Patients with hepatitis B virus infection treated with entecavir monotherapy remained at risk for developing hepatocellular carcinoma, according to study results.
Patients treated with entecavir (ETV; n=744) were recruited from 11 European centers in the Vigilance against Viral Resistance network. All patients had been positive for hepatitis B virus (HBV) for at least 6 months and had been treated with ETV for at least 3 months between 2005 and May 2013. The majority of patients were Caucasian (42%) and Asian (29%).
Fourteen patients developed hepatocellular carcinoma (HCC), including nine with cirrhosis at baseline, during a median follow-up of 167 weeks. Patients with cirrhosis had a greater cumulative 5-year incidence rate of HCC compared with noncirrhotic patients (10.9% vs. 2.1%, P<.001). The HCC incidence rate also was greater among older patients (P<.001).
Virologic response (VR) occurred in 655 patients with HBV DNA levels below 80 IU/mL; 12 patients with HCC achieved VR before their diagnosis. The cumulative probabilities of achieving VR over 6 months, 1, 2, 3, 4 and 5 years were 53%, 76%, 90%, 94%, 97% and 99%, respectively.
Greater HCC risk scores were associated with developing HCC at baseline when age, sex and cirrhosis and albumin, bilirubin and HBV DNA levels were included. Predicted risk for HCC based on those scores, however, decreased during therapy (P<.001). Discriminatory performance of risk scores was limited, especially in Caucasian patients, at baseline and throughout treatment.
“We showed that continuous ETV therapy effectively suppresses HBV DNA in the vast majority of patients,” the researchers wrote. “While the risk of HCC in ETV-treated patients is low through up to 5 years of treatment, ETV therapy does not eliminate the risk of HCC. Screening of risk groups, therefore, remains necessary despite successful ETV therapy, at least during the first years of treatment.”
Disclosure: See the study for a full list of relevant financial disclosures.