Long-term entecavir therapy of chronic hepatitis B in real-life setting-Importance of quantitative HBsAg level.

BACKGROUND: The global burden of chronic hepatitis B remains high and the best possible treatment remains long-term viral suppression expecting cure.

METHODS: Total 154 patients of chronic hepatitis B (48 HBeAg positive, e + ve) treated with oral entecavir (0.5 mg/1 mg per day) were recruited from June 2007 and followed prospectively until December 2022 for persistent HBV DNA negativity, HBeAg and HBsAg loss/seroconversion and other liver and drug-related events in real-life settings.

RESULTS: The mean duration of therapy was 6.78 (2-14) years with 1364 person-years of follow-up. All patients were HBV DNA negative by 15 months and remained so until the last follow-up. As many as 16.7% lost HBeAg after eight to 13 years of therapy, but not HBsAg. The mean fall in serum HBsAg level per year was 0.158 log IU/mL, being significantly higher in e + ve patients at baseline and until two years of therapy. The decline was significant until six years in e + ve patients compared to two years in e - ve ones. None had biochemical or virological breakthrough (except eight defaulters), flares or any untoward effects. The incidence of liver-related events, hepatocellular carcinoma and death was 10.4%, 1.9% and 14.3%, respectively, and 5.2% deaths were liver-related whose predictors were presence of cirrhosis (log rank 46.5, p > 0.001) and higher HBsAg level > 4 log IU/mL (log rank 18.15, p < 0.001) at baseline.

CONCLUSION: Long-term entecavir therapy provides additional benefits of continuous reduction of serum HBsAg levels beyond suppression of HBV DNA.