Impact of long-term tenofovir disoproxil fumarate on incidence of hepatocellular carcinoma in patients with chronic hepatitis B

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dc.contributor.authorKim, W. Ray
dc.contributor.authorLoomba, Rohit
dc.contributor.authorBerg, Thomas
dc.contributor.authorSchall, Raul E. Aguilar
dc.contributor.authorYee, Leland J.
dc.contributor.authorDinh, Phillip V.
dc.contributor.authorFlaherty, John F.
dc.contributor.authorMartins, Eduardo B.
dc.contributor.authorTherneau, Terry M.
dc.contributor.authorJacobson, Ira
dc.contributor.authorFung, Scott
dc.contributor.authorButi, Maria
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.accessioned2022-05-11T06:33:11Z
dc.date.available2022-05-11T06:33:11Z
dc.date.issued2015-10-15
dc.description.abstractBACKGROUND: Efficacy trials have shown that antiviral therapy improves the outcomes of patients with chronic hepatitis B virus (HBV) infection. However, prospective data regarding the effect of antiviral therapy on the incidence of hepatocellular carcinoma (HCC), especially among patients without cirrhosis, are limited. The authors examined the impact of tenofovir disoproxil fumarate (TDF) on the incidence of HCC using a validated prediction model. METHODS: The incidence of HCC in patients treated with TDF was obtained in the pivotal TDF registration studies after 384 weeks of follow-up. The predicted risk of HCC in individual patients was calculated using the Risk Estimation for Hepatocellular Carcinoma in Chronic Hepatitis B (REACH-B) model, which estimates HCC incidence for up to 10 years based on age, sex, alanine aminotransferase level, hepatitis B e antigen status, and HBV-DNA. Standardized incidence ratios (SIRs) were calculated comparing the observed and predicted numbers of HCC cases in the study cohort. RESULTS: Among 634 patients with evaluable baseline biopsies, 152 had cirrhosis (Ishak fibrosis score of 5 or 6) and 482 did not. During the 384 weeks of study, 14 cases of HCC were reported, with 4 occurring within the first year. The incidence of HCC was 0.37% per year in the study as a whole (0.28% among patients without cirrhosis and 0.65% among patients with cirrhosis). Among patients without cirrhosis, the observed incidence of HCC was significantly lower than predicted (SIR, 0.40; 95% confidence interval, 0.199-0.795). The last HCC case in a patient with cirrhosis occurred around week 192 with an SIR of 0.51 (95% confidence interval, 0.231-1.144) reported at week 384. CONCLUSIONS: Based on the REACH-B risk calculator, long-term therapy with TDF was associated with a reduced incidence of HCC among patients without cirrhosis who met treatment criteria.en_US
dc.description.sponsorshipAmerican Gastroenterological Association Foundation-Sucampo-ASP Designated Research Award in Geriatric Gastroenterologyen_US
dc.description.sponsorshipT. Franklin Williams Scholarship Awarden_US
dc.description.sponsorshipAtlantic Philanthropies Incen_US
dc.description.sponsorshipJohn A. Hartford Foundationen_US
dc.description.sponsorshipAssociation of Specialty Professorsen_US
dc.description.sponsorshipAmerican Gastroenterological Associationen_US
dc.description.sponsorshipGilead Sciencesen_US
dc.description.sponsorshipUnited States Department of Health & Human Services National Institutes of Health (NIH) - USA NIH National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) (K23DK090303)en_US
dc.identifier.citationKim, W. R. vd. (2015). "Impact of long-term tenofovir disoproxil fumarate on incidence of hepatocellular carcinoma in patients with chronic hepatitis B". Cancer, 121(20), 3631-3638.en_US
dc.identifier.endpage3638tr_TR
dc.identifier.issn0008-543X
