and hip\/spine BMD observed during double\u2010blind TDF improved after switching to OL TAF. No patients developed resistance to TAF.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Long\u2010term TAF treatment exhibited favourable safety and tolerability with high rates of viral suppression and no development of resistance.<\/jats:p>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      numbers NCT01940341 and NCT01940471.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.18278","type":"journal-article","created":{"date-parts":[[2024,9,27]],"date-time":"2024-09-27T03:03:39Z","timestamp":1727406219000},"page":"1573-1586","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":41,"title":["Eight\u2010year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials"],"prefix":"10.1111","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0732-3078","authenticated-orcid":false,"given":"Maria","family":"Buti","sequence":"first","affiliation":[{"name":"Hospital Universitario Vall d'Hebron  Barcelona Spain"},{"name":"CIBEREHD del Instituto Carlos III  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1544-577X","authenticated-orcid":false,"given":"Young\u2010Suk","family":"Lim","sequence":"additional","affiliation":[{"name":"Asan Medical Center University of Ulsan College of Medicine  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henry Lik Yuen","family":"Chan","sequence":"additional","affiliation":[{"name":"Faculty of Medicine The Chinese University of Hong Kong, HMA Office  Tai Wai Shatin Hong Kong"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kosh","family":"Agarwal","sequence":"additional","affiliation":[{"name":"Institute of Liver Studies King's College Hospital NHS Foundation Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Marcellin","sequence":"additional","affiliation":[{"name":"Hepatology Department, H\u00f4pital Beaujon, APHP, INSERM University of Paris  Clichy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurizia R.","family":"Brunetto","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine University of Pisa and Hepatology Unit, Pisa University Hospital  Pisa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wan\u2010Long","family":"Chuang","sequence":"additional","affiliation":[{"name":"Kaohsiung Medical University Hospital, Kaohsiung Medical University  Kaohsiung City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harry L. 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