Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis b virus ınfection

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dc.contributor.authorTsai, Naoky
dc.contributor.authorPetersen, Joerg
dc.contributor.authorFlisiak, Robert
dc.contributor.authorKrastev, Zahary
dc.contributor.authorSchall, Raul Aguilar
dc.contributor.authorFlaherty, John F.
dc.contributor.authorMartins, Eduardo B.
dc.contributor.authorCharuworn, Prista
dc.contributor.authorKitrinos, Kathryn M.
dc.contributor.authorSubramanian, G. Mani
dc.contributor.authorGane, Edward
dc.contributor.authorMarcellin, Patrick
dc.contributor.buuauthorGürel, Selim
dc.contributor.departmentUludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı/Gastroenteroloji Bilim Dalı.tr_TR
dc.contributor.scopusid7003706434tr_TR
dc.date.accessioned2022-05-10T12:50:19Z
dc.date.available2022-05-10T12:50:19Z
dc.date.issued2015-05
dc.description.abstractBackground Long-term tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB) is associated with sustained viral suppression and regression of fibrosis and cirrhosis at year 5 (240 weeks) and no TDF resistance through 6 years (288 weeks). Aim We assessed the efficacy, safety, and resistance of TDF for up to 7 years (336 weeks) in HBeAg-positive and HBeAg-negative CHB patients. Methods Patients who completed 1 year (48 weeks) of randomized treatment with TDF or adefovir dipivoxil were eligible to receive open-label TDF for a total duration of 8 years (384 weeks). Results Of 641 patients initially randomized, 585 (91.3 %) entered the open-label phase; 437/585 (74.7 %) remained on study at year 7. For patients on treatment at year 7, 99.3 % maintained viral suppression (HBV DNA < 69 IU/mL), 80.0 % achieved serum alanine aminotransferase normalization, and in HBeAg-positive patients, 84/154 (54.5 %) and 25/154 (11.8 %) achieved HBeAg and HBsAg loss, respectively. One/375 (0.3 %) HBeAg-negative patients achieved HBsAg loss. No resistance to TDF was detected through 7 years. During the open-label phase, grade 3/4 drug-related adverse events were uncommon (1.0 %); ten (1.7 %) patients had elevation of serum creatinine >= 0.5 mg/dL above baseline. No significant change in bone mineral density was observed from year 4 to year 7 (week 192 to week 336). Conclusions Long-term TDF treatment was associated with sustained virologic, biochemical, and serologic responses, without resistance. TDF treatment was well tolerated, with a low incidence of renal and bone events. These data confirm the safety and efficacy of long-term TDF for CHB.en_US
dc.description.sponsorshipGilead Sciencesen_US
dc.identifier.citationButi, M. vd. (2009). "Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis b virus ınfection". Digestive Diseases and Sciences, 60(5), 1457-1464.en_US
dc.identifier.endpage1464tr_TR
dc.identifier.issn0163-2116
dc.identifier.issue5tr_TR
dc.identifier.pubmed25532501tr_TR
dc.identifier.scopus2-s2.0-84939650468tr_TR
dc.identifier.startpage1457tr_TR
dc.identifier.urihttps://doi.org/10.1007/s10620-014-3486-7
dc.identifier.urihttps://link.springer.com/article/10.1007/s10620-014-3486-7
dc.identifier.urihttp://hdl.handle.net/11452/26360
dc.identifier.volume60tr_TR
dc.identifier.wos000355570200045tr_TR
dc.indexed.pubmedPubMeden_US
dc.indexed.scopusScopusen_US
dc.indexed.wosSCIEen_US
dc.language.isoenen_US
dc.publisherSpringeren_US
dc.relation.collaborationYurt dışıtr_TR
dc.relation.journalDigestive Diseases and Sciencesen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergitr_TR
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAntiviral agenten_US
dc.subjectCirrhosisen_US
dc.subjectHepatitis B e antigenen_US
dc.subjectLiver diseaseen_US
dc.subjectLong-term efficacyen_US
dc.subjectAdefovir dipivoxilen_US
dc.subjectEntecavir treatmenten_US
dc.subjectNaive patientsen_US
dc.subjectLamivudineen_US
dc.subjectCirrhosisen_US
dc.subjectRisken_US
dc.subjectGastroenterology & hepatologyen_US
dc.subject.emtree9-(2-((bis(pivaloyloxymethoxy)phosphinoyl)methoxy)propyl)adenineen_US
dc.subject.emtreeAdenineen_US
dc.subject.emtreeAntivirus agenten_US
dc.subject.emtreeBiological markeren_US
dc.subject.emtreeHepatitis B(e) antigenen_US
dc.subject.emtreePhosphorous aciden_US
dc.subject.emtreeVirus DNAen_US
dc.subject.emtreeAnalogs and derivativesen_US
dc.subject.emtreeAntiviral resistanceen_US
dc.subject.emtreeBlooden_US
dc.subject.emtreeControlled studyen_US
dc.subject.emtreeDrug administrationen_US
dc.subject.emtreeDrug effectsen_US
dc.subject.emtreeGeneticsen_US
dc.subject.emtreeHepatitis B virusen_US
dc.subject.emtreeHepatitis B, chronicen_US
dc.subject.emtreeHumanen_US
dc.subject.emtreeImmunologyen_US
dc.subject.emtreeRandomized controlled trialen_US
dc.subject.emtreeTimeen_US
dc.subject.emtreeTreatment outcomeen_US
dc.subject.emtreeVirus loaden_US
dc.subject.meshAdenineen_US
dc.subject.meshAntiviral agentsen_US
dc.subject.meshBiomarkersen_US
dc.subject.meshDNA, viralen_US
dc.subject.meshDrug administration scheduleen_US
dc.subject.meshDrug resistance, viralen_US
dc.subject.meshHepatitis B e antigensen_US
dc.subject.meshHepatitis B virusen_US
dc.subject.meshHepatitis B, chronicen_US
dc.subject.meshHumansen_US
dc.subject.meshPhosphorous acidsen_US
dc.subject.meshTime factorsen_US
dc.subject.meshTreatment outcomeen_US
dc.subject.meshViral loaden_US
dc.subject.scopusHepatitis B E Antigen; Entecavir; Liver Cell Carcinomaen_US
dc.subject.wosGastroenterology & hepatologyen_US
dc.titleSeven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis b virus ınfectionen_US
dc.typeArticle
dc.wos.quartileQ4en_US

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