{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,25]],"date-time":"2026-02-25T17:31:52Z","timestamp":1772040712155,"version":"3.50.1"},"reference-count":29,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,1,6]],"date-time":"2022-01-06T00:00:00Z","timestamp":1641427200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Gastro and Hepatol"],"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and Aim<\/jats:title><jats:p>Tenofovir disoproxil fumarate (TDF) is a first\u2010line treatment for chronic hepatitis B virus (HBV) infection for its high potency and a low rate of drug resistance. This study investigated the efficacy and safety of TDF in Chinese patients with chronic hepatitis B (CHB) infection after treatment failure with multiple nucleos(t)ide analogues (NAs).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients included were aged 18\u201365\u00a0years, with treatment failure with multiple NAs (serum HBV DNA\u00a0&gt;\u00a0200\u00a0IU\/mL after more than two different NA treatments). The primary endpoint was proportion of patients with serum HBV DNA\u00a0&lt;\u00a020\u00a0IU\/mL at Week 144 of TDF monotherapy. Secondary endpoints and safety were also assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 213 patients were enrolled. At Week 144, mean HBV DNA decreased significantly from baseline (4.4 <jats:italic>vs<\/jats:italic> 1.4 log<jats:sub>10<\/jats:sub> IU\/mL), with 77.0% patients (95% confidence interval: 71.1, 82.9) achieving serum HBV DNA\u00a0&lt;\u00a020\u00a0IU\/mL. Three (1.4%) patients experienced virological breakthrough during TDF monotherapy, without hepatitis flare. At Week 144, 15.3% and 4.7% patients (hepatitis B e antigen [HBeAg]\u2010positive at baseline) experienced HBeAg loss and HBeAg seroconversion, respectively; 68.3% patients achieved normalized alanine aminotransferase levels. Overall, 58.7% patients experienced more than one adverse event (AE). Most common AEs were upper respiratory tract infection and blood creatine phosphokinase increase; 8.5% patients experienced study drug\u2010related AEs; 9.4% patients experienced serious AEs (none were TDF\u2010related). Among renal safety parameters, overall trend of mean serum phosphorous level remained stable, while mean estimated glomerular filtration rate increased slightly.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Tenofovir disoproxil fumarate monotherapy is efficacious in CHB patients with multiple NAs treatment failure with no new safety findings.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jgh.15757","type":"journal-article","created":{"date-parts":[[2021,12,11]],"date-time":"2021-12-11T06:53:12Z","timestamp":1639205592000},"page":"471-479","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Tenofovir disoproxil fumarate for multiple nucleos(t)ide analogues treatment failure hepatitis B: Is monotherapy enough?"],"prefix":"10.1111","volume":"37","author":[{"given":"Xieer","family":"Liang","sequence":"first","affiliation":[{"name":"Nanfang Hospital Southern Medical University  Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2582-8803","authenticated-orcid":false,"given":"Qing","family":"Xie","sequence":"additional","affiliation":[{"name":"School of Medicine Ruijin Hospital Affiliated to Jiaotong University  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jia","family":"Shang","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases Henan Provincial People's Hospital  Zhengzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9790-6225","authenticated-orcid":false,"given":"Hong","family":"Tang","sequence":"additional","affiliation":[{"name":"West China Hospital of Sichuan University  Chengdu China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Min","family":"Xu","sequence":"additional","affiliation":[{"name":"Guangzhou Eighth Municipal People's Hospital  Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qinghua","family":"Meng","sequence":"additional","affiliation":[{"name":"Beijing You\u2010An Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiming","family":"Zhang","sequence":"additional","affiliation":[{"name":"Huashan Hospital Affiliated to Fudan University  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pujun","family":"Gao","sequence":"additional","affiliation":[{"name":"The First Hospital of Jilin University  Changchun China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jifang","family":"Sheng","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Collaborative Innovation Centre for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, School of Medicine Zhejiang University  Hangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hao","family":"Wang","sequence":"additional","affiliation":[{"name":"Peking University People's Hospital  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jidong","family":"Jia","sequence":"additional","affiliation":[{"name":"Beijing Friendship Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guiqiang","family":"Wang","sequence":"additional","affiliation":[{"name":"Peking University First Hospital  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shunquan","family":"Wu","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline R&amp;D Company Limited  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jingna","family":"Ping","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline R&amp;D Company Limited  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8230-8583","authenticated-orcid":false,"given":"Jinlin","family":"Hou","sequence":"additional","affiliation":[{"name":"Nanfang Hospital Southern Medical University  Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,1,6]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"World Health Organization.Hepatitis B fact sheet 2019.https:\/\/www.who.int\/en\/news\u2010room\/fact\u2010sheets\/detail\/hepatitis\u2010b. Accessed November 15 2019."},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(18)30056-6"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.18.219469"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000010484"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2018.04.002"},{"key":"e_1_2_8_7_1","first-page":"322","article-title":"for CR\u2010HepB study group, Beijing, China. Baseline characteristics and treatment patterns of the patients recruited to the China registry of hepatitis B","volume":"7","author":"Shan S","year":"2019","journal-title":"J. Clin. Transl. Hepatol."},{"key":"e_1_2_8_8_1","unstructured":"Gilead press release.U.S. Food and Drug Administration approves Viread(R) for chronic hepatitis B in adults 2008.https:\/\/www.gilead.com\/news\u2010and\u2010press\/press\u2010room\/press\u2010releases\/2008\/8\/us\u2010food\u2010and\u2010drug\u2010administration\u2010approves\u2010vireadr\u2010for\u2010chronic\u2010hepatitis\u2010b\u2010in\u2010adults. 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