Kim, W. RayLoomba, RohitBerg, ThomasSchall, Raul E. AguilarYee, Leland J.Dinh, Phillip V.Flaherty, John F.Martins, Eduardo B.Therneau, Terry M.Jacobson, IraFung, ScottButi, MariaMarcellin, Patrick2022-05-112022-05-112015-10-15Kim, 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), 3631-3638.0008-543Xhttps://doi.org/10.1002/cncr.29537https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.29537http://hdl.handle.net/11452/26373BACKGROUND: 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.eninfo:eu-repo/semantics/openAccessAntiviral therapyChronic hepatitis BFumarateHepatocellular carcinomaREACH-BTenofovir disoproxilVirus infectionAntiviral therapyPredictive scoreRisk-factorsCirrhosisHistoryDiseaseAnalogsOncologyAdultAntiviral agentsCarcinoma, hepatocellularDouble-blind methodDrug administration scheduleFemaleHepatitis B, chronicHumansIncidenceLiver cirrhosisLiver neoplasmsMaleMiddle agedRisk assessmentTenofovirArticle0003632627000112-s2.0-84943531655363136381212026177866OncologyHepatitis B E Antigen; Entecavir; Liver Cell CarcinomaAdefovir dipivoxilAlanine aminotransferaseHepatitis B(e) antigenTenofovir disoproxilVirus DNAAntivirus agentTenofovirAdultAgeAgedAlanine aminotransferase blood levelArticleCancer incidenceCancer riskChronic hepatitis bControlled studyDouble blind procedureFemaleFollow upGenderHumanHuman tissueLiver biopsyLiver cell carcinomaLiver cirrhosisLong term careMajor clinical studyMaleNonhumanPredictionPriority journalRegisterRisk Estimation for hepatocellular carcinoma in chronic hepatitis BStandardized incidence ratioCarcinoma, hepatocellularComplicationDrug administrationHepatitis B, chronicIncidenceLiver cirrhosisLiver neoplasmsMiddle agedRandomized controlled trialRisk assessmentVirology