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Entecavir reduced hepatocellular carcinoma incidence among patients with chronic HBV

Patients with chronic HBV treated with long-term entecavir developed hepatocellular carcinoma significantly less frequently than untreated controls in a recent study.

Researchers evaluated incidence rates of hepatocellular carcinoma (HCC) in patients with hepatitis B, including 472 treated with entecavir (ETV) and 1,143 controls. Follow-up analysis was conducted every 1 to 3 months until HCC diagnosis or study completion. Mean follow-up was 3.2 years in the ETV group and 9.5 years for controls. Patients’ risk for HCC was measured according to three risk scales that included age, sex, cirrhosis and levels of ALT, albumin, bilirubin, HBV DNA and HBeAg.

HCC developed in 2.54% of ETV recipients and 12.6% of controls through follow-up, with incidence rates of 76 per 10,000 patient years and 116 per 10,000 patient years for ETV and controls, respectively. Demographic differences observed between groups prompted investigators to establish cohort subgroups of 316 participants via propensity score matching. The 5-year HCC incidence rates within these subgroups were 3.7% and 13.7% for ETV recipients and controls, respectively (P<.001).

Based on the risk score scales, patients at greater risk for HCC experienced the greatest risk reduction (P<.001 for high risk, P=.062 for medium risk). Multivariate analysis showed a significant association between entecavir use and reduced risk for HCC (adjusted HR=0.37; 95% CI, 0.15-0.91). Factors associated with increased HCC risk were advanced age (aHR=1.06; 95% CI, 1.03-1.09 per year), alcohol consumption more than 200 kg over 5 years (aHR=2.21; 95% CI, 1.18-4.16), pre-existing cirrhosis (aHR=4.28; 95%CI, 1.88-9.73), HBeAg positivity (aHR=2.26; 95% CI, 1.18-4.34) and a platelet count less than 1.5 x 105/mm3 (aHR=5.64; 95% CI, 2.13-15.0).

“Most studies [that] have examined the relationship between antiviral treatment and the risks of HCC involved older drugs, lacked a control group or were of relatively short duration,” the researchers wrote. “Our study suggests that long-term ETV therapy would significantly suppress the development of HCC in HBV-infected patients when compared with HBV-infected patients in the control group.”

Disclosure: Researcher Hiromitsu Kumada has received speaker’s honoraria from Bristol Myers Squibb.