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dc.contributor.authorMarcellin, Patrick
dc.contributor.authorWong, Dave
dc.contributor.authorSievert, William
dc.contributor.authorBuggisch, Peter
dc.contributor.authorPetersen, Jörg
dc.contributor.authorFlisiak, Robert
dc.contributor.authorManns, Michael
dc.contributor.authorKaita, Kelly
dc.contributor.authorKrastev, Zahari
dc.contributor.authorLee, Samuel S
dc.contributor.authorCathcart, Andrea L
dc.contributor.authorCrans, Gerald
dc.contributor.authorOp den Brouw, Marjoleine
dc.contributor.authorJump, Belinda
dc.contributor.authorGaggar, Anuj
dc.contributor.authorFlaherty, John
dc.contributor.authorButi-Ferret, Maria
dc.identifier.citationLiver Int. 2019 May 28. doi: 10.1111/liv.14155.en_US
dc.description.abstractBackground & Aims Tenofovir disoproxil fumarate (TDF) is a first‐line treatment for chronic hepatitis B (CHB). We aimed to describe the efficacy and safety profiles of TDF treatment for up to 10 years in a well‐described cohort of CHB patients. Methods Hepatitis B e antigen (HBeAg)‐negative and HBeAg‐positive patients from two randomised, double‐blind trials (ClinicalTrials. gov: NCT00117676 and NCT00116805) completed 48 weeks of randomised treatment with TDF or adefovir dipivoxil. A subset of these patients was then eligible to receive open‐label TDF treatment for up to 10 years. At Year 10, patients were assessed for virological suppression, alanine aminotransferase (ALT) normalisation, serological response, safety, and tolerability. Results Of 641 randomised and treated patients, 585 (91%) entered the open‐label extension phase with 203 (32%) patients completing Year 10 of the study. At Year 10, 118/118 (100%) of HBeAg‐negative patients and 78/80 (98%) of HBeAg‐positive patients with available data achieved hepatitis B virus (HBV) DNA <69 IU/mL, while 88/106 (83%) and 60/77 (78%) patients achieved ALT normalisation, respectively. Of the 23 patients with HBeAg status available at Year 10, 12 (52%) and six (27%) experienced HBeAg loss and seroconversion, respectively. No resistance to TDF was documented up to Year 10. In the period between Year 8 and Year 10, the safety profile of TDF was similar to previous reports, with few patients experiencing renal‐ or bone‐related adverse events. Conclusions Over 10 years, TDF had a favourable safety profile, was well tolerated, and resulted in continued maintenance of virological suppression with no documented resistance.en_US
dc.rightsAttribution-NonCommercial-ShareAlike 4.0 International*
dc.subjecthepatitis Ben_US
dc.titleTen-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection.en_US
dc.contributor.departmentHZI,Helmholtz-Zentrum für Infektionsforschung GmbH, Inhoffenstr. 7,38124 Braunschweig, Germany.en_US
dc.identifier.journalLiver internationalen_US
dc.source.journaltitleLiver international : official journal of the International Association for the Study of the Liver

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