Please use this identifier to cite or link to this item: http://hdl.handle.net/11452/26373
Title: Impact of long-term tenofovir disoproxil fumarate on incidence of hepatocellular carcinoma in patients with chronic hepatitis B
Authors: Kim, W. Ray
Loomba, Rohit
Berg, Thomas
Schall, Raul E. Aguilar
Yee, Leland J.
Dinh, Phillip V.
Flaherty, John F.
Martins, Eduardo B.
Therneau, Terry M.
Jacobson, Ira
Fung, Scott
Buti, Maria
Marcellin, Patrick
Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı/Gastroenteroloji Bilim Dalı.
Gürel, Selim
7003706434
Keywords: Antiviral therapy
Chronic hepatitis B
Fumarate
Hepatocellular carcinoma
REACH-B
Tenofovir disoproxil
Virus infection
Antiviral therapy
Predictive score
Risk-factors
Cirrhosis
History
Disease
Analogs
Oncology
Issue Date: 15-Oct-2015
Publisher: Wiley
Citation: Kim, 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.
Abstract: BACKGROUND: 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.
URI: https://doi.org/10.1002/cncr.29537
https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.29537
http://hdl.handle.net/11452/26373
ISSN: 0008-543X
Appears in Collections:Scopus
Web of Science

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