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Impact of long-term tenofovir disoproxil fumarate on incidence of hepatocellular carcinoma in patients with chronic hepatitis B.
- Source :
- Cancer (0008543X); Oct2015, Vol. 121 Issue 20, p3631-3638, 9p
- Publication Year :
- 2015
-
Abstract
- <bold>Background: </bold>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. <bold>Methods: </bold>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. <bold>Results: </bold>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. <bold>Conclusions: </bold>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. [ABSTRACT FROM AUTHOR]
- Subjects :
- TENOFOVIR
ANTIVIRAL agents
COMPARATIVE studies
DRUG administration
FISHER exact test
CIRRHOSIS of the liver
HEPATOCELLULAR carcinoma
LIVER tumors
RESEARCH methodology
MEDICAL cooperation
RESEARCH
RESEARCH funding
RISK assessment
EVALUATION research
RANDOMIZED controlled trials
TREATMENT effectiveness
DISEASE incidence
PROPORTIONAL hazards models
BLIND experiment
DESCRIPTIVE statistics
CHRONIC hepatitis B
MANN Whitney U Test
DISEASE complications
PREVENTION
DISEASE risk factors
THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 0008543X
- Volume :
- 121
- Issue :
- 20
- Database :
- Complementary Index
- Journal :
- Cancer (0008543X)
- Publication Type :
- Academic Journal
- Accession number :
- 110119739
- Full Text :
- https://doi.org/10.1002/cncr.29537