Patients with decompensated cirrhosis who did not achieve virologic response with entecavir treatment were still at risk for hepatocellular carcinoma, compared with compensated patients, according to data from a new study.
Researchers studied 306 patients (mean age, 49.4 years; 68.3% men) with chronic hepatitis B and cirrhosis between December 2006 and September 2011. Each patient was assigned 0.5 mg entecavir (ETV) every 3 to 6 months for at least 12 months at a South Korean hospital. Median follow-up was 37 months.
Compensated cirrhosis was diagnosed in 68.3% of patients, 31.7% had decompensated cirrhosis, and 17% previously had received antiviral treatment before ETV.
Multivariate subgroup analyses revealed that patients with decompensated cirrhosis who did not experience virologic response (VR) at 12 months were at significant risk for hepatocellular carcinoma (HCC; HR=7.74; 95% CI, 1.34-44.78); compensated cirrhosis patients were not (HR=1.17; 95% CI, 0.44-3.13). Overall, 45 patients developed HCC during therapy, and 26.8% developed it over 5 years.
Univariate analysis showed that decompensated cirrhosis, increased baseline serum HBV DNA concentration, increased serum procollagen III N-terminal peptide (PIIINP) level and lack of VR at 12 months were predictive factors for developing HCC. Multivariate Cox regression analysis showed patients aged older than 50 years, male sex and high serum PIIINP concentration at 12 months also were independent risk factors for developing HCC.
“Administration of ETV did not entirely eliminate the risk of developing HCC in the patients with cirrhosis,” the researchers wrote. “Strict surveillance for HCC development is warranted for patients with liver cirrhosis, particularly for men greater than 50 years of age, even if they receive potent antiviral treatment. A roadmap strategy should be adopted for the achievement of VR in patients with decompensated cirrhosis.”
Disclosure: The researchers report no relevant financial disclosures.