Patients with hepatitis B virus (HBV) but without cirrhosis, who met treatment criteria, demonstrated a reduced incidence of hepatocellular carcinoma (HCC) while receiving tenofovir disoproxil fumarate (TDF) as long-term therapy, according to an article published online in the journal Cancer.
In the study, the authors used the Risk Estimation for Hepatocellular Carcinoma in Chronic Hepatitis B (REACH-B) model to predict risk of HCC in patients for up to 10 years based on age, sex, alanine aminotransferase level, hepatitis B e antigen status, and HBV-DNA.
The authors also calculated standardized incidence ratios (SIRs) to compare the observed and predicted numbers of HCC cases in the study cohort.
Results showed that 482 out of 634 patients, with evaluable baseline biopsies, did not have cirrhosis, while 152 patients did (Ishak fibrosis score of 5 or 6).
In total, 14 cases of HCC were reported during the 384-week study with an overall incidence of HCC of 0.37% per year, 0.28% in patients without cirrhosis, and 0.65% in those with cirrhosis.
Furthermore, the observed incidence of HCC was significantly less than the predicted value (SIR, 0.40; 95% CI: 0.199, 0.795) and the last observed HCC case in a patient with cirrhosis was reported around week 192 (SIR, 0.51; 95% CI: 0.231, 1.144).
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.