{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T22:51:20Z","timestamp":1789858280032,"version":"4.0.1"},"reference-count":42,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2012,3,28]],"date-time":"2012-03-28T00:00:00Z","timestamp":1332892800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2012,6]]},"abstract":"<jats:p><jats:bold>Summary.\u2002<\/jats:bold> Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are potent nucleos(t)ide analogues (NUCs) recommended as first\u2010line monotherapies for chronic hepatitis B. In Phase III trials, ETV and TDF demonstrated superior efficacy, and comparable safety compared with other NUCs. In long\u2010term clinical studies, both drugs achieved virologic response rates of around 95%, with very low rates of resistance development and good safety profiles. Clinical trials are conducted under standardized conditions with strict enrolment criteria that limit the heterogeneity of study populations. \u2018Real\u2010life\u2019 populations tend to be composed of a wider range of patients, often older and with different morbidities, comorbidities that may impact treatment efficacy and co\u2010factors, such as smoking and alcohol intake, which can have a direct impact on disease progression. Real\u2010life studies provide better representations of everyday clinical practice and are important to confirm the results reported in clinical studies and to identify rare or late\u2010emerging adverse events. In five \u2018real\u2010life\u2019 studies of ETV in more than 1000 patients, up to 4\u2003years of treatment resulted in virologic responses in 76\u201396% of patients. Two real\u2010life studies of TDF reported response rates of 71\u201392% after up to 21\u2003months of treatment. Low incidences of drug resistance and favourable tolerabilities were reported for both drugs, thus confirming the results from registration trials.<\/jats:p>","DOI":"10.1111\/j.1365-2893.2012.01602.x","type":"journal-article","created":{"date-parts":[[2012,3,30]],"date-time":"2012-03-30T16:35:06Z","timestamp":1333125306000},"page":"377-386","source":"Crossref","is-referenced-by-count":118,"title":["First\u2010line treatment of chronic hepatitis B with entecavir or tenofovir in \u2018real\u2010life\u2019 settings: from clinical trials to clinical practice"],"prefix":"10.1111","volume":"19","author":[{"given":"S.","family":"Pol","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Lampertico","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2012,3,28]]},"reference":[{"key":"e_1_2_11_2_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12072-008-9080-3"},{"key":"e_1_2_11_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2008.10.001"},{"key":"e_1_2_11_4_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23190"},{"key":"e_1_2_11_5_2","doi-asserted-by":"publisher","DOI":"10.1053\/jhep.2003.50208"},{"key":"e_1_2_11_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1746.2011.06695.x"},{"key":"e_1_2_11_7_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2011.06.036"},{"key":"e_1_2_11_8_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23785"},{"key":"e_1_2_11_9_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051285"},{"key":"e_1_2_11_10_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051287"},{"key":"e_1_2_11_11_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23327"},{"issue":"1","key":"e_1_2_11_12_2","first-page":"722A","article-title":"Three years of entecavir re\u2010treatment of HBeAg(\u2212) entecavir patients who previously discontinued entecavir therapy: results from study ETV\u2010901","volume":"48","author":"Shouval D","year":"2008","journal-title":"Hepatology"},{"key":"e_1_2_11_13_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2007.08.025"},{"key":"e_1_2_11_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8278(10)61017-3"},{"key":"e_1_2_11_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8278(09)60022-2"},{"key":"e_1_2_11_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.22841"},{"key":"e_1_2_11_17_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0802878"},{"issue":"1","key":"e_1_2_11_18_2","article-title":"Long\u2010term (4\u2003year) efficacy and safety of tenofovir disoproxil fumarate (TDF) treatment in HBeAg\u2010positive patients with chronic hepatitis B (study 103)","volume":"52","author":"Heathcote EJ","year":"2010","journal-title":"Hepatology"},{"issue":"1","key":"e_1_2_11_19_2","article-title":"Continued efficacy and safety through 4\u2003years of tenofovir disproxil fumarate (TDF) treatment in HBeAg\u2010negative patients with chronic hepatitis B (study 102)","volume":"52","author":"Marcellin P","year":"2010","journal-title":"Hepatology"},{"key":"e_1_2_11_20_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.24078"},{"issue":"1","key":"e_1_2_11_21_2","article-title":"No resistance to tenofovir disoproxil fumarate (TDF) detected following up to 192\u2003weeks of treatment in subjects monoinfected with chronic hepatitis B