{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T06:00:05Z","timestamp":1757311205148},"reference-count":31,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2016,12,21]],"date-time":"2016-12-21T00:00:00Z","timestamp":1482278400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Hepatology Research"],"published-print":{"date-parts":[[2017,9]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>Acquisition of nucleos(t)ide analog (NA) inhibitor resistance is critical in successful chronic hepatitis B treatment. As the pattern of tenofovir disoproxil fumarate (TDF) resistance mutations differs from that of other antiviral drugs, we sought to clarify the salvaging potential of TDF in patients with hepatitis B virus (HBV) infection who are poor responders or resistant to other NAs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A prospective, multicenter, single\u2010arm, open\u2010label study was carried out from December 2011 to October 2014. Poor responders defined as subjects with serum HBV\u2010DNA levels &gt;4\u00a0log<jats:sub>10<\/jats:sub>\u2009copies\/mL were enrolled. Subjects receiving lamivudine (LAM)\u2009+\u2009adefovir pivoxil (ADV) before the initiation of the study were switched to LAM\u2009+\u2009TDF. Subjects on entecavir hydrate (ETV) with or without ADV were switched to ETV\u2009+\u2009TDF. The primary efficacy end\u2010point was the proportion of subjects achieving HBV\u2010DNA &lt;2.1\u00a0log<jats:sub>10<\/jats:sub>\u2009copies\/mL (LLQ) at week 24. The secondary efficacy end\u2010points were the proportion of subjects with LLQ at weeks 48 and 96, serum alanine aminotransferase normalization, hepatitis B envelope antigen\/antibody and hepatitis B surface antigen\/antibody seroconversion.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirty\u2010four subjects were enrolled, 21 subjects were switched to ETV\u2009+\u2009TDF, and 13 subjects were switched to LAM\u2009+\u2009TDF. Drug resistance mutations were determined in 85% of the subjects at the time of the enrolment. The proportion of subjects who achieved LLQ was 59%, 62%, and 71% at weeks 24, 48, and 96, respectively. No serious adverse event related to TDF was reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our study clearly showed that TDF containing regimens were effective in salvaging poor responders and\/or those who are drug\u2010resistant to other NAs. This study is registered with ClinicalTrials.gov (NCT01475851) and the GSK Clinical Study Register (GSK LOC115912).<\/jats:p><\/jats:sec>","DOI":"10.1111\/hepr.12842","type":"journal-article","created":{"date-parts":[[2016,11,16]],"date-time":"2016-11-16T17:33:26Z","timestamp":1479317606000},"page":"1032-1041","source":"Crossref","is-referenced-by-count":11,"title":["Efficacy and safety of tenofovir disoproxil fumarate rescue therapy for chronic hepatitis B patients who failed other nucleos(t)ide analogs"],"prefix":"10.1111","volume":"47","author":[{"given":"Hiromitsu","family":"Kumada","sequence":"first","affiliation":[{"name":"Department of Hepatology Toranomon Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiko","family":"Koike","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine University of Tokyo  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuaki","family":"Suyama","sequence":"additional","affiliation":[{"name":"Medicines Development GlaxoSmithKline K.K.  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