{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T10:51:44Z","timestamp":1740135104394,"version":"3.37.3"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,12,1]],"date-time":"2021-12-01T00:00:00Z","timestamp":1638316800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,12,20]],"date-time":"2021-12-20T00:00:00Z","timestamp":1639958400000},"content-version":"vor","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Gastroenterol"],"published-print":{"date-parts":[[2021,12]]},"abstract":"Abstract<\/jats:title>\n Background<\/jats:title>\n Tenofovir disoproxil fumarate (TDF) is widely used and recommended as first-line treatment for patients infected with the hepatitis B virus (HBV). However, current data are limited regarding the efficacy and safety of switching to TDF for the treatment of chronic hepatitis B in hepatitis B e-antigen (HBeAg)-positive patients who are virologically suppressed with another nucleos(t)ide analogue. The primary objective of this study was to evaluate the hepatitis B surface antigen (HBsAg) reduction potential of switching from entecavir (ETV) to TDF at week 48 in HBeAg-positive chronic hepatitis B patients with undetectable serum HBV-DNA.<\/jats:p>\n <\/jats:sec>\n Methods<\/jats:title>\n In this multicenter, single-arm, open-label, phase 4 clinical study, 75 participants currently treated with ETV 0.5\u00a0mg once daily were switched to TDF 300\u00a0mg once daily for 96\u00a0weeks.<\/jats:p>\n <\/jats:sec>\n Results<\/jats:title>\n At week 48, 3\/74 participants (4%) achieved 0.25 log10<\/jats:sub> reduction of HBsAg levels from baseline (the primary endpoint). Mean HBsAg reduction was \u22120.14 log10<\/jats:sub> IU\/mL and 12% (9\/74) achieved 0.25 log10<\/jats:sub> reduction by 96\u00a0weeks. No participants achieved HBsAg seroclearance. HBsAg reduction at weeks 48 and 96 was numerically greater in participants with higher alanine aminotransferase levels (\u2265\u200960 U\/L). Seventeen participants (25%) achieved HBeAg seroclearance up to week 96. No participants experienced viral breakthrough. All drug-related adverse events (18 participants [24%]) were mild in intensity, including an increase in urine beta-2-microglobulin (15 participants [20%]).<\/jats:p>\n <\/jats:sec>\n Conclusions<\/jats:title>\n In conclusion, HBsAg reduction was limited after switching from ETV to TDF in this study population. Further investigation is warranted to better understand the clinical impact of switching from ETV to TDF.<\/jats:p>\n ClinicalTrials.gov<\/jats:italic>: NCT03258710 registered August 21, 2017. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03258710?term=NCT03258710&draw=2&rank=1<\/jats:ext-link><\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s12876-021-02008-9","type":"journal-article","created":{"date-parts":[[2021,12,20]],"date-time":"2021-12-20T11:12:19Z","timestamp":1639998739000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Switching from entecavir to tenofovir disoproxil fumarate for HBeAg-positive chronic hepatitis B patients: a phase 4, prospective study"],"prefix":"10.1186","volume":"21","author":[{"given":"Fumitaka","family":"Suzuki","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshiyuki","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshiyasu","family":"Karino","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuhito","family":"Tanaka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masayuki","family":"Kurosaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Yatsuhashi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomofumi","family":"Atarashi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masanori","family":"Atsukawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tsunamasa","family":"Watanabe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masaru","family":"Enomoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masatoshi","family":"Kudo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoto","family":"Maeda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Kohno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kouji","family":"Joko","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kojiro","family":"Michitaka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koichiro","family":"Miki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiro","family":"Takahashi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatsuya","family":"Ide","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shigetoshi","family":"Fujiyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomoko","family":"Kohno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Itoh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sakiyo","family":"Tsukamoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuko","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2305-1711","authenticated-orcid":false,"given":"Yoshiaki","family":"Kawano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wataru","family":"Sugiura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiromitsu","family":"Kumada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,12,20]]},"reference":[{"issue":"9401","key":"2008_CR1","doi-asserted-by":"publisher","first-page":"2089","DOI":"10.1016\/S0140-6736(03)15108-2","volume":"362","author":"CL Lai","year":"2003","unstructured":"Lai CL, Ratziu V, Yuen MF, Poynard T. 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All participants provided written informed consent to participate in the study. This manuscript was developed following the CONSORT guidelines as much as possible even through this is not a randomized control trial.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not Applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"This study (NCT03258710) was conducted with a research fund from GlaxoSmithKline (GSK), in which FS, YS1, YK1, TA, MA, MK1, TW, YT, ME, MK2, NM, HK1, KJ, KM1, KM2, KT, TI, HY, SF, and HK2 participated as investigators and their institutions received funding in relation to this work. FS has served on the advisory board for GSK, and has received personal fees from AbbVie Inc., Bristol Myers Squibb, and GSK; YT has served on several advisory boards for GSK, has received personal fees from Fujirebio Inc., GSK, and Sysmex Corporation, has received personal fees and grants from Gilead Sciences Inc. and grants from FUJIFILM Corporation and Janssen Pharmaceutical KK, and has served on the Board of Trustees of the Leland Stanford Junior University; MK1 and HY have served on the advisory board for GSK, and have received personal fees from GSK; TA has received grants and personal fees from AbbVie Inc.; MA has received grants and personal fees from AbbVie Inc., and Merck Sharp & Dohme (MSD); KJ has received speaking fees from AbbVie Inc., Gilead Sciences, Inc., MSD, and Otsuka Pharmaceutical Co., Ltd.; TK, HI, YS2, and YK2 are employees of and own stock in GSK; ST is employee of GSK; WS is a former employee of GSK; HK2 has served as a speaker and trainer for AbbVie Inc., Eisai Co. Ltd, Gilead Sciences, Inc., MSD KK, and Sumitomo Dainippon Pharma.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"489"}}