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103
Risk of Hepatocellular Carcinoma Decreases over Time
in Chronic Hepatitis B Patients on Antiviral Therapy with
Entecavir or Tenofovir
Yao-Chun Hsu1, Hsiu-Jon Ho2, Hashem B. El-Serag3, Jaw-Town
Lin4, Chun-Ying Wu2; 1Department of Internal Medicine, E-Da Hospital,
Kaohsiung, Taiwan; 2Taichung Veterans General Hospital,
Taichung, Taiwan; 3Baylor College of Medicine, Houston, TX;
4Fu-Jen Catholic University, New Taipei, Taiwan
Background: How the risk of hepatocellular carcinoma (HCC)
may change over time remains unclear in patients with chronic
hepatitis B (CHB) on optimal antiviral therapy. Methods: This
is a nationwide retrospective cohort study based on analysis
of Taiwan’s national healthcare database. We screened all
Taiwanese residents who received entecavir or tenofovir, and
excluded patients with treatment shorter than 3 months, prior
exposure to lamivudine or telbivudine, any preexistent malignancy
or end-stage organ failure, and those who developed
HCC within 3 months of treatment. Totally 27,820 eligible
patients (median age, 48.1 years, 74.0% men, 31.3% cirrhosis,
and 7.0% HCV) were followed up until occurrence of HCC,
completion of 3 years on therapy, discontinuation of treatment
(defined as gap >3 months), or December 31, 2013. Results:
During a median follow-up of 25.1 (interquartile range, 12.1-
35.6) months, 802 patients developed HCC on therapy, with
1-, 2-, and 3-year cumulative incidence rates of 1.82% (95%
confidence interval [CI], 1.66-1.99%), 3.05% (95% CI, 2.82-
3.28%), and 4.06% (95% CI, 3.77-4.36%), respectively. The
multivariate Poisson regression analysis showed the incidence
rate of HCC was significantly decreased over time year by year
(adjusted incidence rate ratio [IRR] per year, 0.74; 95% CI,
0.67-0.81) with adjustment for cirrhosis (adjusted IRR, 5.16;
95% CI, 4.36-6.11), male sex (adjusted IRR, 1.73; 95% CI,
1.45-2.06), age (adjusted IRR per year, 1.05; 95% CI, 1.05-
1.06), and HCV co-infection (adjusted IRR, 1.26; 95% CI,
1.02-1.57). Conclusions: The incidence rate of HCC decreased
year by year in CHB patients on entecavir or tenofovir. These
findings indicate the need for a time-dependent model for risk
stratification in the era of antiviral therapy.
Risk determinants for HCC on entecavir or tenofovir
The model is built by Poisson regression analysis; IRR, incidence
rate ratio
Disclosures:
Yao-Chun Hsu - Speaking and Teaching: AbbVie, Roche, Bristol-Myers Squibb
Company, Harvester Trading Company
Hashem B. El-Serag - Consulting: Gilead, Wako
The following people have nothing to disclose: Hsiu-Jon Ho, Jaw-Town Lin, Chun-
Ying Wu
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