virus","volume":"52","author":"Snow\u2010Lampart A","year":"2010","journal-title":"Hepatology"},{"issue":"1","key":"e_1_2_11_22_2","article-title":"Five years of treatment with tenofovir DF (TDF) for chronic hepatitis B (CHB) infection is associated with sustained viral suppression and significant regression of histological fibrosis and cirrhosis","volume":"54","author":"Marcellin P","year":"2011","journal-title":"Hepatology"},{"issue":"1","key":"e_1_2_11_23_2","article-title":"A viral load reduction >3 log at 12\u2003week of Entecavir treatment correlated with HBe seroconversion in HBeag positive patients. Results from a real\u2010life setting study (the ORIENTE study)","volume":"52","author":"Buti M","year":"2010","journal-title":"Hepatology"},{"key":"e_1_2_11_24_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.24406"},{"issue":"1","key":"e_1_2_11_25_2","article-title":"Virological response to entecavir is associated with a lower probability of disease progression in chronic hepatitis B","volume":"54","author":"Zoutendik R","year":"2011","journal-title":"Hepatology"},{"key":"e_1_2_11_26_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-1241.2011.02719.x"},{"issue":"1","key":"e_1_2_11_27_2","article-title":"De\u2010novo antiviral therapy with nucleos(t)ide analogues in \u2018real\u2010life\u2019 pateints with chronic hepatitis B infection: comparison of virological responses between lamivudine+adefovir, entecavir vs. tenofovir therapy","volume":"54","author":"Carey I","year":"2011","journal-title":"Hepatology"},{"issue":"1","key":"e_1_2_11_28_2","article-title":"Entecavir monotherapy for nuc\u2010naive chronic hepatitis B patients from field practice: high efficacy and favorable safety profile over 3\u2003years","volume":"54","author":"Lampertico P","year":"2011","journal-title":"Hepatology"},{"key":"e_1_2_11_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8278(11)60750-2"},{"issue":"1","key":"e_1_2_11_30_2","article-title":"2\u2003year effectiveness and safety of tenofovir in 302 NUC\u2010naive patients with chronic hepatitis B: a multicenter European study in clinical practice","volume":"54","author":"Lampertico P","year":"2011","journal-title":"Hepatology"},{"key":"e_1_2_11_31_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01122-07"},{"key":"e_1_2_11_32_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23346"},{"issue":"14","key":"e_1_2_11_33_2","first-page":"PS","article-title":"Prospektive Untersuchung von Laktat\u2010Konzentrationen im Blut von Patienten mit chronischer Hepatitis B und dekompensierter Leberzirrhose w\u00e4hrend der Therapie mit Nukleos(t)id\u2010Analoga","volume":"1","author":"Lange CM","year":"2010","journal-title":"Med Klin"},{"key":"e_1_2_11_34_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2009.11.007"},{"key":"e_1_2_11_35_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23952"},{"key":"e_1_2_11_36_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.24361"},{"key":"e_1_2_11_37_2","doi-asserted-by":"publisher","DOI":"10.1177\/1756283X09354562"},{"key":"e_1_2_11_38_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2011.03.030"},{"key":"e_1_2_11_39_2","volume-title":"Summary of Product Characteristics","author":"European medicines agency"},{"key":"e_1_2_11_40_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-011-1610-5"},{"key":"e_1_2_11_41_2","doi-asserted-by":"publisher","DOI":"10.3851\/IMP1944"},{"issue":"4","key":"e_1_2_11_42_2","article-title":"Prevalence of renal alterations indicative for proximal tubular damage (PTD) in patients with chronic hepatitis B virus infection during long\u2010term treatment with tenofovir disoproxil fumarate (TDF)","volume":"52","author":"Brodzinski A","year":"2010","journal-title":"Hepatology"},{"issue":"1","key":"e_1_2_11_43_2","article-title":"Effectiveness and safety of tenofovir disproxil fumarate in field practice: a multicentre European cohort study of 737 patients with chronic hepatitis B","volume":"52","author":"Lampertico P","year":"2010","journal-title":"Hepatology"}],"container-title":["Journal of Viral Hepatitis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1365-2893.2012.01602.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1365-2893.2012.01602.x","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/j.1365-2893.2012.01602.x","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1365-2893.2012.01602.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T09:44:50Z","timestamp":1698659090000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1365-2893.2012.01602.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,3,28]]},"references-count":42,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2012,6]]}},"alternative-id":["10.1111\/j.1365-2893.2012.01602.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1365-2893.2012.01602.x","archive":["Portico"],"relation":{},"ISSN":["1352-0504","1365-2893"],"issn-type":[{"value":"1352-0504","type":"print"},{"value":"1365-2893","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,3,28]]}}}