5-year efficacy of entecavir in Indian patients with chronic hepatitis B

Entecavir, a drug with high potency and genetic barrier against hepatitis B virus, was believed to become very effective in reducing the hepatitis B burden in India. Long-term studies on its treatment outcome are scarce.

One hundred and six chronic hepatitis B (CHB) patients (17 cirrhotics of Child class A/B) who received entecavir therapy (0.5/1 mg/day) in a prospective open-label study from January 2010 to September 2015 were included in the analysis. Strict drug compliance was ensured. At least 1-year follow up was mandatory. Patients were followed up for HBV DNA negativity, e antigen seroconversion and hepatic events. Subgroup analysis for HBV DNA negativity was done for age (below and above 60 years), sex, HBV DNA level, e antigen status, cirrhosis and prior other modes of therapy.

One (0.94 %) patient had primary drug resistance. Mean follow up was 2.5 (1 to 5) years. Overall HBV DNA negativity was 89 % to 98 % at 1 to 5 years and e antigen seroconversion rate 18.2 % at 5 years. ALT normalization paralleled HBV DNA negativity. No flare, decompensation, hepatocellular cancer or adverse reaction to drug was observed. Most achieved HBV DNA negativity after 6 months of therapy with lower response in those with high HBV DNA level, cirrhosis and prior therapy at baseline but only up to 1 year. Relapse was universal after stoppage of therapy. None lost HBsAg.

Entecavir will need to be continued indefinitely in Indian patients with CHB.