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Entecavir (<jats:styled-content style=\"fixed-case\">ETV<\/jats:styled-content>) and tenofovir disoproxil fumarate (<jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content>) are the currently preferred first\u2010line agents. The safety of these agents in clinical practice is particularly relevant since long\u2010term treatment is usually required.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To summarise and critically discuss recent real\u2010world evidence on the safety of treatment with <jats:styled-content style=\"fixed-case\">ETV<\/jats:styled-content> or <jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content> in hepatitis B virus (<jats:styled-content style=\"fixed-case\">HBV<\/jats:styled-content>)\u2010monoinfected patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>PubMed and conference proceedings up to 15th June 2015 were searched using the terms ((((Hepatitis_B) <jats:styled-content style=\"fixed-case\">OR HBV<\/jats:styled-content>) <jats:styled-content style=\"fixed-case\">AND<\/jats:styled-content> ((tenofovir) <jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content> entecavir)) <jats:styled-content style=\"fixed-case\">AND<\/jats:styled-content> (((lactic_acidosis) <jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content> bone) <jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content> renal)).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In selected populations included in registration studies, both <jats:styled-content style=\"fixed-case\">ETV<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content> were well tolerated with no clinically significant renal toxicity or lactic acidosis. Growing \u2018real\u2010world\u2019 clinical experience with these agents includes some reports of <jats:styled-content style=\"fixed-case\">ETV<\/jats:styled-content>\u2010associated lactic acidosis and <jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content>\u2010associated renal impairment; however, evidence from cohort studies appears to be conflicting. In the case of <jats:styled-content style=\"fixed-case\">ETV<\/jats:styled-content>\u2010related lactic acidosis, a small number of cases have been reported, all in patients with decompensated cirrhosis. The degree of association between <jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content> treatment and changes in markers of renal function varies between studies: discrepancies may result from the use of different definitions and cut\u2010offs for reporting renal toxicities, and differences in patient populations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Pre\u2010treatment and on\u2010treatment monitoring of <jats:styled-content style=\"fixed-case\">eGFR<\/jats:styled-content> and phosphorus, with prompt appropriate dose adjustment or treatment switch can minimise the impact of <jats:styled-content style=\"fixed-case\">NUC<\/jats:styled-content> renal toxicity. Standardisation of measures of renal impairment and identification of early molecular markers remain an unmet need.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.13659","type":"journal-article","created":{"date-parts":[[2016,5,21]],"date-time":"2016-05-21T21:26:50Z","timestamp":1463866010000},"page":"16-34","source":"Crossref","is-referenced-by-count":111,"title":["Review article: long\u2010term safety of nucleoside and nucleotide analogues in <scp>HBV<\/scp>\u2010monoinfected patients"],"prefix":"10.1111","volume":"44","author":[{"given":"P.","family":"Lampertico","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology \u201cA.M. and A. Migliavacca\u201d Center for Liver Disease Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico Universit\u00e0 degli Studi di Milano Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H. L. 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