dc.identifier.issue20tr_TR
dc.identifier.pubmed26177866tr_TR
dc.identifier.scopus2-s2.0-84943531655tr_TR
dc.identifier.startpage3631tr_TR
dc.identifier.urihttps://doi.org/10.1002/cncr.29537
dc.identifier.urihttps://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.29537
dc.identifier.urihttp://hdl.handle.net/11452/26373
dc.identifier.volume121tr_TR
dc.identifier.wos000363262700011tr_TR
dc.indexed.pubmedPubMeden_US
dc.indexed.scopusScopusen_US
dc.indexed.wosSCIEen_US
dc.language.isoenen_US
dc.publisherWileyen_US
dc.relation.collaborationYurt dışıtr_TR
dc.relation.journalCanceren_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergitr_TR
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAntiviral therapyen_US
dc.subjectChronic hepatitis Ben_US
dc.subjectFumarateen_US
dc.subjectHepatocellular carcinomaen_US
dc.subjectREACH-Ben_US
dc.subjectTenofovir disoproxilen_US
dc.subjectVirus infectionen_US
dc.subjectAntiviral therapyen_US
dc.subjectPredictive scoreen_US
dc.subjectRisk-factorsen_US
dc.subjectCirrhosisen_US
dc.subjectHistoryen_US
dc.subjectDiseaseen_US
dc.subjectAnalogsen_US
dc.subjectOncologyen_US
dc.subject.emtreeAdefovir dipivoxilen_US
dc.subject.emtreeAlanine aminotransferaseen_US
dc.subject.emtreeHepatitis B(e) antigenen_US
dc.subject.emtreeTenofovir disoproxilen_US
dc.subject.emtreeVirus DNAen_US
dc.subject.emtreeAntivirus agenten_US
dc.subject.emtreeTenofoviren_US
dc.subject.emtreeAdulten_US
dc.subject.emtreeAgeen_US
dc.subject.emtreeAgeden_US
dc.subject.emtreeAlanine aminotransferase blood levelen_US
dc.subject.emtreeArticleen_US
dc.subject.emtreeCancer incidenceen_US
dc.subject.emtreeCancer risken_US
dc.subject.emtreeChronic hepatitis ben_US
dc.subject.emtreeControlled studyen_US
dc.subject.emtreeDouble blind procedureen_US
dc.subject.emtreeFemaleen_US
dc.subject.emtreeFollow upen_US
dc.subject.emtreeGenderen_US
dc.subject.emtreeHumanen_US
dc.subject.emtreeHuman tissueen_US
dc.subject.emtreeLiver biopsyen_US
dc.subject.emtreeLiver cell carcinomaen_US
dc.subject.emtreeLiver cirrhosisen_US
dc.subject.emtreeLong term careen_US
dc.subject.emtreeMajor clinical studyen_US
dc.subject.emtreeMaleen_US
dc.subject.emtreeNonhumanen_US
dc.subject.emtreePredictionen_US
dc.subject.emtreePriority journalen_US
dc.subject.emtreeRegisteren_US
dc.subject.emtreeRisk Estimation for hepatocellular carcinoma in chronic hepatitis Ben_US
dc.subject.emtreeStandardized incidence ratioen_US
dc.subject.emtreeCarcinoma, hepatocellularen_US
dc.subject.emtreeComplicationen_US
dc.subject.emtreeDrug administrationen_US
dc.subject.emtreeHepatitis B, chronicen_US
dc.subject.emtreeIncidenceen_US
dc.subject.emtreeLiver cirrhosisen_US
dc.subject.emtreeLiver neoplasmsen_US
dc.subject.emtreeMiddle ageden_US
dc.subject.emtreeRandomized controlled trialen_US
dc.subject.emtreeRisk assessmenten_US
dc.subject.emtreeVirologyen_US
dc.subject.meshAdulten_US
dc.subject.meshAntiviral agentsen_US
dc.subject.meshCarcinoma, hepatocellularen_US
dc.subject.meshDouble-blind methoden_US
dc.subject.meshDrug administration scheduleen_US
dc.subject.meshFemaleen_US
dc.subject.meshHepatitis B, chronicen_US
dc.subject.meshHumansen_US
dc.subject.meshIncidenceen_US
dc.subject.meshLiver cirrhosisen_US
dc.subject.meshLiver neoplasmsen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle ageden_US
dc.subject.meshRisk assessmenten_US
dc.subject.meshTenofoviren_US
dc.subject.scopusHepatitis B E Antigen; Entecavir; Liver Cell Carcinomaen_US
dc.subject.wosOncologyen_US
dc.titleImpact of long-term tenofovir disoproxil fumarate on incidence of hepatocellular carcinoma in patients with chronic hepatitis Ben_US
dc.typeArticle
dc.wos.quartileQ1en_US

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