Therapy with entecavir reduced the risk for hepatic events, hepatocellular carcinoma and mortality among patients with chronic hepatitis B and cirrhosis in a recent study.
Researchers evaluated outcomes in a cohort of 1,446 patients with chronic hepatitis B treated with 0.5 mg entecavir daily for 12 months or more between December 2005 and June 2012, along with a historical control cohort of 424 treatment-naive patients who received standard care. Cirrhosis was present in 482 treated and 69 control group patients. Follow-up occurred every 3 to 6 months for a mean of 36 months and 114 months in the treated and control groups, respectively.
Among treated patients, hepatic events occurred in 130 cases, and 38 patients died during follow-up, including 22 because of liver-related causes. Eighty-nine controls experienced hepatic events, with 60 deaths, 33 were liver related. Overall, no statistically significant differences were observed between groups regarding any hepatic event incidence or all-cause or liver-related mortality. Treated patients with cirrhosis had a lower 5-year cumulative probability of hepatic events compared with cirrhotic controls (25.5% vs. 45.8%; P=.001).
After adjustment for MELD score, treated patients with cirrhosis had a reduced risk for evaluated outcomes compared with cirrhotic controls, including all-cause (HR=0.34; 95% CI, 0.18-0.62) and liver-related mortality (HR=0.26; 95% CI, 0.13-0.55), hepatocellular carcinoma (HR=0.55; 95% CI, 0.31-0.99) and hepatic events (HR=0.51; 95% CI, 0.34-0.78). Treated patients with cirrhosis who did not achieve undetectable levels of HBV DNA (22% of cases) following treatment faced similar risk for hepatic events, HCC and all-cause and liver-related mortality as cirrhotic controls.
“This was one of the first large-scale, real-life cohort studies demonstrating the efficacy of entecavir therapy in reducing various complications of chronic hepatitis B,” the researchers wrote. “Patients of more advanced liver disease [who] can achieve maintained viral suppression benefit most from this antiviral therapy. Our results have provided important evidence to support the current recommendation of entecavir being one of the first-line antiviral therapies for CHB patients.”
Disclosure: See the study for a full list of relevant disclosures.